Heart valve positioning device, heart valve replacement assembly and implantation method

Abstract

The application provides a heart valve positioning device, which comprises a first curved structure, a second curved structure, and a third curved structure. The first curved structure forms a spiral curved structure with a first size in a released state. The second curved structure forms a spiral curved structure with a second size in a released state, and the second size is greater than the first size. The second curved structure has a hollow first cavity for the first curved structure to pass through, forming the third curved structure. The distal end of the third curved structure is a free end, and the proximal end is connected with a delivery system. The third curved structure forms a spiral curved structure with a third size in a released state, and the first size is less than the third size and less than or equal to the second size. The embodiment of the application can reduce left ventricular outflow tract obstruction caused by large-scale movement of the anterior leaflet.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a heart valve positioning device, a heart valve replacement assembly, and an implantation method. Background Technology

[0002] The mitral and tricuspid valves have complex structures, consisting of annulus, leaflets, chordae tendineae, and papillary muscles. Organic or functional changes in any of these components can lead to mitral or tricuspid regurgitation, meaning that the valves fail to close completely during cardiac systole, causing blood to flow backward into the left ventricle. Treatment for mitral and tricuspid regurgitation includes valve repair and replacement. Valve repair is a common first-line treatment, but valve replacement is the ultimate and fundamental solution.

[0003] Valve replacement can be performed surgically or via transcatheter intervention. For some patients with mitral regurgitation who are not suitable for surgery due to high-risk factors such as poor cardiac function, multiple comorbidities, or advanced age, transcatheter intervention can be considered. While various structural designs and delivery methods for transcatheter mitral valves have emerged in recent years, most are still in the research stage, mainly due to the following limitations: The mitral valve has a complex structure; compared to the aortic valve, its overall structure is D-shaped, with a larger annulus and less calcification, which cannot provide sufficient support for the artificial valve to fix it at the diseased mitral valve site. Anatomically, the left ventricular outflow end is adjacent to the anterior leaflet of the mitral valve; implantation of the artificial mitral valve may also cause left ventricular outflow end obstruction (LVOTO). The larger annulus of the mitral valve necessitates a larger diameter stent for the artificial valve, requiring a larger leaflet area, which reduces leaflet fatigue resistance and increases the size of the delivery device, thereby increasing the risk of vascular complications.

[0004] The tricuspid valve, as the atrioventricular valve of the right heart, has a similar structure to the atrioventricular valve (mitral valve) of the left heart. The same design principle used in mitral valve replacement can be applied to tricuspid valve replacement.

[0005] Therefore, there is an urgent need for an artificial valve system that can reduce the size of the artificial valve delivery system, facilitate the replacement of the mitral or tricuspid valve, and prevent left ventricular outflow tract obstruction. Summary of the Invention

[0006] In view of the above problems, this application provides a heart valve positioning device, a heart valve replacement assembly, and an implantation method to overcome or at least partially solve the above problems.

[0007] This application provides a cardiac valve positioning device connected to a delivery system. When in a delivery state, the device is delivered to the heart via the delivery system, and when in a release state, it is released between the original valve leaflets. The positioning device includes: a first curved structure, which in the release state forms a helical curved structure with a first size; a second curved structure, which in the release state forms a helical curved structure with a second size, the second size being greater than the first size. The second curved structure has a hollow first cavity for the first curved structure to pass through, forming a third curved structure; the distal end of the third curved structure is a self- The third curved structure is connected to the delivery system from the distal end to the proximal end. In the released state, the third curved structure forms a spiral curved structure with a third dimension, wherein the first dimension < the third dimension ≤ the second dimension. When in the delivery state, the third curved structure is placed in the delivery system in an extended state. When in the release state, the third curved structure is gradually released from the distal end to the proximal end and enters the outer surface from the inner surface of the original leaflet through the anterior and posterior junction of the original leaflet. It captures the original leaflet in a spiral shape with the third dimension. Then, the second curved structure separates from the first curved structure and is withdrawn with the delivery system, leaving the first curved structure with the first dimension at the original valve.

[0008] Optionally, the first bending structure includes a plurality of first coils, and the second bending structure includes a plurality of second coils.

[0009] Optionally, the stiffness of the second bending structure is greater than that of the first bending structure.

[0010] Optionally, in the released state, the configuration of the second bending structure may be the same as or different from the configuration of the first bending structure.

[0011] Optionally, the diameter of the first coil located at the distal end is greater than or equal to the diameter of the first coil located at the non-distal end.

[0012] Optionally, the diameters of the plurality of first coils in the first curved structure decrease sequentially from the proximal end to the distal end.

[0013] Optionally, the first curved structure has a first spacing between adjacent first coils, and the first spacing is the maximum spacing between adjacent first coils; the second curved structure has a second spacing between adjacent second coils, and the second spacing is the minimum spacing between adjacent second coils, wherein the second spacing is greater than or equal to the first spacing.

[0014] Optionally, after the third curved structure captures the original leaflet in a spiral shape, at least a portion of the first coil and the second coil are distributed on the inner surface of the original leaflet.

[0015] Optionally, the first curved structure is provided with an arc-shaped extension, one end of which is detachably connected to the conveying system, and the other end is fixedly connected to the first coil located at the proximal end. In the released state, the diameter of the arc-shaped extension is larger than the diameter of the first coil.

[0016] Optionally, the second bending structure includes multiple bending portions with different stiffnesses, such that when in the released state, the second bending structure forms at least two second coils with different diameters.

[0017] Optionally, the inner side of the second coil of the second curved structure is formed with a plurality of slits, and the opposite two sides of the slits are respectively formed with protrusions and grooves that match each other in shape. When the second coil of the second curved structure is bent, the protrusions and the grooves abut against each other to form a second dimension.

[0018] Optionally, the height of the slit extending along the radial direction of the second coil is less than or equal to 60% of the outer diameter circumference of the second coil.

[0019] Optionally, the first curved structure is slidably inserted into the second curved structure.

[0020] Optionally, the distal end of the first curved structure is provided with a protective member having a smooth surface.

[0021] Optionally, at least one of the first and second curved structures has a passive locking member at its proximal end for locking connection with the conveying system.

[0022] An embodiment of this application also provides a heart valve replacement assembly, the assembly including: the heart valve positioning device described above; an artificial valve including: an artificial leaflet; and a cylindrical support unit, the artificial leaflet being circumferentially fixed to the inner side of the support unit, and the support unit being adapted to the first curved structure so that when the second curved structure is disengaged from the first curved structure, the artificial valve is implanted into the inner side of the first curved structure.

[0023] Optionally, the component also includes a conveying system provided with an active locking element to lock or release from the passive locking element.

[0024] An embodiment of this application also provides a method for locating a heart valve, the method comprising: placing the third curved structure of the aforementioned heart valve locating device in an extended state in the delivery system; after being delivered to the vicinity of the native leaflet by the delivery system, the third curved structure is gradually released from the distal end to the proximal end, and enters the outer surface from the inner surface of the native leaflet through the anterior-posterior junction of the native leaflet, thereby spirally capturing the native leaflet; thereafter, the second curved structure disengages from the first curved structure, and the second curved structure is withdrawn with the delivery system.

[0025] One embodiment of this application discloses a method for heart valve replacement. The method includes: placing the third curved structure of the aforementioned heart valve positioning device in an extended state in the delivery system; after being delivered to the vicinity of the original leaflet by the delivery system, the third curved structure is gradually released from the distal end to the proximal end and enters the outer surface from the inner surface of the original leaflet through the anterior-posterior commissure of the original leaflet, thereby spirally capturing the original leaflet; then, the second curved structure detaches from the first curved structure and is withdrawn with the delivery system; an artificial valve is implanted, and the artificial valve is implanted inside the first curved structure.

[0026] As can be seen from the above technical solutions, the positioning device of this application captures the native leaflet with a larger third diameter and then withdraws the second curved structure, leaving the first curved structure at the native leaflet, providing anchoring support for the native valve of the heart with the first size. Since the mitral valve annulus accompanied by regurgitation is larger, the distance between the anterior and posterior leaflets during diastole increases. If the diameter of the positioning device is too small (for example, if the positioning device only uses a smaller diameter first curved structure), the distal end of the positioning device can easily enter the inner surface of the leaflet when passing the anterior and posterior commissure of the valve during release, leading to failure in capturing the native leaflet. Therefore, delivering with a larger third diameter allows for better capture of the native leaflet. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings.

[0028] Figure 1A It is an anatomical diagram of the heart structure;

[0029] Figure 1B This is a schematic diagram of an embodiment of a positioning device according to this application;

[0030] Figure 2A-2H This is a schematic diagram of several embodiments of a first bending structure of a positioning device according to this application;

[0031] Figure 2I It is Figure 2A A cross-sectional view of the embodiment shown after the second bending structure has been removed following the release of the first bending structure.

[0032] Figure 2J Is Figure 2I A schematic diagram of an embodiment of releasing an artificial valve based on [the above].

[0033] Figure 3AThis is a schematic diagram of an embodiment of a first bending structure of a positioning device according to this application;

[0034] Figure 3B It is Figure 3A A cross-sectional view of the embodiment of the first curved structure after the second curved structure has been removed;

[0035] Figure 4A This is a schematic diagram of another embodiment of the first bending structure of a positioning device according to this application;

[0036] Figure 4B It is Figure 4A A cross-sectional view of the embodiment of the first curved structure after the second curved structure has been removed;

[0037] Figure 5 This is a schematic diagram of an embodiment of a second curved structure in which multiple slits are formed on the inner side of the second coil;

[0038] Figure 6A yes Figure 5 A schematic diagram of the slit state when the second coil of the second curved structure is not bent;

[0039] Figure 6B yes Figure 5 A schematic diagram showing the state of the slit when the second coil of the second bending structure is bent.

[0040] Figure 7A This is a schematic diagram of an embodiment of the third bending structure of this application during in vivo release;

[0041] Figure 7B This application provides a schematic diagram of an embodiment of a third bending structure after partial ventricular release;

[0042] Figure 7C This application provides a schematic diagram of an embodiment of a second bending structure after removal.

[0043] Component designation

[0044] 10: Positioning device; C2: Anterior and posterior junction of the original leaflet; 101: First curved structure; 102: Second curved structure; 103: Third curved structure; 112: First coil; 112-1: Proximal first coil; 112-2: Distal first coil; 113: Second coil; W: First spacing; N: Second spacing; 122: Arc-shaped extension; 123: Slit; 123a: Protrusion; 123b: Groove; H: Height of the second coil in the radial direction; 131: Protective component; 141: Passive locking component; 20: Delivery system; 201: First delivery device; 202: Second delivery device; 30: Artificial valve; 301: Support unit. Detailed Implementation

[0045] To enable those skilled in the art to better understand the technical solutions in the embodiments of this application, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art should fall within the protection scope of the embodiments of this application.

[0046] The term "proximal" refers to the end of the artificial valve assembly closest to the atrium or ventricle when the heart valve positioning device is implanted in the heart. The term "distal" refers to the end of the artificial valve assembly furthest from the atrium or ventricle when the artificial valve assembly is implanted in the heart.

[0047] "Inflow end" and "outflow end" refer to the direction of blood flow from the atria into the ventricles via the heart valves.

[0048] The artificial valve assembly of this application is suitable for at least partially replacing the native mitral or tricuspid valve of the human heart. The embodiments of this application will be described using the mitral valve as an example.

[0049] like Figure 1A As shown, the mitral valve, also known as the left atrioventricular valve, is a barrier formed between the left ventricle and left atrium. Normally, the opening and closing of the mitral valve is regulated by the pressure difference between the left atrium and left ventricle. During diastole, the pressure in the left atrium is greater than that in the left ventricle, and the mitral valve opens; conversely, during systole, the pressure in the left ventricle is greater than that in the left atrium, and the mitral valve closes. Compared to the aortic valve, the mitral valve has a D-shaped overall structure, a larger annulus, and less calcification. If an artificial valve is implanted, the native mitral valve cannot provide sufficient support for the artificial valve, causing it to become fixed at the diseased mitral valve site. Furthermore, since the left ventricular outflow tract is adjacent to the anterior leaflet of the mitral valve, the implantation of an artificial valve may also cause left ventricular outflow tract obstruction (LVOTO).

[0050] The specific implementation of the embodiments of this application will be further described below with reference to the accompanying drawings.

[0051] See Figures 1B to 7C In one specific implementation of this application, a heart valve positioning device 10 is provided, which is connected to a delivery system 20 for delivering the positioning device 10 to the heart via the delivery system 20 when in a delivery state. The delivery system 20 may be a delivery system including a sheath, in which the positioning device 10 is placed in the sheath and delivered to the heart valve via a human catheter, such as a blood vessel, for release. When in a release state, the positioning device 10 is released between the original valve leaflets.

[0052] The positioning device 10 includes: a first bending structure 101, which forms a spiral bending structure with a first dimension in the released state; a second bending structure 102, which forms a spiral bending structure with a second dimension in the released state, the second dimension being greater than the first dimension; the second bending structure 102 has a hollow first cavity for the first bending structure 101 to pass through, forming a third bending structure 103; the distal end of the third bending structure 103 is a free end, and the proximal end is connected to the conveying system 20; the third bending structure 103 forms a spiral bending structure with a third dimension in the released state. A spiral bending structure, wherein a first dimension < a third dimension ≤ a second dimension; when in the conveying state, the third bending structure 103 is placed in the conveying system 20 in an extended state; when in the release state, the third bending structure 103 is gradually released from the distal end to the proximal end, and enters the outer surface from the inner surface of the original leaflet through the anterior-posterior junction of the original leaflet, thereby capturing the original leaflet in a spiral shape with the third dimension. Then, the second bending structure 102 detaches from the first bending structure 101 and is withdrawn with the conveying system 20, leaving the first bending structure with the first dimension at the original valve. The first bending structure 101 is slidably inserted into the second bending structure 102. The first bending structure 101 and the second bending structure 102 can be made of memory material to pre-set their respective dimensions and shapes in the release state. The stiffness of the second bending structure 102 can be greater than or less than the stiffness of the first bending structure 101. For example, when the second bending structure 102 is pre-set to a second size, that is, when it is at the second size in the released state, the stiffness of the second bending structure 102 can be greater than the stiffness of the first bending structure 101; when the second bending structure 102 cannot be pre-set to a second size, that is, when its size in the released state does not reach the second size and external force is needed to reach the second size (e.g.) Figure 5 In the embodiment shown, the stiffness of the second bending structure 102 can be less than the stiffness of the first bending structure 101. Therefore, the shape of the third bending structure is primarily determined by the second bending structure 102, and in the released state, the configuration of the second bending structure 102 can be the same as or different from the configuration of the first bending structure 101.

[0053] When the positioning device 10 is released, the first curved structure 101 passes through the first cavity of the curved structure to form a third curved structure 103, and is released with a third diameter. The end of the positioning device 10 away from the delivery system 20 passes through the anterior and posterior commissure of the valve C2 and is in contact with the outer surface of the original leaflet (i.e., the side facing the ventricular wall). As the third curved structure 103 is released, the distal end of the third curved structure 103 moves around the outer surface of the original leaflet, encircling the original leaflet within the third curved structure 103. Since the mitral valve annulus with regurgitation is large, the distance between the anterior and posterior leaflets during diastole increases. If the diameter of the positioning device 10 is too small (for example, the positioning device 10 only uses the first curved structure 101 with a smaller diameter), the distal end of the positioning device 10 can easily enter the inner surface of the leaflet when it passes through the anterior and posterior commissure of the valve during the release process, resulting in failure to capture the original leaflet. Therefore, when delivered with a larger third diameter, it can be ensured that the original leaflet is completely captured.

[0054] After the positioning device 10 captures the native leaflet with a larger third diameter, the second curved structure 102 is withdrawn, and the first curved structure 101 remains at the native leaflet, providing anchoring support for the native valve of the heart with a first size. The portion of the first curved structure 101 in the ventricle captures the native leaflet inside the first curved structure 101, which restricts the movement of the native leaflet to a certain extent. This can prevent the left ventricular outflow tract obstruction caused by large-scale movement of the anterior leaflet. At the same time, the native leaflet can still maintain a certain degree of opening and closing, and will not cause acute severe regurgitation. Before the artificial valve is implanted, it can also maintain normal leaflet function and has little impact on the human circulatory system.

[0055] One embodiment of this application also provides an artificial valve 30 for use with a positioning device 10, comprising: an artificial leaflet; and a cylindrical support unit 301. The artificial leaflet is circumferentially fixed to the inner side of the support unit 301, and the support unit 301 is adapted to a first bending structure 101 so that when the second bending structure 102 disengages from the first bending structure 101, the artificial valve 30 is placed inside the first bending structure 101 to hold the original leaflet between the cylindrical support unit 301 and the positioning device 10. The cylindrical support unit 301 can be cylindrical, conical, or other non-cylindrical. The inner dimensions and diameter of the first coil match the outer side of the cylindrical support unit 301 (e.g., the inner diameter of the first coil matches the outer diameter of the cylindrical support unit 301). The artificial valve 30 is anchored to the original leaflet by radial interference fit and friction with the positioning device 10, replacing the function of the original leaflet. In addition, after the second coil 113 is withdrawn, the first coil has returned to the first size (the first size is smaller than the diameter of the original valve annulus). Then, the appropriate artificial valve 30 is delivered and released into the interior of the first coil, realizing the stepwise delivery of the positioning device 10 and the artificial valve 30. This can reduce the size of the delivery system 20 (e.g., the size of the sheath) and reduce the risk of vascular complications.

[0056] Please refer to Figures 3A to 4B In one embodiment of this application, the first curved structure 101 may include a plurality of first coils, and the second curved structure 102 may include a plurality of second coils 113. Adjacent first coils or adjacent second coils 113 may be interconnected to form a spiral structure or other shapes. The configuration of the second curved structure 102 may be the same as or different from that of the first curved structure 101. Figure 3A As shown, in an optional embodiment, the plurality of first coils of the first bent structure 101 have the same diameter, while the plurality of second coils 113 of the second bent structure 102 used in conjunction with the first bent structure 101 may have the same or different diameters. Figure 4AAs shown, in another optional embodiment, the diameters of the plurality of first coils of the first curved structure 101 decrease sequentially from proximal to distal, i.e., the inflow diameter is larger than the outflow diameter, forming a structure similar to an inverted cone. The diameters of the plurality of second coils 113 of the matching second curved structure 102 can decrease sequentially from proximal to distal or be presented in other ways, such as all second coils 113 having the same diameter. This can be matched with the inverted cone-shaped cylindrical support unit 301, making it less likely to detach into the ventricle under the pressure of the atrium. The first coils of the first curved structure 101 can be composed of solid filament or hollow tubes with a certain outer diameter. The cross-section of the first coil can be elliptical, rectangular, circular, or any other suitable shape. It should be noted that the diameter of the second coil 113 does not necessarily correspond exactly to that of the first coil 112. Even if the shape of the first coil 112 is different, since the stiffness of the second coil 113 is greater than that of the first coil 112, when the first coil 112 is placed in the second coil 113 to assemble into the third bending structure 103, the first coil 112 is still constrained by the second coil 113, so that the shape of the third bending structure 103 is close to the shape of the second coil 113.

[0057] It should be noted that, in the embodiments of this application, "second dimension" and "first dimension" refer to the dimensions of the second curved structure 102 and the first curved structure 101 after they are released independently, that is, the dimensions of the second curved structure 102 and the first curved structure 101 after they are released when the first curved structure 101 is not inserted into the first cavity of the second curved structure 102. "Third dimension" refers to the dimensions of the third curved structure 103 formed by the first curved structure 101 being inserted into the first cavity of the second curved structure 102 after it is released.

[0058] Furthermore, the "first dimension," "second dimension," and "third dimension" refer to the dimensions formed in space after the first bending structure 101, the second bending structure 102, and the third bending structure 103 are released. When comparing the dimensions, for example, second dimension > first dimension and first dimension < third dimension ≤ second dimension means comparing the diameters of the corresponding parts or coils of the first bending structure 101, the second bending structure 102, and the third bending structure 103 to be compared. For example, in one embodiment, second dimension > first dimension means comparing the diameter of each second coil 113 of the second bending structure 102 from the distal end to the proximal end with the diameter of each first coil 112 of the first bending structure 101 from the distal end to the proximal end, and the comparison result is greater than.

[0059] When all the second coils 113 and the first coil 112 are of equal diameter, "second dimension," "first dimension," and "third dimension" refer to the diameters of the second coil 113, the first coil 112, and the coil of the third curved structure 103, respectively. When one or all of the second coils 113 and the first coil 112 are not of equal diameter, "second dimension," "first dimension," and "third dimension" refer to the dimensions measured at corresponding parts of the coils of the second coil 113, the first coil 112, and the third curved structure 103 using the same standard. For example, when the coils at the far ends of the second coil 113 and the first coil 112 are arc-shaped, while the other coils are circles of equal diameter (as shown in Figure 1), "second dimension" and "first dimension" include both the dimensions of the far-end coils and the dimensions of the other coils. The dimension of the far-end coil can be the radius of the arc of the coil, and the dimensions of the other coils can be the diameter of the coil.

[0060] Because the stiffness of the second bending structure 102 is greater than that of the first bending structure 101, the shape of the first bending structure 101 may be the same as or different from that of the second bending structure 102. After the second bending structure 102 and the first bending structure 101 are assembled into the third bending structure 103, the first bending structure 101 will tend to form a shape close to that of the second bending structure 102. For example, when the first bending structure 101 includes a plurality of first coils 112 of equal diameter, the second bending structure 102 may include a plurality of second coils 113 of different diameters; when the first bending structure 101 includes a plurality of first coils 112 of decreasing diameter to form a cone shape, the second bending structure 102 may include a plurality of second coils 113 of equal diameter.

[0061] As shown in Figure 1, in one embodiment of this application, the diameter of the distal first coil 112-2 is larger than the diameter of the other non-distal first coils 112. Correspondingly, the diameter of the distal second coil 113 is larger than the diameter of the other non-distal second coils 113, to facilitate the capture of the original leaflets. The stiffness of the material of the distal first coil 112 or the distal second coil 113 can be greater than the stiffness of the material of the other first coils 112 or the distal second coil 113, or a first bending structure 101 or a second bending structure 102 can be made with the same material, and the diameter of the distal first coil 112 or the distal second coil 113 can be processed to be larger than the diameter of the other first coils 112 or the distal second coil 113. Alternatively, the distal first coil 112 or the distal second coil 113 can be processed separately and then assembled with the other first coils 112 or the distal second coil 113 by riveting, welding, or other means.

[0062] In one embodiment of this application, adjacent first coils 112 of the first curved structure 101 have a first distance W, which is the maximum distance between adjacent first coils 112. The maximum distance refers to the largest distance value among multiple pairs of adjacent first coils 112 of the first curved structure 101 when their distances are different. Adjacent second coils 113 of the second curved structure 102 have a second distance N, which is the minimum distance between adjacent second coils 113. The minimum distance refers to the smallest distance value among multiple pairs of adjacent second coils 113 of the second curved structure 102 when their distances are different, where the second distance N ≥ the first distance W. Therefore, during transport, the distance between adjacent coils of the third curved structure 103 can be close to the distance between adjacent coils of the second curved structure 102. When the second curved structure 102 is detached from the first curved structure 101, the distance between adjacent coils of the first curved structure 101 returns to a smaller distance, so that adjacent coils are less likely to interfere with each other during the capture leaf clamping process.

[0063] In one embodiment of this application, after the third bending structure 103 spirally captures the original leaflet, the second bending structure 102 is withdrawn, leaving the first bending structure 101 at the original leaflet. At least a portion of the first coil 112 of the first bending structure 101 is distributed on the inner surface of the original leaflet, and may be half a coil, two-thirds of a coil, a single coil, or other numbers of coils, such as... Figure 2I , 3B As shown in 4B, the original leaflets are clamped from both the inner and outer surfaces, resulting in a more secure clamping.

[0064] like Figure 2A-2G As shown, in one embodiment of this application, the first curved structure 101 is provided with an arc-shaped extension 122. One end of the arc-shaped extension 122 is detachably connected to the delivery system 20, and the other end is fixedly connected to a first coil 112-1 located near the proximal end of the first curved structure 101. In the released state, the diameter of the arc-shaped extension 122 is larger than the diameter of the first coil 112. After release, the arc-shaped extension 122 and one or more first coils 112 near the proximal end are formed on the inner surface of the original leaflet, located at the valve annulus of the atrium, to increase the fixing force of the first curved structure 101 at the original valve. Correspondingly, the second curved structure 102 is also made with a similar structure to the first curved structure 101 to allow the first curved structure 101 to pass through. Figure 2A-2D The arc-shaped extension 122 can be arc-shaped, wavy, gourd-shaped, barbed, etc., to increase friction. For example... Figure 2E As shown, the arc-shaped extension 122 can be composed of multiple coils connected in a helical structure, and the diameter of these coils can be larger than that of the first coil 112. Figure 2FAs shown, the arcuate extension 122 includes multiple coils, with both ends of the coils connected together. One end is detachably connected to the conveying system 20, and the other end is fixedly connected to the first coil 112-1 located near the first curved structure 101. Figure 2G As shown, the arcuate extension 122 includes multiple coils, one end of which is connected together and the other end is free, thus forming multiple ends, all of which are detachably connected to the conveying system 20. The arcuate extension 122 described above is for illustrative purposes only, and other configurations may also be used for the arcuate extension 122.

[0065] like Figure 5-6B As shown in one embodiment of this application, a plurality of slits 123 are formed on the inner side of the second coil 113 of the second bending structure 102. The opposite sides of the slits 123 are respectively formed with protrusions 123a and grooves 123b of matching shapes. When the second coil 113 of the second bending structure 102 bends, the protrusions 123a and grooves 123b abut against each other, forming a second dimension. The plurality of slits 123 can be equidistantly distributed, so that the second coil 113 has a specified minimum bending curvature to form a second diameter; the plurality of slits 123 on the second coil 113 can also be distributed at different intervals, so that the plurality of second coils 113 have different minimum bending curvatures to form different diameters.

[0066] Optionally, the height H of the slit 123 unfolding along the radial plane of the second coil of the second curved structure 102 is less than or equal to 60% of the outer diameter circumference of the coil of the second curved structure 102.

[0067] like Figure 2A As shown, in one embodiment of this application, the distal end of the first curved structure 101 is provided with a protective member 131. The protective member 131 has a smooth surface and its shape can be a circular protrusion or other suitable shape. The distal end of the second curved structure 102 can be slightly shorter than the distal end of the first curved structure 101 to expose the protective member 131, so as to avoid scratching the original leaflet or other human tissue when the first curved structure 101 and the second curved structure 102 are implanted.

[0068] like Figure 2A As shown, in one embodiment of this application, at least one of the first curved structure 101 and the second curved structure 102 has a passive locking member 141 at its proximal end for locking connection with the conveying system 20. The passive locking member 141 can be a through hole, a blind hole, a groove, etc., and can be part of the first curved structure 101 or the second curved structure 102, or connected to the proximal end of the first curved structure 101 by welding, riveting, or bonding. Correspondingly, the conveying system 20 has an active locking member to lock or release from the passive locking member 141.

[0069] like Figure 2H As shown, in one embodiment of this application, the outer surface of the first curved structure 101 may be covered with a biocompatible polymer coating, which can promote endothelialization.

[0070] The conveying system 20 may include a first conveying device 201 and a second conveying device 202 having a conveying sheath, wherein the diameter of the conveying sheath of the second conveying device 202 is smaller than the diameter of the conveying sheath of the first conveying device 201, so that the conveying sheath of the second conveying device 202 is placed inside the conveying sheath of the first conveying device 201.

[0071] like Figures 7A-7C As shown, one embodiment of this application also provides a method for locating a heart valve. The method includes: placing the third curved structure 103 of the heart valve locating device 10 in an extended state in a delivery system 20; first, passing the first delivery device 201 through the interatrial septum; then, through the passage established by the first delivery device 201, delivering the distal end of the second delivery device 202 to the anterior-posterior commissure C2 of the original leaflet; the locating device 10 is delivered to the anterior-posterior commissure C2 of the original leaflet through the second delivery device 202; when the locating device 10 is released, the third curved structure 103 is gradually released from the distal end to the proximal end, and first passes through the anterior-posterior commissure C2 of the original leaflet, entering the outer surface from the inner surface of the original leaflet through the anterior-posterior commissure of the original leaflet; as the third curved structure 103 is released with a third diameter, the coil of the third curved structure 103 spirally captures the original leaflet from the distal end to the proximal end, capturing it into the coil formed by the third curved structure 103. After the third bending structure 103 is fully released, the second bending structure 102 is withdrawn from the distal end to the proximal end to the junction C2. The first bending structure 101 is also gradually released, and its diameter returns to the first dimension. At the same time, the spacing between adjacent first coils 112 of the first bending structure 101 is reduced. Then, the second bending structure 102 and the second conveying device 202 are withdrawn together into the first conveying device 201. The first coil 112 and the arcuate extension 122 at the proximal end of the first bending structure 101 are released. Then, the passive locking member 141 of the first bending structure 101 is disengaged from the active locking member on the first conveying device 201 or the second conveying device 202, completing the release of the first bending structure 101.

[0072] like Figure 7CAs shown, when the second bending structure 102 is completely removed, the first bending structure 101 remains in the body. The connection between the atrial and ventricular portions of the first bending structure 101 is radiopaque. This radiopaqueness can be achieved through the material properties of the structure itself or by adding radiopaque structures (such as radiopaque rings, radiopaque wires, radiopaque films, etc.). During release, the connection is positioned near the anterior-posterior commissure C2 of the original leaflet. The atrial portion extends from the connection to the left atrium, and the ventricular portion extends a semi-circle along the inner surface of the original leaflet from the connection, clamping the leaflet between the adjacent coil located on the outer surface of the original leaflet and preventing the first bending structure 101 from slipping off the leaflet. Figure 2F As can be seen, the first coil 112 located on the outer surface of the leaflet encircles the front and rear leaflets into the first curved structure 101, so that the leaflets can open and close freely while preventing the front leaflet from blocking the left ventricular outflow tract. The first coil 112 at the inflow end is located on the inner surface of the valve, and the remaining first coils 112 are located on the outer surface of the leaflet.

[0073] Another embodiment of this application also provides a method for heart valve replacement, the method comprising implanting an artificial valve 30 thereafter, and implanting the artificial valve 30 inside a first curved structure 101.

[0074] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them; although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A heart valve positioning device, connected to a delivery system, for delivering the positioning device to the heart via the delivery system when in a delivery state, and for releasing the positioning device between the original valve leaflets when in a release state, characterized in that, The positioning device includes: The first bending structure, in the released state, forms a spiral bending structure with a first dimension; The second bending structure, in the released state, forms a spiral bending structure with a second dimension, the second dimension being greater than the first dimension. The second bending structure has a hollow first cavity for the first bending structure to pass through, forming a third bending structure. The distal end of the third curved structure is a free end, and the proximal end is connected to the conveying system. In the released state, the third curved structure forms a spiral curved structure with a third dimension, wherein the first dimension < the third dimension ≤ the second dimension. When in the delivery state, the third curved structure is placed in the delivery system in an extended state. When in the release state, the third curved structure is gradually released from the distal end to the proximal end and enters the outer surface from the inner surface of the original leaflet through the anterior and posterior junction of the original leaflet, and captures the original leaflet in a spiral shape with a third dimension. Then, the second curved structure separates from the first curved structure and is withdrawn with the delivery system, leaving the first curved structure at the original valve with a first dimension. The first curved structure includes multiple first coils, and the second curved structure includes multiple second coils. Multiple slits are formed on the inner side of the second coils of the second curved structure. The opposite two sides of the slits form protrusions and grooves with matching shapes. When the second coil of the second curved structure bends, the protrusions abut against the grooves to form a second dimension.

2. The heart valve positioning device according to claim 1, characterized in that, The stiffness of the second bending structure is greater than that of the first bending structure.

3. The heart valve positioning device according to claim 1, characterized in that, The height of the slit extending along the radial direction of the second coil is less than or equal to 60% of the outer diameter circumference of the second coil.

4. The heart valve positioning device according to claim 1, characterized in that, In the released state, the configuration of the second bending structure may be the same as or different from that of the first bending structure.

5. The heart valve positioning device according to claim 4, characterized in that, The diameter of the first coil located at the far end is greater than or equal to the diameter of the first coil not located at the far end.

6. The heart valve positioning device according to claim 4, characterized in that, The diameters of the multiple first coils in the first curved structure decrease sequentially from the proximal end to the distal end.

7. The heart valve positioning device according to claim 1, characterized in that, The first curved structure has a first spacing between adjacent first coils, and the first spacing is the maximum spacing between adjacent first coils. The second curved structure has a second spacing between adjacent second coils, and the second spacing is the minimum spacing between adjacent second coils, wherein the second spacing is greater than or equal to the first spacing.

8. The heart valve positioning device according to claim 1, characterized in that, After the third curved structure captures the original leaflet in a spiral shape, at least a portion of the first coil and the second coil are distributed on the inner surface of the original leaflet.

9. The heart valve positioning device according to claim 1, characterized in that, The first curved structure has an arc-shaped extension, one end of which is detachably connected to the conveying system, and the other end is fixedly connected to the first coil located at the proximal end. In the released state, the diameter of the arc-shaped extension is larger than the diameter of the first coil.

10. The heart valve positioning device according to claim 1, characterized in that, The second bending structure includes multiple bending sections with different stiffnesses, such that when in the released state, the second bending structure forms at least two second coils with different diameters.

11. The heart valve positioning device according to claim 1, characterized in that, The first curved structure is slidably inserted into the second curved structure.

12. The heart valve positioning device according to claim 1, characterized in that, The distal end of the first curved structure is provided with a protective element having a smooth surface.

13. The heart valve positioning device according to claim 1, characterized in that, At least one of the first and second curved structures has a passive locking element at its proximal end for locking connection with the conveying system.

14. A heart valve replacement assembly, characterized in that, This component includes: The heart valve positioning device according to any one of claims 1 to 13; Artificial valves, including: Artificial leaflets; and A cylindrical support unit is provided, in which the artificial valve leaflet is circumferentially fixed to the inner side of the support unit, and the support unit is adapted to the first curved structure so that when the second curved structure is detached from the first curved structure, the artificial valve is implanted into the inner side of the first curved structure.

15. The replacement component according to claim 14, characterized in that, The component also includes a conveying system equipped with an active locking element to lock or release the passive locking element.

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