Heart valve positioning devices, artificial heart valve systems, implantation systems and methods

Abstract

This application provides a heart valve positioning device, which is delivered to a heart valve via a delivery device. The delivery device includes a guide. The positioning device includes: a support unit comprising a body and a first cavity penetrating the body; the body having a first end and a second end; the support unit bending in a released state so that the first end and the second end approach each other to form an annular structure; a locking unit capable of engaging with the first end and the second end of the support unit, and the locking unit having two through holes for the guide to pass through; and a skirt circumferentially attached to the body, which is contractible or expandable. The heart valve positioning device of this application can prevent the anterior leaflet of the mitral valve from moving into the left ventricular outflow tract, thus avoiding left ventricular outflow tract obstruction.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a heart valve positioning device, an artificial heart valve system, an implantation system, 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 ventricles. 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 or tricuspid regurgitation who are not suitable for surgery due to high-risk factors such as poor cardiac function, multiple comorbidities, or advanced age, transcatheter intervention is a viable option. While various structural designs and delivery methods have emerged for transcatheter mitral valves in recent years, most are still in the research stage, primarily 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 in place at the diseased mitral valve site. Anatomically, the left ventricular outflow tract is adjacent to the anterior leaflet of the mitral valve, and implantation of the artificial mitral valve may cause left ventricular outflow tract obstruction (LVOTO). The valve also contains chordae tendineae and papillary muscles, making its structure complex. Furthermore, the leaflet shape is irregular.

[0004] Current transcatheter mitral valve replacement procedures typically involve transapical and transfemoral approaches. The transfemoral approach includes simple transseptal delivery and a combination of transseptal and transaortic delivery. Compared to simple transseptal delivery, the transapical and transseptal / transaortic approaches carry a higher risk of injury and require a longer recovery time. Furthermore, the mitral valve annulus is larger, necessitating a larger diameter stent for the prosthetic valve, resulting in a larger leaflet area and reduced leaflet fatigue resistance. Additionally, the larger diameter of the compressed prosthetic valve requires a larger delivery system, increasing the risk of vascular complications. The tricuspid valve, as the atrioventricular valve of the right heart, shares a similar structure with the left atrioventricular valve (mitral valve), and the same design principles 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 is easy to operate, minimally invasive, and can be effectively fixed at the mitral or tricuspid valve. Summary of the Invention

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

[0007] This application provides a heart valve positioning device, which is delivered to a heart valve via a delivery device. The delivery device includes a guide. The positioning device includes: a support unit, which includes a body and a first cavity penetrating the body. The body has a first end and a second end. In a released state, the support unit bends so that the first end and the second end approach each other to form an annular structure; a locking unit, which is configurable with the first end and the second end of the support unit, and the locking unit has two through holes for the guide to pass through; and a skirt, which is coupled to one of the support unit and the guide, and the skirt is retractable or expandable. In the delivery state, the guide passes through the first cavity. In the released state, the support unit gathers at least a portion of the original leaflet into the annular structure formed by the support unit, and the guide extends out of the first end and the second end, and passes through the two through holes of the locking unit, guiding the locking unit to connect with the first end and the second end.

[0008] Optionally, after the locking unit is connected to the first end and the second end, the guide can be withdrawn from the first cavity via the first end or the second end, or the guide can remain in the first cavity.

[0009] Optionally, the positioning device further includes an anchoring element, which includes an arc-shaped member with a locking unit. The diameter of the arc-shaped member is larger than the diameter of the annular structure formed after the support unit is released. After the positioning device is released, the anchoring element is anchored at the original petiole annulus.

[0010] Optionally, the locking unit can be engaged with the first end and the second end of the support unit.

[0011] Optionally, the inner sides of the first end and the second end of the support unit are respectively provided with protrusions. The locking unit includes: two first pillars connected to each other, and the outer diameter of the first pillar is smaller than the inner diameter of the first end or the second end, and each through hole is respectively provided on the top of each first pillar; two first extensions that are elastic, and each first extension extends upward from the bottom of the first pillar and forms an acute angle with the outer surface of the first pillar.

[0012] Optionally, the first end and the second end of the support unit each include: a first opening disposed on the outer wall of the first end and the second end; an inner extension extending radially inward from the inner side of the first end and the second end, the inner diameter of the inner extension being smaller than the diameter of the first cavity; the locking unit includes: two second pillars connected to each other, the outer diameter of the second pillars being smaller than the inner diameter of the first end or the second end, and each through hole being disposed on the top of each second pillar; and two second extensions extending radially outward from the ends of the second pillars, the outer diameter of the second extensions being larger than the inner diameter of the inner extensions.

[0013] Optionally, the skirt includes at least one elastic unit having a connecting portion and a free portion, the connecting portion being coupled to one of the support unit and the guide, and the free portion extending from the connecting portion in a direction away from the support unit.

[0014] Optionally, the connecting part is attached to the main body.

[0015] Optionally, the outer side of the body is provided with a hanging rod, the two ends of the hanging rod are connected to the body, the connecting part is axially slidably connected to the hanging rod and circumferentially fixed, and at least one of the hanging rod and the connecting part has a non-circular cross-section.

[0016] Optionally, the support unit has a second opening on its body, the connecting part circumferentially surrounds at least a portion of the guide and in the released state, the connecting part is located in the second opening, the free part extends out from the second opening, the connecting part is axially slidably connected to the guide and circumferentially fixedly connected, and at least one of the guide and the connecting part has a non-circular cross-section.

[0017] In another aspect, this application provides a heart valve positioning device for implantation between the aortic valves. The positioning device includes: a support unit comprising a body and a first cavity penetrating the body, the body having a first end and a second end; the support unit bending in a released state to bring the first end and the second end closer together to form an annular structure; a guide slidably inserted into the first cavity; a locking unit capable of engaging with the first end and the second end of the support unit, the locking unit having two through holes for the guide to pass through; and a skirt coupled to one of the support unit and the guide, the skirt being retractable or expandable. In a delivery state, the guide passes through the first cavity; in a released state, the support unit gathers at least a portion of the original leaflet into the annular structure formed by the support unit, and the guide extends out of the first end and the second end, passing through the two through holes of the locking unit, guiding the locking unit to connect with the first end and the second end.

[0018] Optionally, the positioning device further includes an anchoring element, which includes an arc-shaped member with a locking unit. The diameter of the arc-shaped member is larger than the diameter of the annular structure formed after the support unit is released. After the positioning device is released, the anchoring element is anchored at the original petiole annulus.

[0019] Optionally, the inner sides of the first end and the second end of the support unit are respectively provided with protrusions. The locking unit includes: two first pillars connected to each other, and the outer diameter of the first pillar is smaller than the inner diameter of the first end or the second end, and each through hole is respectively provided on the top of each first pillar; two first extensions that are elastic, and each first extension extends upward from the bottom of the first pillar and forms an acute angle with the outer surface of the first pillar.

[0020] Optionally, the first end and the second end of the support unit each include: a first opening disposed on the outer wall of the first end and the second end; an inner extension extending radially inward from the inner side of the first end and the second end, the inner diameter of the inner extension being smaller than the diameter of the first cavity; the locking unit includes: two second pillars connected to each other, the outer diameter of the second pillars being smaller than the inner diameter of the first end or the second end, and each through hole being disposed on the top of each second pillar; and two second extensions extending radially outward from the ends of the second pillars, the outer diameter of the second extensions being larger than the inner diameter of the inner extensions.

[0021] Optionally, the skirt includes at least one elastic unit having a connecting portion and a free portion, the connecting portion being coupled to one of the support unit and the guide, and the free portion extending from the connecting portion in a direction away from the support unit.

[0022] Optionally, the outer side of the body is provided with a hanging rod, the two ends of the hanging rod are connected to the body, the connecting part is axially slidably connected to the hanging rod and circumferentially fixed, and at least one of the hanging rod and the connecting part has a non-circular cross-section.

[0023] Optionally, the support unit has a second opening on its body, the connecting part circumferentially surrounds at least a portion of the guide and in the released state, the connecting part is located in the second opening, the free part extends out from the second opening, the connecting part is axially slidably connected to the guide and circumferentially fixedly connected, and at least one of the guide and the connecting part has a non-circular cross-section.

[0024] In another aspect, this application also provides an artificial heart valve system, which optionally includes the aforementioned positioning device and an artificial valve. The artificial valve has: an artificial leaflet; and a cylindrical support member, wherein the artificial leaflet is circumferentially fixed to the inner side of the support member, and the support member is adapted to the support unit so that when the locking unit is connected to the first end and the second end, the artificial valve is implanted into the inner side of the support unit.

[0025] In another aspect, this application also provides an artificial heart valve implantation system, which includes: the aforementioned heart valve positioning device; and a delivery device having a delivery conduit for delivering the heart valve positioning device to the heart and then releasing it.

[0026] Optionally, the conveying device includes a first conveying member and a second conveying member, the first conveying member and the second conveying member respectively having an inner cavity, the outer diameter of the second conveying member being smaller than the inner diameter of the first conveying member, and the inner cavity of the second conveying member having a diaphragm, the diaphragm dividing the inner cavity of the second conveying member into a first cavity and a second cavity.

[0027] Optionally, the conveying device further includes a push rod, and the locking unit is further provided with a pushing part, the push rod being movably connected to the pushing part.

[0028] In another aspect, this application also provides a method for implanting a heart valve positioning device into the heart. The method includes: when the heart valve positioning device is delivered, the guide passes through the first cavity; when released, the first end of the support unit enters the outer surface from the inner surface of the original leaflet through the anterior-posterior junction of the original leaflet, so that at least a portion of the original leaflet is gathered in the annular structure formed by the support unit; and the guide extends out of the first end and the second end, and passes through the two through holes of the locking unit, guiding the locking unit to connect with the first end and the second end.

[0029] As can be seen from the above technical solutions, the heart valve positioning device of this application delivers and releases the support unit, and locks the locking unit and both ends of the support unit with the guide to form a closed annular structure. The skirt attached to the main body can expand at a preset position and angle after release, thereby blocking the movement of the anterior mitral valve leaflet into the left ventricular outflow tract and avoiding left ventricular outflow tract obstruction. After the support unit is implanted, an artificial valve of appropriate size can be released into the interior of the support unit, and the native valve leaflet is clamped between the artificial valve and the support unit. Through the friction and radial force between the artificial valve and the support unit, the artificial valve is fixed at the native valve, replacing the function of the native valve. The annular structure formed by the support unit of this application is relatively simple, so it is more accurate and easier to capture the native valve leaflet.

[0030] The heart valve positioning device in this invention can be delivered to the mitral or tricuspid valve via the femoral vein through a catheter, providing an anchoring position for the artificial valve. Subsequently, an artificial valve of appropriate size is delivered to the positioning device via the femoral vein, realizing the delivery of the positioning device and the artificial valve through the same femoral vein pathway. This simplifies the surgical procedure, ensures that the implanted artificial valve has good fatigue performance, and reduces the risk of vascular complications and aortic valve damage. Attached Figure Description

[0031] 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.

[0032] Figure 1 This is a schematic diagram of an embodiment of a heart valve positioning device according to this application;

[0033] Figure 2 This is a schematic diagram of one embodiment of the support unit of this application;

[0034] Figure 3 This is a schematic diagram of an embodiment of the skirt in the retracted state;

[0035] Figure 4 This is a schematic diagram of an embodiment of the skirt in the expanded state;

[0036] Figure 5 This is a schematic diagram of one end of the capture guide of the capture device in this application;

[0037] Figure 6 This is a schematic diagram of the other end of the capture guide of the capture device in this application;

[0038] Figure 7 This is a schematic diagram of an embodiment in which the locking unit of this application moves along the guide to approach the first and second ends of the support unit;

[0039] Figure 8 This is a schematic diagram of an embodiment in which the locking unit of this application moves to the first end and the second end of the support unit and connects with the first end and the second end of the support unit;

[0040] Figures 9A-9D This is a schematic diagram of different embodiments of the connection structure between the first end and the second end of the locking unit and the supporting unit of this application;

[0041] Figure 10AThis is a perspective view of another embodiment of the connection structure between the first and second ends of the locking unit and the supporting unit of this application in an unconnected state.

[0042] Figure 10B yes Figure 10A A perspective view of the locking unit advancing towards the first and second ends of the support unit;

[0043] Figure 10C yes Figure 10A A cross-sectional view showing the locking unit engaging with the first and second ends of the support unit;

[0044] Figure 11A-11B These are schematic diagrams of two embodiments of the anchoring component of this application;

[0045] Figure 12A-12D , Figure 12G-12I These are schematic diagrams of seven embodiments of the skirt portion of this application;

[0046] Figure 12E for Figure 12D The diagram shown is a schematic of the anchoring element of this application in the contracted state;

[0047] Figure 12F for Figure 12D The diagram shown is an enlarged view of a portion G of the anchoring element of this application;

[0048] Figure 13A A schematic diagram showing the state of the heart valve positioning device being released after being delivered to the heart by the delivery device;

[0049] Figure 13B for Figure 13A A magnified view of a portion of the image;

[0050] Figure 13C for Figure 13B A schematic diagram of the cross-section of the sheath along the AA direction;

[0051] Figure 13D This is a schematic diagram of the heart valve positioning device of this application after release;

[0052] Figure 13E for Figure 13D A schematic diagram of the cross-section of the sheath along the BB direction;

[0053] Figure 13F This is a schematic diagram showing the state in which the push rod of the delivery device of the heart valve positioning device of this application pushes the locking unit to slide along the guide after the release of the device.

[0054] Figure 13G for Figure 13F A schematic diagram of the cross-section of the sheath along the DD direction;

[0055] Figure 13H A schematic diagram showing the state in which the artificial valve of this application is delivered to the heart and passes through the annular structure formed by the support unit;

[0056] Figure 13I for Figure 13H A schematic diagram of the cross-section of the sheath along the EE direction;

[0057] Figure 13J This is a schematic diagram of an embodiment of the artificial valve of this application after it has been fully deployed into the heart.

[0058] Figure 13K This is a schematic diagram of another embodiment of the artificial valve of this application after it has been fully deployed in the heart.

[0059] Component designation

[0060] 20: Conveying device; 101: Support unit; 1011: Body; 1012: First end; 1013: Second end; 102: Locking unit; 103: Skirt; 1021, 1022: Through holes; 30: Guide; 40: Anchor; 104: Artificial valve; 1041: Support; 1014: Protrusion; 1023: First column; 1024: First extension; 1015: First opening; 1016: Inner extension; 1025: Second column; 1026: Second extension; 1031: Elastic unit; 1032: Connector Part; 1033: Free part; 1017: Second opening; 1018: Hanging rod; 201: First conveyor; 202: Second conveyor; 2022: First cavity; 2023: Second cavity; 2024: Diaphragm; 203: Push rod; 1027: Pushing part; 204: Catch; 2041: Catch head; 301: Third end; 302: Fourth end; 1019: Cutting slit; 304a: Protective part; 1033a: Arc-shaped structure; 1033b: Arc-shaped extension; 205: Third conveyor; 501, 502: Groove; 503: Protrusion. Detailed Implementation

[0061] 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.

[0062] The term "proximal" refers to the end closer to the operator relative to the operator. The term "distal" refers to the end closer to the patient's heart valves relative to the operator.

[0063] The term "coupling" refers to direct or indirect connection.

[0064] The term "top" refers to the uppermost point relative to the plane of the paper on which the illustration is located.

[0065] The following is an example of the embodiments of this application. Figures 1 to 13K The specific implementation of the embodiments of this application will be further explained.

[0066] See Figures 1 to 13K In one specific implementation of this application, a heart valve positioning device is provided, which is delivered to the heart valve via a delivery device 20. The delivery device 20 includes a guide 30, which can be a hollow tubular or solid cylindrical material with elasticity, such as a filament. The two ends (third end 301 and fourth end 302) of the guide 30 can be provided with protective members (304a), such as circular protrusions, to facilitate capture by the capture device 204.

[0067] In one embodiment of this application, the positioning device includes a support unit 101, a locking unit 102, and a skirt 103. The support unit 101 includes a body 1011 and a first cavity penetrating the body 1011. The body 1011 has a first end 1012 and a second end 1013. In the released state, the support unit 101 bends, causing the first end 1012 and the second end 1013 to approach each other to form a ring structure. The locking unit 102 can be engaged with the first end 1012 and the second end 1013 of the support unit 101, for example, by snapping. The locking unit 102 has two through holes (102...). 1, 1022), respectively, are used for the guide 30 to pass through; the skirt 103 is coupled to the support unit 101 or the guide 30, and the skirt 103 can retract or expand; wherein, in the conveying state, the guide 30 passes through the first cavity, and in the release state, the support unit 101 gathers at least a portion of the original leaflets into the annular structure formed by the support unit 101, and the guide 30 extends out of the first end 1012 and the second end 1013, and passes through the two through holes (1021, 1022) of the locking unit 102, and the locking unit 102 is connected to the first end 1012 and the second end 1013.

[0068] The skirt 103 may be elastic, allowing it to be compressed and then transported into the delivery device 20, and to return to its original state after release. This effectively blocks the movement of the anterior mitral valve leaflet into the left ventricular outflow tract, preventing left ventricular outflow tract obstruction. The first end 1012 and the second end 1013 of the body 1011 may be radiopaque, either as radiopaque material itself or with radiopaque structures such as radiopaque rings, radiopaque films, or radiopaque filaments. This facilitates observation and guidance of operations after the support unit 101 is delivered to the heart, such as identifying and locking the first end 1012 and the second end 1013 of the body 1011, and releasing the artificial valve 104 to a designated position. The locking unit 102 may also be radiopaque.

[0069] The body 1011 can be made of shape memory material or flexible polymer material. In the conveying state, the body 1011 is placed in the sheath of the conveying device 20 in a basically linear or arc-shaped state. In the released state, the first end 1012 and the second end 1013 of the body 1011 approach each other to form a ring structure. The body 1011 of the support unit 101 can be a smooth elastic tube, such as... Figure 1 As shown, it can also include multiple slits 1019 arranged along the axial direction, such as Figure 2 As shown, for details of the principle of the slit 1019, please refer to Chinese Patent Application No. CN202210642095.1.

[0070] like Figure 13J As shown, in another embodiment of this application, an artificial heart valve system is also provided, including a heart valve positioning device and an artificial valve 104. The artificial valve 104 has: an artificial leaflet (not shown); and a cylindrical support member 1041. The artificial leaflet is circumferentially fixed to the inner side of the support member 1041, and the support member 1041 is adapted to a support unit 101 so that when the locking unit 102 is connected to the first end 1012 and the second end 1013, the artificial valve 104 is implanted into the inner side of the support unit 101. In the delivery state, the artificial valve 104 is compressed into a bundle-like shape, and after release, the support member 1041 forms a cylindrical shape.

[0071] The first end 1012 and the second end 1013 of the support unit 101 can be engaged with the locking unit 102, i.e., in a snap-fit ​​relationship. For example... Figure 9AAs shown, in one embodiment of this application, the inner sides of the first end 1012 and the second end 1013 of the support unit 101 are respectively provided with annular or non-annular protrusions 1014. The locking unit 102 includes two first pillars 1023 and two first extensions 1024, each first extension 1024 corresponding to one first pillar 1023. The two first pillars 1023 are connected to each other, and each through hole (1021, 1022) is respectively provided on the top of each first pillar 1023. The outer diameter of the first pillar 1023 is smaller than the inner diameter of the first end 1012 or the second end 1013. Optionally, the outer diameter of the first pillar 1023 is smaller than the inner diameter of the inner protrusions 1014 of the first end 1012 and the second end 1013. The first extension 1024 may be elastic, extending upward from the bottom of the first pillar 1023, and the first extension 1024 forms an acute angle with the outer surface of the first pillar 1023. When the locking unit 102 enters the first end 1012 or the second end 1013 of the support unit 101, the first extension 1024 is compressed by the protrusion 1014, making the first extension 1024 closer to or against the column, so that the first extension 1024 passes over the protrusion 1014 and enters the lower cavity of the protrusion 1014, thereby locking the locking unit 102 with the first end 1012 or the second end 1013 of the support unit 101.

[0072] like Figures 10A-10CAs shown, in another embodiment of this application, the first end 1012 and the second end 1013 of the support unit 101 each include a first opening 1015, which is disposed on the outer wall of the first end 1012 and the second end 1013. The first opening 1015 can be one or two. An inner extension 1016 extends radially inward from the inner side of the first end 1012 and the second end 1013. The inner diameter of the inner extension 1016 is smaller than the diameter of the first cavity. The locking unit 102 includes two second pillars 1025 and two second extensions 1026. The two second pillars 1025 are connected to each other. Each through hole (1021, 1022) is disposed on the top of each second pillar 1025. The outer diameter of the second pillar 1025 is smaller than the inner diameter of the first end 1012 or the second end 1013. Each second extension 1026 extends radially outward from the end of the second pillar 1025. The outer diameter of the second extension 1026 is larger than the inner diameter of the inner extension 1016. Optionally, the end of the second extension 1026 can be a bevel, forming a cone shape to facilitate the second extension 1026 opening the first opening 1015 and thus entering the first cavity more smoothly. When the locking unit 102 enters the first end 1012 or the second end 1013 of the support unit 101, the second extension 1026 expands the first opening 1015 of the support unit 101. When the second extension 1026 completely passes the inner extension 1016 and enters the first cavity, the first opening 1015 returns to its original size, thereby locking the locking unit 102 to the first end 1012 or the second end 1013 of the support unit 101.

[0073] The cooperation method between the support unit 101 and the locking unit 102 is not limited to the two mentioned above. After the support unit 101 and the locking unit 102 are engaged, the locking unit can be repeatedly removed from the end of the support unit or can be made non-removable. For example Figure 9B As shown, the support unit 101 may also have a boss 1014 on its entire circumference or in a partial area on its inner side. The first column 1023 may be cylindrical or spherical, such as... Figure 9C As shown, the first column 1023 can also be a column, sphere, or other shape with a groove 501. Figure 9D As shown, the inner side of the support unit 101 is provided with a groove 502 in the entire circumference or in part, and the first column 1023 is a column, sphere or other shape with a protrusion 503.

[0074] like Figure 11A-11B ,as well as Figure 13KAs shown, in one embodiment of this application, the positioning device further includes an anchoring member 40, which includes an arc-shaped component. The arc-shaped component can be a perfect circle or a non-perfect circle, such as a semicircle. A locking unit 102 is provided on the arc-shaped component, and the locking unit has two through holes (1021, 1022) for the guide member 30 to pass through. The locking unit 102 is connected to the first end 1012 and the second end 1013 so that after the positioning device is released, the anchoring member 40 is anchored at the original annulus. The diameter of the arc-shaped component can be larger than the diameter of the annular structure formed by the support unit 101, so that the anchoring member 40 can be more firmly anchored at the original annulus after release.

[0075] like Figure 11A When the arc-shaped component is a perfect circle, the locking unit 102 of the arc-shaped component is connected to the first end 1012 and the second end 1013 respectively, so that the ring structure formed by the support unit 101 is a closed ring. Figure 11B When the arc-shaped component is not a perfect circle, one end of the arc-shaped component is provided with a locking unit 102, and the other end is a free end. The locking unit 102 makes the ring structure formed by the support unit 101 a closed ring.

[0076] like Figure 3-4 As shown in 12A-12I, in some optional embodiments of this application, the skirt 103 includes one or more elastic units 1031. Each elastic unit 1031 has a connecting portion 1032 and a free portion 1033. The connecting portion 1032 is connected to the support unit 101 or the guide 30, and the free portion 1033 extends from the connecting portion 1032 in a direction away from the support unit 101. Figure 3-4 As shown, the connecting part 1032 can be directly attached (e.g., fixed) to the outer surface of the body 1011 by bonding, sewing or other suitable means. In the conveying state, the free part 1033 can retract into the sheath of the conveying device 20, and in the released state, the free part 1033 returns to the expanded state.

[0077] In another embodiment, such as Figure 12CAs shown, the support unit 101 may also have a second opening 1017 on its body 1011. A connecting portion 1032 circumferentially surrounds at least a portion of the guide member 30. The connecting portion 1032 is axially slidably connected to the guide member 30 and circumferentially fixedly connected. For example, at least a portion of the guide member 30 or the cross-section of the connecting portion 1032 is non-circular, such as square, rhomboid, triangular, or other regular or irregular non-circular shapes. In the released state, the connecting portion 1032 is located in the second opening 1017, and the free portion 1033 extends out from the second opening 1017. The axial sliding connection between the connecting portion 1032 and the guide member 30 facilitates the guide member 30's movement within the first inner cavity, while the circumferentially fixed connection allows the free portion 1033 to expand at a predetermined angle during release.

[0078] In another embodiment of this application, such as Figure 12A-12B As shown in 12D-12G, the difference between this embodiment and the previous embodiment is that the outer side of the body 1011 is closed, and a hanging rod 1018 is provided on the outer side of the body 1011 to replace the guide as the connection part with the skirt. The two ends of the hanging rod 1018 are connected to the body 1011, and the part between the two ends of the hanging rod 1018 is separated from the edge of the body 1011. The shape of the hanging rod 1018 fits the body 1011 of the support unit 101. The connecting part 1032 is axially slidably connected to the hanging rod 1018 and circumferentially fixed. At least one of the hanging rod 1018 and the connecting part 1032 has a non-circular cross-section.

[0079] The elastic unit 1031 can be made of woven mesh, and the connecting part 1032 circumferentially covers the guide 30 or the hanging rod, which can prevent the skirt 103 from restricting the deformation of the body 1011 of the support unit 101, and can also enhance the rigidity and supporting force of the body 1011 of the support unit 101. Figure 12A and Figure 12C As shown, the free portion 1033 extends from the connecting portion 1032 in a direction away from the support unit 101 and can form a sheet-like structure. The edge of the free portion 1033 can be arc-shaped, square, or any other suitable shape. Figure 12B As shown, the connecting part 1032 can be two rings with an opening between them, and the edge of the free part 1033 can still be arc-shaped, square, or any other suitable shape. Figure 12D-12FAs shown, the elastic unit 1031 can be filamentous and U-shaped. Both ends (i.e., connecting portions 1032) of the elastic unit 1031 circumferentially surround the guide 30 or hanging rod. The connecting portions 1032 can slide freely axially on the guide 30 or hanging rod 1018, but are relatively fixed circumferentially. When the body 1011 of the support unit 101 is retracted into the conveying device 20, under pressure, the two connecting portions 1032 slide to both sides along the hanging rod 1018, and the free portion 1033 adheres to the guide 30, hanging rod 1018, or body 1011. Only one end of the elastic unit 1031 may be freely movable, while the other end is fixed to the body 1011. The elastic unit 1031 can also be V-shaped, W-shaped, wavy, S-shaped, L-shaped, rectangular, trapezoidal, or other shapes. The surface of the elastic unit 1031 can be covered with a biocompatible polymer film.

[0080] like Figure 12G As shown, the free portion 1033 can be composed of an arc-shaped structure 1033a and two arc-shaped extensions 1033b. The two ends of the two arc-shaped extensions 1033b are connected to the arc-shaped structure 1033a, thereby increasing the contact area between the free portion 1033 and the original leaflet, resulting in a better blocking effect. The two arc-shaped extensions 1033b can slide freely on the arc-shaped structure 1033a to adapt to deformation during compression. The free portion 1033 can be composed of metal or polymer materials, possessing good elasticity.

[0081] like Figure 12H As shown, the elastic unit 1031 is connected to the body 1011 of the support unit 101 at only one end (i.e., the connecting part 1032), and the other end is a free end; as Figure 12I As shown, multiple elastic units 1031 can be distributed on the body 1011 of the support unit 101. The elastic unit 1031 has multiple extensions to increase the contact area between the skirt 103 and the petals, thereby achieving a better blocking effect.

[0082] In another embodiment of this application, a heart valve positioning device is provided. In addition to the support unit 101, the locking unit 102, and the skirt 103, the device also includes a guide 30. The guide 30 is slidably inserted into the first cavity, that is, in this embodiment, the guide 30 is part of the heart valve positioning device.

[0083] This application also provides an artificial heart valve implantation system, which includes the heart valve positioning device and delivery device 20 described in the above embodiments. The delivery device 20 has a delivery conduit for delivering the heart valve positioning device to the heart and then releasing it. In one embodiment, the delivery device 20 is provided with a control element, and a guide 30 is connected to the control element. The control element controls the movement of the guide 30 within the delivery conduit. The control element can be a structure with stretching and pushing functions. Additionally, an operator can manually control the movement of the guide 30 within the delivery conduit.

[0084] like Figure 13E As shown, in one embodiment, the conveying device 20 includes a first conveying member 201 and a second conveying member 202. The first conveying member 201 and the second conveying member 202 are respectively provided with inner cavities. The outer diameter of the second conveying member 202 is smaller than the inner diameter of the first conveying member 201. The inner cavity of the second conveying member 202 is provided with a diaphragm 2024, which divides the inner cavity of the second conveying member 202 into a first cavity 2022 and a second cavity 2023.

[0085] like Figure 7-8 As shown, in one embodiment, the conveying device 20 further includes a push rod 203, and the locking unit 102 is further provided with a pushing part 1027, with the push rod 203 movably connected to the pushing part 1027. For example, the push rod 203 abuts against the pushing part 1027 during use to push the pushing part 1027.

[0086] like Figure 5-6 As shown, in one embodiment, the conveying device 20 further includes a catcher 204 having an annular gripper head 2041 for catching the guide 30 from the first end 1012 or the second end 1013.

[0087] During transport, the support unit 101 and the skirt 103 can be transported through the tubular first transport member 201 and the second transport member 202. Both the first transport member 201 and the second transport member 202 can be flexible. The support unit 101 is placed in the second transport member 202 in a linear state. The second transport member 202 is transported through the cavity of the first transport member 201.

[0088] In another aspect, this application also provides a method for implanting an artificial heart valve implantation system into the heart. The method includes: during delivery, a guide 30 passes through a first cavity; during release, a first end 1012 of a support unit 101 enters the outer surface from the inner surface of the original leaflet through the anterior-posterior junction of the original leaflet, causing the original leaflet to converge into the annular structure formed by the support unit 101; and the guide 30 extends out of the first end 1012 and the second end 1013, and passes through the two through holes (1021, 1022) of the locking unit 102, guiding the locking unit 102 to connect with the first end 1012 and the second end 1013.

[0089] like Figure 13A-13J As shown, during delivery, the first delivery member 201 can be passed through the interatrial septum first, and then the distal end of the second delivery member 202 can be delivered to the anterior and posterior commissure of the valve C2 through the passage established by the first delivery member 201. The second end 1013 of the support unit 101 is aligned with the fourth end 302 of the guide 30, and the support unit 101 and the skirt 103 are released. The second end 1013 of the support unit 101 will first pass through the anterior and posterior commissure of the valve C2, and enter the outer surface of the valve from the inner surface side of the valve. As the support unit 101 is continuously released, the original leaflet is captured in the annular structure formed by the support unit 101. The support unit 101 and the skirt 103 are transported through the first cavity 2022. At this time, the first end 1012 of the guide 30 is located outside the patient's body. When the second end 1013 of the support unit 101 circles the leaflet and reaches the anterior and posterior commissure C2 of the valve again, the grabber 204 is transported to C2 through the second cavity 2023 of the second transporter 202. The grabber 204 captures the fourth end 302 of the guide 30. After successful capture, the fourth end 302 of the guide 30 is pulled out of the patient's body. The fourth end 302 of the guide 30 drives the third end 301 to move in the first cavity 2022 until the third end 301 of the guide 30 located in the first cavity 2022 is transported to C2. The third end 301 of the guide 30 is captured again by the capture device 204 and placed into the second cavity 2023, so that both the third end 301 and the fourth end 302 of the guide 30 are located in the second cavity 2023, so as to realize the delivery of the connecting part 1032.

[0090] Subsequently, the third end 301 and the fourth end 302 of the guide 30 are passed through the two through holes (1021, 1022) of the locking unit 102 respectively. With the guide 30 as a guide rail, the locking unit 102 is delivered to the first end 1012 and the second end 1013 of the support unit 101 under the push of the push rod 203. Then, the locking unit 102 and the first end 1012 and the second end 1013 of the support unit 101 are engaged and locked together, so that the support unit 101 forms a closed ring.

[0091] Subsequently, the artificial valve 104 is compressed in the third delivery member 205, delivered to the original valve through the first cavity 2022 and released. Finally, the guide 30 is removed from the first cavity of the support unit 101 or the guide 30 is cut from the first end 1012 and the second end 1013 of the support unit 101 by a suture cutter, thereby achieving complete release of the heart valve positioning device.

[0092] 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 for delivery to a heart valve via a delivery device, the delivery device comprising a guide, characterized in that, The positioning device comprises: a support unit comprising a body and a first cavity penetrating through the body, the body being provided with a first end portion and a second end portion, the support unit being bent in a released state to form a ring structure with the first end portion and the second end portion close to each other; a locking unit cooperatively connected with the first end portion and the second end portion of the support unit, the locking unit being provided with two through holes for the guide member to pass through; a skirt coupled with one of the support unit and the guide member, the skirt being retractable or expandable; wherein in a delivery state, the guide member passes through the first cavity, in the released state, the support unit folds at least a part of the native leaflet into the ring structure formed by the support unit, and the guide member extends out of the first end portion and the second end portion and passes through the two through holes of the locking unit to guide the locking unit to be connected with the first end portion and the second end portion.

2. The heart valve positioning device of claim 1, wherein, After the locking unit is connected with the first end portion and the second end portion, the guide member is withdrawn from the first cavity through the first end portion or the second end portion, or the guide member remains in the first cavity.

3. The heart valve positioning device of claim 1, wherein, The positioning device further comprises an anchor, the anchor comprising an arc-shaped member provided with a locking unit, the diameter of the arc-shaped member being greater than the diameter of the ring structure formed by the support unit after being released, and the anchor is anchored at the native annulus after the positioning device is released.

4. The heart valve positioning device of claim 1, wherein, The locking unit is clamped with the first end portion and the second end portion of the support unit.

5. The heart valve positioning device of claim 4, wherein, The inner side of the first end portion and the second end portion of the support unit is respectively provided with a protrusion, and the locking unit comprises: two first columns connected with each other, the outer diameter of the first column being smaller than the inner diameter of the first end portion or the second end portion, and each through hole is arranged at the top of each first column; two first extension parts having elasticity, each first extension part extending upward from the bottom of the first column and forming an acute angle with the outer surface of the first column.

6. The heart valve positioning device of claim 4, wherein, The first end portion and the second end portion of the support unit each comprise: a first opening arranged on the outer wall of the first end portion and the second end portion; an inner extension part extending radially inward from the inner side of the first end portion and the second end portion, the inner diameter of the inner extension part being smaller than the diameter of the first cavity; The locking unit comprises: two second columns connected with each other, the outer diameter of the second column being smaller than the inner diameter of the first end portion or the second end portion, and each through hole is arranged at the top of each second column; two second extension parts extending radially outward from the end portion of the second column, the outer diameter of the second extension part being greater than the inner diameter of the inner extension part.

7. The heart valve positioning device of claim 1 or 3, wherein, The skirt comprises at least one elastic unit, the elastic unit being provided with a connecting portion and a free portion, the connecting portion being coupled with one of the support unit and the guide member, and the free portion extending away from the support unit from the connecting portion.

8. The heart valve positioning device of claim 7, wherein, The connecting portion is attached to the body.

9. The heart valve positioning device of claim 7, wherein, The outer side of the body is provided with a hanging rod, both ends of the hanging rod being connected with the body, the connecting portion being axially slidingly connected and circumferentially fixedly connected with the hanging rod, and the cross section of at least one of the hanging rod and the connecting portion is non-circular.

10. The heart valve positioning device of claim 7, wherein, The body of the support unit is provided with a second opening, the connecting portion circumferentially surrounds at least a portion of the guide, and in the released state, the connecting portion is located in the second opening, the free portion extends from the second opening, the connecting portion is in axial sliding connection with the guide and circumferential fixed connection, and at least a portion of the guide and at least one of the connecting portions have a non-circular cross section.

11. A heart valve positioning device for implantation between the heart aortic valves, characterized by, The positioning device comprises: A support unit comprising a body and a first cavity penetrating through the body, the body being provided with a first end portion and a second end portion, the support unit being curved in the released state, the first end portion and the second end portion being close to each other to form a ring structure; A guide slidably penetrating through the first cavity; A locking unit cooperatively connected with the first end portion and the second end portion of the support unit, and the locking unit has two through holes for the guide to pass through; A skirt coupled with one of the support unit and the guide, and the skirt is retractable or expandable; In the delivery state, the guide penetrates through the first cavity, in the released state, the support unit folds at least a portion of the native leaflet into the ring structure formed by the support unit, and the guide extends out of the first end portion and the second end portion and penetrates through the two through holes of the locking unit, guiding the locking unit to connect with the first end portion and the second end portion.

12. The heart valve positioning device of claim 11, wherein, The positioning device further comprises an anchor, the anchor comprising an arc-shaped member provided with a locking unit, the diameter of the arc-shaped member is greater than the diameter of the ring structure formed after the support unit is released, and after the positioning device is released, the anchor is anchored at the native annulus.

13. The heart valve positioning device of claim 11, wherein, The locking unit is clamped with the first end portion and the second end portion of the support unit.

14. The heart valve positioning device of claim 13, wherein, The inner side of the first end portion and the second end portion of the support unit is respectively provided with a protrusion, and the locking unit comprises: Two first columns connected with each other, and the outer diameter of the first column is smaller than the inner diameter of the first end portion or the second end portion, and each through hole is arranged at the top of each first column; Two first extension portions having elasticity, and each first extension portion extends upward from the bottom of the first column and forms an acute angle with the outer surface of the first column.

15. The heart valve positioning device of claim 13, wherein, The first end portion and the second end portion of the support unit each comprise: A first opening provided on the outer wall of the first end portion and the second end portion; An inner extension portion radially extending inward from the inner side of the first end portion and the second end portion, and the inner diameter of the inner extension portion is smaller than the diameter of the first cavity; The locking unit comprises: Two second columns connected with each other, and the outer diameter of the second column is smaller than the inner diameter of the first end portion or the second end portion, and each through hole is arranged at the top of each second column; Two second extension portions radially extending outward from the end of the second column, and the outer diameter of the second extension portion is greater than the inner diameter of the inner extension portion.

16. The heart valve positioning device of claim 11, wherein, The skirt comprises at least one elastic unit provided with a connecting portion and a free portion, the connecting portion is coupled with one of the support unit and the guide, and the free portion extends away from the support unit.

17. The heart valve positioning device of claim 16, wherein, The outer side of the body is provided with a hanging rod, both ends of the hanging rod are connected with the body, the connecting part is axially slidingly connected with the hanging rod and circumferentially fixedly connected, the cross section of at least one of the hanging rod and the connecting part is non-circular.

18. The heart valve positioning device of claim 16, wherein, The body of the support unit is provided with a second opening, the connecting part circumferentially surrounds at least a part of the guide, and in the released state, the connecting part is located in the second opening, the free part extends out of the second opening, the connecting part is axially slidingly connected with the guide and circumferentially fixedly connected, the cross section of at least one of the guide and the connecting part is non-circular.

19. A prosthetic heart valve system, characterized in that, The system comprises: The heart valve positioning device according to any one of claims 1-18; The artificial valve comprises: An artificial valve leaflet; and A cylindrical support member, the artificial valve leaflet is circumferentially fixed to the inner side of the support member, and the support member is adapted to the support unit, so that when the locking unit is connected with the first end part and the second end part, the artificial valve is implanted into the inner side of the support unit.

20. A prosthetic heart valve implant system, characterized in that, The implantation system comprises: The artificial heart valve system according to any one of claims 1-19; The delivery device has a delivery conduit for delivering the heart valve positioning device to the heart for release.

21. The prosthetic heart valve implant system of claim 20, wherein, The delivery device comprises a first delivery member and a second delivery member, the first delivery member and the second delivery member are respectively provided with an inner cavity, the outer diameter of the second delivery member is smaller than the inner diameter of the first delivery member, the inner cavity of the second delivery member is provided with a diaphragm, and the diaphragm divides the inner cavity of the second delivery member into a first cavity and a second cavity.

22. The prosthetic heart valve implant system of claim 21, wherein, The delivery device further comprises a push rod, and the locking unit is further provided with a pushing part, the push rod is movably connected with the pushing part. The delivery device further comprises a push rod, and the locking unit is further provided with a pushing part, the push rod is movably connected with the pushing part.

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