Heart valve positioning device, prosthetic valve system and method of implanting the same

Abstract

The application provides a heart valve positioning device which is detachably connected with a delivery system, the heart valve comprises a native valve ring and a native valve leaflet, and the heart valve positioning device comprises: a cylindrical support provided with at least one connecting piece; a plurality of first clamping pieces which are distributed along the outer periphery of the support and are connected with the support; a second clamping piece which is configured to be sleeved on the outer periphery of the first clamping piece; in a delivery state, the heart valve positioning device is contracted in the delivery system, and the connecting piece is connected with the delivery system; in a release state, the connecting piece is separated from the delivery system, the native valve leaflet is clamped between the first clamping piece and the support, and the second clamping piece is folded from the outer periphery of the first clamping piece and clamps the native valve leaflet, so that the native valve leaflet forms a folded structure. The heart valve positioning device of the application can easily pass through chordae tendineae to hook and support the native valve leaflet, and is simple, easy and fast to operate.

Description

TECHNICAL FIELD

[0001] The embodiments of the present application relate to the technical field of medical devices, in particular to a heart valve positioning device, an artificial valve system and an implantation method thereof. BACKGROUND

[0002] Common diseases of the mitral valve, tricuspid valve, aortic valve, and pulmonary valve are valve insufficiency. Taking the mitral valve as an example, during the systole of the heart, part of the blood in the left ventricle flows back to the left atrium through the insufficiency of the mitral valve. The left atrium receives the blood flowing back from the left ventricle and the blood input from the pulmonary vein, and the blood volume in the left atrium increases significantly, and the pressure rises, resulting in left atrial hypertrophy. During the diastole of the heart, more blood flows from the left atrium to the left ventricle, causing the left ventricle to hypertrophy due to enhanced contraction. After the compensatory period evolves into the decompensatory period, the left atrium and left ventricle both suffer from heart failure, and then pulmonary congestion, pulmonary hypertension, right ventricular hypertrophy, right atrial hypertrophy, right heart failure, and systemic congestion occur in turn.

[0003] Traditional treatment methods include actively performing surgical methods or palliatively resisting inevitable heart failure with drugs. The surgical methods further include valve replacement and valve plasty. In the surgical methods, a typical open chest surgery has large invasiveness, needs to establish extracorporeal circulation, and has a high incidence of complications and infection risk. Many patients cannot tolerate the huge surgical risk.

[0004] At present, there are few replacement products for treating mitral and tricuspid regurgitation through minimally invasive percutaneous catheterization in China. These products have problems such as difficult operation, long time, low success rate, displacement of artificial valves, and perivalvular leakage in the healing process, which weaken the treatment effect and even worsen the condition. For example, Chinese patent CN109789019B needs to pass the coil through the delivery system from the junction of the anterior and posterior leaflets into the ventricle from the atrium, and remotely control the coil to be arranged around the chordae tendineae and the ventricular wall, i.e. the chordae tendineae are arranged around the inside of the coil. This operation is difficult, time-consuming, and has a low success rate.

[0005] Therefore, there is an urgent need for a product for treating valve regurgitation through a minimally invasive path, which is easy to operate, reliable in positioning, and good in adhesion to the human body valve. SUMMARY

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

[0007] The embodiment of the present application provides a heart valve positioning device which is detachably connected with a delivery system, the heart valve comprises a native valve ring and native valve leaflets, and the heart valve positioning device comprises: a cylindrical support provided with at least one connecting piece; a plurality of first clamping pieces which are distributed along the outer periphery of the support and are connected with the support; and a second clamping piece which is configured to be sleeved on the outer periphery of the first clamping piece; in a delivery state, the heart valve positioning device is contracted in the delivery system, and the connecting piece is connected with the delivery system; in a release state, the connecting piece is separated from the delivery system, the native valve leaflets are clamped between the first clamping piece and the support, and the second clamping piece is folded from the outer periphery of the first clamping piece and clamps the native valve leaflets, so that the native valve leaflets form a folded structure.

[0008] Optionally, the folded structure comprises a first folded part and a second folded part which are connected with each other; in the release state, the first folded part is clamped between the support and the first clamping piece, and the second folded part is clamped between the first clamping piece and the second clamping piece.

[0009] Optionally, the first folded part and the second folded part respectively comprise a front surface located on the inner side of the native valve leaflet and a back surface located on the outer side of the native valve leaflet; in the release state, the front surface of the first folded part abuts against the outer side of the support, the back surface of the first folded part abuts against the inner side of the first clamping piece, the front surface of the second folded part abuts against the second clamping piece, and the back surface of the second folded part abuts against the outer side of the first clamping piece.

[0010] Optionally, the support comprises a body and an extension column which extends upward in the axial direction from the body and is connected with the connecting piece at an extension end, and the bottom of the first clamping piece is connected with the bottom of the body.

[0011] Optionally, the first clamping piece comprises a first extension part and a second extension part which are connected with each other, the first extension part extends downward from the bottom of the body and is connected with the bottom of the second extension part at an extension end to form a butt joint part, and the second extension part extends upward from the butt joint part.

[0012] Optionally, the first folded part and the second folded part are connected at the top of the second extension part.

[0013] Optionally, the first clamping piece comprises an adjusting part, and the delivery system comprises an adjusting sheath tube, when the adjusting sheath tube enters between the first clamping piece and the support, the adjusting sheath tube pushes the adjusting part to make the top of the second extension part away from the outer surface of the support.

[0014] Optionally, the adjusting part comprises the butt joint part and at least a part of the second extension part.

[0015] Optionally, the second clamping member extends on the top of the body and forms a ring along the outer periphery of the first clamping member.

[0016] Optionally, the second clamping member is provided with a third extension and a fourth extension connected with each other, the third extension extends radially outward from the top of the body to form an arc, the highest point of the arc is higher than the highest point of the first clamping member, and the fourth extension extends circumferentially from the end of the arc to circumferentially surround the first clamping member. Optionally, the second clamping member comprises at least two clamping units, each clamping unit is provided with a third extension and a fourth extension, and each fourth extension extends circumferentially on the outer periphery of the first clamping member to form a non-closed ring.

[0017] Optionally, the fourth extension forms a closed ring.

[0018] Optionally, the second clamping member comprises a closed ring, and the closed ring is provided with an interface for detachable connection with the delivery system.

[0019] Another aspect of the present application also provides a prosthetic valve system, comprising the heart valve positioning device described above, and a prosthetic valve comprising a prosthetic valve leaflet and a cylindrical support member, the prosthetic valve leaflet being circumferentially fixed to the inner side of the support member, and the support member being adapted to the stent so as to implant the prosthetic valve into the inner side of the stent after the heart valve positioning device is released.

[0020] Still another aspect of the present application also provides a method for implanting the prosthetic valve system described above into a heart, comprising the following steps: shrinking the heart valve positioning device in the delivery system, delivering to a heart valve, releasing the heart valve positioning device, clamping the native valve leaflet between the first clamping member and the stent, clamping the native valve leaflet by the second clamping member from the outer periphery of the first clamping member to make the native valve leaflet form a folded structure, disconnecting the connecting member from the delivery system, and then delivering the prosthetic valve to the heart valve for release, so as to implant the prosthetic valve into the inner side of the stent.

[0021] As can be seen from the above technical solutions, the heart valve positioning device of the present application can easily pass through the chordae tendineae to hook and hold the native valve leaflet, and the operation is simple, easy and fast. The native valve leaflet is folded and pressed on the outer side of the first clamping member by the second clamping member, and the positioning and clamping are simple and reliable. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are only some embodiments described in the present application, and other drawings can also be obtained by those skilled in the art according to these drawings.

[0023] Figure 1 is a simplified view of a human heart mitral valve;

[0024] Figure 2A is a perspective view of an embodiment of a heart valve positioning device of the present application;

[0025] Figure 2B is a perspective view of an embodiment of a heart valve positioning device of the present application; Figure 2A is a cross-sectional view of the heart valve positioning device of the present application shown in Fig. 5 in a state where it clamps native valve leaflets after being released;

[0026] Figures 3A-3B are a perspective view and a cross-sectional view, respectively, of another embodiment of a heart valve positioning device of the present application;

[0027] Figure 3C is a perspective view of an embodiment of a heart valve positioning device of the present application; Figure 3A is a schematic view of the heart valve positioning device of the present application shown in Fig. 6 in a state where it clamps native valve leaflets after being released;

[0028] Figures 4A-4B are a perspective view and a top view, respectively, of yet another embodiment of a heart valve positioning device of the present application in a non-use state;

[0029] Figures 4C-4D are a perspective view and a cross-sectional view, respectively, of the heart valve positioning device of the present application shown in Fig. 7 clamping native valve leaflets; Figures 4A-4B

[0030] Figure 5 are cross-sectional views of a heart valve positioning device and a prosthetic valve, respectively, after being released in a heart valve;

[0031] Figures 6A-6F are schematic views of different states of delivering a heart valve positioning device to a heart valve and gradually releasing it, wherein Figure 6C is a cross-sectional view of the state shown in Fig. 8; Figure 6B

[0032] Figures 6G-6H are schematic views of different states of implanting a prosthetic valve in a heart valve and gradually releasing it;

[0033] Figure 7 is a schematic view of a heart valve positioning device in a compressed state;

[0034] Figure 8A is a schematic view of an embodiment of a prosthetic valve system of the present application;

[0035] Figures 8B-8C are a perspective view and a cross-sectional view, respectively, of an embodiment of a prosthetic valve system of the present application shown in Fig. 9 clamping native valve leaflets after being released; Figure 8A

[0036] is a cross-sectional view of the state shown in Fig. 10; Figure 8D Figure 8A ​​​A schematic diagram of an embodiment of a prosthetic valve system shown in a delivery state;

[0037] Figures 8E-8F They are Figure 8A One embodiment of the prosthetic valve system is shown capturing a perspective view and a cross-sectional view of the native valve leaflets;

[0038] Figures 8G-8H They are Figure 8A A perspective view and a cross-sectional view of one embodiment of a prosthetic valve system shown in connection with a delivery system;

[0039] Figure 9A is a structural schematic diagram of another embodiment of the artificial valve system of the present application;

[0040] Figures 9B-9C They are Figure 9A Another embodiment of the prosthetic valve system is shown in perspective and cross-sectional views of the prosthetic valve system after release and clamping the native valve leaflets;

[0041] Figure 10A is a structural schematic diagram of another embodiment of the artificial valve system of the present application;

[0042] Figures 10B-10C They are Figure 10A Another embodiment of a prosthetic valve system is shown with perspective and cross-sectional views of the valve holding the native leaflets after release.

[0043] Component number

[0044] 10: Heart valve positioning device; 20: Delivery system; 101: Stent; 1011: Connector;

[0045] 102: first clamping member; 103: second clamping member; 30: native leaflet; 301: first folded portion;

[0046] 302: second folding portion; 3011: front side of the first folding portion; 3012: back side of the first folding portion;

[0047] 3021: The front side of the second folding part; 3022: The back side of the second folding part; 1012: The main body; 1013: The extension column; 1011a: The through hole; 202: The second pull line; 203: The adjusting sheath; 1021: The first extension part; 1022: The second extension part; 1023: The docking part; 1024: The adjusting part; 1031: The third extension part; 1032: The fourth extension part; 1033: The clamping unit; 1034: The closed ring; 1035: The interface; 40: The artificial valve; 401: The artificial valve leaflet; 402: The support member; 50: The artificial valve system; 501: The support body; 502: The biocompatible membrane; 503: The first pull line. DETAILED DESCRIPTION

[0048] In order to make the personnel in the art better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the embodiments of the present application, all other embodiments obtained by the person of ordinary skill in the art shall belong to the scope protected by the embodiments of the present application.

[0049] The "top" and "upper" refer to the relative upper side with respect to the paper on which the drawing is shown. The "bottom" and "lower" refer to the relative lower side with respect to the paper on which the drawing is shown.

[0050] The "proximal end" refers to the end close to the operator's hand when the heart valve positioning device is delivered, and the "distal end" refers to the end away from the operator's hand when the heart valve positioning device is delivered.

[0051] The specific implementation of the embodiments of the present application will be further described below in combination with the drawings of the embodiments of the present application.

[0052] Referring to Figures 1-7 In a specific implementation of the present application, a heart valve positioning device 10 is provided, which is detachably connected with a delivery system 20. The heart valve includes a native annulus and native leaflets. The heart valve positioning device 10 includes: a cylindrical support 101, the support 101 being provided with at least one connecting piece 1011; a plurality of first clamping pieces 102, the first clamping pieces 102 being distributed along the outer periphery of the support 101, and the first clamping pieces 102 being connected with the support 101; a second clamping piece 103, which is configured to be sleeved on the outer periphery of the first clamping piece 102; in a delivery state, the heart valve positioning device 10 is contracted in the delivery system 20, and the connecting piece 1011 is connected with the delivery system 20; in a release state, the connecting piece 1011 is disconnected from the delivery system 20, the native leaflets 30 are captured between the first clamping piece 102 and the support 101, and the second clamping piece 103 is folded from the outer periphery of the first clamping piece 102 and clamps the native leaflets 30, so that the native leaflets 30 form a folded structure. The native leaflets 30 captured between the first clamping piece 102 and the support 101 can be preliminarily clamped by the first clamping piece 102 and the support 101, and the second clamping piece 103 can further clamp the captured native leaflets 30.

[0053] The stent 101, the first clamping member 102 and the second clamping member 103 can all have elasticity, so that the stent 101 can be compressed for delivery, and the first clamping member 102 and the second clamping member 103 can expand or contract based on the radial direction relative to the outer surface of the stent 101. In a non-use state (when the heart valve positioning device 10 is released without being implanted in the heart), the diameter of the closed or non-closed ring formed by the second clamping member 103 can be greater than, equal to, or less than the diameter of the ring formed by the first clamping member 102.

[0054] The first clamping member 102 can pass through the chordae tendineae and push against the tissue surface on the ventricular side, thereby providing support for the second clamping member 103 to flip the native leaflet 30, and the second clamping member 103 rolls outward by its own elastic force, pushing the inside of the native leaflet 30, and rolling the leaflet around the outside of the first clamping member 102.

[0055] The stent 101 can be a net-like elastic structure, which can be compressed to a smaller outer diameter so as to be accommodated in the sheath tube of the delivery system 20, and when the stent 101 is pushed away from the lumen of the sheath tube of the delivery system 20, the stent 101 can expand to an open state under the action of its own elasticity. The first clamping member 102 and the second clamping member 103 can also be compressed and expanded after being released.

[0056] In an embodiment of the present application, the folded structure formed by the native leaflet 30 includes a first folded portion 301 and a second folded portion 302 connected to each other; in the released state, the first folded portion 301 is clamped between the stent 101 and the first clamping member 102, and the second folded portion 302 is clamped between the first clamping member 102 and the second clamping member 103. The front surface 3011 of the first folded portion 301 and the front surface 3021 of the second folded portion 302 are located on the inside of the native leaflet 30, and the back surface 3012 of the first folded portion 301 and the back surface 3022 of the second folded portion 302 are located on the outside of the native leaflet 30. In the released state, the front surface 3011 of the first folded portion 301 abuts against the outside of the stent 101, the back surface 3012 of the first folded portion 301 abuts against the inside of the first clamping member 102, the front surface 3021 of the second folded portion 302 abuts against the second clamping member 103, and the back surface 3022 of the second folded portion 302 abuts against the outside of the first clamping member 102.

[0057] In one embodiment of the present application, the stent 101 includes a body 1012 and an extension column 1013. The extension column 1013 extends axially upward from the top of the body 1012 and is connected to the connector 1011 at the extended end. The connector 1011 can be a through hole 1011a. The delivery system 20 is provided with a first pull wire, which is used to connect to or disconnect from the through hole 1011a. During delivery, the first pull wire passes through the through hole 1011a to connect the heart valve positioning device 10 to the delivery system 20. After release, the first pull wire is disconnected from the through hole 1011a, and the extension column 1013 clamps the inner side of the native valve leaflet 30 from the front surface 3011 of the first folded portion 301. The delivery system 20 may also be provided without the first pull wire and connected to or disconnected from the connector 1011 by other suitable means. For example, the delivery system 20 may be provided with a protrusion that can engage with or disengage from the through hole 1011a.

[0058] The conveying system 20 may also be provided with a second pull line 202, which is used to connect to or disconnect from the second clamping member 103. Figures 6B-6D As shown, the second pull wire 202 passes through the second clamping member 103. By pulling the second pull wire 202 passing through the second clamping member 103, the second clamping member 103 can be pulled up, releasing the second pull wire 202. The second pull wire 202 is separated from the second clamping member 103, and the second clamping member 103 will be deformed under the action of its own elasticity. The second clamping member 103 extends to the outer periphery of the first clamping member 102 and clamps the inner side of the native leaflet 30 from the front side 3021 of the second folding portion 302.

[0059] In one embodiment of the present application, there may be two or more first clamping members 102, and the bottom of the first clamping member 102 is connected to the bottom of the main body 1012. The first clamping member 102 includes a first extension portion 1021 and a second extension portion 1022 that are connected to each other. The first extension portion 1021 extends downward from the bottom of the main body 1012, and the extension end is connected to the bottom of the second extension portion 1022 to form a docking portion 1023. The second extension portion 1022 extends upward from the docking portion 1023. As the second extension portion 1022 extends upward, it can gradually approach the outer surface of the bracket 101, or extend upward in the axial direction (parallel to the axis of the bracket 101), that is, parallel to the outer surface of the bracket 101. The first folding portion 301 can be connected to the second folding portion 302 at the top of the second extension portion 1022.

[0060] In an embodiment of the present application, the first clamping member 102 comprises an adjusting portion 1024, and the delivery system comprises an adjusting sheath 203, when the adjusting sheath 203 enters between the first clamping member 102 and the stent 101, the adjusting sheath 203 pushes the adjusting portion 1024 to make the top of the second extending portion 1022 away from the outer surface of the stent 101. The adjusting portion 1024 can comprise the abutting portion 1023 and at least a part of the second extending portion 1022, or the adjusting portion 1024 can not comprise the abutting portion 1023 but only comprise a part of the second extending portion 1022. For example, as shown in Figure 6C , when the adjusting sheath 203 enters between the first clamping member 102 and the stent 101, the adjusting sheath 203 can first contact the abutting portion 1023, and since the connector 1011 is connected with the delivery system 20, the operator can control the adjusting sheath 203 to gradually move downward (i.e. in the direction of the ventricle) relative to the stent 101, in the process, the adjusting sheath 203 pushes the adjusting portion 1024 (e.g. a part of the second extending portion 1022) to make the top of the second extending portion 1022 away from the outer surface of the stent 101, i.e. the gap between the second extending portion 1022 and the outer surface of the stent 101 becomes larger, so that the native leaflet 30 is captured between the second extending portion 1022 and the outer surface of the stent 101; then when the adjusting sheath 203 gradually withdraws, the gap between the second extending portion 1022 and the outer surface of the stent 101 becomes smaller, and the second extending portion 1022 and the stent 101 limit and preliminarily clamp the native leaflet 30. The first extending portion 1021 and the second extending portion 1022 can form a circular arc shape (as shown in Figures 2A-5 ), a V shape, a U shape or other suitable shape after being connected.

[0061] In the delivery state, the second extending portion 1022 can be folded by 180 degrees to the distal end and be shrunk in the delivery system 20, as shown in Figure 6A , or can not be folded and be directly compressed and shrunk in the delivery system 20, as shown in Figure 7 .

[0062] The delivery system 20 can comprise a plurality of sub-delivery systems, each of which is respectively provided with a first pull wire, a second pull wire 202 and an adjusting sheath 203.

[0063] The second clamping member 103 extends on the top of the body 1012 and forms a ring along the outer periphery of the first clamping member 102. The second clamping member 103 can comprise a non-closed ring formed by a plurality of arc-shaped rings (as shown in Figure 2A ), or comprise a closed whole ring (as shown in Figure 3A and Figure 4A ).

[0064] In an embodiment of the present application, as shown in Figure 2AAs shown, the second clamping member 103 comprises two clamping units 1033, each of which is provided with a third extension 1031 and a fourth extension 1032 connected with each other. The third extension 1031 of each clamping unit 1033 extends radially and outwardly from the top of the body 1012 to form an arc, and the highest point of the arc is higher than the highest point of the first clamping member 102. The fourth extension 1032 of each clamping unit 1033 extends circumferentially from the end of the arc, so that each clamping unit 1033 is connected end to end to form a non-closed ring, thereby circumferentially surrounding the first clamping member 102. The third extension 1031 of each clamping unit 1033 can comprise two, and the fourth extension 1032 is clamped between the two third extensions 1031 to form part of the ring. The highest point of the arc can also be lower than the highest point of the first clamping member 102. In this embodiment, the second clamping member 103 is integrated with the stent 101 and the first clamping member 102, which is more stable and reliable for clamping and positioning the native leaflet 30. The number of clamping units can also be three or more.

[0065] In another embodiment of the present application, as shown in Figure 3A The second clamping member 103 comprises a closed ring 1034, and the closed ring 1034 is provided with two interfaces 1035 for detachable connection with the delivery system 20.

[0066] In yet another embodiment of the present application, as shown in Figure 4A The second clamping member 103 only comprises one clamping unit, and the fourth extension 1032 forms a closed ring, i.e. the second clamping member 103 comprises a third extension 1031 and a closed ring connected with the third extension 1031. The third extension 1031 can be at least one, for example two or more.

[0067] As shown in Figure 5 In another embodiment of the present application, an artificial valve system is also provided, which comprises the above-mentioned heart valve positioning device 10 and an artificial valve 40. The artificial valve 40 comprises artificial valve leaflets 401 and a cylindrical support member 402, the artificial valve leaflets 401 are fixed circumferentially to the inner side of the support member 402, and the support member 402 is adapted to the stent 101, so that when the heart valve positioning device 10 is released, the artificial valve 40 is implanted into the inner side of the stent 101.

[0068] The artificial valve 40 can comprise a self-expandable or expandable support 402, and a plurality of artificial valve leaflets 401 arranged inside the support 402 to control blood flow. The artificial valve 40 can be accommodated in a delivery tube when in a compressed state, so as to be delivered to a target position. When the heart valve positioning device 10 has been arranged on the native valve, the artificial valve 40 is delivered coaxially into the central hole of the stent 101, and the artificial valve 40 is released to press the inner periphery of the stent 101, so that the artificial valve 40 and the heart valve positioning device 10 are fixed together, at this time the inner periphery of the valve leaflets is pressed by the artificial valve 40, and the outer periphery is limited by the second clamping member 103, so that the valve leaflets are clamped more tightly.

[0069] The application also provides a method for implanting the artificial valve system into a heart, comprising: compressing the heart valve positioning device 10 in the delivery system 20, delivering to a heart valve, releasing the heart valve positioning device 10, capturing the native valve leaflets 30 between the first clamping member 102 and the stent 101, clamping the native valve leaflets 30 by the second clamping member 103 from the outer periphery of the first clamping member 102, making the native valve leaflets 30 form a folded structure, disconnecting the connecting member 1011 from the delivery system 20, and then delivering the artificial valve 40 to the heart valve for release, and implanting the artificial valve 40 into the inner periphery of the stent 101.

[0070] As shown in the specific embodiment, Figures 6A-6G The method for implanting the artificial valve system into a heart is as follows: the heart valve positioning device 10 is compressed in the sheath of the delivery system 20, and is pushed out of the sheath through the blood vessels and the interatrial septum into the left atrium and the left ventricle, the first clamping member 102 is opened by the elastic force, the gap between the second extension 1022 and the outer surface of the stent 101 is enlarged by adjusting the sheath 203 to push the adjusting part 1024, when the second extension 1022 is opened to a suitable size, the second extension 1021 is passed through the chordae tendineae by the delivery system 20, and is hooked to the outer periphery of the native valve leaflets 30 near the annulus, at this time the native valve leaflets 30 are captured between the second extension 1022 and the outer surface of the stent 101. At this time, part of the stent 101 and the second clamping member 103 are limited in the delivery system 20. The heart valve positioning device 10 is further pushed out of the sheath, the stent 101 and the first clamping member 102 continue to deform by elastic force, and the native valve leaflets 30 are further clamped between the stent 101 and the second extension 1022. The second pull wire 202 is released and withdrawn, the second clamping member 103 is rolled outward by the elastic force, and the native valve leaflets 30 are folded and pressed around the outer periphery of the first clamping member 102. The delivery system 20 is disconnected, the interface is released, and the anchoring of the heart valve positioning device 10 on the native valve leaflets 30 is completed.

[0071] AsFigure 5 As shown, when the artificial valve 40 has a self-expandable support 402, the artificial valve 40 is compressed in the sheath of the delivery system (not shown in the figure), and after being delivered to the target position, the artificial valve 40 is pushed out of the sheath, and the artificial valve 40 is self-expanded and tightly pressed against the inside of the stent 101, and the delivery system is released. The pushing force generated by the expansion of the cylindrical support 402 makes the heart valve positioning device 10, the native valve leaflet 30 and the artificial valve 40 more tightly pressed together in the circumferential direction, so that the artificial valve 40 is reliably fixed on the heart valve.

[0072] As shown, when the artificial valve 40 has a self-expandable support 402, the artificial valve 40 is compressed in the sheath of the delivery system (not shown in the figure), and after being delivered to the target position, the artificial valve 40 is pushed out of the sheath, and the artificial valve 40 is self-expanded and tightly pressed against the inside of the stent 101, and the delivery system is released. The pushing force generated by the expansion of the cylindrical support 402 makes the heart valve positioning device 10, the native valve leaflet 30 and the artificial valve 40 more tightly pressed together in the circumferential direction, so that the artificial valve 40 is reliably fixed on the heart valve. Figure 6G As shown, when the artificial valve 40 has an expandable support 402, the artificial valve 40 is compressed in the sheath of the delivery system, and after being delivered to the target position, the artificial valve 40 is pushed out of the sheath, and the frame is expanded in the circumferential direction by the delivery system. The pushing force generated by the expansion makes the heart valve positioning device 10, the native valve leaflet 30 and the artificial valve 40 more tightly pressed together in the circumferential direction, so that the artificial valve system is reliably fixed on the native valve. When the artificial valve 40 is placed, it will squeeze the stent 101 to expand outward in the circumferential direction, and the second clamping member 103 will be tightened inward from the outermost side, thereby firmly clamping the folded native valve leaflet 30. The present application is simple to operate, firmly and reliably fixed on the native valve of the human body, and greatly reduces the risk of displacement after implantation of the artificial valve system. In addition, by squeezing the second clamping member 103 inward in the circumferential direction, paravalvular leakage can be effectively prevented.

[0073] Because the native valve leaflet 30 tissue has softness, the heart valve positioning device 10 is controlled to deform by the delivery system 20, and gradually drives the native valve leaflet 30 tissue to deform, and finally tightly locates on the native valve leaflet 30. The heart valve positioning device 10 of the present application can easily pass through the chordae tendineae to hook and support the native valve leaflet 30, and is simple and easy to operate. The native valve leaflet 30 is folded and pressed on the outside of the first clamping member 102 in the circumferential direction by the second clamping member 103, and the positioning is simple and reliable.

[0074] As shown, when the artificial valve 40 has an expandable support 402, the artificial valve 40 is compressed in the sheath of the delivery system, and after being delivered to the target position, the artificial valve 40 is pushed out of the sheath, and the frame is expanded in the circumferential direction by the delivery system. The pushing force generated by the expansion makes the heart valve positioning device 10, the native valve leaflet 30 and the artificial valve 40 more tightly pressed together in the circumferential direction, so that the artificial valve system is reliably fixed on the native valve. When the artificial valve 40 is placed, it will squeeze the stent 101 to expand outward in the circumferential direction, and the second clamping member 103 will be tightened inward from the outermost side, thereby firmly clamping the folded native valve leaflet 30. The present application is simple to operate, firmly and reliably fixed on the native valve of the human body, and greatly reduces the risk of displacement after implantation of the artificial valve system. In addition, by squeezing the second clamping member 103 inward in the circumferential direction, paravalvular leakage can be effectively prevented. Figures 8A-10CAs shown, unlike the above embodiments, the following embodiment is a prosthetic valve system 50 that integrates a prosthetic valve with a heart valve positioning device. Specifically, the prosthetic valve system 50 includes a cylindrical support body 501 provided with at least one connecting member, an inner side of the support body 501 being circumferentially provided with prosthetic valve leaflets; a plurality of first clamping members connected to a bottom of the support body 501 and distributed on an outer periphery of the support body 501; a second clamping member configured to be sleeved on an outer periphery of the first clamping member; in a delivery state, the connecting member is connected to the delivery system, and the prosthetic valve system 50 is shrunk in the delivery system; in a released state, the connecting member is disconnected from the delivery system, the native valve leaflet is captured between the first clamping member and the support body 501, and the second clamping member is folded from the outer periphery of the first clamping member and clamps the native valve leaflet, so that the native valve leaflet forms a folded structure. The native valve leaflet 30 captured between the first clamping member 102 and the support body 501 can be preliminarily clamped by the first clamping member 102 and the support body 501, and the second clamping member 103 can further clamp the captured native valve leaflet 30.

[0075] The support body 501, the first clamping member 102, the second clamping member 103, and the prosthetic valve leaflets can all have elasticity, so that the prosthetic valve system 50 can be compressed for delivery, and the first clamping member 102 and the second clamping member 103 can expand or contract radially relative to an outer surface of the support body 501. In a non-use state (the prosthetic valve system 50 is released when not implanted in the heart), the diameter of the closed or non-closed ring formed by the second clamping member 103 can be greater than, equal to, or less than the diameter of the ring formed by the first clamping member 102. In an optional embodiment, the inner side or both the inner side and the outer side of the support body 501 is provided with a biocompatible membrane 502 by suturing, welding, or other processes. The prosthetic valve leaflets can include one or more valve leaflets for controlling blood flow, which can be connected to the inner side of the support body 501 by suturing or other processes. The prosthetic valve leaflets can contract radially when compressed and expand radially when released.

[0076] The support body 501 can be a net-like elastic structure composed of a plurality of diamond-shaped cells, parallelogram-shaped cells, or cells of other shapes, which can be compressed to a smaller outer diameter so as to be accommodated in the sheath of the delivery system 20, and when the support body 501 is pushed out of the lumen of the sheath of the delivery system 20, the support body 501 can expand to an open state under the action of its own elasticity. The first clamping member 102 and the second clamping member 103 can also be compressed and expanded after release.

[0077] The first clamping member 102 can pass through the chordae tendineae and push the hook on the tissue surface on the ventricular side, thereby providing support for the second clamping member 103 to flip the native leaflet 30. The second clamping member 103 rolls outward through its own restoring elastic force, pushing the inner side of the native leaflet 30, and pressing the leaflet to be rolled around the outer side of the first clamping member 102.

[0078] In one embodiment of the present application, the folded structure formed by the native leaflet 30 includes a first folded portion 301 and a second folded portion 302 that are connected to each other. In the released state, the first folded portion 301 is clamped between the support body 501 and the first clamping member 102, and the second folded portion 302 is clamped between the first clamping member 102 and the second clamping member 103. The front surface 3011 of the first folded portion 301 and the front surface 3021 of the second folded portion 302 are located on the inner side of the native leaflet 30, while the back surface 3012 of the first folded portion 301 and the back surface 3022 of the second folded portion 302 are located on the outer side of the native leaflet 30. In the released state, the front face 3011 of the first folding portion 301 abuts against the outer side of the support body 501, the back face 3012 of the first folding portion 301 abuts against the inner side of the first clamping member 102, the front face 3021 of the second folding portion 302 abuts against the second clamping member 103, and the back face 3022 of the second folding portion 302 abuts against the outer side of the first clamping member 102.

[0079] The connector 1011 can be a through hole 1011a provided at the top of the support body 501. The delivery system 20 is provided with a first pull wire 503, which is used to connect to or disconnect from the through hole 1011a. During delivery, the first pull wire 503 passes through the through hole 1011a to connect the artificial valve system 50 to the delivery system 20. After release, the first pull wire 503 disconnects from the through hole 1011a, and the support body 501 clamps the inner side of the native leaflet 30 from the front side 3011 of the first folded portion 301. The delivery system 20 can also be connected to or disconnected from the connector 1011 by other suitable means without the first pull wire 503. For example, the delivery system 20 can be provided with a protrusion that can be engaged with or disconnected from the through hole 1011a.

[0080] The conveying system 20 may also be provided with a second pull line 202, which is used to connect to or disconnect from the second clamping member 103. Figures 8G-8H As shown, the second pull wire 202 passes through the second clamping member 103. By pulling the second pull wire 202 passing through the second clamping member 103, the second clamping member 103 can be pulled up, releasing the second pull wire 202. The second pull wire 202 is separated from the second clamping member 103, and the second clamping member 103 will be deformed under the action of its own elasticity. The second clamping member 103 extends to the outer periphery of the first clamping member 102 and clamps the inner side of the native leaflet 30 from the front side 3021 of the second folding portion 302.

[0081] In one embodiment of the present application, there may be two or more first clamping members 102, and the bottom of the first clamping member 102 is connected to the bottom of the support body 501. The first clamping member 102 includes a first extension portion 1021 and a second extension portion 1022 that are connected to each other. The first extension portion 1021 extends downward from the bottom of the support body 501, and the extension end connects with the bottom of the second extension portion 1022 to form a docking portion 1023. The second extension portion 1022 extends upward from the docking portion 1023. As the second extension portion 1022 extends upward, it can gradually approach the outer surface of the support body 501, or extend upward in the axial direction (parallel to the axis of the support body 501), that is, parallel to the outer surface of the support body 501. The first folding portion 301 can be connected to the second folding portion 302 at the top of the second extension portion 1022.

[0082] In one embodiment of the present application, the first clamping member 102 includes an adjusting portion 1024, and the delivery system includes an adjusting sheath 203. When the adjusting sheath 203 enters between the first clamping member 102 and the support body 501, the adjusting sheath 203 pushes against the adjusting portion 1024 to move the top of the second extension portion 1022 away from the outer surface of the support body 501. The adjusting portion 1024 may include a docking portion 1023 and at least a portion of the second extension portion 1022. The adjusting portion 1024 may also include only a portion of the second extension portion 1022 without including the docking portion 1023. For example, Figure 8F As shown, after the adjustment sheath 203 enters between the first clamping member 102 and the support body 501, the adjustment sheath 203 may first contact the docking portion 1023. Since the connector 1011 is connected to the delivery system 20, the operator may control the adjustment sheath 203 to gradually move downward (i.e., toward the ventricle) relative to the support body 501. During this process, the adjustment sheath 203 pushes the adjustment portion 1024 (e.g., a portion of the second extension portion 1022) to move the top of the second extension portion 1022 away from the outer surface of the support body 501, i.e., the gap between the second extension portion 1022 and the outer surface of the support body 501 becomes larger, thereby capturing the native leaflet 30 between the second extension portion 1022 and the outer surface of the support body 501. When the adjustment sheath 203 is gradually withdrawn, the gap between the second extension portion 1022 and the outer surface of the support body 501 becomes smaller, and the second extension portion 1022 and the support body 501 restrict and preliminarily clamp the native leaflet 30. After the first extension portion 1021 and the second extension portion 1022 are connected, they can form an arc shape (such as Figures 2A-5 as shown), V-shaped, U-shaped or other suitable shapes.

[0083] In the delivery state, the second extension portion 1022 can be folded 180 degrees toward the distal end and retracted into the delivery system 20. Figure 8DAs shown; or can not be folded, directly compressed in the delivery system 20.

[0084] The delivery system 20 can include a plurality of sub-delivery systems, each of which is respectively provided with a first pull wire 503, a second pull wire 202 and an adjustment sheath 203.

[0085] In an embodiment, the second clamping member 103 extends on the top of the support body 501 and forms a ring along the outer periphery of the first clamping member 102. The second clamping member 103 can include a non-closed ring formed by a plurality of arc-shaped rings (as shown in Figures 8A-8H ), or a closed whole ring (as shown in Figures 9A-10C ).

[0086] In an embodiment of the present application, as shown in Figure 8A , the second clamping member 103 includes two clamping units 1033, each of which is respectively provided with a third extension 1031 and a fourth extension 1032 connected to each other. The third extension 1031 of each clamping unit 1033 extends radially outward from the top of the support body 501 to form an arc shape, and the highest point of the arc shape is higher than the highest point of the first clamping member 102. The fourth extension 1032 of each clamping unit 1033 extends circumferentially from the end of the arc shape, so that the two clamping units 1033 are connected end to end to form a non-closed ring, thereby circumferentially surrounding the first clamping member 102. The third extension 1031 of each clamping unit 1033 can include two, and the fourth extension 1032 is clamped between the two third extensions 1031 to form part of the ring. The highest point of the arc shape can also be lower than the highest point of the first clamping member 102. In this embodiment, the second clamping member 103 is integrated with the support body 501 and the first clamping member 102, and the clamping and positioning of the native leaflet 30 are more stable and reliable. The number of clamping units can also be three or more.

[0087] In another embodiment of the present application, as shown in Figure 3A , the second clamping member 103 includes a closed ring 1034, and the closed ring 1034 is provided with two interfaces 1035 for detachable connection with the delivery system 20.

[0088] In still another embodiment of the present application, as shown in Figure 9A , the second clamping member 103 only includes one clamping unit, and the fourth extension 1032 forms a closed ring, that is, the second clamping member 103 includes a third extension 1031 and a closed ring connected to the third extension 1031. The third extension 1031 can be at least one, for example, two or more.

[0089] The application also provides a method for implanting the artificial valve system 50 into a heart, which comprises: compressing the artificial valve system 50 in the delivery system 20, delivering to a heart valve, releasing the artificial valve system 50, capturing the native valve leaflet 30 between the first clamping member 102 and the support body 501, clamping the native valve leaflet 30 from the outer periphery of the first clamping member 102 by the second clamping member 103, forming a folded structure of the native valve leaflet 30, and disconnecting the connecting member 1011 from the delivery system 20.

[0090] In a specific embodiment, the method for implanting the artificial valve system 50 into a heart is as follows: compressing the artificial valve system 50 in the sheath of the delivery system 20, entering the left atrium and the left ventricle through the blood vessels and the interatrial septum of the human body, gradually pushing the artificial valve system 50 out of the sheath, and opening the first clamping member 102 by the elastic force of itself. The gap between the second extension 1022 and the outer surface of the support body 501 is enlarged by adjusting the sheath 203 to push the adjusting part 1024. When the second extension 1022 is opened to a suitable size, the second extension 1021 is passed through the chordae tendineae by the delivery system 20, and the native valve leaflet 30 is hooked on the outside of the annulus. At this time, the native valve leaflet 30 is captured between the second extension 1022 and the outer surface of the support body 501. At this time, part of the support body 501 and the second clamping member 103 are limited in the delivery system 20. Further pushing the heart valve positioning device 10 out of the sheath, the support body 501 and the first clamping member 102 continue to deform by the elastic force, and the native valve leaflet 30 is further clamped between the support body 501 and the second extension 1022. The second pull wire 202 is released and withdrawn, the second clamping member 103 is rolled outward by the elastic force of itself, and the native valve leaflet 30 is folded and pressed on the outside of the first clamping member 102. The delivery system 20 is disconnected, the interface is released, and the anchoring of the support body 501 on the native valve leaflet 30 is completed.

[0091] Because the native valve leaflet 30 tissue has softness, the artificial valve system 50 controls the deformation by the delivery system 20, gradually drives the deformation of the native valve leaflet 30 tissue, and finally tightens and positions on the native valve leaflet 30. The artificial valve system 50 of the application can easily pass through the chordae tendineae to hook the native valve leaflet 30, and the operation is simple, easy and fast. The native valve leaflet 30 is folded and pressed on the outside of the first clamping member 102 by the second clamping member 103, and the positioning is simple and reliable.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the application, rather than limit them; although the 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 recorded in the foregoing embodiments, or make equivalent replacement for part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the application.

Claims

1. A heart valve positioning device, detachably connectable with a delivery system, the heart valve comprising a native annulus and native leaflets, characterized in that, The heart valve positioning device comprises: a cylindrical support provided with at least one connecting member; a plurality of first clamping members distributed along the outer periphery of the support and connected to the support; a second clamping member configured to be sleeved on the outer periphery of the first clamping member; in a delivery state, the heart valve positioning device is contracted in the delivery system, and the connecting member is connected to the delivery system; in a released state, the connecting member is disconnected from the delivery system, the native valve leaflet is captured between the first clamping member and the support, and the second clamping member is folded from the outer periphery of the first clamping member and clamps the native valve leaflet, so that the native valve leaflet forms a folded structure; the folded structure comprises a first folded part and a second folded part connected to each other; in the released state, the first folded part is clamped between the support and the first clamping member, and the second folded part is clamped between the first clamping member and the second clamping member; the first folded part and the second folded part each comprise a front surface inside the native valve leaflet and a back surface outside the native valve leaflet; in the released state, the front surface of the first folded part abuts against the outer side of the support, the back surface of the first folded part abuts against the inner side of the first clamping member, the front surface of the second folded part abuts against the second clamping member, and the back surface of the second folded part abuts against the outer side of the first clamping member.

2. The heart valve positioning device of claim 1, wherein, the support comprises a body and an extension column extending axially upward from the body and connected to the connecting member at an extension end, and the bottom of the first clamping member is connected to the bottom of the body.

3. The heart valve positioning device of claim 2, wherein, the first clamping member comprises a first extension part and a second extension part connected to each other, the first extension part extends downward from the bottom of the body, and an extension end thereof is connected to the second extension part to form a butt joint part, and the second extension part extends upward from the butt joint part.

4. The heart valve positioning device of claim 3, wherein, the first folded part and the second folded part are connected at the top of the second extension part.

5. The heart valve positioning device of claim 3, wherein, the first clamping member comprises an adjusting part, and the delivery system comprises an adjusting sheath, when the adjusting sheath enters between the first clamping member and the support, the adjusting sheath pushes the adjusting part to make the top of the second extension part away from the outer surface of the support.

6. The heart valve positioning device of claim 5, wherein, the adjusting part comprises the butt joint part and at least a part of the second extension part.

7. The heart valve positioning device of claim 2, wherein, the second clamping member extends at the top of the body and forms a ring along the outer periphery of the first clamping member.

8. The heart valve positioning device of claim 7, wherein, the second clamping member is provided with a third extension part and a fourth extension part connected to each other, the third extension part extends radially outward from the top of the body to form an arc shape, the highest point of the arc shape is higher than the highest point of the first clamping member, and the fourth extension part extends circumferentially from the end of the arc shape to circumferentially surround the first clamping member.

9. The heart valve positioning device of claim 8, wherein, the second clamping member comprises at least two clamping units, each clamping unit is provided with a third extension part and a fourth extension part, and each fourth extension part extends circumferentially along the outer periphery of the first clamping member to form a non-closed ring.

10. The heart valve positioning device of claim 8, wherein, the fourth extension part forms a closed ring.

11. The heart valve positioning device of claim 7, wherein, the second clamping member comprises a closed ring, and an interface is arranged on the closed ring for detachable connection with the delivery system.

12. An artificial valve system comprising: the heart valve positioning device according to any one of claims 1 to 11; an artificial valve comprising: an artificial valve leaflet; and ​ A cylindrical support member, the artificial valve leaflets are circumferentially fixed to the inner side of the support member, and the support member is matched with the stent to implant the artificial valve into the inner side of the stent after the heart valve positioning device is released.

13. A prosthetic valve system detachably connectable with a delivery system, characterized in that The artificial valve system comprises: A cylindrical support body provided with at least one connecting member, the inner side of the support body is circumferentially provided with artificial valve leaflets; A plurality of first clamping members connected to the bottom of the support body and distributed on the outer periphery of the support body; A second clamping member configured to be sleeved on the outer periphery of the first clamping member; In the delivery state, the connecting member is connected with the delivery system, and the artificial valve system is shrunk in the delivery system; in the released state, the connecting member is separated from the delivery system, the native valve leaflets of the heart valve are captured between the first clamping member and the support body, and the second clamping member is folded from the outer periphery of the first clamping member and clamps the native valve leaflets, so that the native valve leaflets form a folded structure; The folded structure comprises a first folded part and a second folded part connected to each other; in the released state, the first folded part is clamped between the support body and the first clamping member, and the second folded part is clamped between the first clamping member and the second clamping member; The first folded part and the second folded part respectively comprise a front surface located on the inner side of the native valve leaflet and a back surface located on the outer side of the native valve leaflet; in the released state, the front surface of the first folded part abuts against the outer side of the support body, the back surface of the first folded part abuts against the inner side of the first clamping member, the front surface of the second folded part abuts against the second clamping member, and the back surface of the second folded part abuts against the outer side of the first clamping member.

14. The prosthetic valve system of claim 13, wherein, The first clamping member comprises a first extension part and a second extension part connected to each other, the first extension part extends downward from the bottom of the support body, and the extension end is connected with the second extension part to form a butt joint part, and the second extension part extends upward from the butt joint part.

15. The prosthetic valve system of claim 14, wherein, The first folded part and the second folded part are connected at the top of the second extension part.

16. The prosthetic valve system of claim 14, wherein, The first clamping member comprises an adjusting part, and the delivery system comprises an adjusting sheath, when the adjusting sheath enters between the first clamping member and the support body, the adjusting sheath pushes the adjusting part to make the top of the second extension part away from the outer surface of the support body.

17. The prosthetic valve system of claim 16, wherein, The adjusting part comprises the butt joint part and at least a part of the second extension part.

18. The prosthetic valve system of claim 13, wherein, The second clamping member extends at the top of the support body and forms a ring along the outer periphery of the first clamping member.

19. The prosthetic valve system of claim 18, wherein, The second clamping member is provided with a third extension part and a fourth extension part connected to each other, the third extension part extends radially outward from the top of the support body to form an arc shape, the highest point of the arc shape is higher than the highest point of the first clamping member, and the fourth extension part extends circumferentially from the end of the arc shape to circumferentially surround the first clamping member.

20. The prosthetic valve system of claim 19, wherein, The second clamping member comprises at least two clamping units, each clamping unit is respectively provided with a third extension part and a fourth extension part, and each fourth extension part extends circumferentially on the outer periphery of the first clamping member to form a non-closed ring.

21. The prosthetic valve system of claim 19, wherein, The fourth extension part forms a closed ring.

22. The prosthetic valve system of claim 18, wherein, The second clamping member comprises a closed ring, and an interface is arranged on the closed ring for detachable connection with the delivery system.

Images