Heart valve positioning device, artificial heart valve system, implantation system and method

Abstract

The present application provides a heart valve positioning device, comprising: a supravalvular structure, a subravalvular structure, a connector, and a locking structure, wherein the supravalvular structure, the subravalvular structure, and the connector are all tubular structures, and the supravalvular structure and the subravalvular structure each form a curved structure in the released state; the subravalvular structure has a first end and a second end, the first end and the second end are separated from each other in the delivery state, and can be connected to each other through the locking structure in the released state, so that the subravalvular structure forms a closed ring, and the subravalvular structure retracts at least a portion of the native valve leaflets inside the closed ring, and the supravalvular structure is anchored to the inside of the native valve ring. The heart valve positioning device of the present application and the artificial valve are delivered through the atrial septum from the same pathway, which is simple to operate and can avoid causing damage to the aortic valve.

Description

Technical Field

[0001] The embodiments of the present application relate 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 a method. Background Art

[0002] The mitral valve, also known as the left atrioventricular valve, is a barrier formed between the left ventricle and the left atrium. Under normal circumstances, the opening and closing of the mitral valve is regulated by the pressure difference between the left atrium and the left ventricle. During diastole, the pressure in the left atrium is greater than that in the left ventricle, and the mitral valve opens. Conversely, during systole, the pressure in the left ventricle is greater than that in the left atrium, and the mitral valve closes. The mitral valve has a complex structure and is composed of the valve annulus, valve leaflets, chordae tendineae, and papillary muscles. Organic or functional changes in any of these parts may cause mitral regurgitation, that is, the mitral valve cannot close completely during systole, allowing blood from the left ventricle to flow back into the left ventricle. Treatments for mitral regurgitation include valve repair and replacement. Valve repair is the common first choice of treatment, but valve replacement is the ultimate and fundamental solution.

[0003] Valve replacement can be performed through surgery or transcatheter intervention. For some patients with mitral regurgitation, who are not suitable for surgery due to high-risk factors such as poor heart function, multiple comorbidities, and advanced age, transcatheter intervention treatment can be used. Transcatheter aortic valve replacement is a well-established treatment for aortic valve disease, with several transcatheter aortic valve products currently on the market. While various transcatheter mitral valve designs and delivery methods have emerged in recent years, most remain in the research phase, primarily due to the following limitations: The mitral valve is structurally complex. Compared to the aortic valve, the mitral valve has a D-shaped overall structure, a larger annulus, and less calcification, which in turn prevents the prosthetic valve from providing sufficient support to secure it to the diseased mitral valve. Anatomically, the left ventricular outflow tract is adjacent to the anterior mitral leaflet, and implantation of the mitral prosthesis may also cause left ventricular outflow tract obstruction (LVOTO), which must be avoided during prosthetic valve design. The mitral valve annulus is larger, requiring a larger diameter stent for a single-layer prosthesis compared to the aortic valve. This increases the leaflet area corresponding to the prosthesis, reducing leaflet fatigue resistance and increasing the size of the delivery system, thereby increasing the risk of vascular complications.

[0004] Therefore, there is an urgent need for a product that does not require changing the heart structure and can treat valvular regurgitation through a minimally invasive approach. Summary of the Invention

[0005] In view of the above problems, the present application provides a method to overcome the above problems or at least partially solve the above problems.

[0006] An embodiment of the present application provides a heart valve positioning device, which can be delivered to a heart valve via a delivery device, wherein the heart valve includes a native leaflet and a native valve ring, and the heart valve positioning device includes: a supravalvular structure, a subravalvular structure, a connector and a locking structure, wherein the supravalvular structure, the subravalvular structure and the connector are all tubular structures, the supravalvular structure and the subravalvular structure are connected by the connector to form a bent structure, and the supravalvular structure and the subravalvular structure each form a bent structure in a released state; the subravalvular structure has a first end and a second end, the first end and the second end are separated from each other in a delivered state, and can be connected to each other by the locking structure in a released state, so that the subravalvular structure forms a closed ring, and the subravalvular structure retracts at least a portion of the native leaflet to the inner side of the closed ring, and the supravalvular structure is anchored to the inner side of the native valve ring.

[0007] Optionally, the supraplaval structure and the subraplaval structure are parallel to each other, and an angle α between the connector and the subraplaval structure is greater than 90°.

[0008] Optionally, the extension direction of the supraplaval structure is the same as or opposite to the extension direction of the subraplaval structure.

[0009] Optionally, the supravalvular structure, the subravalvular structure, and the connector are respectively provided with a tube body and a cavity formed inside the tube body, and the cavities of the supravalvular structure, the subravalvular structure, and the connector are interconnected; the positioning device also includes: a guide member, which has a distal end and a proximal end, and is configured to be inserted into the cavities of the supravalvular structure, the subravalvular structure, and the connector, and the distal end of the guide member is close to the first end. After the positioning device is delivered to the heart valve, the proximal end of the guide member is located outside the patient's body; a capturing member, which is configured to capture the distal end of the guide member and drag the distal end of the guide member toward the proximal end, so that the first end and the second end are interconnected through the locking structure.

[0010] Optionally, the second end portion is provided with a through hole for the capture member to pass through.

[0011] Optionally, the capture member passes through the perforation from outside the positioning device into the cavity of the subvalvular structure to capture the distal end of the guide member near the first end.

[0012] Optionally, the supraplaval structure has a first main cavity and a first auxiliary cavity, wherein the first main cavity is connected to the connector for the guide member to pass through it; the first auxiliary cavity is used for the capture member to pass through and enter the cavity of the subraplaval structure through the perforation to capture the distal end of the guide member near the first end.

[0013] Optionally, the subvalvular structure has a second main cavity and a second auxiliary cavity, the second main cavity is communicated with the connector for the guide member to pass through it; the second auxiliary cavity at least partially surrounds the second main cavity.

[0014] Optionally, the diameter of the supraplaval structure is not less than the diameter of the subraplaval structure.

[0015] Optionally, the width of the subvalvular structure is greater than the width of the suprapalpla! structure, and the width of the subvalvular structure is greater than the width of the connector.

[0016] Optionally, the locking structure includes a mating body and a receiving body, and the mating body and the receiving body are respectively arranged at one of the first end and the second end. The mating body and the receiving body can be connected to each other in a cooperative manner, and the outer diameter of the receiving body is less than the inner diameter of the mating body, so that when the mating body and the receiving body are connected to each other in a cooperative manner, the receiving body enters the interior of the mating body.

[0017] Optionally, the fitting body has an extension portion, and the receiving body has an expansion portion and a contraction portion, and the outer diameter of the expansion portion is greater than the outer diameter of the contraction portion; when the fitting body and the receiving body are in a docking state, the expansion portion applies an expansion force to the extension portion to expand the inner diameter of the extension portion and the receiving body enters the fitting body; when the fitting body and the receiving body are in an engaged state, the extension portion is engaged with the contraction portion, and the inner diameter of the extension portion returns to its initial state.

[0018] Optionally, the extension portion includes: a first extension portion, which extends radially outward from the first end portion; and a second extension portion, which is elastic and extends radially inward from the end portion of the first extension portion, so that the first extension portion and the second extension portion together form a trumpet-shaped structure.

[0019] Optionally, the extension portion extends radially inward from the first end portion, and a side wall of the first end portion is provided with at least one opening.

[0020] Optionally, the end of the expansion portion is a tapered structure.

[0021] Optionally, the receiving body has a boss, and a spring sheet is provided on the outer periphery of the mating body, which extends radially outward from the second end; when the mating body and the receiving body are in a docking state, the boss applies pressure to the spring sheet so that the spring sheet is squeezed and passes over the boss; when the mating body and the receiving body are in a locked state, the spring sheet returns to an expanded state and is locked to the inner side of the boss.

[0022] Optionally, the mating body and the receiving body are respectively provided with one of a first protrusion and a first groove, and when the mating body and the receiving body are docked, the first protrusion enters the first groove.

[0023] Optionally, the mating body is provided with a second protrusion, and when the mating body and the receiving body are docked, the second protrusion is engaged with the outer surface of the receiving body.

[0024] On the other hand, the present application provides an artificial heart valve system, which includes: the above-mentioned heart valve positioning device; an artificial valve, which includes: artificial valve leaflets; and a tubular support member, which is circumferentially fixed to the inner side of the support member, and the support member is adapted to the heart valve positioning device so that when the heart valve positioning device is released, the artificial valve is implanted into the inner side of the subvalvular structure.

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

[0026] On the other hand, the present application also provides an implantation method of an artificial heart valve system, which includes: placing the heart valve positioning device in a delivery device, which is delivered to the native leaflet commissure through the atrial septum and then slowly releasing the subvalvular structure, so that the subvalvular structure moves around the native leaflet to form an open ring, and the native leaflet is gathered inside the ring; the capture member captures the distal end of the guide member and drags the distal end of the guide member toward the proximal end until the distal end of the guide member is brought out of the body; the proximal and distal ends of the guide member are fixed, and the supravalvular structure is pushed toward the distal end, so that the first end and the second end of the subvalvular structure are interconnected by the locking structure, so that the subvalvular structure forms a closed ring; the guide member and the capture member are withdrawn, and the connector and the supravalvular structure are released in turn; the artificial valve is delivered to the inside of the subvalvular structure through the atrial septum and released.

[0027] It can be seen from the above technical solutions that the artificial valve of the present application in the embodiment of the present application is relatively small in size, which can avoid problems such as vascular complications during transportation and premature failure of artificial valve leaflets after implantation caused by implanting larger artificial valves. In addition, the artificial valve of the present application has a lower subvalvular height, which can avoid blocking the left ventricular outflow tract and causing the occurrence of left ventricular outflow tract obstruction. Secondly, the subvalvular structure of the positioning device of the present application can form a closed ring through a locking structure, clamping the native leaflets between the subvalvular structure and the artificial valve, and utilizing the fit between the native leaflet tissue and the subvalvular structure and the artificial valve to achieve a good sealing effect, thereby avoiding the occurrence of paravalvular leakage after the artificial valve is implanted.

[0028] The present application can lock the subvalvular structure with the locking structure at one time when releasing the subvalvular structure, forming a closed ring and improving the efficiency of the operation.

[0029] The heart valve positioning device and the artificial valve of the embodiment of the present application are delivered through the atrial septum from the same pathway, which is simple to operate and can avoid tissue damage caused by multi-pathway delivery, such as damage to the aortic valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0031] Figure 1-3 They are respectively a three-dimensional view, a side view and a top view of an embodiment of a heart valve positioning device of the present application;

[0032] Figure 4 This is a schematic diagram of the installation method of the guide member and the capture member of a heart valve positioning device of the present application;

[0033] Figure 5 is a schematic diagram of an artificial heart valve system of the present application after being released from the heart;

[0034] Figure 6 is a schematic diagram of another embodiment of a heart valve positioning device of the present application;

[0035] Figure 7 is a schematic diagram of another embodiment of a heart valve positioning device of the present application;

[0036] Figure 8 is a schematic diagram of another embodiment of a heart valve positioning device of the present application;

[0037] Figures 9A-9B Schematic diagrams of the first embodiment of the locking structure of the present application in the unlocked and locked states respectively;

[0038] Figure 10A 1 is a schematic diagram of the second embodiment of the locking structure of the present application in unlocked and locked states;

[0039] Figure 10B yes Figure 10A A cross-sectional view of an embodiment of the locking structure of the present application in a locked state is shown;

[0040] Figure 11 is a cross-sectional view of the third embodiment of the locking structure of the present application in a locked state;

[0041] Figure 12-14 are cross-sectional views of the fourth to sixth embodiments of the locking structure of the present application in the locked state;

[0042] Figures 15A-15F They are schematic diagrams of the process of the artificial heart valve system from delivery to release into the heart.

[0043] Component number

[0044] 101: supraplaval structure; 102: subraplaval structure; 103: connector; 104: locking structure; 105: first end; 106: second end; 107: guide member; 108: capture member; 109: perforation; 110: first main cavity; 111: first auxiliary cavity; 112: second main cavity; 113: second auxiliary cavity; 114: fitting member; 115: receiving member; 116: expansion portion; 117: contraction portion; 118: first extension portion; 119: second extension portion; 120: boss; 121: spring piece; 122: first protrusion; 123: first groove; 124: second protrusion; 125: artificial valve; 126: support member; 127: delivery device; 128: delivery pipe; 129: extension portion; 130: opening. DETAILED DESCRIPTION

[0045] In order to enable those skilled in the art to 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 conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field should fall within the scope of protection of the embodiments of the present application.

[0046] The “distal end” refers to the end that is implanted in or close to the heart when the positioning device is implanted in the heart. The “proximal end” refers to the end that is away from the heart when the positioning device is implanted in the heart.

[0047] The specific implementation of the embodiment of the present application is further explained below in conjunction with the accompanying drawings of the embodiment of the present application.

[0048] See also Figures 1 to 14In a specific implementation of the present application, a heart valve positioning device is provided, which can be delivered to the heart valve via a delivery device 127, wherein the heart valve includes native leaflets and a native valve ring, and the heart valve positioning device includes: a supravalvular structure 101, a subravalvular structure 102, a connector 103 and a locking structure 104, wherein the supravalvular structure 101, the subravalvular structure 102, and the connector 103 are all tubular structures, and the tubular structure may include one or more penetrating cavities. The supraplaval structure 101 and the subraplaval structure 102 are connected by the connector 103 to form a bent structure, and the supraplaval structure 101 and the subraplaval structure 102 each form a bent structure in the released state, such as an arc or a circle that is not round; the subraplaval structure 102 has a first end 105 and a second end 106, and the first end 105 and the second end 106 are separated from each other in the conveying state, and can be connected to each other through the locking structure 104 in the released state, so that the subraplaval structure 102 forms a closed ring, and the subraplaval structure 102 retracts at least a part of the native leaflet to the inner side of the closed ring, and the supraplaval structure 101 is anchored to the inner side of the native valve ring.

[0049] The extending direction of the supraplaval structure 101 and the extending direction of the subraplaval structure 102 can be the same or opposite. The extending direction refers to the direction in which the supraplaval structure 101 or subraplaval structure 102 extends from the connection point with the connector 103. Figure 1 As shown, the supraplaval structure 101 extends in a clockwise direction, and the subraplaval structure 102 extends in a counterclockwise direction. The extending direction of the supraplaval structure 101 is opposite to the extending direction of the subraplaval structure 102. Figure 8 As shown, the supraplaval structure 101 and the subraplaval structure 102 both extend in a counterclockwise direction, with the supraplaval structure 101 extending in the same direction as the subraplaval structure 102. When the supraplaval structure 101 extends in the opposite direction to the subraplaval structure 102, the subraplaval structure 102 can be ensured to surround the anterior leaflet during release, ensuring sufficient operating space.

[0050] The supraplaval structure 101 and the subraplaval structure 102 may be parallel or non-parallel or extend irregularly to each other. In one embodiment, the angle α between the connector 103 and the subraplaval structure 102 is greater than 90°, so that the angle on the other side between the connector 103 and the subraplaval structure 102 is less than 90°, which is conducive to the deformation of the positioning device and its storage in the conveying device.

[0051] In one embodiment, if Figure 3 As shown, the diameter of the supravalvular structure 101 is not less than the diameter of the subravalvular structure 102, so that the supravalvular structure 101 can be more firmly anchored to the inner side of the native valve ring.

[0052] The width of the subvalvular structure 102 is greater than the width of the supravalvular structure 101, and the width of the subvalvular structure 102 is greater than the width of the connector 103, so as to enhance the stability of the subvalvular structure 102 after capturing the native leaflets, and to enhance the support force of the subvalvular structure 102 on the artificial valve 125. However, the width of the subvalvular structure 102 is not limited to this, and can also be less than or equal to the width of the supravalvular structure 101. The "width" mentioned above refers to the diameter or maximum dimension of the cross section of the subvalvular structure 102 or the supravalvular structure 101.

[0053] In one embodiment, the supraplaval structure 101, the subraplaval structure 102, and the connector 103 are each provided with a tubular body and one or more cavities formed within the tubular body, and the cavities of the supraplaval structure 101, the subraplaval structure 102, and the connector 103 are interconnected. The supraplaval structure 101 and the subraplaval structure 102 may be provided with one, two, or more cavities at the same time, or one may be provided with one cavity and the other with two or more cavities, and one of the cavities of the supraplaval structure 101 and the subraplaval structure 102 may be respectively communicated with the connector 103.

[0054] In one embodiment, the positioning device further includes a guide member 107 and a capture member 108. The guide member 107 has a distal end and a proximal end. The guide member 107 is configured to be inserted into the cavities of the supravalvular structure 101, the subvalvular structure 102, and the connector 103, with the distal end of the guide member 107 adjacent to the first end 105. After the positioning device is delivered to the heart valve, the proximal end of the guide member 107 is located outside the patient's body. The capture member 108 is configured to capture the distal end of the guide member 107 and drag it proximally until it is removed from the patient's body. The positions of the first end 105 and the second end 106 are interchangeable.

[0055] The guide member 107 can be a guide wire, and the end of the guide member 107 can be provided with an auxiliary capture structure to facilitate capture by the capture member 108. The auxiliary capture structure can be an integral structure with the guide member 107, and can be formed into a J-shape, S-shape, spiral shape, etc. by bending and shaping the end of the guide member 107. The auxiliary capture structure can also be separate from the guide member 107, and the two are connected together by bonding, welding, riveting, etc. to form a spherical, cylindrical, J-shape, S-shape, spiral shape, etc. When the capture member 108 captures the guide member 107, the guide member 107 forms a guide ring in the subvalvular structure 102, and when a thrust is applied to the first end 105, the receiving part enters the mating part, so that the subvalvular structure 102 forms a closed ring.

[0056] In one embodiment, the second end portion 106 may be provided with a perforation 109 for the passage of the capture member 108. In another embodiment, the perforation 109 may not be provided, and the supraplaval structure 101, the subraplaval structure 102, and the connector 103 may each be provided with two cavities. The guide member 107 may pass through one of the cavities of the supraplaval structure 101 and the connector 103 and enter into one of the cavities of the subraplaval structure 102. The capture member 108 may pass through the other cavity of the supraplaval structure 101 and the connector 103 and enter into the other cavity of the subraplaval structure 102 to reach the second end portion 106, thereby capturing the guide member 107 located at the first end portion 105.

[0057] In one embodiment, if Figure 6 As shown, the supravalvular structure 101 has a first main cavity 110 and a first auxiliary cavity 111, wherein the first main cavity 110 is in communication with the connector 103 for the guide member 107 to pass through; the first auxiliary cavity 111 is used for the capture member 108 to pass through and enter the cavity of the subvalvular structure 102 via the perforation 109 to capture the distal end of the guide member 107 near the first end 105. The subvalvular structure 102 has a second main cavity 112 and a second auxiliary cavity 113, wherein the second main cavity 112 is in communication with the connector 103 for the guide member 107 to pass through; the second auxiliary cavity 113 at least partially surrounds the second main cavity 112, which can enhance the support force of the subvalvular structure 102 on the artificial valve 125.

[0058] The main cavity can be composed of a metal tube body with greater rigidity, and the auxiliary cavity can be formed by covering the main cavity with a fabric, a polymer tube body, or a metal tube body by bonding, hot melting, welding, etc. The main cavity and the auxiliary cavity can be integrally injection molded. The outer surface of the positioning device can be coated with a film with good biocompatibility. The locking structure 104 can be connected to the main cavity by integral molding, welding, bonding, etc. The auxiliary cavity can enhance the supporting force of the subvalvular structure 102.

[0059] In one embodiment, if Figure 4 As shown, the supravalvular structure 101 and the connector 103 each have a cavity, and the subravalvular structure 102 has a second main cavity 112 and a second auxiliary cavity 113. The second main cavity 112 is connected to the connector 103 for the guide member 107 to pass through it; the second auxiliary cavity 113 at least partially surrounds the second main cavity 112 to enhance the supporting force of the subravalvular structure 102 on the artificial valve 125, and the capturing member 108 can pass through the perforation 109 from the outside of the positioning device into the cavity of the subravalvular structure 102 to capture the distal end of the guide member 107 near the first end 105.

[0060] In one embodiment, if Figure 9A-14As shown, the locking structure 104 includes a mating body 114 and a receiving body 115, and the mating body 114 and the receiving body 115 are respectively arranged at one of the first end 105 and the second end 106, for example, the mating body 114 is arranged at the first end 105, and the receiving body 115 is arranged at the second end 106, or the two are interchangeable, and the mating body 114 and the receiving body 115 can be matched and connected with each other, and the outer diameter of the receiving body 115 is less than the inner diameter of the mating body 114, so that when the mating body 114 and the receiving body 115 are matched and connected with each other, the receiving body 115 enters the interior of the mating body 114.

[0061] In one embodiment, if Figures 9A-10B As shown, the fitting body 114 has an extension portion, and the receiving body 115 has an expansion portion 116 and a contraction portion 117, and the outer diameter of the expansion portion 116 is greater than the outer diameter of the contraction portion 117; when the fitting body 114 and the receiving body 115 are in a docking state, the expansion portion 116 applies an expansion force to the extension portion to expand the inner diameter of the extension portion and the receiving body 115 enters the fitting body 114; when the fitting body 114 and the receiving body 115 are in an engaged state, the extension portion is engaged with the contraction portion 117, and the inner diameter of the extension portion returns to its initial state.

[0062] like Figures 9A-9B As shown, in one embodiment, the extension portion includes: a first extension portion 118 extending radially outward from the first end portion 105; and a second extension portion 119, which is elastic and extends radially inward from the end of the first extension portion 118, so that the first extension portion 118 and the second extension portion 119 together form a trumpet-shaped structure. One or both of the first extension portion 118 and the second extension portion 119 can be elastic. The constriction portion 117 can be a groove, which can be curved or not. The end of the expansion portion 116 can be a tapered structure to further facilitate the expansion portion 116 to be pushed into the fitting body 114. When the receiving body 115 enters the interior of the matching body 114, the expansion portion 116 squeezes the second extension portion 119 radially outward, and the second extension portion 119 drives the first extension portion 118 to expand together, so that the expansion portion 116 enters the inner cavity of the matching body 114 until the second extension portion 119 is engaged in the contraction portion 117, thereby realizing the mutual locking of the first end portion 105 and the second end portion 106, so that the sub-petal structure 102 forms a closed ring.

[0063] like Figures 10A-10BAs shown, in one embodiment, an extension portion 129 extends radially inward from the first end portion 105, and the sidewall of the first end portion 105 is provided with at least one opening 130. The end of the expansion portion 116 is tapered. When the receiving body 115 enters the interior of the fitting body 114, the expansion portion 116 radially presses the extension portion outward, enlarging the opening 130 and allowing the expansion portion 116 to enter the inner cavity of the fitting body 114 until the extension portion 129 engages with the contraction portion 117, thereby locking the first end portion 105 and the second end portion 106 together, forming a closed ring of the subvalvular structure 102.

[0064] like Figure 11 As shown, in one embodiment, the receiving body 115 has a boss 120, and the inner side wall of the matching body 114 is provided with one or more spring pieces 121, which extend radially inward from the inner side wall; when the matching body 114 and the receiving body 115 are in a docking state, the boss 120 applies pressure to the spring piece 121 so that the spring piece 121 is squeezed and passes over the boss 120; when the matching body 114 and the receiving body 115 are in a locked state, the spring piece 121 returns to an expanded state and is locked to the inner side of the boss 120.

[0065] In one embodiment, the matching body 114 and the receiving body 115 are respectively provided with one of the first protrusion 122 and the first groove 123. Figure 12 As shown, the matching body 114 is provided with a first protrusion 122, and the receiving body 115 is provided with a first groove 123; Figure 13 As shown, the mating body 114 is provided with a first groove 123, and the receiving body 115 is provided with a first protrusion 122. When the mating body 114 and the receiving body 115 are docked, the first protrusion 122 enters the first groove 123, so that the first end 105 and the second end 106 are locked with each other, thereby forming the sub-petal structure 102 into a closed ring.

[0066] In one embodiment, if Figure 14 As shown, the matching body 114 is provided with a second protrusion 124. When the matching body 114 and the receiving body 115 are docked, the second protrusion 124 is engaged with the outer surface of the receiving body 115, so that the first end 105 and the second end 106 are locked with each other, thereby forming the sub-petal structure 102 into a closed ring.

[0067] like Figure 5As shown, in one embodiment, the present application further provides an artificial heart valve system, which includes: the above-mentioned heart valve positioning device and an artificial valve 125, wherein the artificial valve 125 includes: artificial valve leaflets; and a tubular support member 126, wherein the artificial valve leaflets are circumferentially fixed to the inner side of the support member 126, and the support member 126 is adapted to the heart valve positioning device so that when the heart valve positioning device is released, the artificial valve 125 is implanted into the inner side of the subvalvular structure 102. In another embodiment, the present application further provides an artificial heart valve implantation system, which includes an artificial heart valve system and a delivery device 127, wherein the delivery device 127 has a delivery tube 128 for delivering the heart valve positioning device to the heart and then releasing it, and the delivery device 127 may include one or more sets of structures including the delivery tube 128.

[0068] During delivery, the delivery tube 128 can be positioned at the leaflet commissures C1 or C2. If the positioning device is released from C1, the supravalvular structure 101 is designed to rotate counterclockwise. If the positioning device is released from C2, the supravalvular structure 101 is designed to rotate clockwise. After the positioning device is released, the supravalvular structure 101 is positioned at the posterior annulus, ensuring good fixation of the positioning device at the native annulus.

[0069] like Figures 15A-15FAs shown, in another embodiment, the present application also provides an implantation method of an artificial heart valve system, the implantation method comprising: placing the heart valve positioning device in a delivery device 127, delivering the delivery device 127 through the atrial septum to the native leaflet commissure, and then slowly releasing the subvalvular structure 102 in the left atrium, passing the delivery tube 128 through the leaflet commissure C2, entering the ventricular side, pushing the subvalvular structure 102 and the guide wire out of the delivery tube 128, so that the subvalvular structure 102 moves around the native leaflet to form an open ring, and the native leaflet is gathered inside the ring; the capture member 108 captures the distal end of the guide member 107, The distal end of the guide 107 is removed from the body, forming a ring within the subvalvular structure 102. The guide 107 is fixed, and the supravalvular structure 101 is pushed distally so that the receptor of the locking structure 104 enters the fitting body 114. The first end 105 and the second end 106 of the subvalvular structure 102 are connected to each other via the locking structure 104, forming a closed ring within the subvalvular structure 102. The guide 107 and the capturing member 108 are withdrawn, and the connector 103 and the supravalvular structure 101 are released in sequence. The artificial valve 125 is then delivered through the atrial septum to the inner side of the subvalvular structure 102 and released. The supravalvular structure 101 is supported near the native valve annulus, close to the atrial side, so that the positioning device is fixed to the native valve. The subvalvular structure 102 is located on the ventricular side, and the native valve leaflets are gathered within the subvalvular structure 102 to provide an anchoring support point for the artificial valve 125. The inner diameter of the closed ring matches the outer diameter of the artificial valve 125. The radial force between the two secures the artificial valve 125 to the native valve leaflets, replacing the function of the native valve. Before the artificial valve 125 is implanted, the native valve leaflets can still open and close normally, ensuring normal hemodynamics.

[0070] Compared with the prior art, the artificial valve 125 of the present application is smaller in size, which can avoid problems such as vascular complications during transportation and premature failure of the artificial valve leaflets after implantation caused by implanting a larger artificial valve 125. In addition, the artificial valve 125 of the present application has a lower subvalvular height, which can avoid blocking the left ventricular outflow tract and causing left ventricular outflow tract obstruction. Secondly, the subvalvular structure 102 of the positioning device of the present application can form a closed ring through the locking structure 104, clamping the native leaflets between the subvalvular structure 102 and the artificial valve 125, and utilizing the fit between the native leaflet tissue and the subvalvular structure 102 and the artificial valve 125 to achieve a good sealing effect, thereby avoiding the occurrence of paravalvular leakage after the artificial valve 125 is implanted.

[0071] If the positioning device and the artificial valve 125 are delivered through the aorta and the atrial septum respectively, the operation is complicated and there is a risk of damaging the aortic valve. The positioning device and the artificial valve 125 in this application are delivered through the same pathway through the atrial septum to avoid causing damage to the aortic valve.

[0072] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, and not to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements 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 the present application.

Claims

1. A heart valve positioning device, which can be delivered to a heart valve via a delivery device, wherein: The heart valve comprises a native leaflet and a native valve ring, and is characterized in that the heart valve positioning device comprises: a supravalvular structure, a subravalvular structure, a connector and a locking structure, wherein: The supraplaval structure, the subraplaval structure, and the connector are all tubular structures. The supraplaval structure and the subraplaval structure are connected by the connector to form a bent structure, and the supraplaval structure and the subraplaval structure each form a bent structure in a released state. The subvalvular structure has a first end and a second end, the first end and the second end being separated from each other in a delivery state and being connectable to each other via the locking structure in a released state, so that the subvalvular structure forms a closed ring, and the subvalvular structure gathers at least a portion of the native valve leaflets inside the closed ring, clamping the native valve leaflets between the subvalvular structure and the artificial valve, and the supravalvular structure is anchored inside the native valve annulus; The supraplaval structure and the subraplaval structure are parallel to each other, and an extending direction of the supraplaval structure is the same as or opposite to an extending direction of the subraplaval structure.

2. The heart valve positioning device according to claim 1, characterized in that: The included angle α between the connector and the subvalvular structure is greater than 90°.

3. The heart valve positioning device according to claim 1, characterized in that: The supraplaval structure, the subraplaval structure, and the connector are respectively provided with a tube body and a cavity formed inside the tube body, and the cavities of the supraplaval structure, the subraplaval structure, and the connector are interconnected; the positioning device further comprises: a guide member having a distal end and a proximal end, the guide member being configured to be inserted into the supravalvular structure, the subvalvular structure, and the cavity of the connector, with the distal end of the guide member being adjacent to the first end portion, and the proximal end of the guide member being located outside the patient's body after the positioning device is delivered to the heart valve; The capturing member is configured to capture the distal end of the guide member and drag the distal end of the guide member toward the proximal end, so that the first end and the second end are connected to each other through the locking structure.

4. The heart valve positioning device according to claim 3, characterized in that: The second end portion is provided with a through hole for the capture member to pass through.

5. The heart valve positioning device according to claim 4, characterized in that: The capture member passes through the perforation from the outside of the positioning device into the cavity of the subvalvular structure to capture the distal end of the guide member near the first end.

6. The heart valve positioning device according to claim 4, characterized in that: The supraplaval structure has a first main cavity and a first auxiliary cavity, wherein the first main cavity is connected to the connector for the guide member to pass through it; the first auxiliary cavity is used for the capture member to pass through and enter the cavity of the subraplaval structure through the perforation to capture the distal end of the guide member near the first end.

7. The heart valve positioning device according to claim 4, characterized in that: The subvalvular structure has a second main cavity and a second auxiliary cavity, and the second main cavity is communicated with the connector so that the guide member can pass through the second main cavity; The second auxiliary cavity at least partially surrounds the second main cavity.

8. The heart valve positioning device according to claim 1, characterized in that: The diameter of the supraplaval structure is not less than the diameter of the subraplaval structure.

9. The heart valve positioning device according to claim 1, characterized in that: The width of the subvalvular structure is greater than the width of the supraplaval structure, and the width of the subvalvular structure is greater than the width of the connector.

10. The heart valve positioning device according to claim 1, characterized in that: The locking structure includes a mating body and a receiving body, and the mating body and the receiving body are respectively arranged at one of the first end and the second end. The mating body and the receiving body can be matched and connected with each other, and the outer diameter of the receiving body is less than the inner diameter of the mating body, so that when the mating body and the receiving body are matched and connected with each other, the receiving body enters the interior of the mating body.

11. The heart valve positioning device according to claim 10, characterized in that: The matching body has an extension part, and the receiving body has an expansion part and a contraction part, and the outer diameter of the expansion part is greater than the outer diameter of the contraction part; when the matching body and the receiving body are in a docking state, the expansion part applies an expansion force to the extension part to expand the inner diameter of the extension part and the receiving body enters the matching body; when the matching body and the receiving body are in an engaged state, the extension part is engaged with the contraction part, and the inner diameter of the extension part returns to its initial state.

12. The heart valve positioning device according to claim 11, characterized in that: The extension includes: a first extension portion extending radially outward from the first end portion; and The second extension portion is elastic and extends radially inward from the end portion of the first extension portion, so that the first extension portion and the second extension portion together form a trumpet-shaped structure.

13. The heart valve positioning device according to claim 11, characterized in that: The extension portion extends radially inward from the first end portion, and a side wall of the first end portion is provided with at least one opening.

14. The heart valve positioning device according to claim 11, characterized in that: The end of the expansion portion is a tapered structure.

15. The heart valve positioning device according to claim 10, characterized in that: The receiving body has a boss, and the outer periphery of the mating body is provided with a spring sheet, which extends radially outward from the second end; when the mating body and the receiving body are in a docking state, the boss applies pressure to the spring sheet so that the spring sheet is squeezed and passes over the boss; when the mating body and the receiving body are in a clamping state, the spring sheet returns to an expanded state and is clamped on the inner side of the boss.

16. The heart valve positioning device according to claim 10, characterized in that: The matching body and the receiving body are respectively provided with one of a first protrusion and a first groove. When the matching body and the receiving body are docked, the first protrusion enters the first groove.

17. The heart valve positioning device according to claim 10, characterized in that: The matching body is provided with a second protrusion, and when the matching body and the receiving body are docked, the second protrusion is engaged with the outer surface of the receiving body.

18. An artificial heart valve system, characterized in that: The system includes: The heart valve positioning device according to any one of claims 1 to 17; An artificial valve, comprising: Prosthetic valve leaflets; 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 heart valve positioning device so that when the heart valve positioning device is released, the artificial valve is implanted into the inner side of the subvalvular structure.

19. An artificial heart valve implantation system, characterized in that: The implant system includes: The artificial heart valve system of claim 18; The delivery device has a delivery channel and is used for delivering the heart valve positioning device to the heart and then releasing it.

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