Artificial heart valve replacement system

Abstract

An artificial valve replacement system, in which at least a portion of a clamping material (3) is disposed in a valve clamping mechanism (21), and a valve clamping fixation device (2) is configured to be capable of assuming a first form and a second form that appears after the first form, and when the valve clamping fixation device (2) is in the first form, the valve clamping mechanism (21) is configured to be capable of capturing and clamping the native valve leaflet, and after the valvular stent (1) is radially expanded, the valve clamping fixation device (2) is in the second form.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims priority from a patent application with patent application number 202111164164.4, filed on September 30, 2021, and the content disclosed in the application is hereby incorporated by reference.

[0002] This application relates to the field of medical devices, and specifically to an artificial valve replacement system.

Background Art

[0003] Viewed from the cardiac structure, whether it is the mitral valve or the tricuspid valve, due to their special physiological structures, it is very difficult to accurately position and fix the products. In particular, the specific anatomical position of the mitral valve within the heart and its complex anatomical structure pose extremely great challenges to mitral valve replacement surgery.

[0004] In related technologies, the technique of locking a mitral / tricuspid valve prosthesis into the heart during surgery makes good use of the radial supporting force of the stent on the atrioventricular valve annulus. The disadvantage of such a technique is that it is easy to compress the surrounding tissues of the valve annulus, and the stent and the compressed tissues are likely to affect the outflow tract. From the perspective of the influence of the long - term use of the replacement valve membrane, as the postoperative patient's usage time elapses, the regurgitation decreases, the ventricular and atrial pressures drop, the cardiac structure is reconstructed, and a large - size stent affects the reduction of the valve annulus size and affects the internal structure of the heart, which is clearly an undesirable result.

[0005] In addition, for the locking technique, a docking device can be implanted in the valve tip in advance, and the stent can be fixed to the valve tip by being expanded inside the docking device. Patent CN109789019A describes the Edwards Lifesciences heart valve docking coil and system. In the patent disclosure, by wrapping the docking device around the outside of the valve tip, the valve tip and the stent are firmly clamped together. Although the superiority of such a stent fixation method is remarkable, the anterior leaflet is tightly clamped by the stent, and the interference with the blood flow in the left outflow tract has not been resolved.

[0006] From the above, currently, for mitral valve replacement prostheses, there are at least the following technical pain points: 1. After prosthesis replacement, the anterior valve leaflet blocks the left ventricular outflow tract; 2. When a large-sized stent supports the native annulus radially, it affects the internal structure of the heart and leads to the occurrence of a large number of complications. In the industry, in order to solve the above and other technical problems, a new transcatheter heart valve replacement system is urgently needed.

Summary of the Invention

Problems to be Solved by the Invention

[0007] According to various embodiments of the present application, the present application provides an artificial valve replacement system. The present application mainly aims to overcome some problems and deficiencies of the related technology.

Means for Solving the Problems

[0008] According to one aspect of the present application, an artificial valve replacement system is disclosed, which includes a valve membrane stent and a valve clamping and fixing device that operates in cooperation with the valve membrane stent. The valve clamping and fixing device is composed of a valve clamping mechanism for clamping the native valve leaflet and a clamping material disposed on the valve clamping mechanism. Among them, the valve clamping and fixing device is configured to be capable of presenting a first form and a second form subsequent to the first form. When the valve clamping and fixing device is in the first form, the valve clamping mechanism is configured to be capable of capturing and clamping the native valve leaflet. After the valve membrane stent expands radially, the valve clamping and fixing device is in the second form, and due to the radial expansion of the valve membrane stent, the clamping material moves the native valve leaflet upward to displace it and clamp the valve membrane stent.

[0009] According to one embodiment, the distal end of the valve clamping mechanism is removably connected. In the first form of the valve clamping and fixing device, the valve leaflets around the valve clamping mechanism can achieve self-opening and closing. When the valve membrane stent enters the valve clamping mechanism, the distal end of the valve clamping mechanism is removed, and the valve membrane stent is in a radially expanded state. Due to the radial expansion of the valve membrane stent, the clamping material moves the native valve leaflet upward to displace it and clamp the valve membrane stent.

[0010] According to one embodiment, after the valve membrane stent expands radially, the radial expansion of the valve membrane stent moves the valve clamping mechanism, the clamping material, the native valve leaflet, and the chordae tendineae in an interlocking manner. Among them, at least a part of the clamping material is displaced upward to move the native valve leaflet and the chordae tendineae upward, and the clamping material clamps the valve membrane stent. At this time, the valve clamping and fixing device is in the second form.

[0011] According to one embodiment, in the first form, the valve clamping mechanism clamps a part of the native valve leaflet. In the second form, the native valve leaflets around the valve clamping mechanism are moved upward by the clamping material to be displaced.

[0012] According to one embodiment, the clamping member has a closed-loop structure and passes through the valve clamping mechanism.

[0013] According to another embodiment, the clamping member is connected to the valve clamping mechanism to form a closed-loop structure. The clamping member is a two-stage wire or thread, and both ends are fixedly connected to the valve clamping mechanism.

[0014] According to one embodiment, the clamping member and the valve clamping mechanism have at least two connection points with different heights.

[0015] According to another embodiment, when the artificial valve membrane replacement system is used for replacing the mitral valve membrane, the heights of the connection points of the clamping member in the valve clamping mechanism are different. Specifically, the height of the clamping member in the anterior leaflet region is greater than the height of the clamping member in the posterior leaflet region. This can significantly lift the anterior leaflet and avoid obstructing the left ventricular outflow tract. It can also avoid excessive tension on the chordae tendineae in the posterior leaflet region caused by the clamping member and protect the chordae tendineae tissue.

[0016] According to another embodiment, the valve clamping mechanism includes a plurality of clamping members, and the heights of the connection points between the clamping member and each clamping member are different. Therefore, in the second form, the clamping member presents a wavy form, or in the second form, the height of the clamping member in the anterior leaflet region is higher than the height of the clamping member in the posterior leaflet region. This can lift the anterior leaflet to a high position and avoid obstruction of the left ventricular outflow tract by the anterior leaflet after replacement.

[0017] According to one embodiment, the position of the connection point between the clamping member and the valve clamping mechanism should not be too high. For example, if the position of the connection point is in the region of two-thirds of the proximal end of the native leaflet tip, excessive tension on the chordae tendineae tissue caused by the clamping member can be effectively avoided.

[0018] According to one embodiment, when the valve clamping and fixing device is in the second form, the clamping member is between the chordae tendineae and the native leaflet, and due to the radial expansion of the valve stent, at least a part of the clamping member is displaced upward to move the native leaflet and the chordae tendineae upward.

[0019] According to one embodiment, in the second form of the valve clamping and fixing device, the clamping member is tied to the outer periphery of the valve clamping mechanism in a stretched state, and after the native leaflet is pulled upward by the clamping member, the native leaflet is folded back so that it at least partially overlaps itself.

[0020] According to one embodiment, in the second form, the clamping member further clamps the valve clamping mechanism and the native leaflet to the outer periphery of the valve stent along the circumferential direction.

[0021] According to one embodiment, in the process of the valve clamping and fixing device being converted from the first form to the second form, the valve stent gradually expands radially from a state where it is not radially expanded, and gradually expands the valve clamping and fixing device so that the clamping member gradually unfolds from a slack state and is stretched, thereby gradually pulling up the chordae tendineae and the clamped native leaflet, and clamping the valve stent and the valve clamping mechanism.

[0022] According to one embodiment, in the process of the valve clamping mechanism capturing and clamping the native leaflet, due to the movement of the valve clamping mechanism in the atrial direction, some of the native leaflet and the chordae tendineae are folded back into the leaflet receiving cavity formed by the valve clamping mechanism and / or between the lower part of the native annulus and the clamping member.

[0023] According to one embodiment, in the first form, one end of the valve clamping mechanism is directed to the root of the clamped native leaflet.

[0024] According to one embodiment, the valve clamping and fixing device includes a single valve clamping member, an atrial support segment (after the valve clamping and fixing device is attached to a predetermined position, the atrial support segment is located in the atrium to provide a supporting force), a ventricular segment, and a clamping member. Among them, the clamping member is connected to the valve clamping member and the ventricular segment respectively, and in a cross-section parallel to the central axis of the valve clamping and fixing device, the clamping member presents an inclined form. More specifically, the height of the connection point between the clamping member and the valve clamping member is higher than the height of the partial region of the clamping member. When used for the treatment of the mitral valve, the valve clamping member is used to clamp the anterior leaflet, and the clamping member can significantly pull the anterior leaflet and the related chordae tendineae tissue.

[0025] According to one embodiment, the valve clamping mechanism includes a first clamping half body and a second clamping half body that are removably connected or are two independent members that are separated from each other and are configured to respectively capture and clamp different native leaflets, and the perimeter of the closed loop formed by the clamping member is slightly smaller than the perimeter of the valve membrane stent that is radially expanded at a predetermined position.

[0026] According to one embodiment, the first clamping half body and the second clamping half body together form a substantially sleeve-shaped structure in the constrained state of the valve clamping and fixing device, and the substantially sleeve-shaped structure is fitted onto the inner core tube and the outer periphery is covered by the outer sheath tube.

[0027] According to one embodiment, the first clamping half body and the second clamping half body have complementary shapes and are removably engaged and connected in the constrained state of the valve clamping and fixing device.

[0028] According to one embodiment, the first clamping half body has a first support segment, a first removable coupling segment extending from the first support segment, and a first clamping segment further extending from the first removable coupling segment. The first support segment is provided with a first clamping claw, and the second clamping half body has a second support segment, a second removable coupling segment extending from the second support segment, and a second clamping segment further extending downward from the first removable coupling segment. The second support segment is provided with a second clamping claw.

[0029] According to one embodiment, the first clamping half body and the second clamping half body each include a valve tip capturing member and a valve pressing member, and the clamping member is connected to one end of the valve tip capturing member.

[0030] According to one embodiment, teeth are provided on both the first clamping claw and the second clamping claw. The teeth can limit the relative positions between the first clamping half body, the second clamping half body, and the self-valve tip. The teeth are configured to bite into the clamped self-valve tip to fix the clamped self-valve tip.

[0031] According to one embodiment, the teeth may have an inverted thorn or a structure lockable to other valve tips so that the first clamping half body and the second clamping half body can firmly bite into the self-valve tip.

[0032] According to another embodiment, the teeth may be provided at one end of each of the first clamping half body and the second clamping half body. The teeth can "strike" the self-valve tip, thereby preventing the situation of slippage after the first clamping half body and the second clamping half body clamp the self-valve tip.

[0033] According to one embodiment, the first clamping segment is connected to the first removable coupling segment via an elastic piece segment, the first clamping claw is connected to the first support segment via an elastic piece segment, the second clamping segment is connected to the second removable coupling segment via an elastic piece segment, and the second clamping claw is connected to the second support segment via an elastic piece segment.

[0034] According to one embodiment, the first clamping half-body is integrally formed, and the second clamping half-body is integrally formed.

[0035] According to one embodiment, both the first clamping half-body and the second clamping half-body are made of a shape memory alloy.

[0036] According to one embodiment, both the first clamping half-body and the second clamping half-body are each configured to be able to form a valve tip accommodating cavity. When the first clamping half-body and the second clamping half-body capture and clamp the self-valve tip, some of the self-valve tips are folded back into the valve tip accommodating cavity.

[0037] According to one embodiment, when the first clamping half-body and the second clamping half-body open to capture the self-valve tip, the self-valve tip is located between the opening angle of the first clamping half-body and the opening angle of the second clamping half-body. At this time, the entire valve clamping fixing device moves upward in the atrial direction, and some of the self-valve tips are folded between the first clamping half-body and the second clamping half-body. Specifically, the conveying system can be operated so that the tip portion of the self-valve tip is folded into the valve tip accommodating cavity. By doing so, the length of the self-valve tip can be effectively shortened, thereby avoiding interference with the left ventricular outflow tract.

[0038] According to one embodiment, the valve membrane stent may further be provided with a positioning ring to be positioned in the atrium. The positioning ring is configured in a form adapted to the physiological structure of the self-valve ring, and the positioning ring is provided with auxiliary fixing rods.

[0039] According to one embodiment, the number of the auxiliary fixing rods is three or four, which can play a strong supporting role, avoid excessive tension on the native valve ring, and also reduce the implant.

[0040] According to one embodiment, the positioning ring is provided with a flexible sealing film, and after the valve membrane stent is attached to a predetermined position, the sealing film is adhered to the atrial tissue.

[0041] According to one embodiment, the valve membrane stent is provided with barbs for auxiliary fixation, and the barbs are provided on the positioning ring.

[0042] According to one embodiment, the valve membrane stent is provided with a fixing clamp material, and in the second form, the fixing clamp material clamps the self-valve tip so as to be sandwiched between the valve membrane stent and the fixing clamp material.

[0043] According to one embodiment, the artificial valve membrane replacement system further includes an inner core tube and an outer sheath tube, and the valve clamping and fixing device is configured to be constrained within the outer sheath tube and further capable of presenting a constrained state between the inner core tube and the outer sheath tube, and in the constrained state, the valve clamping and fixing device cannot clamp the self-valve tip.

[0044] According to one embodiment, it further includes an inner core tube, and the valve membrane stent can enter and arrive at an intermediate region of the valve clamping mechanism along the inner core tube.

[0045] According to one embodiment, the first clamping half body and the second clamping half body are removably connected. The inner core tube is provided with an enlarged end. The first clamping half body is provided with a first removably coupled segment. The second clamping half body is provided with a second removably coupled segment. And the first removably coupled segment and the second removably coupled segment realize a removably connection by the inner core tube. And the enlarged end substantially presents a cylindrical structure. The first removably coupled segment and the second removably coupled segment can be mutually fitted to form a connection similar to engagement. Then, the enlarged end is inserted between the first removably coupled segment and the second removably coupled segment to form a removably connection. After the enlarged end is withdrawn from between the first removably coupled segment and the second removably coupled segment, the valve membrane stent provides a radial expansion force to the first clamping half body and the second clamping half body to complete removal and separation.

[0046] According to one embodiment, when the valve membrane stent is in the middle region of the valve clamping mechanism, the enlarged end is retracted proximally relative to the valve clamping mechanism to achieve removal and separation from the valve clamping mechanism.

[0047] According to one embodiment, the valve membrane stent may be a balloon-expandable stent or a self-expandable stent.

[0048] According to one embodiment, the clamping member substantially presents a strip shape, a thread shape, or a hemp rope shape.

[0049] According to one embodiment, the outer periphery of the clamping member is coated, and the coating can increase the frictional force between the clamping member and the self-valve leaflet.

[0050] According to another aspect of the present application, there is further provided a valve clamping fixing device including a valve clamping mechanism in which a first clamping half body and a second clamping half body substantially form a sleeve-like structure in a constrained state, and a clamping member that is connected to the distal end of the valve clamping mechanism and forms a closed loop surrounding the valve clamping mechanism, an inner core tube, an outer sheath tube, and a radially expandable tubular valve membrane stent. Among them, in the constrained state of the valve clamping fixing device, the valve clamping mechanism is fitted onto the inner core tube and constrained within the outer sheath tube. Among them, in the first form of the valve clamping fixing device, the first clamping half body and the second clamping half body are exposed from within the outer sheath tube and deform into a structure capable of clamping the self-valve leaflets respectively, and the clamping member is in a loose state. Among them, in the second form of the valve clamping fixing device, the valve membrane stent is in a radially expanded state and is positioned between the first clamping half body and the second clamping half body, and the clamping member is stretched by the radially expanded valve membrane stent to clamp the valve membrane stent and the first clamping half body and the second clamping half body connected thereto.

[0051] According to one embodiment, in the first form, the self-valve leaflet retains the function of locally opening and closing, and in the second form, at least a part of the self-valve leaflet is folded.

[0052] According to one embodiment, the artificial valve replacement system further comprises a positioning ring, and the positioning ring is configured to have a form adapted to the physiological structure of the native valve annulus.

[0053] According to one embodiment, the positioning ring and the valve clamping and fixing device are integrally integrated.

[0054] According to another aspect of the present application, operating the outer sheath tube of the artificial valve replacement system to enter the surgical site, gradually pulling back the outer sheath tube proximally relative to the inner core tube, gradually exposing the valve clamping mechanism in the constrained state within the outer sheath tube, and gradually releasing the first clamping half and the second clamping half made of shape memory alloy of the valve clamping mechanism with the pulling back of the outer sheath tube so that each captures and clamps the corresponding native valve cusp; completely pulling out the outer sheath tube from the surgical site and leaving the inner core tube in place; operating a valve stent delivery device so that a tubular valve stent enters and reaches and intervenes between the first clamping half and the second clamping half of the valve clamping mechanism along the inner core tube, pulling out the inner core tube; radially expanding the valve stent to radially expand the valve clamping mechanism, thereby deploying and stretching a fastening material tied to the outer periphery of the valve clamping mechanism, and gradually pulling up the chordae tendineae and the native valve cusp along the axial direction of the valve stent until the fastening material clamps the valve stent and the valve clamping mechanism and finally realizes the pulling up and folding back of the native valve cusp; and pulling out the valve stent delivery device. A method of operating an artificial valve replacement system is further provided, which includes the above steps.

[0055] According to one aspect of the present application, there is provided an artificial valve replacement system including a valve stent and a valve clamping and fixing device. The valve clamping and fixing device includes a valve clamping mechanism and a clamping material disposed on the valve clamping mechanism. Among them, the valve clamping and fixing device has a first form and a second form. When the valve clamping and fixing device is in the first form, the valve clamping mechanism is configured to be fixed in the middle region of the native valve in a manner of clamping a local native valve leaflet, the clamping material is in a loose form, and the native valve leaflet can locally retain the function of opening and closing. When the valve clamping and fixing device is in the second form, the valve stent expands radially to move the valve clamping mechanism and the clamping material to deploy synchronously, and the clamping material gradually pulls up the chordae tendineae, the native valve leaflet and the adjacent tissue, and finally realizes the folding back of the native valve leaflet.

[0056] According to one embodiment, when the valve stent expands radially to move the valve clamping mechanism and the clamping material to deploy synchronously, the clamping material pulls the native valve leaflet and the chordae tendineae to displace in the direction of the connection point between the clamping material and the valve clamping mechanism so as to move a part of the native valve leaflet to be folded back. Finally, the clamping material surrounds a part of the native valve leaflet, the chordae tendineae, and the valve clamping mechanism and fixes them to the outer periphery of the valve stent.

[0057] According to one embodiment, in the process of the valve clamping mechanism capturing and clamping the native valve leaflet, due to the movement of the valve clamping mechanism in the atrial direction, a part of the native valve leaflet and the chordae tendineae are folded back between the valve clamping mechanism and / or below the native valve annulus and the clamping material, thereby raising the height of the valve leaflet and avoiding the blockage of the left ventricular outflow tract.

[0058] According to one embodiment, the first clamping half body and the second clamping half body are removably connected, and the first clamping half body and the second clamping half body can respectively capture and clamp different native valve leaflets.

[0059] According to another embodiment, the first clamping half body and the second clamping half body are two independent members and are axially arranged in the outer sheath tube. The first clamping half body and the second clamping half body can independently capture and clamp different native valve leaflets.

Advantages of the Invention

[0060] Compared with related technologies, the advantages and beneficial technical effects of the present application include at least the following.

[0061] 1. Conventional valve prosthesis often anchors the valve prosthesis by the radial supporting force supported by the native valve ring after the implantation surgery. This will compress the native valve ring, which is clearly disadvantageous for long-term use, and the defect of its anchoring is obvious. Moreover, the existing solutions that anchor the stent using the valve leaflets cannot solve the problem of obstruction in the left ventricular outflow tract. According to an embodiment of the present application, by using a valve clamping mechanism to capture and clamp the native valve leaflets to achieve a repair similar to "edge-to-edge", the backflow of the valve membrane can be effectively reduced. At the same time, before the replacement valve membrane stent is implanted, the native valve membrane can still operate normally, gaining time for the surgery and effectively reducing complications. At the same time, the valve membrane stent can smoothly reach the middle region of the valve clamping mechanism along the inner core tube, with accurate positioning and more convenient operation. When the valve membrane stent expands radially and moves to deploy the valve clamping mechanism and the clamping material synchronously, the clamping material pulls the chordae tendineae and the native valve leaflets to displace in the direction of the connection point between the clamping material and the valve clamping mechanism, so that the native valve leaflets are pulled up. After replacement, the obstruction of the native valve leaflets to the left ventricular outflow tract is avoided. Finally, the clamping material surrounds some of the native valve leaflets, chordae tendineae, and the valve clamping mechanism and fixes them to the outer periphery of the valve membrane stent. Its anchoring method avoids supporting the native valve ring radially and avoids having an adverse impact on the form of the native valve membrane. At the same time, it can solve two major technical pain points regarding the treatment of mitral valve replacement in related technologies and has good clinical significance.

[0062] 2. In the related art, the clamping member can only play the role of fixing the valve stent and cannot solve the problem of the interference of the native valve leaflet on the left ventricular outflow tract. As a distinction from the related art, in an embodiment of the present application, the valve clamping mechanism is first anchored to the native valve leaflet, the connection point between the clamping member and the valve clamping mechanism is higher than the connection location between the tip portion of the native valve leaflet and the chordae tendineae tissue, and the length of the clamping member is constant. When the valve stent expands radially, the clamping member moves upward toward the position of the connection point with the valve clamping mechanism. In this process, the clamping member pulls the chordae tendineae with the connection point as the fulcrum and further moves the native valve leaflet upward, so that finally, the clamping member can clamp the valve stent and avoid the support of the native valve annulus in the radial direction. At the same time, the interference of the native valve leaflet on the outflow tract can be effectively avoided, which has good clinical significance.

[0063] 3. As a distinction from the related art, in an embodiment of the present application, valve leaflet receiving cavities are provided at one end of the first clamping half body and one end of the second clamping half body. Thus, when the valve clamping mechanism captures and clamps the valve leaflet, a part of the native valve leaflet can be folded back into the valve leaflet receiving cavity, and the length of the valve leaflet after being folded back is shortened. In this way, the obstruction to the left ventricular outflow tract can be effectively avoided, and the influence of the native valve leaflet tissue on the blood flow after replacement is reduced. Especially when it is used for the replacement of the mitral valve, it is very suitable for the physiological characteristic that the anterior leaflet of the mitral valve is long, which has good clinical significance.

[0064] 4. As a distinction from the related art, in an embodiment of the present application, the positioning ring provides the locking force of the valve annulus or atrium to the valve clamping mechanism. Thus, after the first clamping half body and the second clamping half body capture and clamp the valve leaflet and before the valve stent enters the release position, the valve clamping mechanism can be well held in the position in the heart, and the valve clamping mechanism is prevented from slipping off.

[0065] 5. As a distinction from related technologies, in one embodiment of the present application, the inner core tube can also control the external connection of the valve clamping mechanism, and can also serve as a guiding route for the valve membrane stent to enter the valve clamping mechanism so that the operation time is significantly shortened and the operation accuracy can be improved. The enlarged end only needs to retreat from the middle between the first removable coupling segment and the second removable coupling segment. Then, in the process of the valve membrane stent gradually expanding radially and returning to its functional form, it provides a radially expanding force to the first clamping half body and the second clamping half body, completes the removal and separation thereof, has a simple structure assembly, is very convenient to remove, is advantageous for the development of clinical surgery, and has good clinical significance.

[0066] 6. As a distinction from related technologies, in one embodiment of the present application, the heights of the connection points of the clamping material in the valve clamping mechanism are different. Specifically, the height in the anterior valve tip region of the clamping material is greater than the height in the posterior valve tip region of the clamping material. This can significantly lift the anterior valve tip and avoid obstructing the left ventricular outflow tract, and can also avoid excessive tension on the chordae tendineae in the posterior valve tip region by the clamping material and protect the chordae tendineae tissue.

Brief Description of the Drawings

[0067]

Fig. 1a - 1c

Fig. 2a - 2j

Fig. 3a - 3d

Fig. 4a - 4d

Fig. 5a - 5k

Fig. 6a - 6c

Fig. 7a - 7h

Fig. 8a

Fig. 9a - 9d

Fig. 10a - 10b

Fig. 11a - 11b

Fig. 12a - 12c

Fig. 13a - 13b

Description of Reference Numerals

[0068] 1... valve membrane stent, 11... positioning ring, 2... valve clamping and fixing device, 21... valve clamping mechanism, 211... first clamping half body, 2111... first removable coupling segment, 2112... first support segment, 212... second clamping half body, 2121... second removable coupling segment, 2122... second support segment, 213... teeth, 214... valve tip accommodating cavity, 215... expandable passage, 22... capture control material, 23... removal control material, 24... positioning ring control material, 25... clamping member, 3... clamping material, 4... inner core tube, 41... enlarged end, 5... positioning ring, 51... rod-shaped support material, 52... skirt, 53... self-valve ring adaptation segment, 54... atrial tissue adaptation segment, 55... skeleton, 56... membrane, 6... outer sheath tube, 7... valve membrane stent delivery device, 8... connection structure, 9... fixing clamp material, 10... valve clamping material, 101... atrial support segment, 102... ventricular segment.

Modes for Carrying Out the Invention

[0069] In the present application, "proximal end" refers to the end close to the surgical operator, and "distal end" refers to the end far from the surgical operator.

[0070] Example 1 As schematically shown in FIGS. 1a - 1c and FIGS. 2a - 2j, according to an embodiment of the present application, an artificial valve replacement system is provided, which may include a valve stent 1 and a valve clamping and fixing device 2 arranged together with the valve stent 1. As shown in FIGS. 1a - 1b, the valve clamping and fixing device 2 may include a valve clamping mechanism 21 and a clamping material 3 arranged on the valve clamping mechanism 21.

[0071] As shown in FIGS. 1a - 1c and FIGS. 2a - 2j, the valve clamping mechanism 21 may be composed of two halves made of shape memory alloy, namely, a first clamping half 211 and a second clamping half 212. The first clamping half 211 and the second clamping half 212 can each be integrally formed as shown in FIG. 2e, and as shown in FIGS. 2a - 2b, before the operation, the two are fitted together around an inner core tube 4 (detailed later) to form an overall sleeve - like structure that fits around the inner core tube 4, and can be firmly covered from the outside by an outer sheath tube 6 and constrained within the tube 6.

[0072] As shown in FIGS. 1b and 2c, the first clamping half 211 and the second clamping half 212 can each capture and clamp different native valve leaflets.

[0073] As shown in FIGS. 2e - 2g, teeth 213 are provided on both the first clamping half 211 and the second clamping half 212. The teeth 213 can bite into the native valve leaflets to fix the relative positions between the first clamping half 211, the second clamping half 212, and the native valve leaflets.

[0074] The teeth 213 may be pointed teeth, studs, barbs, or other structures capable of fixing the valve leaflets so that the first clamping half 211 and the second clamping half 212 can firmly bite into the native valve leaflets.

[0075] If the first clamping half 211 and the second clamping half 212 capture and clamp the native valve leaflets, as shown in FIGS. 1b and 2g, valve leaflet accommodation cavities 214 are provided at one end of the first clamping half 211 and one end of the second clamping half 212, and some of the native valve leaflets are folded back into the valve leaflet accommodation cavities 214.

[0076] More specifically, as shown in FIG. 2e, the first clamping half body 211 and the second clamping half body 212 have complementary shapes that cooperate (e.g., fit) with each other and can form a removable connection. For example, when a force is applied, for example, when pulled away from the cooperation part by the enlarged end 41 of the inner core tube 4 and when the valve membrane stent 1 is expanded from the cooperation (e.g., fit) part, they can be separated from each other.

[0077] As shown in FIG. 2e, the first clamping half body 211 can have a first support segment 2112, a first removable cooperation segment 2111 extending from and integral with the first support segment 2112, and a first clamping segment 2113 integrally extending further downward from the first removable cooperation segment 2111. In the first support segment 2112, for example, in the main body of the first support segment 2112, a first clamping claw 2130 that can carry, for example, teeth 213, which is still integrally connected thereto via an elastic piece segment 2131 by laser cutting, may be formed. The first clamping segment 2113 is integrally connected to the first removable cooperation segment 2111 via a similar elastic piece segment 2110. The first clamping half body 211 may be entirely composed of a shape memory alloy, and since the elastic piece segments 2131 and 2110 have a structure of a diamond wave, an S-bar, or a thin straight bar as shown in the drawings, they are easily elastically deformed. For example, they can easily extend straight so as to be placed in the outer sheath tube 6 before the operation (e.g., as shown in FIGS. 2b and 2e), and can easily bend so as to fold back the valve tip during and after the operation (as shown in FIGS. 2j to 3d and as detailed below).

[0078] Similarly, as shown in FIG. 2e, the second clamping half 212 can have a second support segment 2122, a second removable coupling segment 2121 extending from and integral with the second support segment 2122, and a second clamping segment 2123 integrally and further extending downward from the second removable coupling segment 2121. In the second support segment 2122, for example, in the main body of the second support segment 2122, a second clamping claw 2133 that can carry, for example, teeth 213 still integrally connected thereto via an elastic piece segment 2132 may be formed by laser cutting. The second clamping segment 2123 is integrally connected to the second removable coupling segment 2121 via an elastic piece segment 2120 similarly. The second clamping half 212 may be entirely composed of a shape memory alloy, and since the elastic piece segment 2132 and the elastic piece segment 2120 have a structure of a diamond wave, an S-bar, or a thin straight bar as shown in the drawing, they are easily elastically deformed, for example, can easily extend straight so as to be inserted into the outer sheath tube 6 before surgery (e.g., as shown in FIGS. 2b and 2e), and can easily bend so as to fold back the valve tip during and after surgery (as shown in FIGS. 2j to 3d and as detailed below).

[0079] As shown in FIG. 2b, the first clamping half 211 integrally composed of the first support segment 2112, the first removable coupling segment 2111, and the first clamping segment 2113, and the second clamping half 212 integrally composed of the second support segment 2122, the second removable coupling segment 2121, and the second clamping segment 2123 are fitted into the inner core tube 4 in a sleeve-like structure and inserted into the outer sheath tube 6. Among them, the two convex portions 2115 of the first removable coupling segment 2111 and the two complementary-shaped concave portions 2125 of the second removable coupling segment 2121 are correspondingly engaged with each other (or referred to as fitting) to be fixed, and the structure in which the first clamping half 211 and the second clamping half 212 form a sleeve-like shape is maintained. At this time, the enlarged end 41 of the inner core tube 4 has already protruded into the sleeve formed by the first removable coupling segment 2111 and the second removable coupling segment 2121 (as shown in FIGS. 2a to 2b).

[0080] During the operation, when the valve clamping mechanism 21 placed inside the outer sheath tube 6 reaches the surgical position, the outer sheath tube 6 is pulled back proximally (i.e., in the direction along the straight arrow shown in FIG. 2c), first exposing (releasing) the first clamping segment 2113 and the second clamping segment 2123, and the first removable linkage segment 2111 and the second removable linkage segment 2121. At this time, as shown in FIGS. 2c-2d, the first clamping segment 2113 and the second clamping segment 2123 are exposed and released, and due to their own shape memory effect (elastic piece segment), they bend upward (as shown by the curved arrow in FIG. 2c) from the state that was previously straight and aligned with the first and second support segments 2112, 2122, respectively, and bend towards the first and second support segments 2112, 2122. During the operation, in such a state, the autologous valve leaflet has already been placed and aligned on the first clamping segment 2113 and the second clamping segment 2123.

[0081] Thereafter, the outer sheath tube 6 is further pulled back to expose the first support segment 2112 and the first clamping claw 2130 thereon, and the second support segment 2122 and the second clamping claw 2133 thereon (FIG. 2f). The first clamping claw 2130 and the second clamping claw 2133 are each deformed through their elastic piece segments from the state where they were previously fitted inside the first and second support segments 2112, 2122 respectively and adapted to their overall shapes, and bend downward (as shown by the curved arrow in FIG. 2f), and are pressed against the corresponding first clamping segment 2113 and second clamping segment 2I23 as shown in FIGS. 2h-2i. As shown in FIG. 2j, during the operation, in such a state, the autologous valve leaflet that was previously placed and aligned on the first clamping segment 2113 is clamped between the first clamping claw 2130 and the first clamping segment 2113, and the teeth 213 on the first clamping claw 2130 bite and fix it. The autologous valve leaflet that was previously placed and aligned on the second clamping segment 2123 is clamped between the second clamping claw 2133 and the second clamping segment 2123, and the teeth 213 on the second clamping claw 2133 bite and fix it.

[0082] At this time, the valve clamping mechanism 21 is in a capturing state, and between the first support segment 2112 and the second support segment 2122, as shown in FIG. 2j, an expandable passage 215 is formed for the subsequent valve membrane stent 1 to enter and prepare an expansion space.

[0083] The valve membrane stent 1 is carried by the valve membrane stent conveying device 7 (for example, as shown in FIG. 5c), enters along the path of the inner core tube 4, is fitted into the first and second support segments 2112 and 2122, and enters the expandable passage 215. After that (FIG. 5e), the enlarged end 41 of the inner core tube 4 is pulled back and separated from the valve clamping mechanism 21 (FIG. 5f), and the valve membrane stent 1 is released and expands (inflates) radially to a functional form, which can promote further separation of the first clamping half 211 and the second clamping half 212 (FIGS. 5g - 5h).

[0084] The clamping material 3 is generally composed of a linear or strip - shaped flexible material, and passes through, for example, the perforations (FIGS. 2c - 2d) at the ends of the first clamping segment 2113 and the second clamping segment 2123 to form a closed loop or loop that can restrain the positions of the first clamping segment 2113 and the second clamping segment 2123 (i.e., expand radially) after release.

[0085] The circumferential length of the clamping member 3 in a fully deployed state is generally set to be smaller than the circular circumference of the cross-section of the valve membrane stent 1 after sufficient expansion (inflation). In this way, after the valve membrane stent 1 expands (inflates) in the radial direction, it can be firmly clamped by the clamping member 3 with a predetermined prestress (at this time, as shown in FIGS. 2j and 5i - 5j, the clamping member 3 further firmly clamps with the self-valve ring in the middle), and it can be ensured that the valve membrane stent 1 is restrained so as to avoid being overly expanded to be larger than the size of the self-valve ring and causing damage. On the other hand, in the process of the valve membrane stent 1 expanding radially to a predetermined position and returning to the functional form, since the valve membrane stent 1 is firmly clamped by the clamping member 3 connected to the valve clamping mechanism 21 that sandwiches the self-valve tip and receives radial support therefrom, the valve membrane stent 1 is indirectly fixed to the self-valve tip tissue by the clamping member 3.

[0086] The clamping member 3 may generally be a flexible ring or loop, for example, it may be a ring or loop made of a strip, thread, wire, twisted wire or cord-like material that exhibits flexibility. The outer periphery of the clamping member 3 may be coated, for example, and when coated, the frictional force between it and the self-valve tip can be increased.

[0087] The clamping member 3 may have a closed-loop structure or may cooperate with the valve clamping mechanism 21 to form a closed-loop structure. After the valve clamping mechanism 21 captures the self-valve tip, the clamping member 3 is located on the outer periphery of the self-valve tip and surrounds the self-valve tip (as shown in FIGS. 2j and 5i - 5j).

[0088] The valve membrane stent 1 may be, for example, a self-expanding mesh stent, and its shape may be, for example, a cylindrical structure that can expand at the reached surgical site and be fixed at a predetermined position.

[0089] The valve membrane stent 1 may be further provided with a positioning ring 11 that is positioned in the atrium during surgery, and the positioning ring 11 is configured in a form adaptable to the physiological structure of the self-valve ring. The positioning ring 11 may be coated so as to avoid the occurrence of perivalvular leakage.

[0090] From the above, the valve clamping and fixing device 2 can exhibit the first form and the second form.

[0091] When the valve clamping and fixing device 2 is in the first form, the valve clamping mechanism 21 is configured to be fixed in advance to, for example, the middle region of the self-valve membrane in a manner of clamping a local part of the self-valve tip. At this time, the clamping member 3 is in a loose form in which the valve membrane stent 1 is not tightened. At this time, the self-valve tip can retain the function of opening and closing locally.

[0092] When the valve clamping and fixing device 2 is in the second form, the valve membrane stent 1 expands in the radial direction to move the valve clamping mechanism 21 and the clamping member 3 synchronously to expand, and finally is tightly tightened by the clamping member 3. In this process, the clamping member 3 is located between the self-valve tip and the chordae tendineae, and gradually pulls up the self-valve tip and the adjacent tissue (as shown by the upward arrow in FIG. 5h) to tighten, and moves the clamped self-valve tip upward and gradually folds it back.

[0093] According to an example, when the valve membrane stent 1 expands in the radial direction to move the valve clamping mechanism 21 and the clamping member 3 synchronously to deploy, the clamping member 3 pulls up the self-valve tip and the chordae tendineae being tightened upward so as to be displaced in the direction of the connection point between the clamping member 3 and the valve clamping mechanism 21, moves the self-valve tip to fold it back, and finally, as shown in FIG. 1c for example, the clamping member 3 fixes a part of the self-valve tip and the chordae tendineae and the valve clamping mechanism 21 to the outer periphery of the valve membrane stent 1 in the circumferential direction.

[0094] According to one example, when the valve clamping mechanism 21 captures and clamps the native valve leaflet tip, the valve clamping mechanism 21 moves in the atrial direction, and when the valve stent 1 expands radially and returns to the preset form, the valve stent 1 and the clamping material 3 cooperate to fold back some of the native valve leaflet tips and at the same time pull them upward, raising the position of the valve leaflet tips and avoiding blocking the left ventricular outflow tract. In contrast, because the length of the anterior native valve leaflet tip of the mitral valve is long, in the conventional replacement surgery, the obstruction of the left ventricular outflow tract by the anterior native valve leaflet tip is very significant. By using the present case, the influence of the native valve leaflet tissue on the blood flow after replacement can be effectively reduced. This is because not only is a part of the native valve leaflet tissue folded back to reduce the risk of flow obstruction, but it is also pulled upward by the radial expansion of the valve stent 1, reducing the possibility of inhibiting the blood flow in the left ventricular outflow tract.

[0095] Operation of the artificial valve replacement system One exemplary operation process for repairing the mitral valve of this Example 1 is as follows.

[0096] 1. As shown in FIGS. 4a - 4d, operate the outer sheath tube 6 to enter the heart from the inferior vena cava, and then operate the outer sheath tube 6 so that the valve clamping mechanism 21 passes through the atrial septum. Subsequently, operate the outer sheath tube 6 to bend so that the valve clamping mechanism 21 faces the orifice of the mitral valve. 2. As shown in FIGS. 5a - 5b, operate the outer sheath tube 6 so that the first clamping half - body 211 and the second clamping half - body 212 of the valve clamping mechanism 21 capture the anterior and posterior leaflets of the mitral valve respectively, and together with the first clamping claw 2130 and the second clamping claw 2133 respectively, clamp the corresponding anterior and posterior leaflets. The specific steps can be referred to in relation to those shown and described in FIGS. 2a - 2g for example. After the valve leaflet tip is clamped by the valve clamping mechanism 21, pull out the outer sheath tube 6 from the body and leave the inner core tube 4 in place. 3. Then, as shown in FIGS. 5c to 5e, the valve stent delivery device 7 is operated to enter, and is made to enter the heart along the path of the inner core tube 4. As shown in FIGS. 5f and 5g, when the valve stent 1 enters the intermediate region of the valve clamping mechanism 21, the inner core tube 4 is operated (for example, retracted) so as to be removed and separated from the valve clamping mechanism 21. Then, the valve stent delivery device 7 is further operated to gradually release the valve stent 1 to radially expand and return to its functional form. 4. As shown in FIGS. 5h to 5k, due to the radial expansion of the valve stent 1, the first clamping half body 211 and the second clamping half body 212 of the valve clamping mechanism 21 approach or even move further, for example, in the direction shown by the curved arrow in FIG. 3a, so as to be applied to the outer periphery of the valve stent 1. As a result, the clamped valve leaflet is partially folded back. With further radial expansion of the valve stent 1, it expands outward and is supported by the clamping material 3 that clamps the outer periphery of the valve stent 1, returns to its functional form, and is anchor-fixed in the heart. At this time, the self-valve leaflet is clamped between the clamping material 3 and the valve stent 1. Then, the valve stent delivery device 7 can be withdrawn from the body.

[0097] Embodiment 2 Embodiment 2 is substantially the same as Embodiment 1, but is different in that the valve clamping mechanism 21 in this embodiment further includes a positioning ring 5. As shown in FIGS. 6a to 6c, the positioning ring 5 can provide an anchor force at the valve ring or atrium for the valve clamping mechanism 21. Thereby, after the first clamping half body 211 and the second clamping half body 212 capture and clamp the valve leaflet, and when the valve stent 1 has not yet entered the release position, the valve clamping mechanism 21 can be well held in the position in the heart, and the occurrence of the dropping of the valve clamping mechanism 21 is avoided.

[0098] In this embodiment, the valve clamping and fixing device 2 may include a valve clamping mechanism 21 and a clamping member 3, and the clamping member 3 may be arranged on the valve clamping mechanism 21. In this embodiment, a positioning ring 5 is further provided, and the positioning ring 5 can be configured in a form adapted to the physiological structure of the valve ring. Among them, the valve clamping and fixing device 2 can have a first form and a second form. When the valve clamping and fixing device 2 is in the first form, the valve clamping mechanism 21 can be configured to be fixed in, for example, the middle region of the self-valve membrane in a manner of clamping a local self-valve tip, the clamping member 3 may be in a loose form, and the self-valve tip can retain the function of locally opening and closing. The positioning ring 5 is located in the atrium. When the valve clamping and fixing device 2 is in the second form, the valve membrane stent 1 can be expanded radially to move the valve clamping mechanism 21 and the clamping member 3 to deploy synchronously. The clamping member 3 can gradually lift the self-valve tip and the adjacent tissue, and finally realize the folding of the self-valve tip.

[0099] More specifically, in this embodiment, as shown in FIGS. 6a - 6c, the positioning ring 5 may be composed of a radial rod-shaped support member 51. The rod-shaped support member 51 can effectively prevent the left and right swaying of the valve membrane stent and contribute to reducing or avoiding the occurrence of perivalvular leakage. The rod-shaped support member 51 may include two main support members 511 and at least one auxiliary support member 512. One end of the rod-shaped support member 51 may be fixedly connected to the main body of the positioning ring as a fixed end, and the other end of the rod-shaped support member 51 may be free as a free end. A flexible skirt 52, for example, may be provided between adjacent rod-shaped support members 51. For example, as shown in FIG. 6c, when the positioning ring 5 is completely released, it can adapt itself to form a closed-loop structure, such as a D-shaped structure. The connecting line of the free ends of the main support members 511 may form a straight-line segment providing the D-shaped structure, and the free ends of the auxiliary support members 512 may be located on the arc segment of the D-shaped structure.

[0100] In this embodiment, the artificial valve replacement system may further include a capture control member 22, a removal control member 23, and a positioning ring control member 24. Among them, the removal control member 23 can control the removal and separation of the first clamping half body 211 and the second clamping half body 212.

[0101] In this embodiment, during pre-assembly, the first clamping half body 211 and the second clamping half body 212 are joined to each other and placed in the outer sheath tube 6 in a straight and pulled form. When the valve clamping fixing device 2 needs to be in, for example, the middle region of the self-valve membrane and capture the self-valve leaflet, the outer sheath of the outer sheath tube 6 is retracted to the proximal end. By further manipulating the capture control member 2, the distal ends of the first clamping half body 211 and the second clamping half body 212 can be released to return to the preset form, and the valve clamping fixing device 2 can be brought into the first form.

[0102] In this embodiment, after the first clamping half body 211 and the second clamping half body 212 capture and clamp the self-valve leaflet, the outer sheath of the outer sheath tube 6 continues to be retracted to the proximal end so that the valve clamping fixing device 2 is completely exposed. By manipulating the positioning ring control member 24, the positioning ring 5 can be released to return to the preset form. The positioning ring 5 can adapt to the uneven contours of the patient's own valve membrane and valve ring and does not limit the atrial contraction function.

[0103] In this embodiment, as shown in FIG. 7e, the first clamping half body 211 and the second clamping half body 212 may be two independent members and are respectively fixedly connected to the positioning ring 5. The first clamping half body 211 and the second clamping half body 212 may be made of, for example, any metal memory alloy material, such as a nickel-titanium alloy.

[0104] In this embodiment, the positioning ring 5 has a preset form. As shown in FIG. 6b, the positioning ring 5 may exhibit a mesh-like or "Z"-shaped structure or a wavy structure. With such a structure, the positioning ring 5 can still perform large-scale size adjustment while remaining within the range of elastic deformation.

[0105] In this embodiment, the positioning ring 5 and the valve clamping mechanism 21 may have an integral structure, or may have a separate structure as shown in Fig. 8a.

[0106] In this embodiment, the positioning ring 5 may be made of a shape memory alloy material such as nickel-titanium alloy, and the positioning ring 5 may be coated.

[0107] One exemplary operation process for repairing the mitral valve leaflet of this Example 2 is as follows.

[0108] 1. As shown in Figs. 4a to 4d, operate the outer sheath tube 6 to enter the heart from the inferior vena cava, and then operate the outer sheath tube 6 so that the valve clamping mechanism 21 passes through the atrial septum, and then continue to operate the outer sheath tube 6 to bend so that the valve clamping mechanism 21 faces the orifice of the mitral valve.

[0109] 2. As shown in Figs. 7c to 7g, operate the outer sheath of the outer sheath tube 6 to retract it proximally, and further by manipulating the capture control material 2, the first clamping half body 211 and the second clamping half body 212 can be made such that the distal end is released and returns to the preset form, and each captures and clamps the anterior cusp and the posterior cusp of the mitral valve respectively. After the valve clamping mechanism 21 clamps the valve cusp, continue to retract the outer sheath of the outer sheath tube 6 proximally so that the valve clamping fixing device 2 is completely exposed, and by manipulating the positioning ring control material 24, release the positioning ring 5 and return it to the preset form, withdraw the outer sheath tube 6 from the body, and leave the inner core tube 4 in its original position.

[0110] 3. As shown in Fig. 7h, operate the valve leaflet stent delivery device 7 to enter the heart along the path of the inner core tube 4. When the valve leaflet stent 1 enters the middle region of the valve clamping mechanism 21, manipulate the removal control material 23 to separate the first clamping half body 211 and the second clamping half body 212 from each other, and further operate the valve leaflet stent delivery device 7 to gradually release the valve leaflet stent 1 by expanding it radially and returning it to the preset form.

[0111] 4. By radially expanding the valve stent 1, the first clamping half 211 and the second clamping half 212 of the valve clamping mechanism 21 are applied to the outer periphery of the valve stent 1. By further radial expansion, it supports the clamping material 3, returns to the preset form and is anchor-fixed in the heart. The self-valve tip is sandwiched between the clamping material 3 and the valve stent 1, and then the valve stent delivery device 7 is withdrawn from the body.

[0112] Regarding this, since the related structure and concept of Example 2 are similar to those of Example 1, they will not be repeatedly described here.

[0113] Example 3 Example 3 is substantially the same as Example 1, but is different in that the valve stent 1 in this example is a balloon-expandable stent.

[0114] In this example, as shown in FIGS. 9a-9d, the valve stent 1 may be a balloon-expandable valve. When the valve clamping mechanism 21 captures and clamps the self-valve tip, the valve clamping mechanism 21 moves in the atrial direction. When the valve stent 1 is, for example, in the middle region of the valve clamping mechanism 21, the valve stent 1 can be radially expanded and released to return to the functional form. The valve stent 1 and the clamping material 3 can cooperate to gradually fold some of the self-valve tips in an increasing degree (as shown in FIGS. 3d and 5b-5j), and at the same time, pull up (as shown by the upward arrow in FIG. 5h) and move the self-valve tip upward to fold it, thereby further expanding the left ventricular outflow tract and reducing the risk of the self-valve tip blocking the left ventricular outflow tract. Compared with that, since the length of the anterior self-valve tip of the mitral valve is long, in the conventional replacement surgery, the obstruction of the left ventricular outflow tract by the anterior self-valve tip is very significant. On the other hand, the axial height of the balloon-expandable stent is shorter, and after the stent is implanted, the influence on the blood flow in the left ventricular outflow tract can be further reduced. The inventive concept and technical effect of the present application clearly solve this technical problem that has not been solved in the industry for a long time.

[0115] In this regard, since the related structures and concepts of Example 3 are similar to those of Example 1, they will not be repeatedly described here.

[0116] Example 4 Example 4 is almost the same as Example 3. However, as shown in FIGS. 10a and 10b, the height of the connection point between the clamping member 3 and the valve clamping mechanism 21 in this example is different, so the clamping member 3 is different in pulling up its own valve tip to the target.

[0117] In this example, when the replacement system is used for replacing the mitral valve leaflet, the height of the position of the connection point between the clamping member 3 and the valve clamping mechanism 21 is different. Specifically, the connection point between the clamping member 3 and the valve clamping mechanism 21 in the anterior valve tip region is higher than the connection point in the posterior valve tip region. The advantage of such a design is that, as can be seen from the physiological and anatomical structure, the length of the anterior valve tip is long, and after replacement, the anterior valve tip is likely to block the left ventricular outflow tract. Therefore, the connection position between the clamping member 3 and the valve clamping mechanism 21 in the anterior valve tip region of the clamping member 3 is high. In the case of the second form, the clamping member 3 has a larger pulling-up width for the anterior valve tip, ensuring that the anterior valve tip does not affect the left ventricular outflow tract. On the other hand, in the posterior valve tip region, the pulling width of the clamping member 3 is small, which can avoid excessive pulling on the chordae tendineae tissue by the clamping member 3 and is beneficial to tissue protection.

[0118] In this regard, since the related structures and concepts of Example 4 are similar to those of Example 1, they will not be repeatedly described here.

[0119] Example 5 Example 5 is almost the same as Example 1. However, as shown in FIGS. 11a and 11b, the valve clamping mechanism 21 in this example includes a plurality of clamping members 25, and the height of the connection point between the clamping member 3 and each of the clamping members 25 is different. Therefore, in the second form, the clamping member 3 is different in presenting a wavy form.

[0120] In this example, the valve clamping mechanism 21 includes a plurality of clamping members 25, and the height of the connection point between the clamping member 3 and each of the clamping members 25 is different. Therefore, in the second form, the clamping member 3 presents a wavy form.

[0121] In this embodiment, the connection position between the clamping member 25 and the clamping material 3 in the anterior leaflet region is higher than the connection position between the clamping member 25 and the clamping material 3 in the posterior leaflet region. Such a design is because, as can be seen from the physiological and anatomical structure, the length of the anterior leaflet is long, and after replacement, the anterior leaflet is likely to block the left ventricular outflow tract. Therefore, the connection position between the clamping material 3 and the valve clamping mechanism 21 in the anterior leaflet region is high. In the case of the second form, the clamping material 3 has a larger pulling-up width for the anterior leaflet to ensure that the anterior leaflet does not affect the left ventricular outflow tract. On the other hand, in the posterior leaflet region, the pulling width of the clamping material 3 is small, which aims to avoid excessive pulling on the chordae tendineae tissue by the clamping material 3 and is advantageous for tissue protection.

[0122] Regarding this, since the related structure and concept of Example 5 are similar to those of Example 1, they will not be repeatedly described here.

[0123] Example 6 Example 6 is substantially the same as Example 1, but is different in that a fixed clamping material 9 is provided on the valve membrane stent 1 in this example. The fixed clamping material 9 is used to clamp the self-leaflet, plays a role of a certain anchor, and at the same time increases the adhesion between the leaflet and the valve membrane stent 1, and can also play a good role in preventing leakage.

[0124] In this embodiment, as shown in FIGS. 12a - 12c, the valve membrane stent 1 is provided with a fixed clamping material 9, and in the second form, the fixed clamping material 9 clamps the self-leaflet so that it is sandwiched between the valve membrane stent 1 and the fixed clamping material 9.

[0125] In this embodiment, the position of the fixed clamping material 9 does not overlap with the valve clamping mechanism 21.

[0126] Regarding this, since the related structure and concept of Example 6 are similar to those of Example 1, they will not be repeatedly described here.

[0127] Example 7 Example 7 is substantially the same as Example 1, except that the valve clamping and fixing device 2 in this example only has a single valve clamping member 10, one side of the clamping member 3 is connected to the valve clamping member 10, and the other side of the clamping member 3 is connected to the ventricular segment 102.

[0128] In this embodiment, as shown in FIGS. 13a and 13b, the valve clamping and fixing device 2 includes a single valve clamping member 10, an atrial support segment 101, a ventricular segment 102, and a clamping member 3. Among them, the clamping member 3 is connected to the valve clamping member 10 and the ventricular segment 102 respectively, and in a cross-section parallel to the central axis of the valve clamping and fixing device 2, the clamping member 3 presents an inclined form. The atrial support segment 101 is located in the atrium and provides a supporting force to the valve clamping and fixing device 2. The valve clamping member 10 is connected to the ventricular segment 102 and is located on the anterior cusp side. The clamping member 3 is connected to the valve clamping member 10, and the clamping member 3 is fixedly connected to the ventricular segment 102 located in the posterior cusp region. Thus, in a cross-section parallel to the central axis of the valve clamping and fixing device 2, the clamping member 3 presents an inclined form.

[0129] In this embodiment, the valve clamping member 10 is used to clamp the anterior cusp, and the height of the clamping member 3 in the region of the valve clamping member 10 is higher than the height of the clamping member 3 in the posterior cusp region. Such a design is to avoid pulling up the anterior cusp and related chordae tendineae tissues upward as a target and affecting the left ventricular outflow tract after the valve clamping and fixing device 2 is installed at a predetermined position. On the other hand, in the posterior cusp region, the clamping member 3 is clearly aimed at reducing the influence on the native tissue without pulling the chordae tendineae and the posterior cusp.

[0130] Regarding this, since the related structures and concepts of Example 7 are similar to those of Example 1, they will not be repeatedly described here.

[0131] For purposes of explanation, a foregoing description of exemplary embodiments of the present application is provided. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise arrangement and / or configuration disclosed. According to the foregoing guidance, it will be apparent to those of ordinary skill in the art that many modifications and variations can be made without departing from the present application. The scope and equivalents of the present application are intended to be limited by the appended claims.

Claims

1. An artificial valve replacement system comprising a valve stent and a valve clamping and fixing device that operates in cooperation with the valve stent, wherein the valve clamping and fixing device is configured as a valve clamping mechanism for clamping the native valve leaflets and a clamping member at least partially disposed in the valve clamping mechanism, the valve clamping and fixing device is configured to be capable of presenting a first configuration and a second configuration that appears after the first configuration, when the valve clamping and fixing device is in the first configuration, the valve clamping mechanism is configured to be able to capture and clamp the native valve leaflets, after the valve stent expands radially, the valve clamping and fixing device is in the second configuration, and due to the radial expansion of the valve stent, the clamping member moves the native valve leaflets upward to displace and clamp the valve stent, in the first configuration of the valve clamping and fixing device, the valve leaflets around the valve clamping mechanism are capable of achieving self-opening and closing. When the valve stent enters the valve clamping mechanism, the distal end of the valve clamping mechanism is removed, and the valve stent is in a radially expanded state. Due to the radial expansion of the valve stent, the clamping member moves the native valve leaflets upward to displace and clamp the valve stent, characterized in that it is an artificial valve replacement system.

2. The distal end of the valve clamping mechanism is removably connected. The artificial valve replacement system according to claim 1, characterized in that.

3. The radial expansion of the valve stent moves the valve clamping mechanism, the clamping member, the native valve leaflets, and the chordae tendineae in an interlocking manner. The clamping member is at least partially displaced upward to move the native valve leaflets and the chordae tendineae upward, and at least one of the native valve leaflets and the chordae tendineae tissue is clamped between the clamping member and the valve stent. The artificial valve replacement system according to claim 1, characterized in that.

4. In the first configuration, the valve clamping mechanism clamps some of the native valve leaflets. In the second configuration, the native valve leaflets around the valve clamping mechanism are moved upward by the clamping member. The artificial valve replacement system according to claim 1, characterized in that.

5. Further comprising an inner core tube, the distal end of the inner core tube is removably connected in cooperation with the distal end of the valve clamping mechanism, and the valve stent enters the valve clamping mechanism along the inner core tube. The artificial valve replacement system according to claim 1, characterized in that.

6. The clamping member and the valve clamping mechanism each have at least two connection points with different heights. The artificial valve membrane replacement system according to claim 1, characterized in that.

7. The valve clamping and fixing device includes a single valve clamping member, an atrial support segment, a ventricular segment, and a clamping member connected to the valve clamping member and the ventricular segment respectively, and having an inclined form in a cross section parallel to the central axis of the valve clamping and fixing device. The artificial valve membrane replacement system according to claim 1, characterized in that.

8. The valve clamping mechanism includes a plurality of clamping members, and since the heights of the connection points between the clamping member and each of the clamping members are different, in the second form, the clamping member has a wavy form. The artificial valve membrane replacement system according to claim 1, characterized in that.

9. The valve clamping mechanism is removably connected or is two independent members that separate from each other, and includes a first clamping half body and a second clamping half body configured to respectively capture and clamp different native valve leaflets. The artificial valve membrane replacement system according to claim 5, characterized in that.

10. The first clamping half body and the second clamping half body have complementary shapes and are removably engaged and connected by the inner core tube in the constrained state of the valve clamping and fixing device. The artificial valve membrane replacement system according to claim 9, characterized in that.

11. The valve membrane stent can be further provided with a positioning ring to be positioned in the atrium, the positioning ring is configured in a form adapted to the physiological structure of the native valve ring, and an auxiliary fixing rod is provided. The artificial valve membrane replacement system according to claim 1, characterized in that.

12. The valve membrane stent is provided with a fixing clamp member, and in the second form, the fixing clamp member clamps the native valve leaflet between the valve membrane stent and the fixing clamp member. The artificial valve membrane replacement system according to claim 1, characterized in that.

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