A prosthetic valve replacement system

Abstract

The application relates to the field of medical devices, in particular to an artificial valve prosthesis replacement system, which comprises a valve support, a delivery system for delivering the valve support, a valve leaflet clamping mechanism arranged on the valve support, an anchoring ring connected with the valve leaflet clamping mechanism, the delivery system comprises an outer sheath, an inner core tube, a control wire and a connecting mechanism, the connecting mechanism comprises a connecting piece and a protection piece arranged at the distal end of the connecting piece, the distal end of the inner core tube is fixedly connected with the connecting piece, and the valve leaflet clamping mechanism is detachably connected with the connecting mechanism through the control wire; in the application, the connecting mechanism and the control wire are matched, so that the delivery device and the valve support realize a stable controllable detachable structure, the opening and closing of the clamping arm can be controlled, the loading pipe diameter can be reduced, recovery can be realized, intracardiac adjustment is facilitated and the like, and the application has good clinical significance.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to an artificial valve prosthesis replacement system. Background Technology

[0002] From a cardiac structural perspective, both the mitral and tricuspid valves have unique physiological structures, making accurate product positioning and fixation extremely difficult. The mitral valve's location within the heart and its complex anatomical structure, in particular, pose a significant challenge to mitral valve replacement.

[0003] Existing patent CN202211180680.0 discloses a replacement system that can avoid outflow tract obstruction, including: a valve stent, a valve clamping and fixing device that operates in conjunction with the valve stent, the valve clamping and fixing device being configured to clamp the autologous valve leaflet and a clamping member, the clamping member being at least partially disposed on the valve clamping mechanism, and after the valve stent is installed in place, the clamping member driving the autologous valve leaflet to move upward and clamp the valve stent; the valve clamping mechanism includes a clamping arm, a control rod, and a control wire, wherein the clamping arm includes a fixed arm and a capturing arm, the capturing arm being hinged to the fixed arm, the control rod being detachably connected to the capturing arm through the control wire, and pulling / pushing the control rod can cause the capturing arm to open / close. While this technical solution can prevent the anterior leaflet from obstructing the left ventricular outflow tract, the detachable connection between the leaflet clamping arm and the distal end of the delivery system is controlled by only one control wire. In actual use, the control wire may deform, making it difficult to remove during disassembly. Secondly, the distal end of the delivery system lacks a structure to protect the heart tissue, which can easily scratch the heart tissue during intracardiac adjustments.

[0004] In conclusion, although the above technologies have achieved some clinical success, they all have shortcomings, and there is an urgent need for a new transcatheter heart valve replacement system to solve these problems. Summary of the Invention

[0005] In view of the above and other concepts, this application is made. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0006] Regarding the application of atrioventricular valve surgery, this application aims to provide an artificial valve prosthesis replacement system for patients with atrioventricular valve lesions who require interventional treatment. This system can solve problems in existing heart valve replacement systems, such as the inability to stably disassemble and separate the clamping arm and delivery system, and the inability to scratch heart tissue during adjustment of the distal end of the delivery system.

[0007] According to one aspect of this application, an artificial valve prosthesis replacement system is provided, including a valve stent, a delivery system for delivering the valve stent, the valve stent having a leaflet clamping mechanism and an anchoring ring connected to the leaflet clamping mechanism, the delivery system including an outer sheath, an inner core tube, a control wire, and a connecting mechanism, the connecting mechanism including a connector and a protective member disposed at the distal end of the connector, wherein the distal end of the inner core tube is fixedly connected to the connector, and the leaflet clamping mechanism is detachably connected to the connecting mechanism via the control wire.

[0008] As a further improvement of the present invention, the leaflet clamping mechanism includes a clamping arm connected to the valve stent and a linkage rod hinged to the clamping arm, wherein the linkage rod is hinged to the connecting member.

[0009] As a further improvement of the present invention, the connector includes a connecting body, a positioning block disposed on the connecting body, and a plurality of guide blocks, wherein the positioning block is provided with positioning holes.

[0010] As a further improvement of the present invention, the bottom of the connector is a planar structure.

[0011] As a further improvement of the present invention, the distal end of the linkage is provided with a connection hole, wherein the control wire extends from the inside of the inner core tube and passes through the positioning hole and the connection hole, so that the linkage is detachably connected to the connecting body through the control wire.

[0012] As a further improvement of the present invention, the guide block is provided with a guide hole, wherein the control wire passes through the guide hole, the positioning hole and the connecting hole, so that the linkage rod is detachably connected to the connecting body through the control wire, and the guide block is symmetrically distributed on both sides of the positioning block.

[0013] As a further improvement of the present invention, the connector is provided with a connecting hole at its center, and the control wire extends from the connecting hole and passes through the guide hole, the positioning hole and the connecting hole.

[0014] As a further improvement of the present invention, the outer peripheral surface of the protective component has a smooth, rounded structure.

[0015] As a further improvement of the present invention, the inner core tube pushes or pulls back the linkage member to the distal end, and the linkage member drives the clamping arm to fold to control the angle between the clamping arm and the valve stent.

[0016] As a further improvement of the present invention, in the natural state, the clamping arm is against the outer side of the valve stent, wherein when the inner core tube is operated to push the linkage to the maximum stroke, the angle between the clamping arm and the valve stent is 180°.

[0017] As a further improvement of the present invention, during pre-installation, the inner core tube is pushed distally to its maximum stroke. At this point, the axial length of the valve stent is at its maximum, and the valve stent, clamping arm, and linkage do not overlap in the axial direction, which significantly reduces the loading tube diameter and facilitates delivery via the vascular access route. When the valve stent reaches the atrium via the vascular access route, the outer sheath is retracted and the inner core tube is pulled proximally, causing the linkage to drive the clamping arm to fold proximally. At this point, the valve stent, clamping arm, and linkage overlap in the axial direction, shortening the axial length. This allows the valve stent to be angled within the atrium and bent towards the autologous valve, ensuring that the valve stent is aligned with the center of the autologous valve, thus facilitating delivery of the valve stent into the ventricle.

[0018] As a further improvement of the present invention, an arc segment is provided between the clamping arm and the valve stent, and the arc segment is deflected in the circumferential direction of the valve stent; since the clamping arm is straightened and loaded inside the outer sheath, the fatigue resistance of the clamping arm is required to be very high, and the deflection of the arc segment in the circumferential direction of the valve stent allows the arc segment to maintain a large R angle while avoiding the outer sheath from directly applying pressure to the arc segment during loading.

[0019] As a further improvement of the present invention, the linkage rod is always located on the outside of the clamping arm during the process of driving the clamping arm to fold.

[0020] As a further improvement of the present invention, the valve stent includes a stent body, an artificial valve disposed within the stent body, and a sealing ring disposed at the proximal end of the stent body. The stent body is a mesh-like stent, and the free end of the clamping arm extends outward from the stent body and is arranged in an arc shape, which can effectively prevent the clamping arm from damaging the autologous leaflet.

[0021] As a further improvement of the present invention, the artificial valve can be made of biological materials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials.

[0022] As a further improvement of the present invention, after the valve stent is installed in place, the anchoring ring pulls the chordae tendineae tissue and lifts the autologous leaflet. The autologous leaflet and chordae tendineae tissue are sandwiched between the valve stent and the clamping arm. Furthermore, the anchoring ring tightens the valve stent. The anchoring ring serves both to lift the chordae tendineae to prevent the autologous leaflet from blocking the outflow tract and to fix the stent.

[0023] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following:

[0024] 1. In existing replacement systems, the control wire for disassembly deforms during withdrawal due to concentrated force at the connection point, increasing resistance during withdrawal. Furthermore, the distal end of the delivery system can easily scrape against cardiac tissue during valve stent adjustment, potentially causing damage. In one embodiment of this application, the connecting structure includes a connector for the control wire's connection and a protective component to prevent damage to cardiac tissue during valve stent adjustment. The connector includes a connecting body, positioning blocks, and multiple guide blocks. The control wire passes through guide holes, positioning holes, and connection holes to form a detachable connection. The bottom of the connecting body is a flat surface, ensuring the control wire does not deform under stress. One end of the linkage is positioned between two positioning blocks, resulting in a shorter stress-bearing section and greater rigidity for the control wire. Therefore, even with a thinner control wire, deformation is less likely. The guide blocks prevent premature withdrawal of the control wire, ensuring the stability of the disassembly connection. This design provides a stable and reliable disassembly connection structure for the valve stent while preventing damage to cardiac tissue during valve stent adjustment, offering significant clinical benefits.

[0025] 2. In one embodiment of this application, manipulating the inner core tube allows the linkage to apply an axial force to the clamping arm, making the angle between the clamping arm and the valve stent controllable. Furthermore, since the linkage remains on the outside of the clamping arm during the folding process, there is no interference between the linkage and the clamping arm. The clamping arm can be stretched up to 180° with the valve and aligned with the linkage, significantly reducing the loading diameter of the delivery catheter and facilitating transvascular delivery. Additionally, when the valve stent is delivered to the atrium via a blood vessel, the inner core tube can be manipulated to align the leaflet clamping mechanism with the valve stent, thereby shortening the axial length and allowing the valve stent to bend within the atrium for smooth entry into the ventricle. This method is convenient and adaptable to various application scenarios, offering significant advantages over existing products.

[0026] 3. In one embodiment of this application, an arc segment is provided between the clamping arm and the valve stent, and the arc segment is deflected in the circumferential direction of the valve stent. Since the clamping arm is straightened and loaded inside the outer sheath, the fatigue resistance of the clamping arm is highly required. The deflection of the arc segment in the circumferential direction of the valve stent allows the arc segment to maintain a large R angle (because the larger the R angle, the better the fatigue resistance) while avoiding the outer sheath from directly applying pressure to the arc segment during loading.

[0027] The embodiments of this application can achieve other beneficial technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0028] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0029] Figures 1-5 This is a schematic diagram of the overall structure of the valve replacement system of the present invention, wherein, Figure 3 This is an enlarged view of the connector.

[0030] Figure 6 and Figure 7 This is a schematic diagram of the arc segment of the present invention.

[0031] Figure 8 This is a schematic diagram of the valve stent of the present invention.

[0032] Figures 9-16 This is a schematic diagram of the operation process of the valve replacement system of the present invention.

[0033] The parts referred to by the numbers in the attached diagram are as follows: 1-valvular stent, 11-stent body, 12-sealing ring, 2-delivery system, 21-outer sheath, 22-inner core tube, 23-control wire, 24-connection mechanism, 25-protective component, 26-connector, 261-connecting body, 262-guide block, 2621-guide hole, 263-positioning block, 2631-positioning hole, 3-leaflet clamping mechanism, 31-clamping arm, 32-linkage rod, 321-connecting hole, 4-anchoring ring, 5-arc segment. Detailed Implementation

[0034] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0035] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0036] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter and their equivalents, as well as any possible additional items.

[0037] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0038] In this application, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator. Specific Implementation Example

[0039] like Figure 1 and Figure 2 As shown, when the valve prosthesis is used for mitral valve treatment, an artificial valve prosthesis replacement system includes a valve stent 1 and a delivery system 2 for delivering the valve stent 1. The valve stent 1 is provided with a leaflet clamping mechanism 3 and an anchoring ring 4 connected to the leaflet clamping mechanism 3. The delivery system 2 includes an outer sheath 21, an inner core tube 22, a control wire 23, and a connecting mechanism 24. The connecting mechanism 24 includes a connector 26 and a protective member 25 disposed at the distal end of the connector 26. The distal end of the inner core tube 22 is fixedly connected to the connector 26, and the leaflet clamping mechanism 3 is detachably connected to the connecting mechanism 24 through the control wire 23.

[0040] In this embodiment, as Figure 1 and Figure 4 As shown, the leaflet clamping mechanism 3 includes a clamping arm 31 connected to the valve stent 1 and a linkage rod 32 hinged to the clamping arm 31. The linkage rod 32 is hinged to the connecting member 26. By operating the inner core tube 22 (specifically pushing it to the distal end or pulling it back to the proximal end), the linkage rod 32 can apply an axial force to the clamping arm 31, thereby causing the clamping arm 31 to fold, thus controlling the angle between the clamping arm 31 and the valve stent 1.

[0041] In this embodiment, as Figure 2 and 3 As shown, the bottom of the connector 26 is a planar structure. The connector 26 includes a connecting body 261, two positioning blocks 263 and two guide blocks 262 disposed on the connecting body 261. The positioning blocks 263 are provided with positioning holes 2631. The distal end of the linkage rod 32 is disposed between the two positioning blocks 263, and the distal end of the linkage rod 32 is provided with a connecting hole 321. Figure 4As shown, the control wire 23 extends from the inside of the inner core tube 22 and passes through the positioning hole 2631 and the connecting hole 321, so that the linkage rod 32 is detachably connected to the connecting body 261 through the control wire 23. Furthermore, the centers of the positioning hole 2631 and the connecting hole 321 are on the same axis. The purpose of this design is that even if the control wire 23 is subjected to a large pulling force, it will not deform or bend.

[0042] In this embodiment, the guide block 262 is provided with a guide hole 2621, wherein the control wire 23 passes through the guide hole 2621, the positioning hole 2631 and the connecting hole 321, so that the linkage rod 32 is detachably connected to the connecting body 261 through the control wire 23, and the guide block 262 is symmetrically distributed on both sides of the positioning block 263.

[0043] In this embodiment, the connector 26 has a connecting hole at its center, and the control wire 23 extends from the connecting hole and passes through the guide hole 2621, the positioning hole 2631 and the connecting hole 321.

[0044] In this embodiment, the outer peripheral surface of the protective component 25 has a smooth, rounded structure, which means that even if the valve stent 1 scrapes against the heart tissue when adjusting its position according to the image after entering the atrium, it will not cause serious damage.

[0045] In this embodiment, during pre-installation, the inner core tube 22 is pushed to its maximum stroke at the distal end, such as... Figure 5 As shown, at this time, the axial length of the valve stent 1 is at its maximum. The valve stent 1, the clamping arm 31, and the linkage rod 32 do not overlap in the axial direction, which allows for a significant reduction in the loading tube diameter, facilitating delivery via the vascular access. When the valve stent 1 reaches the atrium via the vascular access, the outer sheath 21 is retracted and the inner core tube 22 is pulled proximally, causing the linkage rod 32 to drive the clamping arm 31 to fold proximally. Figure 1 As shown, at this time, the valve stent 1, clamping arm 31 and linkage rod 32 overlap in the axial direction, shortening the axial length. This allows the valve stent 1 to be angled in the atrium and bent towards the autologous valve, so that the valve stent 1 can be directly aligned with the center of the autologous valve, so as to facilitate the delivery of the valve stent 1 into the ventricle.

[0046] In this embodiment, as Figure 6 and Figure 7As shown, an arc segment 5 is provided between the clamping arm 31 and the valve stent 1. The arc segment 5 is deflected in the circumferential direction of the valve stent 1. Since the clamping arm 31 is straightened and loaded inside the outer sheath 21, the fatigue resistance of the clamping arm 31 is very high. The deflection of the arc segment 5 in the circumferential direction of the valve stent 1 ensures that the arc segment 5 maintains a large R angle while avoiding the outer sheath 21 from directly applying pressure to the arc segment 5 during loading.

[0047] In this embodiment, during the process of folding the clamping arm 31, the linkage 32 is always located on the outside of the clamping arm 31.

[0048] In this embodiment, the valve stent 1 includes a stent body 11, an artificial valve disposed within the stent body 11, and a sealing ring 12 disposed near the proximal end of the stent body 11. The stent body 11 is a mesh-like stent, and the free end of the clamping arm 31 extends outward from the stent body 11 and is arranged in an arc shape, which can effectively prevent the clamping arm 31 from damaging the autologous valve leaflet. Figure 8 As shown.

[0049] In this embodiment, the artificial valve can be made of biomaterials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials.

[0050] In this embodiment, after the valve stent 1 is installed in place, the anchoring ring 4 pulls the chordae tendineae tissue and lifts the autologous leaflet. The autologous leaflet and chordae tendineae tissue are sandwiched between the valve stent 1 and the clamping arm 31. Furthermore, the anchoring ring 4 tightens the valve stent 1. The anchoring ring 4 serves both to lift the chordae tendineae to prevent the autologous leaflet from blocking the outflow tract and to fix the stent.

[0051] An exemplary procedure for repairing the mitral valve using an artificial valve prosthesis replacement system in this embodiment is as follows:

[0052] 1. Operate the delivery system 2 via a transvascular approach, passing through a septum so that the distal portion of the delivery system 2 enters the atrium, as follows: Figure 9 As shown;

[0053] 2. Retract the outer sheath 21 so that its linkage 32 and clamping arm 31 extend out from the outer sheath 21, as follows: Figure 10 As shown, the inner core tube 22 is pulled back towards the proximal end, causing the clamping arm 31 to fold upwards until the inner core tube 22 is pulled back to its maximum stroke, as shown. Figure 11 As shown, the clamping arm 31, the linkage rod 32, and the stent body overlap axially. Then, the distal end of the delivery system 2 is bent to allow the valve stent 1 to enter the ventricle downwards. Figure 12 As shown;

[0054] 3. Pushing the inner core tube 22 distally causes the clamping arm 31 to open outwards towards the valve stent 1 to capture the autologous leaflet, as... Figure 13 and Figure 14 As shown, after capturing the autologous leaflet, the stent body 11 and sealing ring 12 are gradually released to complete the implantation, as follows. Figure 15 As shown.

[0055] 4. Remove delivery system 2 from the body to complete the surgery, such as... Figure 16 As shown.

[0056] The foregoing description of exemplary embodiments of this application has been provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations and / or constructions disclosed. Clearly, many modifications and variations can be made by those skilled in the art based on the teachings above without departing from the invention. The scope and equivalents of this invention are intended to be defined by the appended claims.

Claims

1. An artificial valve prosthesis replacement system, comprising a valve stent and a delivery system for delivering the valve stent, characterized in that: The valve stent is provided with a leaflet clamping mechanism and an anchoring ring connected to the leaflet clamping mechanism. The delivery system includes an outer sheath, an inner core tube, a control wire, and a connecting mechanism. The connecting mechanism includes a connector and a protective member disposed at the distal end of the connector. The distal end of the inner core tube is fixedly connected to the connector. The leaflet clamping mechanism is detachably connected to the connecting mechanism through the control wire. The leaflet clamping mechanism includes a clamping arm connected to the valve stent and a linkage rod hinged to the clamping arm. In its natural state, the clamping arm is against the outer side of the valve stent. The inner core tube pushes or pulls back the linkage rod at the distal end. The linkage rod drives the clamping arm to fold to control the angle between the clamping arm and the valve stent to be 180°.

2. The artificial valve prosthesis replacement system according to claim 1, characterized in that: The linkage member is hinged to the connecting member.

3. The artificial valve prosthesis replacement system according to claim 2, characterized in that: The connector includes a connecting body, a positioning block disposed on the connecting body, and a plurality of guide blocks, wherein the positioning block is provided with positioning holes.

4. The artificial valve prosthesis replacement system according to claim 3, characterized in that: The distal end of the linkage is provided with a connection hole, wherein the control wire extends from the inside of the inner core tube and passes through the positioning hole and the connection hole, so that the linkage is detachably connected to the connecting body through the control wire.

5. The artificial valve prosthesis replacement system according to claim 4, characterized in that: The guide block is provided with a guide hole, wherein the control wire passes through the guide hole, the positioning hole and the connecting hole, so that the linkage rod is detachably connected to the connecting body through the control wire, and the guide block is symmetrically distributed on both sides of the positioning block.

6. The artificial valve prosthesis replacement system according to claim 5, characterized in that: The connector has a connecting hole at its center, and the control wire extends from the connecting hole and passes through the guide hole, the positioning hole, and the connecting hole.

7. The artificial valve prosthesis replacement system according to claim 5, characterized in that: The outer peripheral surface of the protective component has a smooth, rounded structure.

8. The artificial valve prosthesis replacement system according to claim 1, characterized in that: When the inner core tube is pushed to the distal end to the maximum stroke of the linkage, the angle between the clamping arm and the valve stent is 180°.

9. The artificial valve prosthesis replacement system according to claim 1, characterized in that: An arc segment is provided between the clamping arm and the valve stent, and the arc segment is deflected in the circumferential direction of the valve stent.

10. The artificial valve prosthesis replacement system according to claim 1, characterized in that: During the process of folding the clamping arm, the linkage is always located on the outside of the clamping arm.

11. The artificial valve prosthesis replacement system according to claim 1, characterized in that: The valve stent includes a stent body, an artificial valve disposed within the stent body, and a sealing ring disposed near the proximal end of the stent body. The stent body is a mesh-like stent, and the free end of the clamping arm extends outward from the stent body and is arranged in an arc shape.

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