Prosthetic valve prosthesis replacement system

Abstract

The invention relates to the field of medical instruments, in particular to an artificial valve prosthesis replacement system which comprises a valve support and a conveying system used for conveying the valve support, and a valve leaflet clamping mechanism and an anchoring ring connected with the valve leaflet clamping mechanism are arranged on the valve support. The conveying system comprises an outer sheath tube, 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 far end of the connecting piece, the far 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; according to the scheme, the connecting mechanism is matched with the control wire, so that the conveying instrument and the valve support are of a stable and controllable detachable structure, opening and closing of the clamping arms can be controlled, the loading pipe diameter can be reduced, recycling is achieved, intracardiac adjustment is facilitated, and good clinical significance is achieved.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an artificial valve prosthesis replacement system. Background Art

[0002] From the perspective of heart structure, both the mitral valve and the tricuspid valve have special physiological structures, which makes it very difficult to accurately position and fix the product. In particular, the position of the mitral valve in the heart and its complex anatomical structure bring great challenges to mitral valve replacement.

[0003] The existing patent CN202211180680.0 discloses a replacement system that can avoid outflow tract obstruction, including: a valve stent, a valve clamping fixing device that cooperates with the valve stent, the valve clamping fixing device is constructed as a valve clamping mechanism and a clamping member for clamping autologous valve leaflets, and the clamping member is at least partially configured on the valve clamping mechanism. After the valve stent is installed in place, the clamping member drives the autologous valve leaflets to shift 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 capture arm, the capture arm is hinged on the fixed arm, the control rod is detachably connected to the capture arm through the control wire, and pulling back / pushing the control rod can cause the capture arm to open / or close. Although this technical solution can prevent the anterior valve leaflet from blocking the left ventricular outflow tract, the detachable connection structure between the valve 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 be deformed, making it difficult to remove the control wire during disassembly. Secondly, the distal end of the delivery system has no structure to protect the heart tissue, and the heart tissue is easily scratched when adjusting inside the heart.

[0004] In summary, although the above technologies have achieved some clinical results, they all have shortcomings, and a new transcatheter heart valve replacement system is urgently needed to solve the above problems. Summary of the invention

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

[0006] In terms of application in atrioventricular valve surgery, the present application aims to provide an artificial valve prosthesis replacement system for patients with atrioventricular valve lesions who require interventional treatment, thereby solving the problems in the prior art of the clamping arm and the delivery system of the heart valve replacement system being able to be stably disassembled and separated, and the distal end of the delivery system being able to avoid scratching the heart tissue during adjustment.

[0007] According to one aspect of the present application, an artificial valve prosthesis replacement system is provided, comprising a valve stent and a delivery system for delivering the valve stent, wherein the valve stent is provided with a leaflet clamping mechanism and an anchoring ring connected to the leaflet clamping mechanism, the delivery system comprises an outer sheath tube, an inner core tube, a control wire and a connecting mechanism, the connecting mechanism comprises a connecting piece and a protective piece arranged at the distal end of the connecting piece, wherein the distal end of the inner core tube is fixedly connected to the connecting piece, 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 support, and a linkage rod hinged to the clamping arm, and the linkage rod is hinged to the connecting member.

[0009] As a further improvement of the present invention, the connecting piece includes a connecting body, a positioning block arranged on the connecting body, and a plurality of guide blocks, and the positioning block is provided with a positioning hole.

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

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

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

[0013] As a further improvement of the present invention, a connection hole is provided at the center position of the connection piece, and the control wire extends out from the connection 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 element is a smooth round head structure.

[0015] As a further improvement of the present invention, the inner core tube pushes or pulls back the linkage rod toward the distal end, and the linkage rod 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 a 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 rod distally to a 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 the maximum stroke, at which point the axial length of the valve stent is at its maximum, and the valve stent, the clamping arm and the linkage rod do not overlap in the axial direction, so that the loading tube diameter can be greatly reduced, which is convenient for delivery through the vascular access route; when the valve stent reaches the atrium through the vascular access route, the outer sheath tube is withdrawn and the inner core tube is pulled proximally so that the linkage rod drives the clamping arm to fold proximally, at which point the valve stent, the clamping arm and the linkage rod overlap in the axial direction, shortening the axial length, which enables the valve stent to be adjusted in angle in the atrium and bent toward the direction of the native valve, so that the valve stent can face the center of the native valve, so as to facilitate 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 in the outer sheath tube, high requirements are placed on the fatigue resistance of the clamping arm, and the deflection of the arc segment in the circumferential direction of the valve stent enables the arc segment to maintain a larger R angle while avoiding the outer sheath tube from directly applying pressure to the arc segment during loading.

[0019] As a further improvement of the present invention, when the linkage rod drives the clamping arm to fold, the linkage rod is always located outside the clamping arm.

[0020] As a further improvement of the present invention, the valve stent includes a stent body, an artificial valve arranged in the stent body, and a sealing ring arranged at the proximal end of the stent body. The stent body is a grid-like stent, and the free end of the clamping arm extends to the outside of the stent body and is arranged in an arc-shaped structure, which can effectively prevent the clamping arm from damaging the native valve leaflet.

[0021] As a further improvement of the present invention, the artificial valve can be made of biological materials such as bovine pericardium, porcine pericardium, etc., and can also 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 tissue and lifts the autologous leaflets, the autologous leaflets and chordae tissue are clamped between the valve stent and the clamping arm, and the anchoring ring tightens the valve stent, wherein the anchoring ring not only pulls the chordae to prevent the autologous leaflets from blocking the outflow tract, but also fixes the stent. Compared with the prior art, the advantages and beneficial technical effects of the present application include at least the following: 1. When the wire for controlling disassembly in the existing replacement system is withdrawn, the force is concentrated at the connection point, causing the disassembly wire to deform, and the resistance becomes larger when withdrawn. Secondly, the distal end of the delivery system is easy to scrape the heart tissue when adjusting the valve stent, which is easy to cause damage. In one embodiment of the present application, the connection structure includes a connection piece for the control wire to be connected and a protective piece that can prevent the valve stent from damaging the heart tissue during the adjustment process, wherein the connection piece includes a connection body, a positioning block and a plurality of guide blocks, and the control wire passes through the guide hole, the positioning hole and the connection hole to form a detachable connection. The bottom of the connection body is a plane to ensure that the control wire is not deformed when subjected to force, and one end of the linkage rod is arranged between the two positioning blocks, so that the force section of the control wire is shorter and its rigidity is larger. Therefore, even if a thinner control wire is selected, it is not easy to deform, and the setting of the guide block makes it difficult for the control wire to be withdrawn in advance, ensuring the stability of its disassembly connection, so that the connection mechanism can not only provide a stable and reliable disassembly connection structure for the valve stent, but also prevent the valve stent from causing damage to the heart tissue during the adjustment process, which has good clinical significance.

[0023] 2. In one embodiment of the present application, manipulating the inner core tube can cause the linkage rod to apply an axial force to the clamping arm, so that the angle between the clamping arm and the valve stent becomes controllable, and because the linkage rod is always on the outside of the clamping arm during the process of driving the clamping arm to fold, the linkage rod and the clamping arm will not interfere with each other, and the clamping arm and the valve can be straightened to 180° and be in a straight line with the linkage rod, so as to greatly reduce the loading diameter of the delivery catheter and facilitate delivery through the vascular access route. In addition, when the valve stent is delivered to the atrium through the blood vessel, the inner core tube can be operated to make its leaflet clamping mechanism fit the valve stent, thereby shortening the axial length and facilitating the valve stent to bend in the atrium so that it can smoothly enter the ventricle. The operation is convenient and can be flexibly changed for multiple application scenarios. Compared with existing products, it has outstanding advantages.

[0024] 3. In one embodiment of the present 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 in the outer sheath tube, high requirements are placed on the fatigue resistance of the clamping arm, and the deflection of the arc segment in the circumferential direction of the valve stent enables the arc segment to maintain a larger R angle (because the larger the R angle, the better the fatigue resistance) while avoiding the outer sheath tube from directly applying pressure to the arc segment during loading.

[0025] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. These other technical effects may be partially described below and are predictable and understandable to those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The above-mentioned features and advantages and other features and advantages of these embodiments and the manner in which they are achieved will become more apparent, and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which: Figure 1-Figure 5 FIG. 1 is a schematic diagram of the overall structure of the valve replacement system of the present invention, wherein: Figure 3 yes Figure 2 Enlarged view of part A in the middle.

[0027] Figure 6 and Figure 7 It is a structural schematic diagram of the arc segment of the present invention.

[0028] Figure 8 It is a schematic structural diagram of the valve stent of the present invention.

[0029] Figure 9-Figure 16 It is a schematic diagram of the operation process of the valve replacement system of the present invention.

[0030] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-valve 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 part, 26-connection part, 261-connecting body, 262-guide block, 2621-guide hole, 263-positioning block, 2631-positioning hole, 3-leaflet clamping mechanism, 31-clamping arm, 32-linking rod, 321-connecting hole, 4-anchoring ring, 5-arc segment. DETAILED DESCRIPTION

[0031] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0032] 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 may be implemented or executed in various ways. Each example is provided by explaining the disclosed embodiments rather than limiting them. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence disclosed in the present application. For example, a feature illustrated or described as part of an embodiment may be used together with another embodiment to still produce another embodiment. Therefore, the present application discloses and covers such modifications and variations within the scope of the appended claims and their equivalent elements.

[0033] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents, as well as possible additional items.

[0034] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0035] In this application, the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator. Specific embodiments Example

[0036] 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 connecting piece 26 and a protective piece 25 arranged at the distal end of the connecting piece 26, wherein the distal end of the inner core tube 22 is fixedly connected to the connecting piece 26, and the leaflet clamping mechanism 3 is detachably connected to the connecting mechanism 24 through the control wire 23.

[0037] In this embodiment, 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 piece 26. By operating the inner core tube 22 (specifically pushing the inner core tube 22 toward the distal end or pulling it back toward the proximal end), the linkage rod 32 can apply an axial force to the clamping arm 31, thereby folding the clamping arm 31, thereby controlling the angle between the clamping arm 31 and the valve stent 1.

[0038] In this embodiment, Figure 2 and 3 As shown, the bottom of the connecting member 26 is a planar structure, and the connecting member 26 includes a connecting body 261, two positioning blocks 263 and two guide blocks 262 arranged on the connecting body 261, and the positioning blocks 263 are provided with positioning holes 2631. The distal end of the linkage rod 32 is arranged 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 forms a detachable connection with the connecting body 261 through the control wire 23, and the centers of the positioning hole 2631 and the connecting hole 321 are on the same axis. The purpose of such design is that even if the control wire 23 is subjected to a large pulling force, it will not cause deformation, bending, etc. of the control wire 23.

[0039] In this embodiment, a guide hole 2621 is provided on the guide block 262, 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 forms a detachable connection with the connecting body 261 through the control wire 23, and the guide blocks 262 are symmetrically distributed on both sides of the positioning block 263.

[0040] In this embodiment, a connecting hole is provided at the center of the connecting member 26 , and the control wire 23 extends out from the connecting hole and passes through the guiding hole 2621 , the positioning hole 2631 and the connecting hole 321 .

[0041] In this embodiment, the outer peripheral surface of the protective member 25 is a smooth round head structure, so that after the valve stent 1 enters the atrium, when the position of the valve stent 1 is adjusted according to the image, even if it scrapes the heart tissue, it will not cause serious damage.

[0042] In this embodiment, during pre-installation, the inner core tube 22 is pushed to the far end to the maximum stroke. Figure 5 As shown, at this time, the axial length of the valve stent 1 is the largest, and the valve stent 1, the clamping arm 31 and the linkage rod 32 do not overlap in the axial direction, so that the loading tube diameter can be greatly reduced, which is convenient for delivery through the vascular access; when the valve stent 1 reaches the atrium through the vascular access, the outer sheath tube 21 is withdrawn and the inner core tube 22 is pulled proximally so that the linkage rod 32 drives the clamping arm 31 to fold proximally, as shown in FIG. Figure 1 As shown, at this time, the valve stent 1, the clamping arm 31 and the linkage rod 32 overlap in the axial direction, shortening the axial length, which allows the valve stent 1 to be adjusted in angle in the atrium and bent toward the direction of the native valve, so that the valve stent 1 can face the center of the native valve, so as to facilitate the delivery of the valve stent 1 into the ventricle.

[0043] In this embodiment, Figure 6 and Figure 7As shown, an arc segment 5 is provided between the clamping arm 31 and the valve stent 1, and the arc segment 5 is deflected toward the circumferential direction of the valve stent 1; since the clamping arm 31 is straightened and loaded in the outer sheath tube 21, high requirements are imposed on the fatigue resistance of the clamping arm 31, and the arc segment 5 is deflected toward the circumferential direction of the valve stent 1 so that the arc segment 5 maintains a larger R angle while avoiding the outer sheath tube 21 from directly applying pressure to the arc segment 5 during loading.

[0044] In this embodiment, when the linkage rod 32 drives the clamping arm 31 to fold, the linkage rod 32 is always located outside the clamping arm 31 .

[0045] In this embodiment, the valve stent 1 includes a stent body 11, an artificial valve arranged in the stent body 11, and a sealing ring 12 arranged at the proximal end of the stent body 11. The stent body 11 is a grid-shaped stent, and the free end of the clamping arm 31 extends to the outside of the stent body 11 and is arranged in an arc-shaped structure, which can effectively prevent the clamping arm 31 from damaging the native valve leaflet. Figure 8 shown.

[0046] In this embodiment, the artificial valve can be made of biological materials such as bovine pericardium, porcine pericardium, etc., and can also be made of polymer materials.

[0047] In this embodiment, after the valve stent 1 is installed in place, the anchoring ring 4 pulls the chordae tissue and lifts the autologous leaflets, the autologous leaflets and chordae tissue are clamped between the valve stent 1 and the clamping arm 31, and the anchoring ring 4 tightens the valve stent 1, wherein the anchoring ring 4 not only pulls the chordae to prevent the autologous leaflets from blocking the outflow tract, but also fixes the stent.

[0048] An exemplary operation process of repairing a mitral valve of an artificial valve prosthesis replacement system of the first embodiment is as follows: 1. Operate the delivery system 2 through the vascular access route, through the septum, and place the distal end of the delivery system 2 into the atrium, such as Fig. 9 As shown; 2. Retract the outer sheath tube 21 so that the linkage rod 32 and the clamping arm 31 extend out of the outer sheath tube 21. Fig.10 As shown, the inner core tube 22 is pulled back toward the proximal end so that the clamping arm 31 is folded upward until the inner core tube 22 is pulled back to the maximum stroke, as shown in FIG. Fig.11 As shown, the clamping arm 31, the linkage rod 32 and the stent body overlap in the axial direction, and then the distal end of the delivery system 2 is bent so that the valve stent 1 enters the ventricle downward, as shown in FIG. Fig.12 As shown; 3. Push the inner core tube 22 to the distal end so that the clamping arms 31 open to the outside of the valve stent 1 to capture the native valve leaflets. Fig.13 and Fig.14 As shown, after capturing the native valve leaflet, the stent body 11 and the sealing ring 12 are gradually released to complete the implantation. Fig.15 shown.

[0049] 4. Remove the delivery system 2 from the body and complete the operation, such as Fig.16 shown.

[0050] The foregoing description of the exemplary embodiments of the present application is presented for the purpose of illustration. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configuration and / or construction disclosed, and it is apparent that, based on the teachings above, a person skilled in the art may make many modifications and variations without departing from the present invention. The scope and equivalents of the present 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 tube, an inner core tube, a control wire and a connecting mechanism. The connecting mechanism includes a connecting piece and a protective piece arranged at the distal end of the connecting piece, wherein the distal end of the inner core tube is fixedly connected to the connecting piece, and the leaflet clamping mechanism is detachably connected to the connecting mechanism via the control wire.

2. The artificial valve prosthesis replacement system according to claim 1, characterized in that: The leaflet clamping mechanism comprises a clamping arm connected to the valve support and a linkage rod hinged to the clamping arm, wherein the linkage rod is hinged to the connecting member.

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

4. The artificial valve prosthesis replacement system according to claim 3, characterized in that: A connecting hole is provided at the distal end of the linkage rod, wherein the control wire extends from the interior of the inner core tube and passes through the positioning hole and the connecting hole, so that the linkage rod forms a detachable connection with 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 with the connecting body through the control wire, and the guide blocks are symmetrically distributed on both sides of the positioning block.

6. The artificial valve prosthesis replacement system according to claim 5, characterized in that: A connection hole is provided at the center of the connection piece, and the control wire extends out from the connection 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 element is in a smooth round head structure.

8. The artificial valve prosthesis replacement system according to claim 2, characterized in that: The inner core tube pushes or pulls back the linkage rod toward the distal end, and the linkage rod drives the clamping arm to fold to control the angle between the clamping arm and the valve support.

9. The artificial valve prosthesis replacement system according to claim 8, characterized in that: In a 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 rod distally to a maximum stroke, the angle between the clamping arm and the valve stent is 180°.

10. 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 support, and the arc segment is deflected toward the circumferential direction of the valve support.

11. The artificial valve prosthesis replacement system according to claim 1, characterized in that: When the linkage rod drives the clamping arm to fold, the linkage rod is always located outside the clamping arm.

12. The artificial valve prosthesis replacement system according to claim 1, characterized in that: The valve stent includes a stent body, an artificial valve arranged in the stent body and a sealing ring arranged at the proximal end of the stent body. The stent body is a grid-shaped stent, and the free end of the clamping arm extends to the outside of the stent body and is arranged in an arc-shaped structure.

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