Valve replacement system convenient for capturing valve leaflet

Abstract

The invention relates to the field of medical instruments, in particular to a valve replacement system convenient for capturing valve leaflets.The valve replacement system comprises a valve support and a conveying system used for conveying the valve support, the valve support is provided with a clamping arm, a linkage rod piece connected with the clamping arm and an anchoring ring connected with the linkage rod piece, the far end of the linkage rod piece is detachably connected with the far end of the conveying system, the conveying system is operated to push the linkage rod piece towards the far end or pull the linkage rod piece back, and the linkage rod piece drives the clamping arms to be folded so as to control the included angle between the clamping arms and the valve support. According to the scheme, opening and closing of the clamping arms can be controlled by operating the conveying system, the loading pipe diameter can be reduced, recycling can be 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 a valve replacement system that facilitates capturing valve leaflets. 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 CN202111164164.4 discloses an artificial valve replacement system, comprising: a valve stent; a valve clamping fixing device that cooperates with the valve stent, the valve clamping fixing device comprising a valve clamping mechanism and a clamping member configured to clamp autologous valve leaflets, and the clamping member is configured to be connected to the valve clamping mechanism; the valve clamping fixing device is configured to be able to present a first form and a second form; when the valve clamping fixing device is in the first form, the valve clamping mechanism is configured to capture and clamp the autologous valve leaflets; after the valve stent radially expands, the valve clamping fixing device is in the second form, and the radial expansion of the valve stent causes the clamping member to drive the autologous valve leaflets to shift upward and tighten the valve stent. Although this technical solution can prevent the anterior valve leaflet from blocking the left ventricular outflow tract, the opening angle of the valve clamp mechanism cannot be controlled and it can only be compressed in the sheath. When the sheath is withdrawn, the valve clamp mechanism folds upward, which makes it impossible to retract the valve clamp mechanism after opening and has a low fault tolerance rate. Secondly, the folded loading method of the valve clamp mechanism also makes the entire valve stent very long, which makes it difficult to bend the valve stent to the position below the valve after entering the atrium, and it is also easy to scratch the tissue.

[0004] 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, 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 disassembly 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 disassembly wire, and pulling back / pushing the control rod can make the capture arm open / or close. Although this technical solution can controllably adjust the clamping arm, the adjustment angle of the clamping arm is limited. Theoretically, the control structure can control the opening angle of the clamping arm to be greater than 180°, but the valve stent is extended and released in the sheath, which makes the hinge points between the two clamping arms very close to each other, causing the short arm to hit the hinge point of the other clamping arm when folding, and the two clamping arms interfere with each other (the applicant found in the experiment that the maximum opening angle of its clamping arm is only 160°), resulting in the clamping arm being unable to continue to fold down. Therefore, this patent solution cannot open the clamping arm to a straight line with the valve stent (i.e., an opening angle of 180°), thereby affecting the loading tube diameter of the valve stent and the angle adjustment in the atrium, etc.

[0005] 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

[0006] 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.

[0007] In terms of application in atrioventricular valve surgery, the present application aims to provide a valve replacement system that is easy to capture the valve leaflets for patients with atrioventricular valve lesions who require interventional treatment, thereby solving the problems in the prior art that the clamping arms of the heart valve replacement system cannot be controlled when released and the valve stent is too long to be delivered.

[0008] According to one aspect of the present application, a valve replacement system is provided for facilitating the capture of valve leaflets, comprising a valve stent and a delivery system for delivering the valve stent, wherein the valve stent is provided with a clamping arm, a linkage rod connected to the clamping arm, and an anchoring ring connected to the linkage rod, wherein the distal end of the linkage rod is detachably connected to the distal end of the delivery system, and the delivery system is operated to push or pull 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.

[0009] 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, and the stent body is a grid-shaped stent.

[0010] 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.

[0011] As a further improvement of the present invention, the inner core tube is pushed to the distal end to a maximum stroke, at which time the axial length of the valve stent is the maximum; the inner core tube is pulled back to the proximal end to a maximum stroke, at which time the axial length of the valve stent is the minimum.

[0012] 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.

[0013] 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 to the maximum stroke distally, the angle between the clamping arm and the valve stent is 180°. At this time, the valve stent is pre-installed in the outer sheath tube, which can effectively reduce the loading tube diameter of the outer sheath tube.

[0014] As a further improvement of the present invention, the proximal end of the linkage rod is hinged to the clamping arm.

[0015] 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.

[0016] As a further improvement of the present invention, the clamping arm includes a first clamping arm and a second clamping arm, and a corrugated section is provided between the first clamping arm and the second clamping arm. The corrugated section can avoid excessive stress concentration on the clamping arm during loading, thereby effectively improving the fatigue resistance of the clamping arm.

[0017] As a further improvement of the present invention, when the inner core tube is pulled back to the maximum stroke, the linkage rod is located between the first clamp arm and the second clamp arm; the advantage of such a design is that the linkage rod does not occupy excess loading space.

[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 arc segment is deflected in the circumferential direction of the valve stent so that the arc segment maintains a large R angle while avoiding the outer sheath tube directly exerting pressure on the arc segment during loading. (A figure is required to show the arc segment) 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.

[0019] As a further improvement of the present invention, the free end of the clamping arm extends toward the outside of the bracket body and is arranged in an arc-shaped structure.

[0020] As a further improvement of the present invention, in a natural state, the free end of the clamping arm abuts against the sealing ring; after the clamping arm is released, the free end of the clamping arm will press against the native valve leaflet and abut against the sealing ring, and the free end of the clamping arm extends toward the outside of the stent body and is arranged in an arc shape, which can effectively prevent the clamping arm from damaging the native valve leaflet. Compared with the prior art, the advantages and beneficial technical effects of the present application include at least the following: 1. Although the existing replacement system can use the clamp to pull the tendon to lift the native valve leaflet, thereby avoiding obstruction of the left ventricular outflow tract, the opening angle of the valve clamp mechanism cannot be controlled and can only be compressed in the sheath. When the sheath is withdrawn, the valve clamp mechanism folds upward, which makes it impossible to recycle the valve clamp mechanism after opening, and the fault tolerance rate is low. Secondly, the loading method of the folded valve clamp mechanism also makes the length of the entire valve stent very long, which makes it difficult to bend the valve stent into the position below the valve after entering the atrium, and it is also easy to scratch the tissue. In one embodiment of the present application, a linkage rod is provided on the clamping arm, and the distal end of the linkage rod is detachably connected to the distal end of the inner core tube. Then, by pushing or pulling back the inner core tube, the linkage rod can drive the clamping arm to fold, so as to control the angle between the clamping arm and the valve stent, so that the inner core tube can be pushed to the maximum stroke when the valve stent is loaded, 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. After entering the atrium, the inner core tube can be pulled back to the maximum stroke to shorten the axial length of the valve stent, which is convenient for adjusting the bend to enter the ventricle. In addition, when the clamping arm captures the valve leaflet, the opening angle of the clamping arm can also be controlled by the inner core tube. The operation is convenient and has great clinical significance.

[0021] 2. 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.

[0022] 3. In the prior art, since the clamping arm part is in a crossed state, the crossed hinge point is pushed by the rod so that the free end of the clamping arm can be folded outward (essentially using the lever principle), but after being folded to a certain angle, the clamping arms will interfere with each other, resulting in the folding angle not being able to reach 180°. In one embodiment of the present application, the inner core tube is pushed so that the linkage rod applies an axial force to the clamping arm so that the clamping arm can be folded, and during the folding process of the clamping arm, the linkage rod is always on the outside of the clamping arm, so that when the clamping arm is folded, the clamping arm and the linkage rod will not interfere with each other, so that the clamping arm can be folded downward 180°, and further the clamping arm, the linkage rod and the valve stent can be adjusted into a straight line, so as to reduce the loading diameter of the delivery sheath and adjust the angle in the atrium.

[0023] 4. In one embodiment of the present application, the free end of the clamping arm is against the sealing ring; after the clamping arm is released, the free end of the clamping arm will press against the native valve leaflet and the sealing ring, and the free end of the clamping arm extends toward the outside of the stent body and is arranged in an arc shape, which can effectively prevent the clamping arm from damaging the native valve leaflet.

[0024] 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 can be anticipated and understood by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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 3 It is a schematic diagram of the overall structure of the valve replacement system of the present invention.

[0026] Figure 4 and Figure 5 It is a schematic structural diagram of the clamping arm and the arc segment of the present invention.

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

[0028] Figure 8-Figure 13 It is a schematic diagram of the operation process of the valve replacement system of the present invention.

[0029] 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, 13-artificial valve, 2-delivery system, 21-outer sheath, 22-inner core tube, 3-clamping arm, 31-first clamping arm, 32-second clamping arm, 33-wave segment, 4-linkage rod, 5-anchoring ring, 6-arc segment. Implementation

[0030] 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.

[0031] 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.

[0032] 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.

[0033] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0034] 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

[0035] like Figure 1-Figure 3 As shown, when the valve prosthesis is used for mitral valve treatment, in this embodiment, a valve replacement system that is convenient for capturing valve leaflets includes a valve stent 1 and a delivery system 2 for delivering the valve stent 1, wherein the valve stent 1 is provided with a clamping arm 3, a linkage rod 4 connected to the clamping arm 3, and an anchoring ring 5 connected to the linkage rod 4, wherein the distal end of the linkage rod 4 is detachably connected to the distal end of the delivery system 2, and the delivery system 2 is operated to push or pull back the linkage rod 4 toward the distal end, and the linkage rod 4 drives the clamping arm 3 to fold to control the angle between the clamping arm 3 and the valve stent 1. Specifically, during pre-installation, the inner core tube 22 is pushed toward the distal end to the maximum stroke, as shown in FIG. Figure 3 As shown, at this time, the axial length of the valve stent 1 is the largest, and the valve stent 1, the clamping arm 3 and the linkage rod 4 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 toward the proximal end so that the linkage rod 4 drives the clamping arm 3 to fold toward the proximal end, as shown in FIG. Figure 1As shown, at this time, the valve stent 1, the clamping arm 3 and the linkage rod 4 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 to the ventricle. When the valve stent 1 enters the ventricle, the clamping arm 3 is released, and the opening angle of the clamping arm 3 is controlled by operating the inner core tube 22 to capture the native valve leaflet, so that the opening angle of the clamping arm 3 is controllable. Moreover, when the position of the valve stent 1 is not ideal or needs to be recovered due to other factors, the inner core tube 22 can be operated to reload the clamping arm 3 and the linkage rod 4 into the delivery system 2. It is easy to operate and has a high fault tolerance rate.

[0036] In this embodiment, the valve stent 1 includes a stent body 11, an artificial valve 13 disposed in the stent body 11, and a sealing ring 12 disposed at the proximal end of the stent body 11. The stent body 11 is a grid-shaped stent. Figure 6 and Figure 7 shown.

[0037] In this embodiment, the artificial valve 13 can be made of biological materials such as bovine pericardium, porcine pericardium, etc., and can also be made of polymer materials.

[0038] In this embodiment, the inner core tube 22 is pushed to the distal end to the maximum stroke. At this time, the axial length of the valve stent 1 is the maximum. Figure 3 As shown, at this time, the radial diameter is the smallest, which is convenient for loading and transportation; the inner core tube 22 is pulled back to the maximum stroke toward the proximal end, as shown in FIG. Figure 1 As shown, at this time, the axial length of the valve stent 1 is the smallest, which is convenient for other operations such as bending and swinging in the atrium.

[0039] In this embodiment, in a natural state, the clamping arm 3 is abutted against the outer side of the valve stent 1, wherein when the inner core tube 22 is operated to push the linkage rod 4 distally to the maximum stroke, the angle between the clamping arm 3 and the valve stent 1 is 180°. At this time, the valve stent 1 is pre-installed in the outer sheath tube 21, which can effectively reduce the loading tube diameter of the outer sheath tube 21.

[0040] In this embodiment, the proximal end of the linkage rod 4 is hinged to the clamping arm 3. Figure 1 and Figure 2 shown.

[0041] In this embodiment, the clamping arm 3 includes a first clamping arm 31 and a second clamping arm 32, and a wave section 33 is provided between the first clamping arm 31 and the second clamping arm 32. Figure 6 As shown, the wave section 33 can prevent the clamping arm 3 from excessive stress concentration during loading, thereby effectively improving the fatigue resistance of the clamping arm 3 .

[0042] In this embodiment, when the inner core tube 22 is pulled back to the maximum stroke, the linkage rod 4 is located between the first clamp arm 31 and the second clamp arm 32 ; the advantage of such a design is that the linkage rod 4 will not occupy excess loading space.

[0043] In this embodiment, Figure 5 and Figure 6 As shown, an arc segment 6 is provided between the clamping arm 3 and the valve stent 1, and the arc segment 6 is deflected toward the circumferential direction of the valve stent 1; since the clamping arm 3 is straightened and loaded in the outer sheath tube 21, high requirements are placed on the fatigue resistance of the clamping arm 3, and the deflection of the arc segment 6 toward the circumferential direction of the valve stent 1 enables the arc segment 6 to maintain a larger R angle while avoiding the outer sheath tube 21 from directly applying pressure to the arc segment 6 during loading.

[0044] In this embodiment, after the valve stent 1 is installed in place, the anchoring ring 5 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 3, and the anchoring ring 5 tightens the valve stent 1, wherein the anchoring ring 5 not only pulls the chordae to prevent the autologous leaflets from blocking the outflow tract, but also fixes the stent.

[0045] In this embodiment, in a natural state, the free end of the clamping arm 3 abuts against the sealing ring 12. Figure 6 As shown; after the clamping arm 3 is released, the free end of the clamping arm 3 will press against the native valve leaflet and the sealing ring 12, and the free end of the clamping arm 3 extends to the outside of the stent body 11 and is arranged in an arc shape, which can effectively prevent the clamping arm 3 from damaging the native valve leaflet.

[0046] An exemplary operation process of repairing a mitral valve of a valve replacement system that is convenient for capturing valve leaflets in 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 Figure 8 As shown; 2. Retract the outer sheath 21 so that the linkage rod 4 and the clamping arm 3 extend out of the outer sheath 21. Fig. 9 As shown, the inner core tube 22 is pulled back toward the proximal end so that the clamping arm 3 is folded upward until the inner core tube 22 is pulled back to the maximum stroke, as shown in FIG. Fig.10 As shown, the clamping arm 3, the linkage rod 4 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.11 As shown; 3. Push the inner core tube 22 to the distal end so that the clamping arm 3 opens to the outside of the valve stent 1 to capture the native valve leaflet, such as Fig.12 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.13 shown.

[0047] 4. The delivery system 2 is removed from the body to complete the operation.

[0048] 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. A valve replacement system for facilitating the capture of valve leaflets, comprising a valve stent and a delivery system for delivering the valve stent, characterized in that: The valve stent is provided with a clamping arm, a linkage rod connected to the clamping arm, and an anchoring ring connected to the linkage rod, wherein the distal end of the linkage rod is detachably connected to the distal end of the conveying system, and the conveying system is operated to push or pull 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.

2. The valve replacement system for facilitating the capture of valve leaflets according to claim 1, characterized in that: The delivery system comprises an outer sheath tube and an inner core tube, the valve stent is preinstalled in the outer sheath tube, and the distal end of the linkage rod is detachably connected to the distal end of the inner core tube.

3. The valve replacement system for facilitating the capture of valve leaflets according to claim 2, characterized in that: The inner core tube is pushed to the distal end to a maximum stroke, at which point the axial length of the valve stent is the maximum; the inner core tube is pulled back to the proximal end to a maximum stroke, at which point the axial length of the valve stent is the minimum.

4. The valve replacement system for facilitating the capture of valve leaflets according to claim 2, 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°.

5. The valve replacement system for facilitating the capture of valve leaflets according to claim 1, characterized in that: The proximal end of the linkage rod is hinged to the clamping arm.

6. The valve replacement system for facilitating the capture of valve leaflets 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.

7. The valve replacement system for facilitating the capture of valve leaflets according to claim 1, characterized in that: The clamping arm comprises a first clamping arm and a second clamping arm, and a wave section is provided between the first clamping arm and the second clamping arm.

8. The valve replacement system for facilitating the capture of valve leaflets according to claim 2, characterized in that: When the inner core tube is pulled back to a maximum stroke, the linkage rod is located between the first clamping arm and the second clamping arm.

9. The valve replacement system for facilitating the capture of valve leaflets 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.

10. The valve replacement system for facilitating the capture of valve leaflets according to claim 8, characterized in that: The valve stent comprises a stent body, an artificial valve arranged in the stent body and a sealing ring arranged at the proximal end of the stent body, and the stent body is a grid-shaped stent.

11. The valve replacement system for facilitating the capture of valve leaflets according to claim 10, characterized in that: The free end of the clamping arm extends toward the outside of the bracket body and is arranged in an arc-shaped structure.

12. The valve replacement system for facilitating the capture of valve leaflets according to claim 10, characterized in that: In a natural state, the free end of the clamping arm abuts against the sealing ring.

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