A valve replacement system that facilitates the capture of leaflets

Abstract

The application relates to the field of medical devices, in particular to a valve replacement system facilitating the capture of valve leaflets, comprising a valve support, a delivery system for delivering the valve support, the valve support being provided with a clamping arm, a linkage rod connected with the clamping arm, and an anchoring ring connected with the linkage rod, wherein the distal end of the linkage rod is detachably connected with the distal end of the delivery system, and the delivery system is operated to push or pull the linkage rod to the distal end, the linkage rod drives the clamping arm to fold to control the included angle between the clamping arm and the valve support; in the application, the opening and closing of the clamping arm can be controlled by operating the delivery system, the loading pipe diameter can be reduced, recovery can be realized, and intracardiac adjustment is facilitated, and the application has good clinical significance.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to a valve replacement system that facilitates the capture of valve leaflets. 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 CN202111164164.4 discloses an artificial valve replacement system, comprising: a valve stent; a valve clamping and fixing device cooperating with the valve stent, the valve clamping and fixing device including a valve clamping mechanism configured to clamp autologous valve leaflets and a clamping member, the clamping member being configured to be connected to the valve clamping mechanism; the valve clamping and fixing device is configured to present 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 capture and clamp the autologous valve leaflets; after the valve stent expands radially, the valve clamping and fixing device is in the second form, the radial expansion of the valve stent causing the clamping member to move the autologous valve leaflets upward and clamp the valve stent. While this technical solution can prevent the anterior leaflet from obstructing the left ventricular outflow tract, the opening angle of the valve clamping mechanism cannot be controlled. It can only be compressed inside the sheath. When the sheath retracts, the valve clamping mechanism folds upward, which means that the valve clamping mechanism cannot be retracted after opening, resulting in a low fault tolerance rate. Secondly, the folding loading method of the valve clamping mechanism also makes the entire valve stent very long, making it difficult to bend the stent into the position below the valve after it enters the atrium, and it is also easy to scratch the tissue.

[0004] 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 disassembly screw, 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 disassembly screw, and pulling / pushing the control rod can cause the capturing arm to open / close. Although this technical solution allows for controllable adjustment of the clamping arms, the adjustment angle of the clamping arms is limited. Theoretically, the control structure can manipulate the opening angle of the clamping arms to be greater than 180°. However, since the valve stent extends and is released from within the sheath, the hinge points between the two clamping arms are very close. This causes the shorter arm to abut against the hinge point of the other clamping arm when it is folded, resulting in interference between the two clamping arms (the applicant found in the experiment that the maximum opening angle of the clamping arms is only 160°). This prevents the clamping arms from folding down further. Therefore, this patented solution cannot open the clamping arms to a straight line with the valve stent (i.e., an opening angle of 180°), thus affecting the loading diameter of the valve stent and the angle adjustment within the atrium, etc.

[0005] 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

[0006] 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.

[0007] In terms of applications in atrioventricular valve surgery, this application aims to provide a valve replacement system that facilitates leaflet capture 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 control the release of the clamping arms and the difficulty in delivering excessively long valve stents.

[0008] According to one aspect of this application, a valve replacement system for facilitating leaflet capture is provided, including a valve stent and a delivery system for delivering the valve stent. 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. The distal end of the linkage rod is detachably connected to the distal end of the delivery system. Furthermore, by operating the delivery system to push or pull the linkage rod distally, the linkage rod causes 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 disposed within the stent body, and a sealing ring disposed at the proximal end of the stent body, wherein the stent body is a mesh-shaped stent.

[0010] 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.

[0011] As a further improvement of the present invention, 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; the inner core tube is pulled proximally back to the maximum stroke, at which point the axial length of the valve stent is at its minimum.

[0012] 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.

[0013] As a further improvement of the present invention, in the natural state, the clamping arm is against the outer side of the valve stent. 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°. At this time, the valve stent is pre-installed in the outer sheath, which can effectively reduce the loading diameter of the outer sheath.

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

[0015] 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.

[0016] As a further improvement of the present invention, the clamping arm includes a first clamping arm and a second clamping arm, and a waveform segment is provided between the first clamping arm and the second clamping arm. The waveform segment can prevent the clamping arm from being overly stressed 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 its maximum stroke, the linkage is located between the first clamping arm and the second clamping arm; the advantage of this design is that the linkage does not occupy extra 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 inside the outer sheath, the fatigue resistance of the clamping arm is highly demanding. The deflection of the arc segment in the circumferential direction of the valve stent ensures that the arc segment maintains a large radius angle while avoiding direct pressure from the outer sheath on the arc segment during loading. (The arc segment needs to be shown in the attached drawing.)

[0019] 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.

[0020] As a further improvement of the present invention, the free end of the clamping arm extends outward from the support body and is arranged in an arc shape.

[0021] As a further improvement of the present invention, in the 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 autologous leaflet and abut against the sealing ring, and the free end of the clamping arm extends outward to the outside of the support body and is arranged in an arc shape, which can effectively avoid the clamping arm from damaging the autologous leaflet.

[0022] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following:

[0023] 1. While existing replacement systems can utilize clamps to pull the chordae tendineae, elevating the valve leaflets and preventing obstruction of the left ventricular outflow tract, the opening angle of the valve clamping mechanism cannot be controlled. It is compressed within the sheath, and when the sheath retracts, the clamping mechanism folds upwards. This results in the inability to retract the clamping mechanism after opening, leading to low tolerance. Furthermore, the folding loading method of the clamping mechanism results in a very long valve stent, making it difficult to bend and position it below the valve after entering the atrium, and also increasing the risk of tissue abrasion. In one embodiment of this application, a linkage rod is provided on the clamping arm, the distal end of which is detachably connected to the distal end of the inner core tube. Next, by pushing or pulling back the inner core tube, the linkage can cause the clamping arm to fold, thereby controlling the angle between the clamping arm and the valve stent. This allows the inner core tube to be pushed to its maximum stroke during valve stent loading, ensuring that the valve stent, clamping arm, and linkage do not overlap in the axial direction. This significantly reduces the loading tube diameter, facilitating transvascular access. After entering the atrium, the inner core tube can be pulled back to its maximum stroke to shorten the axial length of the valve stent, making it easier to bend and enter the ventricle. In addition, the opening angle of the clamping arm can also be controlled by the inner core tube when the clamping arm captures the leaflets. This convenient operation has significant clinical value.

[0024] 2. 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.

[0025] 3. In the prior art, since the clamping arms are in a crossed state, the free end of the clamping arms can be folded outward by pushing the hinge point of the cross using a rod (essentially using the lever principle). However, after folding to a certain angle, the clamping arms will interfere with each other, causing the folding angle to not reach 180°. In one embodiment of this application, pushing the inner core tube causes the linkage rod to apply an axial force to the clamping arm, enabling the clamping arm to fold. Furthermore, during the folding process, the linkage rod is always on the outside of the clamping arm, so that the clamping arm and the linkage rod will not interfere with each other when the clamping arm is folded, allowing the clamping arm to fold downward 180°. This further allows the clamping arm, the linkage rod, and the valve stent to be adjusted into a straight shape, which facilitates reducing the loading diameter of the delivery sheath and adjusting the angle within the atrium.

[0026] 4. In one embodiment of this application, 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 abut against the sealing ring of the autologous leaflet, and the free end of the clamping arm extends outward to the outside of the support body and is arranged in an arc shape to effectively avoid damage to the autologous leaflet by the clamping arm.

[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 1-3 This is a schematic diagram of the overall structure of the valve replacement system of the present invention.

[0030] Figure 4 and Figure 5 This is a schematic diagram of the clamping arm and arc segment of the present invention.

[0031] Figure 6 and Figure 7 This is a schematic diagram of the valve stent of the present invention.

[0032] Figures 8-13 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-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-waveform segment, 4-linkage rod, 5-anchoring ring, 6-arc segment. 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 Figures 1-3 As shown, when the valve prosthesis is used for mitral valve treatment, in this embodiment, a valve replacement system that facilitates leaflet capture includes a valve stent 1 and a delivery system 2 for delivering the valve stent 1. 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. The distal end of the linkage rod 4 is detachably connected to the distal end of the delivery system 2. Operating the delivery system 2 to push or pull the linkage rod 4 distally causes the clamping arm 3 to fold, thereby controlling the angle between the clamping arm 3 and the valve stent 1. Specifically, during pre-installation, the inner core tube 22 is pushed distally to its maximum stroke. Figure 3 As shown, at this time, the axial length of the valve stent 1 is at its maximum. The valve stent 1, the clamping arm 3, and the linkage rod 4 do not overlap in the axial direction, which allows for a significant reduction in the loading tube diameter, facilitating delivery via the vascular access route. When the valve stent 1 reaches the atrium via the vascular access route, the outer sheath 21 is retracted and the inner core tube 22 is pulled proximally, causing the linkage rod 4 to drive the clamping arm 3 to fold proximally. Figure 1As shown, at this time, the valve stent 1, clamping arm 3, and linkage rod 4 overlap in the axial direction, shortening the axial length. This allows the valve stent 1 to be angled within the atrium and bent towards the autologous valve, so that the valve stent 1 is aligned with the center of the autologous valve, facilitating the delivery of the valve stent 1 into 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 autologous valve leaflet, making the opening angle of the clamping arm 3 controllable. Moreover, when the valve stent 1 is not in an ideal position or needs to be retrieved due to other factors, operating the inner core tube 22 can reinstall the clamping arm 3 and linkage rod 4 into the delivery system 2. The operation is convenient and has a high fault tolerance.

[0040] In this embodiment, the valve stent 1 includes a stent body 11, an artificial valve 13 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, such as... Figure 6 and Figure 7 As shown.

[0041] In this embodiment, the artificial valve 13 can be made of biomaterials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials.

[0042] In this embodiment, the inner core tube 22 is pushed distally to its maximum stroke. At this point, the axial length of the valve stent 1 is at its maximum. Figure 3 As shown, at this point, the radial diameter is at its minimum, facilitating loading and transportation; the inner core tube 22 is pulled back to its maximum stroke near the end, as... Figure 1 As shown, at this time, the axial length of the valve stent 1 is at its minimum, which facilitates other operations such as bending and swinging within the atrium.

[0043] In this embodiment, in its natural state, the clamping arm 3 is attached to the outer side of the valve stent 1. When the inner core tube 22 is operated to push the linkage rod 4 to its 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 diameter of the outer sheath tube 21.

[0044] In this embodiment, the proximal end of the linkage 4 is hinged to the clamping arm 3, such as... Figure 1 and Figure 2 As shown.

[0045] In this embodiment, the clamping arm 3 includes a first clamping arm 31 and a second clamping arm 32, and a wave segment 33 is provided between the first clamping arm 31 and the second clamping arm 32, such as... Figure 6 As shown, the waveform segment 33 can prevent excessive stress concentration in the clamping arm 3 during loading, effectively improving the fatigue resistance of the clamping arm 3.

[0046] In this embodiment, when the inner core tube 22 is pulled back to its maximum stroke, the linkage 4 is located between the first clamping arm 31 and the second clamping arm 32; the advantage of this design is that the linkage 4 will not occupy extra loading space.

[0047] In this embodiment, as Figure 5 and Figure 6 As shown, an arc segment 6 is provided between the clamping arm 3 and the valve stent 1. The arc segment 6 is deflected in the circumferential direction of the valve stent 1. Since the clamping arm 3 is straightened and loaded inside the outer sheath 21, the fatigue resistance of the clamping arm 3 is very high. The deflection of the arc segment 6 in the circumferential direction of the valve stent 1 ensures that the arc segment 6 maintains a large R angle while avoiding the outer sheath 21 from directly applying pressure to the arc segment 6 during loading.

[0048] In this embodiment, after the valve stent 1 is installed in place, the anchoring ring 5 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 3. Furthermore, the anchoring ring 5 tightens the valve stent 1. The anchoring ring 5 serves both to lift the chordae tendineae to prevent the autologous leaflet from blocking the outflow tract and to fix the stent.

[0049] In this embodiment, under natural conditions, the free end of the clamping arm 3 abuts against the sealing ring 12, such as... Figure 6 As shown; after release, the free end of the clamping arm 3 will press against the autologous leaflet and abut against the sealing ring 12. Furthermore, the free end of the clamping arm 3 extends outward from the support body 11 and is arranged in an arc shape, which can effectively prevent the clamping arm 3 from damaging the autologous leaflet.

[0050] The following is an exemplary procedure for repairing a mitral valve using a valve replacement system with easy leaflet capture, as described in Embodiment 1:

[0051] 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 8 As shown;

[0052] 2. Retract the outer sheath 21 so that its linkage 4 and clamping arm 3 extend out from inside the outer sheath 21, as shown. Figure 9 As shown, the inner core tube 22 is pulled back towards the proximal end, causing the clamping arm 3 to fold upwards until the inner core tube 22 is pulled back to its maximum stroke, as shown. Figure 10 As shown, the clamping arm 3, the linkage rod 4, 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 11 As shown;

[0053] 3. Pushing the inner core tube 22 distally causes the clamping arm 3 to open outwards towards the valve stent 1 to capture the autologous leaflet, as... Figure 12 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 13 As shown.

[0054] 4. Remove delivery system 2 from the body to complete the surgery.

[0055] 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. A valve replacement system for facilitating leaflet capture, 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. The distal end of the linkage rod is detachably connected to the distal end of the delivery system, and the proximal end of the linkage rod is hinged to the clamping arm. In its natural state, the clamping arm rests against the outer side of the valve stent. Operating the delivery system to push or pull the linkage rod distally causes the clamping arm to fold, controlling the angle between the clamping arm and the valve stent. The delivery system includes an outer sheath and an inner core tube. The valve stent is pre-installed in the outer sheath, and the distal end of the linkage rod is detachably connected to the distal end of the inner core tube. Pushing the inner core tube distally to its maximum stroke results in the maximum axial length of the valve stent; pulling the inner core tube proximally to its maximum stroke results in the minimum axial length of the valve stent.

2. The valve replacement system for easy capture of leaflets 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°.

3. The valve replacement system for easy capture of leaflets 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.

4. The valve replacement system for easy capture of leaflets according to claim 1, characterized in that: The clamping arm includes a first clamping arm and a second clamping arm, and a wave segment is provided between the first clamping arm and the second clamping arm.

5. The valve replacement system for easy capture of leaflets according to claim 4, characterized in that: When the inner core tube is pulled back to its maximum stroke, the linkage is located between the first clamping arm and the second clamping arm.

6. The valve replacement system for easy capture of leaflets 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.

7. The valve replacement system for easy capture of leaflets according to claim 5, characterized in that: 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-shaped stent.

8. The valve replacement system for easy capture of leaflets according to claim 7, characterized in that: The free end of the clamping arm extends outward from the support body and is arranged in an arc shape.

9. The valve replacement system for easy capture of leaflets according to claim 7, characterized in that: In its natural state, the free end of the clamping arm abuts against the sealing ring.

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