Valve replacement system convenient for capturing valve leafletsTechnical Field
The application relates to the field of medical instruments, in particular to a valve replacement system convenient for capturing valve leaflets.
Background
From the point of view of heart structure, both mitral valve and tricuspid valve have special physiological structures, which makes accurate positioning and fixing of the product very difficult. In particular, the endocardial location of the mitral valve and its complex anatomy present significant challenges for mitral valve replacement.
Prior patent CN202111164164.4 discloses a prosthetic valve replacement system comprising a valve holder, a clip-valve fixation device cooperating with the valve holder, the clip-valve fixation device comprising a clip mechanism configured to grip native leaflets and a hoop member configured to be connected to the clip mechanism, the clip-valve fixation device being configured to assume a first configuration and a second configuration, the clip mechanism being configured to capture and grip native leaflets when the clip-valve fixation device is in the first configuration, the clip-valve fixation device being in the second configuration upon radial expansion of the valve holder, the radial expansion of the valve holder causing the hoop member to displace the native leaflets upward and to pinch the valve holder. According to the technical scheme, although the front valve leaflet can be prevented from shielding the left ventricular outflow tract, the opening angle of the valve clamping mechanism cannot be controlled and can only be compressed in the sheath tube, the sheath tube is retracted, the valve clamping mechanism is upwards turned over, the valve clamping mechanism cannot be recycled after being opened, the fault tolerance rate is low, and secondly, the whole valve support is long due to the fact that the valve support is folded by the valve clamping mechanism in a loading mode, the valve support is difficult to bend and enter the position below the valve after entering an atrium, and tissues are easy to scratch.
Prior patent CN202211180680.0 discloses a replacement system for avoiding outflow obstruction, comprising a valve support, a clip fixing device cooperating with the valve support, the clip fixing device being configured to clamp a clip mechanism of a native valve leaflet and a hoop member, the hoop member being at least partially arranged on the clip mechanism, the hoop member driving the native valve leaflet to displace upwards and to pinch the valve support after the valve support is in place, the clip mechanism comprising a clamping arm, a control rod and a detachment wire, wherein the clamping arm comprises a fixing arm and a capturing arm, the capturing arm is hinged on the fixing arm, the control rod is detachably connected with the capturing arm by the detachment wire, and the control rod is pulled back/pushed to open/close the capturing arm. Although the clamping arms can be controllably adjusted, the adjusting angle of the clamping arms is limited, in theory, the control structure can control the opening angle of the clamping arms to be larger than 180 degrees, but the valve support extends out of the sheath tube and is released, so that the hinge points between the two clamping arms are very close, the short arm of the valve support can abut against the hinge point of the other clamping arm when being folded, the two clamping arms interfere with each other (the applicant finds that the maximum opening angle of the clamping arms is only 160 degrees in the test), and the clamping arms cannot be turned down continuously, therefore, the patent scheme cannot open the clamping arms to be in a straight line (namely, the opening angle is 180 degrees) with the valve support, and loading pipe diameters of the valve support, angle adjustment in an atrium and the like are affected.
In view of the foregoing, although there are several clinical advantages to the above techniques, there is a need for a new transcatheter heart valve replacement system that addresses the above problems.
Disclosure of Invention
The present application has been made in view of the above and other ideas. The primary purpose of the present application is to overcome some of the problems and deficiencies of the prior art.
In the aspect of application of atrioventricular valve operation, the application aims to provide a valve replacement system which is convenient for capturing valve leaflets for patients with atrioventricular valve lesions and interventional treatment, so that the problems that a clamping arm of a heart valve replacement system in the prior art cannot be controlled when released, the length of a valve support is too long and the valve support is difficult to convey and the like can be solved.
According to one aspect of the application, a valve replacement system convenient for capturing valve leaflets is provided, the valve replacement system comprises a valve support and a conveying system used for conveying the valve support, a clamping arm, a linkage rod piece connected with the clamping arm and an anchoring ring connected with the linkage rod piece are arranged on the valve support, wherein the distal end of the linkage rod piece is detachably connected with the distal end of the conveying system, the conveying system is operated to push or pull the linkage rod piece back to the distal end, and the linkage rod piece drives the clamping arm to fold so as to control an included angle between the clamping arm and the valve support.
As a further improvement of the invention, the valve stent comprises a stent body, a prosthetic valve arranged in the stent body and a sealing ring arranged at the proximal end of the stent body, wherein the stent body is a grid-shaped stent.
As a further improvement of the invention, the artificial valve can be made of biological materials such as bovine pericardium, porcine pericardium and the like, and also can be made of high polymer materials.
As a further improvement of the invention, the inner core tube is pushed to the maximum stroke distally, the axial length of the valve support is the maximum, and the inner core tube is pulled back to the maximum stroke proximally, the axial length of the valve support is the minimum.
When the valve stent reaches into an atrium through a vascular access, the outer sheath tube is retracted and the inner core tube is pulled proximally to enable the linkage rod piece to drive the clamping arm to fold proximally, at the moment, the valve stent, the clamping arm and the linkage rod piece are overlapped in the axial direction, the axial length is shortened, the valve stent can be adjusted in an angle in the atrium, and the valve stent can be bent towards the direction of the self valve, so that the valve stent can face to the center of the self valve, and the valve stent can be conveyed into the ventricle conveniently.
As a further improvement of the invention, the clamping arm is abutted against the outer side of the valve support in a natural state, wherein when the inner core tube is operated to push the linkage rod piece to the maximum stroke distally, the included angle between the clamping arm and the valve support is 180 degrees, and at the moment, the valve support is preloaded in the outer sheath tube, so that the loading tube diameter of the outer sheath tube can be effectively reduced.
As a further improvement of the present invention, the proximal end of the linkage rod is hinged to the clamping arm.
As a further improvement of the invention, the linkage rod piece is always positioned at the outer side of the clamping arm in the process of driving the clamping arm to turn over.
As a further improvement of the invention, the clamping arm comprises a first clamping arm and a second clamping arm, and a waveform section is arranged between the first clamping arm and the second clamping arm, and can avoid the excessive concentration of stress of the clamping arm during loading, thereby effectively improving the fatigue resistance of the clamping arm.
As a further improvement of the invention, the linkage rod is positioned between the first clamping arm and the second clamping arm when the inner core tube is pulled back to the maximum stroke, and the design has the advantage that the linkage rod does not occupy redundant loading space.
As the clamping arm is straightened and loaded in the outer sheath tube, the fatigue resistance of the clamping arm is required, and the arc section deflects towards the circumferential direction of the valve support to ensure that the arc section keeps a larger R angle and simultaneously avoids the outer sheath tube from directly exerting pressure on the arc section when loading. (the drawings are required to show arc segments)
As a further improvement of the invention, after the valve holder is mounted in place, the anchoring ring pulls chordae tissue and pulls the native valve leaflet, the native valve leaflet and chordae tissue being sandwiched between the valve holder and the clamping arms, and the anchoring ring hoops the valve holder, wherein the anchoring ring serves both to pull chordae, avoid the native valve leaflet from occluding the outflow tract, and to secure the holder.
As a further improvement of the invention, the free ends of the clamping arms extend to the outer side of the bracket body and are arranged in an arc-shaped structure.
As a further improvement of the invention, the free end of the clamping arm is propped against the sealing ring in a natural state, the free end of the clamping arm can prop against the self valve leaflet after being released, and the free end of the clamping arm extends to the outer side of the bracket body and is arranged in an arc-shaped structure, so that the damage of the self valve leaflet by the clamping arm can be effectively avoided.
Compared with the prior art, the application has the advantages and beneficial technical effects that at least the following are included:
1. The existing replacement system can utilize the hoop part to lift the chordae tendineae from the valve leaflets, so that the left ventricular outflow tract is prevented from being blocked, but the opening angle of the valve clamping mechanism can not be controlled and can only be compressed in the sheath tube, the sheath tube is retracted, the valve clamping mechanism is upwards turned over, the valve clamping mechanism can not realize recovery after being opened, the fault tolerance is low, secondly, the loading mode of turning over the valve clamping mechanism also enables the length of the whole valve support to be long, the valve support is difficult to bend to enter a position below a valve after entering an atrium, tissue is scratched easily, in one embodiment of the application, the linkage rod piece is arranged on the clamping arm, the distal end of the linkage rod piece is detachably connected with the distal end of the inner core tube, the linkage rod piece can drive the clamping arm to be turned over by pushing or pulling back the inner core tube, so that the included angle between the clamping arm and the valve support is controlled, the valve support can be pushed to the maximum stroke when the valve support is loaded, the valve support, the clamping arm and the linkage rod piece and the valve support are not overlapped in the axial direction, the pipe diameter of the whole valve support is enabled to be large, after the valve support enters the atrium, the atrium is convenient to bend and the valve support through the largest, the length can be controlled to enter the valve support after the valve support, and the valve support is pulled into the atrium, and the valve support is convenient to bend and has the axial length to bend and easy to control the valve.
2. In one embodiment of the application, an arc section is arranged between the clamping arm and the valve support, the arc section deflects towards the circumferential direction of the valve support, and because the clamping arm is straightened and loaded in the outer sheath tube, high requirements are imposed on the fatigue resistance of the clamping arm, and the arc section deflects towards the circumferential direction of the valve support, so that the arc section maintains a larger R angle (because the larger R angle is, the better the fatigue resistance is), and the outer sheath tube is prevented from directly exerting pressure on the arc section during loading.
3. In the prior art, as the clamping arm part is in a crossed state, the free ends of the clamping arms can be outwards folded by pushing the crossed hinge points through the rod pieces (basically adopting the lever principle), but after the clamping arms are folded to a certain angle, the clamping arms can interfere with each other, so that the folded angle cannot reach 180 degrees, in one embodiment of the application, the inner core tube is pushed to enable the linkage rod pieces to apply an axial force to the clamping arms, the clamping arm can be folded, and the linkage rod piece is always positioned on the outer side of the clamping arm in the folding process of the clamping arm, so that the clamping arm can not interfere with each other when the clamping arm is folded, the clamping arm can be folded downwards by 180 degrees, and the clamping arm, the linkage rod piece and the valve support can be adjusted to be in a linear form, so that the loading pipe diameter of the conveying sheath pipe can be reduced, the angle of the conveying sheath pipe can be adjusted in an atrium, and the like.
4. In one embodiment of the application, the free end of the clamping arm is propped against the sealing ring, and after the clamping arm is released, the free end of the clamping arm is propped against the sealing ring of the self-body valve leaflet, and the free end of the clamping arm extends to the outer side of the bracket body and is arranged in an arc-shaped structure, so that the damage of the self-body valve leaflet by the clamping arm can be effectively avoided.
Embodiments of the application may achieve other advantageous technical effects not listed one by one, which may be partially described below, and which may be expected and understood by those skilled in the art after reading the present application.
Drawings
The above-mentioned and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description taken in conjunction with the accompanying drawings, wherein:
fig. 1-3 are schematic views of the overall structure of a valve replacement system of the present invention.
Fig. 4 and 5 are schematic structural views of the clamping arm and arc segment of the present invention.
Fig. 6 and 7 are schematic structural views of the valve stent of the present invention.
Fig. 8-13 are schematic views of the operation of the valve replacement system of the present invention.
The parts indicated by the numbers in the drawings are named as a 1-valve bracket, a 11-bracket body, a 12-sealing ring, a 13-artificial valve, a 2-conveying system, a 21-outer sheath tube, a 22-inner core tube, a 3-clamping arm, a 31-first clamping arm, a 32-second clamping arm, a 33-waveform section, a 4-linkage rod piece, a 5-anchoring ring and a 6-arc section.
Description of the embodiments
The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.
It is to be understood that the illustrated and described embodiments are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. Examples are provided by way of explanation, not limitation, of the disclosed embodiments. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the various embodiments of the application without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still a further embodiment. Accordingly, the present disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.
Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items if any.
The application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.
In the present application, the proximal end means an end close to an operator, and the distal end means an end far from the operator.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
Examples
As shown in fig. 1-3, when the valve prosthesis is used for mitral valve treatment, in this embodiment, a valve replacement system for facilitating capture of valve leaflets comprises a valve support 1, a delivery system 2 for delivering the valve support 1, wherein a clamping arm 3, a linkage rod 4 connected with the clamping arm 3, and an anchoring ring 5 connected with the linkage rod 4 are arranged on the valve support 1, wherein the distal end of the linkage rod 4 is detachably connected with the distal end of the delivery system 2, and the delivery system 2 is operated to push or pull back the linkage rod 4 distally, the linkage rod 4 drives the clamping arm 3 to fold back so as to control an included angle between the clamping arm 3 and the valve support 1, in particular, when the valve support 1 is preloaded, the inner core tube 22 is pushed distally to a maximum stroke, as shown in fig. 3, and at the moment, the axial length of the valve support 1 is maximum, the clamping arm 3 and the linkage rod 4 are not overlapped in the axial direction, so that the valve support 1, the clamping arm 3 and the linkage rod 4 can be greatly contracted for loading and delivery into a blood vessel is facilitated; when the valve support 1 reaches the atrium through the vascular access, the outer sheath 21 is retracted and the inner core 22 is pulled proximally, so that the linkage rod 4 drives the clamping arms 3 to fold proximally, as shown in fig. 1, at this time, the valve support 1, the clamping arms 3 and the linkage rod 4 overlap in the axial direction, shortening the axial length, which enables the valve support 1 to perform angle adjustment in the atrium, and bend towards the direction of the native valve, so that the valve support 1 can face the center of the native valve, so that the valve support 1 can be conveyed into the ventricle, and when the valve support 1 enters the ventricle, the clamping arms 3 are released, and, control the opening angle of the clamping arm 3 through the operation inner core tube 22 in order to catch the autologous valve leaflet for the opening angle of the clamping arm 3 is controllable, moreover, when valve support 1 position is not ideal or because other factors need to retrieve, the operation inner core tube 22 can reload clamping arm 3 and linkage member 4 into conveying system 2, and its simple operation is and fault-tolerant is high.
In this embodiment, the valve stent 1 includes a stent body 11, a prosthetic valve 13 disposed in the stent body 11, and a sealing ring 12 disposed at a proximal end of the stent body 11, and the stent body 11 is a mesh-shaped stent, as shown in fig. 6 and 7.
In this embodiment, the prosthetic valve 13 may be made of biological materials such as bovine pericardium and porcine pericardium, or may be made of polymer materials.
In this embodiment, the inner core tube 22 is pushed to the maximum stroke distally, the axial length of the valve support 1 is the maximum, as shown in fig. 3, the radial diameter is the minimum, so as to facilitate loading and delivery, and the inner core tube 22 is pulled back to the maximum stroke proximally, as shown in fig. 1, the axial length of the valve support 1 is the minimum, so as to facilitate other operations such as bending and swinging in the atrium.
In this embodiment, in a natural state, the clamping arm 3 is abutted against the outer side of the valve support 1, wherein when the inner core tube 22 is operated to push the linkage rod 4 to the maximum stroke distally, an included angle between the clamping arm 3 and the valve support 1 is 180 °, and at this time, the valve support 1 is preloaded into the outer sheath 21, so that the loading tube diameter of the outer sheath 21 can be effectively reduced.
In this embodiment, the proximal end of the linkage rod 4 is hinged to the clamping arm 3, as shown in fig. 1 and 2.
In this embodiment, the clamping arm 3 includes a first clamping arm 31 and a second clamping arm 32, and a wave-shaped section 33 is disposed between the first clamping arm 31 and the second clamping arm 32, as shown in fig. 6, the wave-shaped section 33 can avoid too concentrated stress of the clamping arm 3 during loading, and effectively improve fatigue resistance of the clamping arm 3.
In this embodiment, when the inner core tube 22 is pulled back to the maximum stroke, the link member 4 is located between the first clamping arm 31 and the second clamping arm 32, and this has the advantage that the link member 4 does not occupy an excessive loading space.
In this embodiment, as shown in fig. 5 and 6, an arc section 6 is disposed between the clamping arm 3 and the valve support 1, the arc section 6 deflects towards the circumferential direction of the valve support 1, and because the clamping arm 3 is straightened and loaded in the outer sheath 21, there is a high requirement on fatigue resistance of the clamping arm 3, and the arc section 6 deflects towards the circumferential direction of the valve support 1 to enable the arc section 6 to maintain a larger R angle, and simultaneously, the outer sheath 21 is prevented from directly applying pressure to the arc section 6 during loading.
In this embodiment, after the valve support 1 is installed in place, the anchoring ring 5 pulls the chordae tissue and lifts the native valve leaflet, the native valve leaflet and the chordae tissue are clamped between the valve support 1 and the clamping arm 3, and the anchoring ring 5 clamps the valve support 1, wherein the anchoring ring 5 not only plays a role of lifting the chordae, avoiding the native valve leaflet from blocking the outflow channel, but also plays a role of fixing the support.
In this embodiment, in a natural state, the free end of the clamping arm 3 abuts against the sealing ring 12, as shown in fig. 6, after the clamping arm 3 is released, the free end of the clamping arm 3 abuts against the native valve leaflet and abuts against the sealing ring 12, and the free end of the clamping arm 3 extends to the outside of the bracket body 11 and is arranged in an arc-shaped structure, so that damage to the native valve leaflet by the clamping arm 3 can be effectively avoided.
An exemplary prosthetic mitral valve of a valve replacement system that facilitates capture of leaflets in accordance with the first embodiment operates as follows:
1. Operating the delivery system 2 from the transvascular access, through the septum, and into the atrium, as shown in fig. 8, with the distal portion of the delivery system 2;
2. Withdrawing the outer sheath 21 so that the linkage rod 4 and the clamping arm 3 extend out of the outer sheath 21, and proximally withdrawing the inner core tube 22 as shown in fig. 9 so that the clamping arm 3 turns upwards until the inner core tube 22 is withdrawn to the maximum stroke as shown in fig. 10, axially overlapping the clamping arm 3, the linkage rod 4 and the stent body, and then bending the distal end of the delivery system 2 so that the valve stent 1 thereof enters the ventricle downwards as shown in fig. 11;
3. Distal pushing of the inner core tube 22 causes the gripping arms 3 to expand outwardly of the valve stent 1 to capture the native leaflets, as shown in fig. 12, after which the stent body 11 and sealing ring 12 are gradually released to complete implantation, as shown in fig. 13.
4. The delivery system 2 is withdrawn from the body and the procedure is completed.
The foregoing description of the exemplary embodiments of the application has been presented for the purposes of illustration and description. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration and/or construction disclosed, and obviously many modifications and variations may be effected by one skilled in the art in light of the above teachings without departing from the application. The scope and equivalents of the application are intended to be defined by the appended claims.