CN118252668A - Asymmetric valve clamping device and valve repair instrument - Google Patents

Abstract

An asymmetric valve clamping device is disclosed for clamping leaflets of a heart valve to repair regurgitation of the valve. The asymmetric valve clasper includes a first clasper unit and a second clasper unit, the first clasper unit and the second unit having asymmetric clasper areas for clasping different leaflets of a valve. The invention also discloses a valve repair device which comprises the asymmetric valve clamping device and a conveying device detachably connected with the asymmetric valve clamping device.

Description

Asymmetric valve clamping device and valve repair instrument

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an asymmetric valve clamping device and a valve repair instrument.

Background

The atrioventricular valves, such as mitral valve, tricuspid valve, are one-way valves within the heart that allow normal healthy atrioventricular valves to control blood flow from the atrium to the ventricle while avoiding blood flow from the ventricle to the atrium. For example: as shown in fig. 1, the mitral valve MV is a one-way valve between the left atrium LA and the left ventricle LV of the heart that can control the flow of blood from the left atrium LA to the left ventricle LV while avoiding the flow of blood from the left ventricle LV to the left atrium LA; the tricuspid valve TV is a one-way valve located between the right atrium RA and the right ventricle RV of the heart that can control the flow of blood from the right atrium RA to the right ventricle RV while avoiding the flow of blood from the right ventricle RV to the right atrium RA.

The mitral valve includes anterior and posterior lobes, and the tricuspid valve includes anterior, posterior and septal lobes. Normally, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve should be fully coaptated, avoiding blood flow from the ventricle to the atrium. If the mitral or tricuspid valve is not properly coaptated, the mitral or tricuspid valve cannot be fully closed when the left or right ventricle contracts, resulting in regurgitation of blood from the ventricle to the atrium, causing a series of pathophysiological changes known as "mitral regurgitation" or "tricuspid regurgitation.

The ratio of the anterior and posterior leaflet sizes of the mitral valve leaflet is about 2:1, in the case of common leaflet prolapse, there are cases where one leaflet prolapse is wider on one side and narrower on the other side, or one leaflet prolapse is not, and the other leaflet prolapse is not. The leaflet structure of the tricuspid valve is usually asymmetric, and there is a certain difference in length, width and thickness of the leaflet. For example, it is common that the anterior leaflet of the tricuspid valve is wider, the posterior leaflet is narrower, and the leaflet size is centered. And in valves with regurgitation lesions, there is often a prolapse of the leaflets on one side and no prolapse on the other side.

The existing interventional valve clamping operation is characterized in that a valve clamping device is implanted into an atrioventricular valve such as a mitral valve, a tricuspid valve and the like, two valve leaflets which are originally in poor involution are pulled to each other, and a valve leaflet gap is reduced or eliminated, so that reflux is treated, however, because the above-mentioned size asymmetry exists between the valve leaflets of the mitral valve or the above-mentioned size asymmetry exists between the valve leaflets of the tricuspid valve, the local position of the valve leaflet on one side can be subjected to larger concentrated stress, so that the valve leaflet is damaged, and even the valve leaflet is perforated or the valve clamping device falls off, so that the life and the health of a patient are endangered; in addition, the native structures of the valve leaflet and chordae tendineae are easily damaged, so that the valve leaflet cannot generate a coaptation margin, and thus the regurgitation cannot be effectively relieved.

Disclosure of Invention

In order to solve the technical problems described above or at least partially solve the technical problems described above, the present invention provides an asymmetric valve clamping device and a valve repair apparatus.

In a first aspect of the invention, an asymmetric valve clasper apparatus is provided that includes a first clasper unit and a second clasper unit, the first clasper unit and the second clasper unit having asymmetric clasper areas for clasping different leaflets of a valve.

In a preferred embodiment, the first clamping unit comprises a first clamping arm and the second clamping unit comprises a second clamping arm, the first clamping arm and the second clamping arm differing in overall length and/or overall width.

In a preferred embodiment, the first clamping arm and/or the second clamping arm respectively comprise an inner cavity and flanges positioned at the left side and the right side of the edge of the inner cavity, the inner cavity widths of the first clamping arm and the second clamping arm are different, and/or the widths of the flanges are different.

In a preferred embodiment, the flanges on the left and right sides of the first clamping arm respectively include a first flange section, a second flange section and a third flange section which are in smooth transition, the first flange section is rectangular overall, the second flange section is an arc section, the width of the third flange section is smaller than that of the first flange section, and the second flange section has the maximum flange width in the first flange section, the second flange section and the third flange section.

In a preferred embodiment, the first clamping arm and/or the second clamping arm further have a bending section connected to the flange, which bending section can be unfolded into an extension section of the flange when no external force is applied, the widths of the extension sections of the first and second clamping arms being different.

In a preferred embodiment, the bending section is hollow, two ends of the bending section are respectively a first end point and a second end point, and the first end point and the second end point are respectively positioned in the middle of the flanging.

In a preferred embodiment, the folded section is filled with a mesh wire, which is made of a shape memory material.

In a preferred embodiment, the bending section is filled with a woven mesh, and the woven mesh is a spherical or elliptic mesh body made of nickel titanium metal filaments through the processes of weaving and heat setting.

In a preferred embodiment, the first clamping unit further comprises a first elastic inner clamping arm, the second clamping unit further comprises a second elastic inner clamping arm, the first elastic inner clamping arm has a first free end, the second elastic inner clamping arm has a second free end, the first free end and the second free end are connected into a whole through a connecting end, and the first free end and the second free end are provided with asymmetrical barbs.

In a preferred embodiment, the number, location or length of barbs of the first and second free ends are different.

In a preferred embodiment, the device further comprises a blocking member arranged between the first clamping unit and the second clamping unit, the blocking member having a first surface facing the first clamping unit and a second surface facing the second clamping unit, the first surface and the second surface being asymmetrically arranged.

In a preferred embodiment, the blocking member is a three-dimensional net structure made of a plurality of net wires, the shape of the surface of the blocking member facing the first clamping unit and the shape of the surface facing the second clamping unit are different, and/or the densities or materials of the net wires are different.

In a preferred embodiment, the clamping areas of the first clamping units of the two valve clamping devices are each formed by one clamping arm and one side of the blocking piece, the clamping areas of the second clamping units of the two valve clamping devices are each formed by the other clamping arm and the other side of the blocking piece, and the clamping areas of the two sides of the clamping arms and/or the blocking piece are different.

In a second aspect of the present invention, there is provided a valve repair device comprising a valve clamping device as described above, and a delivery device comprising: the valve clamping device comprises a pushing sheath tube with a certain axial length and a mandrel movably penetrating the pushing sheath tube, wherein the pushing sheath tube is detachably connected with the valve clamping device, and the mandrel is used for driving the first clamping unit and the second clamping unit to be unfolded and closed so as to clamp valve tissues.

The asymmetric valve clamping device and the valve repairing instrument provided by the invention are designed with the clamping units with different areas according to the different valve leaflets of the mitral valve or the tricuspid valve, so that the valve clamping device is beneficial to the identification direction positioning of doctors during implantation, the positioning of the valve clamping device is quicker and clearer, the clamping units with large area clamp the valve leaflets with larger thickness or serious prolapse, the clamping units with small area clamp the valve leaflets with smaller thickness or light prolapse, and thus, the valve clamping repairing is more targeted and accurate, and the effect of treating regurgitation is better.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the invention and together with the description, serve to explain the principles of the invention.

In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.

FIG. 1 is a schematic illustration of the mitral and tricuspid valve positions;

FIG. 2 is a schematic perspective view of an asymmetric valve clasper apparatus provided in accordance with a first embodiment of the present invention;

FIG. 3 is a schematic perspective view of the resilient inner clip arm of FIG. 2;

FIG. 4 is a schematic perspective view of the first clamp arm of FIG. 2;

FIG. 5 is a schematic perspective view of the second clamp arm of FIG. 2;

FIG. 6 is a schematic view of another modified embodiment of the stopper spring in FIG. 2;

fig. 7a is a schematic perspective view of a clamping arm according to a second embodiment of the present invention;

FIG. 7b is a schematic view of the bending section of the clamping arm of FIG. 7a in a naturally deployed state without external force;

FIG. 8 is a schematic perspective view of another alternate embodiment of the clamping arm of FIG. 7 a;

FIG. 9 is a perspective view of another alternate embodiment of the clamp arm of FIG. 8;

FIG. 10 is a schematic perspective view of an asymmetric valve clasper apparatus provided in accordance with a third embodiment of the present invention;

FIG. 11 is a schematic top view of a plugging web according to one embodiment of the present invention;

FIG. 12 is a schematic structural view of a support member in an asymmetric valve clasper apparatus in accordance with an embodiment of the present invention mated with a delivery apparatus of a valve repair instrument;

FIGS. 13-14 are schematic views of a valve repair instrument according to an embodiment of the present invention performing repair of adjacent leaflets of a tricuspid valve;

FIG. 15 is a schematic view of an asymmetrical valve clasper apparatus in accordance with an embodiment of the present invention after restoration of adjacent leaflets of the tricuspid valve;

fig. 16 is a schematic view of an asymmetrical valve clasper apparatus in accordance with an embodiment of the present invention after repair of a mitral valve adjacent leaflet.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.

In describing the present invention, it should be noted that:

The terms "upper," "lower," "inner," "outer," and the like are used for convenience in describing and simplifying the description only, and do not denote or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance;

when an element is referred to as being "fixed" or "disposed on" another element, it can be directly connected to the other element or be indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be connected to the other element by one or more connecting elements.

In the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the direction of the rotation central axis of the column body, the tube body and other objects is defined as an axial direction; the circumferential direction is the direction (perpendicular to the axis and the radius of the section) around the axis of the cylinder, the pipe body and the like; radial refers to a direction along a diameter or radius. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the invention.

The valve clamping device provided by the invention is used for performing edge-to-edge repair on heart valves, in particular mitral valve and tricuspid valve.

Referring to fig. 2 and 3 together, the asymmetric valve clasper apparatus 100 according to the first embodiment of the present invention includes a support 110, two elastic inner arms, two arms, and a drive shaft 150. The support member 110 has a certain length, and a base 110a is disposed at the bottom of the support member, and the two clamping arms are relatively pivoted on the pivot hole 110b of the base 110 a.

Each clamp arm and the adjacent elastic inner clamp arm may constitute one clamp unit, and for better description, the first clamp arm 141, the second clamp arm 142, and the first elastic inner clamp arm 131 and the second elastic inner clamp arm 132 are distinguished, and the constructed clamp units are described as a first clamp unit 140a and a second clamp unit 140 b.

In this embodiment, the two elastic inner clamping arms are in an integral structure, one end of each of the first elastic inner clamping arm 131 and the second elastic inner clamping arm 132 is free, the other end of each of the first elastic inner clamping arm and the second elastic inner clamping arm is integrally connected through the connecting end 133, the connecting end 133 is a hollow base, and the bottom base 110a of the supporting member 110 is disposed in the connecting end 133. The first elastic inner clamping arm 131 and the second elastic inner clamping arm 132 are opened to two sides in a natural state, and can respectively bear against the first clamping arm 141 and the second clamping arm 142, and can be controlled to be in a vertically upright folded state (see fig. 2) or in a natural released state (see fig. 3) by penetrating a control line (not shown) through a perforation on the first clamping arm and the second clamping arm.

The connecting end 133 is provided with a first through hole 133a, the supporting member 110 is also provided with a second through hole 110c therethrough, one end of the driving shaft 150 is fixed to a base 151, and the other end of the driving shaft 150 extends into the first through holes 133a,110c and is detachably connected to an external driving device such as a driving rod (not shown) extending into the second through hole 110 c. Referring to fig. 2, a pair of links 152 are pivotally connected to the base 151 at one end and to the clamping arm 140 at the other end. When the driving shaft 150 moves in the axial direction, the base 151 moves back and forth to move the connecting rod 152 outwards or inwards, and the connecting rod 152 moves to push or pull the clamping arm to open or close relative to the supporting member 110.

The first clamping unit 140a and the second clamping unit 140b have asymmetric clamping areas for clamping different leaflets of a valve, and in this embodiment, the different clamping areas of the first clamping unit 140a and the second clamping unit 140b are mainly implemented by different areas of the first clamping arm 141 and the second clamping arm 142. The first clamping arm 141 and the second clamping arm 142 may have different overall lengths and/or overall widths.

Specifically, referring to fig. 4 and 5 together, the first clamping arm 141 may include a first inner cavity 141a and first flanges 141b located at left and right sides of an edge of the first inner cavity 141a, the first clamping arm 142 may also include a second inner cavity 142a and second flanges 142b located at left and right sides of an edge of the second inner cavity 142a, and the first inner cavities 141a,142a may partially accommodate the elastic inner clamping arm 130 to stably clamp when clamping the leaflet of the valve, and the second flanges 142b may better support both sides of the leaflet. The first inner cavities 141a,142a of the first and second clamping arms 141, 142 may be different in width and/or the first flanges 141b,142b may be different in width, resulting in a different overall width. The different width designs are designed for different length, area, etc. of the mitral valve leaflet or the tricuspid valve leaflet, and the wide one of the first clamping arm 141 and the second clamping arm 142 clamps the larger and thicker one of the mitral valve leaflets, such as the anterior leaflet, or the leaflet with serious prolapse; the narrow one of the first and second clamping arms 141, 142 clamps the smaller, thinner one of the mitral valve leaflets, such as the posterior leaflet, or the less prolapsed leaflet, or the anterior leaflet, posterior leaflet, septal leaflet of different size widths or different severity of prolapse in the tricuspid valve.

In this embodiment, the first flanges 141b on the left and right sides of the first clamping arm 141 respectively include a first flange section 141c, a second flange section 141d and a third flange section 141e that are in smooth transition, the first flange section 141c is rectangular overall, the second flange section 141d is an arc-shaped section, the width of the third flange section 141e is smaller than that of the first flange section 141c, and the second flange section 141d in the first flange section 141c, the second flange section 141d and the third flange section 141e has the largest flange width, so that the second flange section 141d can play a role of mainly supporting the edge of the leaflet. The second flanges 142b of the left and right sides of the second clamping arm 142 may be narrowed in proportion to the first flanges 141b of the left and right sides of the first clamping arm 141 or may have different shapes due to the difference in circumference and area of the clamped leaflet.

The first clamping arm 141 or the second clamping arm 142 may be scaled in length, i.e. the length of the first clamping arm 141 or the second clamping arm 142 may be set according to the position and driving requirement of the valve clamping device for clamping the valve leaflet. In this embodiment, the first inner cavities 141a,142a of the first clamping arm 141 and the second clamping arm 142 have hollowed designs to increase the elasticity of the opening and closing of the first clamping arm 141 and the second clamping arm 142, but with reference to the weight of the valve leaflet. The first clamping arm 141 and the second clamping arm 142 are typically formed as a clamping plate of a rigid material.

In the above embodiment, referring to fig. 2 again, a locking structure 150a may be designed for the driving shaft 150 in the space of the connecting end 133 of the elastic inner clamping arm 130 or in the space of the bottom base 110a of the supporting member 110, so that when the first clamping unit 140a and the second clamping unit 140b clamp the corresponding leaflet, the locking structure 150a may clamp the driving shaft 150 to make the clamping more stable; or when the clamping angle is found to be inappropriate when clamping the valve leaflet of the mitral valve or tricuspid valve, the locking structure 150a may be unlocked, and the first clamping unit 140a and the second clamping unit 140b may be re-opened and clamp the corresponding valve leaflet, i.e., a secondary clamping adjustment may be performed. The locking and unlocking of the locking structure 150a may be controlled by an external driving means, such as a handle, via a control line.

The first and second elastic inner clip arms 131 and 132 may be provided with barbs 130a so that the barbs 130a may penetrate into tissue or abut against the tissue surface to stabilize the clamping when the first and second clamping units 140a and 140b clamp the leaflet. Referring to fig. 6, in a variant embodiment, more or longer barbs 130a may be designed to provide a more stable grip for different sized leaflets, such as for a greater length, area or thickness of leaflet. The more or longer barbs 130a also facilitate the physician in identifying the left and right sides of the asymmetrical valve clasper in the medical image, thereby more quickly positioning the asymmetrical valve clasper.

Referring to fig. 7a and 7b, in the second embodiment of the present invention, the first clamping arm 141 and the second clamping arm 142 include a bending section in addition to the first inner cavities 141a,142a and the first flanges 141b,142b, one or both of the first clamping arm 141 and the second clamping arm 142, and in this embodiment, the bending section 141f includes two bending sections, which are respectively connected to the first flanges 141b on the left and right sides. The bending section 141f may be a continuous sheet-shaped body, which is preformed to be bent to reduce a space (see fig. 7 a) when an external force is applied, and automatically expanded (see fig. 7 b) when no external force is applied, so that both side areas of the first flange 141b are expanded, and a better supporting effect is achieved when a larger leaflet is clamped. When both of the first and second clamping arms 141, 142 have a curved section, one of them may be scaled down in area, so that it may be distinguished when clamping a larger leaflet and a smaller leaflet, to be quickly positioned to a clamping position, and a suitable clamping area may support the corresponding leaflet. The bending section 141f is located substantially in the middle of the first flange 141 b.

Referring to fig. 8, the hollow design in the middle of the bending section 141f may be deformed into a hollow body, where the hollow body is formed by bending an elastic metal wire into a circular arc shape, and two ends of the hollow body are respectively provided with a first end point and a second end point, and the first end point and the second end point are respectively located in the middle of the first flange 141 b. The hollowed-out body can increase bending elasticity. The flexibility of the bending section 141f allows for reduced volume during delivery into the patient, particularly to facilitate delivery into the body in a delivery sheath, and allows for flattening due to its own elastic or memory function to increase the gripping area when gripping the leaflets.

Referring to fig. 9, in another variant embodiment, the bent section 141f is further filled with a wire 141g in the hollow body, and the wire may be directly pulled transversely by using a nitinol wire. In other embodiments, the hollow body of the bending section 141f may be filled with a spherical or elliptical mesh body made by braiding and heat setting, so as to increase the rigidity and support of the hollow body. The nickel-titanium metal filament also has the shape memory function of elastic deformation and recovery.

Referring to fig. 10, a schematic diagram of an asymmetric valve clamping device 200 according to a third embodiment of the present invention is shown, the asymmetric valve clamping device 200 further includes a blocking member 210, the blocking member 210 is disposed between the first clamping unit 220a and the second clamping unit 220b, sleeved on the supporting member 110, and may have one end fixed on the supporting member 110 and the other end freely suspended relative to the supporting member 110. The blocking member 210 has elasticity, and is compressed to facilitate delivery when being pressed on both sides, and is self-expandable to a three-dimensional shape when not being pressed, preferably a three-dimensional net structure formed by weaving wires or cutting tubes with shape memory function, such as super-elastic materials like nitinol wires, so that the blocking member 210 can adapt to gaps between different valve leaflets to adaptively deform under different clamping angles or different clamping forces of the first clamping unit 220a and the second clamping unit 220b, thereby adjusting the pulling degree of the valve clamping device 200 on the valve leaflets. The outer and/or inner portions of the occluding component 210 of the three-dimensional mesh structure may be covered with a biocompatible membrane that may act as a barrier to enhance reflux therapy and prevent thrombus from forming in the blood entering the occluding component 210 on the one hand and may provide greater biocompatibility to the valve clasper device 200 on the other hand. The material of the film may be, but not limited to, a biocompatible polymer such as PTFE, e-PTFE, polyester, silicone, etc. The effect of the blocking member 210 is to increase the blocking between diseased leaflets, and the blocking member 210 can contact the leaflets, after which the leaflet tissue will slowly form endothelial climbing after contact with the blocking member 210, the heart structure will gradually improve as implantation time increases, and endothelial cells will begin to climb from the site of close apposition with the valve and eventually climb over the entire valve clamping device 200 preventing regurgitation in the center of the leaflet. The blocking member 210 may have an oval or olive shape, and both ends thereof may protrude beyond edges of the first and second clamping units 220a and 220b, thereby increasing a blocking area.

The two sides of the plugging piece 210 form a corresponding first clamping unit 220a and a corresponding second clamping unit 220b with the corresponding clamping arms 222 and the elastic inner clamping arms 223 respectively. The clamping arms 222 of the first and second clamping units 220a, 220b may have an asymmetric clamping area, and the first and second sides 210a, 210b of the closure 210 may be symmetrical or asymmetrical.

Referring to fig. 11, in one embodiment, the first side 210a and the second side 210b of the blocking member 210 are asymmetric. Specifically, the first side 210a may be oval, the second side 210b may be olive-shaped, the olive-shape may have a smaller area in the center portion than the oval contacting the petals She Chushi, and may have a sharp angle in the tip portion than the oval, and the oval-shaped bonding may be used by fully utilizing the respective shapes of the front and rear leaves, or the olive-shaped bonding. The asymmetric occluding member 210 forms an asymmetric gripping area of the first and second gripping units 220a, 220b with the corresponding gripping arms 222, 223, and the physician can determine which gripping unit to use to grip which leaflet and directly position the valve clamping device 200 during surgery.

In other embodiments, the first side 210a and the second side 210b of the blocking member 210 may also be different densities of the mesh, so that the solid area in contact with the valve leaflet is different, and the different densities of the mesh may control different endothelial cell climbing speeds, which are too fast or too fast, because the patient does not have enough time to adapt to the implant, and may cause adverse effects on sudden changes in physiological structures. The different side shapes and weave densities of the occluding component 210 can be used by a physician to control different endothelial cell climbing rates as needed for patient leaflet repair.

In summary, the asymmetric valve clamping device provided by the embodiment of the invention designs that two clamping units of the same valve clamping device have different clamping areas aiming at valve leaflets with different sizes, so that the valve clamping device is positioned definitely when being implanted during the treatment of regurgitation in mitral valve or tricuspid valve operation, the large-area clamping unit clamps the valve leaflets, the small-area clamping unit clamps the small valve leaflets, and thus, the valve clamping repair is more targeted and accurate, and the effect of blocking the regurgitation is better.

Referring to fig. 2 and 12 together, the present application further provides a valve repair apparatus, including the above-mentioned asymmetric valve clamping device 100, and a delivery device 300, wherein the delivery device 300 includes: a push sheath 310 having an axial length and a mandrel (not shown) movably threaded into the push sheath 310. The push sheath 310 is detachably connected to the support 110 of the valve clasper device 100 and the mandrel is detachably connected to the drive shaft 150 for driving the deployment and closure of the clasper arms 141, 142. The second through hole 110c of the support 110 penetrates the entire support to form a penetration passage to be coupled with the driving member and the conveying device 200. An S-shaped connecting buckle 110e is provided on the pipe wall of the pipe body of the supporting member 110, and is used for detachably connecting with the conveying device 300. For example, the delivery device 300 is provided with a complementary S-shaped connector 310f, and after the S-shaped connector 110e is engaged with the S-shaped connector 310f, the delivery device 300 is engaged with the support member 110, so that the valve clasper 100 can be delivered, and after the S-shaped connector 110e is disengaged from the S-shaped connector 310f, the delivery device 300 is separated from the valve clasper 100. It should be understood that the support 110 structure is provided herein by way of example only and is not intended to limit the present application, and that other support structures may be employed by those of ordinary skill in the art based on the teachings herein and are within the scope of the present application.

In this embodiment, the proximal end of the drive shaft 150 is externally threaded, and the spindle is threadably coupled to the drive shaft 150 so that axial movement of the drive shaft 150 can be controlled by the spindle outside the patient. It should be appreciated that only a portion of the structure of the delivery device is listed herein, and any other portion may be implemented in any suitable structure that is not described herein.

Referring to fig. 2, 10, 13-14, and taking the repair procedure of the anterior leaflet and the septal leaflet of the tricuspid valve as an example, the valve clasper device 100 of fig. 2 is added with the blocking member 210 of fig. 9, and the operation method of the valve repair apparatus of the present invention mainly comprises the following steps:

The distal end of the delivery device 300 and the asymmetrical valve clasper device 100 are delivered via the inferior vena cava to the right atrium RA by transfemoral venipuncture; the valve clasper device 100 is then controlled to approximate the anterior leaflet and septal leaflet of the tricuspid valve TV; unlocking the locking structure 150a, pushing the mandrel and drive shaft 150 distally, driving the clamping arms 141, 142 open relative to the support 110 and the blocking member 210, adjusting the orientation of the clamping arms 141, 142, at which point the relative positions of the clamping arms 141, 142 and the anterior leaflet and septal leaflet of the tricuspid valve TV can be observed by a medical imaging or developing device such that the clamping arms 141, 142 are substantially perpendicular to the free edges of the anterior leaflet and septal leaflet; pushing the valve clamping device 100 to the right ventricle RV by the delivery device 300, placing the valve clamping device 100 under the anterior leaflet and the septal leaflet, continuing to open the clamping arms 141, 142 to the capture position; meanwhile, the elastic inner clamping arms 131, 132 are controlled to be attached to the outer surface of the blocking piece 210, and at this time, a leaflet accommodating space is formed between each elastic inner clamping arm 131, 132 and one clamping arm 141, 142 adjacent to the elastic inner clamping arm;

Simultaneously or sequentially releasing the elastic inner clamping arms 131, 132 at the two sides, wherein the two elastic inner clamping arms 131, 132 and the two clamping arms 141, 142 are matched to catch the front leaf and the partition leaf; the mandrel and drive shaft 150 are then pulled proximally, thereby driving the two clamp arms 141, 142 closed such that the anterior leaflet and the septal leaflet are clamped between the closure 210 and the two clamp arms 141, 142;

The threaded connection between the mandrel and the drive shaft 150 is released, the mandrel is withdrawn, the two branches of the connecting rod 152 are restored to the closed state, the S-shaped connecting buckle 310f is separated from the S-shaped connecting buckle 110e of the supporting member 110, the connection between the valve clamping device 100 and the delivery device 300 is released, the delivery device 300 is withdrawn from the body, the implanted state as shown in fig. 15 and 16 is obtained, the valve clamping device 100 pulls the anterior leaflet and the septal leaflet of the tricuspid valve TV toward each other, and the edge-to-edge repair of the anterior leaflet and the septal leaflet is completed.

After the asymmetric valve clamping device 100 is implanted, an elastic blocking piece 210 is filled between the clamped anterior leaflet and the septal leaflet, on one hand, gaps among the leaflets are blocked to reduce regurgitation, and on the other hand, radial supporting force is provided for the leaflets, and the blocking piece 210 has a buffering effect on the beating leaflets, so that the traction degree of the valve clamping device 100 on the leaflets can be adjusted to avoid damage to the leaflets.

The asymmetrical valve clasper device 100 is suitable for use in tricuspid valve claspers, although it may be used in mitral valve claspers, with only a difference in the path of intervention, such as the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-left ventricle, or the transapical approach.

It will be appreciated that the valve clasper systems provided by the present invention may include any of the atrioventricular valve clasper devices described above and a delivery device capable of delivering the atrioventricular valve clasper device from outside the body to adjacent the tricuspid valve or mitral valve and for clasping the leaflets.

The foregoing is only a specific embodiment of the invention to enable those skilled in the art to understand or practice the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (12)

1. An asymmetric valve clasper comprising a first clasper unit and a second clasper unit, wherein the first clasper unit and the second clasper unit have an asymmetric clasper area for clasping different leaflets of a valve.

2. The asymmetric valve clasper device of claim 1, wherein the first clasper unit comprises a first clasper arm and the second clasper unit comprises a second clasper arm, the first clasper arm and the second clasper arm differing in overall length and/or overall width.

3. The asymmetrical valve clasper of claim 2 wherein the first and second clasper arms each comprise an inner lumen and cuffs on left and right sides of the inner lumen edge, wherein the inner lumen widths of the first and second clasper arms are different and/or the cuffs are different.

4. The asymmetrical valve clasper of claim 3, wherein the left and right side flanges of the first and/or second clamp arms each comprise a rounded first flange section, a second flange section, and a third flange section, the first flange section is generally rectangular, the second flange section is an arcuate section, the third flange section has a width less than the width of the first flange section, and the second flange section has a maximum flange width among the first flange section, the second flange section, and the third flange section.

5. The asymmetrical valve clasper of claim 3 wherein the first clamp arm and/or the second clamp arm further have a bend section connected to the cuff, the bend section being expandable into an extension of the cuff when not subjected to an external force, the widths of the extension of the first clamp arm and the second clamp arm being different.

6. The asymmetrical valve clip of claim 5, wherein the bent segment is hollowed, and has a first end and a second end at each end, the first end and the second end being located in a middle portion of the flange.

7. The valve clasper of claim 6 wherein said crimped section is filled with a mesh wire, said mesh wire being made of a shape memory material.

8. The asymmetrical valve clasper of claim 2 wherein the first clamping unit further comprises a first resilient inner clip arm and the second clamping unit further comprises a second resilient inner clip arm, the first resilient inner clip arm having a first free end and the second resilient inner clip arm having a second free end, the first free end and the second free end being integrally connected by a connecting end, the first free end and the second free end configured with asymmetrical barbs.

9. The asymmetric valve clip apparatus of claim 8, wherein the number, location, or length of barbs of the first and second free ends are different.

10. The asymmetric valve clamping device of claim 1, further comprising a blocking member disposed between the first clamping unit and the second clamping unit, the blocking member having a first surface facing the first clamping unit and a second surface facing the second clamping unit, the first surface and the second surface being asymmetrically disposed.

11. The asymmetrical valve clasper device of claim 10, wherein the blocking member is a three-dimensional mesh structure made of a plurality of mesh wires, the blocking member has a surface facing the first clamping unit and a surface facing the second clamping unit that are different in shape, and/or the mesh wires have different densities or materials.

12. A valve repair device comprising the asymmetric valve clamping apparatus of any one of claims 1 to 11, and a delivery apparatus comprising: the device comprises a pushing sheath tube with a certain axial length and a mandrel movably penetrating the pushing sheath tube, wherein the pushing sheath tube is detachably connected with the asymmetric valve clamping device, and the mandrel is used for driving the first clamping unit and the second clamping unit to be unfolded and closed so as to clamp valve tissues.