CN118252667A - Valve clamping device and valve repair instrument - Google Patents

Abstract

The invention discloses a valve clamping device and a valve repair instrument comprising the same. The valve clamping device comprises a supporting piece, a blocking piece and a clamping piece; the plugging piece is sleeved on the supporting piece, the clamping piece is arranged on the outer side of the plugging piece and can be unfolded or closed relative to the plugging piece, and the plugging piece has elasticity and can be self-expanded into a three-dimensional shape; the plugging piece comprises two holding and clamping parts which are oppositely arranged in the X direction and two end parts which are oppositely arranged in the Y direction, wherein the outer contours of the two end parts respectively form outward tips in the Y direction, the two holding and clamping parts and the two end parts jointly form a main body part, one end of the main body part along the Z direction extends to form a connecting part, one part of the connecting part is connected with the supporting piece, and at least one part of the outer edge of the connecting part is contacted with the edge of a valve leaflet of the valve.

Description

Valve clamping device and valve repair instrument

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a valve clamping device and a valve repairing 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 interventional valve pinching operation is to implant a valve pinching device into an atrioventricular valve such as a mitral valve and a tricuspid valve, so that two valve leaflets which are originally not properly coaptated are pulled to each other, and a valve leaflet gap is reduced or eliminated, thereby treating regurgitation.

An existing valve clamping device is provided with an elastic blocking ball between two clamp arms, adjacent valve leaflets are respectively clamped between one clamp arm and the blocking ball, the pulling degree of the clamp arms on the valve leaflets is adjusted through deformation of the blocking ball, and gaps among the valve leaflets are blocked, so that reflux is reduced. However, in the conventional valve clamping device, the two ends a and B of the sealing ball, which are not clamped by the clamp arms, cannot be sufficiently bonded by the adjacent two leaflets L, and as shown in fig. 2, leaks C and D capable of flowing back blood exist near the two ends, thereby affecting the reflux treatment effect.

It should be noted that, compared to mitral regurgitation, the tricuspid regurgitation is mostly caused by expansion of the tricuspid annulus, but the leaflets of the tricuspid valve are more fragile, so as to avoid perforation or tearing caused by excessive stress on the leaflets, the tricuspid valve leaflets are not too tightly clamped by the valve clamping device, the acting force of the clamp arms on the blocking ball is not too great, the deformation degree of the blocking ball is limited, compared with the case of clamping the mitral valve leaflets, the two ends a and B are more obviously spread on the adjacent leaflet L nearby, the leakage ports C and D are larger, and the regurgitation generated through the leakage ports C and D is more.

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 a valve clamping device and a valve repair apparatus.

In a first aspect of the present invention, there is provided a valve clamping device, comprising a support member, a blocking member and a clamping member, wherein the central axial direction of the blocking member is taken as a Z direction, the direction parallel to the width direction of the clamping member and perpendicular to the Z direction is taken as a Y direction, and the direction perpendicular to the Z direction and perpendicular to the Y direction is taken as an X direction; the support piece is provided with a Z-direction height, the plugging piece is sleeved on the support piece along the Z-direction, the clamping piece is arranged on the outer side of the plugging piece and can be unfolded or closed relative to the plugging piece, and the plugging piece is elastic and can be self-expanded into a three-dimensional shape; the plugging piece comprises two holding and clamping parts which are oppositely arranged in the X direction and two end parts which are oppositely arranged in the Y direction, at least part of the end parts are exposed out of the clamping piece in the Y direction, the outer contours of the two end parts respectively form outward tips in the Y direction, the two holding and clamping parts and the two end parts jointly form a main body part, one end of the main body part in the Z direction extends to form a connecting part, one part of the connecting part is connected with the supporting piece, and at least one part of the outer edge of the connecting part is contacted with the edge of a valve leaflet of the valve.

In a preferred embodiment, the ratio of the height of the main body portion in the Z direction to the height of the connecting portion in the Z direction is 2/7 to 7/2.

In a preferred embodiment, the ratio of the height of the main body portion in the Z direction to the height of the connecting portion in the Z direction is 2/7 to 1/1.

In a preferred embodiment, the minimum width distance of the main body part is greater than the minimum width distance of the connecting part, and in the XZ plane, the connecting part is in a long column shape, and the width dimension of the main body part is gradually increased and then gradually decreased.

In a preferred embodiment, the tip is proximate to the sharp corner and has an arc of 0.005mm-5mm radius at the end of the sharp corner.

In a preferred embodiment, the end portion tapers from the collet to the tip in the XY plane and conforms to an olive-shaped curve profile.

In a preferred embodiment, the Y-direction width dimension of the clip-receiving portion is equal to the width of the clip-receiving member, and the clip-receiving portion is a position of initial attachment to the valve when the clip-receiving member is closed, from which position endothelial cells of the valve climb to the center and both ends of the occluding member, and the rate of climbing to the center is greater than the rate of climbing to both ends.

In a preferred embodiment, the dimension of the closure member in the X direction is in the range of 3mm to 8mm, the dimension in the Y direction is in the range of 5mm to 13mm, and the Y-direction width dimension of the clip receiving portion is in the range of 4mm to 6mm.

In a preferred embodiment, the Y-direction width dimension of the end from the collet to the tip is 1-3 times the Y-direction width dimension of the collet.

In a preferred embodiment, the connecting portion is fixed to a steel sleeve, the steel sleeve is sleeved on the supporting member and has a degree of freedom of rotation, and the other end of the main body portion, which is far away from the connecting portion, is freely suspended relative to the supporting member.

In a preferred embodiment, the body portion is curved on both sides in the X-direction, and the curved surfaces on both sides are symmetrical or asymmetrical.

In a preferred embodiment, the closure is a three-dimensional mesh structure formed by interlacing a plurality of threads made of a shape memory material and covered externally and/or internally with a biocompatible film, the deformation capacity of the bearing clip of the three-dimensional mesh structure being smaller than that of the end of the three-dimensional mesh structure.

In a second aspect of the invention, a valve repair device is provided, comprising a valve clamping device as described above and a delivery device. The conveying device comprises: the pushing sheath tube is detachably connected with the supporting piece, and the mandrel is used for driving the clamping piece to be unfolded and closed.

The valve clamping device provided by the invention has the advantages that the plugging piece is arranged to comprise two clamping parts which are oppositely arranged in the X direction and used for clamping the clamping piece, and two end parts which are oppositely arranged in the Y direction, wherein the outer contours of the two end parts respectively form an outward tip in the Y direction, at least part of the end parts are exposed out of the clamping piece in the Y direction, the plugging piece is provided with a main body part and a connecting part, at least part of the outer edge of the connecting part can be in contact with the edge of the valve leaflet, so that the main body part can plug the gap between the valve leaflets of the valve, the connecting part can be naturally attached to the sagged edge (namely the leaflet folding edge), and the leaflet folding edge can be naturally folded by virtue of the connecting part and cannot be spread by the main body part, so that the filling and repairing of the edge folding edge can be better realized.

The valve clamping device implanted in the atrioventricular valve is used for clamping adjacent valve leaflets with gaps of the mitral valve or the tricuspid valve, and particularly when the valve clamping device is applied to the tricuspid valve, even if the deformation degree of the blocking piece is limited, compared with the prior art, as the two end parts of the blocking piece are provided with the pointed ends, the corresponding parts of the adjacent valve leaflets near the two end parts are easy to conform to and attach the pointed ends until the two end parts are attached, namely the two end parts can be fully attached by the adjacent valve leaflets, so that leakage holes near the two end parts can be reduced or even eliminated, as in the prior art, the two end parts can effectively block reflux, and the reflux treatment effect of the atrioventricular valve clamping device is improved.

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 valves in a normal state;

FIG. 2 is a schematic diagram of the prior art showing the presence of blood flashback leak near the ends of the occlusion ball;

FIG. 3 is a schematic front view of a valve clip apparatus of an embodiment of the present invention as the clip is deployed;

FIG. 4 is a schematic front view of a valve clamping device of an embodiment of the present invention with the clamping member in a first closed state;

FIG. 5 is a schematic front view of a valve clamping device of an embodiment of the present invention with the clamping member in a second closed state;

FIG. 6 is a schematic top view of a valve clamping device of an embodiment of the present invention with the clamping member in a first closed state;

FIG. 7 is a schematic top view of a valve clamping device of an embodiment of the present invention with the clamping member in a second closed state;

FIG. 8a, FIG. 8b, FIG. 8c is a schematic illustration of the olive shape versus circular and oval shape of the occluding member of the valve clasper device in accordance with the embodiments of the present invention in comparison to the endothelial climbing after initial attachment;

FIG. 9 is a schematic front view of the attachment of the closure member of the valve clasper apparatus of the embodiments of the present invention with the steel sheath;

FIG. 10 is a schematic top view of a closure member of a valve clasper apparatus in accordance with an embodiment of the present invention;

FIG. 11 is a schematic front view in XZ of a closure member of a valve clasper apparatus in accordance with a preferred embodiment of the present invention;

FIG. 12 is a schematic illustration of the effect of a valve clasper device in contact with a simulated leaflet using the occluding member of FIG. 11;

FIG. 13 is a schematic top view of a mesh density zoning design based on the closure of FIG. 11;

FIG. 14 is a schematic view of the configuration of the support member of the valve clasper apparatus in accordance with an embodiment of the present invention in cooperation with the delivery device of the valve repair instrument;

15-17 are schematic views of a process by which a valve repair instrument of an embodiment of the present invention performs repair of adjacent leaflets of a tricuspid valve;

FIG. 18 is a schematic view of a valve clasper device in accordance with an embodiment of the present invention after the repair of adjacent leaflets of the tricuspid valve;

fig. 19 is a schematic view of a valve clamping apparatus of an embodiment of the present invention after repair of adjacent leaflets of a mitral valve.

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 repairing heart valves, in particular mitral valves and tricuspid valves.

Referring to fig. 3 and 4, a valve clamping device 100 according to an embodiment of the present invention includes a support member 110, a blocking member 120, and a clamping member 130. The supporting member 110 has a certain length, the blocking member 120 is sleeved on the supporting member 110, and the clamping member 130 can be opened and closed relative to the blocking member 120. The clamping member 130, when closed against the occluding member 120, may clamp a valve, such as the leaflets of a mitral or tricuspid valve, between the clamping member 130 and the occluding member 120.

The clamping member 130 can be opened and closed relative to the closure member 120 substantially by a combination of a base 142, a link 143, a drive shaft 141, and a coupling seat 140. In this embodiment, the support member 110 is hollow, one end of the driving shaft 141 is fixedly connected to the base 142, and the other end extends into the support member 110 through the coupling seat 140 for detachable connection with a driving device, such as a driving rod (not shown) of an instrument. In some embodiments, the support member 110 is fixedly connected or integrally formed with the coupling seat 140.

The clamping member 130 preferably includes a pair of clamping pieces 130a disposed on both sides of the blocking member 120. The clamping piece 130a is rotatably hinged on the coupling seat 140 through a rotating shaft 132. The connecting rod 143 also includes a pair of connecting rods pivotally connected to the base 142 and the clamping piece 130a, respectively, that is, two ends of the connecting rod 143 can rotate relative to the base 142 and the clamping piece 130a, respectively. When the driving shaft 141 is driven in the axial direction, the base 142 may move forward or backward following the driving shaft 141, thereby causing the link 143 to rotate, and the link 143 rotates to pull or push the grip piece 130a to open or close.

Referring to fig. 5, preferably, the closing angle of the clamping member 130 relative to the plugging member 120 can be further adjusted, that is, in the closed state, the clamping member 130 can have different clamping angles or different forms of clamping forces. For example, when the mitral or tricuspid valve leaflet is clamped, the clamp 130 may be re-opened and the angle at which the clamp 130 closes relative to the occluding component 120 may be adjusted. In this case, a locking and unlocking structure (not shown) may be provided in the coupling seat 140, for example, the locking piece may have different angles under control, so as to lock the driving shaft 141 or release the driving shaft 141, so that it may freely move again, thereby readjusting the opening or closing angle of the clamping member 130 with respect to the blocking member 120, and locking again after the angle is adjusted.

In this embodiment, the valve clamping device 100 further includes a pair of limiting elastic pieces 151, and the limiting elastic pieces 151 are disposed between the blocking member 120 and the clamping piece 130 a. The width of the limiting elastic sheet 151 is narrower, the width of the clamping sheet 130a is wider, the limiting elastic sheet 151 plays a role in limiting and clamping, the valve leaflet of the mitral valve or tricuspid valve can be clamped between the limiting elastic sheet 151 and the clamping sheet 130a, the valve leaflet is wider, especially the area of the anterior leaflet of the mitral valve is larger, the circumference is longer, and when the valve leaflet is clamped between the limiting elastic sheet 151 and the clamping sheet 130a, part of the valve She Tie is attached to the blocking piece 120.

The occluding component 120 is resilient, as shown in figures 6 and 7, and corresponds to the changing of the shape of the occluding component 120 in different compression states of figures 4 and 5, respectively, and is reversible. The entire valve clasper device 100, during delivery to a surgical site in the body, is either in a compressed state that approximates fig. 7 or is less compressed than fig. 7 to facilitate delivery. The occluding member 120 self-expands to a solid shape when the clamping member 130 is opened relative to the occluding member 120. In one embodiment, the blocking member 120 is a three-dimensional mesh structure, preferably a three-dimensional mesh 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 120 can adapt to the gaps between different leaflets and adaptively deform under different clamping angles or different clamping forces of the clamping member 130, thereby adjusting the traction degree of the atrioventricular valve clamping device 100 on the leaflets. For example, for larger but thinner and weaker tricuspid adjacent leaflets (which may be anterior and posterior, anterior and septal, or posterior and septal) the clip 130 may be closed at a larger clip angle (A1 as shown in fig. 4), avoiding excessive stress to the leaflets, preventing the leaflets from perforating or tearing; for the mitral valve adjacent leaflets (i.e., anterior and posterior leaflets of the mitral valve), the clamp 130 can be closed at a small clamping angle (A2 as shown in fig. 5) to provide a large clamping force to the leaflets. It should be noted that the three-dimensional mesh structure includes a plurality of meshes formed by interweaving a plurality of first wires and a plurality of second wires, and the mesh shape of each mesh may be, but not limited to, quadrilateral.

The outer and/or inner portions of the occluding component 120 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 120 on the one hand and may provide greater biocompatibility to the valve clamping device 100 on the other hand. The material of the film may be, but not limited to, a biocompatible polymer such as PTFE, EPTFE, polyester, silicone, and the like.

To better illustrate the closure 120 of the present invention, the central axial direction of the closure 120 is defined as the Z-direction, the direction parallel to the width direction of the clip and perpendicular to the Z-direction is defined as the Y-direction, and the direction perpendicular to the Z-direction and perpendicular to the Y-direction is defined as the X-direction. Referring again to fig. 6 and 7, the blocking member 120 has an olive shape in an XY plane, and the outer contours of the two ends 123 of the blocking member 120 have two ends 123 in a Y direction parallel to the width direction of the clamping member 130, at least a portion of the ends 123 are exposed to the outside of the clamping member 130 in the Y direction, and the contours of the two ends 123 are gradually reduced to form outward tips 125, respectively. The tip 125 is close to the tip, but may have an arc with a radius of 0.005mm-5mm at the end of the tip, and with the smaller radius, the profile of the two ends 123 tends to decrease gradually as the time for implanting the occluding component 120 in the body increases until the tip can make the corresponding portions of adjacent leaflets near the ends conform to and attach to the tip 125 until apposition occurs, i.e., the two ends can be sufficiently attached by the adjacent leaflets to reduce or even eliminate the leakage orifice existing near the two end flaps, so that the two ends can also effectively occlude regurgitation.

The plugging piece 120 is curved on two sides in the X-direction, the two sides are provided with two opposite holding and clamping parts 121, and the two holding and clamping parts 121 can be tightly attached to the clamping piece 130a on the surface after expansion and provide a certain supporting force, so that the capturing force of the plugging piece on the valve leaflet is improved, and the function of initially clamping the valve leaflet is formed together with the clamping piece 130 a. In the olive shape, the two ends 123 of the blocking member 120 are longer, and the initial contact between the two clip receiving portions 121 and the clip 130a is smaller. As shown in fig. 8a, 8b and 8c, the olive shape of fig. 8a is in contact with petals She Chushi at a smaller location than the circular shape of fig. 8b, and even the oval-shaped occluding component of fig. 8c is in contact with petals She Chushi. After the valve leaflet contacts the blocking piece 120, the tissue of the valve leaflet gradually forms endothelial climbing, and due to the small olive-shaped initial contact position, endothelial cells of the tissue climb from the initial attachment position to the center and the two end parts of the blocking piece; under circular and even oval plugs, endothelial cells climb from a larger contact area to the middle due to the large initial contact position, so that under circular and oval plugs, endothelial cells of tissue climb faster, while under olive-shaped plugs 120, endothelial cells of tissue climb slower. The slower endothelial cell climbing helps to extend the time for adaptive function of the occluding component 120. The slow climbing process can avoid adverse reactions possibly caused by sudden changes of physiological structures. As implantation time increases, cardiac architecture gradually improves, and endothelial cells begin to crawl from the site of close apposition with the valve and eventually crawl over the entire valve clasper preventing regurgitation in the center of the valve leaflets.

In this embodiment, the plugging member 120 has different mesh densities in different areas, the mesh of the plugging member 120 near the middle area is denser than the mesh of the two ends on the XY plane, that is, the mesh of the holding and clamping portion 121 is denser than the mesh of the two ends 123, and after the clamping device 100 closes the compressed plugging member 120, the two holding and clamping portions 121 of the plugging member 120 and the suture film covered on the surfaces thereof are further dense, so that the endothelial climbing speed at the two holding and clamping portions 121 is greater than the climbing speed towards the two ends 123 during the endothelial climbing. Basically, the speed of endothelial climbing is influenced to include mesh density degree, distance and the degree of being impacted by blood flow, and under the condition that the distance and the degree of being impacted by blood flow are basically the same, the effect of better controlling the endothelial climbing speed can be achieved by the mesh density of different designs of the subarea.

On the other hand, since the meshes of the holding and clamping part 121 are denser than those of the two end parts 123, the deformation amplitude is smaller than that of the two end parts 123, and the valve leaflet can be clamped by being matched with the better support of the limiting elastic sheet 151.

Referring to fig. 9 and 10 together, the dimension X1 of the blocking member 120 in the X-direction ranges from 3mm to 8mm, the dimension Y1 in the Y-direction ranges from 5mm to 13mm, and the width dimension of the clip receiving portion 121 in the Y-direction ranges from 4mm to 6mm, depending on the size of the gap between the heart valve leaflets. The clip receiving portion 121 may include a first portion 1211 and a second portion 1213 on opposite sides of the Y-direction middle portion YM. In this embodiment, the Y-direction width of the clip receiving portion 121 is equal to the width W (see fig. 6) of the clamping member 130, and the Y-direction width of the end 123 from the edge of the clip receiving portion 121 to the tip 125 is 1-4 times the Y-direction width of the clip receiving portion 121, so that the end 123 extends out of the clamping member 130. Preferably, the Y-direction width dimension of the end 123 from the edge of the holding and clamping portion 121 to the tip 125 is about 3 times that of the holding and clamping portion 121, so that the two end portions are far larger than the dimension of the holding and clamping portion 121, and after the physiological structure of the patient is gradually adapted with the increase of the implantation time, the two end portions comprise the tip to fill the area of the orifice so as to reduce the leakage. The solid lines on both sides of the collet 121 and on both sides of the tip 125 in fig. 10 generally represent the load bearing or deformation force bearing areas of the collet 121 and the tip 125, with the collet 121 being the location of initial attachment to the valve where deformation is greatest when the occluding component 120 self-expands or is compressed under force, with the tip 125 deforming least, and with the tip having a smaller sharp angle and a smaller deformation.

In this embodiment, the two clamping portions 121 and the two end portions 123 together form a main body portion 120a, and one end ZE1 of the main body portion 120a along the Z direction extends out of the connecting portion 120b. A part of the connection portion 120b is fixed to a steel sleeve 110a, and the steel sleeve 110a is sleeved on the support member 110 and has a degree of freedom of rotation. The connecting portion 120b is substantially cylindrical, the main body portion 120a is curved, the minimum width distance of the main body portion 120a is greater than the minimum width distance of the connecting portion 120b, and in the XZ plane, the connecting portion 120b is substantially elongated and cylindrical, and the connecting portion 120b is gradually enlarged and then gradually reduced from the connecting portion 120b to the main body portion 120a, and the outer contour of the middle ZM in the Z direction is maximized.

The end ZE2 of the main body 120a, which is far away from the connecting portion 120b, is freely suspended relative to the supporting member 110, so as to provide a greater degree of freedom of self-expansion or compression deformation when the plugging member 120 self-expands. The end of the main body 120a away from the connecting portion 120b may be formed with a through hole 1214 for a driving device (not shown) to extend into the main body 120a and connect with the driving shaft 141 extending into the supporting member 110.

The ratio of the height of the main body 120a along the Z direction to the height of the connecting portion 120b along the Z direction is 2/7-7/2. In a preferred embodiment, the ratio of the height of the main body 120a along the Z-direction to the height of the connecting portion 120b along the Z-direction is 2/7-1/1, i.e. the height of the connecting portion 120b is greater than the height of the main body 120 a. In a preferred embodiment, as shown in fig. 11 and 12, the ratio of the height of the main body 120a along the Z direction to the height of the connecting portion 120b along the Z direction is 3/4. The main body 120a may seal the gap between the leaflets of the valve, a portion of the connecting portion 120b connects the support member 110, and a portion of the outer edge of the connecting portion 120b may naturally abut the trailing edge 310 of the leaflet 300 (see fig. 12, or TV, MV in fig. 16-17, where the lower edge of the leaflet is trailing in nature, which may be referred to as the leaflet coaptation edge). The main body 120a and the connecting portion 120b form a shape with a wide upper part and a narrow lower part, the lower connecting portion 120b is suitable for being close to the leaflet folding edge (i.e. the edge where the leaflet sags), the main body 120a is moderate in height, so that no matter how deep or shallow the leaflet is clamped by the clamping device, a part of the leaflet folding edge is always positioned below the lower edge of the main body 120a, and the leaflet folding edge can be folded naturally by the connecting portion 120b without being spread by the main body 120a, thereby preventing most reflux. The main body 120a has a wider width, and can be deformed adaptively when compressed to obtain a better fitting degree with the area above the coaptation edge of the leaflet, thereby playing a role in blocking residual reflux.

As shown in fig. 13, the plugging member 120 has different mesh densities designed in a split area based on the ratio of the main body portion 120a to the connecting portion 120b of fig. 11, and the plugging member 120 has denser meshes near the middle area than at the two ends on the XY plane, i.e., the carrier portion 121 has denser meshes than at the two ends 123. The different mesh densities of the zoned design help control endothelial climbing rate as previously described.

The curved surfaces on both sides of the body 120a may be symmetrical or asymmetrical. The asymmetric situation comprises that the knitting densities of the net wires at two sides are different under the olive shape; or the two sides have the nearly olive shape of the tip, but the curvatures of the two sides are slightly different, and the curved surfaces of the two sides can be adjusted according to the requirement in the equation of the curve. Among the valve leaflets of the heart valve, for example, the area and circumference of each valve leaflet of the mitral valve and the tricuspid valve are different, the two asymmetric sides of the main body portion 120a can be designed according to the fitting requirement of the valve leaflets, so that a better blocking effect is achieved.

In summary, the valve clamping device provided by the invention is characterized in that the blocking piece comprises two holding clamping parts oppositely arranged in the X direction and used for clamping by the clamping piece, and two end parts oppositely arranged in the Y direction, wherein the outer contours of the two end parts respectively form outward tips in the Y direction, at least part of the end parts are exposed out of the clamping piece in the Y direction, the blocking piece is provided with a main body part and a connecting part, the proportion of the main body part and the connecting part is in an optimal range, at least part of the outer edge of the connecting part can be in contact with the edge of the valve leaflet, so that the main body part can block the gap between the valve leaflets of the valve, the connecting part can naturally and normally attach to the sagged edge of the valve leaflet, and the sagged edge of the valve leaflet, namely the coaptation edge of the valve leaflet, can not be spread by the main body part, so that the filling and repairing of the edge to the edge are better realized. The valve clamping device implanted in the atrioventricular valve is used for clamping adjacent valve leaflets with gaps of the mitral valve or the tricuspid valve, and particularly when the valve clamping device is applied to the tricuspid valve, even if the deformation degree of the blocking piece is limited, compared with the prior art, as the two end parts of the blocking piece are provided with the pointed ends, the corresponding parts of the adjacent valve leaflets near the two end parts are easy to conform to and attach to each other until the two end parts are attached to each other, namely the two end parts can be fully attached by the adjacent valve leaflets, so that leakage holes near the two end parts can be reduced or even eliminated, as in the prior art, the two end parts can effectively block reflux, and the reflux treatment effect of the valve clamping device of the atrioventricular valve is improved.

Referring to fig. 3 and 14 together, the present application further provides a valve repair apparatus, including the valve clamping device 100 and a delivery device 200, wherein the delivery device 200 includes: a push sheath 210 having an axial length and a mandrel (not shown) movably mounted in the push sheath 210. The pushing sheath 210 is detachably connected to the support member 110 of the valve clasper device 100, and the mandrel is detachably connected to the driver for driving the deployment and closure of the clasper 130. The support member 110 is further provided with an axial (i.e., Z-direction) through-hole-like penetration passage to be coupled with the driving member and the conveying device 200. At least two clamping positions 114 are arranged on the pipe wall of the pipe body of the supporting piece 110 and are used for being detachably connected with the conveying device 200. For example, the delivery device 200 is provided with a clamping table 221, and after the clamping table 221 is clamped into the clamping position 114, the delivery device 200 is in clamping connection with the support member 110, so that the delivery device 100 can be delivered, and when the clamping table 221 is separated from the clamping position 114, the delivery device 200 is separated from the atrioventricular valve clamping device 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 110 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 141 is externally threaded and the spindle is threadably coupled to the drive shaft 141 so that axial movement of the drive shaft 141 can be controlled outside the patient's body via the spindle. 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. 15 to 17, the following description will take the repair procedure of the anterior leaflet and the septal leaflet of the tricuspid valve as an example, and the operation method of the valve clamping system of the present invention mainly comprises the following steps:

The distal end of the delivery device 200 and the 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 portion 170 in the base 160, pushing the mandrel and the drive shaft 141 distally, driving the clamp 131 to open relative to the support 110 and the blocking member 120, adjusting the direction of the clamp 131, and at this time, observing the relative positions of the clamp 131 and the front leaflet and the septum of the tricuspid valve TV by a medical developing or imaging device, so that the clamp 131 is substantially perpendicular to the free edges of the front leaflet and the septum; pushing the valve clamping device 100 to the right ventricle RV by the delivery device 200, placing the valve clamping device 100 under the anterior leaflet and the septal leaflet, and continuing to open the clamping member 131 to the capturing position; meanwhile, each limiting elastic piece 151 is controlled to be attached to the outer surface of the plugging piece 120, and at this time, a valve leaf accommodating space is formed between each limiting elastic piece 151 and a corresponding clamping piece 131;

Simultaneously or sequentially releasing the limiting elastic pieces 151 at two sides, wherein the two limiting elastic pieces 151 and the two clamping pieces 131 are matched to catch the front leaves and the partition leaves; then the mandrel and the driving shaft 141 are pulled proximally, so that the two clamping pieces 131 are driven to be closed, and the front leaf and the separation leaf are clamped between the plugging piece 120 and the two clamping pieces 131;

the threaded connection between the mandrel and the drive shaft 141 is released, the mandrel is withdrawn, the two branches of the connecting piece 220 are restored to the closed state, the clamping table 221 is separated from the clamping position 114 of the supporting piece 110, the connection between the valve clamping device 100 and the conveying device 200 is released, the conveying device 200 is withdrawn from the body, the implanted state shown in fig. 18 and 19 is obtained, the valve clamping device 100 pulls the anterior leaflet and the septal leaflet of the tricuspid valve TV towards each other, and the edge-to-edge repair of the anterior leaflet and the septal leaflet is completed.

After the valve clamping device 100 is implanted, the elastic blocking piece 120 is filled between the clamped front leaflet and the partition leaflet, so that on one hand, gaps among the leaflets are blocked to reduce reflux, and on the other hand, radial supporting force is provided for the leaflets, and the blocking piece 120 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 valve clasper device 100 is suitable for use in tricuspid valve claspers, although it may be used in mitral valve claspers, with the exception of 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 (13)

1. A valve clamping device, which is characterized by comprising a supporting piece, a blocking piece and a clamping piece;

taking the central axial direction of the plugging piece as a Z direction, taking a direction parallel to the width direction of the clamping piece and perpendicular to the Z direction as a Y direction, and taking a direction perpendicular to the Z direction and simultaneously perpendicular to the Y direction as an X direction;

the support piece is provided with a Z-direction height, the plugging piece is sleeved on the support piece along the Z-direction, the clamping piece is arranged on the outer side of the plugging piece and can be unfolded or closed relative to the plugging piece, and the plugging piece is elastic and can be self-expanded into a three-dimensional shape;

The plugging piece comprises two holding and clamping parts which are oppositely arranged in the X direction and two end parts which are oppositely arranged in the Y direction, at least part of the end parts are exposed out of the clamping piece in the Y direction, the outer contours of the two end parts respectively form outward tips in the Y direction, the two holding and clamping parts and the two end parts jointly form a main body part, one end of the main body part in the Z direction extends to form a connecting part, one part of the connecting part is connected with the supporting piece, and at least one part of the outer edge of the connecting part is contacted with the edge of a valve leaflet of the valve.

2. The valve clasper of claim 1, wherein a ratio of a height of the main body portion in the Z-direction to a height of the connecting portion in the Z-direction is between 2/7 and 7/2.

3. The valve clasper of claim 2, wherein a ratio of a height of the main body portion in the Z-direction to a height of the connecting portion in the Z-direction is between 2/7 and 1/1.

4. The valve clasper of claim 3 wherein the minimum width distance of the body portion is greater than the minimum width distance of the connector portion and wherein the connector portion is elongated and cylindrical in the XZ plane and wherein the width dimension of the body portion is progressively greater and then progressively smaller.

5. The valve clasper of claim 4 wherein the tip is proximate to a sharp corner and has an arc of radius of 0.005mm-5mm at an end point of the sharp corner.

6. The valve clamping device of claim 5, wherein the end portion tapers from the clip receiving portion to the tip in an XY plane and conforms to an olive-shaped curve profile.

7. The valve-clamping arrangement of claim 6, wherein the clip-receiving portion has a Y-direction width dimension equal to the width of the clamping member, the clip-receiving portion being in an initial attachment position to the valve when the clamping member is closed, endothelial cells of the valve climbing from the initial attachment position to the center and both ends of the occluding member, and the climbing rate to the center being greater than the climbing rate to both ends.

8. The valve clip apparatus of claim 6, wherein the dimension of the occluding member in the X-direction ranges from 3mm to 8mm, the dimension in the Y-direction ranges from 5mm to 13mm, and the Y-direction width dimension of the clip portion ranges from 4mm to 6mm.

9. The valve clip of claim 8, wherein a Y-directional width dimension of the end from the clip receiver to the tip is 1-3 times the Y-directional width dimension of the clip receiver.

10. The valve clasper of claim 1, wherein the connection portion is secured to a steel sleeve that is sleeved over the support member and has rotational degrees of freedom, and wherein the other end of the main body portion remote from the connection portion is free to hang relative to the support member.

11. The valve clasper of claim 4, wherein the body portion is curved on both sides in the X-direction and the curved surfaces on both sides are symmetrical or asymmetrical.

12. The valve clasper device of claim 1, wherein the occlusion member is a three-dimensional mesh structure formed by interweaving a plurality of wires made of a shape memory material and covered externally and/or internally with a biocompatible film, the clip bearing portion of the three-dimensional mesh structure having a deformability less than that of the end portion of the three-dimensional mesh structure.

13. A valve repair device comprising a valve clamping apparatus according to any one of claims 1 to 12, and a delivery apparatus comprising: the pushing sheath tube is detachably connected with the supporting piece, and the mandrel is used for driving the clamping piece to be unfolded and closed.