CN117814958B

CN117814958B - Atrioventricular valve clamping device

Info

Publication number: CN117814958B
Application number: CN202410208252.7A
Authority: CN
Inventors: 张泽翰; 郑贤章; 李立光; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2024-02-26
Filing date: 2024-02-26
Publication date: 2024-06-18
Anticipated expiration: 2044-02-26
Also published as: CN117814958A

Abstract

The invention discloses an atrioventricular valve clamping device which comprises a supporting piece, a plugging piece and a clamping piece; taking the central axial direction of the supporting piece as a Z direction, taking a direction parallel to the width direction of the clamping piece and vertical to the Z direction as a Y direction, and taking a direction vertical to the Z direction and vertical to the Y direction as an X direction; the support piece is provided with a Z-direction length, the plugging piece is sleeved on the support piece along the Z-direction, and the pair of clamping pieces are arranged on the outer sides of the plugging piece and can be unfolded or closed relative to the plugging piece. The plugging piece has elasticity and a three-dimensional shape, and comprises two end parts which are oppositely arranged in the Y direction; the outer contours of the two end portions are asymmetrical in the Y direction on the XY plane, and at least one of the end portions is exposed outside the pair of sandwiching pieces in the Y direction. The asymmetrical portion forms an eccentric structure, and the portion of the eccentric structure remote from the pair of clips can be pressed against the prolapsed leaflet.

Description

Atrioventricular valve clamping device

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an atrioventricular valve clamping device.

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 leaflets of the mitral valve MV and tricuspid valve TV are associated with chordae tendineae T.

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.

One existing atrioventricular valve clamping device is provided with an elastic sealing ball between two clamping members, between which adjacent valve leaflets are clamped, respectively, whereas the current atrioventricular valve clamping device is generally only suitable for clamping in the middle of the atrioventricular valve, i.e. in the central region, for example in region B of fig. 2. When regurgitation occurs in the area a or the area C, there is often regurgitation at the boundary area E of the leaflet She Jiao, and the cause of the regurgitation at the boundary area is lengthy chordae tendineae T caused by prolapse syndrome, and partial leaflet P at the boundary area caused by infectious endocarditis and ischemia, namely leaflet P prolapse, at this time, if the leaflet P still clamps the central area of the anterior leaflet L1 and the posterior leaflet L2, the regurgitation problem at the leaflet boundary area cannot be solved well.

Disclosure of Invention

In order to solve the above technical problems or at least partially solve the above technical problems, the present invention provides an atrioventricular valve clamping device.

In a first aspect, the present invention provides an atrioventricular valve clamping device comprising a support member, a blocking member and a clamping member;

Taking the central axial direction of the supporting piece as a Z direction, taking a direction parallel to the width direction of the clamping piece and vertical to the Z direction as a Y direction, and taking a direction vertical to the Z direction and vertical to the Y direction as an X direction;

The support piece is provided with a Z-direction length, the plugging piece is sleeved on the support piece along the Z-direction, and the pair of clamping pieces are arranged on the outer sides of the plugging piece and can be unfolded or closed relative to the plugging piece;

The plugging piece has elasticity and a three-dimensional shape, and comprises two end parts which are oppositely arranged in the Y direction;

The outer contours of the two end portions are asymmetrical in the Y direction on the XY plane, and at least one of the end portions is exposed outside the pair of sandwiching pieces in the Y direction.

In a preferred embodiment, the blocking member comprises a first blocking portion and a second blocking portion, the first blocking portion being located between the pair of clamping members, the second blocking portion extending from the first blocking portion, and at least part of the second blocking portion being exposed beyond the pair of clamping members in the Y-direction.

In a preferred embodiment, the second blocking portion extends from the first blocking portion only to one side of the pair of clips.

In a preferred embodiment, the second blocking portion comprises a connecting section connected to the first blocking portion, and a valve-pressing section extending from the connecting section for pressing against at least part of the leaflet of the atrioventricular valve.

In a preferred embodiment, the first blocking portion has a proximal end face with an opening, the support extends out of the opening, the connecting section of the second blocking portion extends upwardly from the end face of the first blocking portion, and a portion of the connecting section is in contact with a side face of the support.

In a preferred embodiment, the second blocking portion extends from the end of the first blocking portion in the Y-direction by a length of between 1mm and 15mm, and at least a portion of the flap section extends obliquely downward.

In a preferred embodiment, in the X direction, the width of the first blocking portion is greater than the width of the connecting section, the width of the flap section is greater than the width of the connecting section, and a shape formed by thickening and then thickening is formed among the first blocking portion, the connecting section and the flap section.

In a preferred embodiment, the first blocking portion and the second blocking portion are hollow respectively, and the second blocking portion is integrally formed with the first blocking portion, or after the second blocking portion is partially formed with the first blocking portion, the second blocking portion is connected to the first blocking portion through a connecting piece.

In a preferred embodiment, in the XZ plane, the first blocking portion has two oppositely disposed clip receiving portions for cooperating with the pair of clips to hold the leaflet, the first blocking portion being in a natural expanded state when the angle between the pair of clips is 45 degrees, and the outer contours of the two clip receiving portions being in contact with the pair of clips, respectively.

In a preferred embodiment, the second blocking portion is exposed beyond opposite sides of the pair of clips in the Y-direction, and at least a portion of the second blocking portion extends obliquely downward.

In a preferred embodiment, a tether is attached to a portion of the second blocking portion that is exposed beyond the pair of clips.

In a preferred embodiment, the atrioventricular valve clamping device is delivered to the atrioventricular valve via a catheter, a portion of the second blocking portion depending from one side of the first blocking portion when the atrioventricular valve clamping device is received in the catheter.

In a preferred embodiment, the device further comprises a cover film, and the first blocking portion, the second blocking portion and the tether are covered by the cover film.

In a preferred embodiment, the first blocking portion has a proximally located end face with an opening, the support is below or flush with the opening, the second blocking portion extends outwardly from a side of the first blocking portion, and at least a portion of the second blocking portion is flush with the first blocking portion at the end face.

In a second aspect, the present invention provides an atrioventricular valve pinching apparatus for use in or adjacent to an atrioventricular valve interface region, comprising:

a support;

the blocking piece is sleeved on the supporting piece; and

A pair of clamping members arranged outside the blocking member and capable of being unfolded or closed relative to the blocking member,

The occluding component has a portion that is symmetrical with respect to the supporting component and an portion that is asymmetrical with respect to the supporting component, at least a portion of the asymmetrical portion being for pressing against tissue in the atrioventricular valve interface.

In a preferred embodiment, at least a portion of the asymmetric portion is higher than the symmetric portion.

The atrioventricular valve clamping device provided by the invention has the blocking piece between the pair of clamping pieces, the blocking piece is provided with the asymmetric part in the Y direction, the asymmetric part forms an eccentric structure, the part of the eccentric structure, which is close to the pair of clamping pieces, can block the leakage opening at the edge of the clamping position, and the part of the eccentric structure, which is far away from the pair of clamping pieces, can be pressed on the prolapsed valve leaf, so that the prolapsed valve leaf can not float too far to cause the leakage opening in the cardiac cycle because of the lengthy tendon rope.

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 diagram of the structure of the mitral valve and tricuspid valve.

Fig. 2 is a schematic plan view of the mitral valve of fig. 1.

Fig. 3 is a schematic perspective view of an atrioventricular valve clamping device according to a first embodiment of the invention.

Fig. 4 is another angular perspective view of the atrioventricular valve clamping device of fig. 3.

Fig. 5 is a schematic front view of a closure member of the atrioventricular valve clamping device of fig. 3.

Fig. 6 is a schematic top view of the closure of fig. 5.

Fig. 7 is a schematic front view of a closure provided in a variant embodiment.

Fig. 8 is a schematic top view of the closure of fig. 7.

Fig. 9 is a schematic front view of a pair of clamping members of the atrioventricular valve clamping device of fig. 4 relatively closed to an angle of about 20 degrees.

Fig. 10 is a schematic front view of a pair of clamping members of the atrioventricular valve clamping device of fig. 4 relatively deployed to a maximum included angle of about 300 degrees.

Fig. 11 is a side view schematic of the atrioventricular valve clamping device of fig. 10.

Fig. 12 is a schematic view of the atrioventricular valve clamp device of fig. 4 as applied to a regurgitation case of leaflet prolapse adjacent a commissure area of the atrioventricular valve.

Fig. 13 is an enlarged partial schematic view of the gripping leaflet and the pressure-holding prolapsed leaflet of the atrioventricular valve clamping device of fig. 12.

Fig. 14 is a schematic view of the atrioventricular valve clamp device of fig. 4 with a tether attached to a second occlusion.

Fig. 15 is a schematic view of the atrioventricular valve clamp device of fig. 4 mounted at the distal end of a delivery catheter as it is delivered through the catheter.

Fig. 16 is a schematic view of the atrioventricular valve clamp device of fig. 15 retracted into the introducer sheath with the delivery catheter.

Fig. 17 is a schematic view of the first and second occlusion portions of the atrioventricular valve clamp device of fig. 14 covered with a covering film.

Fig. 18 is a schematic view of a closure member of an atrioventricular valve pinching device according to a second embodiment of the present invention.

Fig. 19 is a schematic view of a closure member of a atrioventricular valve pinching apparatus provided in a third embodiment of the invention.

Fig. 20 is a schematic view of the second blocking portion of fig. 19 after being connected to the first blocking portion.

Fig. 21 is a schematic view of a closure member of a atrioventricular valve pinching apparatus according to a fourth embodiment of the present invention.

Fig. 22 is a schematic view of the second occlusion of fig. 21 after attachment to the first occlusion.

Fig. 23 is a perspective view of a ventricular valve clamping device according to a fifth embodiment of the invention when a pair of clamping members are opened.

Fig. 24 is a schematic perspective view of the atrioventricular valve clamp device of fig. 23 when a pair of clamp members are closed.

Fig. 25 is a schematic view of the regurgitation of the central region of the atrioventricular valve.

Fig. 26 is a schematic view of the atrioventricular valve clamping device of fig. 23 as applied to the central region of the atrioventricular valve of fig. 25 for treating regurgitation.

Fig. 27 is a schematic perspective view of an atrioventricular valve clamping device according to a sixth embodiment of the present invention.

Fig. 28 is another angular and relatively closed perspective view of the atrioventricular valve clamping device of fig. 27.

Fig. 29 is a schematic perspective view of the occluding grid of fig. 28.

Fig. 30 is a schematic side view of the occluding grid of fig. 29.

Fig. 31 is a schematic top view of the occluding grid of fig. 30.

Fig. 32 is a partial schematic view of a delivery device of a transcatheter atrioventricular valve repair system according to an embodiment of the present invention.

FIG. 33 is a schematic diagram of a transcatheter atrioventricular valve repair system according to an embodiment of the present invention, ready to perform repair of a mitral valve leaflet.

Fig. 34 is a schematic view of the atrioventricular valve clamping device of fig. 33 extended into a ventricle ready to clamp a leaflet.

Fig. 35 is a schematic view of the atrioventricular clamping device of fig. 34 closed to hold the leaflets apart from the delivery device.

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 atrioventricular valve clamping device is suitable for performing reflux treatment on atrioventricular valves, such as mitral valve and tricuspid valve, and is particularly suitable for reflux treatment of atrioventricular valve juncture areas.

Example 1

Referring to fig. 3 to 6, an atrioventricular valve clamping device 100 according to a first embodiment of the present invention mainly includes a support member 110, a blocking member 120 and a pair of clamping members 130.

For clarity and convenience of description, the following directions are defined: the center axis direction O-O of the supporter 110, that is, the center axis direction of the supporter 110 is the Z direction, the direction parallel to the width of the nip 130 and perpendicular to the Z direction is the Y direction, and the direction perpendicular to the Z direction and perpendicular to the Y direction is the X direction. The XY plane refers to a plane perpendicular to the Z direction and defined by a straight line extending in the X direction and a straight line extending in the Y direction intersecting the straight line, and it is understood that there may be a plurality of XY planes, and a plurality of XY planes may be arranged in parallel in the Z direction. The XZ plane refers to a plane perpendicular to the Y direction and defined by a straight line extending in the X direction and a straight line extending in the Z direction intersecting the straight line, and it is understood that there may be a plurality of XZ planes, and the plurality of XZ planes may be arranged in parallel in the Y direction. The YZ plane refers to a plane perpendicular to the X direction and defined by a straight line extending in the Y direction and a straight line extending in the Z direction intersecting the straight line, and it is understood that there may be a plurality of YZ planes, and the plurality of YZ planes may be arranged in parallel in the X direction.

The support member 110 has a certain axial length, i.e. a Z-direction length, the blocking member 120 is sleeved on the support member 110 along the Z-direction, one end of the blocking member 120 is fixed on the support member 110 through a collar 110a, and the other end has an opening 120a. The pair of clamping members 130 are provided on the outer side of the blocking member 120 and can be opened or closed with respect to the blocking member 120. The pair of clamping members 130 may be relatively unfolded such that a maximum included angle between the pair of clamping members 130 is about 300 degrees (see fig. 10-11). The pair of clamping members 130 may be relatively closed such that the angle between the pair of clamping members 130 is approximately 0 degrees to facilitate delivery into a patient's body within a catheter, or may be relatively closed to about 10 degrees, or about 20 degrees when clamping leaflets of an atrioventricular valve (see fig. 9).

The plugging member 120 has elasticity and a hollow three-dimensional shape, and comprises two clamping parts 121 oppositely arranged in the X direction and two end parts oppositely arranged in the Y direction. In this embodiment, the plugging member 120 is a hollow three-dimensional mesh structure, which is preferably a three-dimensional mesh structure formed by weaving wires with a shape memory function or cutting tubes, for example, super-elastic materials such as nitinol wires, and the mesh density of different regions can be designed according to requirements. The occluding component 120 may collapse when subjected to an external force, such as the pressure of a pair of clamping components 130 (see figure 9); and naturally expands to restore to the maximum extent of deployment without external forces (see fig. 10-11).

At least a portion of the occluding member 120 is positioned between the pair of clamping members 130 such that when the pair of clamping members 130 clamp a pair of leaflets of a housing valve, there is a blood occluding effect on the space between the pair of clamping members 130.

The blocking member 120 may be formed from two parts, including, for example, a first blocking portion 122 and a second blocking portion 124, the first blocking portion 122 being located between the pair of clamping members 130, and the second blocking portion 124 extending from the first blocking portion 122. At least a portion of the second blocking portion 124 is exposed outside the pair of clamping members 130 in the Y-direction.

In this embodiment, the first blocking portion 122 and the second blocking portion 124 are integrally formed, and the second blocking portion 124 extends from the first blocking portion 122 only to one side of the pair of clamping members 130 (see fig. 3). The portion of the second blocking portion 124 exposed to the outside of the pair of clips 130 in the Y direction may be one end portion of the entire blocking member 120 in the Y direction, and the other end portion of the entire blocking member 120 in the Y direction may be one end portion of the first blocking portion 122 in the Y direction, so that the second blocking portion 124 also constitutes an asymmetric portion, i.e., asymmetric with respect to the supporting member 110.

The end of the first blocking portion 122 in the Y direction may or may not extend beyond the pair of clamping members 130. The end of the first blocking portion 122 in the Y-direction may be gently shaped or may have a pointed end, and in particular, the overall shape of the first blocking portion 122 may be a drum-ball shape, an olive shape, a shuttle shape, a diamond shape, a straight cylinder shape, or the like, and may be substantially symmetrical with respect to the support 110, for example, symmetrical with respect to the support 110 from the Y-direction. In this embodiment, the first blocking portion 122 has a drum shape, and its end in the Y direction is gentle, has no tip, and does not exceed the pair of clamping members 130. In other embodiments, referring to fig. 7-8, the first blocking portion 122e is approximately cylindrical, and the first blocking portion 124f is integrally connected to the first blocking portion 122e and extends from the first blocking portion 122 e. The straight cylinder is smaller in size and is suitable for a smaller-sized atrioventricular valve clamping device.

The two holding and clamping parts 121 are ends of the first plugging part 122 in the X direction, and preferably, when the included angle between the pair of clamping pieces 130 is 45 degrees, the first plugging part 122 is in a natural expansion state, and the outer contour of the two holding and clamping parts 121 just contacts with the pair of clamping pieces 130, which is designed for the shape and the size of the first plugging part 122 in the natural state. At this point, the pair of clasps 130 may continue to close relatively until they close relatively to within 20 degrees of each other, resulting in a significant improvement in regurgitation of the atrioventricular valve. In general, 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 can close at a larger clip angle, avoiding excessive stress on 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 smaller clamp angle to provide a greater clamping force to the leaflets.

The two clip bearing portions 121 can cooperate with the pair of clips 130 to grip the leaflet, and the two clip bearing portions 121 provide an adjustable and adaptable support force when the pair of clips 130 are relatively closed, thereby forming a pull on the leaflet. The two clip bearing portions 121 can adaptively deform to accommodate gaps between different leaflets, thereby adjusting the extent to which the atrioventricular valve clamping device 100 pulls on the leaflets.

Referring to fig. 3 and 6 together, in the present embodiment, the first blocking portion 122 has a proximal end surface 122a, the opening 120a of the entire blocking member 120 is opened on the end surface 122a, the supporting member 110 extends out of the opening 120a, and the second blocking portion 124 has a connecting section 124a connected to the first blocking portion 122, and a flap section 124b extending from the connecting section 124 a.

The second blocking portion 124 may be higher than the first blocking portion 122 or partially higher than the first blocking portion 122 as viewed in the Z-direction. In this embodiment, the connection section 124a extends upward from the end face 122a of the first blocking portion 122, so that the connection section 124a is higher than the first blocking portion 122. The flap section 124b extends outwardly from the connecting section 124a as viewed in the Y-direction.

Preferably, the connecting section 124a extends obliquely upward from the end face 122a of the first blocking portion 122, and the flap section 124b extends slightly downward from the connecting section 124 a. A portion of the flap segment 124b may be above the first occlusion 122 and a portion of the flap segment 124b may be below the first occlusion 122. The valve pressing section 124b is configured to contact at least part of the leaflets of the atrioventricular valve, the shape of the valve pressing section 124b is not limited, the Z direction is still the height in fig. 3, the Y direction is the length, the X direction is the width, which is preferably a three-dimensional shape with unequal length and width, and the width of the valve pressing section 124b may be greater than the width of the connecting section 124 a. Referring to fig. 5, as the flap segment 124b extends outwardly, the entire second blocking portion extends from the end of the first blocking portion 122 in the Y-direction by a length D between 1mm and 15 mm.

As seen from the X direction, referring to fig. 6, the width W1 of the first blocking portion 122 is greater than the width W2 of the connecting section 124a, the width W3 of the flap section 124b is greater than the width W2 of the connecting section 124a, and the first blocking portion 122, the connecting section 124a and the flap section 124b form a shape that is formed by tapering and then thickening, i.e. the connecting section 124a forms a waist.

Preferably, a portion of the connecting segment 124a contacts the side of the support member 110 such that when the flap segment 124b is pushed up against the second blocking portion 124 by the flap She Piaodong, the support member 110 can provide a certain bearing barrier to the connecting segment 124a of the second blocking portion 124 so that the second blocking portion 124 does not fly too far. Moreover, due to the support of the support member 110, the deformation (dimensional change) of the connecting section 124a and the flap section 124b of the second blocking portion 124 when subjected to a force can be minimized.

Referring to fig. 12-13, in the case of regurgitation where the atrioventricular valve clamping device 100 is used to treat leaflet prolapse adjacent the commissure area of the atrioventricular valve, for example, the mitral valve, the pair of clamping members 130 of the atrioventricular valve clamping device 100 are preferably clamped at or adjacent to the anterior leaflet L1 and the posterior She Jiao commissure area E, and the valve pressing segment 124b of the second occluding portion 124 is pressed against the leaflet, such as leaflet P, of the mitral valve prolapse. The portion of the second blocking portion 124 near the pair of clamping members 130 can block blood reflux at the edge of the clamping portion, and the portion of the second blocking portion 124 far away from the pair of clamping members 130 presses and holds the prolapsed leaflet P at the junction, so that the prolapsed leaflet P at the junction cannot float far to cause leakage due to lengthy chordae in the cardiac cycle.

In actual treatment, the portion of the pressure segment 124b adjacent to the pair of clips 130, together with the connecting segment 124a, may have the effect of sealing the leakage of the edge at the clip, while the portion of the pressure segment 124b remote from the pair of clips 130 presses against the prolapsed leaflet.

Referring to fig. 14, the second blocking portion 124 of the above-mentioned atrioventricular clamping device 100 is connected with a tether 125, one end of the tether 125 is connected to a middle portion or a distal end of the second blocking portion 124, and the other end can extend into the collar 110a (see fig. 4) and be connected to the supporting member 110. The tether 125 may prevent the second occluding portion 124 from drifting too far when pushed by the upward drifting of the leaflets of the atrioventricular valve, especially because the prolapsed leaflets P tend to drift farther upward due to the lengthy chordae tendineae, and the tether 125 may pull the second occluding portion 124 from drifting too far. The tether 125 may have a certain elasticity, so that the second blocking portion 124 may return to the initial position according to the up-and-down movement of the leaflet of the heart cycle.

Referring to fig. 15-16, the atrioventricular valve clamping device 100 is delivered to the atrioventricular valve of the heart via a multi-layered catheter of a delivery device, the support member 110 is detachably connected to a delivery catheter 510 of the delivery device, the atrioventricular valve clamping device 100 is accommodated in an introducer sheath 530 when delivered, the pair of clamping members 130 are relatively closed to a minimum extent, and the first blocking portion 122 is compressed between the pair of clamping members 130; or the implantation position is not suitable during the operation, and when the atrioventricular clamping device 100 needs to be retracted, the delivery catheter 510 and the second blocking portion 124 together can hang on one side of the first blocking portion 122 and the pair of clamping members 130 because the second blocking portion 124 extends and is deformable when the guiding sheath 530 is retracted. The outer surface of the second blocking portion 124 may be arc-shaped to fit the inner wall of the guiding sheath 530, so as to reduce hooking.

The above-mentioned three-dimensional net-shaped occluding member 120 may be covered with a biocompatible film on the outside and/or inside, which may serve as a flow blocking film to enhance the reflux treatment effect and prevent thrombus from being formed by blood entering the occluding member 120 on the one hand, and may provide the atrioventricular valve clamping device 100 with a stronger biocompatibility 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.

Referring to fig. 17, in the present embodiment, the outer surfaces of the first blocking portion 122 and the second blocking portion 124 and the upper tether 125 are covered under the same covering film 127, and other components of the atrioventricular clamping device 100, such as a pair of clamping members 130, may also be covered with the covering film 131, and the covering films between the components may be different.

Referring again to fig. 3-4, in this embodiment, the atrioventricular valve clamping device 100 further includes a driving member for driving the clamping member 130 to open or close relative to the occluding member 120. Specifically, the driving member is respectively connected to each of the clamping members 130 to drive each of the clamping members 130 to rotate about the first blocking portion 122 of the blocking member 120, so that the clamping members 130 are close to or far from the first blocking portion 122. In the delivery state, the driving member drives the clamping member 130 to close around the blocking member 120, thereby reducing the outer diameter of the atrioventricular valve clamping device 100, facilitating delivery; after the atrioventricular valve clamping device 100 is deployed in the heart, the driving member drives the clamping member 130 to clamp the leaflet between the clamping member 130 and the first occlusion portion 122, thereby achieving leaflet clamping.

In a preferred implementation of the present embodiment, the atrioventricular valve clamping device 100 further comprises a gripping member comprising two gripping arms 151 symmetrically arranged with respect to the occluding member 120. A gripping member, such as gripping arm 151, is disposed between the clamp member 130 and the blocking member 120 and is deployable or closeable relative to the first blocking portion 122. The grasping arms 151 cooperate with the clip 130 to perform a leaflet capturing function.

In the delivery state, the gripping members are at least partially received in the inner surface of the clip 130, i.e., the gripping arms 151 are at least partially received in the inner surface of the clip 130, thereby reducing the outer diameter of the atrioventricular valve clip device 100, facilitating delivery. After the clamping member 130 cooperates with the gripping arms 151 to capture the leaflet, the gripping arms 151 clamp the leaflet She Yaru into the inner surface of the clamping member 130, which can increase the contact area of the clamping member 130 with the leaflet, increasing the clamping force against the leaflet.

In this embodiment, the supporting member 110 integrally extends from a base 160, and each of the clamping members 130 is rotatably connected to the base 160. Each of the clips 130 are pivotally connected together at a base 160, the pivot constituting a pivot point 132. The end of the first blocking portion 122 near the base 160 is fixed to the support member 110 by a collar 110a and spaced apart from the base 160 in the Z-direction, and each of the clamping members 130 is engaged with each other by the driving member to be opened and closed around the first blocking portion 122 with the pivot point 132 as a rotation center.

In this embodiment, the driving member includes: a drive shaft 141, a base 142, and two links 143. One end of each connecting rod 143 is rotatably connected with the clamping member 130, and the other end is rotatably connected with the base 142; one end of the driving shaft 141 is fixedly connected with the base 142, and the other end is movably installed in the base 160. Specifically, one end of each link 143 is connected to the clamping member 130, and the other end is pivotally connected to the base 142, i.e., each clamping member 130 is pivotally connected to the base 142 via a link 143 on a corresponding side. The driving shaft 141 movably passes through the base 160, and when the driving shaft 141 moves in the Z direction relative to the base 160, the driving rod 143 is driven to rotate and drive the two clamping members 130 to open or close with the pivot point 132 as the rotation center.

Specifically, the connecting rods 143 are disposed in a one-to-one correspondence with the disposition of the clamping members 130, one end of each connecting rod 143 is rotatably connected to the base 142 by a pivot such as a pin, and the other end is connected to the corresponding clamping member 130, and each clamping member 130 is rotatably connected to the base 160 by a pivot such as a pin. When the drive shaft 141 is moved distally in the Z-direction relative to the base 160, the link 143 is moved, and the clamp 130 is rotated about the pivot point 132 to open relative to the base 160 by the pull of the link 143. When drive shaft 141 is moved proximally in an axial direction relative to base 160, link 143 urges clamp 130 to rotate about pivot point 132 to close relative to base 160. The shape of the base 142 may be any configuration such as a hemisphere, a spherical cap, or a bullet head to facilitate pushing the atrioventricular valve clamping device 100 in the body. The driving shaft 141 and the base 142 may be integrally formed or may be non-integrally formed. To ensure safety after implantation, the drive shaft 141 and the base 142 are made of biocompatible materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy, or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.

Referring again to fig. 3-4, the atrioventricular clamping device 100 preferably further includes a locking portion 170 disposed in the base 160, the locking portion 170 limiting relative movement of the drive shaft 141 and the base 160. In the delivery state, the locking portion 170 limits the relative movement of the drive shaft 141 and the base 160, thereby ensuring that the clamping member 130 remains in a closed state relative to the blocking member 120 and the supporting member 110 at all times, avoiding accidental deployment of the clamping member 130; after reaching the vicinity of the tricuspid valve or mitral valve, the restraint of the driving shaft 141 by the locking part 170 is unlocked through the unlocking wire 171, so that the clamping member 130 can be driven by the driving member to spread and support the valve leaflet relative to the blocking member 120 and the supporting member 110; after clamping the leaflet, the locking part 170 again restricts the relative movement of the driving shaft 141 and the base 160, thereby maintaining the clamped state of the leaflet. Any suitable structure of the locking portion may be used, and will not be described here.

Example two

Referring to fig. 18, in the plugging member of the atrioventricular valve clamping device according to the second embodiment of the present invention, the connecting section 124a of the second plugging portion 124c does not extend completely obliquely upward from the end surface of the first plugging portion 122c, but extends partially obliquely upward from the side surface below the end surface of the first plugging portion 122c. The second blocking portion 124c may be still integrally formed with the first blocking portion 122c, and a portion of the second blocking portion 124c is higher than the first blocking portion 122c.

Example III

Referring to fig. 19-20, in the plugging member of the atrioventricular valve clamping device according to the third embodiment of the present invention, the second plugging portion 124d and the first plugging portion 122d are separately formed and respectively have a hollow elastic net shape. The edge of the second blocking portion 124d adjacent to the first blocking portion 122d may be sewn to the first blocking portion 122d by a connecting member 128, such as a loop or stitch.

Example IV

Referring to fig. 21-22, the second blocking portion 124e has a longer connecting section 124f, which can extend into the first blocking portion 122d through the opening of the upper end surface of the first blocking portion 122d, and then the connecting section 124f is connected to the first blocking portion 122d through the connecting member 128.

Example five

Referring to fig. 23-24, a fifth embodiment of the present invention provides an atrioventricular valve clamping device 200, wherein the atrioventricular valve clamping device 200 is different from the atrioventricular valve clamping device 100 described above in that: the second blocking portion 126 of the atrioventricular valve clamping device 200 is exposed at both ends of the first blocking portion 122 in the Y direction and is also exposed outside of the opposite sides of the pair of clamping members 130, and the second blocking portion 126 is higher than the first blocking portion 122, and the second blocking portion 126 may not need the above-mentioned waist-shaped connecting section 124a (see fig. 5). The second blocking portion 126 is located above the first blocking portion 122, and an end surface of the second blocking portion 126 located at the proximal end may be provided with an opening penetrating through the first blocking portion 122, and the support 110 (see fig. 3) may be located below the opening.

The first blocking portion 122 may be disposed in a central symmetry with respect to the support 110, and the second blocking portion 126 may be asymmetric with respect to the support 110. Specifically, the second blocking portion 126 includes two end portions 126a, 126b exposing both sides of the pair of sandwiching pieces 130, the end portions 126a being exposed longer and the end portions 126b being exposed shorter. At least a portion of the end 126a extends downwardly and at least a portion of the end 126a is adapted to bear against a prolapsed leaflet.

Referring to fig. 25-26, one type of patient with mitral regurgitation in the heart is degenerative mitral regurgitation (DEGENERATIVE MITRAL Regurgitation, DMR), where the anterior leaflet L1 of the mitral valve of the DMR patient is prolapsed, the posterior leaflet L2 is short, the atrioventricular clamping device 200 can be clamped in the central region of the atrioventricular valve, the exposed longer end 126a of the second sealing portion 126 can be pressed against the anterior leaflet L1, and because the posterior leaflet L2 is pulled toward the anterior leaflet L1, a portion of the end 126a can also be pressed against the posterior leaflet L2. The end 126a, being the portion near the pair of clamps, can be used to close the leak at the edge of the clamp, due to its shorter length.

Example six

Referring to fig. 27-31, a sixth embodiment of the present invention provides an atrioventricular valve clamping device 300, wherein the atrioventricular valve clamping device 300 is different from the atrioventricular valve clamping device 100 described above in that: the second blocking portion 128 of the atrioventricular clamping device 300 extends outwardly from a side of the first blocking portion 127, the first blocking portion 127 having a proximally located end face 127a with an opening 127b, the support member 110 being lower than the opening 127a or flush with the opening 127 a.

The proximal end face 128a of the second blocking portion 128 may be substantially flush with the first blocking portion 127 at the end face 127 a. The first blocking portion 127 has a fixing section 127c at a lower, distal end thereof for fixing to the support member 110, and the fixing section 127c may be fitted over the support member 110 by a collar 110a (see fig. 5). The second blocking portion 128 extends outward from the upper side of the fixing section 127c, and the height of the second blocking portion 128 in the Z-direction is substantially the same as that of the first blocking portion 127 except for the fixing section 127 c.

The width of the second blocking portion 128 is larger than the width of the first blocking portion 127 as viewed in the X-direction. The first blocking portion 127 is substantially symmetrical with respect to the support 110 as viewed in the Y direction; the second blocking portion 128 is not symmetrical about the support 110. The first blocking portion 127 and the second blocking portion 128 are continuously formed like a figure 8 in the Z direction, but are not symmetrical in the up-down size.

The second blocking portion 128 forms an asymmetric portion in the Y direction, i.e. forms an eccentric structure, and the portion of the eccentric structure near the pair of clamping members 130 can block the leakage opening at the edge of the clamping portion, and the portion of the eccentric structure far from the pair of clamping members 130 can be used to press against the prolapsed leaflet.

It is to be understood that the above-described atrioventricular valve clamping device 300 can be applied at or adjacent to the interface area of the atrioventricular valve, or at a central area with prolapse, and that the applications of the above-described atrioventricular valve clamping devices 100, 200 and 300 can be interchanged.

In summary, the atrioventricular valve clamping device provided by the invention has the blocking piece 120 between the pair of clamping pieces 130, the blocking piece 120 is provided with an asymmetric part in the Y direction, the asymmetric part forms an eccentric structure, the part of the eccentric structure, which is close to the pair of clamping pieces 130, can block the leakage opening at the edge of the clamping position, and the part of the eccentric structure, which is far away from the pair of clamping pieces, can be pressed on the prolapsed valve leaf, so that the prolapsed valve leaf can not float too far to cause the leakage opening in the cardiac cycle because of long tendon ropes.

Referring to fig. 15 and 32 together, the present application further provides a valve clamping system, including the above-mentioned atrioventricular valve clamping device 100, and a delivery device 500, wherein the delivery device 500 includes: a delivery catheter 510 having an axial length and a mandrel 520 movably mounted through delivery catheter 510, the delivery catheter 510 being removably coupled to the support member 110, the mandrel 520 being adapted to be removably coupled to a driver of the atrioventricular valve clamp device 100 for driving the deployment and closure of the clamp 130. The support member 110 is further provided with an axial (i.e., Z-direction) through-hole-like penetration passage to be in interlocking engagement with the driving member and the conveying device 500. The pipe wall of the pipe body of the supporting member 110 is provided with a clutch connection structure 110b for detachably connecting with the conveying device 500. For example, the end of the delivery tube 510 is provided with a complementary connector 510a, and after the connector 510a is clamped into the clutch connection structure 110b, the delivery device 500 is clamped with the support member 110, so that the atrioventricular valve clamping device 100 can be delivered, and when the connector 510a is separated from the clutch connection structure 110b, the delivery device 500 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 driving shaft 141 of the driving member is provided with an external thread, and the spindle 520 is connected to the driving shaft 141 by the thread, so that the axial movement of the driving shaft 141 can be controlled outside the patient through the spindle 520. 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.

The coupling head 510a and the clutch connection structure 110b are hollow, and when assembling, the mandrel 520 of the delivery device 500 is inserted into the delivery tube 510 until the mandrel 520 is inserted into the coupling head 510a, the mandrel is screwed with the driving shaft 141, and the coupling head 510a is clamped into the clutch connection structure 110b, so that the coupling head 510a is connected with the clutch connection structure 110b, that is, the atrioventricular clamping device 100 is connected with the delivery device 500. When the mandrel 520 is withdrawn from the coupling head 510a and the clutch connection structure 110b, the coupling head 510a and the clutch connection structure 110b lose the force of the mandrel 520, so that they can be automatically separated from each other, and the atrioventricular clamping device 100 and the delivery device 500 are disconnected. The connection head 510a may be made of nickel titanium or other material having a certain hardness and elasticity. The delivery catheter 510 may employ a multi-layer composite tubing. The mandrel 520 may be made of stainless steel material or nitinol material.

The support 110 has a through hole as a penetration passage of the driving shaft 141, and the driving shaft 141 is slidably penetrated in the penetration passage of the support 110 in the axial direction (i.e., Z direction). After the clamping member 130 and the gripping member cooperate and capture the leaflet, the mandrel 520 drives the drive shaft 141 to move in the Z direction to drive the clamping member 130 to close relative to the support member 110, such that the atrioventricular valve clamping device 100 is in a closed state and is dropped below the valve. The connection between the mandrel 520 and the drive shaft 141 can then be released, the mandrel is retracted from the coupling head 510a, and the coupling head 510a is separated from the clutch connection 110b of the support 110, thereby releasing the atrioventricular valve clamping device 100 and the delivery device 500.

Referring to fig. 3-4, 12 and 33-35, the following will take the repair procedure of the mitral valve interface as an example, and illustrate the operation method of the atrioventricular valve clamping system of the present invention, which mainly comprises the following steps:

The distal end of delivery catheter 510 of delivery device 500 and atrioventricular valve clasper device 100 are passed through the inferior vena cava-right atrium by transfemoral venipuncture, and then the atrial septum is punctured to the left atrium; the atrioventricular valve clamping device 100 is then controlled to approach the mitral valve at the intersection E of the anterior and posterior leaflets (see fig. 12); unlocking the locking portion 170 in the base 160, pushing the mandrel 520 and the drive shaft 141 distally, driving the clip 130 open relative to the support 110 and the occluding member 120, adjusting the orientation of the clip 130, at which point the relative positions of the clip 130 and the anterior and posterior leaflets of the mitral valve can be viewed by a medical imaging or developing device such that the clip 130 is generally perpendicular to the free edges of the anterior and posterior leaflets, and the second occluding portion 124 is aligned with the prolapsed leaflet P (see fig. 12); pushing the atrioventricular valve clamping device 100 to the left ventricle through the conveying device 200, placing the atrioventricular valve clamping device 100 under the front leaf and the rear leaf, and continuously opening the two clamping pieces 130 to the capturing position; meanwhile, each gripping arm 151 is controlled to be attached to the outer surface of the plugging member 120, and at this time, a leaflet accommodating space is formed between each gripping arm 151 and a corresponding clamping member 130.

Then, simultaneously or sequentially releasing the two gripping arms 151, wherein the two gripping arms 151 and the two clamping pieces 130 are matched to catch the front leaf and the rear leaf; the mandrel 520 and drive shaft 141 are then pulled proximally to drive the two jaws 130 closed such that the anterior and posterior leaflet at E (see fig. 12) are clamped between the first occluding portion 122 of the occluding component 120 and the two jaws 130, while the second occluding portion 124 is also pressed against just a portion of the leaflet, such as leaflet P, at the interface.

Finally, the threaded connection between the mandrel 520 and the drive shaft 141 is released, and the mandrel 520 is retracted, the connector 510a and the clutch connection structure 110b are automatically separated, the connection between the atrioventricular valve clamping device 100 and the delivery device 500 is released, and then the delivery device 500 is withdrawn from the body, resulting in the implanted state as shown in fig. 35.

After the atrioventricular valve clamping device 100 is implanted, the first blocking part 122 of the elastic blocking piece 120 is filled between the clamped front leaf and the clamped rear leaf, so that on one hand, gaps among the valve leaves are blocked to reduce reflux, on the other hand, radial supporting force is provided for the valve leaves, and a buffer effect is provided for the beating valve leaves, so that the traction degree of the atrioventricular valve clamping device 100 on the valve leaves can be adjusted to avoid damage to the valve leaves; the second occluding portion 124 is pressed against a portion of the leaflet, such as leaflet P, at the interface so that the prolapsed leaflet P does not leak during the cardiac cycle due to lengthy migration of chordae from the distal position.

The atrioventricular valve clamping device 100 is suitable for use in mitral valve clamping, but may be used in tricuspid valve clamping, where the path of intervention is different, such as femoral vein-inferior vena cava-right atrium-right ventricle, or transapical approach.

In addition, the atrioventricular valve clamping device 100 of this embodiment is capable of achieving a dynamic balance of the state of the valve She Gage: when the leaflet applies a larger pulling force to the atrioventricular valve clamping device 100, the clamping angle of the clamping arm 151 and the clamping member 130 can be adjusted within a certain range due to the elastic action of the first blocking portion 122 of the blocking member 120, and the leaflet is prevented from being damaged due to the excessive pulling force.

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

1. The atrioventricular valve clamping device is characterized by comprising a supporting piece, a plugging piece and a pair of clamping pieces;

2. The atrioventricular valve clamping device of claim 1, wherein the blocking member comprises a first blocking portion and a second blocking portion, the first blocking portion being located between the pair of clamping members, the second blocking portion extending from the first blocking portion, and at least a portion of the second blocking portion being exposed beyond the pair of clamping members in the Y-direction.

3. The atrioventricular valve clamping device of claim 2, wherein the second blocking portion extends from the first blocking portion only to one side of the pair of clamping members.

4. A atrioventricular valve clamping device according to claim 3, wherein the second blocking part comprises a connecting section connected to the first blocking part, and a valve pressing section extending from the connecting section for pressing against at least part of the leaflets of the atrioventricular valve.

5. The atrioventricular valve clamping device of claim 4, wherein the first occlusion portion has a proximal end face having an opening, the support member extends out of the opening, the connecting section of the second occlusion portion extends upwardly from the end face of the first occlusion portion, and a portion of the connecting section is in contact with a side face of the support member.

6. The atrioventricular valve clamping device of claim 4, wherein the second blocking portion extends from an end of the first blocking portion in the Y-direction by a length of between 1mm and 15mm, and at least a portion of the valve pressing section extends obliquely downward.

7. The atrioventricular valve clamping device of claim 4, wherein in an X-direction, a width of the first blocking portion is greater than a width of the connecting section, a width of the valve pressing section is greater than a width of the connecting section, and a shape formed by tapering and re-thickening is formed among the first blocking portion, the connecting section and the valve pressing section.

8. The atrioventricular valve clamping device of claim 2, wherein the first blocking portion and the second blocking portion are hollow, the second blocking portion is integrally formed with the first blocking portion, or the second blocking portion is connected to the first blocking portion through a connecting member after the second blocking portion is partially formed with the first blocking portion.

9. The atrioventricular valve clamping device according to claim 2, wherein on the XZ plane, the first blocking portion has two oppositely disposed holding clamp portions for cooperating with the pair of clamping members to clamp the valve leaflet, the first blocking portion is in a natural expanded state when an included angle between the pair of clamping members is 45 degrees, and outer contours of the two holding clamp portions are respectively in contact with the pair of clamping members.

10. The atrioventricular valve clamp device of claim 2, wherein the second blocking portion is exposed beyond opposite sides of the pair of clamps in the Y-direction, and at least a portion of the second blocking portion extends obliquely downward.

11. The atrioventricular valve clamp device of claim 2, wherein a tether is attached to a portion of the second occlusion portion that is exposed beyond the pair of clamps.

12. The atrioventricular valve clamping device of claim 2, wherein the atrioventricular valve clamping device is delivered to the atrioventricular valve via a catheter, and wherein a portion of the second blocking portion depends from a side of the first blocking portion when the atrioventricular valve clamping device is received in the catheter.

13. The atrioventricular valve clamping device of claim 11, further comprising a cover membrane, wherein the first occlusion, the second occlusion, and the tether are covered by the cover membrane.

14. A atrioventricular valve clamping device according to claim 3, wherein the first blocking portion has a proximal end face having an opening, the support member is below or flush with the opening, the second blocking portion extends outwardly from a side face of the first blocking portion, and at least a portion of the second blocking portion is flush with the first blocking portion at the end face.

15. A atrioventricular valve pinching apparatus for use in or adjacent to an atrioventricular valve interface region, comprising:

a support;

the blocking piece is sleeved on the supporting piece; and

16. The atrioventricular valve clamping device of claim 15, wherein at least a portion of the asymmetric portion is higher than the symmetric portion.