CN114762636A

CN114762636A - Self-adaptive valve clamping device and valve clamping system

Info

Publication number: CN114762636A
Application number: CN202110265922.5A
Authority: CN
Inventors: 张庭超; 张伟伟; 王泽涛; 郑贤章
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-01-15
Filing date: 2021-03-11
Publication date: 2022-07-19
Also published as: CN215130900U

Abstract

The application discloses a self-adaptive valve clamping device and a valve clamping system. The self-adaptive valve clamping device comprises a supporting part, a hollow adjusting part and a clamping part. The supporting portion includes a first seat and a second seat. The first base is arranged in the adjusting part. The adjustment portion includes opposing first and second ends and a self expanding body positioned between the first and second ends. The first end is movably sleeved outside the second seat body and can move along the axial direction relative to the second seat body, and the second end is suspended in the air. The first base body is closer to the second end of the adjusting portion than the second base body. The clamping part comprises at least two clamp arms, each clamp arm is rotatably connected to the supporting part, the part of the clamp arm in rotating connection is close to the first end of the adjusting part, and the clamp arms rotate around the supporting part to be close to or far away from the adjusting part. This self-adaptation valve clamping device can increase the position that the tong arm rotates to be connected and be close to the space of regulating part department, and the regulating part of this department can adapt to the deformation of leaflet better, avoids causing the damage to the leaflet of this department.

Description

Self-adaptive valve clamping device and valve clamping system

Technical Field

The application relates to the technical field of implanted medical equipment, in particular to a self-adaptive valve clamping device and a valve clamping system comprising the same.

Background

Referring to fig. 1, the mitral valve MV is a one-way valve located between the left atrium LA and the left ventricle LV of the heart, and a normal, healthy mitral valve MV can control blood flow from the left atrium LA to the left ventricle LV while preventing blood flow from the left ventricle LV to the left atrium LA. The mitral valve MV comprises a pair of leaflets, called anterior AML and posterior PML. The anterior AML and posterior PML are fixed to the papillary muscles of the left ventricle LV by chordae tendinae. Normally, when the left ventricle LV of the heart contracts, the edges of the anterior AML and posterior PML are completely apposed to prevent blood from flowing from the left ventricle LV to the left atrium LA. Referring to fig. 2, when the leaflets of the mitral valve MV or their associated structures undergo organic or functional changes, such as the rupture of chordae tendineae, the coaptation of the anterior and posterior leaflets AML and PML of the mitral valve MV is poor, and thus, when the left ventricle LV of the heart contracts, the mitral valve MV does not close completely, causing blood to flow back from the left ventricle LV to the left atrium LA, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

Mitral valve intervention clamping refers to the treatment of mitral regurgitation by using a valve clamping device to draw the anterior and posterior leaflets towards each other through a pair of pivotally connected closable clamping arms, reducing or eliminating the leaflet gap. The existing valve clamping device is additionally provided with an elastic body in two clamp arms, valve leaflets on each side are respectively clamped between one clamp arm and one side of the elastic body, gaps between the clamp arms on two sides are filled through the elastic body, central regurgitation is reduced, and the distance between the valve leaflets is adapted through deformation of the elastic body, so that the drawing degree of the valve leaflets by the clamp arms is adjusted. However, the closer the jawarms are to the jawarm junction when closed, the less space there is. When a leaflet is grasped by the clamp arms, a portion of the leaflet fills and accumulates in the space, thereby affecting the closing of the clamp arms. Meanwhile, if the leaflet filling condition at the position cannot be found in time through medical images, when an operator forcibly closes the clamping device, the clamp arms can damage the leaflet at the position.

Disclosure of Invention

In order to solve the above technical problem or at least partially solve the above technical problem, the present application provides an adaptive valve clamping device and a valve clamping system including the same.

In a first aspect, the present application provides an adaptive valve clamping device comprising:

the supporting part comprises a first seat body and a second seat body connected with the first seat body;

the first seat body is arranged in the adjusting part, the adjusting part comprises a first end and a second end which are opposite, and a self-expanding main body which is positioned between the first end and the second end, the first end of the adjusting part is movably sleeved outside the second seat body and can axially move relative to the second seat body, the second end of the adjusting part is suspended, and the first seat body is close to the second end of the adjusting part compared with the second seat body;

the clamping part comprises at least two clamp arms, each clamp arm is rotatably connected to the supporting part, the part where the clamp arms are rotatably connected is close to the first end of the adjusting part, and the clamp arms rotate around the supporting part so as to be close to or far away from the adjusting part.

In a second aspect, the application provides a valve clamping system, including above-mentioned self-adaptation valve clamping device and conveyor, conveyor including the propelling movement axle that has certain axial length and the dabber of wearing the dress in the propelling movement axle with moving about, the propelling movement axle with the connection can be dismantled to the supporting part, the dabber is used for the drive the tong arm winds the supporting part rotates.

In a third aspect, the application further provides a valve clamping system, which includes the above adaptive valve clamping device and a delivery device, where the delivery device includes a pushing shaft having a certain axial length and a mandrel movably inserted into the pushing shaft, the pushing shaft is detachably connected to the supporting portion, and the mandrel is used to drive the forceps arms to rotate around the supporting portion;

the conveying device further comprises an operating wire, wherein the operating wire penetrates through at least one mesh to enter the cavity of the self-expanding main body and is detachably connected with the first connecting section and the second connecting section.

In the self-adaptation valve clamping device that this application embodiment provided and contain this self-adaptation valve clamping device's valve clamping system, the first end movable sleeve of regulating part is established in the second pedestal outside of supporting part, the second end of regulating part is unsettled and is closer to first pedestal relatively, the regulating part can be for supporting part axial displacement, when the tong arm of clamping part is close to the closed centre gripping leaflet of regulating part, the regulating part is whole to move to first pedestal along the axial, can increase the position that the tong arm rotates the connection and be close to the space of regulating part department, avoid the excessive space of piling up in this department of leaflet. At the closed in-process of clamping portion, this department's regulating part can adapt to the deformation of leaflet better to can adjust clamping portion to the whole tractive of leaflet, make the axial atress of leaflet more balanced, be favorable to clamping portion closed better after grabbing the leaflet, avoid causing the damage to the leaflet of this department.

Drawings

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

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art to obtain other drawings without inventive exercise.

FIG. 1 is a schematic view of a mitral valve in a normal state;

FIG. 2 is a schematic representation of a diseased mitral valve;

fig. 3 is a schematic structural diagram of an adaptive valve clamping device according to a first embodiment of the present application;

fig. 4 is a schematic structural diagram of an adaptive valve clamping device in an open state according to a first embodiment of the present application;

fig. 5 is a schematic structural diagram of an adaptive valve clamping device in a closed state according to a first embodiment of the present application;

FIG. 6 is a schematic view of the combined structure of the adjustment part and the support part in FIG. 4;

FIG. 7 is a schematic view showing the structure of the regulating portion of FIG. 4;

8-10 are different structural schematic diagrams of the regulating part of the first embodiment of the application;

FIG. 11 is another schematic structural view of an adaptive valve clamping device according to the first embodiment of the present application;

fig. 12 is a schematic structural diagram of a supporting portion according to a first embodiment of the present application;

fig. 13 is a schematic structural view of the first seat in fig. 12;

fig. 14 is a schematic structural view of the third seat in fig. 12;

fig. 15 is a schematic view of the connection between the conveying device and the supporting part according to the first embodiment of the present application;

FIG. 16 is an enlarged view of section I of FIG. 15;

FIGS. 17-21 are schematic views of a procedure for anterograde access and repair of a mitral valve via the left atrium using the adaptive valve clamping device of FIG. 4;

fig. 22 and 23 are schematic structural views of a support part and an adjustment part in a second embodiment of the present application;

fig. 24 is a schematic structural view of a support portion according to a second embodiment of the present application;

fig. 25 is another schematic structural diagram of the supporting portion and the adjusting portion according to the second embodiment of the present application;

FIG. 26 is an exploded view of an adjustment part according to a third embodiment of the present application;

fig. 27 is an exploded view of a support part according to a third embodiment of the present application;

fig. 28 is a schematic structural diagram of an adaptive valve clamping device according to the fourth embodiment of the present application;

fig. 29 is another structural schematic view of the adaptive valve clamping device according to the fourth embodiment of the present application;

fig. 30 is a partial schematic structural view of an adaptive valve clamping device according to the fourth embodiment of the present application;

fig. 31 is a schematic structural view of a valve clamping system according to the fourth embodiment of the present application.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without any inventive step are within the scope of protection of the present application.

In the description of the present application, it is to be noted that the terms "upper", "lower", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be configured in a specific orientation, and operate, and thus, should not be construed as limiting the present application. 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 "secured to" 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 through one or more connecting elements.

In the description of the present application, it is noted that, 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; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The above definitions are for convenience only and are not to be construed as limiting the present application. The term "end" as used in the words "proximal", "distal", "one end", "the other end", "distal", "first end", "second end", and the like, is not limited to a tip, end or end of an element, but also includes a portion extending an axial or radial distance from the tip, end or end on the element to which the tip, end or end pertains.

Example one

Referring to fig. 3 to 5, an adaptive valve clamping device 100 according to an embodiment of the present application can be used for mitral valve or tricuspid valve edge-to-edge repair to treat mitral regurgitation or tricuspid regurgitation. To ensure safety of the adaptive valve clipping device 100 after implantation, the entire adaptive valve clipping device 100 is made of a biocompatible material. The use of the adaptive valve clamping device 100 for mitral valve rim-to-rim repair is described in detail below. The operator uses the delivery device 200 to push the adaptive valve clamping device 100 to the mitral valve of the patient, and then remotely operates the adaptive valve clamping device 100 to clamp the anterior leaflet and the posterior leaflet of the mitral valve together. When the leaflets of the mitral valve are aligned edge to edge, the operator can release the connection between the delivery device 200 and the adaptive valve clamping device 100, thereby implanting the adaptive valve clamping device 100 in the patient and securing the anterior leaflet and the posterior leaflet of the mitral valve together to achieve "edge to edge repair" of the mitral valve.

Referring to fig. 6, the adaptive valve clamping device 100 includes a supporting portion 110, a hollow adjusting portion 120 and a clamping portion 130. The supporting portion 110 includes a first base 112 and a second base 114 connected to the first base 112. The first seat 112 is disposed in the adjusting portion 120. The adjustment portion 120 includes opposing first and second ends 122, 124 and a self expanding body 121 positioned between the first and second ends 122, 124. The first end 122 of the adjusting portion 120 is movably sleeved outside the second seat 114 and can move axially relative to the second seat 114, and the second end 124 of the adjusting portion 120 is suspended. The first fastening structure 112 is closer to the second end 124 of the adjusting portion 120 than the second fastening structure 114. The clamping portion 130 includes at least two clamp arms 132, and each clamp arm 132 is rotatably connected to the supporting portion 110. The portion of the jawarm 132 pivotally connected is proximate the first end 122 of the adjustment portion 120 and the jawarm 132 pivots about the support portion 110 to move toward or away from the adjustment portion 120.

In the adaptive valve clamping device 100 of the above embodiment, the first end 122 of the adjusting portion 120 is movably sleeved outside the second seat body 114 of the supporting portion 110, the second end 124 of the adjusting portion 120 is suspended and relatively closer to the first seat body 112, the adjusting portion 120 can move axially relative to the supporting portion 110, when the clamp arm 132 of the clamping portion 130 closes to clamp the valve leaflet near the adjusting portion 120, the adjusting portion 120 moves integrally along the axial direction toward the first seat body 112, the space a where the rotating connection portion of the clamp arm 132 is close to the adjusting portion 120 can be increased, and the valve leaflet is prevented from being excessively accumulated in the space a. In the process of closing the clamping part 130, the adjusting part 120 can better adapt to the deformation of the valve leaflet, so that the integral traction of the clamping part 130 on the valve leaflet can be adjusted, the axial stress of the valve leaflet is more balanced, the clamping part 130 can be closed better after the valve leaflet is grabbed, and the valve leaflet at the position can be prevented from being damaged.

It can be understood that the clamp arm 132 of the clamping portion 130 is rotatably connected to the supporting portion 110, and the first end 122 of the adjusting portion 120 is movably sleeved outside the second seat 114 of the supporting portion 110, i.e. the clamping portion 130 is disposed outside the adjusting portion 120. The clamp arm 132 of the clamping part 130 rotates around the supporting part 110 to approach the adjusting part 120, i.e. the clamping part 130 is closed relative to the adjusting part 120; the clamp arms 132 of the clamping portion 130 are rotated about the support portion 110 away from the adjustment portion 120, i.e., the clamping portion 130 is opened relative to the adjustment portion 120.

The second end 124 of the adjusting portion 120 is suspended and closer to the first seat 112 of the supporting portion 110, and the first seat 112 is disposed in the adjusting portion 120, so that a gap exists between the second end 124 of the adjusting portion 120 and the first seat 112 of the supporting portion 110, which can prevent the second end 124 of the adjusting portion 120 from interfering or winding with the first seat 112 of the supporting portion 110, thereby ensuring the implantation safety of the instrument. The self-expanding body 121 of the adjustment part 120 is deformable in radial and axial directions, and thus the adjustment part 120 includes a natural state and a compressed state. The self-expanding body 121 may be made of a shape memory material. When the clamping part 130 is opened relative to the adjusting part 120, the clamping part 130 is not in contact with the adjusting part 120, and the adjusting part 120 is in a natural state; when the clamping portion 130 is closed relative to the adjusting portion 120, the adjusting portion 120 is radially compressed and axially extends toward the first seat 112 of the supporting portion 110, and is in a compressed state. In the process that the clamping portion 130 is closed relative to the adjusting portion 120, the adjusting portion 120 is gradually radially compressed and axially extends toward the first seat 112 of the supporting portion 110, and the distance between the second end 124 of the adjusting portion 120 and the first seat 112 of the supporting portion 110 is gradually increased. Because the first end 122 of the adjusting portion 120 is movably sleeved outside the second seat body 114 of the supporting portion 110, the first end 122 of the adjusting portion 120 also moves toward the first seat body 112 of the supporting portion 110, so as to increase the space a at which the portion of the clamp arm 132 rotatably connected is close to the first end 122 of the adjusting portion 120, prevent the valve leaflets from being excessively accumulated in the space a, and ensure that the clamping portion 130 is normally closed without damaging the valve leaflets.

Meanwhile, the first end 122 of the adjusting portion 120 is movably sleeved outside the second seat body 114 of the supporting portion 110, and the second end 124 of the adjusting portion 120 is suspended, so that the adjusting portion 120 is not limited by the supporting portion 110, the axial deformation capability of the adjusting portion 120 is improved, and the axial bending deformation capability of the adjusting portion is enhanced. Therefore, when the adaptive valve clamping device 100 is radially compressed into the delivery sheath for in vivo delivery, the device can be easily compressed into the sheath, and can adapt to blood vessels with different bending curvatures during delivery in the blood vessel, so that the delivery sheath can be conveniently passed through the blood vessel, and the damage to the blood vessel wall is reduced. The first end 122 of the adjusting portion 120 is movably sleeved outside the second seat 114 of the supporting portion 110, and the second end 124 of the adjusting portion 120 is suspended, so that the center of gravity of the adjusting portion 120 is always located in the axial direction of the supporting portion 110 (i.e., the axial line of the adjusting portion 120), and therefore the self-centering performance of the adjusting portion 120 is better and the adjusting portion is not prone to tilt.

In addition, after the adaptive valve clamping device 100 is implanted, in the process of clamping the valve leaflets and the adjusting part 120 through the clamping part 130, the elastic fitting performance of the valve leaflets and the adjusting part 120 can be improved because the axial deformation of the adjusting part 120 is not limited, and then the adaptability of the valve leaflet physiological structures of different patients is improved.

With reference to fig. 17-21, in the adaptive valve clamping device 100 of the present embodiment, the supporting portion 110 is detachably connected to the delivering device 200 (such as a threaded connection or a snap connection), and the delivering device 200 pushes the adaptive valve clamping device 100 into the heart through a catheter, so that the second end 124 of the adjusting portion 120 is a proximal end thereof, and the first end 122 of the adjusting portion 120 is a distal end thereof; the first seat 112 of the support portion 110 is near the proximal end of the adaptive valve clamping device 100, and the second seat 114 is near the distal end of the adaptive valve clamping device 100. It is understood that in other embodiments, the adaptive valve clamping device 100 may be transapically accessed into the heart, with the second end 124 of the regulating portion 120 being the distal end thereof and the first end 122 of the regulating portion 120 being the proximal end thereof; the first seat 112 of the support portion 110 is near the distal end of the adaptive valve clamping device 100, and the second seat 114 is near the proximal end of the adaptive valve clamping device 100.

The adaptive valve clamping device 100 is delivered in a closed state and can be released to open at the mitral valve delivered to the patient to clamp the valve leaflets. The first seat 112 of the supporting portion 110 is located in the hollow adjusting portion 120 no matter in the delivering state or in the releasing and opening state, and is not exposed in the delivering device 200 or in the heart all the time, so as to avoid the blood from washing away and reduce the formation of thrombus after implantation as much as possible. Moreover, after the adaptive valve clamping device 100 is implanted, the supporting portion 110 is prevented from directly contacting with the valve leaflet, and the supporting portion 110 is prevented from wearing the valve leaflet and even causing perforation of the valve leaflet along with the long-term pulsation of the valve leaflet, so that the safety is improved.

Referring to fig. 6 and 7, the first end 122 of the adjusting portion 120 is provided with a first sealing head 126, and the first sealing head 126 is movably sleeved outside the second seat body 114. The inner cavity surface of the first sealing head 126 is in clearance fit with the outer surface of the second holder body 114. In this way, the first end 122 of the adjusting portion 120 is closed by the first sealing head 126, and the first sealing head 126 can move on the second seat body 114 of the supporting portion 110, so that the adjusting portion 120 can move relative to the supporting portion 110.

Specifically, the first sealing head 126 has a double-layer structure, and includes two tubes that are coaxially nested. One end of the interlayer cavity between the two tubes is closed, and the other end is open for folding the first end 122 of the adjusting part 120. The two ends of the tube body with smaller radial dimension are both open, and the inner cavity of the tube body is the inner cavity of the first sealing head 126. The first head 126 may be a metal steel sleeve.

In order to ensure that the adjusting portion 120 is movably sleeved on the second seat 114 of the supporting portion 110, a fit clearance between the inner cavity surface of the first sealing head 126 and the outer surface of the second seat 114 is in a range of 0.01-3 mm, preferably 0.05-3 mm. Preferably, the fit clearance between the inner cavity surface of the first sealing head 126 and the outer surface of the second seat 114 is in a range of 0.05-1 mm, so as to avoid the first sealing head 126 and the adjusting portion 120 from shaking outside the supporting portion 110 due to an excessively large fit clearance. More preferably, the fit clearance between the inner cavity surface of the first sealing head 126 and the outer surface of the second seat 114 is in the range of 0.05-0.2 mm, so that the first sealing head 126 can be prevented from freely sliding and rotating on the second seat 114 due to an excessively large fit clearance, and the first sealing head 126 can still be axially moved relative to the second seat 114 by applying a proper force to the first sealing head 126 and/or the second seat 114.

Further, the surface roughness of the inner cavity surface of the first sealing head 126 ranges from 0.1 to 2.5 micrometers, and/or the surface roughness of the outer surface of the second seat 114 ranges from 0.1 to 2.5 micrometers. It can be understood that the inner cavity surface of the first sealing head 126 and/or the outer surface of the second retaining body 114 are rough, so that the contact surface between the first sealing head 126 and the second retaining body 114 is not smooth, and the effect of limiting the first sealing head 126 to slide and rotate freely on the second retaining body 114 can be further ensured. By properly setting the surface roughness range, the first head 126 can still be moved axially relative to the second housing 114 by applying a suitable force to the first head 126 and/or the second housing 114.

The second end 124 of the adjustment portion 120 has an opening 128 to facilitate the delivery device 200 to penetrate into the adjustment portion 120 and connect with the support portion 110, while the second end 124 has no seal or the like exposed to avoid the generation of thrombus and abrasion of valve leaflets. The size of the opening 128 is smaller than or equal to the size of the first fastening structure 112 of the supporting portion 110, so as to ensure that the first fastening structure 112 of the supporting portion 110 does not extend out of the adjusting portion 120 in both the natural state and the compressed state.

The self-expanding body 121 of the adjusting portion 120 has a hollow accommodating cavity, and the first seat 112 of the supporting portion 110 is disposed in the hollow accommodating cavity. In one embodiment, the self-expanding body 121 is a hollow mesh structure with a plurality of mesh holes, the mesh structure is made of shape memory material through weaving or cutting, and may be selected from metal material, polymer material or metal-polymer composite material, and is preferably made of shape memory metal material such as stainless steel, cobalt-chromium alloy or nickel titanium with certain elasticity. For example, the material can be selected from super elastic nickel titanium alloy material to weave or cut, and after heat setting treatment, the natural state is formed. Specifically, all the wires of the mesh structure are fixedly gathered in the interlayer cavity of the first end enclosure 126 at the first end 122, and the winding portions of all the wires of the mesh structure at the edge of the second end 124 surround to form the opening 128, and the winding shape may be set as required, for example, one winding, or multiple windings to form at least one loop and then wind back, and so on. Further, referring to fig. 7, the adjusting portion 120 further includes a ring structure 123 disposed at the edge of the second end 124 to stabilize the shape of the opening 128, and all the mesh wires of the mesh structure at the second end 124 are wound around and connected to the ring structure 123. The loop 123 is made of a flexible or elastic material having a larger diameter than the mesh of the woven mesh, thereby providing some support to the opening 128 of the mesh, but without affecting the axial deformability and bendability of the mesh. The surface of the nickel-titanium alloy can be coated with Polytetrafluoroethylene (PTFE) by spraying, dip coating, etc. to have excellent corrosion resistance, chemical resistance and wear resistance, so that the surface can be protected, the corrosion can be prevented, and the service life of the parts can be prolonged, and meanwhile, since the PTFE has a good friction coefficient, the damage of the self-expanding main body 121 to the valve leaflet can be effectively reduced.

Of course, the self-expanding body 121 of the adjusting part 120 may be other hollow structures having elasticity, for example, the self-expanding body 121 may be a compact structure or a porous structure, the compact structure is a colloidal silica body, and the porous structure is a sponge body. The edge of the second end 124 of the dense or porous structure forms an opening 128 and the first end 122 is provided with a first seal 126.

For the self-expandable body 121 with a compact structure, since the self-expandable body 121 is filled between the anterior leaflet and the posterior leaflet of the mitral valve, the self-expandable body 121 can completely obstruct the blood flow from washing the inside of the adaptive valve clamping device 100, and avoid that the adaptive valve clamping device 100 is washed by the blood flowing at a high speed and falls off in the fine adjustment process, the clamping part 130 is continuously impacted and falls off by the blood after implantation, and the blood is prevented from accumulating at the dead angle between the clamping parts 130 of the adaptive valve clamping device 100 to form thrombus. The self-expandable main body 121 with a mesh structure has better elastic deformation capability, can better adapt to the anatomical structure of the mitral valve, and avoids the damage of the valve leaflets caused by excessively pulling the valve leaflets.

Further, a coating film (not shown) is applied to at least a portion of the outer surface of the self-expanding body 121 of the mesh structure, and the coating film may be a woven mesh structure having a plurality of meshes. The self-expandable body 121 with a covering membrane can further improve the blocking effect on blood flow, reduce central regurgitation, increase biocompatibility, avoid valve tissue allergy and inflammatory reaction, improve product safety, and form an artificial barrier at the atrium side of the valve leaflet to prevent thrombus formed by repeated flushing of blood at the internal dead angle of the self-adaptive valve clamping device 100 from flowing out. The film coating material may be made of a polymer material such as polyethylene terephthalate (PET), Polypropylene (PP), polytetrafluoroethylene (ptfe), Polyurethane (Polyurethane), or the like. Preferably, the film covering material is made of PET.

To avoid the self-expanding body 121 affecting the relative opening and closing between the clamping portion 130 and the supporting portion 110 and thus the clamping effect on the valve leaflet, the diameter of the portion of the self-expanding body 121 near the first end 122 should be smaller than the diameter of the other portion of the self-expanding body 121. For example, in the example of fig. 7, the self-expanding body 121 has a cylindrical shape in the middle, tapers at both ends, and the taper angles of the tapers at both ends are the same. It will be appreciated that the self expanding body 121 may be any other shape as long as the diameter of the portion near the first end 122 does not affect the gripping effect. For example, a spindle-shaped structure having the same taper angles at both ends as shown in fig. 8, or a structure having different taper angles at both ends as shown in fig. 9.

Referring to fig. 10 and 11, the self-expanding body 121 may include a plurality of first curved surfaces 1212 and a plurality of second curved surfaces 1214, wherein the first curved surfaces 1212 and the second curved surfaces 1214 are adjacent to each other and smoothly connected together, that is, the first curved surfaces 1212 are only adjacent to the second curved surfaces 1214, the second curved surfaces 1214 are also only adjacent to the first curved surfaces 1212, and one ends of the plurality of first curved surfaces 1212 and the plurality of second curved surfaces 1214 are connected to each other and form the opening 128. The first curved surface 1212 faces the nip portion 130, and the area of the second curved surface 1214 is smaller than that of the first curved surface 1212. As the adaptive valve clamping device 100 is closed, the first curved surface 1212 is pressed by the clamping portion 130 and the valve leaflet, and the adjusting portion 120 extends along the axial direction, gradually fits to the valve leaflet to ensure the contact area with the valve leaflet, so as to better adapt to the shape of the valve leaflet. By increasing the contact area between the first curved surface 1212 and the valve leaflet, the gap between the adaptive valve clamping device 100 and the valve leaflet is reduced, which may slow down blood flow and prevent flushing of the adaptive valve clamping device 100 by blood flow. Preferably, the curvature of the first curved surface 1212 may also be greater than the curvature of the second curved surface 1214, such that the self-expanding body 121 assumes a flat ellipsoid shape, avoiding affecting the closure of the pinch 130, and more conforming to the anatomy of the leaflet.

In other embodiments, the first end 122 of the regulating portion 120 is provided with a first sealing head 126, and the second end 124 of the regulating portion 120 is provided with a second sealing head. The inner cavity surface of the first sealing head 126 is in clearance fit with the outer surface of the second holder body 114. As such, the first end 122 and the second end 124 of the adjustment portion 120 are both closed by the closure. In this embodiment, the specific structure of the second end enclosure is the same as that of the first end enclosure 126, and both are the aforementioned double-layer structure, which is not described herein again.

Referring to fig. 12, the supporting portion 110 further includes a third seat 116 connected to the second seat 114. The inner diameter of the first sealing head 126 is smaller than the outer diameter of the first retaining body 112, and the inner diameter of the first sealing head 126 is smaller than the outer diameter of the third retaining body 116. Thus, the first end 126 of the first end 122 of the adjusting portion 120 is limited by the first seat 112 and the third seat 116, and the adjusting portion 120 can axially move on the second seat 114 and cannot fall off from the second seat 114. Because the adjusting portion 120 has a certain weight, the initial position of the adjusting portion 120 is located at the distal end of the second seat 114, close to the proximal end of the third seat 116 under the action of gravity.

Specifically, the inner diameter of the first sealing head 126 should be at least 0.01 mm smaller than the outer diameter of the first seat 112, preferably 0.05-3 mm smaller. The inner diameter of the first head 126 should be at least 0.01 mm, preferably 0.05-3 mm, smaller than the outer diameter of the third body 116. The first sealing head 126 and the second seat 114 can both be circular tube structures, which facilitates the axial movement of the first sealing head 126 on the second seat 114. The first fastening structure 112 and the second fastening structure 114 can be integrally formed or can be separately formed and then welded. The third seat 116 and the second seat 114 can be fixed together by welding, bonding, screwing, crimping, bolting, and other common detachable or non-detachable connection methods, and in this embodiment, the third seat is connected by welding. Specifically, the distal end of the second seat 114 of the supporting portion 110 can be inserted into the second end 124 of the adjusting portion 120 and then inserted out of the first end 122 of the adjusting portion 120, and then the distal end of the third seat 116 and the proximal end of the second seat 114 can be integrally connected by welding.

In other embodiments, the supporting portion 110 further includes a third seat 116 connected to the second seat 114. The end of the second base 114 connected to the first base 112 is provided with a limiting member (not shown). The inner diameter of the first sealing head 126 is smaller than the outer diameter of the limiting member, and the inner diameter of the first sealing head 126 is smaller than the outer diameter of the third seat 116. Thus, the first end 126 of the first end 122 of the adjusting portion 120 is limited by the limiting member and the third seat 116 in the moving stroke, and the adjusting portion 120 can axially move on the second seat 114 and cannot fall off from the second seat 114.

Referring to fig. 12-16, the supporting portion 110 is axially provided with a through channel 111 for cooperating with the driving portion 140 and the conveying device 200. The first seat 112 and the second seat 114 are both circular tubes with two axially-through end faces. At least two clamping positions 1122 are disposed on the wall of the first seat 112 for detachable connection with the clamping table 222 of the conveying device 200. After the clamping platform 222 (see fig. 16) of the delivery device 200 is clamped into the clamping position 1122, the delivery device 200 is clamped to the supporting portion 110, so that the adaptive valve clamping device 100 can be delivered, and when the clamping platform 222 is separated from the clamping position 1122, the delivery device 200 is separated from the adaptive valve clamping device 100 and released in vivo.

The distal end of the third seat 116 is a square structure, and the proximal end is a step structure. The distal end of the third seat 116 is radially provided with a receiving cavity 1162 penetrating through two opposite side surfaces of the third seat 116. The proximal end and the distal end of the second seat 114 are formed with through holes axially penetrating the accommodating cavity 1162. Two opposite planes of the step structure at the proximal end of the second seat body 114 are respectively provided with a connecting block 1164 in a protruding manner, and the connecting block 1164 is provided with a connecting hole for rotatably connecting with the clamping portion 130. The tube cavity of the first seat 112, the tube cavity of the second seat 114, the through hole of the third seat 116, and the accommodating cavity 1162 are communicated to form the through passage 111. It should be understood that the structure of the supporting portion 110 is only used as an example and not a limitation of the present application, and those skilled in the art can adopt other structures of the supporting portion 110 based on the teaching of the present application within the protection scope of the present application.

Referring to fig. 3 and 4, the clamping portion 130 is rotatably connected to the third seat 116 of the supporting portion 110. The clamping portion 130 includes at least two clamping arms 132, that is, at least two clamping arms 132 are rotatably connected to the third seat 116 of the supporting portion 110, and the at least two clamping arms 132 are circumferentially symmetrically disposed with respect to the adjusting portion 120. Further, the adaptive valve clamping device further comprises a driving part 140, wherein the driving part 140 is respectively connected with each of the forceps arms 132 to drive each of the forceps arms 132 to rotate around the supporting part 110, so as to drive each of the forceps arms 132 to close to the adjusting part 120 or open away from the adjusting part 120. Each of the plurality of jawarms 132 is pivotally connected to the third base 116 by a connecting shaft 134, the connecting shaft 134 passes through the connecting holes of each of the plurality of jawarms 132 and the third base 116, so that the plurality of jawarms 132 are pivotally connected to the third base 116, and the plurality of jawarms 132 are driven by the driving portion 140 to open or close in cooperation with each other with respect to the support portion 110. When the jawarms 132 are closed, the second ends 124 of the adjustment portions 120 are slightly below the end faces of the free (i.e., proximal) ends of the jawarms 132; thus, the adjustment portion 120 is not exposed to the proximal surface of the closed clamp arms 132, ensuring that the everted ends of the clamp arms 132 abut the leaflets to increase the contact area of the leaflets, conform to the angle and direction of the leaflets, and avoiding the risk of thrombus caused by excessive exposure of the adjustment portion 120 to the left atrium.

In the illustrated example, the clamping portion 130 includes two clamping arms 132 disposed circumferentially symmetrically with respect to the adjustment portion 120 for clamping two leaflets of the mitral valve. In other embodiments, the clamping portion 130 may include three clamping arms 132 disposed circumferentially about the adjustment portion 120 for clamping three leaflets of the tricuspid valve. It should be understood that this is by way of example only and that one of ordinary skill in the art can select an appropriate number of jawarms 132, such as two, three, or more jawarms 132, as desired. In the delivery state, the driving portion 140 drives the forceps arms 132 to close around the adjusting portion 120, so as to reduce the outer diameter of the adaptive valve clamping device 100, thereby facilitating delivery; after the adaptive valve clamping device 100 is opened in vivo, the driving portion 140 drives the clamp arms 132 to clamp the valve leaflets between the clamp arms 132 and the adjusting portion 120, so as to clamp the valve leaflets.

Further, the adaptive valve clamping device 100 further includes a grip portion 150, the grip portion 150 is disposed between the forceps arms 132 and the adjusting portion 120 and can be close to or far from the forceps arms 132, and the grip portion 150 is at least partially received on the inner surfaces of the forceps arms 132 in a natural state (as shown in fig. 3). It will be appreciated that in some embodiments, the grip portion 150 has a shape memory function, such that it may be naturally adjacent to the jawarms 132; in other embodiments, the grip 150 may be made of a material that does not have a shape memory function, and the grip 150 may be driven closer to the jawarms 132 by a push rod or the like. The gripping portion 150 includes at least two gripping arms 152. typically, the number of gripping arms 152 corresponds to the number of jawarms 132 and is arranged in the same manner as the jawarms 132 such that the gripping arms 152 cooperate with the jawarms 132 to perform a clamping function.

Preferably, the grasping arm 152 is made of shape memory material such as nitinol, and the free end of the grasping arm 152 is opened with an adjusting wire hole for connecting an adjusting wire (not shown) of the delivery device 200, and the free end of the grasping arm 152 can be controlled by the adjusting wire extending to the outside of the patient. In the conveying state, the free end of the grip arm 152 is pulled tight by the adjusting wire and attached to the adjusting portion 120; when the jawarms 132 are opened to grasp a leaflet in vivo, releasing the control of the free ends of the adjustment wires releases the grasping arms 152, the grasping arms 152 return to their natural state due to their shape memory function and press the leaflet toward the jawarms 132.

The gripping portion 150 is at least partially received by the inner surface of the clamping portion 130 in a natural state, i.e., the gripping arms 152 are at least partially received by the inner surfaces of the clamping arms 132, such that the outer diameter of the adaptive valve clamping device 100 in a delivery state can be reduced after the adaptive valve clamping device 100 is closed, thereby facilitating delivery. After the clamp arms 132 engage the leaflet gripping arms 152, the concave inner surfaces of the clamp arms 132 can increase the contact area of the clamp arms 132 with the leaflet and cause the gripping arms 152 to press the leaflet into the inner surfaces of the clamp arms 132, increasing the gripping force on the leaflet.

Referring to fig. 4, the driving portion 140 includes a driving shaft 142, a connecting seat 144, and at least two connecting rods 146. Each link 146 has one end connected to one of the clamp arms 132 and the other end pivotally connected to the connecting base 144. One end of the driving shaft 142 is connected to the connecting seat 144, and the other end is movably inserted into the third seat 116. Specifically, the number of links 146 corresponds to the number of jawarms 132. Each link 146 is connected at one end to one of the jawarms 132 and at the other end to the link base 144 by a pivot 148. The driving shaft 142 axially penetrates through the penetrating passage 111 of the supporting portion 110 and movably penetrates through the third seat 116 to be connected with the connecting seat 144. When the driving shaft 142 moves axially relative to the third seat 116, the connecting rod 146 rotates and drives the clamp arm 132 to open and close relative to the third seat 116. When the driving shaft 142 moves axially and distally relative to the third seat 116, the connecting rod 146 rotates and drives the forceps arms 132 to open, and the adaptive valve clamping device 100 is in an open state; when the driving shaft 142 moves axially and proximally relative to the third seat 116, the connecting rod 146 rotates and drives the forceps arms 132 to close, and the adaptive valve clamping device 100 is in a closed state.

In the illustrated example, the clamping portion 130 includes two jawarms 132, and correspondingly, two cooperating links 146 are provided. The distal end of the jawarm 132 is pivotally connected to the third housing 116 by a connecting shaft 134, such as a pin or bolt, the distal end of a link 146 is pivotally connected to the connecting base 144 by a pivot 148, such as a pin or bolt, and the proximal end of the link 146 is connected to the jawarm 132. When the driving shaft 142 moves axially and distally relative to the third seat 116, the connecting rod 146 rotates to drive the clamp arms 132 to rotate around the connecting shaft 134 and open relative to the third seat 116, and the adaptive valve clamping device 100 is in an open state. When the driving shaft 142 moves axially and proximally relative to the third seat 116, the connecting rod 146 rotates to drive the clamp arm 132 to rotate around the connecting shaft 134 and close relative to the third seat 116.

The connecting base 144 may be shaped as any one of a hemisphere, a spherical cap, or a bullet, so that the adaptive valve clamping device 100 can be pushed in vivo more easily. The driving shaft 142 and the connecting seat 144 may be an integral structure or a non-integral structure. The coupling seat 144 may be fixedly disposed at a distal end of the driving shaft 142 by welding or the like. To ensure the safety after implantation, the driving shaft 142 and the connecting seat 144 are made of a biocompatible material such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy, or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.

Further, the driving part 140 further includes a locking member 141 disposed in the third seat 116, and the locking member 141 is used for locking the driving shaft 142 to limit the relative movement between the driving shaft 142 and the third seat 116. In the conveying state, the locking member 141 limits the relative movement between the driving shaft 142 and the third seat 116, so as to ensure that the clamping portion 130 is always kept in a closed state relative to the adjusting portion 120 and the supporting portion 110, and prevent the clamping portion 130 from being opened accidentally. After the adaptive valve clamping device 100 reaches the vicinity of the mitral valve, the driving shaft 142 is released from the locking member 141, so that the clamping part 130 can be driven by the driving part 140 to open and clamp the valve leaflets relative to the adjusting part 120 and the supporting part 110. The locking member 141 may be a combination of a steel plate and a deformable elastic sheet in the prior art, the driving shaft 142 penetrates through the steel plate and the elastic sheet, and the elastic sheet abuts against the steel plate and is obliquely arranged in the third seat 116, so that the steel plate is obliquely clamped on the driving shaft 142 to lock the driving shaft 142; through pulling the steel sheet rotation, shell fragment elastic deformation for the drive shaft 142 is gapped with the link hole of steel sheet and shell fragment, and drive shaft 142 can be followed the axial displacement.

Referring to fig. 4 and 5, a valve clamping system is further provided according to an embodiment of the present application. The valve clamping system includes the adaptive valve clamping device 100 and the delivery device 200. The delivery device 200 includes a pusher shaft 210 having an axial length and a mandrel (not shown) movably disposed through the pusher shaft 210. The pushing shaft 210 is detachably connected to the supporting portion 110, and the mandrel is used to drive the clamp arm 132 of the clamping portion 130 to rotate around the supporting portion 110. It should be understood that only a portion of the structure of the delivery device 200 is shown, and any other portion may be any suitable structure that is known in the art and will not be described herein.

Specifically, the mandrel is detachably connected to the driving portion 140, and the mandrel is used for driving the clamp arms 132 of the clamp portion 130 to rotate around the supporting portion 110 through the driving portion 140, so as to drive the clamp portion 130 to open or close. Referring to fig. 15 and 16, two clamping portions 1122 communicated with the tube cavity are symmetrically formed on the tube wall of the proximal end of the first seat 112 of the supporting portion 110, a fixing member 220 is disposed at the distal end of the pushing shaft 210, the fixing member 220 includes two branches, and the end of each branch is a raised clamping platform 222. In the natural state, both branches point toward the central axis of the fixture 220. When the adaptive valve clamping device 100 and the delivery device 200 are assembled, the fixing member 220 at the distal end of the pushing shaft 210 is inserted into the first seat 112 of the supporting portion 110, and then the mandrel is inserted into the pushing shaft 210 until the mandrel is inserted into the fixing member 220 to jack up the two branches of the fixing member 220 outward, so that the clamping tables 222 at the ends of the branches are respectively clamped into the clamping positions 1122, thereby connecting the supporting portion 110 with the pushing shaft 210, i.e., connecting the adaptive valve clamping device 100 and the delivery device 200. The proximal end of the drive shaft 142 is externally threaded and the mandrel is internally threaded and is threadably coupled to the drive shaft 142 after insertion into the fastener 220 so that axial movement of the drive shaft 142 can be controlled by the mandrel.

When the mandrel is released from the driving shaft 142 and the mandrel is withdrawn from the fixing element 220 and the pushing shaft 210, the two branches of the fixing element 220 return to the inward natural state, and the retainer 222 is disengaged from the retainer 1122 of the first seat 112, so that the adaptive valve clamping device 100 and the delivery device 200 are disconnected. The fixing member 220 may be made of a material having a certain hardness and elasticity, such as nitinol. The pusher shaft 210 may be a multi-layer composite tube. The mandrel can be made of stainless steel material.

It can be understood that after the adaptive valve clamping device 100 is connected to the delivery device 200, and the adaptive valve clamping device 100 is in the closed state, the adaptive valve clamping device 100 is delivered to the mitral valve of the patient through the delivery device 200. Then, the driving shaft 142 is driven by the mandrel to move distally along the axial direction, the driving shaft 142 drives the connecting rod 146 to rotate, and the connecting rod 146 drives the forceps arms 132 to open until the forceps arms 132 are completely opened relative to the adjusting portion 120 and the supporting portion 110, so that the adaptive valve clamping device 100 is in an open state. After the clamping portion 130 and the gripping portion 150 are engaged and clamp the valve leaflets of the valve tissue, the driving shaft 142 is driven by the mandrel to move axially toward the proximal end, the driving shaft 142 drives the connecting rod 146 to rotate, the connecting rod 146 drives the clamp arms 132 to close until the clamp arms 132 are completely closed relative to the adjusting portion 120 and the supporting portion 110, so that the adaptive valve clamping device 100 is in a closed state and drops below the valve. The mandrel can then be disconnected from the drive shaft 142, the mandrel can be withdrawn from the fastener 220, and the retainer 222 can be disengaged from the retainer 1122 on the support portion 110, thereby releasing the adaptive valve clamping device 100 and the delivery device 200.

Since the connection (i.e., the detachment) of the adaptive valve clamping device 100 and the delivery device 200 is located in the adjustment portion 120 of the adaptive valve clamping device 100, when the second end 124 of the adjustment portion 120 is provided with the opening 128, there is no component to hook the catch 222 at the branch end of the fixing member 220, which facilitates the release of the adaptive valve clamping device 100. In addition, the release part is arranged inside the adjusting part 120, so that the axial size of the release part can be reduced, the weight of the whole self-adaptive valve clamping device 100 is reduced, and the load of the heart is reduced; the detached part is not directly washed by blood, so that the valve leaflet damage caused by repeated abrasion of the valve leaflet at the detached part can be avoided, and the risk of thrombosis can be reduced.

Referring to fig. 17-21, the procedure of using the adaptive valve clamping device 100 of the present application is illustrated, for example, to anterograde approach and repair of a mitral valve via the left atrium:

the first step is as follows: as shown in fig. 17, the delivery device 200 and the adaptive valve clamping device 100 connected thereto are advanced from the left atrium LA, through the mitral valve MV to the left ventricle LV by means of a guiding device such as an adjustable curved sheath (not shown);

the second step: adjusting the adaptive valve clamping device 100 to approximate the anterior AML and posterior PML of the mitral valve MV;

the third step: as shown in fig. 18, the locking member 141 in the third seat 116 is unlocked, the spindle and the driving shaft 142 are pushed to the distal end, the clamp arm 132 is driven to open relative to the supporting portion 110 and the adjusting portion 120, and the direction of the clamp arm 132 is adjusted, so that the relative positions of the clamp arm 132 and the anterior leaflet AML and the posterior leaflet PML of the mitral valve MV can be observed by medical imaging equipment such as X-ray, and the like, so that the clamp arm 132 is perpendicular to the coaptation line of the mitral valve MV;

the fourth step: as shown in fig. 19, the entire adaptive valve clamping device 100 is withdrawn proximally, causing the clamping arms 132 to hold the leaflet on the LV side of the left ventricle, releasing the adjustment wires to release the gripping arms 152 on both sides, the gripping arms 152 on each side pressing against the leaflet on the atrial side and engaging the clamping arms 132 on that side to secure the leaflet in full clamping of the leaflet;

the fifth step: as shown in FIG. 20, when the anterior leaflet AML and posterior leaflet PML of the mitral valve MV are clamped between the pair of clamp arms 132 and the gripping arm 152, respectively, the mandrel and drive shaft 142 are pulled proximally, thereby driving the clamp arms 132 closed;

and a sixth step: the threaded connection between the mandrel and the drive shaft 142 is released and the mandrel is withdrawn to release the connection between the adaptive valve clamping device 100 and the delivery device 200, after which the delivery device 200 is withdrawn from the body to obtain the implanted state shown in fig. 21, at which time the adaptive valve clamping device 100 pulls the anterior leaflet AML and the posterior leaflet PML of the mitral valve MV towards each other to obtain a bilayered mitral valve, and the edge-to-edge repair of the mitral valve is completed.

After the adaptive valve clamping device 100 is implanted, the flexible adjustment portion 120 fills the space between the anterior leaflet AML and the posterior leaflet PML of the clamped mitral valve MV and abuts against the clamp arms 132, thereby reducing central regurgitation and improving the treatment effect. The self-expanding body 121 (e.g., a mesh structure or a porous structure) of the adjustment portion 120 has a buffering effect on the beating leaflets, so that the pulling degree of the adaptive valve clamping device 100 on the leaflets can be adaptively adjusted to avoid damaging the leaflets. The self-expandable body 121 can be squeezed and deformed along with the pulsation of the valve leaflet, and the generated elastic force pushes the part of the valve leaflet close to the self-expandable body 121 to the direction far away from the support part 110, so that the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle of the clamp arm 132, the pulling of the clamping part 130 to the valve leaflet can be reduced, and the pulling degree of the self-adaptive valve clamping device 100 to the valve leaflet is always kept in a reasonable range. In addition, when the adjusting portion 120 is under the pressure of the valve leaflet, a certain degree of deformation is generated, and the degree of deformation increases along with the increase of the pressure, so that the squeezing force of the clamp arms 132 on the self-expanding main body 121 is prevented from acting on the clamp arms 132 in reverse after the valve leaflet is grasped, and the grasping effect of the self-adaptive valve clamping device 100 on the valve leaflet after release is ensured to be consistent with that before release.

Example two

Referring to fig. 22-25, the adaptive valve clamping device of the second embodiment of the present application is different from the adaptive valve clamping device 100 of the first embodiment in that the first sealing head 426 of the adjusting portion 420 and the second seat 414 of the supporting portion 410 have different structures.

Specifically, the first sealing head 426 is movably sleeved outside the second seat 414 of the supporting portion 410, a first rotation stopping member 4260 is disposed in an inner cavity of the first sealing head 426, a second rotation stopping member 4140 is disposed on an outer surface of the second seat 414 corresponding to the first rotation stopping member 4260, and the first rotation stopping member 4260 is detachably connected to the second rotation stopping member 4140 in a matching manner. In this way, the first rotation-stopping element 4260 and the second rotation-stopping element 4140 which are detachably connected in a matching manner are arranged to limit the axial rotation of the adjusting portion 420, so as to prevent the adjusting portion 420 from rotating relative to the second seat 414, thereby reducing the contact area between the adjusting portion 420 and the valve leaflet and affecting the clamping effect of the valve leaflet.

Referring to fig. 22-24, the first rotation stop member 4260 comprises at least one flat surface 4262 and/or at least one curved surface 4264, and the second rotation stop member 4140 comprises at least one flat surface 4142 and/or at least one curved surface 4144. In the example of fig. 22, the first rotation stop member 4260 comprises two opposite flat surfaces 4262 and two opposite arc surfaces 4264, i.e., the inner cavity of the first head 426 is provided with two opposite flat surfaces 4262 and two opposite arc surfaces 4264. Correspondingly, the second anti-rotation member 4140 includes two opposite flat surfaces 4142 and two opposite arc surfaces 4144, i.e., the outer surface of the second seat 414 is provided with two opposite flat surfaces 4142 and two opposite arc surfaces 4144. During assembly, the plane 4262 of the first sealing head 426 is opposite to the plane 4142 of the second seat body 414, and the arc surface 4264 of the first sealing head 426 is opposite to the arc surface 4144 of the second seat body 414. Therefore, the first sealing head 426 is sleeved outside the second seat 414, so that the axial movement of the adjusting portion 420 is not affected, and the two planes 4142 of the second seat 414 opposite to the first sealing head 426 can prevent the adjusting portion 420 from rotating on the second seat 414 around the axis. The spacing between the flat surfaces 4262 of the first head 426 should be at least 0.01 mm, preferably 0.02-1 mm, larger than the spacing between the flat surfaces 4142 of the second housing 414. The distance between the two curved surfaces 4264 of the first sealing head 426 should be at least 0.01 mm, preferably 0.05-3 mm, larger than the distance between the two curved surfaces 4144 of the second seat 414. In the example of fig. 23, the first rotation stop member 4260 comprises one flat surface 4262 and one arcuate surface 4264 and the second rotation stop member 4140 comprises two flat surfaces 4142 and one arcuate surface 4144. In the example of fig. 24, the second rotation stop 4140 includes three flat faces 4142 and three arced faces 4144. Preferably, the arc surface may be a circular arc surface. Of course, it is also possible that the first rotation stop member 4260 comprises an arc 4264, and the second rotation stop member 4140 comprises a plurality of flat surfaces 4142, i.e. the inner cavity surface of the first sealing head 426 is a circumferential arc, and the cross-sectional profile of the outer surface of the second seat 414 is a polygon.

Of course, the first and

second rotation stoppers

4260 and 4140 may be polyhedral structures that are coupled cooperatively. For example, the first rotation stop member 4260 and the second rotation stop member 4140 are both triangular prism-shaped structures, i.e., the inner cavity of the first end cap 426 has three interconnected planes, and the outer surface of the second seat 414 has three corresponding interconnected planes.

Referring to fig. 25, one of the first rotation stopper 4260 and the second rotation stopper 4140 is a slide groove extending in the axial direction, and the other is a protrusion engaged with the slide groove. The axial rotation of the regulating part 420 is restricted by the engagement of the slide groove and the protrusion, while the axial movement of the regulating part 420 is not affected. In the illustration, the second seat 414 is provided with a sliding groove 4146 extending along the axial direction, and the inner cavity of the first sealing head 426 is provided with a protrusion 4266 protruding inwards and capable of moving along the sliding groove. Preferably, the second seat 414 is provided with two opposite sliding grooves 4146, and the first end cap 426 is provided with two protrusions 4266 protruding inwards. Of course, the second seat 414 may also be provided with an outward protrusion, and the first sealing head 426 may be provided with a sliding groove.

In other embodiments, the second seat 414 may be provided with an outward protrusion, and the inner cavity of the first sealing head 426 may be provided with an inward protrusion. The convex structures of the two parts are matched to have a track for guiding movement, and simultaneously, the adjusting part 420 can be prevented from rotating along the supporting part 410.

In the second embodiment, the first sealing head 426 is integrally formed with the first rotation stopping member 4260, and the second seat 414 is integrally formed with the second rotation stopping member 4140.

EXAMPLE III

Referring to fig. 26 and 27, the adaptive valve clamping device according to the third embodiment of the present invention is different from the adaptive valve clamping device according to the second embodiment in that the first sealing head 526 of the adjusting portion 520 and the second seat 514 of the supporting portion 510 have different structures. In this embodiment, the first sealing head 526 is separately connected to the first rotation stopper 5260, and/or the second seat 524 is separately connected to the second rotation stopper 5140. Specifically, the first sealing head 526 and the first rotation stopper 5260 can be fixed together by welding, bonding, screwing, crimping, bolting, and other common detachable or non-detachable connection methods. The second seat 514 and the second rotation stop member 5140 can be fixed together by welding, bonding, screwing, pressing, bolting, or other common detachable or non-detachable connection methods. The present embodiment employs a welded connection.

Example four

Referring to fig. 28-31, the adaptive valve clamping device 600 of the fourth embodiment of the present application is different from the adaptive valve clamping device 100 of the first embodiment in that the driving part 640 further includes an unlocking control member 643 connected to the locking member 641. Moreover, the delivery device 200 of the valve clamping system of the present embodiment further includes a manipulation wire 230 detachably connected to the unlocking control 643.

It can be understood that the functional structure of the locking member 641 disposed on the third seat 616 of the supporting portion 610 is the same as that of the first embodiment, and is not described herein again. The present embodiment provides an unlocking controller 643 for pulling the lock 641 to unlock the drive shaft 642 from the lock 641. The unlocking control 643 in this embodiment is a single-side unlocking, and the single-side unlocking means that the unlocking control 643 is connected to a single side of the lock member 641. Specifically, the unlocking controller 643 is connected to one end of the locking member 641, and the first end 622 of the self-adjusting portion 620 pulls the unlocking controller 643 toward the second end 624, so that the locking member 641 unlocks the driving shaft 642, and the driving shaft 642 can move in the axial direction. When the pulling force on the unlock control 643 is released, the lock 641 restores the lock of the driving shaft 642, so that the driving shaft 642 is fixed relative to the third seat 616.

To facilitate remote control of the unlock control 643 outside of the body, the delivery device 200 further includes a wire 230, the wire 230 being detachably connected to the unlock control 643. The distal end of the operating wire 230 extends outside the patient's body through the delivery device 200. The operating wire 230 is typically made of a polymer material. Before the adaptive valve clamping device 600 is released, the operating wire 230 is connected with the unlocking control 643, when the operating wire 230 is tensioned, the unlocking control 643 releases the limitation of the locking piece 641 on the driving shaft 642, and the adaptive valve clamping device 600 is in an unlocked state; otherwise, the self-locking state is realized.

In this embodiment, the self-expanding body 621 of the adjusting portion 620 is a hollow mesh structure having a plurality of meshes, and a first sealing head 626 is disposed at one end of the self-expanding body 620. The unlocking control 643 has one end connected to the locking element 641 and the other end axially passing through at least one mesh and located within the cavity of the self-expanding body 621. The first end 622 (i.e., the end having the first seal 626) of the adjusting portion 620 is movably sleeved outside the second seat 614 of the supporting portion 610, the second end 624 of the adjusting portion 620 is suspended, and the adjusting portion 620 can move axially relative to the supporting portion 610. Since the unlocking control 643 penetrates through the mesh of the self-expanding body 621, the relative position between the unlocking control 643 and the supporting portion 610 is fixed, the first sealing head 626 at the first end 622 of the adjusting portion 620 can be prevented from rotating on the second seat body 614, and a limiting effect of preventing the adjusting portion 620 from rotating is achieved. The embodiment utilizes the penetrating position of the unlocking control element 643 on the self-expanding main body 621 to prevent the rotation of the adjusting part 620, the structure is simple, the first seal head 626 and the second seat body 614 do not need to be provided with anti-rotation structures, and the processing difficulty of parts is reduced. In addition, when the self-expanding body 621 in the hollow net structure is welded and fixed with the first sealing head 626, the direction does not need to be limited, and the welding difficulty is reduced.

Referring to fig. 31, the unlocking control member 643 includes an unlocking section 6431, and a first connecting section 6432 and a second connecting section 6433 connected to both ends of the unlocking section 6431. The unlocking segment 6431 overlaps the surface of the locking element 641 away from the self-expanding main body 621, and the first connecting segment 6432 and the second connecting segment 6433 respectively extend toward the self-expanding main body 621 and respectively penetrate through at least one mesh into the cavity of the self-expanding main body 62. In this way, by operating the first connecting section 6432 and the second connecting section 6433, the unlocking section 6431 pulls the locking member 641 to release the locking of the locking member 641 to the drive shaft 642. Preferably, the first connecting section 6432 and the second connecting end 6433 are symmetrically disposed in the cavity of the self-expanding body 621, so that the force applied by the unlocking control 643 to the locking member 641 is balanced when unlocking, and the unlocking is easy.

Specifically, the unlocking control member 643 is a double-line structure arranged side by side, the double lines of the first connecting section 6432 and the second connecting section 6433 are both U-shaped, and the double lines of the first connecting section 6432 enter the cavity of the self-expanding body 621 through the same mesh; the double wires of the second connecting section 6433 enter the cavity of the self-expanding body 621 through another mesh. In this way, the self-expanding body 621 is prevented from being deformed when the unlocking control 643 is pulled. When the unlocking control piece 643 is stressed, two lines are simultaneously stressed, the transmission stability of the unlocking force can be better ensured, and the requirement of the unlocking force can be met by selecting the unlocking control piece 643 with a smaller wire diameter.

Further, the adjusting portion 620 further includes a covering film (not shown) covering the outer surface of the self-expanding body 621, the covering film has an opening, and the first connecting segment 6432 and the second connecting segment 6433 sequentially enter the cavity of the self-expanding body 621 through the opening and the mesh, respectively. It can be understood that the covering film covers the self-expandable body 621, which can prevent the self-expandable body 621 from directly contacting the clamped valve tissue, thereby reducing or avoiding tissue allergy and inflammatory reaction, and avoiding damage to the clamped valve tissue. The film can be coated with the functional medicine by biological modification, dipping, brushing, dripping or spraying. For example, anticoagulant such as heparin can be applied to the surface of the coating film through a dipping mode, a spraying mode and the like, or the surface of the coating film can be biologically modified to enable the coating film to have the property of antithrombin, and a drug coating can be applied to the coating film and contains at least one of anticoagulant drugs, antiplatelet drugs or anti-tissue proliferation drugs, so that endothelialization is promoted, tissue hyperproliferation is avoided, the morbidity of corresponding complications is reduced, and the survival rate after operation is improved.

In the valve clamping system of this embodiment, the operation wire 230 passes through at least one mesh of the self-expanding body 621 and enters the cavity of the self-expanding body 621, and is detachably connected to the first connection segment 6432 and the second connection segment 6433. The number of the operation wire 230 may be one, and both ends of the operation wire 230 bypass the first connection segment 6432 and the second connection segment 6433, respectively. Specifically, the operating wire 230 is inserted into the U-shaped first connecting section 6432 and the U-shaped second connecting section 6433, and the first connecting section 6432 and the second connecting section 6433 are pulled, so as to control the unlocking control member 643. Of course, the number of the manipulation wires 230 may be two, wherein one manipulation wire 230 is connected to the first linking section 6432 and the other manipulation wire 230 is connected to the second linking section 6433. It can be appreciated that, since the operation wire 230 passes through the mesh of the self-expanding body 621, the operation wire 230 plays a further role in limiting the rotation of the adjustment part 620 in addition to playing a role in facilitating the remote control of the unlocking control 643 outside the body. When the operating wire 230 is tightened, the rotation of the adjusting portion 620 is preferably limited.

It will be appreciated that the present application provides a valve coaptation system that includes any of the adaptive valve coaptation devices described above and a delivery device capable of delivering the adaptive valve coaptation device extracorporeally to the mitral valve or the vicinity of the tricuspid valve and coapting the leaflets. The above description of the valve clamping device is provided by way of example and not by way of limitation, and valve clamping devices and valve clamping systems incorporating the same, as taught herein, by one of ordinary skill in the art are within the scope of the present application.

It is noted that, in this document, relational terms such as "first" and "second," and the like, may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.

The above description is merely exemplary of the present application and is presented to enable those skilled in the art to understand and practice the present application. 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 application. Thus, the present application 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. An adaptive valve clamping device, comprising:

the first seat body is arranged in the adjusting part, the adjusting part comprises a first end and a second end which are opposite, and a self-expanding main body which is positioned between the first end and the second end, the first end of the adjusting part is movably sleeved outside the second seat body and can axially move relative to the second seat body, the second end of the adjusting part is suspended, and the first seat body is close to the second end of the adjusting part compared with the second seat body; and

the clamping part comprises at least two clamp arms, each clamp arm is rotatably connected to the supporting part, the rotatably connected part of each clamp arm is close to the first end of the adjusting part, and the clamp arms rotate around the supporting part to be close to or far away from the adjusting part.

2. The adaptive valve clamping device according to claim 1, wherein a first seal is disposed at the first end of the adjustment portion, and the inner cavity surface of the first seal is in clearance fit with the outer surface of the second seat.

3. The adaptive valve clamping device of claim 2, wherein a fit clearance between the inner lumen surface of the first seal and the outer surface of the second seat is in a range of 0.01-3 mm.

4. The adaptive valve clamping device of claim 3, wherein a fit clearance between the luminal surface of the first seal and the outer surface of the second seat is in the range of 0.05-1 mm.

5. The adaptive valve clamping device of claim 4, wherein a fit clearance between the inner lumen surface of the first seal and the outer surface of the second seat is in a range of 0.05-0.2 mm.

6. The adaptive valve clamping device of any one of claims 3-5, wherein the surface roughness of the inner lumen surface of the first seal is in the range of 0.1-2.5 microns and/or the surface roughness of the outer surface of the second seat is in the range of 0.1-2.5 microns.

7. The adaptive valve clamping device according to claim 2, wherein a first rotation stopping member is arranged in the inner cavity of the first sealing head, a second rotation stopping member is arranged on the outer surface of the second seat body corresponding to the first rotation stopping member, and the first rotation stopping member and the second rotation stopping member are detachably connected in a matched manner.

8. The adaptive valve clamping device of claim 7, wherein the first seal is integrally or separately connected to the first rotation stop member and the second seat is integrally or separately connected to the second rotation stop member.

9. The adaptive valve clamping device of claim 7, wherein the first rotation stop comprises at least one flat surface and/or at least one curved surface and the second rotation stop comprises at least one flat surface and/or at least one curved surface.

10. The adaptive valve clamping device of claim 9, wherein the first and second rotation stops are mating connected polyhedral structures.

11. The adaptive valve clamping device of claim 7, wherein one of the first and second rotation stop members is an axially extending slide slot and the other is a protrusion that engages the slide slot.

12. The adaptive valve clamping device according to claim 2, wherein the support portion further comprises a third seat body connected to the second seat body, a limiting member is disposed at an end of the second seat body connected to the first seat body, an inner diameter of the first sealing head is smaller than an outer diameter of the limiting member, and an inner diameter of the first sealing head is smaller than an outer diameter of the third seat body.

13. The adaptive valve clamping device of claim 2, wherein the support portion further comprises a third seat connected to the second seat, the first seal has an inner diameter smaller than an outer diameter of the first seat, and the first seal has an inner diameter smaller than an outer diameter of the third seat.

14. The adaptive valve clamping device according to claim 12 or 13, wherein the at least two clamp arms are rotatably connected to the third seat, and the at least two clamp arms are circumferentially symmetrically arranged with respect to the adjustment portion.

15. The adaptive valve clamping device according to claim 12 or 13, further comprising a driving part, wherein the driving part comprises a driving shaft, a connecting seat and at least two connecting rods, one end of each connecting rod is connected with one of the forceps arms, the other end of each connecting rod is pivoted with the connecting seat, one end of the driving shaft is connected with the connecting seat, and the other end of the driving shaft is movably inserted into the third seat.

16. The adaptive valve clamping device of claim 15, wherein the actuating portion further comprises a locking member disposed in the third seat for locking the drive shaft to limit relative movement of the drive shaft and the third seat.

17. The adaptive valve clamping device of claim 16, wherein the actuator further comprises an unlocking control connected to the lock, the unlocking control for pulling the lock to unlock the actuator shaft from the lock.

18. The adaptive valve clamping device of claim 17, wherein the self-expanding body is a hollow mesh structure having a plurality of mesh openings, and the unlocking control member has one end connected to the locking member and another end axially passing through at least one of the mesh openings and located within the cavity of the self-expanding body.

19. The adaptive valve clamping device of claim 18, wherein the unlocking control member comprises an unlocking section and a first connecting section and a second connecting section connected to two ends of the unlocking section, the unlocking section is overlapped on the surface of the locking member far away from the self-expanding main body, and the first connecting section and the second connecting section respectively extend towards the self-expanding main body and respectively penetrate through at least one mesh opening to enter the cavity of the self-expanding main body.

20. The adaptive valve clamping device of claim 19, wherein the first and second connection segments are symmetrically disposed within the cavity of the self-expanding body.

21. The adaptive valve clamping device of claim 19 or 20, wherein the unlocking control is a double wire structure arranged side by side, the double wires of the first and second connecting sections are both U-shaped, and the double wires of the first connecting section enter the cavity of the self-expanding body through the same mesh; the double wires of the second connection section enter the cavity of the self-expanding body via the other mesh.

22. The adaptive valve clamping device of claim 19, wherein the adjustment portion further comprises a covering membrane covering an outer surface of the self-expanding body, the covering membrane having an opening, the first and second connection segments entering the cavity of the self-expanding body sequentially through the opening and the mesh, respectively.

23. The adaptive valve clamping device of claim 1, wherein the second end of the adjustment portion has an opening.

24. The adaptive valve clamping device of claim 23, wherein the second end of the adjustment portion is further provided with a second seal.

25. The adaptive valve clamping device of claim 1, further comprising a gripping portion disposed between the clamp arms and the adjustment portion and movable toward and away from the clamp arms, the gripping portion being at least partially received in an inner surface of the clamp arms in a natural state.

26. A valve clamping system comprising the adaptive valve clamping device of any one of claims 1 to 25 and a delivery device, the delivery device comprising a push shaft having an axial length and a mandrel movably mounted in the push shaft, the push shaft being detachably connected to the support portion, the mandrel being configured to drive the clamp arms to rotate about the support portion.

27. A valve clamping system, comprising the adaptive valve clamping device of any one of claims 19 to 25 and a delivery device, wherein the delivery device comprises a pushing shaft with a certain axial length and a mandrel movably arranged in the pushing shaft, the pushing shaft is detachably connected with the supporting part, and the mandrel is used for driving the clamp arms to rotate around the supporting part;

28. The valve clamping system of claim 27, wherein the number of the operating wire is one, and both ends of the operating wire bypass the first connecting section and the second connecting section, respectively.

29. The valve clamping system of claim 27, wherein the number of the manipulation wires is two, one of the manipulation wires is connected to the first connection section, and the other of the manipulation wires is connected to the second connection section.