CN112704580A

CN112704580A - Clamping device with expandable arm and plugging netting

Info

Publication number: CN112704580A
Application number: CN202110049494.2A
Authority: CN
Inventors: 戴宇峰; 潘炳跃; 王智杰
Original assignee: Shanghai Hanyu Medical Technology Co ltd
Current assignee: Shanghai Hanyu Medical Technology Co ltd
Priority date: 2021-01-14
Filing date: 2021-01-14
Publication date: 2021-04-27

Abstract

The invention provides a clamping device with expandable arms and a plugging netting, which comprises an upper clamping assembly, a lower clamping assembly, a base, a locking mechanism, a link arm, an expansion arm and a central plugging netting, wherein the upper clamping assembly is arranged on the upper clamping assembly; the number of the upper clamp assemblies is equal to that of the lower clamp assemblies, and the upper clamp assemblies and the lower clamp assemblies are matched to form clamping parts; backflow at two sides of the clamping device can be effectively blocked through the two side expanding arms, central backflow can be further reduced through the blocking netting of the central area, stress of valve leaflets is reduced, and valve leaflet damage is avoided; the lower clamp component is firmly closed by adopting a mechanical locking mode, so that the clamp is not easy to fall off after being implanted into a body. Meanwhile, the device can implant a clamping device through the femoral vein atrial penetration septum in a minimally invasive mode to repair the mitral valve. The device is characterized in that the operation is finished without stopping jumping in the heart to form an effective double-hole structure, the device shortens the operation time, reduces the wound degree and reduces the operation difficulty and the operation risk.

Description

Clamping device with expandable arm and plugging netting

Technical Field

The invention relates to the field of medical equipment, in particular to a repair system for treating heart valve regurgitation, and specifically relates to a clamping device with expandable arms and a sealing mesh.

Background

The mitral valve, the left atrioventricular valve, is also known as the mitral valve, and is attached to the left fibrous atrioventricular ring. The function of the mitral valve depends on its own structural integrity. The normal mitral valve is composed of an annulus, valve leaflets, chordae tendinae and papillary muscles, the integrity of the function of the mitral valve requires that the annulus of the mitral valve is proper in size, the valve leaflets are complete in structure, the chordae tendinae are pulled by the contraction of the papillary muscles to play a role in supporting the valve leaflets, the closing force generated by the contraction of the muscle of the left ventricle is proper, and the shape and the function of the ventricle are normal. These factors together determine the integrity of the mitral valve, and abnormalities in either factor can lead to mitral regurgitation. Mitral Regurgitation (MR) is the most common disease of heart valves.

In recent years, with the development of science and technology, instrument manufacturers at home and abroad develop a batch of interventional instruments for treating mitral regurgitation. Mainly comprises a limbal-to-limbal repair technique, an annuloplasty technique, a chordae implantation technique and the like. The edge-to-edge repair technology has a long history and better safety, and is currently used in other repair technologies, of which Yapei MitraClip and Edward PASCAL are typical representatives. MitraClip delivered clip from atrium down to the vicinity of mitral valve by interatrial puncture through catheter femoral vein puncture, holding and fixing the free edges of anterior and posterior leaflets, and clipping mitral valve into double holes with clip, making the leaflets align well at end systole, reducing regurgitation. Edward PASCAL also uses a clip to double the mitral valve by femoral vein puncture, transductal interatrial puncture, but with a unique separate capturing leaflet.

However, because the range of clip clamping is limited, and the mitral regurgitation range of patients is often wider, the problem of regurgitation leakage still occurs at the two sides and the top of the clip after the mitral valve is clamped by the clip by the edge-to-edge repair technology of MitraClip and chinese patent CN211325891U, and the valve leaflet has large stress, so that the good effect can be achieved only by frequently using a plurality of clips in clinical use, thereby increasing the probability of valve stenosis after mitral valve repair, which increases the difficulty of the operation, increases the operation risk and also increases the medical cost. Although the PASCAL can realize the blocking and backflow prevention at the two sides and the central top of the clamp, the PASCAL is an elastic lower clamp component and a self-locking clamp, the closing force of the clamp has variable degree and is not firm enough, and the clamp is easy to fall off when being implanted into a body.

Compared with the prior art, the invention has the beneficial effects that: according to the valve clamping device, the backflow at two sides of the clamping device can be effectively blocked through the expansion arms at two sides, the backflow at the center can be further reduced through the blocking netting of the central area, the stress of valve leaflets is reduced, and the valve leaflets are prevented from being damaged; the lower clamp component is firmly closed by adopting a mechanical locking mode, so that the clamp is not easy to fall off after being implanted into a body. Meanwhile, the device can implant a clamping device through the femoral vein atrial penetration septum in a minimally invasive mode to repair the mitral valve. The device is characterized in that the operation is finished without stopping jumping in the heart to form an effective double-hole structure, the device shortens the operation time, reduces the wound degree and reduces the operation difficulty and the operation risk.

Disclosure of Invention

In order to overcome the disadvantages of the prior art, the invention aims to provide a clamping device with expandable arms and a plugging netting, which can solve the problem that the existing clamping device can not realize the backflow prevention of the plugging of the two sides and the central top part at the same time and realize firm locking.

A clamp with an expandable arm and a plugging netting comprises an upper clamp assembly, a lower clamp assembly, a base, a locking mechanism, an expansion arm and a plugging netting; the number of the upper clamp assemblies is equal to that of the lower clamp assemblies, and the upper clamp assemblies and the lower clamp assemblies are matched in an opening and closing mode to form clamping parts; the base comprises a base body and a base supporting rod, and the base supporting rod is vertically arranged on the upper surface of the base body; the locking mechanism is movably sleeved on the base supporting rod, and the bottom of the locking mechanism is supported to the upper surface of the base body in an abutting mode; the lower part of the upper clamp assembly is fixedly arranged on one side surface of the locking mechanism, and the lower clamp assembly is movably connected to the locking mechanism and is positioned below the upper clamp assembly; the expansion arm is detachably arranged at the upper part of the lower clamping assembly and extends towards the two sides of the clamping bottom plate of the lower clamping assembly; when the upper clamping component and the lower clamping component are in a working clamping state, the expansion arms expand the valve on two sides of the clamping part, the outer edges of the expansion arms are positioned between the two adjacent or opposite lower clamping components, and the clamping range is enlarged; the expansion arm has deformability and is in a contraction state during conveying, so that the clamp is integrally compressed into a conveying system, and the injury during operation is reduced; the plugging netting is positioned in the center of the upper part of the clamping device and is arranged on the locking mechanism; the blocking netting and the expansion arm are linked to change from a contraction state to an expansion state, so that central backflow is reduced, valve leaf stress is reduced, and valve leaf damage is avoided.

Preferably, go up the clamp subassembly including the elasticity punch holder that has shape memory function set up at least one through wires hole on the plate body of elasticity punch holder the elasticity punch holder towards be equipped with coarse structure on the one side of clamp subassembly down, coarse structure includes dentate structure, barb structure or protruding structure.

Preferably, the upper clamp assembly further comprises an upper clamp connecting base plate, two ends of the upper clamp connecting base plate are respectively provided with one elastic upper clamp plate, the upper clamp connecting base plate and the elastic upper clamp plates at the two ends are integrally arranged to be of a concave structure, an upper clamp through hole is formed in the middle of the upper clamp connecting base plate, upper clamp guide limiting holes are formed in the lower parts of the two elastic upper clamp plates in a penetrating manner, and the upper clamp guide limiting holes play a role in stress release in the upper clamp heat treatment forming process; the upper surface of the upper clamp connecting bottom plate is attached to the bottom surface of the locking mechanism, and the inner side surface of the lower portion of the two elastic upper clamping plates is attached to the outer side surface of the locking mechanism.

Preferably, the elastic upper splint with the shape memory function has a preset expansion angle α, and α is 30 to 135 °.

Preferably, the lower clamp assembly comprises a lower clamp bottom plate and lower clamp side plates which are vertically arranged at two sides of the lower clamp bottom plate, and an accommodating groove cavity matched with the upper clamp assembly is formed by the lower clamp bottom plate and the lower clamp side plates; the lower part of the lower clamping side plate is connected with an outward expanding plate and a hinged plate, and the lower clamping side plate is movably connected to the locking mechanism through the outward expanding hinged plate.

Preferably, the hinged plate is provided with a hinged hole for connecting the lower clamp assembly with the locking mechanism; and the outer expanding plate is provided with a linkage hole.

Preferably, the inner sides of the upper edges of the lower clamp bottom plate and the lower clamp side plate are provided with round corners or flanges extending outwards in an arc shape.

Preferably, the locking mechanism comprises a locking seat, a hollow locking accommodating cavity is formed in the lower portion of the locking seat, an inclined boss is arranged on one side wall of the locking accommodating cavity and protrudes into the cavity, and the inclined boss is used for being embedded with the base support rod so that the locking mechanism can be positioned on the base. The locking mechanism adopts mechanical locking, and when the lower clamping assembly is closed, the locking mechanism is closed and tightly embraces the base supporting rod, so that the expansion arm is limited to be opened.

Preferably, the expansion arm comprises a strip-shaped or tubular expansion outer frame, and the expansion arm is in a form of one of, but not limited to, a semicircular ring, an omega shape formed by connecting two semicircular rings, two irregular curved butt-joint semicircular rings, two butt-joint trapezoids, or a U shape.

Preferably, an expansion inner net is arranged at the concave part of the expansion outer frame of the expansion arm.

Preferably, the pores of the expanded inner braid of the expansion arm are smaller than the outer diameter of the anti-fluid.

Preferably, the upper clamp assembly comprises two elastic upper clamp plates and is oppositely arranged at two sides of the locking mechanism, and two lower clamp assemblies are correspondingly arranged.

Preferably, the expansion arm is connected with the lower clamp assembly in a manner including but not limited to plugging, riveting, welding or screwing; wherein, the expansion arm is made of alloy or degradable high polymer material with shape memory function.

Preferably, the alloy includes, but is not limited to, nickel titanium alloy and magnesium alloy with shape memory function, and the polymer material includes degradable levorotatory polymerized lactic acid.

Preferably, the rough structure is a sawtooth row or a barb row obliquely formed from two side edges of the elastic upper clamping plate body, or a sawtooth row structure with two continuous sides being a whole strip.

Preferably, the clamping device further comprises a link arm, the link arm comprises a link base plate and a link side plate vertically arranged on the side edge of the link base plate, the lower portion of the link side plate is movably connected to the base body of the base, the upper portion of the link side plate is movably connected to the linkage hole of the lower clamping assembly, a four-link linkage mechanism is formed, and an accommodating groove formed by the link base plate and the link side plate is accommodated and matched with the lower outer contour of the lower clamping assembly.

Preferably, the expanded state of the plugging netting is in a filbert shape, an ellipsoid shape, a cone shape, a shoe-shaped ingot shape, a pillow shape, a horn shape, a saddle shape, a spherical shape, a flat spherical shape or an irregular shape; the top of the plugging woven net is provided with a preformed hole convenient for the matching of a conveying system, and the bottom of the plugging woven net is connected with the periphery of the locking mechanism through each end part of each woven net or connected with the top of the locking mechanism through a bottom contraction end of the plugging woven net.

The locking mechanism adopts a mechanical locking mode. When the lower clamp assembly is closed, the locking mechanism is closed and tightly clasps the lower rod of the base, so that the expansion arm of the lower clamp assembly is limited to be opened.

Preferably, the outer surfaces of the upper clamp assembly, the lower clamp assembly, the base, the locking mechanism, the expansion arm, the link arm and the plugging netting are coated with a biocompatible PET covering film.

Compared with the prior art, the invention has the beneficial effects that: the valve clamping device of this scheme through both sides expansion arm can effectual shutoff clamping device both sides palirrhea, nets through the shutoff of central zone and can further reduce central palirrhea, reduces valve leaf stress, avoids the valve leaf damage. Meanwhile, the device can implant a clamping device through the femoral vein atrial penetration septum in a minimally invasive mode to repair the mitral valve. The device is characterized in that the operation is finished without stopping jumping in the heart to form an effective double-hole structure, the device shortens the operation time, reduces the wound degree and reduces the operation difficulty and the operation risk.

Drawings

FIG. 1 is a schematic view of a clip with expandable arms and an occluding mesh according to the present invention;

FIG. 2 is a side view of the binder;

FIG. 3 is a schematic structural view of a part of the clamping device without the plugging netting;

FIG. 4 is a schematic top view of the original state of the binder without the plugging netting;

FIG. 5 is a schematic top view of the binder without the occluding netting in a compressed state;

FIG. 6 is a schematic view of the expansion arms increasing the capture area;

FIG. 7 is a schematic view showing a partially exploded structure of a folder with a semi-circular expanding arm and a filbert-shaped plugging net;

FIG. 8 is a schematic view of a different embodiment of the upper clamp assembly as it opens approximately 90;

FIG. 9 is a schematic view of a portion of a clip assembly with an upper clip assembly;

FIG. 10 is a bottom view of the base;

FIG. 11 is a schematic structural view of various embodiments of the dilating arms;

fig. 12 is a schematic structural view of different embodiments of the plugging netting.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.

It should be understood that "system", "device", "unit" and/or "module" as used in this specification is a method for distinguishing different components, elements, parts or assemblies at different levels. However, other words may be substituted by other expressions if they accomplish the same purpose.

As used in this specification and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural, unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include other steps or elements.

Flow charts are used in this description to illustrate operations performed by a system according to embodiments of the present description. It should be understood that the preceding or following operations are not necessarily performed in the exact order in which they are performed. Rather, the various steps may be processed in reverse order or simultaneously. Meanwhile, other operations may be added to the processes, or a certain step or several steps of operations may be removed from the processes.

A binder with expandable arms and an occluding netting, see fig. 1-12, the binder comprises an upper clamp assembly 1, a lower clamp assembly 2, a base 3, a locking mechanism 4, an expansion arm 5, a linkage arm 6 and an occluding netting 7. The clamping device of the artificial heart valve can effectively treat Mitral Regurgitation (MR) after being implanted into a human body through a minimally invasive surgery way, and can also be used for treating Tricuspid Regurgitation (TR).

The number of the upper clamp assemblies 1 is equal to that of the lower clamp assemblies 2, and the upper clamp assemblies and the lower clamp assemblies are matched to form clamping parts in an opening and closing mode. Preferably, the upper clamp assembly 1 and the lower clamp assembly 2 are respectively provided with two groups, and are symmetrically and movably connected to two sides of the locking mechanism 4. Of course, a plurality of the components can be arranged according to actual needs.

The lower clamp assembly 2, the base 3, the locking mechanism 4 and the link arm 6 form a four-bar linkage mechanism, so that the opening and closing of the valve clamp are easier to operate.

The base 3 comprises a base body 31 and a base support rod 32, wherein the base support rod 32 is vertically arranged on the upper surface of the base body 31. Two base connection holes 33 are provided on the side surface of the base body 31, and base screw holes 34 are provided on the bottom surface of the base 31.

The locking mechanism 4 is sleeved on the base support rod 32 and is supported on the upper surface of the base body 31 at the bottom; the lower portion of the upper clamp assembly 1 is fixedly arranged on one side face of the locking mechanism 4, and the lower clamp assembly 2 is movably connected to the locking mechanism 4 and located below the upper clamp assembly 1. The locking mechanism 4 is mechanically locked, and when the lower clamp assembly 2 is closed, the locking mechanism 4 is closed and hugs the base strut 32, thereby limiting the opening of the expansion arm 5.

Wherein, the base support rod 32 is a threaded rod or a disk string type rod (fig. 1 and 7) or other different embodiments.

The expansion arm 5 is detachably arranged at the upper part of the lower clamping component 2 and extends towards two sides of a clamping bottom plate of the lower clamping component 2. When the upper clamp assembly 1 and the lower clamp assembly 2 are in a working clamping state, the expansion arm 5 expands the outer edge between the two adjacent or opposite lower clamp assemblies 2 to clamp the valves on two sides of the clamping part, so as to increase the clamping range. The expansion arm 5 has deformability, and is in a contraction state during conveying, so that the clamp is integrally compressed into a conveying system, and the injury during operation is reduced.

Alternatively, the expansion arms 5 may be integrally provided on the lower clamp assembly 2.

The plugging netting 7 is positioned in the center of the upper part of the clamping device and is arranged on the locking mechanism 4. The plugging netting 7 and the expansion arm 5 are linked to change from a contraction state to an expansion state, so that central backflow is reduced, leaflet stress is reduced, and leaflet damage is avoided.

Wherein, go up clamp assembly 1 including the elasticity punch holder 11 that has shape memory function set up at least one through wires hole 12 on the plate body of elasticity punch holder 11 the face of elasticity punch holder 11 is equipped with coarse structure 14 on the one side of lower clamp assembly 2, coarse structure includes dentate structure, barb structure or protruding structure, can be for the parallel also can be the bidentate side by side structure (figure 6 and figure 8) of monodentate (figure 3, 7, 8 and 9). In an optional case, the rough structure 14 is a plurality of spaced flat plate-shaped teeth protruding perpendicularly outward from the back surface of the elastic upper clamping plate 11, and the teeth protrude outward from the outer side surface of the elastic upper clamping plate 11 to form side-by-side rectangular sheets or rectangular teeth. The interval setting can also be gradually reduced or increased from one end to the other end. The rough structure 14 is a saw tooth row or a barb row obliquely formed from two side edges of the elastic upper clamping plate 11, or a saw tooth row structure with a whole strip continuously formed on two sides.

In one embodiment, the roughness structure 14 is a row of serrations or barbs formed obliquely from both side edges of the plate body of the elastic upper clamping plate 11. The roughness 14 serves to improve the clamping force on the target tissue during clamping, enhancing the stability of the captured leaflets during surgery. The protrusions of the coarse structure 14 can be sequentially side-length, short, constant and the like from bottom to top, and can also be arranged in a long-short mode at intervals.

The threading hole 12 is used for threading a thread (not described here), fine adjustment during an operation, and the like.

The upper clamp assembly 1 comprises two elastic upper clamp plates 11 and is oppositely arranged at two sides of the locking mechanism 4, and two lower clamp assemblies 2 are correspondingly arranged.

The upper clamp assembly 1 further comprises an upper clamp connecting base plate 13, the two ends of the upper clamp connecting base plate 13 are respectively provided with one elastic upper clamp plate 11, the upper clamp connecting base plate 13 and the elastic upper clamp plates 11 at the two ends are integrally arranged to be of a concave structure, an upper clamp through hole 15 is formed in the middle of the upper clamp connecting base plate 13, an upper clamp guide limiting hole 16 is formed in the lower portion of the elastic upper clamp plate 11 in a penetrating mode, and the upper clamp guide limiting hole 16 plays a role in stress release in the upper clamp heat treatment forming process. The upper surface of the upper clamp connecting bottom plate 13 is attached to the bottom surface of the locking mechanism 4, and the inner side surface of the lower part of the two elastic upper clamp plates 11 is attached to the outer side surface of the locking mechanism 4.

Furthermore, the elastic upper splint 11 with shape memory function has a preset expansion angle α, and α is 30 to 135 °, preferably 90 °.

When the device is used in work, the elastic upper splint 11 reaches the expansion angle alpha through two independent control lines, and the valve leaflets are sequentially and independently controlled and captured.

The lower clamping assembly 2 comprises a lower clamping bottom plate 21 and lower clamping side plates 22 which are vertically arranged on two sides of the lower clamping bottom plate 21, and the lower clamping bottom plate 21 and the lower clamping side plates 22 form accommodating groove cavities matched with the upper clamping assembly 1. The lower part of the lower clamping side plate 22 is connected with an outward expanding plate 23 and a hinged plate 24, and is movably connected to the locking mechanism 4 through the outward expanding hinged plate 24.

Furthermore, the inner sides of the upper edges of the lower clamp bottom plate 21 and the lower clamp side plate 22 are rounded or flanged to extend outwards in an arc shape.

A through-hole 25 is provided in the hinge plate 24 for connecting the lower clamp assembly 2 to the locking mechanism 4. The outer expanding plate 23 is provided with a linkage hole 26.

Projections, not limited to strips, may be provided in the receiving slot to make the clamping more stable.

Wherein, the shape of the base body 31 of the base 3 can be a hemisphere, a spherical crown, a bullet shape, a symmetrical flat tip and other structures.

The locking mechanism 4 comprises a locking seat 41, a hollow locking accommodating cavity is formed in the lower portion of the locking seat 41, an inclined boss 42 is arranged on one side wall of the locking accommodating cavity and protrudes into the cavity, and the inclined boss 42 is used for being embedded with the base support rod 32 so that the locking mechanism 4 can be positioned on the base 3. Furthermore, a coupling channel is vertically opened on the locking seat 41, and the base support rod 32 of the base 3 is inserted into the coupling channel through the bottom plate hole 411 at the bottom of the locking seat 41.

Further, a locking hinge hole 412 is formed on the side surface of the locking seat 41 adjacent to the side surface on which the upper clamp assembly 1 is mounted, so that the hinge plate 24 of the lower clamp assembly 2 is movably connected to the corresponding side surface of the locking seat 41.

When the base support rod 32 of the disk string type rod is adopted, the lower end of the locking seat 41 is locked in the accommodating cavity and is provided with two inclined plane bosses 42 which are relatively flush with each other, and the two inclined plane bosses can also be plane bosses which are used for matching and positioning the disk strings on the embedded base support rod 32, so that the locking mechanism 4 is positioned on the base 3.

The movable connection includes, but is not limited to, a hinge, a pivot, etc.

Wherein the expansion arm 5 comprises a strip-shaped or tubular expansion frame 51, and the expansion arm form (see fig. 11) adopts one of, but not limited to, a semi-circular form (fig. 1-7), an omega form (fig. 5c) formed by connecting two semi-circular forms, two irregular curved butt semi-circular forms (fig. 5a), two butt-jointed trapezoidal forms (fig. 5b), or a U form (not shown).

Further, referring to fig. 11d, an expanded inner netting 52 is disposed at the inner concave portion of the expanded outer frame 51 of the expansion arm 5. The two ends of the expansion outer frame are used for connecting the lower clamp assembly 2 and the link arm 6.

Further, the pores of the expanded inner braid 52 of the expansion arms 5 are smaller than the outer diameter of the anti-fluid.

The expansion arm 5 is connected with the lower clamp assembly 2 by means of, but not limited to, plugging, riveting, welding or screwing. Wherein, the expansion arm 5 is an alloy or a degradable high polymer material with a shape memory function.

Expanding arm material: the alloy includes but is not limited to nickel-titanium alloy and magnesium alloy with shape memory function, and the high molecular material includes degradable levorotatory polymeric lactic acid.

The clamping device further comprises a link arm 6, the link arm 6 comprises a link bottom plate 61 and a link side plate 62 vertically arranged perpendicular to the side edge of the link bottom plate 61, the lower portion of the link side plate 62 is movably connected to the base body 31 of the base 3, the upper portion of the link side plate 62 is movably connected to the linkage hole 26 of the lower clamping assembly 2, so that a four-link linkage mechanism is formed, and the accommodating groove formed by the link bottom plate 61 and the link side plate 62 is accommodated and matched with the lower outer contour of the lower clamping assembly 2.

The link arm 6 further includes a link hinge hole 63 formed in a lower portion of the link side plate 62 and a link hole 64 formed in an upper portion of the link side plate 62.

The lower parts of the two connecting rod side plates 62 are movably connected with the two base connecting holes 33 of the base 3 through connecting rod hinge holes 63, such as hinged connection, pin joint and the like.

Similarly, the upper edges of the link bottom plate 61 and the link side plate 62 of the link arm 6 are rounded or flanged to extend in an outward arc, thereby reducing the damage of the plate edges or end parts to tissues.

Wherein the expanded plugging net 7 is in the shape of filbert (fig. 1, 7 and 12a), ellipsoid, cone (fig. 12c), ingot, pillow (fig. 12d), horn, saddle, sphere (fig. 12b), oblate sphere or irregular. The top of the plugging netting 7 is provided with a preformed hole convenient for the matching of a conveying system, so that the conveying system can be conveniently adopted for conveying, releasing and dissociating. The bottom of the plugging braided net 7 is connected with the periphery of the locking mechanism 4 through each end part of each braided net, or is connected with the top of the locking mechanism 4 through the bottom contraction end head of the plugging braided net 7.

Here the connection includes welding, mechanical locking, etc. conceivable means.

When not used or transported, the plugging netting 7 can be compressed into a smaller sheath, and the shape of the expanded plugging netting can be set into various flat or ellipsoidal states, so long as the plugging netting expands to play a plugging role.

The plugging netting 7 is preferably woven by shape memory metal, is thermally treated to be in a specific shape, and has radial supporting force for supporting.

Therefore, the centrally located plugging netting has three functions: reducing the reverse flow of a central area; reducing the stress of valve leaflets in the opening process of the mitral valve; and enlarging the effective valve orifice area.

Further, the outer surfaces of the upper clamp assembly 1, the lower clamp assembly 2, the base 3, the locking mechanism 4, the expansion arm 5, the link arm 6 and the plugging netting 7 are coated with a biocompatible PET (polyethylene terephthalate) coating film.

In another embodiment, the upper clamp assembly 1, the lower clamp assembly 2, the base 3, the locking mechanism 4, the expansion arm 5, the link arm 6 and the occlusion mesh 7 are themselves made at least partially of a biocompatible material such as polyester, silicone, stainless steel, cobalt alloy, nickel titanium, cobalt chromium alloy or titanium alloy, preferably stainless steel or cobalt chromium alloy.

In another embodiment, the upper clamp assembly 1, the lower clamp assembly 2, the base 3, the locking mechanism 4, the expansion arm 5, the link arm 6 and the plugging mesh 7 are made of a metal material or a metal alloy selected from common implantation metals such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. The utility model provides a take fastener of expansible arm and shutoff netting which characterized in that: the clamping device comprises an upper clamping assembly (1), a lower clamping assembly (2), a base (3), a locking mechanism (4), an expansion arm (5) and a plugging netting (7); the upper clamp assemblies (1) and the lower clamp assemblies (2) are equal in number and are matched in an opening and closing manner to form clamping parts;

the base (3) comprises a base body (31) and a base supporting rod (32), and the base supporting rod (32) is vertically arranged on the upper surface of the base body (31);

the locking mechanism (4) is movably sleeved on the base supporting rod (32) and the bottom of the locking mechanism is supported to the upper surface of the base body (31) in an abutting mode;

the lower part of the upper clamp assembly (1) is fixedly arranged on one side surface of the locking mechanism (4), and the lower clamp assembly (2) is movably connected to the locking mechanism (4) and is positioned below the upper clamp assembly (1);

the expansion arm (5) is detachably arranged at the upper part of the lower clamp assembly (2) and extends towards the two sides of the clamping bottom plate of the lower clamp assembly (2); when the upper clamping component (1) and the lower clamping component (2) are in a working clamping state, the expansion arm (5) expands the outer edge between the two adjacent or opposite lower clamping components (2) to clamp the valves on two sides of the clamping part, so as to increase the clamping range; the expansion arm (5) has deformability and is in a contraction state during conveying, so that the clamp is integrally compressed into a conveying system, and the damage during operation is reduced;

the plugging netting (7) is positioned in the center of the upper part of the clamping device and is arranged on the locking mechanism (4); the plugging netting (7) and the expansion arm (5) are linked to change from a contraction state to an expansion state, so that central backflow is reduced, valve leaf stress is reduced, and valve leaf damage is avoided.

2. The binder of claim 1, wherein: go up clamp assembly (1) including elasticity punch holder (11) that have shape memory function set up at least one through wires hole (12) on the plate body of elasticity punch holder (11) the orientation of elasticity punch holder (11) is equipped with coarse structure (14) down on the one side of clamp assembly (2), coarse structure includes dentate structure, barb structure or protruding structure.

3. The binder of claim 2, wherein: the upper clamp assembly (1) further comprises an upper clamp connecting base plate (13), two ends of the upper clamp connecting base plate (13) are respectively provided with one elastic upper clamp plate (11), the upper clamp connecting base plate (13) and the elastic upper clamp plates (11) at the two ends are integrally arranged to be of a concave structure, an upper clamp through hole (15) is formed in the middle of the upper clamp connecting base plate (13), upper clamp guide limiting holes (16) are formed in the lower parts of the two elastic upper clamp plates (11) in a penetrating mode, and the upper clamp guide limiting holes (16) play a role in stress release in the process of an upper clamp heat treatment forming process; the upper surface of the upper clamp connecting bottom plate (13) is attached to the bottom surface of the locking mechanism (4), and the inner side surface of the lower part of the two elastic upper clamp plates (11) is attached to the outer side surface of the locking mechanism (4).

4. A binder as claimed in claim 2 or 3, wherein: the elastic upper splint (11) with the shape memory function has a preset expansion angle alpha which is 30-135 degrees.

5. The binder of claim 4, wherein: the lower clamp assembly (2) comprises a lower clamp bottom plate (21) and lower clamp side plates (22) which are vertically arranged at two sides of the lower clamp bottom plate (21), and an accommodating groove cavity matched with the upper clamp assembly (1) is formed by the lower clamp bottom plate (21) and the lower clamp side plates (22);

the lower part of the lower clamping side plate (22) is connected with an outward expanding plate (23) and a hinged plate (24), and the lower clamping side plate is movably connected to the locking mechanism (4) through the outward expanding hinged plate (24).

6. The binder of claim 5, wherein: a hinged hole (25) is formed in the hinged plate (24) in a penetrating manner and is used for connecting the lower clamping assembly (2) with the locking mechanism (4); and a linkage hole (26) is formed in the outer expanding plate (23).

7. The binder of claim 5, wherein: and the inner sides of the upper edges of the lower clamp bottom plate (21) and the lower clamp side plate (22) are rounded or flanged outwards in an arc extension manner.

8. The binder of claim 4, wherein: the locking mechanism (4) comprises a locking seat (41), a hollow locking accommodating cavity is formed in the lower portion of the locking seat (41), an inclined boss (42) is arranged on one side wall of the locking accommodating cavity in a protruding mode and used for being embedded into the base support rod (32), and the locking mechanism (4) is located on the base (3); the locking mechanism (4) adopts mechanical locking, and when the lower clamping assembly (2) is closed, the locking mechanism (4) is closed and tightly embraces the base support rod (32), so that the expansion arm (5) is limited to be opened.

9. The binder of claim 4, wherein: the expansion arm (5) comprises a strip-shaped or tubular expansion outer frame (51), and the expansion arm is in a form of one of, but not limited to, a semicircular ring, an omega shape formed by connecting two semicircular rings, two irregular curved butt joint semicircular rings, two butt joint trapezoids or a U shape.

10. The clip according to claim 9, wherein: an expansion inner net (52) is arranged at the concave part of the expansion outer frame (51) of the expansion arm (5).

11. The clip of claim 10, wherein: the pores of the expanded inner netting (52) of the expansion arm (5) are smaller than the outer diameter of the anti-fluid.

12. The binder of claim 4, wherein: the upper clamp assembly (1) comprises two elastic upper clamp plates (11) which are oppositely arranged on two sides of the locking mechanism (4), and two lower clamp assemblies (2) are correspondingly arranged.

13. The clip of claim 10, wherein: the expansion arm (5) is connected with the lower clamp assembly (2) in a connecting mode including but not limited to inserting, riveting, welding or threaded connection; wherein, the expansion arm (5) is made of alloy or degradable high polymer material with shape memory function.

14. The clip according to claim 13, wherein: the alloy includes but is not limited to nickel-titanium alloy and magnesium alloy with shape memory function, and the high molecular material includes degradable levorotatory polymeric lactic acid.

15. The binder of claim 2, wherein: the rough structure (14) is a sawtooth row or an agnail row formed by inclining from two side edges of the elastic upper clamping plate (11) plate body, or a sawtooth row structure with two continuous sides being a whole strip.

16. The binder of claim 6, wherein: the clamping device further comprises a link arm (6), the link arm (6) comprises a link bottom plate (61) and a link side plate (62) which is perpendicular to the side edge of the link bottom plate (61), the lower portion of the link side plate (62) is movably connected to the base body (31) of the base (3), the upper portion of the link side plate (62) is movably connected to the linkage hole (26) of the lower clamping assembly (2) to form a four-link linkage mechanism, and an accommodating groove formed by the link bottom plate (61) and the link side plate (62) is accommodated and matched with the lower outer contour of the lower clamping assembly (2).

17. The binder of claim 1, wherein: the expanded state of the plugging netting (7) is in a filbert shape, an ellipsoid shape, a cone shape, a shoe-shaped ingot shape, a pillow shape, a horn shape, a saddle shape, a spherical shape, a flat spherical shape or an irregular shape; the top of the plugging netting (7) is provided with a preformed hole convenient for the matching of a conveying system, and the bottom of the plugging netting (7) is connected with the periphery of the locking mechanism (4) through each end part of each netting or connected with the top of the locking mechanism (4) through the bottom contraction end of the plugging netting (7).

18. The clip of claim 16, wherein: the outer surfaces of the upper clamp assembly (1), the lower clamp assembly (2), the base (3), the locking mechanism (4), the expansion arm (5), the link arm (6) and the plugging netting (7) are coated with a biocompatible PET film.