CN116407343A - Valve repairing device capable of being clamped secondarily - Google Patents

Abstract

The invention provides a valve repairing device capable of being clamped secondarily, which comprises a pushing catheter, a chuck assembly and a pre-clamping assembly. The chuck assembly comprises a chuck push rod movably penetrating the pushing catheter and a proximal chuck and a distal chuck which can be opened and closed relatively. The pre-clamping assembly comprises an upper clamping piece and a lower clamping piece, the upper clamping piece comprises an upper push rod and an upper clamping part arranged at the far end of the upper push rod, and the lower clamping piece comprises a lower push rod and a lower clamping part arranged at the far end of the lower push rod. The valve repair device has a working state, in the working state, the upper clamping part is provided with a first clamping surface, the lower clamping part is provided with a second clamping surface, the first clamping surface is matched with the second clamping surface to clamp the valve leaflet, and the proximal clamping head is matched with the distal clamping head to clamp the valve leaflet again; wherein the ratio of the area of the first clamping surface to the area of the leaflet ranges from [ 1/6-1); the ratio of the area of the second clamping surface to the area of the valve leaflet is 1/6-1, so that the valve leaflet can be prevented from folding, and the operation effect is ensured.

Description

Valve repairing device capable of being clamped secondarily

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a valve repairing device capable of being clamped secondarily.

Background

Heart valves such as mitral and tricuspid valves are unidirectional "valves" between the atrium and ventricle, ensuring that blood can only flow from the atrium to the ventricle. Failure of the heart may be caused by valve insufficiency when chordae tendineae of the heart valve are diseased or ruptured, causing mitral regurgitation or tricuspid regurgitation, resulting in regurgitation of blood from the ventricles to the atria, causing a series of pathological changes and clinical symptoms of the heart, and in severe cases.

Wherein the mitral valve comprises two leaflets of anterior and posterior leaflet, and the tricuspid valve comprises three leaflets of anterior leaflet, septal leaflet and posterior leaflet. The valve leaflet comprises a rough belt and a transparent belt, wherein the rough belt is positioned at the edge of the valve leaflet and is an involution surface for opening and closing the valve leaflet, and the structure is thicker; the transparent belt is positioned above the rough belt, and the structure is thinner.

A traditional suture implanter can treat valve insufficiency, the suture implanter clamps valve leaflets through two chucks, then suture is implanted on rough bands positioned at the edges of the valve leaflets, and the heart valve insufficiency is treated through the suture. Because the area of the capture surface of the suture implant for capturing the leaflet is too small and the leaflet can swing up and down during heart activity, the two jaws must rely on the instrument's anterior tip leaflet to effect the clamping of the leaflet when clamping the leaflet. However, the operation mode has the risks of leaflet folding and stacking caused by inaccurate clamping amount of the leaflets and excessive clamping, and the two chucks are easy to clamp to the transparent belt of the leaflets, so that the suture implantation position is too close to the transparent belt, and the suture is subjected to excessive leaflet resultant force to influence the service life of the suture; moreover, the thickness of the transparent belt is thinner, so that the anchoring force applied to the suture is smaller, and the risk of falling off the suture is larger.

Disclosure of Invention

In order to solve the technical problems, the invention provides a valve repairing device capable of being clamped secondarily, which can avoid the condition that a valve leaflet is folded in a secondary clamping mode, so that a suture is stably and accurately implanted into a rough belt positioned at the edge of the valve leaflet, the implantation position of the suture is ensured to be safe and reliable, the service life of the suture is prolonged, the suture is not easy to fall off, and the effect of an operation is ensured.

The invention provides a valve repair device capable of being clamped secondarily, which comprises a pushing catheter, a chuck assembly and a pre-clamping assembly. The chuck assembly comprises a chuck push rod movably penetrating through the pushing catheter, a proximal chuck and a distal chuck, wherein the proximal chuck and the distal chuck can be opened and closed relatively, the proximal chuck is arranged at the distal end of the pushing catheter, and the distal chuck is arranged at the distal end of the chuck push rod. The pre-clamping assembly comprises an upper clamping piece and a lower clamping piece, the upper clamping piece comprises an upper push rod movably arranged in the pushing duct in a penetrating mode and an upper clamping portion arranged at the far end of the upper push rod, and the lower clamping piece comprises a lower push rod movably arranged in the pushing duct in a penetrating mode and a lower clamping portion arranged at the far end of the lower push rod. The valve repair device has an operating state in which the upper clamping portion and the lower clamping portion are located outside the distal end of the pushing catheter, the upper clamping portion has a first clamping surface, the lower clamping portion has a second clamping surface, the first clamping surface cooperates with the second clamping surface to clamp the leaflet, and the proximal collet cooperates with the distal collet to again clamp the leaflet. Wherein the ratio of the area of the first clamping surface to the area of the leaflet ranges from [ 1/6-1); the ratio of the area of the second clamping surface to the area of the leaflet ranges from [1/6-1 ].

According to the valve repair device provided by the invention, the clamp head assembly and the pre-clamping assembly are conveyed to the vicinity of a valve through the pushing catheter; then, the valve leaflet is pre-clamped by the first clamping surface of the upper clamping part and the second clamping surface of the lower clamping part, and then the proximal clamp and the distal clamp are operated by the clamp push rod penetrating through the pushing catheter to secondarily clamp the valve leaflet. Because the area ratio range of the first clamping surface and the second clamping surface to the valve leaflet is 1/6-1), when the valve leaflet is clamped by the first clamping surface and the second clamping surface, the valve leaflet can be completely flattened, and the condition that the valve leaflet is folded and piled up is avoided, so that the valve leaflet is kept flattened after the valve leaflet is clamped again by the proximal chuck and the distal chuck, the suture can be stably and accurately implanted into a rough belt positioned at the edge position of the valve leaflet, the implantation position of the suture is ensured to be safe and reliable, the suture is prevented from being subjected to larger valve leaflet alignment force, and the service life of the suture is prolonged; and because the thickness of the rough belt is thicker, the suture implanted in the rough belt can be subjected to larger anchoring force, so that the suture is not easy to fall off, and the effect of the operation is ensured.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic perspective view of a valve repair device capable of being clamped secondarily in an operating state according to an embodiment of the present invention.

Fig. 2 is an enlarged view of the portion II in fig. 1.

Fig. 3 is a schematic perspective view of the valve repair device of fig. 1 in a delivery state.

Fig. 4 is an enlarged view of the IV portion in fig. 3.

Fig. 5 is an exploded perspective view of the valve repair device of fig. 1.

Fig. 6 is a schematic perspective view of the pre-clamping assembly of fig. 5.

Fig. 7 is a schematic perspective view of the pusher catheter and proximal clip of fig. 5.

Fig. 8 is a schematic perspective view of the omitted proximal chuck of fig. 7.

Fig. 9 is a schematic perspective view of a proximal clip, a pusher catheter, and a distal clip when another valve repair device according to an embodiment of the present invention is in a delivery configuration.

Fig. 10 is a top view of the valve repair device of fig. 1 holding a leaflet.

Fig. 11 is a top view of another valve repair device provided in an embodiment of the present invention holding a leaflet.

Fig. 12 is a top view of yet another valve repair device provided by an embodiment of the present invention holding a leaflet.

Fig. 13 is a schematic view of a portion of the upper and lower holders of fig. 5 holding the leaflet.

Fig. 14 is another perspective view of the pusher catheter and proximal clip of fig. 5.

Fig. 15 is an enlarged view of the XV portion in fig. 14.

Fig. 16 is a schematic perspective view of the push catheter, proximal collet and pre-clamping assembly of fig. 5 assembled.

Fig. 17 is an enlarged view of the XVII portion in fig. 16.

Fig. 18 is a schematic perspective view of the push catheter, pre-grip assembly and handle assembly of fig. 5 (with the housing and seal omitted).

Fig. 19 is a cross-sectional view taken along XIX-XIX of fig. 18.

Fig. 20 is an exploded perspective view of the first stopper ring, the upper coupling knob, the second stopper ring and the lower coupling knob of fig. 18.

Fig. 21 is a schematic perspective view of the push catheter of fig. 18 assembled with a connecting structure.

Fig. 22 is an exploded perspective view of the push catheter and connection structure of fig. 18.

Fig. 23 is a partial cross-sectional view of the valve repair device of fig. 5, as assembled, in an axial direction.

Fig. 24 is an enlarged view of the XXIV portion in fig. 23.

Fig. 25 is a schematic perspective view of a suture assembly provided in an embodiment of the present invention.

Fig. 26 is an enlarged view of the XXV portion in fig. 5.

FIGS. 27-33 are schematic views of a valve repair device according to an embodiment of the present invention, during suture implantation in the anterior leaflet of the mitral valve; wherein fig. 31 is an enlarged view of the portion XXXI in fig. 30.

Detailed Description

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

Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional terms, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present invention are merely referring to the directions of the attached drawings, and thus, directional terms are used for better, more clear explanation and understanding of the present invention, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

Orientation definition: for clarity of description, the end proximal to the operator and the end distal to the operator will be referred to as the "proximal end" in the surgical procedure; axial refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction; the connection between the "component a" and the "component B" may be a direct contact connection between the "component a" and the "component B", or an indirect connection between the "component a" and the "component B" via the "component C". The above definitions are for convenience of description only and are not to be construed as limiting the invention.

Referring to fig. 1 and 33, avalve repair device 100 capable of being clamped twice is provided in an embodiment of the invention. Thevalve repair device 100 may be used to intervene in mitral regurgitation or tricuspid regurgitation via the apex path, as described in detail below with respect to thevalve repair device 100. In use of thevalve repair device 100, one of the leaflets is pre-clamped, re-clamped, through the orifice of the mitral valve and thensutures 201 are implanted on theleaflet 1 to reduce or eliminate mitral regurgitation.Suture 201 may be used as an artificial chordae to replace diseased or broken chordae within the patient's heart; or a plurality ofsutures 201 secured to one another to effect edge-to-edge repair of the mitral valve. Theleaflet 1 of the mitral valve includes ananterior leaflet 1b and aposterior leaflet 1a, and the leaflet of the tricuspid valve includes an anterior leaflet, a septal leaflet, and a posterior leaflet. The orifice of the mitral valve refers to the space between theanterior leaflet 1b and theposterior leaflet 1 a.

Referring to fig. 1 to 12, a secondary-clampvalve repair device 100 according to an embodiment of the present invention includes apush catheter 10, achuck assembly 20, and apre-clamp assembly 30. Thecollet assembly 20 comprises acollet push rod 21 movably inserted into thepush catheter 10, aproximal collet 22 and adistal collet 23 which are relatively openable and closable, wherein theproximal collet 22 is disposed at the distal end of thepush catheter 10, and thedistal collet 23 is disposed at the distal end of thecollet push rod 21. Thepre-clamping assembly 30 comprises anupper clamping piece 31 and alower clamping piece 32, wherein theupper clamping piece 31 comprises anupper push rod 311 movably penetrating through the pushingcatheter 10 and anupper clamping part 312 arranged at the far end of theupper push rod 311, and thelower clamping piece 32 comprises alower push rod 321 movably penetrating through the pushingcatheter 10 and alower clamping part 322 arranged at the far end of thelower push rod 321. Thevalve repair device 100 has an operating state in which theupper clamp portion 312 and thelower clamp portion 322 are located outside the distal end of thepush catheter 10, theupper clamp portion 312 has afirst clamp surface 3121, thelower clamp portion 322 has asecond clamp surface 3221, thefirst clamp surface 3121 cooperates with thesecond clamp surface 3221 to clamp theleaflet 1, and theproximal clamp head 22 cooperates with thedistal clamp head 23 to again clamp theleaflet 1. Wherein the ratio of the area of thefirst clamping surface 3121 to the area of theleaflet 1 ranges from [ 1/6-1); the ratio of the area of thesecond clamping surface 3221 to the area of theleaflet 1 ranges from [1/6-1 ].

Thevalve repair device 100 is configured to deliver thecollet assembly 20 and thepre-clamping assembly 30 to the vicinity of the valve via thepush catheter 10; then, thefirst clamping surface 3121 of theupper clamping portion 312 and thesecond clamping surface 3221 of thelower clamping portion 322 are used for pre-clamping thevalve leaflet 1, and then theproximal clamp 22 and thedistal clamp 23 are operated to secondarily clamp thevalve leaflet 1 by operating theclamp push rod 11 penetrating thepush catheter 10, and after theproximal clamp 22 and thedistal clamp 23 clamp thevalve leaflet 1, the operation of implanting thesuture thread 201 into thevalve leaflet 1 can be performed to treat the heart valve insufficiency. Because the area ratio range of thefirst clamping surface 3121 and thesecond clamping surface 3221 to thevalve leaflet 1 is 1/6-1, when thevalve leaflet 1 is clamped by thefirst clamping surface 3121 and thesecond clamping surface 3221, thevalve leaflet 1 can be completely flattened, the condition that thevalve leaflet 1 is folded and piled up is avoided, thevalve leaflet 1 is kept flattened after thevalve leaflet 1 is clamped again by theproximal clamping head 22 and thedistal clamping head 23 is ensured, thesuture 201 can be stably and accurately implanted into a rough belt positioned at the edge position of thevalve leaflet 1, the implantation position of thesuture 201 is ensured to be safe and reliable, thesuture 201 is prevented from being subjected to larger valve leaflet aligning force, and the service life of thesuture 201 is prolonged; and because the thickness of the rough belt is thicker, thesuture 201 implanted in the rough belt can bear larger anchoring force, so that thesuture 201 is not easy to fall off, and the effect of the operation is ensured.

It should be noted that, taking the ratio of the area of thefirst clamping surface 3121 to the area of theleaflet 1 as an example, the ratio range is [1/6-1 ], it means that the ratio of the area of thefirst clamping surface 3121 to the area of theleaflet 1 may be 1/6, or any value greater than 1/6 and less than 1. Preferably, the ratio of the area of thefirst clamping surface 3121 to the area of theleaflet 1 and the ratio of the area of thesecond clamping surface 3221 to the area of theleaflet 1 are both in the range of [1/4-4/5], more preferably the ratio is in the range of [1/3-4/5], such as 1/2, so that thefirst clamping surface 3121 and thesecond clamping surface 3221 are easy to clamp theleaflet 1 and theleaflet 1 is more effective in flattening. The area of theleaflet 1 can be obtained by taking an average of a plurality of samples. Since the areas of the mitral valve and the tricuspid valve are different, the area of thefirst clamping surface 3121 and the area of thesecond clamping surface 3221 are set fordifferent valve leaflets 1; thesuture 201 is implanted indifferent valve leaflets 1, and thevalve repair device 100 with different specifications can be selected in a targeted manner.

In the present invention, the distal face of theproximal collet 22 cooperates with the proximal face of thedistal collet 23 to again grip theleaflet 1. Optionally, the distal surface of theproximal chuck 22 is parallel to the proximal surface of thedistal chuck 23, so that when theproximal chuck 22 and thedistal chuck 23 clamp theleaflet 1, the distal surface of theproximal chuck 22 and the proximal surface of thedistal chuck 23 have a larger contact area with theleaflet 1, which is beneficial for theproximal chuck 22 and thedistal chuck 23 to clamp theleaflet 1. In one example, the proximal face of thedistal collet 23 is disposed distally inclined from thecollet push rod 21, and the distal face of theproximal collet 22 is parallel to the proximal face of thedistal collet 23.

In the present invention, in the operating state, theupper clamp portion 312 is located on the distal end side of thelower clamp portion 322, thefirst clamp surface 3121 is a surface of theupper clamp portion 312 facing thelower clamp portion 322, and thesecond clamp surface 3221 is a surface of thelower clamp portion 322 facing theupper clamp portion 312. The following is based on this description. The "first", "second", etc. are for convenience of description only and are not to be construed as limiting the invention.

Referring to fig. 1 to 6, in some embodiments, theupper clamping portion 312 and thelower clamping portion 322 are made of a material with a shape memory function. Thevalve repair device 100 also has a delivery state. In the delivery state, theupper clamping portion 312 and thelower clamping portion 322 are compressively deformed and at least partially received in thepush catheter 10; in the working state, theupper clamping part 312 completely penetrates thepush catheter 10 and expands, theupper clamping part 312 bends relative to theupper push rod 311, thelower clamping part 322 completely penetrates thepush catheter 10 and expands, thelower clamping part 322 bends relative to thelower push rod 321, and theupper clamping part 312 and thelower clamping part 322 are both positioned between thedistal chuck 23 and thepush catheter 10.

It will be appreciated that theupper clamping portion 312 and thelower clamping portion 322 are made of a material having a shape memory function, and theupper clamping portion 312 and thelower clamping portion 322 can be kept flat (as shown in fig. 2) when they are not exposed to an external force after being shaped, and can be deformed to reduce the volume (as shown in fig. 4) when they are exposed to an external force. Therefore, theupper clamping portion 312 and thelower clamping portion 322 can be sized larger, ensuring that the area of thefirst clamping surface 3121 and thesecond clamping surface 3221 in the operating state is sufficiently large. Thus, when thefirst clamping surface 3121 and thesecond clamping surface 3221 clamp the leaflet 1 (as shown in fig. 10), both can complete flattening of theleaflet 1, avoiding folding and stacking of theleaflet 1. In the working state, theupper clamping portion 312 and thelower clamping portion 322 are bent along the radial direction away from thechuck push rod 21 relative to theupper push rod 311 and the lower push rod 321 (as shown in fig. 2), so that interference between theupper clamping portion 312 and thelower clamping portion 322 and thechuck push rod 21 can be avoided, and further, the situation that theupper clamping portion 312 and thelower clamping portion 322 cannot be completely unfolded due to blocking of thechuck push rod 21 is avoided; on the other hand, since theupper clamping portion 312 and thelower clamping portion 322 are bent in the same direction relative to theupper push rod 311 and thelower push rod 321, the projections of theupper clamping portion 312 and thelower clamping portion 322 in the radial direction have a larger overlapping area or substantially overlap, which is beneficial for theupper clamping portion 312 and thelower clamping portion 322 to clamp theleaflet 1. The material having a shape memory function may be selected from ti—ni based shape memory alloys, copper based shape memory alloys, iron based shape memory alloys, shape memory polymers, etc., such as nickel titanium alloys, to which the present invention is not limited in any way.

When thevalve repair device 100 is in the delivery state, theproximal clamp 22 and thedistal clamp 23 are in a closed state, and thevalve repair device 100 has a smaller cross-sectional area in the radial direction due to the compression deformation of theupper clamping portion 312 and thelower clamping portion 322 and the at least partial accommodation in thepush catheter 10; on the one hand, the size of the operation wound caused by the delivery of thevalve repair device 100 is reduced, and the postoperative rehabilitation of a patient is facilitated; on the other hand, it is advantageous to avoid damage to theleaflet 1 by pressing the leaflet 1 (as shown in fig. 10) when thevalve repair device 100 passes through the orifice of the mitral valve. After thevalve repair device 100 passes through the orifice of the mitral valve, thevalve repair device 100 is switched from the delivery state to the operational state. Thecollet pusher 21 moves thedistal collet 23 distally to open theproximal collet 22. Theupper push rod 311 drives theupper clamping part 312 to completely penetrate out of the distal end of the pushingcatheter 10, and theupper clamping part 312 bends and expands relative to theupper push rod 311 under the action of the shape memory function of theupper push rod 311; thelower push rod 321 drives thelower clamping part 322 to completely penetrate out of the distal end of the pushingcatheter 10, and thelower clamping part 322 bends and expands relative to thelower push rod 321 under the action of the self shape memory function; thefirst clamping surface 3121 cooperates with thesecond clamping surface 3221 to clamp theleaflet 1, and theproximal clamp 22 cooperates with thedistal clamp 23 to again clamp theleaflet 1.

Referring to fig. 5 to 8, in some embodiments, thepush catheter 10 includes amain body 11, thepush catheter 10 is provided with apush rod cavity 12 and apush cavity 111 extending axially through opposite end surfaces of themain body 11, achuck push rod 21 is movably inserted into thepush rod cavity 12, and anupper push rod 311 and alower push rod 321 are movably inserted into thepush cavity 111. Further, the pushingcavity 111 includes an upper pushingcavity 1111 and a lower pushingcavity 1112, the upper pushingcavity 1111 is closer to thepush rod cavity 12 than the lower pushingcavity 1112, theupper push rod 311 is movably mounted in the upper pushingcavity 1111, and thelower push rod 311 is movably mounted in the lower pushingcavity 1112.

It can be appreciated that, since thecollet push rod 21, theupper push rod 311 and thelower push rod 321 are movably installed in different inner cavities of thepush catheter 10, friction or collision of thecollet push rod 21, theupper push rod 311 and thelower push rod 321 during moving in thepush catheter 10 can be avoided, and smoothness of axial movement of thecollet push rod 21, theupper push rod 311 and thelower push rod 321 is ensured. In other embodiments, theupper push rod 311 and thelower push rod 321 may be movably disposed in the pushingcavity 111.

In the examples of fig. 5 to 8, in the working state, theupper clamping portion 312 and thelower clamping portion 322 are both in a non-closed annular structure, and the number of theupper push rod 311 and thelower push rod 321 is two. Opposite ends of theupper clamping part 312 are respectively connected with distal ends of the twoupper push rods 311, and opposite ends of thelower clamping part 322 are respectively connected with distal ends of the twolower push rods 321. Theupper clamping part 312 forms a stable non-closed loop structure by being connected to the twoupper push rods 311, and thelower clamping part 322 forms a stable non-closed loop structure by being connected to the twolower push rods 321. The non-closed ring structure may be a non-closed circular ring, a non-closed elliptical ring, a non-closed square ring, a non-closed rectangular ring, etc., and the shape of theupper clamping portion 312 and thelower clamping portion 322 is not particularly limited in the present invention. It should be noted that the shape of theupper clamping portion 312 and thelower clamping portion 322 may be the same or different.

Correspondingly, the number of theupper push cavity 1111 and thelower push cavity 1112 is two, the twoupper push cavities 1111 are respectively located at two sides of thepush rod cavity 12, and the twolower push cavities 1112 are respectively located at two sides of thepush rod cavity 12. The twoupper push rods 311 are respectively movably arranged in the twoupper push cavities 1111 in a penetrating way; two push downrods 321 are movably mounted in the two push downchambers 1112, respectively. When thevalve repairing device 100 is converted from the working state to the delivery state, the twoupper push rods 311 move axially and proximally in the twoupper push cavities 1111 respectively, so that the opposite ends of theupper clamping portion 312 can be driven to move axially and proximally and penetrate into the twoupper push cavities 1111 respectively until theupper clamping portion 312 abuts against thepush catheter 10 or theproximal chuck 22 to be tightened; the two push downrods 321 move axially and proximally in the two push downchambers 1112 respectively, and can drive the opposite ends of thelower clamping portion 322 to move axially and proximally to penetrate into the two push downchambers 1112 respectively until thelower clamping portion 322 abuts against thepush catheter 10 or theproximal chuck 22 to tighten. Thus, when thevalve repair device 100 is in the delivery state, the upper andlower clip portions 312, 322 are mostly received in thepush lumen 111, and a small portion is exposed outside the distal end of thepush lumen 111, i.e., outside the distal end of thepush catheter 10.

In other embodiments, theupper push chamber 1111 and thelower push chamber 1112 on the same side of thepush rod chamber 12 may also communicate, i.e., theupper push rod 311 and thelower push rod 321 on the same side of thepush rod chamber 12 share onepush chamber 111.

Referring to fig. 4 and 7, in some embodiments, theproximal chuck 22 is protruding from thedistal end surface 112 of themain body 11, and arelief groove 222 is formed between thesidewall 221 of theproximal chuck 22 and thedistal end surface 112 of themain body 11, where therelief groove 222 communicates with the upper pushingcavity 1111 and the lower pushingcavity 1112. In the transport state, theupper clamp 312 is accommodated in theescape groove 222 and theupper push chamber 1111, and thelower clamp 322 is accommodated in theescape groove 222 and thelower push chamber 1112. It will be appreciated that theproximal collet 22 may be integrally formed with thepush catheter 10; or may be secured to thepusher catheter 10 by welding, as not limited in this application.

In the example of fig. 7, distal outlets of the twoupper push chambers 1111 and the twolower push chambers 1112 are both provided on thedistal end face 112 of themain body section 11, and theavoidance groove 222 communicates with the twoupper push chambers 1111 and the twolower push chambers 1112. When thevalve repair device 100 is in the delivery state, theproximal clip 22 and thedistal clip 23 are in the closed state, the portion of theupper clip portion 312 exposed outside thepush catheter 10 is received in theevacuation groove 222, and the portion of thelower clip portion 322 exposed outside thepush catheter 10 is received in theevacuation groove 222. At this point, the upper andlower clamp portions 312, 322 are partially located between the distal face of the push catheter 10 (i.e., the distal face of the body section 11) and the proximal face of thedistal collet 23. The design of theavoidance groove 222 can avoid theupper clamping portion 312 and thelower clamping portion 322 interfering with the closing of theproximal chuck 22 and thedistal chuck 23, and theproximal chuck 22 and thedistal chuck 23 can be relatively closed to almost no gap, so that thevalve repair device 100 can form a smooth whole, and the surgical wound caused by pushing thevalve repair device 100 can be reduced.

In other embodiments, therelief groove 222 may not be provided, i.e., thedistal face 112 of thebody segment 11 is completely obscured by theproximal collet 22. The distal outlets of the twoupper push chambers 1111 and the twolower push chambers 1112 are disposed on the distal side wall of themain body section 11, and theupper clamping portion 312 of the non-closed annular structure extends out from the distal outlet of theupper push chamber 1111 to be exposed outside the distal end of thepush catheter 10 and is wound on the distal side wall of themain body section 11, and thelower clamping portion 322 of the non-closed annular structure extends out from the distal outlet of thelower push chamber 1112 to be exposed outside the distal end of thepush catheter 10 and is wound on the distal side wall of themain body section 11.

Referring to fig. 2, 4 and 9, in some embodiments, when thevalve repair device 100 is in the delivery state, theupper clamping portion 312 and thelower clamping portion 322 are sequentially stacked in thedodging slot 222 along the axial direction, in other words, thelower clamping portion 322 is located between theupper clamping portion 312 and thedistal end face 112 of themain body segment 11 along the axial direction. Compared with the design that theupper clamping part 312 and thelower clamping part 322 which are accommodated in theavoidance groove 222 are arranged along the radial direction, the radial dimension of the pushingcatheter 10 is reduced by the design, so that the radial dimension of thevalve repair device 100 in the conveying state is reduced, and thevalve repair device 100 is conveyed more conveniently.

Alternatively, when theupper clamp portion 312 and thelower clamp portion 322 are stacked in theescape groove 222 in order in the axial direction, the groove depth of the escape groove 222 (i.e., the dimension of theescape groove 222 in the axial direction) is equal to or greater than the sum of the dimensions of theupper clamp portion 312 and thelower clamp portion 322 in the axial direction.

In the example of fig. 2 and 4, the groove depth of therelief groove 222 is greater than the sum of the axial dimensions of theupper clamp portion 312 and thelower clamp portion 322. When thevalve repair device 100 is in operation, theleaflet 1 is pressed against the distal surface of theproximal clip 22 after theleaflet 1 is gripped between the distal surface of thepusher catheter 10 and the proximal surface of thedistal clip 23 by theupper grip portion 312 and the lower grip portion 322 (as shown in fig. 10), and the surface of theupper grip portion 312 facing away from thelower grip portion 322 is substantially flush with the distal surface of theproximal clip 22. At this time, theupper clamping portion 312 and thelower clamping portion 322 clamp theleaflet 1 to be completely flattened. In this way, when theproximal chuck 22 and thedistal chuck 23 clamp theleaflet 1 again, theupper clamping portion 312 is prevented from interfering with the secondary clamping of theleaflet 1 by thedistal chuck 23 and theproximal chuck 22, so as to avoid the situation that theleaflet 1 cannot be clamped due to the blocking of theupper clamping portion 311 by thedistal chuck 23 and theproximal chuck 22.

In the example of fig. 9, the groove depth of therelief groove 222 is equal to the sum of the dimensions of theupper clamp portion 312 and thelower clamp portion 322 in the axial direction. The proximal end surface of thedistal chuck 23 is provided with aclearance groove 231 corresponding to theclearance groove 222, and theclearance groove 231 is communicated with theclearance groove 222 when theproximal chuck 22 and thedistal chuck 23 are in a closed state. Because the sum of the axial dimensions of theupper clamping portion 312 and thelower clamping portion 322 is equal to the groove depth of theavoidance groove 222 when theupper clamping portion 322 and thelower clamping portion 322 are accommodated in theavoidance groove 222, when thevalve repair device 100 in the working state clamps the leaflet 1 (as shown in fig. 10) between the distal end surface of thepush catheter 10 and the proximal end surface of thedistal chuck 23 through theupper clamping portion 312 and thelower clamping portion 322, theleaflet 1 is pressed against the distal end surface of theproximal chuck 22, the surface of theupper clamping portion 312 facing away from thelower clamping portion 322 is farther away from thedistal end surface 112 of themain body section 11 than the distal end surface of theproximal chuck 22, and theclearance groove 231 is designed on the proximal end surface of the distal chuck, so that theupper clamping portion 312 can be prevented from interfering with thedistal chuck 23 and theproximal chuck 22 to clamp theleaflet 1 again.

Referring to fig. 6 and 7, in some embodiments, theproximal collet 22 is provided with apush rod channel 223 extending axially through opposite end surfaces thereof in communication with thepush rod chamber 12, and thecollet push rod 21 is axially movably disposed through thepush rod chamber 12 and thepush rod channel 223. Axial movement of thecollet plunger 21 within theplunger cavity 12 andplunger channel 223 moves thedistal collet 23 axially such that theproximal collet 22 and thedistal collet 23 axially open and close relative to each other. In this way, the collet push rod 21 (shown in fig. 2) can pass through the distal end surface of theproximal collet 22, ensuring that thedistal collet 23 and theproximal collet 22 have a larger or substantial overlap in the radial direction, facilitating the upper andlower clamping portions 312, 322 to again clamp the leaflet 1 (shown in fig. 10).

Referring to fig. 11, in some embodiments, in the working state, theupper clamping portion 312 and thelower clamping portion 322 are both in a closed ring structure, the number of theupper push rod 311 and thelower push rod 321 is one, theupper clamping portion 312 is connected to the distal end of theupper push rod 311, and thelower clamping portion 322 is connected to thelower push rod 321. In the delivery state, theupper clamping portion 312 and thelower clamping portion 322 may be all housed in the push cavity 111 (as shown in fig. 7), i.e., theupper clamping portion 312 and thelower clamping portion 322 may be all housed in thepush catheter 10. In the example of fig. 11, the pushingchamber 111 includes an upper pushingchamber 1111 and a lower pushingchamber 1112, the number of the upper pushingchamber 1111 and the lower pushingchamber 1112 is one, and the upper pushingchamber 1111 and the lower pushingchamber 1112 are located on the same side of thepush rod chamber 12. Theupper push rod 311 is movably arranged in theupper push cavity 1111 in a penetrating manner, thelower push rod 321 is movably arranged in thelower push cavity 1112, and theupper clamping part 312 can penetrate along with theupper push rod 311 towards the proximal end along the axial direction and is completely accommodated in theupper push cavity 1111 as theupper clamping part 312 and thelower clamping part 322 can be compressed and deformed; thelower clamping portion 322 is axially and proximally threaded with thelower push rod 321 and is fully received in thelower push cavity 1112. It will be appreciated that theupper clamping portion 312 and thelower clamping portion 322 are provided with clearance spaces to avoid theupper clamping portion 312 and thelower clamping portion 322 from shielding theproximal chuck 22 and thedistal chuck 23, thereby affecting the secondary clamping of theleaflet 1 by theproximal chuck 22 and thedistal chuck 23. In other embodiments, theupper push chamber 1111 and thelower push chamber 1112 may also be located on opposite sides of thepush rod chamber 12.

It should be noted that, one of theupper clamping portion 312 and thelower clamping portion 322 may be a closed loop structure, and the other is a non-closed loop structure, which is not limited in the present invention.

As shown in fig. 10 and 11, when theupper clamping portion 312 and thelower clamping portion 322 are both in a ring structure (the ring structure includes a non-closed ring structure and a closed ring structure), theupper clamping portion 312 faces the outer peripheral surface of thelower clamping portion 322, thefirst clamping surface 3121 is the outer peripheral surface area of theupper clamping portion 312, thesecond clamping surface 3221 is the outer peripheral surface of thelower clamping portion 322 faces theupper clamping portion 312, and the area of thesecond clamping surface 3221 is the outer peripheral surface area of thelower clamping portion 312. Theupper clamping part 312 and thelower clamping part 322 are both annular structures, so that on one hand, the material can be effectively saved, and the cost can be reduced; on the other hand, theupper clamping portion 312 and thelower clamping portion 322 are easy to deform and have smaller compressed volume, which is beneficial for theupper clamping portion 312 and thelower clamping portion 322 to be smoothly accommodated in the pushingcavity 111

Referring to fig. 12, in some embodiments, in the working state, theupper clamping portion 312 and thelower clamping portion 322 are both in a sheet structure, the number of theupper push rod 311 and thelower push rod 321 is one, theupper clamping portion 312 is connected to the distal end of theupper push rod 311, and thelower clamping portion 322 is connected to the distal end of thelower push rod 321. In the delivery state, theupper clamping portion 312 and thelower clamping portion 322 may be all housed in the push cavity 111 (as shown in fig. 7), i.e., theupper clamping portion 312 and thelower clamping portion 322 may be all housed in thepush catheter 10. In the example of fig. 12, thepush cavity 111 includes anupper push cavity 1111 and alower push cavity 1112, the number ofupper push cavity 1111 andlower push cavity 1112 being one, theupper push cavity 1111 and thelower push cavity 1112 being on the same side of thepush rod cavity 12. Theupper push rod 311 is movably arranged in theupper push cavity 1111, and thelower push rod 321 is movably arranged in thelower push cavity 1112. Because theupper clamping portion 312 and thelower clamping portion 322 are both capable of being deformed by compression, theupper clamping portion 312 can be inserted into the upper pushingcavity 1111 along with theupper push rod 311 in the axial direction and is completely accommodated in the proximal direction; thelower clamping portion 322 is axially and proximally threaded with thelower push rod 321 and is fully received in thelower push cavity 1112. It will be appreciated that theupper clamping portion 312 and thelower clamping portion 322 are provided with clearance spaces to avoid theupper clamping portion 312 and thelower clamping portion 322 from shielding theproximal chuck 22 and thedistal chuck 23, thereby affecting the secondary clamping of theleaflet 1 by theproximal chuck 22 and thedistal chuck 23. In other embodiments, theupper push chamber 1111 and thelower push chamber 1112 may also be located on opposite sides of thepush rod chamber 12.

It should be noted that, one of theupper clamping portion 312 and thelower clamping portion 322 may be a ring structure, and the other may be a sheet structure, which is not limited in the present invention.

As shown in fig. 10 to 12, in the operating state, the area of thefirst clamping surface 3121 of theupper clamping portion 312 is larger than the area of thesecond clamping surface 3221 of thelower clamping portion 322. In this way, when theupper clamping portion 312 and thelower clamping portion 322 clamp theleaflet 1, thesecond clamping surface 3221 can be covered by thefirst clamping surface 3121, so as to further ensure that theupper clamping portion 312 and thelower clamping portion 322 have sufficient clamping force when clamping theleaflet 1, thereby more stably clamping theleaflet 1 and enabling the clampedleaflet 1 to be in a better flattened state. In addition, thelower clamping part 322 also plays a role in lifting thevalve leaflet 1, so that theupper clamping part 312 and thelower clamping part 322 can easily clamp thevalve leaflet 1, and thevalve leaflet 1 is ensured to be flattened.

When theupper clamping portion 312 and thelower clamping portion 322 are both in a non-closed ring structure, since the area of thefirst clamping surface 3121 of theupper clamping portion 312 is larger than the area of thesecond clamping surface 3221 of thelower clamping portion 322, thelower clamping portion 322 can press and fix theleaflet 1 into theupper clamping portion 312 when theupper clamping portion 312 and thelower clamping portion 322 clamp theleaflet 1, so that theupper clamping portion 312 and thelower clamping portion 322 can clamp theleaflet 1 more stably.

Referring to fig. 13, in some embodiments, in an operational state, an angle α is formed between thefirst clamping surface 3121 and thesecond clamping surface 3221, and the angle α is in a range of (0 °,30 ° ], such that theupper clamping portion 312 and thelower clamping portion 322 have sufficient clamping force to clamp theleaflet 1 and ensure that theleaflet 1 is in a fully flattened state after being clamped.

The angle α between thefirst clamping surface 3121 and thesecond clamping surface 3221 is in the range of (0 °,30 ° ], which means that the angle α may be 30 °, or any degree greater than 0 ° and less than 30 °.

In other embodiments, thelower clamping portion 322 may be perpendicular to thelower push rod 321, and theupper clamping portion 312 may be inclined proximally with respect to theupper push rod 311. However, theupper clamping portion 312 is inclined proximally relative to theupper push rod 311, and thelower clamping portion 322 is inclined distally relative to thelower push rod 321. Of course, thefirst clamping surface 3121 and thesecond clamping surface 3221 may also be disposed in parallel; for example, theupper clamping portion 312 is perpendicular to theupper push rod 311, and thelower clamping portion 322 is perpendicular to thelower push rod 321.

Referring to fig. 14 to 17, in some embodiments, the pushingcatheter 10 further includes aconnection section 13 connected to the proximal end of themain body section 11, thepush rod cavity 12 extends through the proximal end of theconnection section 13, theconnection section 13 is provided with aguide slot 131 communicating with the pushingcavity 111, theguide slot 131 has an opening extending along the axial direction, the upper clampingmember 31 further includes anupper operating member 313 connected to the proximal end of theupper push rod 311, thelower clamping member 32 further includes alower operating member 323 connected to the proximal end of thelower push rod 321, and theupper operating member 313 and thelower operating member 323 are disposed in theguide slot 131 and partially exposed from the opening of theguide slot 131 to the outside of the pushingcatheter 10. In this way, by controlling theupper operating element 313 and thelower operating element 323 to move axially in theguide groove 131 outside thepush catheter 10, the operator can control theupper push rod 311 and thelower push rod 321 to move axially in thepush cavity 111, and further control theupper clamping portion 312 and thelower clamping portion 322 to be accommodated in thepush cavity 111 or control theupper clamping portion 312 and thelower clamping portion 322 to pass out of thepush cavity 111 for clamping operation. Moreover, due to the limitation of the opening of theguide groove 131, theupper push rod 311 and thelower push rod 321 cannot rotate when moving along the axial direction in the pushingcavity 111, so that theupper clamping part 312 and thelower clamping part 322 penetrating out of the distal end of the pushingcavity 111 cannot deviate, the clamping of theupper clamping part 312 and thelower clamping part 322 is facilitated, the secondary adjustment of theupper clamping part 312 and thelower clamping part 322 is avoided, and the difficulty of operation is reduced.

It should be noted that, since thepush rod lumen 12 extends axially through to the proximal end face of the connectingsegment 13, the proximal end of the collet push rod 21 (as shown in fig. 5) may extend out from the proximal end of the connecting segment 13 (i.e., the proximal end of the push catheter 10).

Further, theguide groove 131 includes anupper guide groove 1311 and alower guide groove 1312 extending along the axial direction, theupper guide groove 1311 is communicated with the upper pushingcavity 1111, theupper push rod 311 is movably installed in the upper pushingcavity 1111 and theupper guide groove 1311, and theupper operating member 313 is arranged in theupper guide groove 1311 and is exposed to the outside of the pushingcatheter 10 from the opening of theupper guide groove 1311; thelower guide groove 1312 communicates with thelower push cavity 1112, thelower push rod 321 is movably inserted into thelower push cavity 1112 and thelower guide groove 1312, and thelower operating member 323 is disposed in thelower guide groove 1312 and exposed to the outside of thepush catheter 10 from the opening of thelower guide groove 1312. In this way, since theupper operating element 313 and thelower operating element 323 move in the axial direction in theupper guide groove 313 and thelower guide groove 323 respectively, on one hand, friction or collision between theupper operating element 313 and thelower operating element 323 when moving in the axial direction is avoided, and smoothness of axial movement of theupper operating element 313 and thelower operating element 323 is ensured; on the other hand, the axial dimension of thepush catheter 10 is effectively reduced, and the size of the valve repair device 100 (shown in fig. 1) is further reduced, thereby facilitating the miniaturized design of thevalve repair device 100.

In the examples of fig. 14 to 17, since theupper clamping portion 312 and thelower clamping portion 322 are in a non-closed annular structure in the working state, the number of theupper push rod 311, thelower push rod 321, theupper push cavity 1111 and thelower push cavity 1112 is two, the twoupper push cavities 1111 are located at two sides of thepush rod cavity 12, the twolower push cavities 1112 are located at two sides of thepush rod cavity 12, and the twoupper push cavities 1111 are closer to thepush rod cavity 12 than the twolower push cavities 1112. Therefore, the number of theupper guide grooves 1311 and thelower guide grooves 1312 is two. Twoupper guide grooves 1311 are respectively located at both sides of thepush rod chamber 12 and are respectively communicated with twoupper push chambers 1111; the twolower guide grooves 1312 are located on both sides of thepush rod chamber 12, respectively, and communicate with the two lowerpush rod chambers 1111, respectively, and the twoupper guide grooves 1311 are closer to thepush rod chamber 12 than the twolower guide grooves 1312.

The number of theupper operating members 313 and thelower operating members 323 is one, the proximal ends of the twoupper push rods 311 are connected with theupper operating members 313, and the proximal ends of the twolower push rods 313 are connected with thelower operating members 323. Theupper operating element 313 and thelower operating element 323 are semicircular and are matched with the connectingsection 13, and the projections of theupper operating element 313 and thelower operating element 323 on the proximal end face of the connectingsection 13 along the axial direction are not overlapped. In this way, friction or collision between theupper operating element 313 and thelower operating element 323 when moving in the axial direction in theguide groove 131 is further avoided, and smooth axial movement of theupper operating element 313 and thelower operating element 323 is further ensured. The shape of theupper operating element 313 and thelower operating element 323 is not particularly limited in the present invention, and may be other shapes, such as a semi-elliptical shape, etc., and the shape of theupper operating element 313 and thelower operating element 323 may be different.

Further, theguide groove 131 penetrates to the proximal end face of the connectingsection 13 in the axial direction. In the example of fig. 14 to 17, theupper guide groove 1311 and thelower guide groove 1312 extend through the proximal end face of the connectingsection 13, respectively, in the axial direction. Thus, when the pre-clamping assembly 30 (shown in FIG. 5) is installed in thepush catheter 10, theupper push rod 311 is movably inserted into theupper push cavity 1111, and the proximal end of theupper push rod 311 is inserted out of the proximal end of the connectingsection 13 through theupper guide slot 1311; then, theupper operating member 313 is mounted on the proximal end of theupper push rod 311, and theupper operating member 313 is pushed axially toward the distal end until theupper operating member 313 penetrates into theupper guide groove 1311 and is partially exposed from the opening of theupper guide groove 1311, whereby theupper clamp 31 is mounted on thepush catheter 10; similarly, thelower clamp 32 is mounted in thepush catheter 10 to facilitate assembly and reduce assembly time.

In other embodiments, the number ofupper operating members 313 andlower operating members 323 may be two, and the proximal end of eachupper push rod 311 is connected to oneupper operating member 313, and the proximal end of eachlower push rod 313 is connected to onelower operating member 323. Of course, the number of theupper operating members 313 and thelower operating members 323 may be different; for example, the number of theupper operating members 313 is one, and the number of thelower operating members 323 is two.

In other embodiments, theupper guide groove 1311 and thelower guide groove 1312 on the same side of thepush rod cavity 12 may be in communication, that is, theupper operating member 313 and thelower operating member 323 on the same side of thepush rod cavity 12 share oneguide groove 131, and theupper push rod 311 and thelower push rod 321 on the same side of thepush rod cavity 12 are movably installed in thesame guide groove 131.

In other embodiments, the number ofguide grooves 131 may also be one, i.e. theguide grooves 131 penetrate the circumferential wall of the connectingsection 13 in the radial direction and communicate with the twoupper push chambers 1111 and the twolower push chambers 1112, so that theguide grooves 131 have two openings in the radial direction. Theupper operating member 313 is partially exposed from one opening of theguide groove 131 to the outside of thepush catheter 10; thelower operating member 323 is partially exposed from the other opening of theguide groove 131 to the outside of thepush catheter 10, and the two push down levers 321, theupper operating member 313 and thelower operating member 323 are movably installed in thesame guide groove 131.

Referring to fig. 1 and 17-20, in some embodiments, thevalve repair device 100 further includes ahandle assembly 40, where thehandle assembly 40 includes anupper connection knob 41 and alower connection knob 42 sleeved on theconnection section 13, theupper connection knob 41 is screwed with theupper operating member 313, and thelower connection knob 42 is screwed with thelower operating member 323. Thus, the operator can control theupper operating element 313 and thelower operating element 323 to move in the axial direction by rotating the upper connectingknob 41 and the lower connectingknob 42, respectively, and the operation is simple.

In the example of fig. 17 to 20, the upper andlower operating members 313 and 323 are each provided with external threads exposed to the outside of thepush catheter 10 through the openings of the upper andlower guide grooves 1111 and 1112, respectively. The upper and lower connection knobs 41 and 42 are respectively provided with internal screw holes corresponding to the external screw threads. The inner threaded hole of theupper connection knob 41 is in fit connection with the outer thread of theupper operation member 313, and the inner threaded hole of thelower connection knob 42 is in fit connection with the outer thread of thelower operation member 323, so that the twoupper push rods 311 can be synchronously controlled to move along the axial direction by rotating theupper connection knob 41, and theupper clamping part 321 can be controlled to move along the axial direction; the two push downrods 321 can be synchronously controlled to move along the axial direction by rotating the lower connectingknob 42 so as to control thelower clamping part 322 to move along the axial direction.

It should be noted that, when theupper clamping portion 312 and thelower clamping portion 312 clamp theleaflet 1, theupper clamping portion 312 is further away from the proximal end than thelower clamping portion 322, and the upper connectingknob 41 should be further away from the proximal end of thepush catheter 10 in the axial direction than the lower connectingknob 42, which is beneficial to reducing the axial dimension of theupper clamping member 311, saving materials and reducing costs.

Referring to fig. 1 and 17-20, in some embodiments, thehandle assembly 40 further includes afirst stop ring 43, asecond stop ring 44, and athird stop ring 451 fixedly sleeved on the connectingsection 13, the upper connectingknob 41 is axially limited between thefirst stop ring 43 and thesecond stop ring 44, and the lower connectingknob 42 is axially limited between thesecond stop ring 44 and thethird stop ring 45. In this way, the upper and lower connection knobs 41 and 42 are secured to be rotatable only and not to be movable in the axial direction, so that the upper andlower operating members 313 and 323 can be controlled to be movable in the axial direction by rotating the upper and lower connection knobs 41 and 42, respectively.

In the examples of fig. 1 and 17 to 20, thefirst stop ring 43 is fixedly sleeved on the connection position of theconnection section 13 and themain body section 11, theconnection section 13 is provided with a clampinggroove 132, and thesecond stop ring 44 is sleeved in the clampinggroove 132. Specifically, thesecond stop ring 44 includes a detachablefirst stop portion 441 and asecond stop portion 442, thefirst stop portion 441 is provided with a through hole, thesecond stop portion 442 is provided with a protruding column adapted to the through hole, when assembled, thefirst stop portion 441 is clamped into the clampinggroove 132, and then the protruding column of thesecond stop portion 442 is embedded in the through hole of thefirst stop portion 441, so that thesecond stop ring 44 is sleeved in the clampinggroove 132, and thesecond stop ring 44 is axially fixed relative to the connectingsection 13 by limiting of the clampinggroove 132; in addition, the detachablefirst stop portion 441 and the detachablesecond stop portion 442 are convenient to be detached. The axial distance between thesecond stop ring 44 and thefirst stop ring 43 is adapted to the axial length of theupper connection knob 41. Thethird stop ring 451 is sleeved on the proximal end of the connectingsection 13, and the axial distance between thesecond stop ring 44 and thethird stop ring 451 is adapted to the axial length of the lower connectingknob 42 so as to axially limit the upper connectingknob 41 and the lower connectingknob 42.

Referring to fig. 5, 21 and 22, the handle assembly 40 (as shown in fig. 1) further includes a connectingstructure 45 and ahousing 46 fixedly connected to the connectingstructure 45, the connectingstructure 45 includes thethird stop ring 451, the proximal end of the connectingsection 13 is inserted into the connectingstructure 45, thechuck assembly 20 further includes achuck operating member 24 connected to the proximal end of thechuck push rod 21, and thechuck operating member 24 is disposed on thehousing 46. In this way, thepush catheter 10 is connected to thehousing 46 by theconnection structure 45. The design of thehousing 46 facilitates grasping by an operator, thereby facilitating manipulation of thevalve repair device 100 by the operator. The design of thechuck operating member 24 facilitates the operator to control the axial movement of thechuck push rod 21 and thus the relative opening and closing of theproximal chuck 22 and thedistal chuck 23.

Referring to fig. 21 and 22, in some embodiments, theconnection structure 45 includes afirst connection member 452 and asecond connection member 453, thethird stop ring 451 is disposed at a distal end of thefirst connection member 452, thefirst connection member 452 is provided with afitting groove 4521 extending through opposite end surfaces thereof in an axial direction, thesecond connection member 453 is provided with a mountinggroove 4531 extending through opposite end surfaces thereof in an axial direction, a proximal end of theconnection member 452 is fixedly disposed in thefitting groove 4521, thefirst connection member 452 is fixedly disposed in the mountinggroove 4531, and thehousing 46 is fixedly sleeved outside thesecond connection member 453.

It can be appreciated that thehousing 46 is fixedly sleeved outside thesecond connector 453, thefirst connector 452 is fixedly installed in theinstallation slot 4531 of thesecond connector 453, and thefirst connector 452 is fixed with thehousing 46 through thesecond connector 453; the proximal end of the connectingsection 452 is secured to themating slot 4521 of thefirst connector 452 and the proximal end of the connectingsection 452 is secured to thehousing 46 by thefirst connector 452 such that thepush catheter 10 may be connected to thehousing 46 by theconnection structure 45. At this time, thethird stop ring 451 is axially fixed with respect to the connectingsection 13.

In the examples of fig. 21 and 22, the engaginggroove 4521 extends along the axial direction and penetrates through opposite end surfaces of thethird stop ring 451, a plurality ofbosses 4522 are provided in the engaginggroove 4521, and thebosses 4522 can be slidably clamped in the twoupper guide grooves 1311 and the twolower guide grooves 1312 along the axial direction one by one, so that the proximal end of the connectingsection 13 can be fixedly installed in thethird stop ring 451 and the first connectingmember 452, and the structure is simple and the processing cost is low.

Further, when thefirst connector 452 is fixedly mounted in the mountinggroove 4531, the proximal end of the connectingsection 13 is fixedly mounted in themating groove 4521 of thefirst connector 452, the proximal end surfaces of the connectingsection 13, thefirst connector 452 and thesecond connector 453 are substantially flush, thereby avoiding the elongate members mounted in the lumens of the push catheter, such as the clamping pushrod portion, from being suspended and unstable.

Referring to fig. 5, 23 and 24, in some embodiments, thehousing 46 includes a removably closedupper housing 461 and alower housing 462. After thepush catheter 10 is assembled with theconnection structure 45, thehousing 46 is fixedly sleeved outside thesecond connector 453. Thecollet push rod 21 protrudes from the proximal end face of the connectingsection 13, the proximal end of thecollet push rod 21 is located in thehousing 46, and thecollet operating member 24 provided at the proximal end of thecollet push rod 21 protrudes radially out of thehousing 46 and is axially movable on thehousing 46. When the operator holds thehousing 46, the axial movement of thechuck push rod 21 can be controlled by axially sliding thechuck operating member 24 outside thehousing 46, and the operation is simple and convenient. In addition, the detachable design of theupper shell 461 and thelower shell 462 is convenient for disassembly and assembly.

Referring to fig. 5, 7, 8 and 25, in some embodiments, thevalve repair device 100 further comprises apuncture assembly 50, wherein thepuncture assembly 50 comprises apuncture plunger 51 movably mounted in thepush catheter 10 and apuncture needle 52 disposed at a distal end of thepuncture plunger 51, thepuncture needle 52 being capable of being connected to asuture 201, and thepuncture needle 52 being used to puncture the leaflet 1 (as shown in fig. 10) to implant thesuture 201 into theleaflet 1.

It will be appreciated that after theproximal collet 22 and thedistal collet 23 again grip theleaflet 1, the piercingneedle 52 can pierce theleaflet 1 and connect with thesuture 201, and pulling the piercingpush rod 61 can drive thesuture 201 to implant theleaflet 1.

Further, thepush catheter 10 is provided with apuncture cavity 113 penetrating through opposite end surfaces thereof along an axial direction, theproximal chuck 22 is provided with apuncture channel 224 penetrating through opposite end surfaces thereof along an axial direction, thepuncture cavity 113 is communicated with thepuncture channel 224 in a one-to-one correspondence manner, and thepuncture push rod 51 is movably arranged in thepuncture cavity 113 and thepuncture channel 224. Thepuncture push rod 51 can drive thepuncture needle 52 to penetrate out of the distal end surface of theproximal chuck 22 from thepuncture channel 224 so as to puncture thevalve leaflet 1, and then is connected with thesuture 201, so that thesuture 201 is driven to be implanted into thevalve leaflet 1, and thepuncture needle 52 can be ensured to puncture thevalve leaflet 1 stably.

Referring to fig. 5, 10, 25 and 26, the embodiment of the present invention further provides asuture assembly 200, wherein thesuture assembly 200 includes thesuture 201 and thesleeve 202 described above. Thesuture 201 includes afirst end 2011 and asecond end 2012, thefirst end 2011 and/or thesecond end 2012 are fixedly connected with asleeve 202, thesuture 201 is accommodated in thecollet push rod 21 and thedistal collet 23, thesleeve 202 is accommodated in thedistal collet 23, and thesleeve 202 is fixedly connected with thepuncture needle 52. Thus, when theproximal chuck 22 and thedistal chuck 23 grip theleaflet 1 again, thepuncture push rod 51 is pushed distally to drive thepuncture needle 52 to puncture theleaflet 1 and then connect thesleeve 202, so that thepuncture needle 52 is connected with thesuture 201, at this time, thepuncture push rod 51 is pulled back proximally to drive thepuncture needle 52 to be pulled back, so as to drive thesleeve 202 to pass through theleaflet 1, and thus thesuture 201 is implanted into theleaflet 1. Because thepuncture needle 52 and thesuture 201 form a stable and reliable indirect connection through thesleeve 202, thesuture 201 is not easy to separate from thepuncture needle 52, and an operator can conveniently and quickly pull one end or two ends of thesuture 201 connected with thesleeve 202 to a preset position to implant thesuture 201 on thevalve leaflet 1.

In the example of fig. 5 and 25, thefirst end 2011 and thesecond end 2012 of thesuture 201 are respectively provided with asleeve 202, and correspondingly, the number of thepuncture push rod 51, thepuncture needle 52, thepuncture cavity 113 and thepuncture channel 224 is two, the two puncture needles 52 are respectively arranged at the distal ends of the twopuncture push rods 51, the twopuncture cavities 113 are respectively communicated with the twopuncture channels 24 in an axial direction, and eachpuncture push rod 51 is movably arranged in onepuncture cavity 113 and onepuncture channel 24. Twosleeves 202 are in one-to-one correspondence with two piercingneedles 52.

Referring to fig. 26, thecollet push rod 21 is provided with a throughsuture passage 211 along its axial direction. Thedistal clip 23 has two suture receiving holes (not shown) and twosleeve holes 232 extending through the proximal end thereof, both of the two suture receiving holes communicating with thesuture passage 211, and the twosleeve holes 232 communicating with the two suture receiving holes in the axial direction, respectively. Thesuture 201 is received in thesuture channel 211 and two suture receiving holes, i.e., thesuture 201 is received in thecollet push rod 21 and thedistal collet 23. Twosleeves 202 disposed at thefirst end 2011 and thesecond end 2012 are respectively received in the twosleeve holes 232, i.e., bothsleeves 202 are received in thedistal clip 23, and the end of thesleeve 202 for connecting with the piercing needle 52 (i.e., the end remote from the suture 201) faces theproximal clip 22.

Alternatively, the fixed connection betweensleeve 202 andneedle 52 may be formed by means including, but not limited to, a threaded connection, an adhesive, a roughened friction connection, an interference fit, etc. Thefirst end 2011 and thesecond end 2012 of thesuture 201 may be fixedly connected to thesleeve 202 by means including, but not limited to, knotting, wrapping, welding, adhesive, clamping, and the like. The material of thesuture 201 may be a high molecular material compatible with human body, a softer metal material, or the like. Preferably, thesuture 201 implanted in the human body is a polymer material such as PET (polyethylene terephthalate, polyethylene Glycol Terephthalate) or e-PTFE (Expanded PTFE).

Referring to fig. 5, 7 and 31, in some embodiments, thevalve repair device 100 further comprises asupport assembly 60, wherein thesupport assembly 60 comprises asupport arm 61 movably mounted in thepush catheter 10 and asupport member 62 disposed at a distal end of thesupport arm 61. Thesupport 62 is made of a resilient and/or flexible material, thesupport arm 61 being adapted to carry thesupport 62 out of the distal side wall of thepush catheter 10, thesupport 62 being adapted to support theleaflet 1. Thesupport 62 can stabilize thebeating leaflet 1, greatly reduce the movement amplitude of theleaflet 1, ensure that theupper clamping portion 312 and thelower clamping portion 322 can stably pre-clamp theleaflet 1, and ensure that theproximal chuck 22 and thedistal chuck 23 can stably secondarily clamp theleaflet 1, thereby ensuring that thevalve repair device 100 can stably and reliably treat mitral regurgitation.

In the example of fig. 5, 7 and 31, thepusher catheter 10 is axially provided with asupport arm lumen 114 extending through its distal end face. Thesupport arm lumen 114 comprises asupport member outlet 1141, thesupport member outlet 1141 being provided in the distal side wall of thebody section 11, i.e. thesupport member outlet 1141 is provided in the distal side wall of thepush catheter 10. Thesupport arm 61 is movably arranged in thesupport arm cavity 114, i.e. thesupport arm 61 is movably arranged in the pushingcatheter 10. Because thesupport 62 is made of a resilient and/or flexible material, thesupport 62 can be compressively deformed and thesupport 62 can be compressively received in thesupport arm cavity 114. Thesupport arm 61 moves axially distally to drive thesupport 62 received in thesupport arm lumen 114 out of thesupport outlet 1141, i.e., thesupport 62 out of the distal sidewall of thepusher catheter 10. The supportingmember 62 stretches under the elastic action of the supportingmember 62, the volume of the supportingmember 62 is increased, and the contact area between the supporting member and thevalve leaflet 1 is increased, so that thevalve leaflet 1 can be stably supported, the pulsatingvalve leaflet 1 is stabilized, the movement amplitude of thevalve leaflet 1 is greatly reduced, and theproximal chuck 22 and thedistal chuck 22 can be ensured to stably and reliably clamp the valve leaflet. It will be appreciated that thesupport 62, which is made of a resilient and/or flexible material, can accommodate the anatomy of theleaflet 1 and the range of motion of theleaflet 1, avoiding damage to theleaflet 1 by thesupport 62.

Preferably, the supportingmember 62 is made of a material having a shape memory function, which may be selected from a Ti-Ni based shape memory alloy, a copper based shape memory alloy, an iron based shape memory alloy, a shape memory polymer, etc., such as a nickel titanium alloy, to which the present invention is not limited in any way. In the example of fig. 31, thesupport 62 is a mesh balloon woven from a plurality of nickel titanium wires. In other embodiments, thesupport 62 may be stretched into other closed structures that support theleaflet 1, such as columns, nests, oblate, discs, etc., and is not particularly limited in this disclosure.

Referring to fig. 5, 7, 8 and 25, in some embodiments, thevalve repair device 100 further includes aprobe assembly 70, theprobe assembly 70 includes at least oneprobe 71, theprobe 71 is movably inserted into the pushingcatheter 10, theproximal chuck 22 is provided with aprobe channel 225, thedistal chuck 23 is provided with aprobe receiving hole 233 opposite to theprobe channel 225, and when thedistal chuck 23 and theproximal chuck 22 are closed, the distal end of theprobe 71 can be extended from theprobe channel 225 and received in theprobe receiving hole 233.

Thus, when theproximal clip 22 and thedistal clip 23 are closed without the leaflet 1 (as shown in fig. 10) therebetween, theprobe 71 may be received in theprobe receiving hole 233 by axially passing through theproximal clip 22 from theprobe passage 225. When theleaflet 1 is clamped between theproximal chuck 22 and thedistal chuck 23 and theleaflet edge 1 is in contact with thechuck push rod 21, the distal end of theprobe 71 is blocked by theleaflet 1 from continuing to advance distally after passing out from the proximal end face of theproximal chuck 22, indicating that theleaflet 1 is better to clamp. At this time, thepuncture assembly 50 may be operated to puncture theleaflet 1 to implant the suture 201 (shown in fig. 26) into theleaflet 1. Moreover, the distal end of theprobe 71 is blocked from entering theprobe receiving hole 233 by theleaflet 1, which also indicates that the position between the edge of theleaflet 1 and thesuture 201 is relatively fixed, improving the reliability of implantation of thesuture 201. The clamping effect of thevalve leaflet 1 can be effectively detected by theprobe 71, and theprobe 71 has a simple structure and is convenient to operate.

Further, thepusher catheter 10 is provided with aprobe lumen 115 extending axially through its proximal and distal faces. Theprobe channel 225 axially extends through opposite end surfaces of theproximal chuck 22 and is in axial communication with theprobe cavity 115, and theprobe receiving hole 233 axially extends through the proximal end surface of thedistal chuck 23, and has an axis collinear with the central axes of theprobe channel 225 and theprobe cavity 115, i.e., theprobe receiving hole 233 is opposite to theprobe channel 225. Theprobe 71 is movably mounted in theprobe cavity 115 and theprobe channel 225 and is extendable from theprobe channel 225 to be received in theprobe receiving cavity 233. Thus, thestylet 71 is movably mounted in thepush catheter 10.

In the examples of fig. 5, 7, 8 and 25, the number ofprobes 71 is two, and twoprobes 71 extend in the axial direction and are juxtaposed in the opposite axial direction. Correspondingly, the number of theprobe cavities 115, theprobe channels 225 and theprobe accommodating holes 233 is two, the twoprobe cavities 115 are respectively axially communicated with the twoprobe channels 225, and the central axis of eachprobe accommodating hole 233 is collinear with the central axes of oneprobe cavity 115 and oneprobe channel 225. Eachprobe 71 is movably mounted in one of theprobe cavities 115 and one of theprobe channels 225 and is extendable from theprobe channel 225 to be received in one of theprobe receiving holes 233. In other embodiments, the number ofprobes 71 may be one, or more, e.g., three, four, etc.; correspondingly, the number of theprobe cavities 115, theprobe channels 225 and theprobe accommodating holes 233 may be one, three or four, and the invention is not limited thereto.

Referring to fig. 5, 23 and 24, in some embodiments, the handle assembly 40 (shown in fig. 1) further includes a sealingstructure 47, the sealingstructure 47 being disposed between thesecond connector 453 and thehousing 46. The sealingstructure 47 includes a sealingtube 471, afixed sleeve 472, a sealinggasket 473, and a sealingnut 474. The sealingtube 471 is sleeved on the proximal end of thesecond connector 453, the fixedsleeve head 472 is fixedly sleeved on the distal end of thesecond connector 453, and the distal end of the sealingtube 471 is in threaded connection with the proximal end of the fixedsleeve head 472, so that the sealingtube 471 is fixedly connected to thesecond connector 453 in a sealing manner. The lumens of the sealingtube 471 communicate with the respective lumens of thepush catheter 10. The sealingtube 471 is accommodated in thehousing 46 and fixedly connected with theupper housing 461 and thelower housing 462, and thehousing 46 is fixedly sleeved outside thesecond connector 453 through the sealingtube 471.

The proximal end inner cavity of the sealingtube 471 is provided with a receivinggroove 4711, and the sealinggasket 473 is received in the receivinggroove 4711. A sealingnut 474 is screwed to the proximal end of the sealingtube 471, the sealingnut 474 pressing against the sealinggasket 473, so that the sealinggasket 473 is fixed in thehousing groove 4711. A sealinggasket 473 is used to seal the proximal opening of the sealingtube 471. Since the sealingtube 471 has a certain axial length, a space exists between the sealinggasket 473 and the proximal end face of thepush catheter 10.

The sealinggasket 473 is provided with a plurality of through holes in one-to-one communication with each of the lumens of thepush catheter 10. Thecollet push rod 21, thepuncture push rod 51, thesupport arm 61, and theprobe 71, which are inserted from the proximal end surface of thepush catheter 10, can be inserted into the inner cavity of the sealingtube 471 and movably inserted into one of the through holes of the sealinggasket 473. Due to the deformability of the sealing gasket, no gap is left between thecartridge push rod 21, thepuncture push rod 51, thesupport arm 61, theprobe 71 and the through hole of the sealinggasket 473, so as to ensure the tightness of the sealingtube 471. It should be noted that, the sealinggasket 473 may be a flexible silica gel gasket or another flexible gasket made of other materials, which is not limited in the present invention.

As shown in fig. 5, the sealingtube 471 is provided with anexhaust connector 4712 communicating with the inner cavity thereof, theexhaust connector 4712 is used for connecting an exhaust pipe (not shown) to fill liquid such as physiological saline to exhaust air in each inner cavity of thepush catheter 10, so as to avoid air embolism caused by air entering the venous system along with blood circulation of the human body after thevalve repairing device 100 enters the human body, thereby ensuring the safety of the operation.

Referring to fig. 2, 5 and 26 to 33, the following describes the use of thevalve repair device 100 according to the embodiment of the present invention by implanting thesuture 201 into theanterior leaflet 1b of theleaflet 1 of the mitral valve via the apex of the heart.

S1, referring to fig. 27, thevalve repair device 100 in the delivery state is introduced into theleft ventricle 2 along the apex puncture site, and then passes through the orifice of the mitral valve to enter theleft atrium 3.

S2, referring to FIG. 28, thechuck operating member 24 is pushed distally along the axial direction to drive thedistal chuck 23 to move distally, so that thedistal chuck 23 and the proximal chuck are in an open state; thesupport 62 is then passed out of the distal sidewall of thepusher catheter 10, with thesupport 62 fully deployed; turning theupper connection knob 41 again to extend theupper clamping portion 312 completely out of the distal end of thepush catheter 10 and deploy it; then, theupper connection knob 41 is continued to be turned, and theupper clamp portion 312 is moved distally until the distal end surface of theupper clamp portion 312 is flush with the proximal end surface of thedistal chuck 23.

S3, please refer to fig. 29, thevalve repair device 100 is retracted until thesupport 62 supports theanterior leaflet 1b for leaflet positioning support.

S4, referring to FIGS. 30 and 31, the lower connectingknob 42 is turned to extend thelower clamping portion 322 from the distal end of thepush catheter 10; then, thelower connection knob 42 is continued to be rotated until thelower clamping portion 322 is fully unfolded to be closely attached to theanterior leaflet 1b, so as to secondarily position theleaflet 1.

S5, referring to FIG. 31 and FIG. 32, the upper connectingknob 42 is turned, and theupper clamping portion 312 moves proximally until theupper clamping portion 312 and thelower clamping portion 322 clamp thefront leaf 1b, and at this time, thefront leaf 1b is completely flattened to be in a horizontal state; then, thechuck operating member 24 is withdrawn proximally in the axial direction, and thedistal chuck 23 is moved proximally until thedistal chuck 23 and theproximal chuck 22 again grip thefront blade 1b.

S6, referring to FIG. 2, theoperation probe 71 is penetrated out from the distal end surface of theproximal chuck 22, theprobe 71 detects whether thefront leaf 1b is clamped by thedistal chuck 23 and theproximal chuck 22, if not, the step S5 is repeated until theprobe 71 detects that thefront leaf 1b is clamped by thedistal chuck 23 and theproximal chuck 22, and the step S7 is entered; if clamped, the process proceeds directly to step S7.

S7, referring to FIGS. 2, 5, 26 and 33, thepuncture plunger 51 is pushed to move distally, so that thepuncture needle 52 punctures thefront blade 1b and then is connected with thesleeve 202 accommodated in thedistal chuck 23, and thepuncture needle 52 is connected with thesuture 201 through thesleeve 202; then, the retractingpenetration plunger 51 is moved proximally such that thesuture 201 connected to thepenetration needle 52 is moved proximally and through theanterior leaflet 1b, thesuture 201 being implanted in theanterior leaflet 1 b.

S8, referring to FIGS. 31-33, thechuck operating member 24 is pushed axially and distally to open thedistal chuck 23 and theproximal clamp 22, and theproximal chuck 22 and thedistal chuck 23 no longer clamp thefront blade 1b; then, theupper connection knob 41 is turned, theupper clamping portion 312 moves distally, and theupper clamping portion 312 and thelower clamping portion 322 no longer clamp thefront leaf 1b; thevalve repair device 100 is then retracted below the papillary muscles; then, theupper connection knob 41 and thelower connection knob 42 are turned to accommodate theupper clamping portion 312 and thelower clamping portion 322 in thepush catheter 10; the operatingsupport 62 is then received in thepush catheter 10 from thesupport outlet 1141; then axially and proximally withdraw thechuck operating member 24 until theproximal chuck 22 and thedistal chuck 23 are in a closed state; finally, thevalve repair device 100 is withdrawn from theleft ventricle 2 to the outside, and thesuture 201 remains in theleft ventricle 3 as artificial chordae instead of ruptured or diseased chordae to treat mitral regurgitation.

In the description of the present specification, reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

While embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the application, the scope of which is defined by the claims and their equivalents.

Claims (18)

1. A secondarily clampable valve repair device, comprising:

a pushing catheter;

the chuck assembly comprises a chuck push rod movably penetrating through the pushing catheter, a proximal chuck and a distal chuck which can be opened and closed relatively, wherein the proximal chuck is arranged at the distal end of the pushing catheter, and the distal chuck is arranged at the distal end of the chuck push rod; and

The pre-clamping assembly comprises an upper clamping piece and a lower clamping piece, the upper clamping piece comprises an upper push rod movably penetrating through the pushing catheter and an upper clamping part arranged at the far end of the upper push rod, and the lower clamping piece comprises a lower push rod movably penetrating through the pushing catheter and a lower clamping part arranged at the far end of the lower push rod;

the valve repair device has an operating state in which the upper clamping portion and the lower clamping portion are located outside the distal end of the push catheter, the upper clamping portion has a first clamping surface, the lower clamping portion has a second clamping surface, the first clamping surface cooperates with the second clamping surface to clamp a leaflet, and the proximal collet cooperates with the distal collet to again clamp the leaflet;

wherein the ratio of the area of the first clamping surface to the area of the leaflet ranges from [ 1/6-1); the ratio of the area of the second clamping surface to the area of the leaflet is in the range of [1/6-1 ].

2. The secondary clip-on valve repair device of claim 1, wherein in the operational state the lower clip portion is located between the upper clip portion and the push catheter, the first clip surface having a larger area than the second clip surface.

3. The secondary clip-on valve repair device of claim 1, wherein in the operational state, an included angle is present between the first clip surface and the second clip surface, the included angle being in the range of (0 °,30 ° ].

4. The secondary clampable valve repair device of claim 1, wherein in the operating state the upper clamping portion is of a sheet-like or ring-like configuration and the lower clamping portion is of a sheet-like or ring-like configuration.

5. The secondary clip-on valve repair device of claim 1, wherein the upper clip portion and the lower clip portion are made of a shape memory material, the valve repair device further having a delivery state;

in the delivery state, the upper clamping portion and the lower clamping portion are compressively deformed and at least partially received in the push catheter;

under the operating condition, the upper clamping part is completely penetrated out of the pushing catheter and unfolded, the upper clamping part is bent relative to the upper push rod, the lower clamping part is completely penetrated out of the pushing catheter and unfolded, the lower clamping part is bent relative to the lower push rod, and the upper clamping part and the lower clamping part are both positioned between the distal chuck and the pushing catheter.

6. The device of claim 5, wherein the pushing catheter comprises a main body section, the pushing catheter is provided with a pushing rod cavity and a pushing cavity which axially penetrate through two opposite end surfaces of the main body section, the chuck pushing rod is movably arranged in the pushing rod cavity in a penetrating manner, and the upper pushing rod and the lower pushing rod are movably arranged in the pushing cavity in a penetrating manner.

7. The secondarily-clampable valve repair device of claim 6, wherein the push cavity comprises an upper push cavity and a lower push cavity, the upper push cavity being closer to the push rod cavity than the lower push cavity, the upper push rod movably mounted in the upper push cavity and the lower push rod movably mounted in the lower push cavity.

8. The secondarily-clamped valve repairing device according to claim 7, wherein the upper clamping portion and the lower clamping portion are of non-closed annular structures, the upper pushing cavity and the lower pushing cavity are two in number, the upper pushing cavity and the lower pushing cavity are respectively located at two sides of the pushing cavity, the lower pushing cavity is respectively located at two sides of the pushing cavity, the upper pushing rod is respectively movably installed in the upper pushing cavity, two opposite ends of the upper clamping portion are respectively connected with distal ends of the upper pushing rod, the lower pushing rod is respectively movably installed in the lower pushing cavity, and two opposite ends of the lower clamping portion are respectively connected with distal ends of the lower pushing rod.

9. The secondarily-clamped valve repairing device according to claim 8, wherein the proximal clamp is convexly arranged on the distal end face of the main body section, an avoidance groove is formed between the side wall of the proximal clamp and the distal end face of the main body section, the avoidance groove is communicated with the upper pushing cavity and the lower pushing cavity, in the conveying state, the upper clamping part is accommodated in the avoidance groove and the upper pushing cavity, and the lower clamping part is accommodated in the avoidance groove and the lower pushing cavity.

10. The secondarily-clampable valve repair device of claim 9, wherein the proximal face of the distal collet has a clearance groove corresponding to the clearance groove, and the clearance groove communicates with the clearance groove when the proximal collet and the distal collet are in a closed state.

11. The secondary clampable valve repair device of any of claims 6-10, wherein the push catheter further comprises a connection section connected to the proximal end of the main body section, the push rod lumen extending axially through to the proximal end of the connection section, the connection section being provided with a guide slot communicating with the push rod lumen, the guide slot having an axially extending opening, the upper clamping member further comprising an upper operating member connected to the proximal end of the upper push rod, the lower clamping member further comprising a lower operating member connected to the proximal end of the lower push rod, the upper operating member and the lower operating member being disposed in the guide slot and partially exposed from the opening to the exterior of the push catheter.

12. The secondary clampable valve repair device of claim 11 further comprising a handle assembly comprising an upper connection knob and a lower connection knob nested within the connection section, the upper connection knob threadably engaging the upper operating member and the lower connection knob threadably engaging the lower operating member.

13. The secondary clip valve repair device of claim 12, wherein the handle assembly further comprises a first stop ring, a second stop ring, and a third stop ring fixedly sleeved on the connecting section, the upper connecting knob being axially limited between the first stop ring and the second stop ring, the lower connecting knob being axially limited between the second stop ring and the third stop ring.

14. The secondary clip-on valve repair device of claim 13, wherein the handle assembly further comprises a connecting structure and a housing fixedly connected to the connecting structure, the connecting structure comprising the third stop ring, the proximal end of the connecting segment being threaded into the connecting structure, the clip assembly further comprising a clip operator connected to the proximal end of the clip pusher, the clip operator being disposed on the housing.

15. The device of claim 14, wherein the connecting structure comprises a first connector and a second connector, the third stop ring is disposed at a distal end of the first connector, the first connector is provided with a fitting groove extending axially through opposite end surfaces thereof, the second connector is provided with a mounting groove extending axially through opposite end surfaces thereof, a proximal end of the connecting section is fixedly disposed in the fitting groove, the first connector is fixedly disposed in the mounting groove, and the housing is fixedly sleeved outside the second connector.

16. The secondary clampable valve repair device of claim 1 further comprising a puncture assembly comprising a puncture plunger movably mounted in the push catheter and a puncture needle disposed at a distal end of the puncture plunger, the puncture needle being capable of connecting a suture, the puncture needle being for puncturing the leaflet to implant the suture into the leaflet.

17. The device of claim 1 or 16, further comprising a support assembly comprising a support arm movably mounted in the push catheter and a support member at a distal end of the support arm, the support member being made of a resilient and/or flexible material, the support arm being configured to drive the support member out of a distal sidewall of the push catheter, the support member being configured to support the leaflet.

18. The device of claim 1, further comprising a probe assembly including at least one probe movably mounted in the push catheter, the proximal collet having a probe passageway, the distal collet having a probe receiving bore opposite the probe passageway, the distal end of the probe being extendable from the probe passageway for receipt in the probe receiving bore when the distal collet and the proximal collet are closed.

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