CN112386367A

CN112386367A - Recoverable valve clamping device and valve clamping device recovery system

Info

Publication number: CN112386367A
Application number: CN201910742196.4A
Authority: CN
Inventors: 张庭超; 张伟伟; 郑贤章; 王泽涛
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-08-12
Filing date: 2019-08-12
Publication date: 2021-02-23

Abstract

The invention provides a recyclable valve clamping device which comprises a main body part and a recovery part arranged at the far end of the main body part. According to the invention, the recovery part is arranged at the far end of the valve clamping device, and after the valve clamping device is implanted into a patient body, the recovery part can be recovered in an interventional mode through a valve clamping device recovery system according to the requirement. The invention also provides a valve clip recovery system for recovering the recoverable valve clip, which comprises a capture device and a cutting device. The cutting device is used for cutting the position where the valve is contacted with the valve clamping device so as to cut off the valve clamping device; the far end of the capturing device is detachably connected with the recovery part of the valve clamping device so as to capture the valve clamping device, the recovery process is simple and convenient, the damage to a patient is small, and the secondary repair is facilitated.

Description

Recoverable valve clamping device and valve clamping device recovery system

Technical Field

The invention relates to the field of medical equipment, in particular to a recyclable valve clamping device and a valve clamping device recycling system.

Background

Referring to fig. 1, a mitral valve 1 is a one-way valve between the left atrium 2 and the left ventricle 3 of the heart, and a normal and healthy mitral valve 1 can control blood flow from the left atrium 2 to the left ventricle 3 while preventing blood flow from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to papillary muscles of the left ventricle 3 by chordae tendineae 4. Under normal conditions, when the left ventricle of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are fully apposed, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Referring to fig. 2, when the leaflets of the mitral valve or their related structures are organically or functionally changed, such as the chordae tendineae 4 are partially broken, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned, so that when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, resulting in the blood flowing back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

The existing minimally invasive treatment operation is based on the edge-to-edge operation principle of a valve, a valve clamp is conveyed to a mitral valve through an interventional catheter, and an anterior leaflet and a posterior leaflet of the mitral valve are clamped simultaneously through relative opening and closing of the clamp, so that the anterior leaflet and the posterior leaflet of the mitral valve are fixed, and the purposes of reducing the gap between the leaflets and reducing the backflow of the mitral valve are achieved. However, after a patient who is implanted with a valve clamp through a minimally invasive treatment surgery lives for years, valve stenosis or coaptation failure may occur again due to ventricular enlargement, rheumatic mitral valve, inflammatory valve diseases, severe calcification of the valve, clamp compression stimulation of valve tissue proliferation and the like, and then regurgitation or stenosis occurs again, and at this time, secondary repair is required. The implanted valve clamp and the valve tissue held together by the valve clamp must be removed prior to secondary repair. However, the valve clamp of the prior art cannot be removed from the patient through an interventional catheter, and can only be cut through a surgical operation, which is high in cost and difficulty, and high in risk because part of the patient cannot tolerate the surgical operation.

Disclosure of Invention

In view of the above, the invention provides a recoverable valve clamp and a valve clamp recovery system, wherein the valve clamp can be recovered by the valve clamp recovery system in an intervention manner as required after being implanted into a patient, the operation process is simple, the damage to the patient is small, and the secondary repair is facilitated.

In order to solve the above technical problems, the present invention provides a retrievable valve clip device, which includes a main body portion and a retrieving portion disposed at a distal end of the main body portion, wherein the retrieving portion is used for connecting with a capturing device to retrieve the valve clip device in an interventional manner.

The invention also provides a valve clamping device recovery system, which is used for recovering the valve clamping device and comprises a capture device and a cutting device, wherein the far end of the capture device is detachably connected with the recovery part of the valve clamping device; the cutting device is used for cutting the position where the valve is contacted with the valve clamping device so as to cut off the valve clamping device, and the capturing device can capture the valve clamping device.

According to the valve clamping device and the valve clamping device recovery system provided by the invention, the recovery part is arranged at the far end of the valve clamping device, and after the valve clamping device is implanted into a patient body, the valve clamping device can be recovered in an intervention mode through the valve clamping device recovery system according to needs, so that the recovery process is simple and convenient, the damage to the patient is small, and the secondary repair is facilitated.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used 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 it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

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

Fig. 2 is a schematic view of a diseased mitral valve.

Fig. 3 is a schematic structural view of a valve clip device according to a first embodiment of the present invention in a closed state.

Figure 4 is a perspective view of another perspective of the valve clip of figure 3.

Figure 5 is a schematic view of the valve binder device of figure 3 in an open position.

Fig. 6 is a perspective view of the connection seat of the valve clip device of fig. 5.

Fig. 7 is a schematic view of the attachment of the proximal clip of the valve clip of fig. 5 to the holder.

Fig. 8 is a perspective view of the fixing base in fig. 7.

Figure 9 is a schematic view of the valve clip of figure 3 after implantation in the mitral valve.

Fig. 10 is a partially enlarged schematic view of a portion XI in fig. 9.

Fig. 11 is a schematic view of the mitral valve of fig. 9 after the valve binder has bound the leaflets and the heart contracts.

Fig. 12 is a schematic view of the mitral valve of fig. 9 at diastole after the valve binder has bound the leaflets.

Figure 13 is a schematic view of a capture device about to be coupled to the valve binder of figure 3.

FIG. 14 is a schematic view of a valve binder retrieval system according to one embodiment of the present invention.

FIG. 15 is a schematic view of an access channel in one embodiment of the valve clip retrieval system of FIG. 14.

FIG. 16 is a schematic view of an access channel of another embodiment of the valve clip retrieval system of FIG. 14.

Figure 17 is a schematic view of the capture device of figure 16 docked with a valve binder.

FIG. 18 is a schematic view of the cutting device of FIG. 16 cutting the valve binder.

Figure 19 is a schematic view of a valve binder and capture device according to a second embodiment of the present invention.

Fig. 20 is a structural view of the coupling seat of the valve clip of fig. 19.

Figure 21 is a schematic view of a valve binder and capture device according to a third embodiment of the present invention.

Fig. 22 is a structural view of a connection seat of the valve clip of fig. 21.

Figure 23 is a schematic view of a valve binder and capture device according to a fourth embodiment of the present invention.

Figure 24 is a schematic view of a valve binder and capture device according to a fifth embodiment of the invention.

FIG. 25 is a schematic view of the attachment base of the valve clip of FIG. 24.

Figure 26 is a schematic view of a valve binder and capture device according to a sixth embodiment of the invention.

Figure 27 is a schematic view of a valve binder and capture device according to a seventh embodiment of the invention.

Figure 28 is a schematic view of another embodiment of a retrieval portion of the valve binder device of figure 27.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 3 to 5, the present invention provides a retrievable valve clip device 100, which includes a main body 130 and a retrieving portion 150 disposed at a distal end of the main body 130, wherein the retrieving portion 150 is used to connect with a capturing device to retrieve the valve clip device 100 in an interventional manner.

In this embodiment, the main body 130 includes a connection seat 10 at a distal end, a push rod 20 connected to the connection seat 10, a fixing seat 30 sleeved outside the push rod 20, two proximal clips 40 and two distal clips 50 radially spread relative to the push rod 20, and two links 60 disposed opposite to each other. Specifically, two proximal clips 40 and two distal clips 50 are disposed symmetrically with respect to the axis of the push rod 20, and the proximal clips 40 correspond to the distal clips 50 one by one. One end of the proximal clip 40 is fixedly connected to the fixing seat 30, the proximal clip 40 is disposed between the distal clip 50 and the fixing seat 30, the opposite end of the proximal clip 40 can be drawn close to the distal clip 50 due to its own elasticity, and a valve accommodating space 45 is formed between the corresponding proximal clip 40 and the distal clip 50. One end of the distal clip 50 is rotatably connected to the fixing base 30, and the distal clip 50 is movably connected to the connecting base 10 through a connecting rod 60. When the push rod 20 moves axially relative to the fixing seat 30, the connecting seat 10 moves relative to the fixing seat 30, the distal clip 50 opens and closes relative to the fixing seat 30 under the pulling of the connecting rod 60, and when the proximal clip 40 fixed on the fixing seat 30 is drawn close to the distal clip 50, the proximal clip can be matched with the distal clip 50 to clamp the valve in the valve accommodating space 45.

Specifically, by detachably connecting the proximal end of the valve binder 100 to a corresponding pushing device, the valve binder 100 can be pushed to the mitral valve of a patient by the pushing device, and then remotely operating the valve binder 100 to clamp the anterior leaflet and the posterior leaflet of the mitral valve together, once the leaflets of the mitral valve are aligned together edge to edge, the operator can release the connection between the pushing device and the valve binder 100, so that the valve binder 100 is released from the distal end of the pushing device and remains in the patient as an implant, thereby reducing or treating "mitral regurgitation".

The pushing device includes an adjusting wire for controlling the release of the proximal end clamping piece 40, a pushing assembly for driving the push rod 20 to move axially and for being detachably connected to the valve clamping device 100, and an operating handle connected to the proximal end of the pushing assembly, which is not described herein again.

In order to ensure the safety after implantation, the proximal clip 40 and the distal clip 50 are made of biocompatible metal material, and the metal material is selected from common implantation metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy. Specifically, the proximal clip 40 is made of an elastic material having a shape memory function, and the distal clip 50 is made of a rigid material to ensure that the two cooperate to clamp and fix the valve. In this embodiment, the proximal clip 40 is made of a super-elastic nickel-titanium alloy, and the distal clip 50 is made of a harder stainless steel or cobalt-chromium alloy.

In the invention, the recovery part 150 is arranged at the far end of the main body part 130 of the valve clamping device 100, so that after the valve clamping device 100 is implanted into a patient, the recovery part 150 can be connected with the capturing device according to the condition of the patient or the requirement of secondary repair, thereby recovering the valve clamping device 100 in an interventional mode, the recovery process is simple and convenient, the damage to the patient is small, and the secondary repair is facilitated.

Specifically, referring to fig. 5 and fig. 6, the connecting seat 10 and the push rod 20 may be an integral structure or a non-integral structure. In this embodiment, the connecting seat 10 and the push rod 20 are not an integral structure. In this embodiment, the push rod 20 is a circular rod, the distal end of the push rod 20 is provided with an external thread, and the push rod 20 is screwed and fixed with the connecting seat 10. In other embodiments, the push rod 20 may be connected with the connecting socket 10 by other detachable or non-detachable connection methods such as a snap fit. In this embodiment, the connecting seat 10 includes two opposite first surfaces 11 and two connecting surfaces connecting the two first surfaces 11, and the two connecting surfaces include a second surface 12 located at a far end and a third surface 13 located at a near end and connected to the second surface 12 in a smooth transition manner, where the first surface 11 and the third surface 13 are planes, and the second surface 12 is a curved surface. Two opposite ends of the connecting base 10 are respectively provided with a pin hole 14 penetrating through the two first surfaces 11 for connecting the connecting rod 60, a connecting hole 15 for connecting with the push rod 20 is axially formed in the center of the third surface 13 of the connecting base 10, and an internal thread corresponding to the external thread at the far end of the push rod 20 is arranged in the connecting hole 15.

The cross-sectional dimension of the connecting seat 10 parallel to the third surface 13 is gradually reduced from the proximal end to the distal end, that is, the connecting seat 10 may be shaped like a hemisphere, a spherical crown, a bullet, etc., so that the valve clip 100 can be pushed in the body of the patient more easily.

Wherein, the outer surfaces of the connecting seat 10 and the push rod 20 are smooth to avoid damaging valves or hooking chordae tendineae.

The connecting seat 10 and the push rod 20 are made of biocompatible materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, and preferably made of stainless steel or cobalt-chromium alloy.

Referring to fig. 5, 7 and 8, the fixing base 30 includes a first base 31 and a second base 32 connected to a distal end of the first base 31, and specifically, the first base 31 and the second base 32 are connected to each other through a third base 33. The first seat 31, the second seat 32 and the third seat 33 may be an integral structure or a non-integral structure. In this embodiment, the first seat 31, the second seat 32 and the third seat 33 are an integral structure.

In this embodiment, the first seat 31 is a cylindrical structure, and a cross section of any position in the axial direction of the first seat 31 is square; two opposite outer sides of the second seat body 32 are respectively provided with a convex block 321 in a protruding manner, the second seat body 32 is further provided with an accommodating cavity 34, a boss 341 is arranged on the inner wall of one side of the accommodating cavity 34, the proximal end surface of the boss 341 is an inclined surface, a steel sheet 343 and a deformation elastic sheet 345 abutting against the proximal end surface of the steel sheet 343 are arranged in the accommodating cavity 34, one end of the steel sheet 343 abuts against the inclined surface of the boss 341, and the steel sheet 343 is obliquely arranged in the accommodating cavity 34 under the elastic force action of the deformation elastic sheet 345; the third seat 33 is substantially a trapezoid block structure, two opposite outer sides of the third seat 33 are respectively provided with a connecting block 331 for rotatably connecting with the distal clip 50 in a protruding manner, a cross section of any position in the axial direction of the third seat 33 is square, and the area of the cross section is gradually increased from the proximal end to the distal end.

Further, the fixing base 30 is axially provided with a through passage 35 penetrating through the first base 31, the second base 32 and the third base 33, and when the fixing base 30 is sleeved outside the push rod 20, the push rod 20 is accommodated in the through passage 35. When the push rod 20 is accommodated in the through passage 35, the push rod 20 passes through the steel sheet 343 and the deformable elastic sheet 345 arranged in the accommodating cavity 34, the steel sheet 343 and the deformable elastic sheet 345 are provided with corresponding through holes, and the area of the through holes is slightly larger than the cross section area of the push rod 20.

It can be understood that the push rod 20 passes through the steel sheet 343 and the deforming elastic sheet 345, and under the elastic force of the deforming elastic sheet 345, the steel sheet 343 forms a certain angle with the push rod 20 after being inclined and contacts at the edge of the through hole, and when there is a tendency of relative movement between the push rod 20 and the fixing base 30, the steel sheet 343 generates a friction force to prevent the push rod 20 from moving relative to the fixing base 30.

In order to ensure the safety after implantation, the fixing base 30 is made of a biocompatible metal material, and the metal material is selected from common implantation metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy, or nickel-titanium alloy, and preferably stainless steel or cobalt-chromium alloy with high hardness.

The steel sheet 343 and the deformable elastic sheet 345 are also made of biocompatible materials, the steel sheet 343 is preferably made of stainless steel or cobalt-chromium alloy with high hardness, and the deformable elastic sheet 345 is made of nickel-titanium alloy with elasticity.

It should be understood that only one embodiment of the fixing base 30 is shown here, and actually, the fixing base 30 may have other structures, which are not described herein.

Further, as shown in fig. 8, two opposite sides of the fixing base 30 are respectively provided with a control member 36, the control member 36 is a metal wire made of nickel-titanium alloy, etc., the control member 36 is attached to the fixing base 30, and a distal end of the control member 36 is bent toward the axial direction of the fixing base 30 and is accommodated in the accommodating cavity 34. Specifically, the distal end of the control member 36 has two branches, one branch abuts against the distal plane of the boss 341, and the other branch abuts against the distal surface of the steel sheet 343 and is close to one end of the steel sheet 343 away from the boss 341. When the control member 36 is pulled in the proximal direction to abut against the branch on the distal end surface of the steel sheet 343, the branch can drive one end of the steel sheet 343 away from the boss 341 to rotate in the proximal direction by taking one end of the steel sheet 343 abutting against the inclined surface of the boss 341 as a supporting point until the steel sheet 343 and the axis of the push rod 20 form 90 degrees, at this time, the through hole of the steel sheet 343 is coaxial with the axis of the push rod 20, the connection locking state between the push rod 20 and the fixed seat 30 is released, and the push rod 20 can move in the axial direction.

The two control members 36 respectively disposed on two opposite sides of the fixing base 30 may be an integral structure or a non-integral structure. In this embodiment, the two control members 36 are an integral structure, and specifically, the same wire may be bent after passing through the bottom of the accommodating cavity 34.

Referring to fig. 5 and 7, the proximal clip 40 includes a connecting end 41 and a free end 42, and the connecting end 41 is fixed on the fixing base 30. In this embodiment, the connecting ends 41 of the two proximal end clamping pieces 40 are connected into a whole through the connecting frame 43, the connecting frame 43 is provided with a through hole for the push rod 20 to pass through, two opposite sides of the connecting frame 43 are further provided with rectangular holes for the bumps 321 on the second seat 32 to pass through, and the connecting frame 43 is sleeved on the second seat 32 and the third seat 33, so that the connecting ends 41 of the two proximal end clamping pieces 40 are fixed relative to the fixing seat 30. In other embodiments, the connecting ends 41 of the proximal clip 40 can be directly fixed to the fixing base 30 by welding or the like.

Wherein the proximal clip 40 is at least partially made of an elastic material having a shape memory function and is heat-set. In the natural state, the proximal clip 40 is in an unfolded U-shape, i.e., the proximal clip 40 is angled with respect to the holder 30 so as to cooperate with the distal clip 50 to hold the valve. The angle between the extending directions of the two sides of the proximal clip 40 ranges from 0 to 200 degrees. In this embodiment, the proximal clip 40 is cut from nitinol and then placed in a sizing mold, the sizing mold is placed in an electrically heated circulating air box furnace, a sizing heat treatment is performed at 300-650 ℃, the proximal clip is taken out and rapidly placed in purified water for cooling, and the sizing mold is removed to obtain the sized proximal clip 40. In this embodiment, the proximal clip 40 is made entirely of a super-elastic nickel-titanium alloy, thereby providing a spring force to the proximal clip 40 to urge the proximal clip 40 toward the distal clip 50 to clamp the valve. In addition, in this embodiment, the connecting frame 43 is also made of elastic nitinol, so that the connecting frame 43 is sleeved on the second seat 32 and the third seat 33.

In other embodiments, the connecting ends 41 of the proximal clips 40 are made of an elastic material, and the free ends 42 of the proximal clips 40 can be made of an inelastic material such as aluminum alloy, and the elastic force of the connecting ends 41 can be used to drive the proximal clips 40 toward the distal clips 50.

It should be noted that the free ends 42 of the proximal clips 40 extending radially outward and proximally relative to the push rod 20 can be controlled by the adjustment wires, such that the free ends 42 of the proximal clips 40 are tensioned by the adjustment wires and fit on the surface of the fixing base 30 in the delivery state, and after the control of the free ends 42 by the adjustment wires is released, the proximal clips 40 rebound due to their elastic memory properties, and the proximal clips 40 return to their natural state and press the valve toward the distal clips 50. Preferably, the included angle between the extending directions of the two sides of the proximal clip 40 in the natural unfolding state should be slightly larger than the included angle between the two distal clips 50, so as to provide a more stable clamping force, that is, the included angle between the extending direction of each side of the proximal clip 40 and the fixing seat 30 is greater than or equal to the included angle between the distal clip 50 and the fixing seat 30 when the distal clip 50 corresponding to the side is unfolded to the maximum state, so as to ensure that a certain clamping force exists between the distal clip 50 and the proximal clip 40, so as to clamp the valve located between the distal clip 50 and the proximal clip 40.

Further, the proximal clip 40 comprises a first surface facing the valve receiving space 45, and a clamping enhancing member is disposed on the first surface to increase the friction between the proximal clip 40 and the valve clamped in the valve receiving space 45, thereby improving the clamping force of the valve clamp 100 on the valve. Specifically, in this embodiment, the gripping enhancement features are two spaced rows of barbs 46 disposed on opposite sides of the first surface. Barbs 46 may be integrally formed on proximal clip 40, or barbs 46 may be formed of the same or different material as proximal clip 40 and attached to the first surface of proximal clip 40, for example, a nickel titanium wire or a nickel titanium rod may be secured to the first surface by a sleeve. The root of the barb 46 is attached to the proximal clip 40 and the end of the barb 46 opposite the root is a free end, with the free end of the barb 46 facing the distal clip 50 in the naturally extended position. The included angle between the extending direction of the barbs 46 and the first surface is less than or equal to 90 degrees to enhance the clamping force of the valve clamp 100 on the valve. Further, the free end of each barb 46 is a smooth arcuate surface to avoid damaging valve tissue.

In other embodiments, the number of barbs 46 may be 1, 2, or other reasonable number.

In other embodiments, the clamping enhancement member can be a protrusion, a boss, or other irregularly distributed protrusions protruding from the first surface, or can be a rough surface at least partially covering the first surface to improve the clamping force on the valve.

Wherein, a plurality of openings are arranged on the proximal end clamping piece 40 to reduce the weight of the proximal end clamping piece 40, avoid the overweight valve clamping device 100 from slipping or damaging the valve leaflet when falling below the valve leaflet for a long time, and simultaneously be beneficial to the creeping, covering and growing of endothelial cells.

Referring to fig. 5, the distal clip 50 includes a connecting section 51 at a distal end and a clamping section 52 connected to a proximal end of the connecting section 51, the distal end of the connecting section 51 is rotatably connected to the connecting block 331 of the fixing base 30, the proximal end of the connecting section 51 is rotatably connected to a proximal end of the connecting rod 60 at a corresponding side, and the distal end of the connecting rod 60 is rotatably connected to the connecting base 10. In this embodiment, the rotational connections are all achieved by corresponding rotational pins. Obviously, in other embodiments, the turning pins may be replaced with bolts.

As described above, by pulling the branch of the control member 36 abutting on the distal end surface of the steel sheet 343, the end of the steel sheet 343 away from the boss 341 can be driven to rotate in the proximal direction with the end of the steel sheet 343 abutting on the inclined surface of the boss 341 as a supporting point until the axes of the steel sheet 343 and the push rod 20 are at 90 degrees, the connection locking state between the push rod 20 and the fixing seat 30 is released, and the push rod 20 can move in the axial direction relative to the fixing seat 30, so that the fixing seat 30 and the connection seat 10 move relative to each other, and under the pulling of the connecting rod 60, the distal clip 50 can rotate around the rotating pin on the connection block 331 to open and close relative to the fixing seat 30, and when the proximal clip 40 is released and freely expands due to its own elastic memory function, the proximal clip 40 can approach the distal clip 50 to clamp the valve in the valve. Further, after the valve is clamped by the proximal clip 40 and the distal clip 50, the connecting seat 10 moves in the axial direction to the proximal direction until the valve clamping device 100 is in the folded state, and then the control of the control member 36 on one end of the steel sheet 343 away from the boss 341 is released, under the elastic force of the deformed elastic sheet 345, the steel sheet 343 contacts with the push rod 20 and forms a certain included angle, the connection between the push rod 20 and the fixing seat 30 is locked, so as to prevent the distal clip 50 from opening relative to the fixing seat 30, and the valve clamping device 100 in the folded state falls below the valve leaflet.

Preferably, the second surface of the distal clip 50 facing the valve receiving space 45 may also be provided with a similar structure as the grip enhancing elements of the proximal clip 40, or for applying an active drug, with a plurality of openings.

Preferably, the second surface is curved to increase the contact area of the distal clip 50 with the valve and the clamping area, thereby providing a stable clamping force. Moreover, the second surface of the curved surface forms a receiving groove, when the proximal clip 40 is closed towards the distal clip 50, the barb 46 on the first surface of the proximal clip 40 can be received in the receiving groove to press the valve in the leaflet receiving space 45, and the volume of the valve binder 100 when it is closed is reduced as much as possible, which is beneficial to the delivery in vivo.

It should be noted that the distal clip 50 has certain dimensional specifications in order to ensure a stable clamping force and to correspond to the size of the leaflets. Specifically, the length of the distal clip 50 must be within a certain range, when the length of the distal clip 50 is too long, the distal clip 50 is easy to clip too many anterior and posterior leaflets together, when the valve binder 100 is folded, the two leaflets are forcibly pulled towards each other and fixed together, when the heart beats and the leaflets move, the too many leaflets are restricted from moving, which not only easily causes abnormal mitral valve function, but also may cause serious consequences such as leaflet tearing; when the distal clip 50 is too short, the valve binder 100 can only clamp a small portion of the valve leaflets, so that the valve leaflets easily slide out, and the binding and fixing effect is poor. In the embodiment of the present invention, the axial length of the distal clip 50, i.e. the distance from the connecting section 51 to the holding section 52, should be greater than or equal to 4mm, preferably 6-10 mm. Furthermore, the width of the distal clip 50 is limited to prevent the distal clip 50 from being too narrow and damaging the leaflets, and to prevent the valve binder 100 from affecting the movement of the leaflets when the width of the distal clip 50 is too wide. The width of the distal clip 50, i.e. the length in a direction perpendicular to the axial direction of the distal clip 50, should be greater than or equal to 2mm, preferably 4-6 mm.

The valve binder 100 provided by the present embodiment can be used to reduce or treat "mitral regurgitation". Specifically, referring to fig. 9 to 12 together, the valve clamping device 100 is placed at the position of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve where they cannot be normally involuted, such that one side of the distal clamping piece 50 and the proximal clamping piece 40 clamps the edge of the anterior leaflet 1a of the mitral valve, and one side of the other distal clamping piece 50 and the proximal clamping piece 40 clamps the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the position of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve where they cannot be normally involuted together, and the direction of the arrow shown in fig. 11 and 12 is the blood flow direction. As shown in fig. 11, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are folded, and the anterior leaflet 1a and the posterior leaflet 1b are partially or completely folded at the position where they cannot be normally combined, the area a of the mitral valve opening is reduced or the mitral valve can be completely closed, and only a small amount of blood flows back into the left atrium from the mitral valve opening, so that the "mitral regurgitation" can be reduced or treated. As shown in fig. 12, when the heart is relaxed, the anterior leaflet 1a and the posterior leaflet 1B are only paired together at the position B where the valve clamping device 100 is clamped, and the other positions of the anterior leaflet 1a and the posterior leaflet 1B are still normally relaxed, so that blood can enter the left ventricle from the left atrium, thereby ensuring the normal circulation of blood.

Referring to fig. 3 and 13, in order to facilitate the second repair of the mitral valve, the valve clip 100 of the present invention is provided with a recovery part 150 at the distal end of the main body 130, and the recovery part 150 is used to connect with the capturing device 210 to recover the valve clip 100 by an interventional method.

In this embodiment, the distal end of each link 60 is provided with a recycling portion 150, and the recycling portion 150 is a groove disposed on the outer side surface of each link 60. Specifically, the connecting rod 60 includes a connecting portion 62 rotatably connected to the distal clip 50, an extension bar 64 extending obliquely from a distal end of the connecting portion 62 toward a center line of the valve binder 100, and a tab 66 disposed outside a distal end of the extension bar 64. The extension bar 64 and the tab 66 enclose the groove. Specifically, the groove is located at the distal end of the outer side surface of the connecting rod 60, and the distance from the surface of the proximal end of the groove to the center line of the valve clamp 100 is greater than the distance from the surface of the distal end of the groove to the center line of the valve clamp 100, so that the groove with the distal end inclined to the center line of the valve clamp 100 is formed.

As shown in fig. 13, the capture device 210 includes a capture catheter 212 having an axial length and a capture device 214 disposed at a distal end of the capture catheter 212, the capture device 214 for detachable connection with the retrieval portion 150 to capture the valve binder 100. Specifically, in this embodiment, the capturing device 214 is a goose neck snare, and the retrieving portion 150 is connected to the capturing device 210 by sleeving the goose neck snare on the grooves of the two opposite connecting rods 60, so as to capture the valve clamp 100, and the valve clamp 100 can be retrieved after being cut off from the valve.

In order to allow the goose-neck snare to be stably fitted into the groove without falling off, it is preferable that the ratio of the minimum outer diameter of the valve binder 100 at the groove to the outer diameter of the distal portion of the valve binder 100 adjacent to the groove is in the range of 0.5 to 0.95.

In other embodiments, the recovery portion 150 may be a protrusion protruding from the outer side of each link 60, specifically, the protrusion protrudes outward from the outer side of the link 60 with a distance decreasing from the proximal end to the distal end, and the gooseneck snare of the capturing device 210 is connected to the recovery portion 150 by being sleeved on the protrusions of the two links 60 disposed opposite to each other. Also, to allow the gooseneck snare to be stably fitted into the groove without falling off, it is preferable that the ratio of the maximum outer diameter of the valve clip 100 at the protrusion to the outer diameter of the valve clip 100 adjacent to the proximal portion of the protrusion be in the range of 1.05-1.25.

Further, referring to fig. 3 and 4, the valve clamping device 100 further includes a separating portion 170, the separating portion 170 is disposed between the main body portion 130 and the retrieving portion 150, and at least a portion of the retrieving portion 150 and the separating portion 170 is coated with an anti-cell proliferation drug or an isolation layer to prevent the retrieving portion 150 from being completely covered by endothelial cells, so as to ensure that the capturing device 210 can be connected with the retrieving portion 150 to facilitate retrieving the valve clamping device 100.

Specifically, in the present embodiment, the isolation portion 170 is disposed on the outer side surface and the opposite two side surfaces of each link 60, which are adjacent to the proximal end of the recovery portion 150, i.e., the distal end of the connecting portion 62 is adjacent to the extension bar 64. The whole area of the partition 170 is coated with an anti-cell-proliferation drug selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives.

Wherein, the coverage range of the isolation part 170 extending along the axial direction is 5-10 mm.

In other embodiments, the entire area of the barrier 170 may be coated with a barrier layer to prevent endothelial growth, the barrier layer being a sleeve or coating of a biocompatible polymeric material selected from at least one of PET, polyester, silicone, PTFE, silicone, or urethane.

In other embodiments, the partition 170 may be coated or isolated with an anti-cell proliferation drug only in a partial region, for example, only in a partial region of the partition 170 located on the lateral side of each link 60 adjacent to the proximal end of the retrieving portion 150, so long as endothelial cells are prevented from fully climbing the retrieving portion 150.

In other embodiments, the recovery portion 150 may also apply an anti-cell proliferation drug coating or coating isolation layer to prevent endothelial cells from fully climbing the recovery portion 150.

In other embodiments, a portion of the attachment seat 10 of the valve clip 100 adjacent to the distal end of the recovery portion 150 may also be provided as the spacer 170.

It will be appreciated that the thickness of the anti-cell proliferation drug coating or isolation layer should avoid affecting the overall outer diameter of the valve clip 100 to facilitate delivery of the valve clip 100 within the patient.

Referring to fig. 13 and 14, the present invention further provides a valve clip recovery system 200 for recovering the valve clip 100. Specifically, the valve clip retrieval system 200 includes a capture device 210 and a cutting device 230. The cutting device 230 is used to cut the position where the valve contacts the valve clip 100 to cut the valve clip 100. As previously described, the capture device 210 is removably attached to the retrieval portion 150 of the valve clip 100 via the distal capture 214 to capture the valve clip 100. Specifically, in the embodiment, the capturing device 214 is a goose-neck snare, and the retrieving portion 150 of the valve clamp 100 is a groove disposed on the outer side surface of each link 60, and the goose-neck snare is sleeved in the groove to capture the valve clamp 100. In other embodiments, the trap 214 may be a three-leaf snare, a vascular foreign object trap, a ligator, a pawl, a magnetic joint, or other forms.

Wherein, the cutting means 230 adopts at least one of mechanical cutting or electric knife cutting. The electric knife is at least one selected from radio frequency electric knife, high frequency electric knife, ultrasonic scalpel, plasma scalpel, laser scalpel or cryosurgical scalpel.

The mechanical cutting means is a direct cutting with a surgical instrument, such as a scissors type or a separately arranged lancet, a biopsy forceps, etc. In this embodiment, a mechanical cutting manner is adopted, and two blades 231 which can be oppositely combined are disposed at the distal end of the cutting device 230. Blade 231 is made of a metal material and has developability to facilitate the operator to observe and cut the valve in real time.

In other embodiments, the outer circumferential surface of the distal end of the cutting device 230 may be circumferentially provided with a conductive portion that is conductive at the surface in contact with the valve to enable the electrotome to cut the valve. Specifically, taking the rf electrotome as an example, the conductive part includes a bare metal or a metal electrode. In order to ensure safety, the outer surface of the rest of the cutting device 230 except the conductive part is insulated in such a way that an insulating coating is applied or an insulator is provided. To further ensure safety, when the cutting device 230 is used for cutting with an electric knife, a temperature sensor electrically connected to the conductive portion may be further provided, and the temperature sensor is in contact with the valve to indicate the local temperature of the portion of the valve in contact with the conductive portion, so as to prevent damage caused by excessive local temperature of the valve.

Preferably, the cutting device 230 is provided with at least one visualization portion at the distal end, and the operator can adjust the position of the distal end of the cutting device 230 according to the position of the visualization portion, so as to accurately cut the valve at the position where the valve contacts the valve holder 100.

The developing section may be in the form of a developing wire, a developing dot, a developing sheet, or the like. The developing part is made of developing materials with strong corrosion resistance and good biocompatibility, such as materials of gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and the like or alloys or compounds of the metals. In this embodiment, the developing portion is a nickel-titanium alloy metal sheet containing tantalum, and the metal sheet is attached to the distal tube body of the cutting device 230.

As shown in fig. 14, valve clip retrieval system 200 further includes a removal device 250, removal device 250 for removing excised valve clip 100 out of the patient. Specifically, the removing device 250 includes a positioning member 251, and the positioning member 251 is movably disposed at a distal end of the removing device 250. The positioning member 251 comprises a radially collapsible and expandable resilient frame that expands to expand and bear under the valve to reduce the pulsatile amplitude of the valve to facilitate the cutting of the valve by the cutting device 230 when the positioning member 251 is extended from the distal end of the removal device 250. Furthermore, the positioning member 251 may be used to receive the valve clip 100 after resection and to receive the valve clip 100 with the positioning member 251 into the removal device 250.

The radial dimension of the elastic frame of the positioning member 251 is gradually reduced from the distal opening to the proximal direction, i.e., the positioning member 251 is cup-shaped, cage-shaped or funnel-shaped. In this embodiment, the positioning member 251 has a cup shape.

Further, the distal opening of the positioning member 251 is provided with an adjustment mechanism comprising at least one control wire for adjusting the radial dimension of the distal opening of the positioning member 251. Specifically, the control line simultaneously passes through different positions on the circumference of the distal end of the positioning member 251, and the length of the control line passing through different positions on the circumference of the positioning member 251 is controlled to adjust the size of the distal opening of the positioning member 251, so that when the excised valve clamp 100 and the valve tissue fall into the cup-shaped positioning member 251, an operator can tighten the control line to tighten the distal opening of the positioning member 251 to wrap the valve clamp 100, and the valve clamp 100 is prevented from falling off, thereby facilitating the recovery of the valve clamp 100.

It should be noted that the capturing device 210 is movably disposed in the removing device 250 and can extend from the distal opening of the positioning member 251 to capture the valve clip 100, and after capturing the valve clip 100, the capturing device 210 is retracted into the removing device 250, at which time the distal opening of the positioning member 251 is tightened to prevent the valve clip 100 from falling off.

Further, as shown in fig. 14, the valve clamp recovery system 200 further includes a guiding device 270 and an adjustable bending sheath 290, the guiding device 270 may be movably disposed in the adjustable bending sheath 290 or may be alternately used in sequence, and the guiding device 270 and the adjustable bending sheath 290 are used for establishing an access channel from outside to inside of the patient.

Wherein the guiding means 270 comprises a puncture guide wire (not shown) and a conical dilator. After the passage is established and the puncture guide wire reaches the vicinity of the valve, the operator can control the tip of the puncture guide wire to enter the left atrium to cross over the valve clamp 100 and reversely extend to the outside of the patient, i.e. the puncture guide wire can apply pulling force to the valve clamp 100 to reduce the fluctuation range of the valve clamp 100, thereby facilitating the connection of the capture device 210 and the recovery part 150 of the valve clamp 100.

The adjustable curved sheath 290, the dilator and the puncture guide wire have similar structures to those of the existing adjustable curved sheath, dilator and puncture guide wire, and are not described herein again.

It will be appreciated that at least one of the capture device 210, the cutting device 230, and the removal device 250 may be delivered to the mitral valve of the patient via the respective access channel using a correspondingly sized, adjustable curved sheath 290. Specifically, referring to fig. 15 and 16 together, various access pathways of the valve clip retrieval system 200 of the present invention are illustrated. As shown in fig. 15, in this embodiment, the capturing device 210 is inserted into the removal device 250 and reaches the mitral valve via the transapical-left ventricular approach through the adjustable curved sheath 290a, while the resection device 230 reaches the mitral valve via the femoral vein-right atrium-interatrial septum-left atrium-mitral valve approach through the adjustable curved sheath 290 b. In other embodiments, as shown in fig. 16, the capture device 210 and the removal device 250 may be accessed to the mitral valve via a femoral artery-aortic arch-aortic valve-left ventricle approach through an adjustable curved sheath 290a, while the resection device 230 may be accessed to the mitral valve via a jugular vein-interatrial septum-left atrium approach through an adjustable curved sheath 290 b.

Of course, in other embodiments, the capture device 210, the cutting device 230, and the removal device 250 may take the same path to the mitral valve, thereby avoiding injury to the patient from multiple punctures.

Preferably, in some embodiments, the valve clip recovery system 200 further includes a detection device movably disposed in the adjustable curved sheath 290 and capable of extending out from the distal end of the adjustable curved sheath 290 and into the left atrium, so as to feed back the pressure value in the heart in real time, thereby timely confirming the "mitral regurgitation" condition and determining whether the resection is completed. In particular, the detection means may be a pressure sensor.

The following will describe the use steps of the valve clip recovery system 200 according to the present invention, taking the recovery process of the valve clip 100 according to the first embodiment of the present invention as an example, as shown in fig. 16 to 18:

the first step is as follows: the guiding device 270 and the adjustable bending sheath 290 of corresponding specifications are used to establish an access channel for the retrieving device (i.e. the capturing device 210 and the removing device 250) and the cutting device 230, respectively. The access path of the retrieval device is via the aortic arch into the left ventricle, and the access path of the cutting device 230 is via the interatrial septum into the left atrium;

the second step is that: withdrawing guide 270, advancing threaded together removal device 250 and capture device 210 through adjustable curved sheath 290a into the left ventricle, advancing cutting device 230 through adjustable curved sheath 290b into the left atrium, as shown in fig. 16;

the third step: the capture device 214 at the distal end of the capture device 210 interfaces with the retrieval portion 150 of the valve clip 100 to capture the valve clip 100 and maintain the captured state, as shown in fig. 17;

the fourth step: cutting the attachment points of the valve clip 100 on the anterior leaflet and the posterior leaflet, respectively, with two cutting edges 231 of the cutting device 230, thereby removing the valve clip 100 from the valve, as shown in fig. 18;

the fifth step: withdrawing the capture device 210 into the removal device 250 to retract the excised valve binder 100 into the removal device 250;

and a sixth step: withdrawing the cutting device 230, the removal device 250, and the capture device 210 and the valve binder 100 housed in the removal device 250 through the respective adjustable curved sheath 290; finally, the adjustable bent sheath 290 is withdrawn to complete the operation.

Optionally, after the first step is completed, the tip of the puncture guidewire of the guiding device 270 may also be passed over the valve clamp 100 and extend back out of the patient. Thus, pulling force is exerted on the valve binder 100 by the piercing guidewire to reduce the amplitude of the undulations of the valve binder 100 that beat with the leaflets, thereby facilitating the interfacing of the capture device 210 with the retriever 150 of the valve binder 100.

After the fifth step is completed, the operator may temporarily leave the adjustable curved sheath 290 in the patient after withdrawing the cutting device 230, the removing device 250, the capturing device 210 and the valve binder 100, so as to perform a secondary intervention repair operation, such as implanting a prosthetic heart valve, through the intervention channel.

It should be noted that the capturing device 210, the cutting device 230, the removing device 250, the guiding device 270, and the adjustable bending sheath 290 respectively have an operating handle close to an operator, and the operator controls the corresponding device to perform capturing, cutting, bending adjustment and other actions through the corresponding operating handle, which is not described herein in detail.

Referring to fig. 19 and 20, a second embodiment of the valve clip 100b of the present invention is similar to the first embodiment of the valve clip 100, except that: in the second embodiment, the recycling portion 150b is disposed on the connecting socket 10b, and specifically, the recycling portion 150b is at least one hook protruding on at least one first surface 11 of the connecting socket 10 b. In this embodiment, each first surface 11 of the connecting seat 10b is provided with a hook. When the valve clamp 100b is recovered, the operator can sleeve the catcher 214 of the catching device 210 on one hook to realize unilateral catching or sleeve the catcher 214 on two hooks to realize bilateral catching according to the position of the valve clamp 100b and the endothelial climbing condition. In this embodiment, the trap 214 is a gooseneck snare.

The shape of the hook includes, but is not limited to, a right-angle hook, a semicircular ring hook, and the like. In this embodiment, the couple is right angle hook.

Wherein, the hook and the connecting seat 10b can be an integral structure or a non-integral structure. In this embodiment, the hook and the connecting seat 10b are integrally formed. In other embodiments, the hook may be separately formed and fixed to the first surface 11 of the coupling holder 10b by welding or the like.

Further preferably, in this embodiment, the two hooks are symmetrically arranged about the central axis of the connecting seat 10 b. When the snare of the capture device 210 is sleeved on the two hooks, the capture force on the valve binder 100b is always on the centroid line thereof, so that the valve binder 100b can enter the removal device more easily, and the operation efficiency is improved.

It will be appreciated that the outward projection of the hooks relative to the first surface 11 of the attachment base 10b is at a distance that avoids affecting the overall outer diameter of the valve clip 100b to facilitate delivery within the patient.

Further, in the second embodiment, the partition 170b of the valve clip 100b is provided on the coupling seat 10b, unlike the first embodiment. Specifically, the isolation portion 170b may be disposed only on the first surface 11 of the connection socket 10b, or may be disposed on the entire connection socket 10b, that is, the isolation portion 170b is disposed at least on a portion of the connection socket 10b adjacent to the hook. In this embodiment, the isolation portion 170b is disposed on the outer surface of the entire connecting socket 10 b.

Referring to fig. 21 and 22, a valve clip 100c according to a third embodiment of the present invention is similar to the valve clip 100b of the second embodiment, except that: in the third embodiment, the recycling portion 150c is a through hole opened in the connecting socket 10c and penetrating through the two first surfaces 11. In this embodiment, the catch 214c of the catch device 210c is a pair of jaws that are inserted into the two ends of the through-hole to retrieve the valve binder 100 c. Preferably, the through hole is opened in the middle of the connecting seat 10c, so that the catching force applied to the valve splicer 100c is always on the centroid line thereof, so that the valve splicer 100c can enter the removing device more easily, and the operation efficiency is improved. In addition, in this embodiment, the connecting seat 10c is provided with a through hole, which can also reduce the weight of the valve clamping device 100c, so as to prevent the overweight valve clamping device 100c from falling below the valve for a long time to pull the valve.

Wherein the proximal ends of the pair of jaws are staggered in order to reduce the outer diameter of the catch means 210 c.

It is understood that in other embodiments, the retrieving portion 150c may be at least one blind hole opened on at least one first surface 11 of the connecting seat 10c, and the claw of the capturing device 210c is inserted into the blind hole to retrieve the valve binder 100 c. Preferably, two first surfaces 11 of the connecting seat 10c opposite to each other are respectively provided with a blind hole, and the two blind holes are symmetrically arranged about the central axis of the connecting seat 10c, so that the catching force applied to the valve adapter 100c is always on the centroid line thereof. Further, can set up the auxiliary member that is used for the supplementary jack catch of connecting trapping apparatus 210c in the blind hole, it is concrete, the auxiliary member can be the piece is inhaled to magnetism, and the piece can adsorb the jack catch in order to prevent that the jack catch from droing from the blind hole to magnetism.

Referring to fig. 23, a valve clip 100d according to a fourth embodiment of the present invention has a structure similar to that of the valve clip 100b of the second embodiment, except that: in the fourth embodiment, the recycling portion 150d is at least one barb or at least one annular body disposed on the second surface 12 of the connecting socket 10 d. In this embodiment, the retrieving portion 150d is a barb projecting outwardly relative to the second surface 12, and the catch 214d of the catch device 210d is a catch ring, which is hooked on the barb to retrieve the valve binder 100 d.

The shape of the barb includes, but is not limited to, a right-angle hook, a semicircular ring hook, and the like. In this embodiment, the barb is a semi-circular loop hook.

Wherein, the barb sets up in the axis position of valve clamping ware 100d, and when catching ring of capture device 210d colluded on the barb, the catching power that valve clamping ware 100d received is all the time on its barycenter line for valve clamping ware 100d gets into in the removal device more easily, improves operation efficiency.

In other embodiments, there may be two barbs, and the capture ring of the capture device 210d can be hooked on both barbs, so that when the capture ring of the capture device 210d is disengaged from one of the barbs, the capture ring can still be hooked on the other barb to ensure that the capture device 210d remains connected to the recovery portion 150d of the valve binder 100 d. Likewise, the two barbs are symmetrically disposed about the attachment receptacle 10d so that the grasping force experienced by the valve clip 100d is always on the line of its center of mass.

In other embodiments, the recovery portion 150d can be at least one annular body made of biocompatible metal or polymer material, and the capturing device 214d of the capturing device 210d can be correspondingly configured as a claw, and the claw of the capturing device 210d can be inserted into at least one annular body to recover the valve binder 100 d.

Referring to fig. 24 and 25 together, a valve clip 100e according to a fifth embodiment of the present invention has a structure similar to that of the valve clip 100d according to the fourth embodiment, except that: in the fifth embodiment, the recovery part 150e is a connection hole opened on the second surface 12 of the connection holder 10e, and a connection member for interfacing with the catching device 210e is provided in the connection hole. In this embodiment, the connection hole is a blind hole 153e opened in the middle of the second surface 12, and a magnetic member is disposed in the blind hole 153 e. In this embodiment, the capturing device of the capturing device 210e is a magnetic catheter adapter 214 e. Magnetic docking of the capture device 210e to the valve binder 100e is achieved by docking the magnetic conduit connector 214e within the attachment hole.

The magnetic member may be a magnetic gasket disposed in the blind hole 153 e.

Further, in order to improve the connection reliability, a screw is provided at the center of the blind hole 153e for screw-fixing with the catching means 210 e. In this embodiment, the screw member is a threaded hole 155e opened at the inner bottom of the connection hole, and the distal end of the capturing device 210e is provided with a threaded connector 216e, and the threaded connector 216e is movably disposed in the magnetic conduit connector 214 e. After the magnetic conduit connector 214e of the capturing device 210e is magnetically abutted with the blind hole 153e of the connecting seat 10e, the threaded connector 216e can be extended out of the magnetic conduit connector 214e and screwed with the threaded hole 155e in the blind hole 153e, so that the capturing device 210e and the valve clamp 100e are screwed and locked.

In other embodiments, the threaded member may be a stud protruding into the connecting hole, and the distal end of the capturing device 210e is provided with a connecting tube with internal threads, which is movably disposed in the magnetic catheter adapter and can be extended to be threaded with the stud in the connecting hole.

In other embodiments, magnetic catheter adapter 214e may be disposed at the distal end of removal device 250e, or threaded adapter 216e may be disposed at the distal end of removal device 250 e.

Of course, in other embodiments, the connection hole may be provided with only a magnetic member or a screw member.

Referring to fig. 26, a sixth embodiment of the present invention provides a valve clip 100f having a structure substantially similar to the valve clip 100 of the first embodiment, except that: in the sixth embodiment, the distal end of the main body portion is provided with a through groove for connection with the catch 214f of the capturing device 210f, the through groove extending in a direction perpendicular to the axial direction of the valve clip 100f, the through groove forming the recovery portion 150 f.

Specifically, in this embodiment, the connecting section 51f of each distal clip 50f is hollow, the connecting section 51f of each distal clip 50f includes two connecting pieces, each connecting piece is provided with a sliding slot extending from the distal end to the proximal end, the two connecting pieces of the two distal clips 50f located on the same side of the connecting seat 10f are stacked one on another, the sliding slots of the two connecting pieces are communicated, one end of a first pin sequentially passes through the sliding slots of the two connecting pieces of the two distal clips 50f located on the same side of the connecting seat 10f, then passes through the pin hole of the connecting seat 10f, and finally is inserted into the sliding slots of the two connecting pieces of the two distal clips 50f located on the opposite side of the connecting seat 10f, so that the distal ends of the connecting sections 51f of the two distal clips 50f are movably connected to the connecting seat 10 f; the near end of the connecting section 51f of each far end clip 50f is provided with a pin hole, the two opposite ends of the fixed seat 30f are provided with corresponding fixed holes, and the two second pins respectively penetrate through the pin holes on the two far end clips 50f and are inserted into the corresponding fixed holes on the fixed seat 30f, so that the near ends of the connecting sections 51f of the two far end clips 50f are respectively and rotatably connected to the two opposite ends of the fixed seat 30 f. At this time, the connecting seat 10f, the fixing seat 30f and the two distal end clips 50f are located between two sets of connecting pieces on two opposite sides of the connecting seat 10f and the fixing seat 30f, so as to form the through groove, the through groove penetrates through two opposite sides of the valve clamping device 100f, and the claw 214f of the capturing device 210f can be inserted into the through groove and abutted against the third surface 13 of the connecting seat 10f, so as to recover the valve clamping device 100 f.

Further, in the sixth embodiment, unlike the first embodiment, the partition 170f of the valve clip 100f is provided at the distal end of the clip section 52f of the distal clip 50 f.

Referring to fig. 27, a seventh embodiment of the present invention provides a valve clip 100g having a structure substantially similar to the valve clip 100 of the first embodiment, except that: in the seventh embodiment, the valve clamping device 100g comprises two V-shaped clamping members which can be folded relatively, wherein both clamping members are fixed on the fixing seat 30g, the distal end of the fixing seat 30g is provided with a recovery part 150g, and the capturing device 214g of the capturing device 210g is connected with the recovery part 150g to recover the valve clamping device 100 g.

Specifically, in this embodiment, the recovery portion 150g is a groove circumferentially opened at the distal end of the fixing base 30g, and the catcher 214g is a goose-neck snare, and the valve clip 100g is recovered by sleeving the snare in the groove.

Referring to fig. 28, it is understood that, in other embodiments, the recovery portion 150g ' may be a hook, a barb or an annular body protruding from the distal end of the fixing base 30g ', or may be a blind hole, a through hole or a connecting hole opened on the surface of the fixing base 30g ', and will not be described herein again.

Further, unlike the first embodiment, in the seventh embodiment, the partition 170g of the valve clamping device 100g is provided at least in a portion of the fixing base 30g adjacent to the recovery portion 150g, and in this embodiment, the partition 170g is provided on the outer surface of the entire fixing base 30 g.

It should be noted that the above description is given by way of example of a valve clip for reducing or treating "mitral regurgitation". It is understood that, in other embodiments, the valve binder may also be used to alleviate or treat "tricuspid regurgitation", and the principle and structure thereof are substantially the same as those of the valve binder used to solve "mitral regurgitation" in the embodiments of the present invention, and only a plurality of groups of proximal clips and distal clips are required to form a plurality of clamps, and each clamp respectively clamps one leaflet, which is not described herein again.

Obviously, in other embodiments, the valve clamping device provided by the invention can also be applied to other minimally invasive surgical operations needing to clamp more than three pieces of valve tissues together.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. A retrievable valve clip, comprising a main body portion and a retrieval portion disposed at a distal end of the main body portion, the retrieval portion being configured to connect to a capture device to retrieve the valve clip through an interventional procedure.

2. The valve binder of claim 1, wherein the main body portion comprises two links disposed opposite to each other, the distal end of each link is provided with the recovery portion, and the recovery portion is a groove disposed on an outer side surface of each link or a protrusion protruding from an outer side surface of each link.

3. The valve binder of claim 2, wherein the ratio of the smallest outer diameter of the valve binder at the groove to the outer diameter of the valve binder at a distal portion of the valve binder adjacent the groove ranges from 0.5 to 0.95; the ratio of the maximum outer diameter of the valve clip at the protrusion to the outer diameter of the valve clip adjacent the proximal portion of the protrusion ranges from 1.05 to 1.25.

4. The valve binder of claim 1, wherein the body portion comprises a distally located attachment seat, the retrieving portion is disposed on the attachment seat, and the attachment seat comprises two opposing first surfaces and a distally located second surface.

5. The valve binder of claim 4, wherein the retrieving portion is at least one hook, barb, or annulus protruding from at least one of the first surface or the second surface.

6. The valve binder of claim 4, wherein the recovery portion is at least one blind hole or through hole opened on at least one of the first surface or the second surface.

7. The valve binder of claim 6, wherein the through hole passes through both of the first surfaces.

8. The valve binder of claim 6, wherein the blind hole is a connecting hole opened in the second surface, and a connecting member for interfacing with the capturing device is disposed in the connecting hole.

9. The valve clip of claim 8 wherein the connector comprises a magnetic member and/or a threaded member.

10. The valve clip according to claim 5 or 6, wherein the number of the recovery parts is two, and the two recovery parts are symmetrically arranged about a central axis of the connecting seat.

11. The valve binder of claim 1, wherein a distal end of the main body portion provides a through slot for connection with the capture device, the through slot extending in a direction perpendicular to an axial direction of the valve binder, the through slot forming the retrieving portion.

12. The valve binder of claim 1, further comprising a separator disposed between the main body portion and the retrieving portion, wherein the retrieving portion and the separator are at least partially coated with an anti-cell proliferation drug or an isolation layer.

13. The valve clip of claim 12, wherein the anti-cell proliferation drug is selected from at least one of rapamycin and derivatives thereof, paclitaxel and derivatives thereof; the isolating layer is a sleeve or a coating made of biocompatible high polymer material, and the high polymer material is selected from at least one of PET, polyester, silicone, PTFE, silica gel or urethane.

14. A valve clip retrieval system for retrieving a valve clip according to any one of claims 1 to 13, wherein the valve clip retrieval system comprises a capture device and a cutting device; the cutting device is used for cutting the position where the valve is contacted with the valve clamping device so as to cut off the valve clamping device; the distal end of the capture device is removably attached to the retrieval portion of the valve clip to capture the valve clip.

15. The valve clip retrieval system of claim 14, wherein the capture device comprises a capture catheter and a capture device disposed at a distal end of the capture catheter, the capture device for detachable connection with the retrieval portion.

16. The valve clip retrieval system of claim 15, wherein the catch is at least one of a snare, a catch ring, a pawl, a magnetic joint, a threaded joint.

17. The valve clip retrieval system of claim 14, wherein the cutting device is provided with at least one visualization portion, at least one visualization portion being provided at a distal end of the cutting device.

18. The valve clip retrieval system of claim 14, wherein the cutting means cuts in a manner selected from at least one of mechanical cutting or electrotome cutting.

19. The valve clip retrieval system of claim 18, wherein the electrotome is selected from at least one of a radio frequency electrotome, a high frequency electrotome, an ultrasonic scalpel, a plasma scalpel, a laser scalpel, or a cryosurgical scalpel.

20. The valve clip retrieval system of claim 19, wherein the outer peripheral surface of the distal end of the cutting device is circumferentially provided with an electrically conductive portion that is electrically conductive at a surface in contact with the valve for electrotome cutting of the valve.

21. The valve clip retrieval system of claim 20, wherein the cutting device further comprises a temperature sensor electrically connected to the conductive portion, the temperature sensor being in contact with the valve; the temperature sensor is for indicating a temperature of a portion of the valve in contact with the conductive portion.

22. The valve clip retrieval system of claim 14, further comprising a removal device for removing the excised valve clip from the patient.

23. The valve binder retrieval system of claim 22, wherein the removal device comprises a retainer movably disposed at a distal end of the removal device, the retainer for holding the valve to reduce the pulsatile amplitude of the valve.

24. The valve clip retrieval system of claim 23, wherein the positioning member comprises a radially collapsible and expandable resilient frame that expands to expand and bear under the valve flap when the positioning member is extended from the distal end of the removal device.

25. The valve clip retrieval system of claim 24, wherein the radial dimension of the resilient frame tapers from the distal opening in a proximal direction.

26. The valve clip retrieval system of claim 23, wherein the distal opening of the positioning member is provided with an adjustment mechanism, the adjustment mechanism comprising at least one control wire, the at least one control wire for adjusting a radial dimension of the distal opening of the positioning member.

27. The valve binder retrieval system of claim 14, further comprising a guide device for accessing the valve binder and extending back over the valve binder to reduce the amplitude of the undulation of the valve binder.