WO2021027589A1 - Recoverable valve clamp and valve clamp recovery system - Google Patents

Abstract

A recoverable valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'), which comprises a main body part (130) and a recovery part (150, 150b, 150c, 150d, 150e, 150f, 150g, 150g') arranged at the distal end of the main body part (130). The recovery part (150, 150b, 150c, 150d, 150e, 150f, 150g, 150g') is arranged at the distal end of the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'), so that after the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g') is implanted in the body of a patient, same may be recovered in an interventional manner by means of a valve clamp recovery system (200) as needed. Further provided is a valve clamp recovery system (200) used for recovering the recoverable valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'), the valve clamp recovery system (200) comprising a capturing device (210, 210c, 210d, 210e, 210f, 210g, 210g') and a cutting device (230). The cutting device (230) is used to cut the position at which a valve and the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g') come into contact so as to remove the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'); and the distal end of the capturing device (210, 210c, 210d, 210e, 210f, 210g, 210g') is detachably connected to the recovery part (150, 150b, 150c, 150d, 150e, 150f, 150g, 150g') of the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g') so as to capture the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'). The recovery process is simple, the damage to the patient is slight, and the process is advantageous for secondary repair.

Description

Recoverable valve clamp and valve clamp recovery system Technical field

This application relates to the field of medical equipment, and in particular to a recyclable valve clamp and a valve clamp recovery system.

Background technique

Please refer to Figure 1. Mitral valve 1 is a one-way valve located between the left atrium 2 and left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3 while preventing blood from flowing from The left ventricle 3 flows to the left atrium 2. The mitral valve 1 includes a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior lobe 1a and the posterior lobe 1b are fixed to the papillary muscle of the left ventricle 3 through the chordae 4. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior lobe 1a and the posterior lobe 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2. When the mitral valve leaflet or its related structure changes qualitatively or functionally, such as partial rupture of the chordae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly aligned. Therefore, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, causing a series of pathophysiological changes called "Mitral Regurgitation" .

There is a minimally invasive surgical operation. Based on the principle of valve edge-to-edge surgery, the valve clamp is delivered to the mitral valve through an interventional catheter, and then the anterior and posterior leaflets of the mitral valve are clamped by the relative opening of the clamp. The leaf makes the anterior leaflet and the posterior leaflet of the mitral valve fixed, thereby achieving the purpose of narrowing the leaflet gap and reducing mitral valve regurgitation. However, patients who have undergone minimally invasive treatment and surgical implantation of valve clamps may survive for several years due to ventricular enlargement, rheumatic mitral valve, inflammatory valve disease, severe valve calcification, and clamp compression to stimulate valve tissue proliferation. This results in valve stenosis or poor alignment, and then regurgitation or stenosis occurs again. At this time, a second repair is required. Before the second repair, the implanted valve clamp and the valve tissue fixed together by the valve clamp must be removed. However, the valve clamp of the prior art cannot be removed from the patient's body through an interventional catheter, and can only be removed by surgical operation, which is costly and difficult, and some patients cannot tolerate the surgical operation, and the risk is high.

Summary of the invention

In view of this, the present application provides a retrievable valve clamp and a valve clamp recovery system. After the valve clamp is implanted in a patient, the valve clamp can pass through the valve clamp recovery system as needed Recovered in an interventional manner, the surgical procedure is simple, and the patient is less damaged, which is beneficial for secondary repair.

In order to solve the above technical problems, the present application provides a retrievable valve clamp, including a main body and a retrieving portion provided at the distal end of the main portion. The retrieving portion is used to connect with a capturing device for retrieving through interventional methods. The valve clamp.

The present application also provides a valve clamp recovery system for recovering the aforementioned valve clamp. The valve clamp recovery system includes a capture device and a cutting device. The distal end of the capture device is connected to the valve clamp. The recovery part of the combiner is detachably connected; the cutting device is used to cut the contact position of the valve with the valve clipper to cut off the valve clipper, and the capture device can capture the valve clipper.

The valve clamp and valve clamp recovery system provided by the present application, by providing a recovery part at the distal end of the valve clamp, after the valve clamp is implanted in the patient's body, the valve can be passed through as needed The clip recovery system is recovered in an interventional manner, the recovery process is simple, and the patient is less damaged, which is conducive to secondary repair.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.

Figure 1 is a schematic diagram of the mitral valve in a normal state.

Figure 2 is a schematic diagram of mitral valve disease.

Fig. 3 is a schematic structural diagram of the valve clamp provided in the first embodiment of the present application in a closed state.

Fig. 4 is a three-dimensional structural diagram of the valve clamp in Fig. 3 from another perspective.

Fig. 5 is a schematic structural diagram of the valve clamp in Fig. 3 in an opened state.

Fig. 6 is a three-dimensional schematic diagram of the connecting seat of the valve clamp in Fig. 5.

Fig. 7 is a schematic diagram of the connection between the proximal end clip of the valve clamp in Fig. 5 and the fixing seat.

FIG. 8 is a schematic diagram of the three-dimensional structure of the fixing seat in FIG. 7.

Fig. 9 is a schematic diagram of the valve clamp in Fig. 3 after being implanted into the mitral valve.

Fig. 10 is a partial enlarged schematic diagram of part XI in Fig. 9.

Fig. 11 is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflets are clamped by the valve clamp in Fig. 9.

Fig. 12 is a schematic diagram of the mitral valve in diastole after the valve clamp in Fig. 9 clamps the valve leaflets.

Fig. 13 is a schematic diagram of the capture device to be connected to the valve clamp in Fig. 3.

Fig. 14 is a schematic diagram of a valve clamp recovery system provided by one embodiment of the present application.

Fig. 15 is a schematic diagram of an intervention channel in one embodiment of the valve clamp recovery system in Fig. 14.

Fig. 16 is a schematic diagram of an intervention channel of another embodiment of the valve clip recovery system in Fig. 14.

Fig. 17 is a schematic diagram of docking the capture device in Fig. 16 with the valve clamp.

Fig. 18 is a schematic diagram of the cutting device in Fig. 16 cutting off the valve clamp.

Fig. 19 is a schematic diagram of a valve clamp and a capture device provided by the second embodiment of the present application.

Fig. 20 is a structural schematic diagram of the connecting seat of the valve clamp in Fig. 19.

Fig. 21 is a schematic diagram of a valve clamp and a capture device provided by the third embodiment of the present application.

Fig. 22 is a schematic structural view of the connecting seat of the valve clamp in Fig. 21.

Fig. 23 is a schematic diagram of a valve clamp and a capture device provided by the fourth embodiment of the present application.

Fig. 24 is a schematic diagram of a valve clamp and a capture device provided by a fifth embodiment of the present application.

Fig. 25 is a structural schematic diagram of the connecting seat of the valve clamp in Fig. 24.

Fig. 26 is a schematic diagram of a valve clamp and a capture device provided by a sixth embodiment of the present application.

Fig. 27 is a schematic diagram of a valve clamp and a capture device provided by a seventh embodiment of the present application.

Fig. 28 is a schematic diagram of another embodiment of the recovery part of the valve clamp in Fig. 27.

detailed description

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the orientation or positional relationship shown in the drawings, and are only for It is convenient to describe the application and simplify the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore cannot be understood as a limitation of the application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.

In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installation", "connection", "connection", etc. should be understood in a broad sense. For example, it may be a fixed connection or a Disassembly connection, or integral connection; it can be directly connected or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in this application can be understood under specific circumstances.

In the description of this application, 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; the axial direction refers to the end parallel to the medical treatment. The direction of the connection between the distal center and the proximal center of the instrument. The above definition is only for the convenience of presentation, and cannot be understood as a limitation of the application.

3 to 5, the present application provides a retrievable valve clamp 100, including a main body 130 and a retrieving portion 150 disposed at the distal end of the main portion 130, the retrieving portion 150 is used to connect with the capture device to pass The valve clamp 100 is recovered in an interventional manner.

In this embodiment, the main body 130 includes a connecting seat 10 at the distal end, a push rod 20 connected to the connecting seat 10, a fixing seat 30 sleeved on the outside of the push rod 20, and two proximal parts radiatingly deployed relative to the push rod 20. An end clip 40 and two distal clips 50, and two opposite connecting rods 60. Specifically, the two proximal clips 40 and the two distal clips 50 are all arranged axisymmetrically with respect to the push rod 20, and the proximal clips 40 and the distal clips 50 correspond one-to-one. One end of the proximal clip 40 is fixedly connected to the fixing base 30, the proximal clip 40 is arranged between the distal clip 50 and the fixing base 30, and the opposite end of the proximal clip 40 can be farther away due to its own elastic force. The end clip 50 closes together, and a valve accommodating space 45 is formed between the corresponding proximal clip 40 and the distal clip 50. One end of the distal end clip 50 is rotatably connected to the fixing base 30, and the distal end clip 50 is movably connected to the connection base 10 through a connecting rod 60. When the push rod 20 moves in the axial direction relative to the fixed seat 30, the connecting seat 10 moves relative to the fixed seat 30. Under the pulling of the connecting rod 60, the distal clip 50 opens and closes relative to the fixed seat 30. When the proximal clip 40 on the seat 30 is close to the distal clip 50, it can cooperate with the distal clip 50 to clamp the valve located in the valve receiving space 45.

Specifically, if the proximal end of the valve clamp 100 is detachably connected to the corresponding pushing device, the valve clamp 100 can be pushed to the mitral valve of the patient through the pushing device, and then the valve clamp can be operated remotely The combiner 100 clamps the anterior and posterior leaflets of the mitral valve together. Once the leaflets of the mitral valve are aligned edge-to-edge, the operator can release the pushing device and the valve clamp 100 The connection between the valve clamper 100 is released from the distal end of the propulsion device and remains in the patient's body as an implant, thereby reducing or treating "mitral valve regurgitation".

Wherein, the pushing device includes an adjustment wire for controlling the release of the proximal clip 40, a pushing assembly for driving the axial movement of the push rod 20 and a detachable connection with the valve clamp 100, and a pushing assembly connected to the pushing assembly The operation handle at the proximal end will not be repeated here.

Among them, in order to ensure the safety after implantation, the proximal clip 40 and the distal clip 50 are made of biocompatible metal materials, and the metal materials are selected from stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel. Commonly used metal materials for implants such as titanium alloys. Specifically, the proximal clip 40 is made of an elastic material with a shape memory function, and the distal clip 50 is made of a rigid material to ensure that the two can clamp and fix the valve. In this embodiment, the proximal clip 40 is made of super-elastic Nitinol, and the distal clip 50 is made of stainless steel or cobalt-chromium alloy with higher hardness.

In this application, by providing the recovery part 150 at the distal end of the main body 130 of the valve clamp 100, after the valve clamp 100 is implanted in the patient, the recovery part 150 can be used according to the patient’s condition or the need for secondary repair. It is connected with the capture device to recover the valve clamp 100 in an interventional manner. The recovery process is simple, and the damage to the patient is small, which is beneficial for secondary repair.

Specifically, please refer to FIG. 5 and FIG. 6 together. The connecting base 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 of a non-integral structure. In this embodiment, the push rod 20 is a round rod body, 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 to the connection base 10 by other detachable or non-detachable connection methods such as snapping. In this embodiment, the connecting seat 10 includes two opposite first surfaces 11 and two connecting surfaces connecting the two first surfaces 11. The two connecting surfaces include a second surface 12 at the distal end and a second surface 12 at the proximal end. The third surface 13 is smoothly connected to the second surface 12, wherein the first surface 11 and the third surface 13 are flat surfaces, and the second surface 12 is a curved surface. The opposite ends of the connecting seat 10 are respectively provided with pin holes 14 penetrating through the two first surfaces 11 for connecting the connecting rod 60, and the third surface 13 of the connecting seat 10 is provided with a connection for connecting with the push rod 20 in the axial direction. The hole 15 is provided with an internal thread corresponding to the external thread of the distal end of the push rod 20 in the connecting hole 15.

Wherein, the cross-sectional size of the connecting seat 10 in the direction parallel to the third surface 13 gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 10 can be a hemisphere, a spherical crown, a bullet shape, etc., so that the valve can be clamped. The device 100 is easier to push in the patient.

Wherein, the outer surfaces of the connecting seat 10 and the push rod 20 are smooth to avoid damage to the valve or hook chordae.

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

Please refer to Figures 5, 7 and 8, the fixing base 30 includes a first base 31 and a second base 32 connected to the distal end of the first base 31. Specifically, the first base 31 and the second base 31 The seat bodies 32 are transitionally connected to each other through a third seat body 33. Among them, the first seat body 31, the second seat body 32, and the third seat body 33 may be an integral structure or a non-integral structure. In this embodiment, the first seat body 31, the second seat body 32 and the third seat body 33 are an integral structure.

In this embodiment, the first seat body 31 has a cylindrical structure, and the cross section of any position in the axial direction of the first seat body 31 is a square; the two opposite outer sides of the second seat body 32 are respectively provided with convex bumps 321. The second seat body 32 is also provided with an accommodating cavity 34. One inner wall of the accommodating cavity 34 is provided with a boss 341. The proximal surface of the boss 341 is an inclined surface. The accommodating cavity 34 is provided with a steel sheet 343 and The deformed elastic piece 345 abuts on the proximal surface of the steel piece 343, one end of the steel piece 343 abuts on the inclined surface of the boss 341, under the elastic force of the deformed elastic piece 345, the steel piece 343 is inclinedly arranged in the accommodating cavity 34 The third seat body 33 is roughly in a trapezoidal block structure, and two opposite outer sides of the third seat body 33 are respectively provided with connecting blocks 331 for rotating connection with the distal end clip 50, and the third seat body 33 is in the axial direction The cross-section of any position is square, and its cross-sectional area gradually increases from the proximal end to the distal end.

Further, the fixing seat 30 is provided with a through passage 35 passing through the first seat body 31, the second seat body 32 and the third seat body 33 along the axial direction. When the fixing seat 30 is sleeved on the outside of the push rod 20, the pushing The rod 20 is received in the through channel 35. Wherein, when the push rod 20 is accommodated in the through passage 35, the push rod 20 passes through the steel sheet 343 and the deformed elastic sheet 345 arranged in the accommodating cavity 34. The steel sheet 343 and the deformed elastic sheet 345 are provided with corresponding through holes. The area of the hole is slightly larger than the cross-sectional area of the push rod 20.

It is understandable that the push rod 20 passes through the steel sheet 343 and the deformed elastic sheet 345. Under the elastic force of the deformed elastic sheet 345, the steel sheet 343 is inclined to form a certain angle with the push rod 20 and contact at the edge of the through hole. When there is a tendency of relative movement between the 20 and the fixed base 30, the steel sheet 343 generates friction to prevent the push rod 20 from moving relative to the fixed base 30.

Among them, in order to ensure the safety after implantation, the fixing seat 30 is made of a biocompatible metal material, and the metal material is selected from stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel titanium alloy and other commonly used implantation metals The material is preferably stainless steel or cobalt-chromium alloy with higher hardness.

Among them, the steel sheet 343 and the deformed elastic sheet 345 are also made of biocompatible materials. The steel sheet 343 is preferably made of stainless steel or cobalt-chromium alloy with higher hardness, and the deformed elastic sheet 345 is made of elastic Nitinol.

It is understandable that only one embodiment of the fixing seat 30 is given here. In fact, the fixing seat 30 may also have other structures, which will not be repeated here.

Further, as shown in FIG. 8, two opposite sides of the fixing base 30 are respectively provided with control members 36. The control members 36 are metal wires made of Nitinol, etc., and the control members 36 are attached to the fixing base 30. The distal end of the control member 36 is bent toward the axial direction of the fixing base 30 and is received in the accommodating cavity 34. Specifically, the distal end of the control member 36 has two branches, one of which abuts on the distal plane of the boss 341, and the other abuts on the distal surface of the steel sheet 343 and is close to the steel sheet 343 away from the boss. One end of 341. When the control member 36 is pulled in the proximal direction to abut against the branch on the distal surface of the steel sheet 343, the branch can drive the end of the steel sheet 343 away from the boss 341 and the steel sheet 343 abuts against the slope of the boss 341 One end of the steel sheet 343 is the support point and rotates in the proximal direction until the axis of the steel sheet 343 and the push rod 20 is 90 degrees. At this time, the through hole of the steel sheet 343 is coaxial with the axis of the push rod 20, and the push rod 20 and the fixed seat The locked state of the connection between 30 is released, and the push rod 20 can move in the axial direction.

Wherein, the two control members 36 respectively provided on the 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. Specifically, the same metal wire can be formed by passing through the bottom of the containing cavity 34 and then bending.

Please refer to FIGS. 5 and 7 together. The proximal clip 40 includes a connecting end 41 and a free end 42 that are oppositely disposed, and the connecting end 41 is fixed on the fixing base 30. In this embodiment, the connecting ends 41 of the two proximal clips 40 are connected as a whole through a connecting frame 43. The connecting frame 43 has a through hole for the push rod 20 to pass through. The two opposite sides of the connecting frame 43 are also provided with The rectangular hole through which the protrusion 321 on the second seat body 32 passes, the connecting frame 43 is sleeved on the second seat body 32 and the third seat body 33 to realize that the connecting ends 41 of the two proximal clips 40 are opposite to each other. The fixing base 30 is fixed. In other embodiments, the connecting end 41 of the proximal clip 40 may be directly fixed to the fixing base 30 by welding or other connection methods.

Wherein, the proximal clip 40 is at least partially made of an elastic material with a shape memory function, and has been heat-set. In a natural state, the proximal clip 40 is in an unfolded U shape, that is, the proximal clip 40 and the fixing seat 30 are arranged at an angle so as to cooperate with the distal clip 50 to clamp 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 a nickel-titanium alloy and placed in a shaping mold, and then the shaping mold is placed in an electrically heated circulating air box furnace, and the shaping heat treatment is performed at 300-650°C, taken out and It is quickly put into purified water to cool, and the shaping mold is removed to obtain the shaped proximal clip 40. In this embodiment, the entire proximal clip 40 is made of super-elastic nickel-titanium alloy, so as to provide elastic force for the proximal clip 40 to drive the proximal clip 40 to the distal clip 50 to clamp the valve. In addition, in this embodiment, the connecting frame 43 is also made of elastic nickel-titanium alloy, so that the connecting frame 43 can be sleeved on the second seat body 32 and the third seat body 33.

In other embodiments, the connecting end 41 of the proximal clip 40 is made of an elastic material, and the free end 42 of the proximal clip 40 can be made of an inelastic material such as aluminum alloy. The proximal end is driven by the elastic force of the connecting end 41. The clip 40 moves closer to the distal clip 50.

It should be noted that the free end 42 of the proximal clip 40 that extends outward and radiating toward the proximal end relative to the push rod 20 can be controlled by an adjustment line. In the conveying state, the free end 42 of the proximal clip 40 The adjustment wire is tightened and fits on the surface of the fixing seat 30, and after releasing the adjustment wire to control the free end 42, the proximal clip 40 rebounds due to its own elastic memory performance, and the proximal clip 40 recovers Natural state, and press the valve toward the distal clip 50. Preferably, the included angle between the extension directions of the two sides of the proximal clip 40 in the natural unfolded state should be slightly larger than the included angle between the two distal clips 50 to provide a more stable clamping force, that is, The 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 distance between the distal clip 50 and the fixing seat 30 when the distal clip 50 corresponding to the side is expanded to the maximum state Therefore, it is ensured that there is a certain clamping force between the distal clip 50 and the proximal clip 40 to clamp the valve between the distal clip 50 and the proximal clip 40.

Further, the proximal clip 40 includes a first surface facing the valve accommodating space 45. A clamping reinforcement is provided on the first surface to increase the gap between the proximal clip 40 and the valve clamped in the valve accommodating space 45. The friction force increases the clamping force of the valve clamp 100 on the valve. Specifically, in this embodiment, the clamping reinforcement is two rows of barbs 46 arranged at intervals on opposite sides of the first surface. The barbs 46 can be formed on the proximal clip 40 by an integral molding method, or the barbs 46 can be formed of the same or different material as the proximal clip 40 and then connected to the first surface of the proximal clip 40 For example, a nickel-titanium metal wire or a nickel-titanium metal rod can be fixed on the first surface through a sleeve. The root of the barb 46 is connected to the proximal clip 40, and the end of the barb 46 opposite to the root is a dangling end. In a natural deployment state, the dangling end of the barb 46 faces the distal clip 50. The angle between the extending direction of the barb 46 and the first surface is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clamp 100 on the valve. Further, the suspended end of each barb 46 is a smooth curved surface, so as to avoid damage to the valve tissue.

In other embodiments, the number of barbs 46 may be one, two, or other reasonable numbers.

In other embodiments, the clamping reinforcement may be a structure such as a rib, a boss or other irregularly distributed protrusions protruding on the first surface, and may also be a rough surface at least partially covering the first surface to improve The clamping force on the valve.

Among them, the proximal clip 40 is provided with a plurality of openings to reduce the weight of the proximal clip 40 and prevent the excessively heavy valve clip 100 from falling under the leaflets for a long time to cause slippage or damage to the leaflets. Conducive to the crawling and growth of endothelial cells.

5, the distal end clip 50 includes a connecting section 51 at the distal end and a clamping section 52 connected to the 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 the proximal end of the connecting rod 60 on the corresponding side, and the distal end of the connecting rod 60 is rotatably connected to the connecting seat 10. In this embodiment, the rotation connections are all realized by corresponding rotation pins. Obviously, in other embodiments, the rotation pin can be replaced by a bolt.

As mentioned above, by pulling the control member 36 to abut against the branch on the distal end of the steel sheet 343, the end of the steel sheet 343 away from the boss 341 can be driven, and the steel sheet 343 abuts against the inclined surface of the boss 341. One end is the support point and rotates in the proximal direction until the axis of the steel sheet 343 and the push rod 20 is 90 degrees, the connection lock state between the push rod 20 and the fixed seat 30 is released, and the push rod 20 can be axially relative to the fixed seat As a result, the fixing seat 30 and the connecting seat 10 move relative to each other. Under the pulling of the connecting rod 60, the distal end clip 50 can rotate around the rotating pin on the connecting block 331 and open and close relative to the fixed seat 30. After the end clip 40 is released and expands freely due to its own elastic memory function, the proximal clip 40 can move closer to the distal clip 50 to clamp the valve in the valve accommodation space 45. Further, after the proximal clip 40 and the distal clip 50 clamp the valve, the connecting seat 10 moves in the axial direction toward the proximal end until the valve clip 100 is in the retracted state, and then releases the control member 36 to the steel plate Under the control of the end of the 343 away from the boss 341, under the elastic force of the deformed elastic piece 345, the steel piece 343 contacts the push rod 20 at a certain angle, and the connection between the push rod 20 and the fixing seat 30 is locked to avoid the distal end The clip 50 is opened relative to the fixing seat 30, and the valve clip 100 in the collapsed state falls below the leaflets.

Preferably, the second surface of the distal clip 50 facing the valve accommodating space 45 can also be provided with a structure similar to the clamping reinforcement of the proximal clip 40, or apply active drugs and provide multiple openings.

Preferably, the second surface is set as a curved surface to increase the contact area and clamping area between the distal end clip 50 and the valve, thereby providing a stable clamping force. Moreover, the second surface of the curved surface forms a receiving groove, and when the proximal clip 40 is close to the distal clip 50, the barbs 46 on the first surface of the proximal clip 40 can be received in the receiving groove to compress The valve is located in the valve leaflet containing space 45, and the volume of the valve clamp 100 when the valve clamp 100 is folded is reduced as much as possible, which is conducive to delivery in the body.

It should be noted that, in order to ensure a stable clamping force and correspond to the size of the valve leaflet, the distal clip 50 has a certain size specification. 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 tends to clamp too many anterior and posterior leaflets together. When the compositor 100 is closed, the two leaflets are forcibly pulled toward each other and fixed together. When the heart beats and the leaflets move, the movement of too many leaflets is restricted, which not only easily leads to abnormal mitral valve function, but also It may cause serious consequences such as tearing of the valve leaflets; when the distal clip 50 is too short, the valve clamp 100 can only clamp a small portion of the valve leaflets, making the leaflets easy to slide out, and the clamping and fixing effect is poor. In the embodiment of the present application, the axial length of the distal end clip 50, that is, the distance from the connecting section 51 to the clamping section 52, should be greater than or equal to 4 mm, preferably 6-10 mm. In addition, the width of the distal clip 50 is also limited to a certain extent, so as to prevent the width of the distal clip 50 from being too narrow and causing damage to the valve leaflets, and also to avoid the valve clip 100 when the width of the distal clip 50 is too wide. The effect on valve leaflet movement. The width of the distal clip 50, that is, the length of the direction perpendicular to the axial direction of the distal clip 50, should be greater than or equal to 2 mm, preferably 4-6 mm.

The valve clamp 100 provided in this embodiment can be used to reduce or treat "mitral valve regurgitation". Specifically, please refer to Figures 9 to 12 together. Place the valve clamp 100 at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot align normally, so that a distal clip 50 and a proximal end One side of the clip 40 clamps the edge of the anterior leaflet 1a of the mitral valve, and the other distal clip 50 and one side of the proximal clip 40 clamp the edge of the posterior leaflet 1b of the mitral valve, so that the mitral valve The positions of the anterior lobe 1a and the posterior lobe 1b that cannot be normally aligned are clamped together, and the arrow direction shown in Fig. 11 and Fig. 12 is the blood flow direction. As shown in Figure 11, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are folded, and the positions where the anterior leaflet 1a and the posterior leaflet 1b cannot align properly are partially or completely folded together. The area of the mitral valve opening is A When the mitral valve becomes smaller or the mitral valve can be completely closed, only a small amount of blood regurgitates from the opening of the mitral valve into the left atrium, which can reduce or treat "mitral valve regurgitation." As shown in Figure 12, when the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only aligned at the position B where the valve clamp 100 is clamped. The other positions of the anterior leaflet 1a and the posterior leaflet 1b are still in normal diastole. This allows blood to enter the left ventricle from the left atrium, thereby ensuring the normal circulation of blood.

Please refer to FIGS. 3 and 13 together. In this application, in order to facilitate the secondary repair of the mitral valve, the distal end of the main body 130 of the valve clamp 100 is provided with a recovery part 150, which is used for capturing The device 210 is connected to recover the valve clamp 100 by intervention.

In this embodiment, the distal end of each connecting rod 60 is provided with a recovery part 150, and the recovery part 150 is a groove provided on the outer surface of each connecting rod 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 the distal end of the connecting portion 62 in the direction of the centerline of the valve clamp 100, and the extension bar 64. The tab 66 outside the distal end. The extension bar 64 and the protrusion 66 enclose the groove. Specifically, the groove is located at the distal end of the outer side of the connecting rod 60, and the distance from the surface of the proximal end of the groove to the centerline of the valve clamp 100 is greater than the surface of the distal end of the groove to the valve clamp 100 The distance between the centerline of the valve clamper 100 and the centerline of the valve clamper 100 are thus formed.

As shown in FIG. 13, the capture device 210 includes a capture catheter 212 with a certain axial length and a capture device 214 disposed at the distal end of the capture catheter 212. The capture device 214 is used to detachably connect with the recovery part 150 to capture the valve clip.合器100。 Combination 100. Specifically, in this embodiment, the catcher 214 is a gooseneck snare, and the gooseneck snare is sleeved on the grooves of two opposite connecting rods 60, so that the recovery part 150 is connected to the catching device 210, thereby The valve clamp 100 is captured, and when the valve clamp 100 is cut from the valve, it can be recovered.

In order to enable the gooseneck snare to be stably sleeved in the groove without falling off, preferably, the minimum outer diameter of the valve clamp 100 at the groove is the same as the outer diameter of the valve clamp 100 adjacent to the distal end of the groove. The range of diameter ratio is 0.5-0.95.

In other embodiments, the recovery portion 150 may be a protrusion protruding from the outer surface of each connecting rod 60. Specifically, the distance between the protrusion and the outer surface of the connecting rod 60 is from the proximal end to the distal end. The direction gradually decreases, and the gooseneck snare of the capture device 210 is sleeved on the protrusions of the two connecting rods 60 arranged opposite to each other to connect with the recovery part 150. Similarly, in order for the gooseneck snare to be stably sleeved in the groove without falling off, preferably, the maximum outer diameter of the valve clamp 100 at the protrusion is the same as the proximal part of the valve clamp 100 adjacent to the protrusion The range of the ratio of the outer diameter is 1.05-1.25.

Further, referring to FIGS. 3 and 4, the valve clamp 100 further includes an isolation portion 170, which is disposed between the main body portion 130 and the recovery portion 150, and the recovery portion 150 and the isolation portion 170 are at least partially applied anti-cell The proliferation drug coating or the isolation layer is used to prevent the recovery part 150 from being completely covered by endothelial cells, so as to ensure that the capturing device 210 can be connected with the recovery part 150 to facilitate the recovery of the valve clamp 100.

Specifically, in this embodiment, the isolation portion 170 is disposed on the outer side surface and the opposite sides of each connecting rod 60 adjacent to the proximal end of the recovery portion 150, that is, the distal end of the connecting portion 62 adjacent to the extension bar 64. The entire area of the isolation portion 170 is coated with an anti-cell proliferation drug, and the anti-cell proliferation drug is selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives.

Wherein, the coverage area of the spacer 170 extending in the axial direction is 5-10 mm.

In other embodiments, the entire area of the isolation portion 170 may be covered with an isolation layer to prevent endothelial growth. The isolation layer is a sleeve or coating made of a biocompatible polymer material, and the polymer material is selected from PET. , At least one of polyester, silicone, PTFE, silica gel or urethane.

In other embodiments, the isolation portion 170 may only apply an anti-cell proliferation drug coating or a coating isolation layer on a part of the area, for example, only when the isolation portion 170 is located on the outer side of each link 60 adjacent to the proximal end of the recovery portion 150 Anti-cell proliferation drug coating or coating isolation layer is applied to some areas of, as long as it can prevent endothelial cells from completely crawling over the recovery part 150.

In other embodiments, the recovery part 150 may also be coated with an anti-cell proliferation drug coating or coated with an isolation layer to prevent endothelial cells from completely crawling over the recovery part 150.

In other embodiments, the portion of the connecting seat 10 of the valve clamp 100 adjacent to the distal end of the recovery portion 150 may also be provided as the isolation portion 170.

It is understandable that the thickness of the anti-cell proliferation drug coating or isolation layer should avoid affecting the overall outer diameter of the valve clamp 100 to facilitate the delivery of the valve clamp 100 in the patient.

Please refer to FIGS. 13 and 14 together. The present application also provides a valve clamp recovery system 200 for recovering the aforementioned valve clamp 100. Specifically, the valve clamp recovery system 200 includes a capturing device 210 and a cutting device 230. The cutting device 230 is used to cut the position where the valve contacts the valve clamp 100 to cut the valve clamp 100. As described above, the capture device 210 is detachably connected to the recovery part 150 of the valve clamp 100 through the capture device 214 at the distal end to capture the valve clamp 100. Specifically, in this embodiment, the catcher 214 is a gooseneck snare, the recovery part 150 of the valve clamp 100 is a groove provided on the outer surface of each connecting rod 60, and the gooseneck snare is sleeved in the groove The valve clamp 100 is captured inside. In other embodiments, the catcher 214 may be a three-leaf snare, a vascular foreign body catcher, a ligator, a claw, a magnetic joint, and other forms.

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

Among them, the method of mechanical cutting refers to direct cutting with surgical instruments, such as inverted scissors or separately provided lancets, biopsy forceps, etc. In this embodiment, a mechanical cutting method is adopted, and the distal end of the cutting device 230 is provided with two blades 231 that can be opposed to each other. The blade 231 is made of metal material and has visual properties to facilitate the operator to observe and cut the valve in real time.

In other embodiments, the outer peripheral surface of the distal end of the cutting device 230 may be provided with a conductive portion in the circumferential direction, and the conductive portion is conductive on the surface in contact with the valve, so as to realize the electrosurgical cutting of the valve. Specifically, taking the radio frequency electrosurgical unit as an example, the conductive part includes a bare metal or metal electrode. In order to ensure safety, the outer surface of the remaining part of the cutting device 230 except for the conductive part is insulated. The method of insulation may be to coat an insulating coating or provide an insulator. In order to further ensure safety, when the electrosurgical cutting method is adopted, the cutting device 230 may also be provided with a temperature sensor electrically connected to the conductive part. The temperature sensor contacts the valve to indicate the local temperature of the part where the valve contacts the conductive part, thereby Prevent damage caused by excessively high local temperature of the valve.

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

Among them, the developing part can be in the form of developing wire, developing dot or developing film. The developing part is made of developing materials with strong corrosion resistance and good biocompatibility, such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other materials or alloys or composites of these metals. In this embodiment, the developing part 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, the valve clamp recovery system 200 further includes a removal device 250 for removing the resected valve clamp 100 outside the patient's body. Specifically, the removal device 250 includes a positioning member 251, and the positioning member 251 is movably disposed at the distal end of the removal device 250. The positioning member 251 includes an elastic frame that can be radially contracted and expanded. When the positioning member 251 extends from the distal end of the removal device 250, the elastic frame expands and expands and supports under the valve to reduce the pulsation amplitude of the valve, thereby This facilitates the removal of the valve by the removal device 230. Moreover, the positioning member 251 can be used to accommodate the valve clamp 100 after resection, and the valve clamp 100 can be accommodated in the removal device 250 along with the positioning member 251.

Wherein, the radial dimension of the elastic frame of the positioning member 251 gradually decreases from the distal opening to the proximal direction, that is, the positioning member 251 is cup-shaped, cage-shaped or funnel-shaped. In this embodiment, the positioning member 251 is cup-shaped.

Further, an adjustment mechanism is provided at the distal opening of the positioning member 251, and the adjustment mechanism includes at least one control wire, and the at least one control wire is used to adjust the radial size of the distal opening of the positioning member 251. Specifically, the control wire passes through different positions of the distal end of the positioning member 251 in the circumferential direction at the same time, and the size of the distal opening of the positioning member 251 is adjusted by controlling the length of the control wire passing through the different positions of the positioning member 251 in the circumferential direction. When the resected valve clamp 100 and valve tissue fall into the cup-shaped positioning member 251, the operator can tighten the control wire to tighten the distal opening of the positioning member 251 to wrap the valve clamp 100 To prevent the valve clamp 100 from falling off, so as to facilitate the recovery of the valve clamp 100.

It should be noted that the capture device 210 is movably disposed in the removal device 250, and can be extended from the distal opening of the positioning member 251 to capture the valve clamp 100. After the valve clamp 100 is captured, the capture device 210 When retracted into the removal device 250, at this time, the distal opening of the positioning member 251 is tightened to prevent the valve clamp 100 from falling off.

Further, as shown in FIG. 14, the valve clip recovery system 200 further includes a guiding device 270 and an adjustable bend sheath 290. The guide device 270 can be movably arranged in the adjustable bend sheath 290 or used alternately in turn. , The guiding device 270 and the adjustable curved sheath 290 are used to establish an intervention channel from outside the patient to the inside of the body.

The guiding device 270 includes a puncture guide wire (not shown in the figure) and a conical dilator. After the channel is established and the puncture guide wire reaches the vicinity of the valve, the operator can control the end of the puncture guide wire to enter the left atrium, cross the valve clamp 100, and extend back to the patient's body, and then the puncture guide wire can be clamped to the valve The device 100 applies a pulling force to reduce the undulation amplitude of the valve clamp 100, thereby facilitating the connection of the capturing device 210 and the recovery part 150 of the valve clamp 100.

Among them, the adjustable curved sheath 290, dilator and puncture guide wire are similar in structure to the existing adjustable curved sheath, dilator and puncture guide wire, and will not be described here.

It is understandable that at least one of the capturing device 210, the cutting device 230, and the removal device 250 can be delivered to the mitral valve of the patient through the corresponding interventional channel by adopting the adjustable curved sheath 290 of corresponding specifications. Specifically, please refer to FIGS. 15 and 16 together, which illustrate different intervention channels of the valve clip recovery system 200 of the present application. As shown in FIG. 15, in this embodiment, the capturing device 210 is inserted into the removal device 250 and reaches the mitral valve through the apex-left ventricle path through the adjustable curved sheath 290a, and the resection device 230 passes through the The bending sheath 290b reaches the mitral valve through the path of femoral vein-right atrium-atrial septum-left atrium-mitral valve. As shown in FIG. 16, in other embodiments, the capture device 210 and the removal device 250 can reach the mitral valve through the path of the femoral artery-aortic arch-aortic valve-left ventricle through the adjustable curved sheath 290a, and The resection device 230 can reach the mitral valve via the jugular vein-atrial septum-left atrium through the adjustable curved sheath 290b.

Of course, in other embodiments, the capture device 210, the cutting device 230, and the removal device 250 can use the same path to reach the mitral valve, so as to avoid injury to the patient from multiple punctures.

Preferably, in some embodiments, the valve holder recovery system 200 further includes a detection device, which is movably inserted in the adjustable bend sheath 290 and can extend from the distal end of the adjustable bend sheath 290 And enter the left atrium for real-time feedback of the pressure value in the heart, so as to confirm the "Mitral regurgitation" situation in time and determine whether the resection is complete. Specifically, the detection device may be a pressure sensor.

The following takes the recovery process of the valve clamp 100 of the first embodiment of the present application as an example to illustrate the use steps of the valve clamp recovery system 200 provided in the present application, as shown in FIGS. 16 to 18:

The first step: using the guiding device 270 and the adjustable curved sheath 290 of corresponding specifications to establish an intervention channel for the recovery device (ie, the capturing device 210 and the removing device 250) and the cutting device 230, respectively. The intervention path of the recovery device is to enter the left ventricle through the aortic arch, and the intervention path of the cutting device 230 is to enter the left atrium through the atrial septum;

Step 2: Withdraw the guiding device 270, push the removing device 250 and the capturing device 210 put on together into the left ventricle through the adjustable curved sheath 290a, and push the cutting device 230 into the left ventricle through the adjustable curved sheath 290b The atrium, as shown in Figure 16;

Step 3: Connect the catcher 214 at the distal end of the catching device 210 to the recovery part 150 of the valve clamper 100 to catch the valve clamper 100 and maintain the catching state, as shown in FIG. 17;

Step 4: Use the two blades 231 of the cutting device 230 to respectively cut the attachment points of the valve clamp 100 on the anterior and posterior leaflets, thereby cutting the valve clamp 100 from the valve, as shown in FIG. 18;

Step 5: Withdraw the capture device 210 into the removal device 250, so as to receive the resected valve clamp 100 into the removal device 250;

Step 6: Withdraw the cutting device 230, the removal device 250, the capture device 210 and the valve clamp 100 contained in the removal device 250 through the corresponding adjustable curved sheath 290; finally withdraw the adjustable curved sheath 290, complete the operation.

Optionally, after the first step is completed, the end of the puncture guide wire of the guiding device 270 can also be passed over the valve clamp 100 and extend back to the outside of the patient. Therefore, a pulling force is applied to the valve clamp 100 through the puncture guide wire to reduce the undulation amplitude of the valve clamp 100 following the pulsation of the valve leaflets, thereby facilitating the capture device 210 and the recovery part 150 of the valve clamp 100 The docking.

After the fifth step is completed, the operator can withdraw the cutting device 230, the removal device 250, the capture device 210, and the valve clamp 100, and then temporarily place the adjustable bend sheath 290 in the patient's body to pass the intervention The channel undergoes secondary interventional repair operations, such as implantation of artificial heart valves.

It should be noted that the capture device 210, the cutting device 230, the removal device 250, the guiding device 270, and the adjustable bend sheath 290 have operating handles close to the operator, and the operator can control the corresponding device through the corresponding operating handles. Actions such as catching, cutting, and bending are not detailed here.

Please refer to FIGS. 19 and 20 together. The structure of the valve clamp 100b provided by the second embodiment of the present application is similar to the structure of the valve clamp 100 of the first embodiment. The difference is that: in the second embodiment Wherein, the recovery portion 150b is disposed on the connection base 10b. Specifically, the recovery portion 150b is at least one hook protruding from at least one first surface 11 of the connection base 10b. In this embodiment, a hook is protrudingly provided on each first surface 11 of the connecting base 10b. When recovering the valve clamp 100b, according to the position of the valve clamp 100b and the condition of endothelial creeping, the operator can put the catcher 214 of the catching device 210 on a hook to realize unilateral catching, or The catcher 214 is sleeved on the two hooks to realize simultaneous catching on both sides. In this embodiment, the catcher 214 is a gooseneck snare.

Among them, the shape of the hook includes, but is not limited to, a right-angle hook, a half-circle hook and the like. In this embodiment, the hook is a right-angle hook.

Wherein, the hook and the connecting seat 10b may 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 connection base 10b by welding or the like.

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

It can be understood that the distance that the hook protrudes from the first surface 11 of the connecting seat 10b should avoid affecting the overall outer diameter of the valve clamp 100b, so as to facilitate delivery in the patient.

Further, different from the first embodiment, in the second embodiment, the isolation portion 170b of the valve clamp 100b is disposed on the connecting seat 10b. Specifically, the isolating portion 170b may be provided only on the first surface 11 of the connecting base 10b, or may be provided on the entire connecting base 10b, that is, the isolating portion 170b is provided at least at the portion of the connecting base 10b adjacent to the hook. In this embodiment, the isolation portion 170b is disposed on the outer surface of the entire connecting base 10b.

Please refer to FIG. 21 and FIG. 22 together. The structure of the valve clamp 100c provided by the third embodiment of the present application is similar to the structure of the valve clamp 100b of the second embodiment. The difference is that: in the third embodiment Among them, the recovery portion 150c is a through hole opened in the connecting seat 10c and passing through the two first surfaces 11. In this embodiment, the catcher 214c of the catching device 210c is a pair of claws, and the valve clamp 100c is recovered by inserting a pair of claws into both ends of the through hole. Preferably, the through hole is opened in the middle position of the connecting seat 10c, so that the grasping force received by the valve adaptor 100c is always on its center of mass line, so that the valve clamp 100c can enter the removal 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 clamp 100c, so as to prevent the excessively heavy valve clamp 100c from falling under the valve for a long time and straining the valve.

Wherein, in order to reduce the outer diameter of the capturing device 210c, the proximal ends of a pair of jaws are staggered.

It can be understood that, in other embodiments, the recovery 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 recover the valve clamp.器100c. Preferably, the two opposite first surfaces 11 of the connecting seat 10c are respectively provided with a blind hole, and the two blind holes are arranged symmetrically with respect to the central axis of the connecting seat 10c, so that the grasping force received by the valve adapter 100c is always at its The centroid line. Further, an auxiliary member for assisting the connection of the claws of the capture device 210c may be arranged in the blind hole. Specifically, the auxiliary member may be a magnetic sheet, which can attract the claw to prevent the claw from falling out of the blind hole.

Referring to FIG. 23, the structure of the valve clamp 100d provided in the fourth embodiment of the present application is similar to the structure of the valve clamp 100b of the second embodiment, except that: in the fourth embodiment, the recovery part 150d It is at least one barb or at least one ring body disposed on the second surface 12 of the connecting seat 10d. In this embodiment, the recovery portion 150d is a barb protruding outward with respect to the second surface 12, and the catcher 214d of the catching device 210d is a catching ring, and the catching ring of the catching device 210d is hooked on the barb To recover the valve clamp 100d.

Among them, the shape of the barb includes, but is not limited to, a right-angled hook, a half-circle hook, etc. In this embodiment, the barb is a half-circle hook.

Wherein, the barb is arranged at the axial position of the valve clamp 100d. When the catch ring of the capturing device 210d is hooked on the barb, the catching force received by the valve adapter 100d is always on its centroid line, making the valve clamp The combiner 100d is easier to enter the removal device, which improves the efficiency of the operation.

In other embodiments, the number of barbs may be two, and the catch ring of the catch device 210d is hooked on the two barbs at the same time, so that when the catch ring of the catch device 210d falls off one of the barbs, The catching ring is still hooked on the other barb to ensure that the catching device 210d remains connected to the recovery part 150d of the valve clamp 100d. Similarly, the two barbs are arranged symmetrically with respect to the connecting seat 10d, so that the grasping force received by the valve clipper 100d is always on its center of mass line.

In other embodiments, the recovery part 150d may be at least one circular body made of biocompatible metal or polymer material, and the capture device 214d of the capture device 210d is correspondingly set as a claw. The claw is inserted into at least one annular body to recover the valve clamp 100d.

Please refer to FIGS. 24 and 25 together. The structure of the valve clamp 100e provided by the fifth embodiment of the present application is similar to the structure of the valve clamp 100d of the fourth embodiment, except that: in the fifth embodiment Among them, the recovery portion 150e is a connecting hole opened on the second surface 12 of the connecting seat 10e, and a connecting piece for docking with the capturing device 210e is provided in the connecting hole. In this embodiment, the connecting hole is a blind hole 153e opened in the middle of the second surface 12, and a magnetic member is arranged in the blind hole 153e. In this embodiment, the capture device of the capture device 210e is a magnetic conduit connector 214e. The magnetic catheter connector 214e is docked in the connecting hole to realize the magnetic docking of the capture device 210e and the valve clamp 100e.

Wherein, the magnetic member may be a magnetic gasket arranged in the blind hole 153e.

Further, in order to improve connection reliability, a threaded member is provided in the center of the blind hole 153e for screwing and fixing with the capturing device 210e. In this embodiment, the threaded member is a threaded hole 155e opened in the inner bottom of the connecting hole, the distal end of the capture device 210e is provided with a threaded joint 216e, and the threaded joint 216e is movably arranged in the magnetic catheter joint 214e. After the magnetic conduit connector 214e of the capture device 210e is magnetically connected to the blind hole 153e on the connecting seat 10e, the threaded connector 216e can be extended out of the magnetic conduit connector 214e and screwed to the threaded hole 155e in the blind hole 153e, thereby connecting the capture device 210e is screwed and locked with the valve clamp 100e.

In other embodiments, the threaded member may be a stud protruding from the connecting hole, and the distal end of the capturing device 210e is provided with a connecting tube with internal threads. The connecting tube is movably arranged in the magnetic catheter joint and can be extended. Screwed with the stud in the connecting hole.

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

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

Referring to FIG. 26, the structure of the valve clamp 100f provided by the sixth embodiment of the present application is basically similar to the structure of the valve clamp 100 of the first embodiment, except that: in the sixth embodiment, the main body A through groove for connecting with the claw 214f of the capture device 210f is provided at the distal end of the valve. The through groove extends in a direction perpendicular to the axial direction of the valve clamp 100f, and the through groove forms a recovery portion 15Of.

Specifically, in this embodiment, the connecting section 51f of each distal clip 50f is hollowed out, and the connecting section 51f of each distal clip 50f includes two connecting pieces, and each connecting piece is opened from the distal end to the proximal end. The extended sliding groove, the two distal clips 50f are located on the same side of the connecting seat 10f, the two connecting pieces are stacked on each other, and the sliding grooves of the two connecting pieces are connected, and one end of a first pin passes through the two distal clips in turn The piece 50f is located at the sliding grooves on the two connecting pieces on the same side of the connecting seat 10f, passes through the pin holes on the connecting seat 10f, and finally is inserted into the two distal clips 50f on the opposite side of the connecting seat 10f. In the sliding grooves on the two connecting pieces, the distal ends of the connecting sections 51f of the two distal clips 50f are movably connected to the connecting seat 10f through the same first pin; the connecting section 51f of each distal clip 50f The proximal end is provided with pin holes, the opposite ends of the fixing base 30f are provided with corresponding fixing holes, and the two second pins respectively pass through the pin holes on the two distal clips 50f and are inserted into the corresponding fixing holes on the fixing base 30f. In this way, the proximal ends of the connecting sections 51f of the two distal end clips 50f are respectively rotatably connected to the opposite ends of the fixing base 30f. At this time, the connecting seat 10f, the fixing seat 30f, and the two distal clips 50f are located between the two sets of connecting pieces on the opposite sides of the connecting seat 10f and the fixing seat 30f to form the through groove, and the through groove penetrates On opposite sides of the valve clamp 100f, the claws 214f of the capturing device 210f can be inserted into the through groove and abut against the third surface 13 of the connecting seat 10f to recover the valve clamp 100f.

Further, different from the first embodiment, in the sixth embodiment, the isolation portion 170f of the valve clamp 100f is provided at the distal end of the clamping section 52f of the distal end clip 50f.

Please refer to FIG. 27, the structure of the valve clamp 100g provided by the seventh embodiment of the present application is basically similar to the structure of the valve clamp 100 of the first embodiment, except that: in the seventh embodiment, the valve clamp The combiner 100g includes two relatively superimposable V-shaped clamping members, wherein both of the clamping members are fixed on the fixing base 30g, the distal end of the fixing base 30g is provided with a recovery part 150g, and the catcher 214g of the capturing device 210g Connect with the recovery part 150g to recover 100g of the valve clamp.

Specifically, in this embodiment, the recovery part 150g is a groove opened in the circumferential direction at the distal end of the fixing seat 30g, and the catcher 214g is a gooseneck snare, and the valve clamp is recovered by socketing the snare in the groove 100g.

Referring to FIG. 28, it can be understood that, in other embodiments, the recovery portion 150g' may be a hook, barb or ring protruding from the distal end of the fixing base 30g', or may be opened on the fixing base 30g' The blind holes, through holes or connecting holes on the surface will not be repeated here.

Further, different from the first embodiment, in the seventh embodiment, the isolation portion 170g of the valve clamp 100g is provided at least at the portion of the fixing seat 30g adjacent to the recovery portion 150g. In this embodiment, the isolation portion 170g is provided On the outer surface of the entire fixing base 30g.

It should be noted that the above content is described with an example in which a valve clamp is used to reduce or treat "mitral regurgitation". It is understandable that in other embodiments, the valve clamp can also be used to reduce or treat "tricuspid regurgitation", and its principle and structure are the same as those used to solve "mitral regurgitation" in the embodiments of this application. The principle and structure of the valve clamp is roughly the same. It only needs to form multiple clamps by multiple sets of proximal and distal clamps, and each clamp can clamp a leaflet separately, which will not be repeated here. .

Obviously, in other embodiments, the valve clamp provided in the present application can also be applied to other minimally invasive surgical operations that require more than three pieces of valve tissue to be clamped together.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims (27)

1. A recoverable valve clamp, which is characterized in that it comprises a main body and a recovery part arranged at the distal end of the main body, and the recovery part is used to connect with a capturing device to recover the valve clamp by intervention Device.
2. The valve clamp according to claim 1, wherein the main body portion includes two oppositely arranged connecting rods, the distal end of each connecting rod is provided with the recovery part, and the recovery part is arranged A groove on the outer surface of each connecting rod or a protrusion protruding from the outer surface of each connecting rod.
3. The valve clamp of claim 2, wherein the minimum outer diameter of the valve clamp at the groove is the same as the outer diameter of the valve clamp near the distal end of the groove The range of the diameter ratio is 0.5-0.95; the range of the ratio of the maximum outer diameter of the valve clamp at the protrusion to the outer diameter of the proximal part of the valve clamp adjacent to the protrusion is 1.05-1.25.
4. The valve clamp according to claim 1, wherein the main body part includes a connecting seat at a distal end, the recovery part is disposed on the connecting seat, and the connecting seat includes two opposite first The surface and the second surface at the distal end.
5. The valve clamp of claim 4, wherein the recovery part is at least one hook, barb or ring protruding on at least one of the first surface or the second surface.
6. The valve clamp of claim 4, wherein the recovery part is at least one blind hole or a through hole opened on at least one of the first surface or the second surface.
7. The valve clamp of claim 6, wherein the through hole penetrates through the two first surfaces.
8. The valve clamp according to claim 6, wherein the blind hole is a connecting hole opened on the second surface, and a connecting piece for docking with the capturing device is provided in the connecting hole.
9. The valve clamp according to claim 8, wherein the connecting member comprises a magnetic member and/or a screw member.
10. The valve clamp according to claim 5 or 6, wherein the number of the recovery parts is two, and the two recovery parts are symmetrically arranged with respect to the central axis of the connecting seat.
11. The valve clamp according to claim 1, wherein the distal end of the main body portion is provided with a through groove for connecting with the capture device, and the through groove extends along a vertical direction of the valve clamp. Extending in the axial direction, the through groove forms the recovery part.
12. The valve clamp according to claim 1, wherein the valve clamp further comprises an isolation part, the isolation part is provided between the main body part and the recovery part, the recovery part and An anti-cell proliferation drug coating or a covering isolation layer is at least partially applied to the isolation portion.
13. The valve clamp of claim 12, wherein the anti-cell proliferation drug is selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives; the isolation layer is a biological A sleeve or coating made of a compatible polymer material, the polymer material is selected from at least one of PET, polyester, silicone, PTFE, silica gel or urethane.
14. A valve clamp recovery system for recovering the valve clamp according to any one of claims 1 to 13, wherein the valve clamp recovery system includes a capturing device and a cutting device; the cutting The device is used to cut the contact position of the valve and the valve clamp to remove the valve clamp; the distal end of the capture device is detachably connected with the recovery part of the valve clamp to capture the Valve clamp.
15. The valve clip recovery system according to claim 14, wherein the capture device comprises a capture catheter and a capture device arranged at the distal end of the capture catheter, and the capture device is used to be detachable from the recovery part connection.
16. The valve clamp recovery system according to claim 15, wherein the catcher is at least one of a snare, a catch ring, a claw, a magnetic joint, and a threaded joint.
17. The valve clip recovery system according to claim 14, wherein the cutting device is provided with at least one developing part, and at least one developing part is arranged at the distal end of the cutting device.
18. The valve clip recovery system according to claim 14, wherein the cutting method of the cutting device is selected from at least one of mechanical cutting or electrosurgical cutting.
19. The valve clamp recovery system according to claim 18, wherein the electrosurgical knife is selected from radio frequency electrosurgical knife, high frequency electrosurgical knife, ultrasonic scalpel, plasma scalpel, laser scalpel, or cryogenic scalpel At least one of.
20. The valve clamp recovery system according to claim 19, wherein the outer peripheral surface of the distal end of the cutting device is provided with a conductive part in the circumferential direction, and the conductive part conducts electricity on the surface in contact with the valve. The knife cuts the valve.
21. The valve clamp recovery system according to claim 20, wherein the cutting device further comprises a temperature sensor electrically connected to the conductive part, the temperature sensor being in contact with the valve; the temperature sensor is used for To indicate the temperature of the part of the valve in contact with the conductive part.
22. The valve clip recovery system according to claim 14, wherein the valve clip recovery system further comprises a removal device, the removal device is used to move the removed valve clip Except to the patient's body.
23. The valve clip recovery system according to claim 22, wherein the removal device comprises a positioning member, the positioning member is movably arranged at the distal end of the removal device, and the positioning member is used for The valve is supported to reduce the pulsation amplitude of the valve.
24. The valve clip recovery system according to claim 23, wherein the positioning member comprises an elastic frame that can be radially contracted and expanded, and when the positioning member extends from the distal end of the removal device , The elastic frame is expanded and expanded and supported under the valve.
25. The valve clip recovery system according to claim 24, wherein the radial dimension of the elastic frame gradually decreases from the distal opening to the proximal direction.
26. The valve clip recovery system according to claim 23, wherein the distal opening of the positioning member is provided with an adjustment mechanism, and the adjustment mechanism includes at least one control wire, and at least one of the control wires is used for Adjust the radial size of the distal opening of the positioning member.
27. The valve clip recovery system according to claim 14, wherein the valve clip recovery system further comprises a guiding device, the guiding device is used to approach the valve clip and pass over the The valve clamp is extended backward to reduce the undulation amplitude of the valve clamp.

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