Independently controlled valve clamping system

Abstract

The present invention provides an independently controllable valve clamping system, including a valve clamp and a conveying device for conveying the valve clamp. The valve clamp includes a fixing seat and a proximal clip that can be folded or unfolded relative to the fixing seat. The conveying device includes a conveying sheath and a control member, the conveying sheath is provided with at least one pair of first holes extending in the axial direction and symmetrical about its axis, each control member is movably arranged in at least one pair of first holes, and each control member is connected to a corresponding proximal clip to control the folding or unfolding of the proximal clip relative to the fixing seat. In the present invention, when the control member is pulled toward the proximal end to control the corresponding proximal clip to be folded relative to the fixing seat, the resultant force of the pulling force of each control member on the corresponding proximal clip is located on the axis of the conveying sheath, thereby avoiding bending of the conveying sheath and swinging of the valve clamp, which is beneficial to reducing the operation time, improving the operation efficiency, and avoiding harm to the patient.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an independently controllable valve clamping system. Background Art

[0002] See also Figure 1 The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from the left ventricle 3 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 leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscle of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 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 organic or functional changes occur in the leaflets of the mitral valve 1 or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned. As a result, 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, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] There is a minimally invasive treatment surgery based on the principle of edge-to-edge surgery of the valve. 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 simultaneously through the relative opening and closing of the clamp, so as to pull the leaflets closer to each other and reduce "mitral regurgitation". In the process of clamping the leaflets, since the two leaflets of the mitral valve are always in a state of opening and closing with large amplitude and force, the clamping is difficult, and it is usually hoped that the clamping action of each leaflet can be controlled separately.

[0004] See also Figure 3 There is a valve clamp 100', which includes two groups of proximal clips 20' and distal clips 30' respectively located on opposite sides of the axis of the delivery sheath 210'. Each proximal clip 20' is controlled to move by a control line 230'. The two proximal clips 20' can be released separately and expand relative to the fixing seat 10' under their own elasticity and move toward the corresponding distal clip 30' to clamp the two leaflets of the mitral valve respectively. However, if Figure 4As shown, in the prior art, the inlet and outlet of the control line 230' for controlling each proximal clip 20' are realized through the same cavity 211' on the side of the axis of the delivery sheath 210'. During repeated surgical operations, when the proximal clip 20' on one side is tightened by the control line 230' and retracted relative to the fixing seat 10', the tension F' acting on the proximal clip 20' is located on the side of the axis of the delivery sheath 210', and the tension F' will generate a certain torque on the valve clamp 100'. , which causes the valve clamp 100' to swing toward the side where the pulling force F' is located, and further causes the delivery sheath 210' to bend, so that the operator needs to adjust the position of the valve clamp 100' several times to accurately release the proximal clip 20' to re-clamp the leaflets of the mitral valve, resulting in a long operation time and low efficiency; furthermore, the swinging of the valve clamp 100' may also pull the leaflets or entangle the chordae tendineae, thereby tearing the leaflets or breaking the chordae tendineae, which will not only cause failure of the operation but may even cause serious harm to the patient. Summary of the invention

[0005] In view of this, the present invention provides an independently controllable valve clamping system, which can not only clamp the valve leaflet on one side independently, but also avoid the bending of the delivery sheath and the swinging of the valve clamper, which is beneficial to reduce the operation time, improve the operation efficiency, and avoid harm to the patient.

[0006] In order to solve the above technical problems, the present invention provides an independently controllable valve clamping system, including a valve clamper and a conveying device for conveying the valve clamper, the valve clamper including a fixing seat and a proximal clip that can be retracted or unfolded relative to the fixing seat, the conveying device including a conveying sheath and a control member, each of the control members correspondingly connected to one of the proximal clips to control the retraction or unfolding of the proximal clip relative to the fixing seat; wherein the conveying sheath is provided with at least one pair of first cavities extending axially, at least one pair of the first cavities are symmetrical about the axial center line of the conveying sheath, and each of the control members is movably disposed in at least one pair of the first cavities.

[0007] The independently controllable valve clamping system provided by the present invention has a control component that passes through at least a pair of first cavities symmetrically opened about the axis of the delivery sheath. When the corresponding proximal clip is controlled to be retracted relative to the fixing seat by the control component, the resultant force of the tension exerted by the control component on the corresponding proximal clip is located on the axis of the delivery sheath, thereby avoiding bending of the delivery sheath and swinging of the valve clamp, which is beneficial to reducing operation time, improving operation efficiency, and avoiding harm to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0009] Figure 1 This is a schematic diagram of the mitral valve in its normal state.

[0010] Figure 2 This is a schematic diagram of a mitral valve disease.

[0011] Figure 3 It is a schematic diagram of the three-dimensional structure of a valve clamp and a delivery sheath in the prior art.

[0012] Figure 4 yes Figure 3 Schematic diagram of the proximal clip on one side of the valve clip being tightened.

[0013] Figure 5 It is a schematic diagram of the three-dimensional structure of the valve clamping system provided in the first embodiment of the present invention.

[0014] Figure 6 yes Figure 5 Schematic diagram of the proximal clip on one side of the valve clip being tightened.

[0015] Figure 7 yes Figure 5 Schematic diagram of the three-dimensional structure of part of the valve clamping system.

[0016] Figure 8 yes Figure 7 Schematic diagram of the three-dimensional structure of the fixing seat.

[0017] Fig. 9 yes Figure 7 Schematic diagram of the three-dimensional structure of the proximal clip in FIG.

[0018] Fig.10 yes Figure 5 Schematic diagram of the valve clip in use.

[0019] Fig.11 yes Fig.10 Schematic diagram of the mitral valve during heart contraction after the valve leaflets are clamped by the valve clip in the figure.

[0020] Fig.12 yes Fig.10 Schematic diagram of the mitral valve during diastole after the valve leaflets are clamped by the valve clip in the figure.

[0021] Fig.13 Figure 5Schematic diagram of the distal end of the delivery sheath.

[0022] Fig.14 and Fig.15 It is a schematic diagram of the distal end of the delivery sheath in other embodiments.

[0023] Fig.16 yes Figure 5 Schematic diagram of the partial three-dimensional structure of the conveying device.

[0024] Fig.17 yes Fig.16 A cross-sectional view of the conveying device in FIG.

[0025] Figures 18 to 21 yes Figure 5 Schematic diagram of the use process of the valve clipping system.

[0026] Fig. 22 It is a three-dimensional structural schematic diagram of a part of the structure of the valve clamping system provided in the second embodiment of the present invention.

[0027] Fig.23 It is a three-dimensional structural schematic diagram of a part of the structure of the valve clamping system provided in the third embodiment of the present invention.

[0028] Fig.24 4 is a schematic structural diagram of a valve clamping system provided in accordance with a fourth embodiment of the present invention. DETAILED DESCRIPTION

[0029] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0030] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0031] 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, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device in the natural state. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

[0032] Please also read Figure 5 and Figure 6 The first embodiment of the present invention provides an independently controllable valve clipping system, including a valve clipper 100 and a delivery device 200 for delivering the valve clipper 100. The valve clipper 100 includes a fixing seat 10 and a proximal clip 20 that can be retracted or expanded relative to the fixing seat 10. The delivery device 200 includes a delivery sheath 210 and a control member 230, each control member 230 correspondingly connected to a proximal clip 20 to control the retraction or expansion of the proximal clip 20 relative to the fixing seat 10. Specifically, the delivery sheath 210 is provided with at least one pair of first cavities 211 extending axially and symmetrically about the axis of the delivery sheath 210, and each control member 230 is movably inserted into at least one pair of first cavities 211. Thus, when the control member 230 is tightened toward the proximal end to control the corresponding proximal clip 20 to be retracted relative to the fixing seat 10, the resultant force F of the tension exerted by each control member 230 on the corresponding proximal clip 20 is located on the axis of the delivery sheath 210, thereby preventing the delivery sheath 210 from bending and the valve clamp 100 from swinging.

[0033] The valve clipper 100 further includes a distal clip 30 rotatably connected to the fixing seat 10 and a driving assembly for driving the distal clip 30 to open and close relative to the fixing seat 10, and the driving assembly includes a push rod 40 axially slidably disposed in the fixing seat 10 and a connecting rod 50 connecting the distal clip 30 and the push rod 40. When the push rod 40 slides axially relative to the fixing seat 10, the distal clip 30 opens relative to the fixing seat 10 under the pull of the connecting rod 50, and after the distal clip 30 is placed in a proper position below the valve, the control of the control member 230 on the proximal clip 20 is released, and the proximal clip 20 is released and unfolded relative to the fixing seat 10, and the proximal clip 20 moves closer to the distal clip 30 to clamp the valve between the two. When the valve is not firmly clamped, the operator can control the corresponding proximal clip 20 to retract relative to the fixing seat 10 by tightening the control member 230, so as to release the proximal clip 20 again to clamp the valve again.

[0034] In the present invention, the control member 230 is inserted into at least one pair of first cavities 211 symmetrically opened about the axis of the delivery sheath 210. When the corresponding proximal clip 20 is controlled to be retracted relative to the fixing seat 10 by the control member 230, the resultant force F of the tension exerted by the control member 230 on the corresponding proximal clip 20 is located on the axis of the delivery sheath 210, so that the torque generated by the resultant force F on the valve clamp 100 is zero, thereby avoiding the bending of the delivery sheath 210 and the swinging of the valve clamp 100. The operator does not need to adjust the position of the valve clamp 100 multiple times to quickly and accurately release the proximal clip 20 to clamp the valve, which is beneficial to reducing the operation time, improving the operation efficiency, and avoiding the damage to the patient caused by the swing of the valve clamp 100.

[0035] In this embodiment, the number of the proximal clips 20 and the distal clips 30 are both two, and the two proximal clips 20 correspond to the two distal clips 30 to form two clamps, and the two clamps are symmetrically arranged about the axis of the fixing seat 10. The valve clip 100 is delivered to the mitral valve of the patient by the delivery device 200, and the two clamps can respectively clamp the anterior leaflet and the posterior leaflet of the mitral valve to reduce the leaflet gap, and remain in the patient's body as an implant to reduce or treat the patient's "mitral regurgitation".

[0036] To ensure safety after implantation, the fixing seat 10, the proximal clip 20 and the distal clip 30 are respectively made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy; the push rod 40 and the connecting rod 50 are respectively made of biocompatible polymer materials or metal materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy. Preferably, in order to improve the clamping force, in this embodiment, the fixing seat 10, the distal clip 30, the push rod 40 and the connecting rod 50 are all made of stainless steel or cobalt-chromium alloy with high hardness, and the proximal clip 20 is made of a material with shape memory function, preferably a superelastic nickel-titanium alloy.

[0037] For details, please refer to Figure 7 and Figure 8 The fixing seat 10 includes a first seat body 11 at the proximal end, a second seat body 12 at the distal end, and a third seat body 13 for transitionally connecting the first seat body 11 and the second seat body 12. The three can be an integral structure or a non-integrated structure. In this embodiment, the three are an integral structure.

[0038] The first seat body 11 is axially provided with a lumen penetrating through both end surfaces. The proximal end of the first seat body 11 is provided with two rectangular clamping holes 111 connected to the lumen and symmetrical about the axis of the first seat body 11 for connecting with the connecting rod 250 of the conveying device 200.

[0039] The second seat body 12 is provided with a receiving cavity 14 extending through two opposite side surfaces of the second seat body 12 in a direction perpendicular to the axial direction. The second seat body 12 is provided with a through hole in the axial direction on the inner wall of the far end of the receiving cavity 14. The axis of the through hole is colinear with the axis of the lumen of the first seat body 11. A rectangular block 121 is protruded from the other two opposite side surfaces of the second seat body 12.

[0040] Two opposite planes of the third seat body 13 are respectively provided with a connecting block 131 , and the connecting block 131 is provided with a pin hole for installing a rotating pin or a bolt.

[0041] Furthermore, the third seat body 13 is axially provided with a through hole (not shown in the figure), and the tubular cavity of the first seat body 11, the through hole of the third seat body 13, the accommodating cavity 14 of the second seat body 12 and the through hole located on the inner wall of the distal end of the accommodating cavity 14 are coaxially connected to form a penetration channel 15.

[0042] Please also read Figure 5 and Figure 6 The driving assembly includes a push rod 40, which is slidably inserted into the through passage of the fixing seat 10 in the axial direction. The proximal end of the push rod 40 is connected to the core shaft (not shown) of the delivery device 200. A connecting seat 45 is provided at the distal end of the push rod 40, and two pin holes are provided at opposite ends of the connecting seat 45. The shape of the connecting seat 45 is any structure such as a hemisphere, a spherical cap or a bullet head, so that the valve clip 100 can be more easily delivered in the body.

[0043] It should be noted that a locking piece is provided in the accommodating cavity of the fixing seat 10, and adjusting pieces are respectively provided on the two opposite sides of the fixing seat 10. The push rod 40 can be fixed or unlocked relative to the fixing seat 10 through the cooperation of the locking piece and the adjusting piece. Specifically, the locking piece can be a combination of deformable spring pieces and steel sheets in the prior art, and the adjusting piece can be a metal wire made of nickel-titanium alloy or the like. Since it is not related to the improvement and creation of the present invention, it will not be elaborated here.

[0044] Further, such as Figure 5 and Figure 6 As shown, in this embodiment, the drive assembly also includes two connecting rods 50 arranged opposite to each other, each connecting rod 50 is used to connect the distal clip 30 on the corresponding side to the connecting seat 45 at the distal end of the push rod 40. When the push rod 40 slides axially in the fixed seat 10, the distal clip 30 can be pulled to open and close relative to the fixed seat 10 by the connecting rod 50.

[0045] Specifically, each distal clip 30 includes a connecting section 31 located at the distal end and a clamping section 32 connected to the proximal end of the connecting section 31. One end of the connecting section 31 away from the corresponding clamping section 32 is rotatably connected to the connecting block 131 of the third seat body 13 of the fixed seat 10, and one end of the connecting section 31 close to the clamping section 32 is rotatably connected to the proximal end of the connecting rod 50 on the corresponding side. The distal end of the connecting rod 50 is rotatably connected to the pin hole of the connecting seat 45 by a rotating pin or bolt.

[0046] In the present invention, the locking member and the adjusting member provided on the fixing seat 10 cooperate to unlock the push rod 40 relative to the fixing seat 10, and the push rod 40 can slide axially toward the distal end and move relative to the fixing seat 10, thereby, the connecting seat 45 at the distal end of the push rod 40 moves relative to the fixing seat 10, and the connecting seat 45 drives the connecting rod 50 to move. Under the pulling of the connecting rod 50, the distal clip 30 can rotate around the center of the pin hole on the connecting block 131 and open relative to the fixing seat 10. When the proximal clip 20 is released, a leaflet accommodating space is formed between the proximal clip 20 and the distal clip 30, and the proximal clip 20 is opened. 0 moves toward the corresponding distal clip 30 to clamp the valve between the two; after the proximal clip 20 and the distal clip 30 clamp the valve, the push rod 40 is driven to slide axially toward the proximal end, and the connecting rod 50 further drives the distal clip 30 to close relative to the fixing seat 10, until the distal clip 30 is completely closed relative to the fixing seat 10. At this time, the valve clamp 100 is in a retracted state, and the push rod 40 is fixed relative to the fixing seat 10 again through the cooperation of the locking member and the adjusting member to prevent the distal clip 30 from opening relative to the fixing seat 10, and the valve clamp 100 in the retracted state falls below the valve.

[0047] When the connecting rod 50 drives the distal clip 30 to open and close relative to the fixing seat 10, the distal clip 30 can be opened and closed within a large range relative to the fixing seat 10, and the angle between the two distal clips 30 can reach a maximum of 300 degrees, that is, after the distal clip 30 is opened relative to the fixing seat 10, it can be turned downward to a certain extent, which is conducive to clamping the valve that is constantly in motion and improving the clamping success rate. In this embodiment, the angle between the two distal clips 30 is preferably in the range of 0-240 degrees, and more preferably 120-180 degrees.

[0048] Preferably, a clamping anti-slip structure (not shown) may be provided on the first surface of the distal clip 30 facing the proximal clip 20 to enhance the friction force when the distal clip 30 contacts the valve, thereby providing a stable clamping force and preventing the distal clip 30 from damaging the valve. The clamping anti-slip structure may be a protrusion or a groove provided on the first surface, or a gasket made of a biocompatible material with a high friction coefficient and attached to the first surface.

[0049] The first surface can be a plane or a curved surface. Preferably, the first surface is set as a curved surface to increase the contact area and clamping area between the distal clip 30 and the valve, so as to provide a stable clamping force; furthermore, the first surface of the curved surface forms a receiving groove, and when the proximal clip 20 moves closer to the distal clip 30, the proximal clip 20 is at least partially received in the receiving groove to compress the valve between the two, and can minimize the volume of the valve clip 100 when it is folded, which is convenient for in vivo delivery.

[0050] Further preferably, active drugs can be applied to the first surface of the distal clip 30, or at least one opening can be opened to promote the crawling and growth of endothelial cells of the valve tissue on the inner surface of the distal clip 30; furthermore, the opening can also reduce the overall weight of the valve clamp 100, thereby preventing the overweight valve clamp 100 from falling under the leaflet for a long time and causing slippage or damage to the leaflet.

[0051] Please also read Figure 5 , Figure 7 and Fig. 9 Each proximal clip 20 includes a connecting end 21 and a free end 22 that are arranged opposite to each other, and the connecting end 21 is fixed relative to the fixing seat 10. In this embodiment, the two proximal clips 20 are connected as a whole through a connecting frame 23, and the connecting frame 23 is provided with a through hole 24 for the push rod 40 to pass through, and the two opposite sides of the connecting frame 23 are also provided with a rectangular hole 25 for the rectangular block 121 on the second seat body 12 to pass through, and the connecting frame 23 is sleeved on the outer side of the second seat body 12 and the third seat body 13 to relatively fix the connecting ends 21 of the two proximal clips 20 to the fixing seat 10. In other embodiments, the connecting ends 21 of the proximal clips 20 can be directly fixed to the fixing seat 10 by welding, crimping, or other connection methods.

[0052] Each proximal clip 20 is at least partially made of a material with shape memory function. After heat setting treatment, in the natural state, the proximal clip 20 extends radially outward relative to the fixing seat 10, and preferably extends toward the proximal end so as to cooperate with the distal clip 30 to clamp the leaflet. In this embodiment, the proximal clip 20 is cut from nickel-titanium alloy and placed in a shaping mold, and then the shaping mold is heat treated at 300-650°C, taken out and quickly cooled, and the shaping mold is removed to obtain the shaped proximal clip 20. Specifically, in this embodiment, the proximal clip 20 is made of superelastic nickel-titanium alloy as a whole, and the connecting frame 23 is also made of nickel-titanium alloy and is integrally formed with the proximal clip 20 to reduce the difficulty of the production process, simplify the process flow, and reduce the production cost. In other embodiments, the connecting frame 23 can also be made of stainless steel and then welded to the proximal clip 20 to improve the connection strength between the connecting frame 23 and the second seat body 12.

[0053] Each proximal clip 20 is provided with at least one connecting structure 26 for connecting with the control member 230. Specifically, Figure 7 As shown, in this embodiment, each proximal clip 20 is provided with a connection hole, which is the connection structure 26. The control member 230 is connected to the connection hole of the corresponding proximal clip 20 and extends to the outside of the patient through the delivery sheath 210. The operator controls the corresponding proximal clip 20 to be retracted or unfolded relative to the fixing seat 10 through the control member 230 outside the body. Preferably, in this embodiment, the connection structure 26 is provided at the end of the proximal clip 20 that is away from the fixing seat 10 after being unfolded relative to the fixing seat 10, that is, the free end 22, which is conducive to the operator to control the retraction of the proximal clip 20 relative to the fixing seat 10 with a small pulling force.

[0054] In other embodiments, the connection structure 26 may be two or more connection holes opened on the proximal clip 20 , and the control member 230 passes through the plurality of connection holes in sequence to control the proximal clip 20 .

[0055] In other embodiments, the connection structure 26 may be at least one connection ring convexly disposed on the surface of the proximal clip 20 facing the fixing seat 10, and the control member 230 is connected to the connection ring to control the proximal clip 20. The connection ring and the proximal clip 20 may be an integral structure or a non-integrated structure. Specifically, in some embodiments, the connection ring is integrally formed with the proximal clip 20 by machining or stamping; in other embodiments, the connection ring may be a part with a connection hole and is combined with the proximal clip 20 by crimping, bonding or welding.

[0056] Among them, when each proximal clip 20 is provided with at least two connecting structures 26, preferably, the center line of the at least two connecting structures 26 is located at or close to the axial center line of the proximal clip 20 (that is, the center line of the proximal clip 20 along the direction from the connecting end 21 to the free end 22), so as to avoid the tension exerted by the control member 230 on the corresponding proximal clip 20 causing the proximal clip 20 to twist and deform around its axial center line.

[0057] Further, a clamping reinforcement member is provided on the second surface of each proximal clip 20 facing the distal clip 30 to increase the friction between the proximal clip 20 and the valve, and improve the clamping force of the valve clip 100 on the valve. Specifically, in this embodiment, the clamping reinforcement member is two rows of barbs 27 arranged at intervals on the opposite sides of the second surface. The barbs 27 can be formed on the proximal clip 20 in an integral molding manner, or the barbs 27 can be formed of the same or different materials as the proximal clip 20 and then connected to the second surface of the proximal clip 20. The angle between the extension direction of the barbs 27 and the second surface is less than or equal to 90 degrees, preferably 30-60 degrees, so as to enhance the clamping force of the valve clip 100 on the valve.

[0058] In other embodiments, the clamping reinforcement may be a ridge, a boss or other irregularly distributed protrusions protruding from the second surface, or a rough surface at least partially covering the second surface, or a combination of the above forms to increase the clamping force on the valve.

[0059] Preferably, active drugs may be applied or at least one opening 28 may be opened on each proximal clip 20 .

[0060] It should be noted that, by tightening the control member 230 toward the proximal end, the free end 22 of the proximal clip 20 can be controlled to retract relative to the fixing seat 10, so that the free end 22 of the proximal clip 20 is attached to the surface of the fixing seat 10 for easy transportation. After the control of the control member 230 on the free end 22 is released, the free end 22 of the proximal clip 20 is released, and the proximal clip 20 rebounds and returns to its natural state due to its own elastic memory property. The free end 22 of the proximal clip 20 expands relative to the fixing seat 10 to press the leaflet toward the distal clip 30. Preferably, the angle between the two proximal clips 20 in the naturally unfolded state should be slightly larger than the angle between the two distal clips 30 to provide a more stable clamping force, that is, the angle between the proximal clip 20 and the fixing seat 10 is larger than or equal to the angle between the distal clip 30 and the fixing seat 10 when the distal clip 30 corresponding to the side is fully opened relative to the fixing seat 10, thereby ensuring that there is a certain clamping force between the proximal clip 20 and the distal clip 30 to clamp the leaflet located therebetween. In this embodiment, the angle between the length direction of the proximal clip 20 and the axial direction of the fixing seat 10 ranges from 0 to 150 degrees, that is, in the natural state, the angle between the two proximal clips 20 can reach a maximum of 300 degrees, and the opening angle between the two proximal clips 20 is preferably in the range of 0 to 240 degrees, and more preferably 160 to 200 degrees.

[0061] As mentioned above, the valve clip 100 provided in this embodiment can be used to alleviate or treat "mitral valve regurgitation". Figures 10 to 12 The valve clip 100 is placed at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned, so that a corresponding set of proximal clips 20 and distal clips 30 clamp the edge of the anterior leaflet 1a of the mitral valve, and another set of corresponding proximal clips 20 and distal clips 30 clamp the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned together. Fig.11 and Fig.12 The arrows in the figure indicate the direction of blood flow. Fig.11 As shown in the figure, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b close together, and the area A of the mitral valve opening becomes smaller or the mitral valve can be completely closed, thereby alleviating or treating "mitral valve regurgitation". Fig.12As shown, when the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only clamped together at position B where the valve clamp 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.

[0062] It is understandable that since the two leaflets of the mitral valve are always in an open and closed state, clamping is difficult, and often only one leaflet is successfully clamped, while the other leaflet may be only partially clamped. This may lead to an unsatisfactory clamping position of the two leaflets of the mitral valve or the partially clamped leaflet eventually slipping out of the valve clamp 100. At this time, the surgical operation can only be repeated, that is, the control member 230 is tightened toward the proximal end to control the proximal clip 20 pressed on the leaflet that is only partially clamped to be retracted relative to the fixing seat 10, and the position of the valve clamp 100 is adjusted so that the distal clip 30 is located at the appropriate position of the leaflet, and then the control member 230 is released from the control of the proximal clip 20, so that the proximal clip 20 is expanded relative to the fixing seat 10 and close to the distal clip 30 to re-clamp the leaflet until the leaflet of the mitral valve is firmly clamped and the regurgitation disappears or reaches the mildest state.

[0063] See also Figure 5 and Figure 6 In order to prevent the tensile force exerted by the control member 230 on the corresponding proximal clip 20 from causing the delivery sheath 210 to bend and the valve clamp 100 to swing, in the present invention, the control member 230 is inserted into at least one pair of first cavities 211 symmetrically opened about the axis of the delivery sheath 210 and extends outside the patient's body. When the corresponding proximal clip 20 is controlled to be retracted relative to the fixing seat 10 by the control member 230, the resultant force F of the tensile force exerted by each control member 230 on the corresponding proximal clip 20 is located on the axis of the delivery sheath 210, so that the torque generated by the resultant force F on the valve clamp 100 is zero, thereby preventing the delivery sheath 210 from bending and the valve clamp 100 from swinging. The operator does not need to adjust the position of the valve clamp 100 multiple times to quickly and accurately release the proximal clip 20 to re-clamp the valve, which is beneficial to reducing the operation time and improving the operation efficiency, and can prevent the valve clamp 100 from swinging and damaging the chordae or tissues to cause harm to the patient.

[0064] like Figure 5 As shown, in this embodiment, the delivery sheath 210 is provided with two pairs of first cavities 211, and each pair of first cavities 211 is provided with a control member 230 for controlling a corresponding proximal clip 20. That is, in this embodiment, the two control members 230 for controlling the two proximal clips 20 are provided in two different pairs of first cavities 211.

[0065] Each control member 230 is a single control line. After the control line is connected to the corresponding proximal clip 20, the two ends of the control line are respectively arranged in a pair of first cavities 211 and extend outside the patient's body. Specifically, the inlet channel of the control line is one of the first cavities 211 in the pair of first cavities 211, and the outlet channel is the other first cavity 211 in the pair of first cavities 211, that is, the inlet channel and the outlet channel of the control line are symmetrical about the axis of the delivery sheath 210. Figure 5 As shown, in this embodiment, the control line reaches the corresponding proximal clip 20 along the inlet channel, passes through the connecting structure 26 on the proximal clip 20, and then bends in the reverse direction and extends to the outside of the patient through the outlet channel. Figure 6 As shown, when the operator tightens one of the control lines toward the proximal end to control the corresponding proximal clip 20 to be retracted relative to the fixing seat 10, the control line bent into two parts acts on the corresponding proximal clip 20 with tensions F1 and F2 respectively. The tensions F1 and F2 are symmetrical about the axis of the delivery sheath 210, and the resultant force F is located on the axis of the delivery sheath 210, so that the torque generated by the resultant force F on the valve clamp 100 is zero, thereby preventing the delivery sheath 210 from bending and the valve clamp 100 from swinging. The operator can quickly adjust the position of the valve clamp 100 and accurately release the proximal clip 20 to re-clamp the valve, which is beneficial to reducing the operation time, improving the operation efficiency, and avoiding the damage to the patient caused by the swing of the valve clamp 100.

[0066] The control wire is a single wire or a plurality of wound wires, and the wire is selected from nickel-titanium wire, stainless steel wire or high-strength polymer wire. In this embodiment, the control wire is a single nickel-titanium wire, that is, the control element 230 is a single nickel-titanium wire.

[0067] The shape of the first cavity 211 can be circular, square, polygonal or other special shapes. In this embodiment, the first cavity 211 is a circular cavity.

[0068] See also Fig.13 In this embodiment, the distances from the axis of the two pairs of first cavities 211 to the axis of the delivery sheath 210 are equal, and the distances between each first cavity 211 and the two first cavities 211 of the other pair of first cavities 211 are equal, that is, the two pairs of first cavities 211 are distributed in a square shape. Obviously, in other embodiments, the distances between each first cavity 211 and the two first cavities 211 of the other pair of first cavities 211 may not be equal, that is, the two pairs of first cavities 211 are distributed in a rectangular shape, such as Fig.14 shown.

[0069] In other embodiments, the distances from the axis of the two pairs of first cavities 211 to the axis of the delivery sheath 210 may be unequal, that is, the two pairs of first cavities 211 are distributed in a parallelogram shape, such as Fig.15 shown.

[0070] In other embodiments, the delivery sheath 210 may only have a pair of first cavities 211, and the two control lines respectively used to control the two proximal clips 20 are both passed through the pair of first cavities 211. Specifically, the inlet channels of the two control lines are the same first cavity 211 in the pair of first cavities 211, and the outlet channels of the two control lines are the other first cavity 211 in the pair of first cavities 211.

[0071] Further, such as Figure 5 and Fig.13 As shown, in this embodiment, the valve clamping system further includes a pressure sensor (not shown in the figure), and the delivery sheath 210 is provided with a second cavity 212 extending in the axial direction, and the pressure sensor is movably arranged in the second cavity 212 and can be extended from the distal end of the second cavity 212. When the delivery device 200 delivers the valve clamp 100 to the left ventricle of the heart and uses the valve clamp 100 to clamp the two leaflets of the mitral valve together, the pressure sensor can be extended from the distal end of the second cavity 212 into the left atrium of the heart, so as to provide real-time feedback of the pressure value in the heart to confirm the reduction of the patient's "mitral regurgitation", so as to determine whether it is necessary to adjust the position of the valve clamp 100 and re-clamp the leaflets of the mitral valve to optimize the treatment effect.

[0072] It is understandable that the pressure sensor may be assembled in the second cavity 212 of the delivery sheath 210 at the factory, or other compatible commercial pressure sensors may be used and assembled in the second cavity 212 of the delivery sheath 210 by the surgical operator before surgery.

[0073] Please also read Figure 5 , Figure 7 , Fig.16 and Fig.17 The valve clipping system provided in this embodiment includes a valve clipper 100 and a delivery device 200. The valve clipper 100 is delivered to the mitral valve by the delivery device 200, and the valve clipper 100 is adjusted to a suitable position of the mitral valve. The delivery device 200 includes an operating handle and a delivery assembly, the proximal end of the delivery assembly is connected to the operating handle, and the distal end of the delivery assembly is detachably connected to the valve clipper 100.

[0074] The delivery assembly includes the aforementioned delivery sheath 210 and a control member 230 inserted into the first bore 211 of the delivery sheath 210. Furthermore, the delivery assembly also includes a connector 250 plugged into the distal end of the delivery sheath 210, a liner 270 movably coaxially sleeved in the lumen of the connector 250, and a mandrel 290 movably coaxially sleeved in the liner 270. The operator can tighten the control member 230 and drive the liner 270 and the mandrel 290 to move or rotate relative to each other through an operating handle placed outside the patient's body.

[0075] The delivery sheath 210 is provided with a third cavity 213 along the axial direction, the connector 250 is plugged into the distal end of the third cavity 213, and the liner 270 and the mandrel 290 pass through the third cavity 213 and extend outside the patient's body. Preferably, in this embodiment, a fixing member 214 is provided at the distal end of the delivery sheath 210, and the connector 250, the liner 270 and the mandrel 290 coaxially sleeved together are plugged into the third cavity 213 of the delivery sheath 210 through the fixing member 214 to improve the connection strength. It can be understood that the fixing member 214 is provided with a plurality of through holes respectively connected to the first cavity 211, the second cavity 212 and the third cavity 213.

[0076] Among them, the delivery sheath 210 can be a multi-lumen tube made of biocompatible metal materials or polymer materials through integral molding, or it can be a multi-lumen tube formed by crimping, welding or bonding of several single tubes made of biocompatible metal materials or polymer materials. The metal material is selected from stainless steel, aluminum alloy or cobalt-chromium alloy; the polymer material is selected from polycarbonate, polyethylene or polyamide. In this embodiment, the delivery sheath 210 is a multi-lumen tube made of integral molding, and a plurality of cavities extending along the axial direction of the delivery sheath 210 are provided, and the plurality of cavities form the aforementioned at least one pair of first cavities 211, a second cavity 212 and a third cavity 213.

[0077] The connecting member 250 is generally tubular, and two connecting rods 253 are axially symmetrically arranged at the distal end of the connecting member 250, and a buckle 255 for detachably connecting with the fixing seat 10 is arranged at the distal end of each connecting rod 253. The inner surfaces of the two axially symmetrical connecting rods 253 facing each other are arc surfaces that smoothly transition and connect with the cylindrical surface in the lumen of the connecting member 250, and the distance from the arc surface of each connecting rod 253 to the axis center line of the connecting member 250 gradually decreases from the proximal end to the distal end, that is, the distal end of each connecting rod 253 is inclined toward the axis center line direction of the connecting member 250, and the two connecting rods 253 gradually close together from the proximal end to the distal end.

[0078] The connecting rod 253 is made of elastic material, and when the connecting rod 253 is pushed radially outward along the connecting member 250, the distal end of the connecting rod 253 expands outward. The liner 270 of the conveying device 200 is movably arranged in the lumen of the connecting member 250, and the liner 270 is driven to move toward the distal end, and the liner 270 pushes the connecting rod 253 radially outward, and the buckle 255 of the connecting rod 253 expands outward and snaps into the snap hole 111 of the fixing seat 10, so that the conveying device 200 is in a connected state with the fixing seat 10 through the connecting member 250; it can be understood that when the liner 270 is withdrawn toward the proximal end, the connecting rod 253 rebounds due to its own elasticity, and the distal end of the connecting rod 253 is retracted toward the axial centerline direction of the connecting member 250, and the buckle 255 withdraws from the corresponding snap hole 111, and the connection state between the conveying device 200 and the fixing seat 10 is released.

[0079] The mandrel 290 is detachably connected to the push rod 40 to drive the push rod 40 to slide along the axial direction of the fixing seat 10, thereby driving the distal clip 30 to open and close relative to the fixing seat 10. In this embodiment, the mandrel 290 is a round rod with an internal threaded hole (not shown in the figure) at the distal end, and the internal threaded hole is used to be threadedly connected with the external thread at the proximal end of the push rod 40.

[0080] In other embodiments, the conveying assembly may not include the liner 270, and the overall diameter of the core shaft 290 or the diameter of the distal portion of the core shaft 290 is larger, so that the distal portion of the core shaft 290 can directly push the buckle 255 at the distal end of the connecting member 250 to expand outward. In other words, the core shaft 290 can be used to push the buckle 255 at the distal end of the connecting member 250 to expand outward, and can also be used to drive the push rod 40 to slide axially along the fixed seat 10.

[0081] It should be noted that the delivery assembly and the valve clamp 100 can be delivered into the patient's body using an existing adjustable curved sheath tube.

[0082] The following takes the mitral valve repair process as an example to illustrate the operation method of the valve clipping system of the present invention, which mainly includes the following steps:

[0083] Step 1: The delivery assembly is detachably connected to the valve clip 100. Specifically, the buckle 255 at the distal end of the connector 250 is pushed outward by the liner 270 so that the buckle 255 is inserted into the clamping hole 111 of the fixing seat 10, so that the fixing seat 10 and the connector 250 are in a connected state; the mandrel 290 is rotated so that the mandrel 290 is screwed and fixed to the push rod 40. The control member 230 is pulled toward the proximal end to control the proximal clip 20 to be retracted relative to the fixing seat 10, so that the free end 22 of the proximal clip 20 is attached to the surface of the fixing seat 10. Then, the mandrel 290 is moved toward the distal end by the operating handle to drive the push rod 40 to slide axially toward the distal end, driving the distal clip 30 to close relative to the fixing seat 10, so that the valve clip 100 is in a completely retracted state, and the proximal clip 20 and the distal clip 30 are both close to the surface of the fixing seat 10, and the retracted state remains unchanged.

[0084] Step 2: Using the trans-atrial septal approach, the delivery assembly and the valve clip 100 are pushed from the left atrium through the adjustable curved sheath tube, through the mitral valve to the left ventricle, such as Fig.18 shown.

[0085] Step 3: Adjust the relative position of the valve clip 100 and the mitral valve so that the valve clip 100 is close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve.

[0086] Step 4: Move the core shaft 290 proximally by operating the handle, thereby driving the push rod 40 to slide proximally to drive the distal clip 30 to open relative to the fixing seat 10, and adjust the direction of the valve clamp 100 so that the distal clip 30 is perpendicular to the mitral valve coaptation line.

[0087] Step 5: withdraw the entire valve clip 100 toward the proximal end, so that the distal clip 30 holds the valve leaflet on the left ventricle side. Fig.19 shown.

[0088] Step 6: Release the control of each control member 230 on the corresponding proximal clip 20, and release the proximal clips 20 on both sides in turn. The proximal clip 20 on each side presses the leaflet on the atrial side and cooperates with the distal clip 30 on that side to clamp the leaflet. During the process of releasing the unilateral proximal clip 20, the operator simultaneously pulls the inlet and outlet ends of the control member 230 corresponding to the proximal clip 20 that needs to be tightened outside the body, and the pulling forces acting on the inlet and outlet are equal. Since the inlet channel and the outlet channel are located in two first cavities 211 symmetrically located along the axis of the delivery sheath 210, the resultant pulling force of the control member 230 on the corresponding proximal clip 20 is located along the axis of the delivery sheath 210 to avoid bending of the delivery sheath 210 and swinging of the valve clamp 100, thereby independently controlling the expansion of each proximal clip 20 relative to the fixing seat 10, and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped between the corresponding proximal clip 20 and the distal clip 30 to achieve complete clamping of the leaflets. Fig. 20 shown.

[0089] Step 7: Extend the pressure sensor from the distal end of the second hole 212 of the delivery sheath 210 into the left atrium to detect the pressure value in the heart to confirm the reduction of the patient's "mitral regurgitation", so as to determine whether it is necessary to adjust the position of the valve clip 100 and re-clamp the valve leaflets to optimize the treatment effect. In the case where the valve leaflets need to be re-clamped, the control member 230 is pulled toward the proximal end to control the proximal clip 20 pressed on the valve leaflet with an undesirable clamping position to be retracted relative to the fixing seat 10, and the position of the valve clip 100 is adjusted so that the distal clip 30 is located at the appropriate position of the valve leaflet, and then the control member 230 is released from the control of the proximal clip 20, so that the proximal clip 20 is unfolded relative to the fixing seat 10 and close to the distal clip 30 to re-clamp the valve leaflet until the valve leaflet of the mitral valve is completely clamped.

[0090] Step 8: Move the mandrel 290 toward the distal end again, and the mandrel 290 drives the push rod 40 to slide axially toward the distal end, thereby driving the distal clip 30 to close relative to the fixing seat 10 until the valve clip 100 is completely retracted. Fig.21 shown.

[0091] Step 9: Use the operating handle to control the rotation of the mandrel 290 to unlock the threaded connection between the mandrel 290 and the push rod 40, and then withdraw the liner 270 and the mandrel 290 toward the proximal end until the buckle 255 at the distal end of the connector 250 is unlocked and separated from the clamp hole 111 of the fixing seat 10, and the valve clamp 100 is completely separated from the delivery assembly. Finally, the delivery assembly is withdrawn from the patient's body. At this time, the valve clamp 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve toward each other to obtain a double-hole mitral valve, completing the edge-to-edge repair of the mitral valve. The valve clamp 100 is left in the patient's body, as shown in FIG. Fig.10 shown.

[0092] It is understandable that the valve clipping system of the present invention may also deliver the valve clipper to the mitral valve via a transapical route or the like.

[0093] See also Fig. 22 The structure of the valve clamping system provided in the second embodiment of the present invention is similar to that of the valve clamping system in the first embodiment, except that: in the second embodiment, each control member 230b includes at least two control wires, that is, each proximal clip 20 is controlled by at least two control wires to achieve the folding or unfolding relative to the fixing seat 10. Specifically, in this embodiment, each control member 230b includes two control wires, and the two control wires are inserted into the same pair of first cavities 211 of the delivery sheath 210. The inlet channels of the two control wires are one of the first cavities 211 in the pair of first cavities 211, and the outlet channels of the two control wires are the other first cavities 211 in the pair of first cavities 211. The inlet channel and the outlet channel of each control wire are still symmetrical about the axis of the delivery sheath 210, so as to prevent the valve clamp 100 from swinging.

[0094] It can be understood that each control member 230b includes at least two control lines, which can improve the control force of each control member 230b on the corresponding proximal clip 20, that is, at least two control lines can provide greater pulling force, so that the proximal clip 20 is as close to the fixing seat 10 as possible, and prevent the proximal clip 20 from being released prematurely due to insufficient pulling force.

[0095] See also Fig.23 The structure of the valve clamping system provided in the third embodiment of the present invention is similar to that of the valve clamping system in the first embodiment, except that in the third embodiment, each control member 230c includes at least one pair of control wires, that is, each proximal clip 20 is controlled by at least one pair of control wires to achieve the folding or unfolding relative to the fixing seat 10. After at least one pair of control wires are respectively connected to the corresponding proximal clip 20, each pair of control wires is arranged in a pair of first cavities 211 of the delivery sheath 210 and extends outside the patient's body.

[0096] In this embodiment, each control member 230c includes a pair of control wires, and the pair of control wires are inserted into a pair of first cavities 211 of the delivery sheath 210. Specifically, among the pair of control wires used to control each proximal clip 20, the inlet and outlet channels of one control wire are both one of the first cavities 211 of the pair of first cavities 211, and the inlet and outlet channels of the other control wire are both the other first cavities 211 of the pair of first cavities 211, that is, the pair of control wires used to control each proximal clip 20 are symmetrically arranged about the axis of the delivery sheath 210, thereby preventing the valve clip 100 from swinging.

[0097] In other embodiments, each control member 230c may include at least two pairs of control wires, each pair of control wires being passed through a pair of first cavities 211 of the delivery sheath 210 and extending outside the patient's body. Among the at least two pairs of control wires used to control each proximal clip 20, two different pairs of control wires may pass through the same pair of first cavities 211 to the patient's body, or may pass through a pair of first cavities 211 to the patient's body respectively.

[0098] It can be understood that each control member 230c includes at least one pair of control lines, which can improve the control force of each control member 230c on the corresponding proximal clip 20, that is, at least one pair of control lines can provide a greater pulling force, so that the proximal clip 20 is as close to the fixing seat 10 as possible, and prevent the proximal clip 20 from being released prematurely due to insufficient pulling force.

[0099] See also Fig.24 The structure of the valve clamping system provided in the fourth embodiment of the present invention is similar to that of the valve clamping system in the first embodiment, except that: in the fourth embodiment, at least one winding post 235 is provided on the connecting member 250 or the fixing seat 10, and the inlet and / or outlet of the control line (i.e., the control member 230) bypasses at least one winding post 235 and extends outside the patient's body. Specifically, in this embodiment, two winding posts 235 are convexly provided on the outer wall of the connecting member 250, and the two winding posts 235 are symmetrical about the axis of the connecting member 250. After the inlet end of the control line is connected to the corresponding proximal clip 20, its outlet end bypasses a winding post 235 and then extends upward into the outlet channel of the delivery sheath 210 until it extends outside the patient's body. In this embodiment, the two control lines used to control the two proximal clips 20 bypass different winding posts 235 respectively.

[0100] In other embodiments, the incoming end of each control line can pass around the winding post 235 and then be connected to the corresponding proximal clip 20, and the outgoing end thereof directly extends upward into the outgoing channel of the delivery sheath 210 until it extends outside the patient's body.

[0101] In other embodiments, the inlet and outlet ends of each control line can bypass the winding rod 235 and extend to the outside of the patient through the inlet channel and outlet channel of the delivery sheath 210 respectively.

[0102] In other embodiments, only one winding post 235 may be provided, and the incoming wire ends and / or outgoing wire ends of two control wires for controlling different proximal clips 20 may bypass the same winding post 235 .

[0103] Preferably, at least one winding groove may be provided on the winding post 235, and the control line is partially wound in the at least one winding groove. When the inlet and outlet ends of the control line or the inlet and / or outlet ends of two control lines for controlling different proximal clips 20 are simultaneously wound on the winding post 235, the winding post 235 is provided with a plurality of winding grooves spaced apart to prevent the control lines from affecting each other.

[0104] It can be understood that the incoming end and / or outgoing end of the control line is wound on the winding post 235. When the control line is tightened toward the proximal end to control the corresponding proximal clip 20 to be retracted relative to the fixed seat 10, the incoming end and / or outgoing end of the control line slides around the winding post 235. The winding post 235 acts as a fixed pulley, which is beneficial for the operator to tighten the proximal clip 20 with a smaller pulling force, thereby avoiding the proximal clip 20 from being released prematurely.

[0105] It should be noted that the above contents are all described by taking the valve clipper used to alleviate or treat "mitral valve regurgitation" as an example. It is understandable that in other embodiments, the valve clipper can also be used to alleviate or treat "tricuspid valve regurgitation", and its principle and structure are roughly the same as the principle and structure of the valve clipper used to solve "mitral valve regurgitation" in the embodiment of the present invention, and it only needs to form multiple clamps through multiple groups of proximal clips and distal clips, and each clamp clamps a valve leaflet respectively, which will not be described in detail here.

[0106] Obviously, in other embodiments, the valve clip provided by the present invention can also be applied to other minimally invasive surgical operations that require clamping three or more leaf-shaped valves together.

[0107] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An independently controllable valve clamping system, characterized in that: include: A valve clamp, the valve clamp comprising a fixing seat, a proximal clip and a distal clip that can be folded or unfolded relative to the fixing seat, and a driving assembly for driving the distal clip to open and close relative to the fixing seat, wherein a leaflet accommodating space is formed between the distal clip and the proximal clip; A delivery device for delivering the valve clipper, the delivery device comprising a delivery sheath and a control member, each of the control members correspondingly connected to a proximal clip to control the proximal clip to be retracted or unfolded relative to the fixing seat; The delivery sheath is provided with at least one pair of first cavities extending in the axial direction, the at least one pair of the first cavities are symmetrical about the axis of the delivery sheath, and each of the control members is movably disposed in the at least one pair of the first cavities; Wherein, each of the control components comprises at least one control line, and after at least one of the control lines is passed through the corresponding proximal clip, the two ends of each of the control lines extend to the outside of the patient's body through a pair of the first cavities respectively; or, each of the control components comprises at least one pair of control lines, and in each pair of the control lines, the inlet channel and the outlet channel of one of the control lines are both one of the first cavities in the pair of first cavities, and the inlet channel and the outlet channel of the other control line are both the other first cavity in the pair of first cavities.

2. The valve clipping system according to claim 1, characterized in that: Each of the control components comprises at least one control line, an inlet channel of each of the control lines is one of the first cavities in a pair of first cavities, and an outlet channel is the other first cavity in the pair of first cavities.

3. The valve clipping system according to claim 1, characterized in that: A connector is provided at the distal end of the delivery device, and the delivery device is detachably connected to the fixing seat via the connector. At least one winding post is provided on the connector or the fixing seat, and the input end and / or output end of the control line bypasses at least one winding post and extends outside the patient's body.

4. The valve clipping system according to claim 3, characterized in that: Each control wire is a single wire or a plurality of wound wires, and the wires are selected from nickel-titanium wires, stainless steel wires or high-strength polymer wires.

5. The valve clipping system according to claim 1, characterized in that: The delivery sheath is provided with two pairs of the first cavities, the distances between the axis lines of the two pairs of the first cavities and the axis line of the delivery sheath are equal or unequal, and each pair of the first cavities is penetrated by a control component.

6. The valve clipping system according to claim 1, characterized in that: Each of the proximal clips is provided with at least one connecting structure, and at least one of the connecting structures is used to connect with the control member.

7. The valve clipping system according to claim 6, characterized in that: The connecting structure is arranged at an end of the proximal clip which is away from the fixing seat after the proximal clip is unfolded relative to the fixing seat.

8. The valve clipping system according to claim 6, characterized in that: Each of the proximal clips is provided with at least two connection structures, and the center line of at least two of the connection structures is located at or close to the axial center line of the proximal clip.

9. The valve clipping system according to any one of claims 6 to 8, characterized in that: The connection structure is a connection hole opened on the proximal clip, or a connection ring protruding from the proximal clip.

10. The valve clipping system according to claim 1, characterized in that: The delivery sheath is a multi-lumen tube made of biocompatible metal material or polymer material by integral molding; or a multi-lumen tube formed by crimping, welding or bonding a plurality of single tubes made of biocompatible metal material or polymer material.

11. The valve clipping system according to claim 1, characterized in that: The proximal clip is at least partially made of a material having a shape memory function, and the hardness of the distal clip is greater than that of the proximal spring sheet.

12. The valve clipping system according to claim 1, characterized in that: The valve clamping system also includes a pressure sensor. The delivery sheath is provided with a second cavity extending along the axial direction. The pressure sensor is penetrated in the second cavity and can extend from the distal end of the second cavity.

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