CN111789699A - Independently controllable valve clamping system - Google Patents

Abstract

The invention provides an independently controllable valve clamping system, comprising a valve clamping device and a delivery device for delivering the valve clamping device. The valve clamp includes a fixed base and a proximal clip that can be retracted or expanded relative to the fixed base. The delivery device includes a delivery sheath and a control member. The delivery sheath is provided with at least a pair of first cavities extending in the axial direction and symmetrical about its axis, and each control member is movably penetrated through at least a pair of the first cavities. Among them, each control element is correspondingly connected with a proximal clip to control the proximal clip to be folded or unfolded relative to the fixing base. In the present invention, when the control member is pulled toward the proximal end to control the corresponding proximal clip to be retracted relative to the fixed seat, the resultant force of the pulling force acting on the corresponding proximal clip by each control member is located on the axis of the delivery sheath. Therefore, the bending of the delivery sheath and the swinging of the valve clamp are avoided, which is beneficial to reduce the operation time, improve the operation efficiency, and avoid harm to the patient.

Description

Independently controllable valve clamping system

technical field

The invention relates to the field of medical devices, in particular to an independently controllable valve clamping system.

Background technique

Please refer to 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 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 atrium 2 to the left ventricle 3. Left ventricle 3 flows into left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a 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 tendineae 4 . Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior lobe 1a and the posterior lobe 1b are completely aligned, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Fig. 2, when the leaflets of mitral valve 1 or their related structures change qualitatively or functionally, such as partial rupture of chordae tendineae 4, the anterior leaflet 1a and posterior leaflet 1b of mitral valve 1 are misaligned Therefore, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, resulting in the regurgitation of blood from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral valve regurgitation" ".

There is a minimally invasive treatment operation, which is based on the principle of edge-to-edge operation of the valve, and the valve clamp is delivered to the mitral valve through an interventional catheter, and the anterior leaflet and the mitral valve are simultaneously clamped through the relative opening of the clamp. the posterior leaflets, thereby drawing the leaflets closer to each other, alleviating "mitral regurgitation". In the process of clamping the valve leaflets, since the two valve leaflets of the mitral valve are always in a state of large and powerful opening and closing activities, the clamping is difficult, and it is generally desirable to control the clamping action of each valve leaflet independently.

Please refer to FIG. 3 , there is a valve clamp 100 ′, which includes two sets of proximal clips 20 ′ and distal clips 30 ′ respectively located on opposite sides of the axis of the delivery sheath 210 ′. The movement of the end clips 20' is controlled by the opposite control wires 230', and the two proximal clips 20' can be released independently and unfold relative to the fixed seat 10' under the action of their own elasticity to move toward the corresponding distal clips 30' close to grip the two leaflets of the mitral valve, respectively. However, as shown in FIG. 4 , in the prior art, the incoming and outgoing wires of the control wire 230 ′ for controlling each proximal clip 20 ′ pass through the same one side of the axis of the delivery sheath 210 ′. The hole 211' is used to realize the operation. During the repeated surgical operation, when the unilateral proximal clip 20' is tightened by the control wire 230' and folded relative to the fixed seat 10', the proximal clip 20 acts on the proximal clip 20'. The pulling force F' on ' is located on the side of the axis of the delivery sheath 210', and the pulling force F' will generate a certain torque on the valve clamp 100', thereby causing the valve clamp 100' to move towards the side where the pulling force F' is located. It swings 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 clamp 20' to re-clamp the mitral valve leaflets, and the operation time is relatively long. In addition, the swinging of the valve clamp 100' may also pull the valve leaflets or entangle the chordae tendineae, thereby tearing the valve leaflets or hanging the chordae tendineae, which will not only cause the failure of the operation, but even harm the patient cause serious injury.

SUMMARY OF THE INVENTION

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, but also avoid the bending of the delivery sheath and the swing of the valve clamp, which is beneficial to reduce the operation time. , Improve surgical efficiency and avoid harm to patients.

In order to solve the above-mentioned technical problems, the present invention provides an independently controllable valve clamping system, including a valve clamping device and a delivery device for delivering the valve clamping device, the valve clamping device comprising a fixing seat and a removable valve clamp. Relative to the proximal clip retracted or unfolded by the fixing base, the delivery device includes a delivery sheath and a control piece, each of the control pieces is correspondingly connected to one of the proximal clips to control the proximal clip retracted or unfolded relative to the fixed seat; wherein, the delivery sheath is provided with at least a pair of first bores extending in the axial direction, and at least a pair of the first bores are about the axis line of the delivery sheath Symmetrically, each of the control elements is movably penetrated in at least a pair of the first cavities.

In the independently controllable valve clamping system provided by the present invention, the control member is penetrated into at least a pair of first cavities symmetrically opened about the axis of the delivery sheath. When the fixing seat is folded, the resultant force of the pulling force acting on the corresponding proximal clip by the control member is located on the axis of the delivery sheath, thereby avoiding the bending of the delivery sheath and the swing of the valve clamp, which is beneficial to reduce the operation time, Improve surgical efficiency and avoid harm to patients.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the implementation manner. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

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

Fig. 2 is a schematic diagram of the mitral valve with lesions.

FIG. 3 is a schematic three-dimensional structural diagram of a valve clamp and a delivery sheath in the prior art.

FIG. 4 is a schematic view of the proximal clip on one side of the valve clip in FIG. 3 when it is tightened.

FIG. 5 is a schematic three-dimensional structural diagram of the valve clamping system provided by the first embodiment of the present invention.

FIG. 6 is a schematic view of the proximal clip on one side of the valve clip in FIG. 5 when the clip is tightened.

FIG. 7 is a three-dimensional schematic diagram of a partial structure of the valve clamping system in FIG. 5 .

FIG. 8 is a schematic three-dimensional structural diagram of the fixing base in FIG. 7 .

FIG. 9 is a schematic three-dimensional structural diagram of the proximal clip in FIG. 7 .

FIG. 10 is a schematic view of the valve clamp in FIG. 5 in use.

Fig. 11 is a schematic diagram of the mitral valve when the heart contracts after the valve clamp in Fig. 10 clamps the valve leaflets.

Fig. 12 is a schematic diagram of the mitral valve during diastole after the valve clamp in Fig. 10 has clamped the valve leaflets.

FIG. 13 is a schematic view of the distal end of the delivery sheath of FIG. 5 .

14 and 15 are schematic views of the distal end of the delivery sheath in other embodiments.

FIG. 16 is a partial perspective structural diagram of the conveying device in FIG. 5 .

FIG. 17 is a cross-sectional view of the delivery device of FIG. 16 .

18 to 21 are schematic diagrams of the use process of the valve clamping system in FIG. 5 .

FIG. 22 is a schematic three-dimensional structural diagram of a partial structure of the valve clamping system provided by the second embodiment of the present invention.

23 is a schematic three-dimensional structural diagram of a partial structure of the valve clamping system provided by the third embodiment of the present invention.

24 is a schematic structural diagram of a valve clamping system provided by a fourth embodiment of the present invention.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the orientations or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the orientations or positional relationships shown in the accompanying drawings, only for the purpose of It is convenient to describe the present invention and to simplify the description, rather than indicating or implying that the device or element referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first," "second," "third," etc. are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

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 away from the operator; the axial direction refers to the end parallel to the natural The direction of the line connecting the center of the distal end and the center of the proximal end of the medical device in the state. The above definitions are only for the convenience of expression, and should not be construed as limiting the present invention.

Please refer to FIG. 5 and FIG. 6 together. The first embodiment of the present invention provides an independently controllable valve clamping system, including a valve clamp 100 and a delivery device 200 for delivering the valve clamp 100 . The valve clamp 100 includes a holder 10 and a proximal clip 20 that can be retracted or deployed relative to the holder 10 . The delivery device 200 includes a delivery sheath 210 and a control member 230 , each control member 230 is correspondingly connected to a proximal clip 20 to control the proximal clip 20 to retract or expand relative to the fixing base 10 . Specifically, the delivery sheath 210 defines at least a pair of first cavities 211 extending in the axial direction and symmetrical with respect to the axis of the delivery sheath 210 , and each control member 230 is movably penetrated through the at least one pair of first cavities In 211, thus, when the control member 230 is pulled proximally to control the corresponding proximal clip 20 to be retracted relative to the fixed seat 10, each control member 230 acts on the resultant force of the pulling force on the corresponding proximal clip 20 F is located on the axis of the delivery sheath 210, so as to avoid the delivery sheath 210 from bending and the valve clamp 100 from swinging.

Wherein, the valve clamp 100 further includes a distal clip 30 rotatably connected to the fixing base 10 and a driving assembly for driving the distal clamping piece 30 to open and close relative to the fixing base 10 , and the driving assembly includes an axially slidable arrangement The push rod 40 in the fixed seat 10 and the connecting rod 50 connecting the distal clip 30 and the push rod 40 . When the push rod 40 slides in the axial direction relative to the fixed seat 10, the distal clip 30 is opened relative to the fixed seat 10 under the pulling of the connecting rod 50, and the distal clip 30 is placed in an appropriate position under the valve after the , the control of the proximal clip 20 by the control member 230 is released, the proximal clip 20 is released and unfolded relative to the fixing seat 10, and the proximal clip 20 is moved closer to the distal clip 30 to clamp the valve. When there is a problem that the valve is not firmly clamped, the operator can control the corresponding proximal clip 20 to retract relative to the fixed seat 10 by tightening the control member 230, so that the proximal clip 20 can be released again to re-clamp the valve .

In the present invention, the control member 230 is inserted through at least a pair of first cavities 211 symmetrically opened about the axis of the delivery sheath 210. When the control member 230 controls the corresponding proximal clip 20 relative to the fixed seat 10 When folded, the resultant force F of the pulling force acting on the corresponding proximal clip 20 by the control member 230 is located on the axis line of the delivery sheath 210, so that the moment generated by the resultant force F on the valve clip 100 is zero, thereby avoiding Due to the bending of the delivery sheath 210 and the swing of the valve clamp 100, the operator can quickly and accurately release the proximal clamp 20 to clamp the valve without adjusting the position of the valve clamp 100 many times, which is beneficial to reduce the operation time. , improve the operation efficiency, and can avoid the damage to the patient caused by the swing of the valve clamp 100 .

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

In order to ensure the 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 fixed 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 higher hardness, and the proximal clip 20 Made from a shape memory material, preferably a superelastic Nitinol.

Specifically, please refer to FIG. 7 and FIG. 8 together, the fixing base 10 includes a first base body 11 at the proximal end, a second base body 12 at the distal end, and a first base body 11 for transitionally connecting the second base body 11 and the second base body 12. The third seat body 13 of the seat body 12 may be an integral structure or a non-integral structure. In this embodiment, the three are integrated into one structure.

The first seat body 11 is provided with a lumen penetrating through both end surfaces in the axial direction, and the proximal end of the first seat body 11 is provided with two rectangular clamping holes 111 that communicate with the lumen and are symmetrical about the axis of the first seat body 11 . For connecting with the connecting rod 250 of the delivery device 200 .

The second seat body 12 is provided with an accommodating cavity 14 extending through two opposite sides of the second seat body 12 along the direction perpendicular to the axial direction. The axis of the through hole is collinear with the axis of the lumen of the first seat body 11 . A rectangular block 121 is respectively protruded from the other two opposite sides of the second base body 12 .

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

Further, the third seat body 13 is provided with a through hole (not shown) in the axial direction, the lumen of the first seat body 11 , the through hole of the third seat body 13 , and 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 is coaxially connected to form a through-hole 15 .

Please refer to FIG. 5 and FIG. 6 together. The drive assembly includes a push rod 40 , and the push rod 40 is axially slidably inserted into the passage of the fixing base 10 . The proximal end of the push rod 40 is connected to a mandrel (not shown) of the delivery device 200 . The distal end of the push rod 40 is provided with a connecting seat 45 , and the opposite ends of the connecting seat 45 are provided with two through pin holes. The shape of the connecting seat 45 is any structure such as a hemisphere, a spherical cap or a bullet shape, so as to make the valve clamp 100 easier to be delivered in the body.

It should be noted that the accommodating cavity of the fixing seat 10 is provided with a locking member, and the two opposite sides of the fixing seat 10 are also provided with adjusting members respectively, and the push rod can be realized by the cooperation of the locking member and the adjusting member. 40 is fixed or unlocked relative to the fixed seat 10. Specifically, the locking member can be a combination of deformed elastic sheets and steel sheets in the prior art, and the adjusting member can be a metal wire made of nickel-titanium alloy, etc. Improvement has nothing to do with creation, so I won't go into details here.

Further, as shown in FIG. 5 and FIG. 6 , in this embodiment, the driving assembly further includes two connecting rods 50 arranged opposite to each other, and each connecting rod 50 is used to connect the distal clip 30 on the corresponding side to the pusher. The connecting base 45 at the distal end of the rod 40 can pull the distal clip 30 to open and close relative to the fixed base 10 through the connecting rod 50 when the push rod 40 slides in the axial direction in the fixed base 10 .

Specifically, each distal clip 30 includes a connecting segment 31 at the distal end and a clamping segment 32 connected to the proximal end of the connecting segment 31 , and one end of the connecting segment 31 away from the corresponding clamping segment 32 is rotatably connected to the fixing base 10 The connecting block 131 of the third seat body 13, 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, and the distal end of the connecting rod 50 is rotatably connected to the connecting rod 50 through a rotating pin or bolt. at the pin hole of the connection seat 45 .

In the present invention, the push rod 40 is unlocked relative to the fixed base 10 through the cooperation of the locking member and the adjustment member disposed on the fixed base 10, and the push rod 40 can slide axially toward the distal end to move relative to the fixed base 10, In this way, 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 surround the pin hole on the connecting block 131 The center of the valve rotates and opens relative to the fixed seat 10. When the proximal clip 20 is released, a leaflet accommodation space is formed between the proximal clip 20 and the distal clip 30, and the proximal clip 20 is directed toward the corresponding distal clip 20. The end clips 30 are drawn together to clamp the valve between them; after the proximal clip 20 and the distal clip 30 clamp the valve, the push rod 40 is driven to slide toward the proximal end in the axial direction, and the connecting rod 50 further drives the The distal clip 30 is closed relative to the fixed seat 10 until the distal clip 30 is completely closed relative to the fixed seat 10. At this time, the valve clip 100 is in a retracted state, and through the cooperation of the locking member and the adjusting member, the valve clamp 100 is closed again. The push rod 40 is fixed relative to the fixing seat 10 to prevent the distal clip 30 from opening relative to the fixing seat 10 and the valve clamp 100 in the retracted state falling below the valve.

Wherein, when the connecting rod 50 drives the distal clip 30 to open and close relative to the fixed seat 10, the distal clip 30 can be opened and closed relative to the fixed seat 10 in a wide range, and the gap between the two distal clips 30 can be realized. The maximum included angle can reach 300 degrees, that is, after the distal clip 30 is opened relative to the fixed seat 10, it can be turned downward to a certain extent, which is conducive to clamping the valve in constant motion and improves the clamping success rate. In this embodiment, the included angle between the two distal clips 30 is preferably 0-240 degrees, more preferably 120-180 degrees.

Preferably, the first surface of the distal clip 30 facing the proximal clip 20 may be provided with a clamping anti-skid structure (not shown in the figure) to enhance the frictional force when the distal clip 30 contacts the valve, thereby providing stability The clamping force can be obtained, and the damage to the valve caused by the distal clip 30 can be avoided. The clamping and anti-skid structure may be a protrusion, a groove, or a gasket made of a biocompatible material with a higher friction coefficient and attached to the first surface.

Wherein, the first surface may be a plane or a curved surface. Preferably, the first surface is set as a curved surface to increase the contact area and the clamping area between the distal clip 30 and the valve, so as to provide a stable clamping force; When the end clip 20 is close to the distal clip 30, the proximal clip 20 is at least partially accommodated in the accommodating groove to compress the valve between the two, and can minimize the volume of the valve clamp 100 when it is folded, Facilitates delivery in the body.

Further preferably, active drugs can also be applied on the first surface of the distal clip 30, or at least one opening can be opened to promote the endothelial cells of the valve tissue on the inner surface of the distal clip 30 to crawl and grow; Furthermore, opening the opening can also reduce the overall weight of the valve clamp 100, thereby preventing the overweight valve clamp 100 from falling under the valve leaflets for a long time to cause slippage or damage to the valve leaflets.

Please refer to FIG. 5 , FIG. 7 and FIG. 9 together. Each proximal clip 20 includes a connecting end 21 and a free end 22 disposed opposite to each other. The connecting end 21 is fixed relative to the fixing base 10 . In this embodiment, the two proximal clips 20 are connected together by a connecting frame 23. The connecting frame 23 is provided with a through hole 24 for the push rod 40 to pass through. A rectangular hole 25 through which the rectangular block 121 on the base body 12 passes, and the connecting frame 23 is sleeved on the outer sides of the second base body 12 and the third base body 13 to connect the connecting ends 21 of the two proximal clips 20 to each other. It is fixed on the fixing base 10 . In other embodiments, the connection end 21 of the proximal clip 20 may be directly fixed to the fixing base 10 by welding, crimping or other connection methods.

Each proximal clip 20 is made, at least in part, of a material with shape memory. After the heat-setting process, in the natural state, the proximal clip 20 radiates outwardly relative to the holder 10, and preferably extends proximally so as to cooperate with the distal clip 30 to hold the valve leaflets. In this embodiment, the proximal clip 20 is cut from a nickel-titanium alloy and placed in a shaping die, then the shaping die is heat-treated at 300-650° C., taken out and rapidly cooled, and the shaping die is removed to obtain a shaped proximal end 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 technological process and reduce the production cost. In other embodiments, the connection frame 23 can also be made of stainless steel, and then welded with the proximal clip 20 to improve the connection strength between the connection frame 23 and the second base body 12 .

Each proximal clip 20 is provided with at least one connecting structure 26 for connecting with the control member 230 . Specifically, as shown in FIG. 7 , in this embodiment, each proximal clip 20 is provided with a connection hole, and the connection hole is the connection structure 26 , and the control member 230 penetrates through the connection of the corresponding proximal clip 20 . The hole is extended to the outside of the patient through the delivery sheath 210 , and the operator controls the corresponding proximal clip 20 to retract or expand relative to the fixing base 10 through the control member 230 of the external part. Preferably, in this embodiment, the connecting structure 26 is disposed at one end of the proximal clip 20 away from the fixing base 10 after being unfolded relative to the fixing base 10 , that is, the free end 22 , which is beneficial for the operator to use a small pulling force to control the The proximal clip 20 is retracted relative to the holder 10 .

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

In other embodiments, the connecting structure 26 may be at least one connecting ring protruding on the surface of the proximal clip 20 facing the fixing base 10 , and the control member 230 penetrates through the connecting ring to control the proximal clip 20 . The connecting ring and proximal clip 20 may be of a unitary structure or a non-unitary structure. Specifically, in some embodiments, the connecting ring is integrally formed with the proximal clip 20 by machining or punching; The clips 20 are assembled together by means of crimping, bonding or welding.

Wherein, 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 centerline of the proximal clip 20 (that is, close to the axial centerline of the proximal clip 20). The centerline of the end clip 20 along the direction from the connection end 21 to the free end 22 ), so as to avoid the tensile force acting on the corresponding proximal clip 20 by the control member 230 to distort the proximal clip 20 around its axial centerline .

Further, a clamping reinforcement is provided on the second surface of each proximal clip 20 facing the distal clip 30, so as to increase the friction force between the proximal clip 20 and the valve, and improve the pairing of the valve clip 100. The clamping force of the valve. Specifically, in this embodiment, the clamping reinforcements are two rows of barbs 27 arranged at intervals on opposite sides of the second surface. The barbs 27 can be formed on the proximal clip 20 by integral molding, or the barbs 27 can be formed of the same or different material as the proximal clip 20 and then connected to the second surface of the proximal clip 20 . The included angle between the extending 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 clamp 100 on the valve.

In other embodiments, the clamping reinforcement may be a structure such as a rib, a boss, or other irregularly distributed protrusions protruding on the second surface, or a rough surface or a few above-mentioned structures that at least partially cover the second surface. A combination of forms to improve the holding force of the valve.

Preferably, active drug or at least one opening 28 can be applied to each proximal clip 20 .

It should be noted that, pulling the control member 230 toward the proximal end can control the free end 22 of the proximal clip 20 to be retracted relative to the fixing base 10 , so that the free end 22 of the proximal clip 20 fits on the surface of the fixing base 10 In order to facilitate delivery, after the control of the free end 22 by the control member 230 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 performance. The free ends 22 of the tabs 20 are deployed relative to the mount 10 to compress the leaflets toward the distal clip 30 . Preferably, the included angle between the two proximal clips 20 in the natural unfolded state should be slightly larger than the included angle between the two distal clips 30 to provide a more stable clamping force, that is, the proximal clip The included angle between the clip 20 and the fixed seat 10 is greater than or equal to the included angle between the distal clip 30 and the fixed seat 10 when the distal clip 30 corresponding to this side is fully opened relative to the fixed seat 10, thereby ensuring a close proximity to the fixed seat 10. There is a certain clamping force between the end clip 20 and the distal clip 30 to clamp the leaflets located therebetween. In this embodiment, the angle range of the included angle between the length direction of the proximal clips 20 and the axial direction of the fixing seat 10 is 0-150 degrees, that is, in the natural state, the angle between the two proximal clips 20 The maximum included angle can reach 300 degrees, and the opening angle range between the two proximal clips 20 is preferably 0-240 degrees, more preferably 160-200 degrees.

As mentioned above, the valve clamp 100 provided in this embodiment can be used to alleviate or treat "mitral regurgitation". Specifically, please refer to FIG. 10 to FIG. 12 together, the valve clamp 100 is placed in the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be properly aligned, so that a corresponding set of proximal clips 20 And the distal clip 30 clamps the edge of the anterior leaflet 1a of the mitral valve, and another set of corresponding proximal clips 20 and the distal clip 30 clamp the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the edge of the mitral valve. The positions where the anterior leaflet 1a and the posterior leaflet 1b cannot be properly aligned are clamped together, and the direction of the arrows shown in FIG. 11 and FIG. 12 is the direction of blood flow. As shown in FIG. 11 , when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b close together, the area A of the mitral valve opening becomes smaller or the mitral valve can be completely closed, thereby reducing or treating "mitral regurgitation". As shown in FIG. 12 , when the heart is diastolic, the anterior leaflet 1a and the posterior leaflet 1b are only abutted together at the position B clamped by the valve clamp 100, and other positions of the anterior leaflet 1a and the posterior leaflet 1b are still normally diastolic, so that the Blood is able to enter the left ventricle from the left atrium, thus ensuring the normal flow of blood.

It is understandable that because the two leaflets of the mitral valve are always in an active state of opening and closing, it is difficult to clamp, and often only one leaflet is successfully clamped, and the other leaflet may only be partially clamped, which may As a result, the two leaflets of the mitral valve are in an unsatisfactory clamping position or the partially clamped leaflets eventually slip out of the valve clamp 100, at which point the surgical operation can only be repeated, ie, tightening proximally The control member 230 is used to control the proximal clip 20 which is pressed on the valve leaflet which is only partially clamped to be retracted relative to the fixing seat 10, and adjust the position of the valve clip 100 so that the distal clip 30 is located in the proper position of the valve leaflet. position, and then release the control member 230 from the control of the proximal clip 20, so that the proximal clip 20 is unfolded relative to the holder 10 and close to the distal clip 30 to re-clamp the valve leaflet until the valve leaflet of the mitral valve is Firmly grip, regurgitation disappears or reaches the slightest state.

Please refer to FIGS. 5 and 6 , in order to avoid the bending of the delivery sheath 210 and the swing of the valve clamp 100 caused by the pulling force of the control member 230 acting on the corresponding proximal clip 20 , in the present invention, the control member 230 is inserted through the The delivery sheath 210 extends out of the patient's body through at least a pair of first cavities 211 symmetrically opened with respect to its axis line. The resultant force F of the pulling force acting on the corresponding proximal clip 20 by the control member 230 is located on the axis of the delivery sheath 210, so that the torque generated by the resultant force F on the valve clip 100 is zero, thereby avoiding the delivery sheath The tube 210 bends and the valve clamp 100 swings, and the operator does not need to adjust the position of the valve clamp 100 many times to release the proximal clamp 20 quickly and accurately to re-clamp the valve, which is beneficial to reduce the operation time and improve the operation time. The operation efficiency is improved, and the injury to the patient caused by the swinging of the valve clamp 100 and the chordae tendineae or tissue can be avoided.

As shown in FIG. 5 , 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 Sheet 20. That is to say, in the present embodiment, the two control members 230 for controlling the two proximal clips 20 respectively pass through two different pairs of the first cavities 211 .

Each control member 230 is a single control wire. After the control wire is passed through the corresponding proximal clip 20 , the two ends of the control wire are respectively passed through a pair of first cavities 211 and extend out of the patient's body. Specifically, the wire inlet channel of the control wire is one of the first holes 211 in the pair of first holes 211 , and the wire outlet channel is the other first hole 211 in the pair of first holes 211 , namely , the incoming wire channel and the outgoing wire channel of the control wire are symmetrical about the axis of the delivery sheath 210 . As shown in FIG. 5 , in this embodiment, the control wire reaches the corresponding proximal clip 20 along the wire entry channel and then passes through the connecting structure 26 on the proximal clip 20 , and then bends in the opposite direction and extends through the wire outlet channel to the corresponding proximal clip 20 . outside the patient's body. As shown in FIG. 6 , when the operator pulls one of the control wires toward the proximal end to control a corresponding proximal clip 20 to retract relative to the fixing base 10 , the control wire that is bent into two parts acts on the corresponding proximal clip 20 . The tensile forces on the proximal clip 20 are respectively F1 and F2, the tensile forces 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 resultant force F is on the valve clamp. The torque generated by the clamp 100 is zero, so that the bending of the delivery sheath 210 and the swing of the valve clamp 100 can be avoided, and the operator can quickly adjust the position of the valve clamp 100 and accurately release the proximal clamp 20 to re-clamp The valve is beneficial to reduce the operation time, improve the operation efficiency, and can avoid the injury to the patient caused by the swing of the valve clamp 100 .

Wherein, 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 adopts a single nickel-titanium wire, that is, the control member 230 is a single nickel-titanium wire.

The shape of the first cavity 211 may be a circle, a square, a polygon or other special shapes. In this embodiment, the first cavity 211 is a circular cavity.

Referring to FIG. 13 , in this embodiment, the distances from the axis lines of the two pairs of first holes 211 to the axis lines of the delivery sheath 210 are equal, and each first hole 211 and the other pair of first holes The distance between the two first cavities 211 of the 211 is equal, that is, the two pairs of the first cavities 211 are distributed in a square. Obviously, in other embodiments, the distances between each first hole 211 and the two first holes 211 of another pair of first holes 211 may be unequal, that is, the two pairs of first holes 211 are distributed in a rectangle. , as shown in Figure 14.

In other embodiments, the distances from the axis lines of the two pairs of first cavities 211 to the axis lines of the delivery sheath 210 may not be equal, that is, the two pairs of first cavities 211 are distributed in a parallelogram, as shown in FIG. 15 . Show.

In other embodiments, the delivery sheath 210 may only have a pair of first cavities 211 , and the two control wires for controlling the two proximal clips 20 respectively pass through the pair of first cavities 211 Specifically, the wire inlet channel of the two control wires is the same first hole 211 in the pair of first holes 211 , and the wire outlet channel of the two control wires is the pair of first holes 211 Another first cavity 211 in the .

Further, as shown in FIG. 5 and FIG. 13 , in this embodiment, the valve clamping system further includes a pressure sensor (not shown in the drawings), and the delivery sheath 210 is provided with a second cavity 212 extending in the axial direction, The pressure sensor is movably penetrated in the second cavity 212 and can protrude from the distal end of the second cavity 212 . After 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, a pressure sensor can be inserted from the distal end of the second bore 212 Extends into the left atrium of the heart to provide real-time feedback of intra-cardiac pressure values to confirm a reduction in the patient's "mitral regurgitation", thereby determining the need to adjust the position of the valve clamp 100 and re-clamp the mitral valve valve leaflets to optimize the treatment effect.

It can be understood that the pressure sensor can be assembled in the second hole 212 of the delivery sheath 210 at the factory, or other compatible commercial pressure sensors can be used, which are assembled by the operator on the inner surface of the delivery sheath 210 before the operation. in the second cavity 212 .

Please refer to FIG. 5 , FIG. 7 , FIG. 16 , and FIG. 17 together. The valve clamping system provided in this embodiment includes a valve clamp 100 and a delivery device 200 , and the valve clamp 100 is delivered to the mitral through the delivery device 200 . valve, and adjust the valve clamp 100 to the appropriate position of the mitral valve. The delivery device 200 includes an operating handle and a delivery component, the proximal end of the delivery component is connected to the operating handle, and the distal end of the delivery component is detachably connected to the valve clamp 100 .

The delivery assembly includes the aforementioned delivery sheath 210 and the control member 230 passing through the first cavity 211 of the delivery sheath 210 . Further, the delivery assembly further includes a connector 250 inserted into the distal end of the delivery sheath 210 , The liner 270 is movably coaxially sleeved in the lumen of the connector 250 , and the mandrel 290 is movably coaxially sleeved in the liner 270 . The operator can tighten the control member 230 through an operating handle placed outside the patient's body, and respectively drive the liner 270 and the mandrel 290 to relatively move or rotate.

A third cavity 213 is defined in the delivery sheath 210 in the axial direction. The connector 250 is inserted into the distal end of the third cavity 213 . The liner 270 and the mandrel 290 pass through the third cavity 213 and extend to the outside of the patient. Preferably, in this embodiment, the distal end of the delivery sheath 210 is provided with a fixing member 214 , and the connecting member 250 , the liner 270 and the mandrel 290 , which are coaxially sleeved together, are inserted into the delivery sheath 210 through the fixing member 214 . inside the third cavity 213 to improve the connection strength. It can be understood that the fixing member 214 defines a plurality of through holes respectively communicating with the first cavity 211 , the second cavity 212 and the third cavity 213 .

The delivery sheath 210 may be a multi-lumen tube made of biocompatible metal material or polymer material by integral molding, or may be several single tubes made of biocompatible metal material or polymer material A multi-lumen tube formed by crimping, welding or bonding. 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 the present embodiment, the pushing catheter 210 is a multi-lumen tube formed by integral molding, and a plurality of cavities extending along the axial direction of the pushing catheter 210 are provided, and the plurality of cavities form the aforementioned at least one pair of the first cavities 211 , A second cavity 212 and a third cavity 213 .

The connecting member 250 is substantially tubular, and two connecting rods 253 are axially symmetrically disposed at the distal end of the connecting member 250 . The inner surfaces of the two connecting rods 253 disposed axially symmetrically opposite to each other are arc surfaces that are smoothly connected to the inner cylindrical surface of the lumen of the connecting piece 250 , and the arc surface of each connecting rod 253 is connected to the axis line of the connecting piece 250 . The distance 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 of the connecting piece 250 , and the two connecting rods 253 gradually converge and approach from the proximal end to the distal end.

The connecting rod 253 is made of an elastic material, and when the connecting rod 253 is pushed outward in the radial direction of the connecting piece 250 , the distal end of the connecting rod 253 expands outward. The liner 270 of the delivery device 200 is movably passed through the lumen of the connector 250 , the liner 270 is driven to move toward the distal end, the liner 270 pushes the connecting rod 253 radially outward, and the buckle 255 of the connecting rod 253 It expands outward and snaps into the hole 111 of the fixing base 10, so that the delivery device 200 is connected to the fixing base 10 through the connecting piece 250; it can be understood that when the liner 270 is retracted to the proximal end, the connecting rod 253 will return due to its own elasticity. The distal end of the connecting rod 253 is retracted toward the axis of the connecting piece 250, the buckle 255 exits the corresponding hole 111, and the connection state of the conveying device 200 and the fixing base 10 is released.

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

In other embodiments, the delivery assembly may not include the liner 270 and the overall diameter of the mandrel 290 or the diameter of the distal portion of the mandrel 290 is larger such that the distal portion of the mandrel 290 can directly push against the distal end of the connector 250 The buckle 255 expands outward, that is to say, the mandrel 290 can be used to push the buckle 255 at the distal end of the connecting piece 250 to expand outward, and can also be used to drive the push rod 40 along the axial direction of the fixed seat 10 slide.

It should be noted that the delivery assembly and the valve clamp 100 can be delivered to the patient by using the existing flexible sheath.

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

Step 1: Removably connect the delivery assembly to the valve clamp 100. Specifically, use the liner 270 to push the buckle 255 at the distal end of the connector 250 outward, so that the buckle 255 is snapped into the fixing seat 10. The fixing seat 10 and the connecting piece 250 are in a connected state in the clamping hole 111 of the locus; The control member 230 is pulled proximally to control the proximal clip 20 to be retracted relative to the holder 10 so that the free end 22 of the proximal clip 20 fits on the surface of the holder 10 . Then, by operating the handle to move the mandrel 290 toward the distal end, the push rod 40 is driven to slide toward the distal end in the axial direction, and the distal clip 30 is driven to close relative to the fixed seat 10, so that the valve clamp 100 is in a fully retracted state, and the proximal The end clips 20 and the distal clips 30 are both close to the surface of the fixing base 10 and remain in a folded state.

Step 2: The delivery assembly and the valve clamp 100 are advanced from the left atrium through the flexible sheath through the trans-atrial septal route, through the mitral valve to the left ventricle, as shown in FIG. 18 .

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

Step 4: Move the mandrel 290 toward the proximal end by operating the handle, thereby driving the push rod 40 to slide toward the proximal end to drive the distal clip 30 to open relative to the fixed seat 10, and adjust the direction of the valve clamp 100 so that the distal The end clips 30 are perpendicular to the mitral valve coaptation.

Step 5: withdraw the entire valve clamp 100 toward the proximal end, so that the distal clamp 30 supports the valve leaflet on the left ventricle side, as shown in FIG. 19 .

Step 6: Release the control of each control member 230 on the corresponding proximal clips 20, release the proximal clips 20 on both sides in turn, and the proximal clips 20 on each side press the valve leaflet on the atrial side and connect with the side. The distal clips 30 of the valve are fitted to clamp the leaflets. In the process of releasing the unilateral proximal clip 20, the operator simultaneously pulls the incoming wire end and the outgoing wire end of the control member 230 corresponding to the proximal clip 20 to be tightened outside the body, acting on the pulling force of the incoming wire and the outgoing wire Equivalently, since the wire inlet channel and the wire outlet channel are located in the two first cavities 211 that are symmetrical about the axis of the delivery sheath 210, the resultant force of the pulling force acting on the corresponding proximal clip 20 by the control member 230 is located in the delivery sheath tube. 210 on the axis line to avoid bending of the delivery sheath 210 and swinging of the valve clamp 100, so as to independently control the deployment of each proximal clip 20 relative to the fixing seat 10, the anterior leaflet 1a and the posterior leaflet of the mitral valve 1b is respectively clamped between the corresponding proximal clips 20 and distal clips 30 to achieve complete clamping of the valve leaflets, as shown in FIG. 20 .

Step 7: Extend the pressure sensor from the distal end of the second cavity 212 of the delivery sheath 210 into the left atrium, and detect the pressure value in the heart to confirm the reduction of the patient's "mitral regurgitation", Thereby, it is determined whether it is necessary to adjust the position of the valve clamp 100 and re-clamp the valve leaflets to optimize the treatment effect. In the case where the valve leaflet needs to be re-clamped, the control member 230 is pulled proximally to control the proximal end clip 20 pressing on the valve leaflet with an unsatisfactory clamping position to be retracted relative to the fixed seat 10, and the valve clamp is adjusted. 100 position, so that the distal clip 30 is located at the proper 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 leaflets until the mitral valve leaflets are fully clamped.

The eighth step: 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 fixed seat 10 until the valve clamp 100 is fully retracted, As shown in Figure 21.

The ninth step: control the rotation of the mandrel 290 by operating the handle to unlock the threaded connection between the mandrel 290 and the push rod 40, and then withdraw the liner 270 and the mandrel 290 towards the proximal end, until the latch at the distal end of the connecting piece 250. The buckle 255 is unlocked and separated from the locking 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 bi-ported mitral valve and complete the edge pairing of the mitral valve. For edge repair, the valve clamp 100 is indwelled in the patient, as shown in FIG. 10 .

It can be understood that, the valve clamping system of the present invention can also be used to deliver the valve clamp to the mitral valve through the apical and other routes.

Referring to FIG. 22 , the structure of the valve clamping system provided by the second embodiment of the present invention is similar to the structure of the valve clamping system in the first embodiment, the difference is: in the second embodiment, each control element 230b includes at least two control wires, that is to say, each proximal clip 20 is controlled by at least two control wires to realize the retraction or deployment relative to the fixing base 10 . Specifically, in this embodiment, each control member 230b includes two control wires, the two control wires are passed through the same pair of first cavities 211 of the delivery sheath 210, and the wire inlet channels of the two control wires are One of the first holes 211 in the pair of first holes 211, the outlet channel of the two control lines is the other first hole 211 in the pair of first holes 211, and each control line The incoming wire channel and the outgoing wire channel are still symmetrical about the axis of the delivery sheath 210, so as to prevent the valve clamp 100 from swinging.

It can be understood that, each control member 230b includes at least two control wires, which can improve the control force of each control member 230b on the corresponding proximal clip 20, that is, at least two control wires can provide a larger pulling force, Make the proximal clip 20 as close to the fixing seat 10 as possible, and prevent the proximal clip 20 from being released in advance due to insufficient tension.

Referring to FIG. 23 , the structure of the valve clamping system provided by the third embodiment of the present invention is similar to the structure of the valve clamping system in the first embodiment, the difference is: in the third embodiment, each control member 230c includes at least one pair of control wires, that is to say, each proximal clip 20 is controlled by at least one pair of control wires to realize the retraction or deployment relative to the fixing base 10 . After at least one pair of control wires are respectively passed through the corresponding proximal clips 20 , each pair of control wires is passed through a pair of first cavities 211 of the delivery sheath 210 and extends outside the patient's body.

In this embodiment, each control member 230 c includes a pair of control wires, and the pair of control wires is passed through the pair of first cavities 211 of the delivery sheath 210 . Specifically, in a pair of control wires used to control each proximal clip 20 , the wire inlet channel and the wire outlet channel of one control wire are the same as one of the first holes in the pair of first holes 211 Cavity 211 , the incoming wire channel and the outgoing wire channel of the other control wire are the same as the other first hole 211 in the pair of first holes 211 , that is, a channel for controlling each proximal clip 20 . The control wire is arranged symmetrically with respect to the axis of the delivery sheath 210 , so as to prevent the valve clamp 100 from swinging.

In other embodiments, each control member 230c may include at least two pairs of control wires, and each pair of control wires passes through a pair of first cavities 211 of the delivery sheath 210 and extends outside the patient's body. Among the at least two pairs of control wires used to control each proximal clip 20, different two pairs of control wires may pass through the same pair of first holes 211 to the outside of the patient's body, or may pass through a pair of first holes 211 respectively. A cavity 211 penetrates out of the patient's body.

It can be understood that, each control member 230c includes at least one pair of control wires, 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 wires can provide a greater pulling force, Make the proximal clip 20 as close to the fixing seat 10 as possible, and prevent the proximal clip 20 from being released in advance due to insufficient tension.

Referring to FIG. 24 , the structure of the valve clamping system provided by 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, the connecting member 250 or The fixing base 10 is provided with at least one winding post 235 , and the incoming end and/or the outgoing end of the control wire (ie, the control member 230 ) bypasses the at least one winding post 235 and extends to the outside of the patient. Specifically, in this embodiment, two winding posts 235 are protruded from the outer wall of the connector 250 . The two winding posts 235 are symmetrical with respect to the axis of the connector 250 , and the incoming end of the control wire is connected to the corresponding After the proximal clip 20 is attached, the wire outlet end bypasses a winding post 235 and then extends upward into the wire outlet channel of the delivery sheath 210 until it extends out of the patient's body. In this embodiment, the two control wires for controlling the two proximal clips 20 bypass different winding posts 235 respectively.

In other embodiments, the incoming end of each control wire can bypass the winding post 235 and then pass through the corresponding proximal clip 20, and the outgoing end of the control wire can directly extend upward into the outgoing channel of the delivery sheath 210 until extended outside the patient's body.

In other embodiments, the incoming wire end and the outgoing wire end of each control wire can bypass the winding post 235 and extend to the outside of the patient through the wire feeding channel and the wire outlet channel of the delivery sheath 210 , respectively.

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

Preferably, at least one winding slot may be formed on the winding post 235, and the control wire is partially wound in the at least one winding slot. When the incoming end and the outgoing end of the control wire or the incoming end and/or outgoing end of the two control wires used to control different proximal clips 20 are wound on the wire winding post 235 at the same time, the wire wrapping post 235 Set up multiple winding slots at intervals to avoid control wires from interfering with each other.

It can be understood that when the incoming end and/or the outgoing end of the control wire is wound on the winding post 235, and the control wire is pulled toward the proximal end to control the corresponding proximal clip 20 to be retracted relative to the fixing seat 10, the control wire can be controlled. The incoming wire end and/or outgoing wire of the wire slides around the winding post 235, and the winding post 235 acts as a fixed pulley, which is beneficial for the operator to tighten the proximal clip 20 with a small pulling force and avoid the proximal clip 20 early release.

It should be noted that, the above contents are all described by taking the valve clamp as an example for alleviating or treating "mitral valve regurgitation". It can be understood that, in other embodiments, the valve clamp can also be used to alleviate or treat "tricuspid valve regurgitation", and its principle and structure are the same as those used to solve "mitral valve regurgitation" in the embodiments of the present invention. The principle and structure of the valve clamp are basically the same, and it is only necessary to form multiple clamps by multiple sets of proximal clamps and distal clamps, and each clamp can clamp a valve leaflet, which will not be repeated here. .

Obviously, in other embodiments, the valve clamp provided by the present invention can also be applied to other minimally invasive surgical operations that need to clamp more than three sheet-shaped valves together.

The above are the implementations of the embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present invention, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection scope of the present invention.

Claims (16)

1. an independently controllable valve clamping system is characterized in that, comprising: a valve clamp, the valve clamp includes a fixed seat and a proximal clip that can be retracted or expanded relative to the fixed seat; A delivery device for delivering the valve clamp, the delivery device includes a delivery sheath and a control member, each of the control members is correspondingly connected to a proximal clip to control the proximal clip relative to the fixing seat is folded or unfolded; Wherein, the delivery sheath is provided with at least a pair of first cavities extending in the axial direction, at least a pair of the first cavities are symmetrical with respect to the axis of the delivery sheath, and each of the control members is movably is penetrated in at least one pair of the first cavities. 2 . The valve clamping system according to claim 1 , wherein each of the control members comprises at least one control wire, and after the at least one control wire is passed through the corresponding proximal clip, each Two ends of one of the control wires are respectively extended to the outside of the patient through a pair of the first holes. 3 . The valve clamping system according to claim 2 , wherein the wire inlet channel of each control wire is one of the first holes in a pair of first holes, and the wire outlet channel is the first hole in the pair of first holes. 4 . The other first cavity of the pair of first cavities. 4. The valve clamping system according to claim 1, wherein each of the control members comprises at least one pair of control wires, and after the at least one pair of the control wires are respectively threaded through the corresponding proximal clips, A pair of the control wires respectively pass through the pair of the first cavities and extend out of the patient's body. 5 . The valve clamping system according to claim 4 , wherein in at least one pair of the control wires, the incoming wire channel and the outgoing wire channel of one control wire are the same in the pair of first cavities. 6 . A first cavity, and the incoming wire channel and the outgoing wire channel of the other control wire are the same as the other first cavity in the pair of first cavity cavities. 6. The valve clamping system according to claim 2 or 4, wherein the distal end of the delivery device is provided with a connecting piece, and the delivery device is detachably connected to the fixing seat through the connecting piece, so that the At least one winding post is arranged on the connector or the fixing base, and the incoming end and/or the outgoing end of the control wire bypasses the at least one of the winding posts and extends outside the patient's body. 7. The valve clamping system according to claim 6, wherein each 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. 8. The valve clamping system according to claim 1, wherein the delivery sheath is provided with two pairs of the first cavities, and the axis lines of the two pairs of the first cavities reach the delivery The distances between the axes of the sheath tubes are equal or unequal, and each pair of the first cavities is provided with the control member. 9 . The valve clamping system according to claim 1 , wherein each of the proximal clips is provided with at least one connecting structure, and at least one of the connecting structures is used for connecting the control member. 10 . 10 . The valve clamping system according to claim 9 , wherein the connecting structure is disposed at an end of the proximal clip that is far away from the fixing base after being unfolded relative to the fixing base. 11 . 11. The valve clamping system according to claim 9, wherein each of the proximal clips is provided with at least two connecting structures, and the center line of the at least two connecting structures is located at or close to the Axial centerline of the proximal clip. 12. The valve clamping system according to any one of claims 9 to 11, wherein the connecting structure is a connecting hole opened on the proximal clip, or is protruded on the proximal clip On-chip connection ring. 13. The valve clamping system according to claim 1, wherein the delivery sheath is a multi-lumen tube made of biocompatible metal material or polymer material by integral molding; or is biocompatible It is a multi-lumen tube formed by crimping, welding or bonding of several single tubes made of flexible metal materials or polymer materials. 14. The valve clamping system according to claim 1, wherein the valve clamp further comprises a distal clip that can be retracted or deployed relative to the fixing seat, the distal clip is connected to the A leaflet accommodating space is formed between the proximal clips. 15. The valve clamping system of claim 1, wherein the proximal clip is at least partially made of a material with a shape memory function, and the distal clip is harder than the proximal elastic hardness. 16. The valve clamping system of claim 1, wherein the valve clamping system further comprises a pressure sensor, the delivery sheath is provided with a second lumen extending in the axial direction, and the pressure sensor passes through the valve. It is arranged in the second cavity and can extend from the distal end of the second cavity.

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