CN114617673A - Valve clip delivery device - Google Patents

Abstract

The present application provides a valve clip delivery device for delivering and controlling the valve clip. The valve clamp includes at least two clamping elements that are relatively open and close, and is also provided with a self-locking mechanism. The valve clip delivery device includes a handle and a catheter, the handle includes a housing, a clamping control component and a locking control safety component, the proximal end of the catheter is fixedly connected to the distal end of the housing, and the clamping controls The assembly and the locking safety assembly are both arranged on the housing, and the locking safety assembly is connected to the self-locking mechanism for controlling the valve to switch between the unlocked state and the self-locking state. The clamp control assembly is used to control the opening or closing of the at least two clamp elements when the valve clamp is in the unlocked state. The valve clip delivery device can reduce the risk of accidental opening of the valve clip.

Description

Valve clip delivery device

technical field

The present application relates to the technical field of medical devices, and in particular, to a valve clip delivery device.

Background technique

The mitral valve is a one-way valve between the left atrium and left ventricle of the heart. A normal, healthy mitral valve controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets called anterior and posterior. Normally, when the left ventricle of the heart contracts, the edges of the anterior and posterior lobes completely coincide, preventing blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or the chordae tendineae, valve annulus, etc. have lesions, such as partial rupture of the chordae tendineae, the anterior leaflet and posterior leaflet of the mitral valve are poorly coapted, then when the left ventricle of the heart contracts, the mitral valve cannot be fully It closes, causing blood to flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation."

Edge-to-edge repair of the mitral valve is an effective method for the treatment of mitral regurgitation. Specifically, the edges of the anterior and posterior leaflets of the mitral valve that cannot be properly aligned are fixed together by sutures or clips, thereby reducing the size of the mitral valve. The valve leaflet gap makes the mitral valve orifice form a double-hole structure, so as to reduce the total area of the mitral valve orifice and reduce or eliminate the regurgitation volume. Traditional mitral valve edge-to-edge repair is performed under the condition of open surgery, usually requires thoracotomy and the establishment of extracorporeal blood circulation, so the risk is high. With the advancement of technology, various minimally invasive and interventional procedures have been developed, which require only a small operating window to be incised in the patient's body, whereby a delivery device is used to deliver the valve clip to the diseased mitral The valve clamp clamps and fixes part of the edges of the two leaflets together, and the mitral valve orifice forms a double-hole structure, thereby reducing regurgitation. However, the existing valve clip delivery devices generally allow the valve clip to be moved at any position and at any time, and there is a risk that the valve clip is accidentally opened and hinders the operation process.

SUMMARY OF THE INVENTION

The technical problem to be solved by the present application is to provide a valve clip delivery device, which can avoid the risk of the valve clip being accidentally opened.

In order to achieve the above purpose, the embodiments of the present application adopt the following technical solutions:

The present application provides a valve clip delivery device for delivering and controlling a valve clip. The valve clip includes at least two clamping elements that open and close relative to each other, and the valve clip is provided with a self-locking mechanism. The valve clip delivery device includes a handle and a catheter, the handle includes a housing, a clamping control component and a locking control safety component, the proximal end of the catheter is fixedly connected to the distal end of the housing, and the clamping controls The assembly and the locking safety assembly are both arranged on the housing, and the locking safety assembly is connected to the self-locking mechanism for controlling the valve to switch between the unlocked state and the self-locking state. The clamp control assembly is used to control the opening or closing of the at least two clamp elements when the valve clamp is in the unlocked state.

The valve clip delivery device provided by the present application is provided with a lock control safety component, which can ensure that the valve clip is delivered in place in a self-locking state, and the valve clip can only be opened after the valve clip is switched to the unlocked state through the lock control safety component The holding element is used to hold the valve leaflets, so that the valve clip can be prevented from being accidentally opened during the delivery process, which is helpful for the smooth progress of the valve edge-to-edge repair.

Description of drawings

Fig. 1 is the three-dimensional assembly schematic diagram of valve clamping system;

Fig. 2 is the three-dimensional schematic diagram of the base, the drive arm and the clamping element of the valve clamp assembled together;

3 is a schematic cross-sectional view of the base, the drive arm, and the clamping element of the valve clamp assembled together;

Fig. 4 is the schematic diagram of the self-locking mechanism of valve clip;

Figure 5 is a schematic three-dimensional assembly diagram of the valve clip and the distal end of the valve delivery device;

6 is a schematic perspective view of the gripping element and the gripping element of the valve clip being radially deployed;

Fig. 7, Fig. 8, Fig. 9 are partial structural assembly schematic diagrams of valve clamping system;

FIG. 10 is a perspective assembly schematic diagram of the handle of the valve clip delivery device;

Fig. 11 is a three-dimensional assembly schematic diagram of the handle in Fig. 10 with a part of the casing removed;

Figure 12 is a perspective exploded schematic view of the handle in Figure 10;

13 is a schematic cross-sectional view of a catheter;

14 is a schematic view of the assembly of the first control rod, the first sleeve and the first fixing member of the locking safety assembly;

Fig. 15 is an exploded schematic view of the first control rod, the first sleeve and the first fixing member of the locking safety assembly;

FIG. 16 is a schematic three-dimensional structural diagram of the first sleeve in the locking safety assembly shown in FIG. 14;

17 is a schematic diagram of the operation of the locking safety component of the valve clip delivery device to switch the valve clip from an unlocked state to a self-locking state;

18 is a schematic view of the operation when the locking safety component of the valve delivery clip delivery device switches the valve clip from a self-locking state to an unlocking state;

19 is a schematic three-dimensional assembly diagram of the clamping control assembly and the release control assembly;

Figure 20 is an exploded perspective view of the clamping control assembly;

FIG. 21 is a schematic structural diagram of a constant force gear of the clamping control assembly;

FIG. 22 is a schematic structural diagram of the knob of the clamping control assembly;

23 is a schematic view of the operation of the clamping control assembly of the valve clamp delivery device to relatively open two clamping elements of the valve clamp;

24 is a schematic view of the operation of the clamping control assembly of the valve clip delivery device to relatively close the two clamping elements of the valve clip;

FIG. 25 is a schematic view of the assembly of the second control rod, the second sleeve and the second fixing member of the grasping control assembly;

FIG. 26 is an exploded schematic view of the second control rod, the second sleeve and the second fixing member of the grasping control assembly;

FIG. 27 is a schematic three-dimensional structural diagram of the second sleeve of the grasping control assembly shown in FIG. 25;

Figure 28 is a schematic diagram of the operation of two grasping control assemblies simultaneously controlling the deployment of two grasping elements;

Fig. 29 is a schematic diagram of the operation of two gripping control assemblies simultaneously controlling two gripping elements to move closer together;

Fig. 30 is a schematic diagram of the operation of the two grasping control assemblies respectively controlling one grasping element to unfold and the other grasping element to keep abutting against the shaft body of the valve clamp;

Figure 31 is a perspective exploded schematic view of the disengagement control assembly and the transmission member;

FIG. 32 is a schematic perspective view of the disengagement control assembly and the transmission member assembled together;

FIG. 33 is a schematic diagram of the operation of the release control assembly when it switches from the first state to the second state.

Detailed ways

In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below with reference to the accompanying drawings.

It should be understood that expressions such as "comprising" and "may include" that may be used in this application denote the presence of a disclosed function, operation, or element and do not limit one or more additional functions, Operations and Components. In this disclosure, terms such as "comprising" and/or "having" may be construed to mean a particular characteristic, number, operation, constituent element, component, or combination thereof, but not to mean one or more other characteristics , number, operation, constituent elements, components or the presence or possibility of addition of their combinations are excluded.

Furthermore, in this application, the expression "and/or" includes any and all combinations of the associated listed words. For example, the expression "A and/or B" may include A, may include B, or may include both A and B.

In this application, expressions including ordinal numbers such as "first" and "second" may modify various elements. However, such elements are not limited by the above expression. For example, the above expressions do not limit the order and/or importance of the elements. The above expressions are only used to distinguish one element from another. Similarly, a first element could be termed a second element, and similarly, a second element could be termed a first element, without departing from the scope of the present disclosure.

When a component is referred to as being "connected" or "connected to" other components, it should be understood that the component is not only directly connected or connected to the other component, but also another component may exist between the component and the other component . On the other hand, when components are referred to as being "directly connected" or "directly connected" to other components, it should be understood that there are no components between them.

In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end. The direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction. The circumferential direction is the direction (perpendicular to the axis and perpendicular to the radius of the section) around the axis of objects such as cylinders and tubes.

Referring to FIG. 1 , a valve clamping system 100 provided by an embodiment of the present application is used for edge-to-edge repair of a heart valve (not shown, which may be a mitral valve or a tricuspid valve). The valve clip system 100 includes a valve clip 20 and a valve clip delivery device 40 . The valve clip 20 is detachably connected to the distal end of the valve clip delivery device 40 for clipping multiple leaflets of the valve to perform edge-to-edge repair of the valve. The valve clip delivery device 40 is used to deliver and control the valve clip 20 .

Please refer to FIG. 2 and FIG. 3 , the valve clamp 20 includes a base 21 , two driving arms 23 rotatably connected to both sides of the base 21 , and two clamping elements 25 . The two driving arms 23 are in one-to-one correspondence with the two clamping elements 25 , each clamping element 25 is rotatably connected with a corresponding driving arm 23 , and the first ends of the two clamping elements 25 are mutually rotated through pins (not shown). connected, the second ends of the two clamping elements 25 are both free ends. The base 21 is detachably connected to the distal end of the clip delivery device 40 . The base 21 , the two driving arms 23 and the two clamping elements 25 form a link mechanism. The axial movement of the base 21 enables the two driving arms 23 to drive the two clamping elements 25 to radially expand or close, thereby realizing the clamping of the valve.

Referring to FIG. 4 , the valve clip 20 further includes a self-locking mechanism 27 for self-locking the valve clip 20 . The base 21 includes a base body 211 and a shaft body 213 protruding from the base body 211 . Two sides of the base body 211 are respectively connected with a clamping element 25 in rotation. The self-locking mechanism 27 includes a frame body 271 , a locking piece 273 and an elastic pressing piece 275 . The frame body 271 is sleeved outside the shaft body 213 and the axial position of the frame body 271 relative to the first ends of the two clamping elements 25 is fixed. The locking piece 273 and the elastic pressing piece 275 are accommodated in the frame body 271 . The locking piece 273 is sleeved outside the shaft body 213, and the elastic pressing piece 275 is arranged between the frame body 271 and the locking piece 273. The elastic pressing piece 275 is used to bias the locking piece 273 to make the locking piece 273 inclined. The through hole through which the shaft body 213 passes, when the locking piece 273 is inclined, the through hole abuts part of the side wall of the shaft body 213, so that the shaft body 213 cannot move in the axial direction and rotate in the circumferential direction.

The valve clip 20 has an unlocked state and a self-locking state, and the valve clip 20 can be switched between the unlocked state and the self-locking state. When the elastic pressing piece 275 biases the locking piece 273, the through hole of the locking piece 273 abuts against the shaft body 213 of the base 21, the shaft body 213 cannot move axially relative to the locking piece 273, and the valve clip 20 is in a self-locking state. When the locking piece 273 is subjected to an external force and overcomes the bias of the elastic pressing piece 275, the locking piece 273 returns to the positive position, so that the through hole on the locking piece 273 for the shaft body 213 to pass through no longer abuts against the shaft body 213 of the base 21, and the shaft The body 213 can move axially relative to the locking piece 273, and the valve clamp 20 is switched from the self-locking state to the unlocking state. At this time, the valve clamp delivery device 40 controls the axial movement of the shaft body 213 to drive the two clamping elements 25 to radiate. open or close.

5, the self-locking mechanism 27 further includes a connecting piece 277, the connecting piece 277 is connected between the locking piece 273 and the valve delivery device 40, and is used to drive the locking piece 273 to overcome the force of the elastic pressing piece 275 under the driving of the valve delivery device 40. Biased, so that the valve clip 20 is switched from the self-locking state to the unlocking state. In this embodiment, the connecting member 277 is substantially U-shaped, and the connecting member 277 includes a folded section 2771 and two connecting sections 2773 respectively extending from two sides of the folded section 2771 . The half-folded section 2771 is connected with the valve delivery device 40 , and the connecting section 2773 is connected with the locking piece 273 . It can be understood that the connecting member 277 is not limited to be U-shaped, and the connecting member 277 only needs to connect the locking piece 273 and the valve delivery device 40 .

Please refer to FIG. 6 , the valve clamp 20 further includes two gripping elements (or barb elastic pieces) 28 , and the two gripping elements 28 are in one-to-one correspondence with the two gripping elements 25 for cooperating with the gripping elements 25 to clamp Hold the leaflets. One end of each gripping element 28 is correspondingly adjacent to the first end of a gripping element 25 , and the other end of each gripping element 28 is connected to the valve clip delivery device 40 . The gripping elements 28 have elastic deformation ability, and the two gripping elements 28 are radially expanded under the action of no external force. In use, after the valve leaflet is positioned between the gripping element 28 and the gripping element 25, the valve clip delivery device 40 controls the gripping element 25 to close, and the gripping element 28 cooperates with the gripping element 25 to capture the leaflet and position the valve. The role of valve leaflets. The gripping element 28 may also be provided with barbs 281 for pressing the leaflet into the inner surface of the clamping element 25 to improve the anchoring and retention of the leaflet.

It can be understood that in other embodiments, the number of clamping elements 25 may be more than two, and the number of driving arms 23 may be more than two, so as to ensure that the valve clamp 20 can clamp or release the valve leaflets, and self-lock or Just unlock it.

Referring to FIGS. 7 and 8 , the valve clip delivery device 40 includes a handle 42 and a catheter 44 . The handle 42 is used to facilitate the operator to hold and control the valve clip 20 . The proximal end of the catheter 44 is fixedly connected to the distal end of the handle 42 , and the distal end of the catheter 44 extends to the valve clip 20 .

Referring to FIGS. 9 , 10 and 11 , the handle 42 includes a housing 422 , a locking safety component 423 , a clamping control component 424 and two grasping control components 428 . The locking safety component 423 , the clamping control component 424 and the two grasping control components 428 are all disposed on the housing 422 . The locking safety component 423 is used to control the valve clip 20 to switch between the unlocked state and the self-locking state. The clamp control assembly 424 is used to control the relative opening or closing of the two clamp elements 25 when the valve clamp 20 is in the unlocked state. A gripping control assembly 428 controls a gripping element 28 correspondingly.

Referring to FIG. 12, in this embodiment, the casing 422 includes a first casing 4221 and a second casing 4223 covering the first casing 4221. The casing 422 has a receiving space (not shown in the figure) for The clamping control assembly 424 , the locking safety assembly 423 and the two grasping control assemblies 428 are accommodated. The connection manner between the first housing 4221 and the second housing 4223 may be, but not limited to, a snap connection, a screw connection, and the like.

Please refer to FIG. 9 and FIG. 12 , the lock control safety component 423 includes a lock control wire 4231 and a first control rod 4232 . The first control rod 4232 is movably disposed in the casing 422 . The locking control wire 4231 is connected to the first control lever 4232 and the locking piece 273 of the self-locking mechanism 27 (as shown in FIG. 4 and FIG. 5 ). The part of the locking control wire 4231 located between the first control rod 4232 and the locking piece 273 of the self-locking mechanism 27 is movably passed through the conduit 44 . The first control rod 4232 drives the locking wire 4231 to move relative to the housing 422 from the distal end to the proximal end, so that the valve clip 20 is switched from the self-locking state to the unlocking state.

The lock control safety component 423 in the valve clamping system 100 provided by the present application can ensure that the valve clamp 20 is delivered in place in a self-locking state, and the valve clamp can be opened only after the valve clamp 20 is controlled to be switched to the unlocked state by the lock control safety component 423 The clamping element 25 of 29 is used to clamp the valve leaflet, so that the valve clamp 20 can be prevented from being accidentally opened during the delivery process, which is helpful for the smooth progress of the valve edge-to-edge repair and ensures the safety of the operation. In addition, the action of releasing the valve clip 20 can only be performed after the valve clip 20 is opened and closed to hold the valve leaflets, so the provision of the locking safety component 423 actually reduces the risk of accidental release of the valve clip 20.

In this embodiment, the locking wire 4231 passes through the first control rod 4232 along the axial direction of the first control rod 4232 and exposes the proximal end of the first control rod 4232; please refer to FIG. 5 again, the locking wire 4231 is U-shaped , the locking wire 4231 includes a folded section 4233 and two connecting sections 4234 respectively extending from both sides of the folded section 4233 .

Referring to FIG. 13 , two first sub-lumens 442 are disposed in the catheter 44 , and the proximal end of a connecting section 4234 correspondingly passes through a first sub-lumen 442 and is connected to the proximal end of the first control rod 4232 . Referring to FIG. 4 , the half-folded section 4233 of the locking wire 4231 passes through the half-folded section 2771 of the connector 277 , so that the locking wire 4231 is movably connected to the self-locking mechanism 27 .

The lock control wire 4231 adopts a U-shape and is connected to the first control rod 4232 in a way of one cavity and one wire, which can prevent the two connecting sections 4234 of the lock control wire 4231 from intertwining with each other, so that when the lock control wire 4231 is withdrawn, It is smoother and easier, avoiding the risk of pulling and disconnecting wires, and improving safety. It can be understood that the connecting piece 277 can be omitted, and the locking wire 4231 can be movably connected directly with the locking piece 273 .

Since the locking wire 4231 needs to respond immediately when the first lever 4232 is withdrawn, the locking wire 4231 is required to have lower ductility and higher tensile breaking stress. Preferably, the locking wire 4231 is stretched The fracture stress value should be greater than or equal to 25Mpa. The locking wire 4231 can be made of at least one of ultra-high molecular weight polyethylene, nickel-titanium alloy, and stainless steel. For example, the locking wire 4231 can be made of ultra-high molecular weight polyethylene suture, nickel-titanium wire, stainless steel wire, polymer In this embodiment, an ultra-high molecular polyethylene suture thread is preferably used.

Please refer to FIG. 9 , FIG. 12 , FIG. 14 and FIG. 15 , the lock-control safety component 423 further includes a first sleeve 4235 and a first fixing member 4236 . The first sleeve 4235 is fixedly received in the housing 422 . The fixing method of the first sleeve 4235 in the housing 422 can be selected from snapping, bonding, screwing, etc., which is not limited here. The first control rod 4232 is movably passed through the first sleeve 4235 . A first guide portion 4230 is provided on the outer wall of the first control rod 4232 .

Please refer to FIG. 16 , the inner wall of the first sleeve 4235 is provided with a second guide portion 4237. The first guide portion 4230 and the second guide portion 4237 are used to guide the axial movement of the first control rod 4232 relative to the housing 422. The smoothness of the axial movement of the first control rod 4232 relative to the housing 422 is improved.

In this embodiment, the first guide portion 4230 is a guide bump, the second guide portion 4237 is a guide groove formed on the inner wall of the first sleeve 4235, and the proximal end of the first sleeve 4235 is further provided with a guide groove Connected limit slot 4238. The limiting groove 4238 extends along the circumferential direction of the first sleeve 4235 and has a limiting step 4239 . The limiting groove 4238 is approximately an arc-shaped groove. The first lever 4232 cannot move distally relative to the first sleeve 4235. The starting end surface of the limiting groove 4238 is flush with the wall surface of the second guide portion 4237 , and the limiting step 4239 is located between the ending end surface 4270 of the limiting groove 4238 and the other wall surface of the second guide portion 4237 . The limiting step 4239 is used to limit the first guide portion 4230 in the limiting groove 4238 to prevent the first guiding portion 4230 from escaping from the limiting groove 4238 . When the first guide portion 4230 is accommodated in the limiting groove 4238 and abuts against the limiting step 4239, the valve clip 20 remains in the unlocked state.

Please refer to FIGS. 9 , 12 , 14 and 15 again, the first fixing member 4236 is detachably connected to the proximal end of the first control rod 4232 for fixing the free end of the connecting section 4234 of the locking wire 4231 to the first control rod 4232 . The proximal end of a lever 4232. In this embodiment, the first fixing member 4236 is a nut, the first fixing member 4236 is screwed with the proximal end of the first control rod 4232, and the part of the locking wire 4231 exposed to the first control rod 4232 (the free connection of the connecting section 4234) end) is fixedly clamped between the inner wall of the first fixing member 4236 and the outer wall of the proximal end of the first control rod 4232 .

The free ends of the two connecting sections 4234 of the locking control wire 4231 away from the folded section 4233 can be wound around the proximal end of the first control rod 4232, and the first fixing member 4236 is screwed on the first control rod 4232 to align the locking control wire 4231. The connecting segment 4234 is away from the free end of the folded segment 4233 and is fixed by pressing; when the first fixing member 4236 is tightened, by pulling the first control rod 4232 to the proximal end, the locking wire 4231 can lift the locking piece 273 to the opposite direction. The horizontal state is returned to the right position, thereby releasing the locking of the shaft body 213 . Correspondingly, by pushing the first control rod 4232 to the distal end, the locking control wire 4231 is loosened, and the locking piece 273 is inclined under the action of the elastic pressing piece 275, so that the valve clamp 20 is in a self-locking state; In this case, by pulling the free end of one of the connecting segments 4234 of the locking wire 4231, the locking wire 4231 can be removed from the body, so as not to hinder the subsequent release of the valve clip 20.

By operating the first control lever 4232 to drive the locking wire 4231, the valve clip 20 can be switched between the self-locking state and the unlocking state. Please refer to FIG. 16 and FIG. 17 , the operation required to switch the valve clip 20 from the unlocked state to the self-locking state is: rotating the first control lever 4232 to make the first guide portion 4230 in the limiting groove 4238 face away from the limiting groove 4238 The end face 4270 of the terminal moves, the first guide portion 4230 escapes from the limiting groove 4238 and enters the second guide portion 4237, and drives the first control rod 4232 to move distally (for example, in the direction indicated by arrow 301 in FIG. 17 ), locking the control wire The 4231 is in a relaxed (relaxed) state, the locking piece 273 is biased by the elastic pressing piece 275, and the valve clamp 20 is switched to the self-locking state.

When the valve clamp 20 needs to be switched from the self-locking state to the unlocking state, please refer to FIG. 18 , drive the first control rod 4232 to move toward the proximal end (for example, in the direction indicated by the arrow 302 in FIG. 18 ), and the locking control line 4231 is straightened In this state, the connecting piece 277 is pulled up, so that the locking piece 273 overcomes the bias of the elastic pressing piece 275 and returns to the positive position, and the valve clamp 20 is unlocked. After that, rotate the first control rod 4232 to make the first guide portion 4230 enter the limiting groove 4238 and move toward the direction of the end face 4270 of the limiting groove 4238 until the first guide portion 4230 abuts against the limiting step 4239, and the first The lever 4232 keeps pulling the locking wire 4231 to keep the valve clamp 20 in an unlocked state, allowing the valve clamp 20 to open or close.

It can be understood that one of the first guide portion 4230 and the second guide portion 4237 is a guide groove extending along the axial direction of the first control rod 4232, and the other is a guide bump, and the guide bump is slidably inserted through the in the guide groove. It can be understood that the first sleeve 4235 can be omitted, and the second guide portion is directly provided on the 422 .

It can be understood that the first fixing member 4236 is not limited to a nut, it can also be a cover body; the first fixing member 4236 can be omitted, and the portion of the locking wire 4231 that exposes the proximal end of the first control rod 4232 and the first control rod The connection method of the 4232 is not limited. For example, the portion of the locking wire 4231 that exposes the proximal end of the first control rod 4232 is directly wound around the first control rod 4232, or the portion of the locking wire 4231 that exposes the proximal end of the first control rod 4232. The end part is directly fixed on the first control rod 4232 by means of bonding, etc., after pulling the first control rod 4232 to the proximal end, cut off the lock control wire 4231, and then pull one of the lock control wires 4232, the same can be The locking wire 4232 is removed outside the body so as not to interfere with the disengagement of the valve clip 20.

It is worth noting that, for the stroke control of the linear movement of the first control rod 4232 relative to the housing 422, it is necessary to consider not only that the locking control wire 4231 can generate the best unlocking force value for the valve clamp 20, but also the locking control wire 4231 in the Loss in the first sub-lumen 442 of the catheter 44 and the effect of the extensibility of the locking wire 4231. Taking the optimal unlocking force value of 6N as an example, the stroke of the first control rod 4232 relative to the linear motion of the housing 422 is preferably set to [9,13] mm. In this way, pulling the first control rod 4232 to the proximal end can unlock the valve clamp. 20. The valve clip 20 and the locking control wire 4231 will not be damaged due to excessive pulling force. Pushing the first control rod 4231 to the distal end can not only realize the self-locking of the valve clip 20, but also ensure that the stacking amount of the locking control wire 4231 is not limited. Too much will cause the locking wire 4231 to catch the valve clip 20. It can be understood that the present application does not limit the stroke of the linear movement of the first control rod 4162 relative to the housing 422 .

It can be understood that the present application does not limit the structure and arrangement of the self-locking mechanism 27 of the valve clip 20 , and does not limit the structure and arrangement of the locking safety component 423 .

Please refer to FIGS. 9 and 12 , the clamping control assembly 424 includes a mandrel 4241 and a transmission member 4242 . The distal end of the mandrel 4241 is detachably connected to the proximal end of the shaft body 213 (shown in FIGS. 2 and 3 ) of the valve clip 20 . In this embodiment, the distal end of the mandrel 4241 is threadedly connected to the proximal end of the shaft body 213 . It can be understood that the distal end of the mandrel 4241 is not limited to be screwed with the proximal end of the shaft body 213, and it can also be connected by other means, such as snap connection, which is not limited here. The proximal end of the mandrel 4241 moves through the catheter 44 and is connected with the transmission member 4242 . The transmission member 4242 is slidably connected with the housing 422 in the axial direction. Please refer to FIG. 13 again, a central cavity 443 is also provided in the catheter 44 , and the mandrel 4241 is movably passed through the central cavity 443 .

More specifically, please refer to FIG. 19 and FIG. 20, the distal end of the transmission member 4242 is further provided with a first guide structure 4243, and the first housing 4221 of the housing 422 is provided with a second guide structure 4225 corresponding to the first guide structure 4243 (as shown in Figure 12). The first guide structure 4243 and the second guide structure 4225 are slidably connected in the axial direction to guide the axial movement of the transmission member 4242 relative to the casing 422, so that the transmission member 4242 can only move in the axial direction relative to the casing 422 and cannot be moved. turn. In this embodiment, the first guide structure 4243 is a guide groove, and the second guide structure 4225 is a guide rail extending in the axial direction. It can be understood that the present application does not limit the first guide structure 4243 and the second guide structure 4225. For example, in other embodiments, the first guide structure 4243 may be a guide rail, and the second guide structure 4225 may be a guide groove.

The clamping control assembly 424 further includes a constant force gear 4244 and a knob 4245 for driving the constant force gear 4244 to rotate. The constant force gear 4245 is screwed on the transmission member 4242 . The rotation of the constant force gear 4244 drives the transmission member 4242 to move in the axial direction, that is, the rotational movement of the constant force gear 4244 is converted into the axial movement of the transmission member 4242 relative to the housing 422 , thereby controlling the opening and closing of the two clamping elements 25 .

In this embodiment, the outer wall of the transmission member 4242 includes a screw segment 4246 , the inner wall of the constant force gear 4244 is provided with a transmission thread 4247 , and the screw segment 4246 is adapted to the transmission thread 4247 provided in the constant force gear 4244 .

The knob 4245 is sleeved on the constant force gear 4244 . When the knob 4245 rotates in the forward direction and the driving force of the knob 4245 to the fixed force gear 4244 is less than the preset force value, the knob 4245 drives the fixed force gear 4244 to rotate in the forward direction synchronously, so that the transmission member 4242 moves toward one end relative to the housing 422 in the axial direction . For example, the knob 4245 drives the fixed force gear 4245 to rotate forward, the transmission member 4242 and the mandrel 4241 move toward the proximal end in the axial direction, and drive the two clamping elements 25 on the valve clamp 20 to close relative to each other. And the greater the distance that the transmission member 4242 moves toward the proximal end, the tighter the closing degree of the two clamping elements 25 is.

When the knob 4245 is rotated in the forward direction and the driving force of the knob 4245 to the constant force gear 4244 is greater than or equal to the preset force value, the knob 4245 rotates independently relative to the constant force gear 4244 . For example, after the two clamping elements 25 clamp and fix the valve, if the knob 4245 is continued to be rotated, the knob 4245 rotates independently relative to the constant force gear 4244, thereby preventing the clamping element 25 from excessively clamping the valve leaflet and damaging the valve leaflet. Even if the driving force of the knob 4245 to the fixed force gear 4244 is larger, once the driving force exceeds the preset force value, the force exerted on the mandrel 4241 will not increase, which is beneficial to protect the mandrel 4241 from being damaged by excessive tension. broken or damaged.

When the knob 4245 rotates in the opposite direction, the knob 4245 drives the constant force gear 4244 to rotate in the opposite direction synchronously, so that the transmission member 4242 slides relative to the housing 422 toward the opposite end in the axial direction. For example, the knob 4245 drives the fixed force gear 4245 to rotate in the opposite direction, the transmission member 4242 and the mandrel 4241 move to the distal end in the axial direction, and drive the two clamping elements 25 on the valve clamp 20 to open relative to each other. And the greater the distance that the transmission member 4242 moves to the distal end, the greater the relative opening angle of the two clamping elements 25 .

The constant force gear 4244 includes a wheel body 4248 and a plurality of tooth arms 4249 protruding from the outer wall of the wheel body 4248 and arranged at intervals along the circumferential direction. The inner wall of the knob 4245 is provided with a plurality of stop parts 4250 that cooperate with the plurality of toothed arms 4249 in the circumferential direction; the preset force value is when the toothed arms 4249 relatively slide over the stop parts 4250, the knob 4245 exerts the action of the given force gear 4244 force value.

One end of the toothed arm 4249 is fixedly connected with the outer wall of the wheel body 4248 , the other end of the toothed arm 4249 is a free end, and at least part of the outer wall of the toothed arm 4249 extends along the circumferential direction of the wheel body 4248 .

Referring to FIG. 21 , a gap 4252 is formed between at least part of the outer wall of the toothed arm 4249 and the outer wall of the wheel body 4248 , so as to provide a deformation space for the elastic deformation of the toothed arm 4249 .

The preset force value can be controlled by setting the maximum outer diameter of the constant force gear 4244, the thickness of the gear arm 4249, the material of the constant force gear 4244, and the like. In this embodiment, the number of gear arms 4249 arranged along the circumferential direction of the wheel body 4248 is 8, the preset force value is about 50N, and the material of the constant force gear 4244 is preferably a polymer PC material with high hardness and toughness , the maximum outer diameter value is set to 35-40mm, and the thickness of the toothed arm 4249 is set to 1.5-2.0mm. When the linear tension value of the mandrel 4241 is greater than a certain force value, the knob 4245 and the fixed force gear 4244 will slip relative to each other. The mandrel 4241 will stop moving in the axial direction, and the force exerted on the mandrel 4241 will not increase any more.

The free end of the toothed arm 4249 includes a first guide sliding surface 4254 and a first anti-slip surface 4256 disposed opposite to the first sliding guide surface 4254 . Please refer to FIG. 22 , the stop portion 4250 of the knob 4245 includes a second sliding surface 4258 and a second sliding surface 4259 opposite to the second sliding surface 4258 . When the knob 4245 is rotated in the forward direction, the first guide sliding surface 4254 is in contact with the second sliding guide surface 4258, so that when the knob 4245 is rotated in the forward direction and the driving force of the knob 4245 to the constant force gear 4244 is greater than or equal to the preset force value , it is convenient for the toothed arm 4249 of the knob 4245 to slide over the stop 4250. When the knob 4245 rotates in the reverse direction, the first anti-slip surface 4256 contacts the second anti-slip surface 4259, so that the constant force gear 4244 rotates in the reverse direction along with the knob 4245.

In this embodiment, the first sliding guide surface 4254 is inclined relative to the first anti-slip surface 4256, the first anti-slip surface 4256 generally extends along the radial direction of the wheel body 4248; The surface 4259 is inclined and the second anti-slip surface 4259 extends substantially along the radial direction of the knob 4245 . The contact between the first sliding surface 4254 and the second sliding surface 4258 is inclined surface contact, and the second sliding surface 4258 presses the first sliding surface 4254 toward the gap 4252, so that the first sliding surface 4254 It is easier to slide relative to the second sliding guide surface 4258 ; and the contact between the first sliding sliding surface 4256 and the second sliding sliding surface 4259 is basically a direct contact, and the second sliding sliding surface 4259 prevents the first sliding sliding surface. The surface 4256 pushes in a direction away from the gap 4252 , so that relative sliding between the first anti-slip surface 4256 and the second anti-slip surface 4259 is unlikely to occur. It can be understood that, in other embodiments, the relative sliding between the first sliding surface 4254 and the second sliding surface 4258 can be made easier by setting different roughness levels on each surface, while the first anti-slip surface 4256 and the Relative sliding between the second anti-slip surfaces 4259 is unlikely to occur. For example, the roughness of the first sliding surface 4254 may be smaller than that of the first sliding surface 4256, and the roughness of the second sliding surface 4258 may be smaller than that of the second sliding surface 4258. The roughness of the anti-slip surface 4258.

Referring to FIG. 23 , when the valve clamp 20 is in the unlocked state, the knob 4245 is rotated in the opposite direction (eg, the direction indicated by the arrow 303 in FIG. 23 ), and the transmission member 4242 drives the mandrel 4241 to move axially toward the distal end (eg, FIG. 23 ). The direction indicated by the arrow 304 in the ), so that the two clamping elements 25 on the valve clamp 20 are relatively opened, that is, the two clamping elements 25 on the valve clamp 20 are spread radially.

Referring to FIG. 24 , when the valve clamp 20 is in the unlocked state, rotate the knob 4245 in a positive direction (eg, the direction indicated by the arrow 305 in FIG. 24 ), and the transmission member 4242 drives the mandrel 4241 to slide axially toward the proximal end (eg, FIG. 24 ). The direction indicated by the arrow 306 in the ), so that the two clamping elements 25 on the valve clamp 20 are relatively closed, that is, the two clamping elements 25 on the valve clamp 20 are relatively close to each other.

Please refer to FIG. 9 , FIG. 11 , and FIG. 12 again. The two gripping control components 428 are located on opposite sides of the housing 422 and the conduit 44 (eg, the central axis of the conduit 44 ), respectively, for controlling the gripping elements on the corresponding sides. 28 and easy to distinguish. The grip control assembly 428 is similar in structure to the locking safety assembly 423 . Each grip control assembly 428 includes a grip wire 4281 and a second lever 4282 . The second control rod 4282 is movably passed through the casing 422 . The gripping wire 4281 is correspondingly connected to the second lever 4282 and the gripping element 28 . The portion of the gripping wire 4281 located between the second control rod 4282 and the gripping element 28 is movably passed through the conduit 44 . It can be understood that the present application does not limit the number of gripping elements 28 and the number of gripping control assemblies 428. In other embodiments, the number of gripping elements 28 may be more than two, and the number of gripping control assemblies 428 may be two More than one, each gripping control assembly 428 controls one gripping element 28 correspondingly.

Referring to FIG. 6 again, each grip line 4281 is U-shaped, and includes a folded section 4283 and two connecting sections 4284 respectively extending from two sides of the folded section 4283 . Please refer to FIG. 13 again, the catheter 44 is provided with four second sub-lumens 444, the proximal end of a connecting section 4284 correspondingly passes through a second sub-lumen 444 and is connected to the corresponding second control rod 4282, and the folded section 4283 is movable The gripping element 28 is connected to the ground.

The grasping wire 4281 adopts a U-shape and is connected to the second control rod 4282 in a way of one cavity and one wire, which can prevent the two connecting sections 4284 of the grasping wire 4281 from intertwining with each other, so that when the grasping wire 4281 is withdrawn, It is smoother and easier, avoiding the risk of pulling and disconnecting wires, and improving safety.

The stroke of the second control rod 4282 should be no less than 2πR×θ/360, where R is the length of the gripping element 28 , and θ is the absolute value of the difference between the first angle and the second angle, so The first angle is the angle between the grasping element 28 and the central axis of the valve clamp 20 (the central axis of the shaft body 213 ) when the grasping elements 28 are relatively close together, and the second angle is the angle between the grasping element 28 when the grasping element 28 is in an orientation. The maximum angle between the gripping element 28 and the central axis of the valve clip 20 after radial deployment. The first angle between the gripping elements 28 and the central axis of the valve clip 20 may be 0 degrees when the gripping elements 28 are relatively close together (or before being released); after the gripping elements 28 are radially deployed (or after being released), the second angle between the gripping element 28 and the central axis of the valve clip 20 may be less than 90 degrees, equal to 90 degrees, or greater than 90 degrees.

Considering the loss of the grip wire 4281 in the second sub-cavity 444, the effective advancing stroke of the second control rod 4282 is preferably set to 2*(2πR*θ/360). For example, before the gripping elements 28 are relatively close together, the free end of the gripping elements 28 corresponds to a perimeter of 13 mm, and the effective stroke of the second control rod 4282 is preferably 25±2 mm. On the one hand, when tightening the gripping elements 28 When the gripping wire 4281 is pulled off or damaged, on the other hand when the gripping element 28 is released, the gripping wire 4281 is not stacked too much.

Please refer to FIGS. 25 and 26 , the grasping control assembly 428 further includes a second sleeve 4285 and a second fixing member 4286 , and the second sleeve 4285 is fixedly accommodated in the housing 422 . The fixing method of the second sleeve 4285 in the housing 422 can be selected from snapping, bonding, screwing, etc., which is not limited here. The second control rod 4282 is movably passed through the second sleeve 4285 . The outer wall of the second control rod 4282 is provided with a third guide portion 4280, and the inner wall of the second sleeve 4285 is provided with a fourth guide portion 4287 (as shown in FIG. 27 ). The third guide portion 4280 and the fourth guide portion 4287 are used for In order to guide the axial movement of the second control rod 4282 relative to the casing 422 , the smoothness of the axial movement of the second control rod 4282 relative to the casing 422 is improved.

In this embodiment, the third guide portion 4280 is a guide bump, the fourth guide portion 4287 is a guide groove formed on the inner wall of the second sleeve 4285, and the proximal end of the second sleeve 4285 is further provided with a guide groove The limit groove 4288 communicates with each other. The limit groove 4288 extends along the circumferential direction of the second sleeve 4285 and has a limit step 4289. The limit groove 4288 is substantially an arc-shaped groove. When the guide protrusion of the second control rod 4282 abuts against the bottom surface of the limiting groove 4288 , the second control rod 4282 cannot move distally relative to the second sleeve 4285 . The starting end surface of the limiting groove 4288 is flush with the wall surface of the third guide portion 4280 , and the limiting step 4289 is located between the ending end surface 4290 of the limiting groove 4288 and the other wall surface of the fourth guide portion 4287 . The limiting step 4289 is used to limit the third guide portion 4280 within the limiting groove 4288 to prevent the third guiding portion 4280 from escaping from the limiting groove 4288 . When the third guide portion 4280 is received in the limiting groove 4288 and abuts against the limiting step 4289 , the gripping wire 4281 is in a straight state, and the gripping wire 4281 pulls the gripping element 28 .

It can be understood that one of the third guide portion 4280 and the fourth guide portion 4287 is a guide groove extending along the axial direction of the second control rod 4282 , and the other is a guide bump, and the guide bump slides through the In the guide groove; the position of the limiting groove 4288 is not limited. It can be understood that the second sleeve 4285 can be omitted, and the second control rod 4282 can be axially moved relative to the housing 422 .

The second fixing member 4286 is fixed to the proximal end of the second control rod 4282 , and the portion of the grasping wire 4281 exposed to the second control rod 4282 is fixed to the proximal end of the second control rod 4282 through the second fixing member 4286 . In this embodiment, the second fixing member 4286 is a nut, the second fixing member 4286 is screwed with the proximal end of the second control rod 4282, and the part of the grasping wire 4281 exposed to the second control rod 4282 is fixedly clamped on the second control rod 4282. Between the inner wall of the fixing member 4286 and the outer wall of the proximal end of the second lever 4282 .

The free ends of the two connecting sections 4284 of the grasping wire 4281 away from the half-folded section 4283 can be wound around the proximal end of the second control rod 4282, and the second fixing member 4286 is screwed on the second control rod 4282, so that the The connecting section 4284 is away from the free end of the folded section 4283 and is fixed by pressing; when the second fixing member 4286 is tightened, the grasping wire 4281 can lift the grasping element by pulling the second control rod 4282 to the proximal end. 28 , so that a leaflet accommodation space is formed between the gripping element 28 and the clamping element 25 . Correspondingly, by pushing the second control rod 4282 to the distal end, the gripping wire 4281 is loosened, and under the elastic action of the gripping element 28, the end of the gripping element 28 connected to the gripping wire 4281 abuts against the gripping element 25, Thereby, the valve leaflet is caught; when the second fixing member 4286 is removed, the free end of one of the connecting segments 4284 of the grasping wire 4281 can be pulled, and the grasping wire 4281 can be removed from the body, so as not to hinder the subsequent valve Release of clip 20.

The material of the gripping wire 4281 can be nickel-titanium wire, stainless steel wire, or high-molecular-weight polymer wire. In this example, a high-strength nickel-titanium wire material is preferred to reduce the risk of wire breakage.

It can be understood that the second fixing member 4236 is not limited to a nut, it can also be a cover body; the second fixing member 4286 can be omitted, and the portion of the grasping wire 4281 that exposes the proximal end of the second control rod 4282 and the second control rod The connection method of the 4282 is not limited. For example, the portion of the grasping wire 4281 that exposes the proximal end of the second control rod 4282 is directly wound around the second control rod 4282, or the portion of the grasping wire 4281 that exposes the proximal end of the second control rod 4282. The end portion is directly fixed on the second control rod 4282 by means of gluing or the like. After the second control rod 4282 is pulled proximally, the grasping wire 4281 is cut, and one of the grasping wires 4281 is pulled again. The grasping wire 4281 can also be removed from the body so as not to hinder the release of the valve clamp 20 .

The movement of the gripping element 28 can be controlled by operating the second lever 4232 to cooperate with the gripping element 25 to grip or release the leaflets. The two gripping control assemblies 428 can be manipulated at the same time. For example, please refer to FIG. 28 . The second lever 4282 of the two gripping control assemblies 428 can be simultaneously operated from the proximal end to the distal end (eg, arrows 307 and 307 in FIG. 28 ). 308) moves, the two gripping wires 4281 are in a relaxed state, and under the action of the gripping element 28 itself, the end connecting the gripping element 28 and the gripping wire 4281 abuts against the gripping element 25, which is convenient for matching the clip The holding element 25 captures the leaflets. For another example, referring to FIG. 29 , the second control rod 4282 synchronously operating the two gripping control assemblies 428 moves from the distal end to the proximal end (eg, in the directions indicated by arrows 309 and 310 in FIG. 29 ), so that each gripping The wire 4281 pulls the corresponding gripping element 28 toward the mandrel 4241, so that an accommodation space (not shown) for accommodating the leaflet is formed between the gripping member 28 and the corresponding clamping member 25, into which the leaflet can enter within the space. It is also possible to individually control the gripping element 28 on one side to capture the dynamic anterior or posterior leaflet. After successfully capturing the unilateral leaflet and adjusting the angle, the other gripping element 28 can be controlled to capture the dynamic anterior leaflet. The posterior leaflet or the anterior leaflet can reduce the difficulty of grasping the valve leaflet, improve the grasping efficiency and the success rate of the operation, for example, please refer to FIG. The distal end (eg, the direction indicated by arrow 311 in FIG. 30 ) moves, and the second lever 4282 of the other grasping control assembly 428 moves from the distal end to the proximal end (eg, the direction indicated by arrow 312 in FIG. 30 ).

Please refer to FIG. 11 and FIG. 12 again, the valve clip delivery device 40 further includes a release control assembly 432 for clamping and fixing the anterior leaflet and the posterior leaflet of the mitral valve in the valve clip 20. After the double-hole treatment is completed, the valve clip 20 Free from mandrel 4241.

Please refer to FIGS. 31 and 32 , the release control assembly 432 includes a core rod 4322 , a one-way gear 4324 and a safety switch 4326 . The core rod 4322 is movably passed through the transmission member 4242 and is fixedly connected with the proximal end of the core shaft 4241 . The one-way gear 4324 only allows the mandrel 4322 to drive the mandrel 4241 to rotate in one direction, so as to release the connection between the mandrel 4241 and the shaft body 213 of the valve clamp 20 , so that the valve clamp 20 is separated from the mandrel 4241 .

In this embodiment, the distal end of the mandrel 4241 is screwed with the proximal end of the shaft body 213 . The distal end of the core rod 4322 is provided with at least a first rotation stop surface 4332, the inner wall of the one-way gear 4324 is provided with a second rotation stop surface 4334 corresponding to the first rotation stop surface 4332, the first rotation stop surface 4332 and the second rotation stop surface 4334 cooperate to prevent the relative rotation between the one-way gear 4324 and the core rod 4322.

The transmission member 4242 is provided with a shaft hole 401 along the axial direction, and the core rod 4322 passes through the shaft hole 401 . The outer wall of the transmission member 4342 is provided with a connecting hole 403 communicating with the shaft hole 401 . The safety switch 4326 passes through the connection hole 403 .

The disengagement control assembly 432 includes a first state and a second state; when the disengagement control assembly 432 is in the first state, the safety switch 4326 abuts against the core rod 4322, and the core rod 4322 is connected with the transmission member 4242 as a whole; the disengagement control assembly 432 In the second state, the safety switch 4326 is separated from the mandrel 4322 , and the mandrel 4322 is driven to rotate in one direction relative to the transmission member 4242 , thereby driving the distal end of the mandrel 4241 to escape from the valve clamp 20 .

The release control assembly 432 further includes an elastic member 4328 , and the elastic member 4328 extends in the axial direction and is held between the core rod 4322 and the transmission member 4242 . In this embodiment, the elastic member 4328 is sleeved on the core rod 4322 and accommodated in the shaft hole 401 .

The release control assembly 432 also includes a release knob 4329 , which is fixed to the proximal end of the core rod 4322 to facilitate the rotation of the core rod 4322 .

When the release control assembly 432 needs to be switched from the first state to the second state, the safety switch 4326 is lifted away from the mandrel 4241 (for example, the direction indicated by the arrow 313 in FIG. 33 ), and the safety switch 4326 is separated from the mandrel 4322 . When the release control assembly 432 is in the second state, the release knob 4329 can be rotated unidirectionally (for example, the direction indicated by the arrow 314 in FIG. 33 ), the transmission member 4242 is stationary relative to the housing 422, and the release knob 4329 drives the core rod 4322 and the core shaft 4241 The relative transmission member 4242 rotates. Once the distal end of the mandrel 4241 is released from the shaft body 213 of the valve clip 20, the pre-compressed elastic member 4328 will automatically pop open, and the mandrel 4322 and the mandrel 4241 will be driven to retreat proximally (for example, in the direction indicated by the arrow 315 in FIG. 33 ). , indicating that the screw connection between the distal end of the mandrel 4241 and the shaft body 213 of the valve clip 20 has been released, and the valve clip 20 has been released.

When the release control assembly 432 needs to be switched from the second state to the first state, press down the safety switch 4326 to make the safety switch 4326 abut against the core rod 4322, and the safety switch 4326 and the core rod 4322 abut to form a whole, the transmission member 4242 Axial movement can drive the mandrel 4241, the mandrel 4322, etc. to move synchronously.

Since the release control assembly 432 is provided with the safety switch 4325, the connection between the mandrel 4241 and the valve clamp 20 can be released only after the safety switch 4325 is pulled up (that is, when the release control assembly 432 is in the second state), which prevents misoperation, The function of preventing the valve clip 20 from being released unexpectedly increases the safety of the operation. The one-way gear 4324 only allows the mandrel 4322 to drive the mandrel 4241 to rotate in the direction of releasing the screw connection, so that the mandrel 4341 can be disengaged efficiently.

As shown in FIG. 1 , FIG. 7 , and FIG. 17 , the valve clip delivery device 40 further includes an adjustable sheath 60 . The adjustable sheath 60 includes a bending handle 62 and is connected to the bending handle 62 and is controlled by the bending handle 62 . Correspondingly curved sheath 64 . The catheter 44 is movably passed through the sheath tube 64 , so that the distal end of the catheter 44 can conform to the bending of the distal end of the sheath tube 64 to be correspondingly bent, so as to conform to the curved intervention path. The adjustable sheath 60 also includes a connecting tube 66 connected to the bending handle 62 . The connecting tube 66 is movably sleeved outside the catheter 44 and extends into the housing 422 , and the connecting tube 66 is detachably connected to the housing 422 . In this embodiment, the connecting pipe 66 and the casing 422 are detachably connected by the installation member 68 , which is preferably a claw screw, and the installation member 68 can fix or release the connection between the connecting pipe 66 and the casing 422 . , in the unfixed state, the distance between the valve clip 22 and the distal end of the adjustable sheath 60 can be adjusted by pushing and pulling the connecting tube 66, so that the valve clip 20 can reach the predetermined position; after the adjustment, the installation member 68 can be used to fix Tube 66 is attached to maintain valve clip 20 in place. It can be understood that the application does not limit the mounting member 68 to be a claw screw, and it can also be other types of mounting member, which can realize the detachable connection between the connecting pipe 66 and the housing 422 .

The working process of the valve clamping system 100 is briefly described below. The valve clip 20 is delivered transcatheterly by a valve delivery device 40 to the vicinity of the patient's mitral valve.

In the initial state, the first control rod 4232 is pushed forward (toward the distal end) so that the valve clamp 20 is kept in a self-locking state, and the two second control rods 4282 are both pulled back proximally and limited, so that the two grasping The elements 28 are in a relatively close state; the safety switch 4326 is in abutment with the core rod 4322 , and the transmission member 4242 and the core rod 4322 are integrally formed. The operator adjusts the bending degree of the sheath tube 64 through the bending handle 62, the catheter 44 inserted in the sheath tube 64 conforms to the sheath tube 64, and the valve clip 20 is delivered to a predetermined position near the patient's mitral valve.

The first control rod 4232 is driven to move toward the proximal end, and the valve clip 20 is switched from the self-locking state to the unlocking state, that is, the self-locking of the valve clip 20 is released through the locking control safety component 423 . The first guide portion 4230 is accommodated in the limiting groove 4238 and abuts against the limiting step 4239 to keep the valve clip 20 in the unlocked state.

The clamping elements 25 of the valve clamp 20 are then controlled to open by the clamping control assembly 424, eg, rotating the knob of the clamping control assembly 424 in the opposite direction (eg, in the direction indicated by arrow 303 in FIG. 23) so that the two clamping elements 25 is relatively open.

Then, the grasping element 28 is controlled by the grasping control assembly 428 to capture the valve leaflet between the clamping element 25 and the grasping element 28. For example, referring to FIG. 30, a second control rod 4282 can be pushed forwardly distally. , to capture one leaflet; and then push the other second control rod 4282 distally to capture the other leaflet.

Next, the anterior and posterior leaflets of the mitral valve are clamped together by controlling the two clamp elements 25 to close by the clamp control assembly 424, eg, rotating the clamp in the forward direction (eg, in the direction indicated by arrow 305 in FIG. 24 ). The knob 4245 of the control assembly 424 is held so that the two clamping elements 25 are closed to clamp the leaflets.

Once the leaflets of the mitral valve are brought together edge-to-edge, the first fixation member 4236 is removed and the locking wire 4231 is withdrawn from the body, and the second fixation member 4286 is removed and the grasping wire 4281 is withdrawn out of the body.

The operator pulls up the safety switch 4326 (for example, the direction indicated by the arrow 313 in FIG. 33 ), separates the safety switch 4326 from the core rod 4322, and rotates the release knob 4329 of the release control assembly 432 (for example, the direction indicated by the arrow 314 in FIG. 33 ), The connection between the mandrel 4241 and the shaft body 213 of the valve clip 20 is released, the valve clip delivery device 40 is withdrawn from the body, and the valve clip 20 remains at the valve to achieve "edge-to-edge repair" of the mitral valve.

It can be understood that the valve clamping system 100 of the present application can also perform edge-to-edge repair on the tricuspid valve in a transcatheter manner.

The above are only preferred embodiments of the present application, and do not limit the present application in any form. Although the present application has been disclosed above in preferred embodiments, it is not intended to limit the present application. Any person skilled in the art, without departing from the scope of the technical solution of the present application, can use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solution of the present application, or be modified into equivalents of equivalent changes. implementation. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present application without departing from the content of the technical solutions of the present application still fall within the protection scope of the technical solutions of the present application.

Claims (20)

1. a valve clip delivery device, for delivery and control valve clip, described valve clip comprises at least two relatively open and closed clamping elements, and described valve clip is provided with self-locking mechanism, it is characterized in that, described valve The clip delivery device includes a handle and a catheter, the handle includes a housing, a clamping control component and a locking control safety component, the proximal end of the catheter is fixedly connected to the distal end of the housing, and the clamping control component is connected to the The lock-control safety components are all arranged on the housing, and the lock-control safety components are connected to the self-locking mechanism for controlling the valve clip to switch between the unlocked state and the self-locking state. A control assembly is used to control the opening or closing of the at least two clamping elements when the valve clamp is in the unlocked state. 2 . The valve clip delivery device according to claim 1 , wherein the lock control safety component comprises a lock control wire and a first control rod, and the first control rod is movably penetrated through the casing, so that the The locking control wire is connected to the first control rod and the self-locking mechanism, and the part of the locking control wire located between the first control rod and the self-locking mechanism is movably passed through the conduit; The first control rod drives the locking wire to move relative to the housing from the distal end to the proximal end, so that the valve clamp is switched from the self-locking state to the unlocking state. 3 . The valve clip delivery device according to claim 2 , wherein the locking wire comprises a half-folded section and two connecting sections respectively extending from both sides of the half-folded section, and two second sections are arranged in the catheter. 4 . A sub-chamber, a proximal end of the connecting section correspondingly movably passes through a first sub-chamber and is connected to the first control rod, and the half-folding section is movably connected to the self-locking mechanism. 4 . The valve clip delivery device according to claim 2 , wherein the lock control safety component further comprises a first sleeve, the first sleeve is fixedly accommodated in the housing, and the first control The rod is movably passed through the first sleeve, the outer wall of the first control rod is provided with a first guide portion, the inner wall of the first sleeve is provided with a second guide portion, and the first guide portion One of the second guide parts is a guide groove extending along the axial direction of the first control rod, and the other is a guide bump, and the guide bump slides through the guide groove . 5 . The valve clip delivery device according to claim 4 , wherein the guide groove is provided on the inner wall of the first sleeve, and the first sleeve is further provided with the guide groove. 6 . A limit groove that communicates with each other, the limit groove extends along the circumferential direction of the first sleeve and has a limit step, and the guide protrusion is accommodated in the limit groove and abuts against the limit step , the valve clamp remains unlocked. 6 . The valve clip delivery device according to claim 2 , wherein the locking wire is made of at least one of ultra-high molecular weight polyethylene, nickel-titanium alloy, and stainless steel. 7 . 7. The valve clip delivery device according to claim 2, wherein the stroke range of the linear motion of the first control rod relative to the housing is [9, 13] mm. 8. The valve clip delivery device of claim 1, further comprising at least two gripping control assemblies, the valve clip further comprising at least two gripping elements, each The grasping control components all include a grasping wire and a second control rod, the second control rod is movably penetrated through the casing, and the grasping wire is correspondingly connected to the second control rod and the grasping element , the part of the grasping wire located between the second control rod and the grasping element is movably penetrated in the conduit; the at least two grasping control components are used to control the at least two The gripping elements are relatively close together or spread out radially. 9 . The valve clip delivery device according to claim 8 , wherein each of the grasping lines comprises a half-folded section and two connecting sections respectively extending from both sides of the half-folded section, and the inner tube of the catheter At least four second sub-chambers are provided, the proximal end of one of the connecting segments is correspondingly movable through a second sub-chamber and is connected to the corresponding second control rod, and the half-folded segments are movably connected to the gripping element . 10. The valve clip delivery device of claim 8, wherein the at least two gripping control assemblies are located on opposite sides of the housing and the catheter, respectively. 11. The valve clip delivery device of claim 8, wherein the stroke of the second lever is greater than or equal to 2πR×θ/360, wherein the R is the length of the gripping element, and the The θ is the absolute value of the difference between the first angle and the second angle, and the first angle is the distance between the grasping element and the central axis of the valve clamp when the grasping element is relatively close to each other The second angle is the maximum angle between the gripping element and the central axis of the valve clamp after the gripping element is radially deployed. 12. The valve clip delivery device according to claim 1, wherein the clamping control assembly comprises a mandrel and a transmission member, the distal end of the mandrel is detachably connected to the valve clip, and the core The proximal end of the shaft passes through the guide tube and is connected with the transmission member, and the transmission member is slidably connected with the housing in the axial direction; in the unlocked state, the transmission member drives the mandrel along the shaft. Axial sliding causes the at least two gripping elements of the valve clip to open or close relative to each other. 13. The valve clip delivery device according to claim 12, wherein the clamping control assembly further comprises a fixed force gear and a knob for driving the fixed force gear to rotate, the fixed force gear being screwed to the On the transmission part, the knob is sleeved on the fixed force gear; When the knob rotates in the forward direction and the driving force of the knob to the fixed force gear is less than the preset force value, the knob drives the fixed force gear to rotate in the forward direction synchronously, so that the transmission member is relatively opposite to the casing. The body slides toward one end in the axial direction; when the knob rotates in the positive direction and the driving force of the knob to the fixed force gear is greater than or equal to the preset force value, the knob rotates independently relative to the fixed force gear ; When the knob rotates in the opposite direction, the knob drives the constant force gear to rotate in the opposite direction synchronously, so that the transmission member slides toward the opposite end in the axial direction relative to the housing. 14 . The valve clip delivery device according to claim 13 , wherein the fixed force gear comprises a wheel body and a plurality of toothed arms protruding from the outer wall of the wheel body and arranged at intervals in the circumferential direction, 14 . The inner wall of the knob is circumferentially provided with a plurality of stop parts matched with the plurality of tooth arms; the preset force value is applied to the knob when the tooth arms relatively slide over the stop parts. The value of the force acting on the constant force gear. 15. The valve clip delivery device according to claim 14, wherein one end of the toothed arm is fixedly connected to the outer wall of the wheel body, the other end of the toothed arm is a free end, and the other end of the toothed arm is a free end. At least part of the outer wall extends along the circumferential direction of the wheel body, and a gap is formed between at least part of the outer wall of the toothed arm and the outer wall of the wheel body. 16. The valve clip delivery device according to claim 15, wherein the free end of the tooth arm comprises a first sliding surface and a first anti-slip surface opposite to the first sliding surface, so The stop part of the knob includes a second sliding surface and a second sliding surface opposite to the second sliding surface; when the knob rotates in the forward direction, the first sliding surface and the second sliding surface are opposite to the second sliding surface. The two guide sliding surfaces are in contact; when the knob is rotated in the opposite direction, the first anti-slip surface is in contact with the second anti-slip surface. 17. The clip delivery device of claim 12, further comprising a disengagement control assembly coupled to the proximal end of the mandrel, the disengagement control assembly for enabling the The mandrel is released from the valve clip. 18. The valve clip delivery device according to claim 17, wherein the distal end of the mandrel is screwed with the valve clip, and the release control assembly comprises a mandrel, a one-way gear and a safety switch, the The core rod is inserted into the transmission member and is fixedly connected with the proximal end of the core shaft, and the one-way gear is fixedly sleeved on the core rod and accommodated in the transmission member; The disengagement control assembly includes a first state and a second state; when the disengagement control assembly is in the first state, the safety switch is abutted against the core rod, and the core rod is connected with the transmission member to form a The whole; when the release control assembly is in the second state, the safety switch is separated from the core rod, and the core rod rotates unidirectionally relative to the transmission member, thereby driving the distal end of the core shaft to disengage the valve clip. 19 . The valve clip delivery device according to claim 18 , wherein the release control assembly further comprises an elastic member, the elastic member extends in the axial direction and abuts against the core rod and the transmission member. 20 . between. 20. The valve clip delivery device according to claim 1, further comprising an adjustable sheath, the adjustable sheath comprising a bending handle and connected to and controlled by the bending handle And the sheath tube with corresponding bending occurs, and the catheter is movably penetrated in the sheath tube; The adjustable sheath also includes a connecting pipe connected to the bending handle, the connecting pipe is movably sleeved outside the catheter and extends into the casing, and the connecting pipe is detachably connected to the casing .

Images