WO2021082822A1

WO2021082822A1 - Adjustable valve clipping system

Info

Publication number: WO2021082822A1
Application number: PCT/CN2020/117250
Authority: WO
Inventors: 张庭超; 王泽涛; 张伟伟; 郑贤章
Original assignee: 杭州德晋医疗科技有限公司
Priority date: 2019-10-30
Filing date: 2020-09-23
Publication date: 2021-05-06

Abstract

An adjustable valve clipping system comprises a delivery device (300) and a valve clip. The valve clip comprises a main body (100) and a clip adjustment mechanism (200). The main body (100) comprises a retaining base (10), a near end clip member (30), and a far end clip member (20). The retaining base (10) is used to connect the delivery device (300) so as to enable delivery of the main body (100) by the delivery device (300), and the near end clip member (30) and the far end clip member (20) engage so as to clip a valve tissue. The clip adjustment mechanism (200) is located between the delivery device (300) and the retaining base (10), and comprises an adjustment member (40) capable of sliding along an axial direction and sleeving onto the retaining base (10). When the main body (100) is closed, the adjustment member (40) presses against the near end clip member (30), so as to adjust a pulling strength of the main body (100) on the valve tissue. The invention ensures sufficient a holding force of the main body (100) to prevent loosening, and adjusts the pulling strength of the main body (100) on the valve tissue by means of the clip adjustment mechanism (200).

Description

Adjustable valve clamping system

Technical field

This application relates to the field of medical devices, and in particular to an adjustable valve clamping system.

Background technique

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

There is a minimally invasive surgical operation, which is based on the principle of valve edge-to-edge surgery. The valve clamp is delivered to the mitral valve through an interventional catheter, and then the anterior leaflet and the mitral valve are clamped by the relative opening of the clamp. The posterior leaflet makes the anterior leaflet and the posterior leaflet of the mitral valve fixed together, so as to achieve the purpose of narrowing the leaflet gap and reducing mitral valve regurgitation. However, due to the differences in the physiological structure of the mitral valve in different patients and the severity of mitral valve regurgitation, the distance between the anterior and posterior mitral valve leaflets of different patients is quite different. For patients with a large distance between the anterior and posterior leaflets of the mitral valve, if in order to reduce the difficulty of clamping the valve leaflets, a valve clamp with a longer arm is used to force the clamping. When the clamp is closed, the anterior and posterior leaflets If they are forcibly pulled toward each other and fixed together, it is easy to pull the valve leaflets too much, which may lead to serious consequences of abnormal valve leaflet function, loss of clamps or even leaflet tear.

The prior art discloses a solution for adding a polymer elastic body to the aligning forceps arms, and the degree of pulling of the valve leaflets by the valve clamp is adjusted by the presence of the elastic body. However, because the valve leaflets are sticky and slippery and always in a pulsating state, when the valve leaflets are clamped by the cooperation between the rigid forceps arm and the elastic body, the clamping force may be insufficient, causing the valve clamp to easily slip off; and, for For patients with small leaflet spacing, because of the presence of elastomers, the leaflets may be unsatisfactory after closure, and mitral valve regurgitation may not be adequately treated.

Summary of the invention

In view of this, the present application provides an adjustable valve clamping system. When the valve clamp clamps the valve tissue, it has sufficient clamping force to avoid slippage, and the pulling of the valve tissue when clamped can be adjusted as needed. degree.

To solve the above technical problems, the present application provides an adjustable valve clamping system, including a pushing device and a valve clamp. The valve clamp includes a clamp body and a clamp adjustment mechanism. The clamp The main body includes a fixing base, a distal clip that can be opened and closed relative to the fixing base, and a proximal clip disposed between the fixing base and the distal clip; the fixing base is detachably connected to The pushing device is used to push the clip body through the pushing device, the distal clip piece cooperates with the proximal clip piece to clamp the valve tissue; the clip adjusting mechanism is located between the pushing device and the Between the fixing seats, the clamp adjusting mechanism includes an adjusting member that can be slid in the axial direction to be sleeved on the fixing seat; when the main body of the clamp is folded, the adjusting member abuts against the proximal end Clip to adjust the degree of traction of the valve tissue by the clip body.

In the adjustable valve clamping system provided by the present application, the main body of the clamp clamps the valve tissue through the cooperation of the proximal and distal clamps, which can ensure that the main body of the clamp has sufficient clamping force to avoid slippage; , When necessary, the adjusting member is driven to slide by the clip adjusting mechanism to be sleeved on the fixing seat to abut against the proximal clip of the clip body in the collapsed state, so as to adjust the traction of the clip body to the valve tissue. It can effectively treat the mitral valve regurgitation in patients with large leaflet spacing.

Description of the drawings

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

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

Figure 2 is a schematic diagram of mitral valve disease.

Fig. 3 is a schematic diagram of the connection between the valve clamp and the pushing device provided by the first embodiment of the present application.

Fig. 4 is a schematic diagram of the adjusting member of the valve clamp in Fig. 3 being released to the fixing seat.

Fig. 5 is a schematic diagram of the valve clamp in Fig. 4 when it is in a folded state.

Fig. 6 is a three-dimensional structural diagram of the fixing seat of the valve clamp in Fig. 3.

FIG. 7 is a schematic diagram of the three-dimensional structure of the proximal clip of the valve clip in FIG. 3.

Fig. 8 is a schematic diagram of the use state of the valve clamp in Fig. 5 when the valve clamp is implanted in a patient with a large leaflet spacing.

Fig. 9 is a schematic diagram of the mitral valve when the heart is contracted after the valve clamp in Fig. 8 clamps the leaflets.

Fig. 10 is a schematic diagram of the mitral valve during diastole after the valve clamp in Fig. 8 clamps the valve leaflets.

FIG. 11 is a three-dimensional schematic diagram of a part of the structure in FIG. 3.

Fig. 12 is a schematic view of the three-dimensional structure of the connector in Fig. 11.

FIG. 13 is a schematic diagram of the three-dimensional structure of the adjusting member in FIG. 11.

Fig. 14 is a partial three-dimensional structural diagram of the pushing device of the valve clamping system provided by one of the embodiments of the present application.

Fig. 15 is a cross-sectional view of the pushing device of Fig. 14.

Figures 16 to 20 are schematic diagrams of the use process of the valve clamp.

21 is a schematic diagram of the structure of the valve clamp body and the adjusting member of the valve clamp provided by the second embodiment of the present application.

Fig. 22 is a schematic structural diagram of an adjusting member of a valve clamp provided by a third embodiment of the present application.

23 and 24 are schematic diagrams of other embodiments of the adjusting member in FIG. 22.

Detailed ways

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

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

In the description of this application, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the end parallel to the medical treatment. The direction of the connection between the center of the distal end and the center of the proximal end of the instrument. The above definition is only for the convenience of presentation, and cannot be construed as a limitation on the application.

3 to 5, the first embodiment of the present application provides an adjustable valve clamping system, including a valve clamp and a push device for conveying the valve clamp, the valve clamp includes a valve for clamping The clamp main body 100 holding the valve tissue and the clamp adjustment mechanism 200 for adjusting the degree of pulling of the valve tissue by the clamp main body 100. The clip body 100 includes a fixing base 10, a distal clip 20 that can be opened and closed relative to the fixing base 10, and a proximal clip 30 disposed between the fixing base 10 and the distal clip 20. The fixing base 10 is detachably connected to the pushing device 300 to push the clip body 100 through the pushing device 300. The distal clip 20 and the proximal clip 30 cooperate to clamp valve tissue. The clip adjusting mechanism 200 is located between the pushing device 300 and the fixing base 10. The clip adjusting mechanism 200 includes an adjusting member 40 that can be slid in the axial direction to be sleeved on the fixing base 10. When the clip main body 100 is folded, The adjusting member 40 abuts the proximal clip 30 to adjust the pulling degree of the valve tissue by the clip body 100.

In this embodiment, the number of the distal end clip 20 and the proximal end clip 30 are both two, and the two distal end clips 20 and the two proximal end clips 30 correspond one-to-one to form two clamps. The clamps are arranged symmetrically with respect to the fixed seat 10, and after the valve clamp is implanted in the patient's body, the two clamps can respectively clamp the anterior leaflet and the posterior leaflet of the mitral valve to reduce or treat "mitral valve regurgitation". Each clamp clamps the valve tissue through the cooperation of the proximal clamp piece 30 and the distal clamp piece 20, which can ensure that the clamp body 100 has sufficient clamping force to avoid slippage; furthermore, when necessary, the clamp is clamped The adjusting member 40 of the clip adjusting mechanism 200 can slide to the proximal clip 30 of the clip body 100 that is sleeved on the fixing seat 10 to abut against the proximal clip 30 of the clip body 100 in the collapsed state, which can reduce the traction of the clip body 100 to the valve tissue. The degree of extension can effectively treat the "mitral regurgitation" of patients with large leaflet spacing.

Among them, in order to ensure the safety after implantation, the fixing base 10, the distal end clip 20 and the proximal end clip 30 are all made of biocompatible metal materials, and the metal materials are selected from stainless steel, cobalt alloy, cobalt-chromium alloy, Commonly used metal materials for implantation, such as titanium alloy or nickel-titanium alloy, are preferably stainless steel or cobalt-chromium alloy with relatively high hardness.

Specifically, please refer to FIGS. 3, 4 and 6 together. The fixing base 10 includes a first base 11 at the proximal end, a second base 12 at the distal end, and a first base 11 for transitional connection. The third seat body 13 with the second seat body 12. In this embodiment, the first seat body 11, the second seat body 12, and the third seat body 13 are an integral structure. Obviously, in other embodiments, the first seat body 11, the second seat body 12, and the third seat body 13 may be a non-integral structure.

In this embodiment, the first seat body 11 is a round tube body with both end faces axially penetrating through it. The proximal outer wall of the first seat body 11 is provided with at least one connecting hole 113 communicating with the lumen of the first seat body 11, and the at least one connecting hole 113 is used to detachably connect the fixing seat 10 to the pushing device 300. The outer wall of the distal end of the first seat body 11 is protruded with at least one protrusion 115 whose proximal end surface is inclined, and the at least one protrusion 115 is used to fix the adjusting member 40 sleeved on the fixing base 10. The number of the connecting hole 113 and the number of the bump 115 are both two.

In this embodiment, the second base body 12 has a block structure. The second seat body 12 is provided with an accommodating cavity 14 passing through two opposite sides of the second seat body 12 along a direction perpendicular to the axial direction. A rectangular block 121 protrudes from the other two opposite sides of the second base 12 respectively. The second seat body 12 defines a through hole along the axial direction on the inner wall of the distal end of the accommodating cavity 14, and the axis of the through hole is collinear with the axis of the lumen of the first seat body 11.

In this embodiment, the third seat body 13 is roughly a ladder structure, and the third seat body 13 has a square cross-section along any position perpendicular to the axial direction, and its cross-sectional area gradually increases from the proximal end to the distal end. Increase. The outer periphery of the third seat body 13 includes two opposite planes and two opposite inclined surfaces. The two opposite planes of the third seat body 13 respectively protrude a connecting block 131, and the connecting block 131 is provided with a pin hole.

Further, the third seat body 13 is provided with a through hole (not shown in the figure) along 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 communicated to form a through channel 15.

Please refer to FIGS. 3 to 6 together. The main body 100 of the clipper further includes a push rod 50 which is slidably inserted in the through channel 15 of the fixing base 10 along the axial direction. In this embodiment, the push rod 50 is a round rod body. The proximal end of the push rod 50 is provided with an external thread (not shown in the figure) for connecting with the mandrel (not shown in the figure) of the pushing device 300. The distal end of the push rod 50 is provided with a connecting seat 55. The connecting seat 55 includes two opposite first planes and two connecting surfaces connecting the two first planes. The two connecting surfaces include a curved surface at the distal end and a proximal end. , And a second plane connected with the smooth transition of the curved surface. The opposite ends of the connecting seat 55 are respectively provided with a pair of pin holes passing through the two first planes. The cross-sectional size of the connecting seat 55 parallel to the second plane direction gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 55 is any structure such as a hemisphere, a spherical crown, or a bullet shape, so that the main body of the clipper 100 is easier to push in the body.

Wherein, the push rod 50 and the connecting seat 55 may be an integral structure or a non-integral structure. In this embodiment, the push rod 50 and the connecting seat 55 are an integral structure, and the outer surfaces of the push rod 50 and the connecting seat 55 are smooth, so as to avoid damage to the valve tissue or hook chordae.

Among them, in order to ensure the safety after implantation, the push rod 50 and the connecting seat 55 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt chromium alloy or titanium alloy, and preferably have a higher hardness. Stainless steel or cobalt-chromium alloy.

It should be noted that the accommodating cavity 14 of the fixed seat 10 is provided with a locking member, and the push rod 50 is fixed or unlocked relative to the fixed seat 10 through the locking member. The locking member may be a deformed elastic sheet in the prior art. Since the combination of the steel sheet and the steel sheet has nothing to do with the improvement and creation of the application, it will not be repeated here.

Please refer to FIGS. 3 and 7 together. The proximal clip 30 includes a connecting end 31 and a free end 32 that are oppositely disposed, and the connecting end 31 is fixed relative to the fixing base 10. In this embodiment, the two proximal clips 30 are connected as a whole through a connecting frame 33. The connecting frame 33 is provided with a through hole 34 for the push rod 50 to pass through. The rectangular hole 35 through which the rectangular block 121 on the two seat bodies 12 passes, the connecting frame 33 is sleeved on the outer side of the second seat body 12 and the third seat body 13 to oppose the connecting ends 31 of the two proximal clips 30 Fixed to the fixed seat 10. Obviously, in other embodiments, the connecting end 31 of the proximal clip 30 can be directly fixed to the fixing base 10 by welding, crimping or other connection methods.

The proximal clip 30 is at least partially made of an elastic material with a shape memory function, and is heat-set. In the natural state, the proximal clip 30 extends radially outward with respect to the holder 10, and preferably extends toward the proximal end so as to cooperate with the distal clip 20 to clamp the valve tissue, that is, the two in the natural unfolded state The included angle between the proximal clips 30 should be slightly larger than the included angle between the two distal clips 20, that is, the included angle between the length direction of the proximal clip 30 and the axial direction of the fixing seat 10 is greater than or It is equal to the angle between the distal clip 20 and the fixing base 10 when the distal clip 20 corresponding to the side is fully opened relative to the fixing base 10, so that the free end 32 of each proximal clip 30 is aligned with the corresponding The distal clips 20 are close to each other and have a certain clamping force to provide a more stable clamping force. Specifically, in this embodiment, the angle between the length direction of the proximal clip 30 and the axial direction of the fixing seat 10 ranges from 0 to 150 degrees, that is, in a natural state, the two proximal clips 30 The included angle between them can be up to 300 degrees, and the included angle between the two proximal clips 30 is preferably 240 degrees, more preferably 160-200 degrees.

In this embodiment, the entire proximal clip 30 is made of super-elastic nickel-titanium alloy, so as to provide elastic force for the proximal clip 30 to drive the proximal clip 30 closer to the distal clip 20 to clamp the valve tissue. In addition, in this embodiment, the connecting frame 33 can also be made of an elastic nickel-titanium alloy and the proximal clip 30 integrally formed, so as to reduce the difficulty of the production process, simplify the process flow, and reduce the production cost; in addition, the elastic connection frame 33 is easier to be sleeved on the outside of the second seat body 12 and the third seat body 13.

It should be noted that the free end 32 of the proximal clip 30 is provided with an adjustment wire hole 36 for connecting the adjustment wire (not shown in the figure) of the pushing device 300, and the free end 32 of the proximal clip 30 can extend to the patient through The regulation line outside the body is controlled. In the conveying state, the free end 32 of the proximal clip 30 is tightened by the adjustment wire and fits against the surface of the fixing seat 10; and after the control of the adjustment wire on the free end 32 is released, the proximal clip 30 is released , The proximal clip 30 restores its natural state due to its own elastic memory performance, and presses the valve tissue to the distal clip 20.

Further, the proximal clip 30 also includes a first surface facing the distal clip 20, and a clamping reinforcement member is provided on the first surface to increase the friction between the proximal clip 30 and the valve tissue, thereby improving The clamping force of the clamp body 100 on the valve tissue. Specifically, in this embodiment, the clamping reinforcement is two rows of barbs 37 arranged at intervals on opposite sides of the first surface. The barb 37 can be formed on the proximal clip 30 by an integral molding method, or the barb 37 can be formed of the same or different material as the proximal clip 30 and then connected to the first surface of the proximal clip 30 For example, a nickel-titanium metal wire or a nickel-titanium metal rod can be fixed on the first surface through a sleeve. The root of the barb 37 is connected to the proximal clip 30, and the end of the barb 37 opposite to the root is a dangling end. In the natural unfolded state, the dangling end of the barb 37 faces the distal clip 20. The angle between the extending direction of the barb 37 and the first surface is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clamp on the valve tissue. The suspended end of each barb 37 is a smooth curved surface, so as to avoid damage to the valve tissue.

In other embodiments, the clamping reinforcement may be a structure such as a rib, a boss or other irregularly distributed protrusions protruding on the first surface, or may be a rough surface at least partially covering the first surface or more than a few. A combination of various forms.

Preferably, active drugs can be applied to the proximal clip 30, and at least one opening 38 can also be opened to reduce the weight of the proximal clip 30 and prevent the overweight clip body 100 from falling under the valve tissue for a long time. Slippage or damage to the valve tissue, but also conducive to the crawling and growth of endothelial cells.

Please refer to FIGS. 4 and 5 together. In this embodiment, the clip body 100 further includes a pair of connecting rods 57 disposed opposite each other, and each distal end clip 20 is connected to the push rod 50 through a connecting rod 57 on a corresponding side. At the distal end of the connecting seat 55, when the push rod 50 slides in the axial direction in the through passage 15 of the fixed seat 10, the connecting rod 57 can drive the distal clip 20 to open and close relative to the fixed seat 10.

Specifically, each distal end clip 20 includes a connecting section 21 located at the distal end and a clamping section 22 connected to the proximal end of the connecting section 21. An end of the connecting section 21 that is away from the clamping section 22 is rotatably connected to the fixing base 10. On the connecting block 131 of the third seat 13, the end of the connecting section 21 close to the clamping section 22 is rotatably connected to the proximal end of the connecting rod 57 on the corresponding side, and the distal end of the connecting rod 57 is rotatably connected by means of rotating pins or bolts.于连接座55上。 On the connection seat 55.

As mentioned above, the push rod 50 is unlocked from the fixing base 10 by the locking member in the accommodating cavity 14, and the push rod 50 can slide toward the distal end in the axial direction to move relative to the fixed base 10. As a result, the push rod 50 The connecting seat 55 at the distal end moves relative to the fixing seat 10, and the connecting seat 55 drives the connecting rod 57 to move. Under the pulling of the connecting rod 57, the distal clip 20 can rotate around the pin hole on the connecting block 131 to be relatively fixed. The seat 10 is opened. When the proximal clip 30 between the fixing seat 10 and the distal clip 20 is released, the proximal clip 30 moves closer to the distal clip 20 and cooperates with the distal clip 20 to clamp Hold the valve tissue between the two. After the proximal clip 30 and the distal clip 20 clamp the valve tissue, the push rod 50 is driven to move proximally in the axial direction, and the distal clip 20 is driven to close relative to the holder 10 through the connecting rod 57 until the distal end The clip 20 is completely closed relative to the fixing seat 10, so that the clip body 100 is in a collapsed state, and then the push rod 50 is relatively fixed to the fixing seat 10 by a locking member, so as to prevent the distal clip 20 from being stretched relative to the fixing seat 10. The clip body 100 in the opened and collapsed state falls below the valve.

It can be understood that the connecting seat 55 at the distal end of the push rod 50 moves in the axial direction to drive the connecting rod 57 to move up and down while opening and closing relative to the fixed seat 10, and then the connecting rod 57 drives the distal clip 20 to be fixed relative to the fixed seat 10. The seat 10 opens and closes. This movement structure can realize the opening and closing of the distal end clip 20 relative to the fixed seat 10 in a larger range. In some embodiments, the included angle between the clamping sections 22 of the two distal clips 20 can reach a maximum of 300 degrees, that is, after the distal clips 20 are opened relative to the fixing seat 10, a certain degree of Flip down, so as to facilitate the clamping section 22 to clamp the valve tissue in constant motion, and improve the clamping success rate. In this embodiment, the included angle between the clamping sections 22 of the two distal clamping pieces 20 is preferably 0-240 degrees, more preferably 120-180 degrees.

Preferably, the second surface of the distal clip 20 facing the proximal clip 30 may be provided with a clamping anti-skid structure (not shown in the figure) to enhance the frictional force when the distal clip 20 contacts the valve tissue, thereby providing Stable clamping force, and can prevent the distal end clip 20 from causing damage to the valve tissue. The clamping anti-skid structure may be a protrusion, a groove provided on the second surface, or a gasket made of a biocompatible material with a relatively high friction coefficient and attached to the second surface.

Wherein, the second surface of the distal clip 20 may be a flat surface or a curved surface. Preferably, the second surface is set as a curved surface to increase the contact area between the distal clip 20 and the valve tissue, thereby providing a stable clamping force. Moreover, the second surface of the curved surface forms a receiving groove. When the proximal clip 30 is close to the distal clip 20, the barbs 37 on the first surface of the proximal clip 30 can be received in the receiving groove to compress The valve tissue can minimize the volume of the clip body 100 when it is folded, which is beneficial for delivery in the body.

Further preferably, active drugs can be applied to the second surface of the distal end clip 20, or at least one opening can be opened.

It should be noted that, in order to ensure a stable clamping force and correspond to the size of the valve, the distal clip 20 has a certain size specification. When the length of the distal clip 20 is too long, the distal clip 20 tends to clamp the excessive anterior and posterior leaflets together. When the clip body 100 is closed, the two leaflets are forcibly pulled toward each other and parallel to each other. Fixed together, when the heart beats and the valve leaflets move, because too many valve leaflets are restricted from moving, it is easy to cause abnormal mitral valve function, and may also cause serious consequences such as valve leaflet tear; when the distal clip 20 When it is too short, the clamp body 100 can only clamp a small part of the valve leaflets, which makes the valve leaflets easy to slide out, and the clamping and fixing effect is poor. In this application, the axial length of the distal clip 20, that is, the distance between the connecting section 21 and the clamping section 22, should be greater than or equal to 4 mm, preferably 6-10 mm. The width of the distal clip 20 is too narrow to cause damage to the valve leaflets, and the width of the distal clip 20 is too wide to affect the movement of the valve leaflets. In this application, the width of the distal clip 20, that is, the length of the direction perpendicular to the axial direction of the distal clip 20, should be greater than or equal to 2 mm, preferably 4-6 mm.

The valve clamp provided in this embodiment can be used to reduce or treat "mitral valve regurgitation". Specifically, please refer to FIGS. 8 to 10 together, and place the clip body 100 at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot align normally, so that a corresponding set of proximal clips 30 And the distal clip 20 clamps the edge of the anterior leaflet 1a of the mitral valve, and the other set of corresponding proximal clip 30 and the distal clip 20 clamp the edge of the posterior leaflet 1b of the mitral valve to hold the edge of the mitral valve The positions of the anterior lobe 1a and the posterior lobe 1b that cannot be normally aligned are clamped together. The arrow direction shown in Figs. 9 and 10 is the direction of blood flow. As shown in Figure 9, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are folded, and the positions where the anterior leaflet 1a and the posterior leaflet 1b cannot be properly aligned are partially or completely folded together, and the opening area A of the mitral valve becomes smaller. Or it is completely closed, only a small amount of blood regurgitates from the opening of the mitral valve into the left atrium, which can reduce or treat "mitral valve regurgitation." As shown in Figure 10, when the heart is in diastole, the anterior leaflets 1a and the posterior leaflets 1b are only aligned at the position B sandwiched by the valve clamp 100, and other positions of the anterior leaflets 1a and posterior leaflets 1b are still in normal diastole, so that Blood can enter the left ventricle from the left atrium to ensure the normal circulation of blood.

Wherein, as shown in FIG. 8, in some embodiments, when the valve clamp provided by the present application is used to reduce or treat the "mitral regurgitation" of patients with a large leaflet spacing, the operator will adjust the adjustment piece as needed. 40 is released and placed inside the clip body 100 to adjust the pulling degree of the clip body 100 on the valve leaflets, to avoid excessive pulling of the valve leaflets, resulting in abnormal valve leaflet function, the clip body 100 falling off or even the leaflets Serious consequences of tearing.

Please refer to Figures 3 to 5, in order to effectively treat the "mitral regurgitation" of different patients with different leaflet spacing, the valve clamp is provided with a clamp adjustment mechanism 200, which is located in the pushing device 300 and the fixing seat 10 of the clip body 100. The clamp adjustment mechanism 200 includes a selectively releasable adjustment member 40. When the operator judges that the patient's valve leaflet spacing is reasonable through medical imaging devices such as ultrasound, the adjustment member 40 does not need to be released, and the distal end clip 20 can be used to communicate with the proximal end. The end clip 30 cooperates to clamp the valve tissue, and the clip body 100 is placed in the patient after being folded; when the operator judges that the patient's valve leaflet spacing is too large, the adjusting member 40 is released, and the adjusting member 40 slides to It is sleeved on the fixing base 10, after the clip body 100 holding the valve tissue is folded, the adjusting member 40 is located inside the clip body 100 and abuts against the proximal clip 30 to adjust the pair of the clip body 100 The degree of traction of the valve tissue.

Specifically, please refer to FIGS. 3, 4, 11 to 13 together. The distal end of the pushing device 300 is provided with a connecting piece 60. The pushing device 300 is detachably connected to the fixing base 10 through the connecting piece 60, and the adjusting piece 40 is along the axis. The through holes 41 penetrating through the two ends are opened, and the adjusting member 40 is slidably sleeved on the outside of the connecting member 60 in the axial direction and can be slid along the connecting member 60 to be sleeved on the fixing seat 10.

The connecting member 60 is substantially tubular. The outer wall of the connecting member 60 is provided with at least one sliding rail 61 along the axial direction. The sliding rail 61 is used for guiding the adjusting member 40 sleeved outside the connecting member 60 to slide along the guide rail 61. At least two connecting rods 63 are provided at the distal end of the connecting member 60, and the distal end of each connecting rod 63 is provided with a buckle 65 for detachably connecting with the fixing base 10. In this embodiment, the outer wall of the connecting member 60 is provided with a group of sliding rails 61 axisymmetrically, and the distal end of the connecting member 60 is provided with a group of connecting rods 63 axisymmetrically.

Wherein, the inner surfaces of the two axisymmetric connecting rods 63 opposite to each other are arc surfaces that are smoothly transitioned to the cylindrical surface of the lumen of the connecting member 60, and the arc surface of each connecting rod 63 is aligned with the axis of the connecting member 60. The distance gradually decreases from the proximal end to the distal end, that is, the distal end of each connecting rod 63 is inclined toward the axis of the connecting member 60, and the two connecting rods 63 gradually converge and approach from the proximal end to the distal end.

The connecting rod 63 is made of an elastic material. When the connecting rod 63 is pushed outward in the radial direction of the connecting member 60, the distal end of the connecting rod 63 expands outward. As shown in FIG. 11, the liner 90 of the pushing device 300 is movably inserted into the lumen of the connecting member 60, and the liner 90 is driven to move toward the distal end, and the liner 90 pushes the connecting rod 63 outward in the radial direction to connect The buckle 65 of the rod 63 expands outwards and snaps into the hole 115 of the fixing base 10, so that the pushing device 300 is in a connected state with the fixing base 10 through the connecting piece 60; it can be understood that the liner 90 is retracted to the proximal end and connected Due to the elastic rebound of the rod 63, the distal end of the connecting rod 63 is retracted toward the axial direction of the connecting member 60, the buckle 65 exits the corresponding hole 115, and the connection state of the pushing device 300 and the fixing base 10 is released.

As shown in Figures 3 and 4, the clip adjustment mechanism 200 further includes a driving member 70 and a control wire 80 connected to the adjustment member 40. The driving member 70 is used to drive the adjustment member 40 to slide toward the distal end in the axial direction to control The wire 80 is used to pull the adjusting member 40 to slide toward the proximal end in the axial direction. In this embodiment, the driving member 70 is an elastic member disposed between the pushing device 300 and the adjusting member 40. The elastic member is sleeved on the outside of the connecting member 60, and the proximal end of the elastic member is detachable or non-detachable by welding or clamping. The detachable connection is fixedly connected with the pushing device 300, and the distal end of the elastic member abuts against the adjusting member 40. In this embodiment, the control wire 80 passes through the adjusting member 40 and extends outside the patient's body. When the control wire 80 is pulled in the proximal direction, the control wire 80 drives the adjusting member 40 to slide in the axial direction toward the proximal end, and the elastic member is compressed; when the control wire 80 is released, the elastic member returns to the extended state and pushes the adjusting member 40 along the axial direction Slide toward the distal end to be sleeved on the fixing base 10, specifically the outside of the first base body 11 sleeved on the proximal end of the fixing base 10.

Wherein, the inner diameter of the through hole 41 of the adjusting member 40 is at least 0.02 mm larger than the outer diameter of the first seat body 11, preferably 0.05-2 mm, so that the adjusting member 40 can slide relative to the first seat body 11 under the push of the elastic member.

Among them, the elastic member can be compressed or stretched along the axial direction of the pushing device, and is usually selected from elastic elements such as leaf springs, springs, or bellows. In this embodiment, the elastic member is a spring.

Wherein, the control wire 80 is made of a single wire such as a nickel-titanium wire, a stainless steel wire or a high-strength polymer wire or a plurality of wound wires. In this embodiment, the control wire 80 is a single nickel-titanium wire, and the control wire 80 is arranged in a group and is connected to the adjusting member 40 axisymmetrically, so that the tension on both sides of the adjusting member 40 is balanced, thereby avoiding clamping due to unbalanced tension. The combiner body 100 swings.

Please refer to FIGS. 11 and 13 together. The inner wall of the through hole 41 of the adjusting member 40 is provided with a set of sliding grooves 411 corresponding to the sliding rail 61 of the connecting member 60. When the adjusting member 40 is sleeved on the outside of the connecting member 60, The sliding rail 61 is received in the sliding groove 411, and the adjusting member 40 slides toward the distal end along the sliding rail 61 under the push of the elastic member, or slides toward the proximal end along the sliding rail 61 under the pulling of the control wire 80.

Wherein, the width of the sliding groove 411 is at least 0.02 mm larger than the width of the sliding rail 61, preferably 0.05-3 mm, so as to ensure that the adjusting member 40 can slide along the sliding rail 61.

The adjusting member 40 includes a sleeve portion 42, a supporting portion 43 and a fixing portion 44 in sequence from the proximal end to the distal end. In this embodiment, both the ferrule portion 42 and the support portion 43 are cylindrical, and the diameter of the ferrule portion 42 is smaller than the diameter of the support portion 43, and a stepped surface (not shown in the figure) is formed between the ferrule portion 42 and the support portion 43. Marked). As shown in FIG. 3, the distal end of the elastic member is sleeved on the outside of the sleeve portion 42 and abuts on the step surface to push the adjusting member 40 to slide along the sliding rail 61 toward the distal end.

In other embodiments, the clamping sleeve portion 42 may have the same diameter as the supporting portion 43, the proximal end of the clamping sleeve portion 42 is provided with a circle of clamping grooves on the peripheral side of the through hole 41, and the elastic member is clamped in the clamping groove to The adjusting member 40 is pushed to slide toward the distal end in the axial direction.

The supporting portion 43 defines at least one threading hole 45 for the control wire 80 to pass through. Specifically, in this embodiment, a set of threading holes 45 is formed axisymmetrically at one end of the supporting portion 43 close to the ferrule portion 42, and a set of control wires 80 respectively pass through a corresponding threading hole 45 and then extend outside the patient's body. In other embodiments, a set of threading holes 45 may be opened in other reasonable positions of the supporting portion 43, for example, the middle position of the supporting portion 43 or one end close to the fixing portion 43.

The fixing portion 44 defines at least one fixing groove or at least one fixing hole penetrating the outer wall surface of the fixing portion 44 on the inner wall of the through hole 41, and the fixing groove or the fixing hole is connected to the protrusion 115 of the first seat body 11 of the fixing seat 10 One-to-one correspondence is used to fix the adjusting member 40 sleeved on the fixing base 10. Specifically, in this embodiment, the distal end of the fixing portion 44 is axisymmetrically provided with a set of fixing holes 46 connected to the through holes 41, when the adjusting member 40 is pushed by the elastic member to slide toward the distal end along the sliding rail 61 to the sleeve. When placed outside the first seat body 11, the protrusion 115 of the first seat body 11 snaps into the corresponding fixing hole 46, and the adjusting member 40 is fixed on the fixing seat 10. Wherein, the distal end of the fixing portion 44 may be provided with an inner chamfer on the edge of the through hole 41, so that the protrusion 115 with a beveled proximal surface can be clamped into the corresponding fixing hole 46.

Preferably, the fixing portion 44 is in the shape of an inverted truncated cone, and the diameter of the fixing portion 44 gradually decreases from the proximal end to the distal end, so that the adjusting member 40 is fixed to the fixing seat 10 without affecting the proximal clip 30 and the distal clip. The relative opening and closing between 20 and the fixing base 10 avoids affecting the clamping effect of the main body 100 of the clipper.

Among them, the adjusting member 40 is an elastic structure made of a biocompatible polymer material, preferably made of materials such as dense silica gel. It is understandable that the adjusting member 40 can also be made of elastic porous materials such as sponge.

Please refer to Figure 3, Figure 14 and Figure 15 together. The adjustable valve clamping system provided by this embodiment includes a pusher 300 and the aforementioned valve clamp. The pusher 300 can deliver the valve clamp to the mitral Valve, and adjust the valve clamp to the appropriate position of the mitral valve. The pushing device 300 includes an operating handle and a pushing component. The proximal end of the pushing component is connected with the operating handle, and the distal end of the pushing component is detachably connected with the valve clamp. Specifically, the pushing assembly includes the aforementioned connecting piece 60, a liner 90 movably coaxially sleeved in the lumen of the connecting piece 60, and a mandrel 93 movably coaxially sleeved in the liner 90. The operator can respectively drive the liner 90 and the mandrel 93 to move or rotate relative to each other through an operating handle placed outside the patient's body.

The mandrel 93 is detachably connected to the push rod 50 to drive the push rod 50 to slide along the axial direction of the fixing base 10 so as to drive the distal end clip 20 to open and close relative to the fixing base 10. In this embodiment, the mandrel 93 is a round rod body with an internal threaded hole (not shown in the figure) opened at the distal end, and the internal threaded hole is used for threaded connection with the stud at the proximal end of the push rod 50.

As mentioned above, when the liner 90 is driven to move toward the distal end, the buckle 65 at the distal end of the connecting member 60 can be pushed to expand outward, so that the buckle 65 is locked into the corresponding buckle 113 of the fixing base 10, thereby realizing the connection. The detachable connection between the member 60 and the fixing base 10; withdrawing the liner 90 to the proximal end can release the connection state of the connecting member 60 and the fixing base 10, which will not be repeated here.

In other embodiments, the pushing assembly may not include the liner 90, and the overall diameter of the mandrel 93 or the diameter of the distal end of the mandrel 93 is larger, so that the distal end of the mandrel 93 can directly push against the distal end of the connector 60 The buckle 65 expands outward, that is, the mandrel 93 can be used to push the buckle 65 at the distal end of the connecting member 60 to expand outward, or it can be used to drive the push rod 50 along the axial direction of the fixing seat 10. slide.

14 and 15, in this embodiment, the pushing assembly further includes a pushing catheter 95 and a fixing member 97 arranged at the distal end of the pushing catheter 95, a connecting member 60, a liner 90 and a mandrel 93 that are coaxially fitted together. The fixing member 97 is sleeved in the pushing catheter 95 to push through the pushing catheter 95.

Wherein, the push tube 95 includes an outer layer hose, a braided mesh, and an inner layer tube from outside to inside. The inner layer of hose has a plurality of cavities extending along the axial direction of the push tube 95 in the circumferential direction, and the cavities are used for Silk threads such as the control wire 80 are passed through to extend outside the patient's body. The specific structure of the push catheter 95 is similar to the structure of the existing push catheter, and will not be repeated here.

Further, the pushing device 300 further includes the aforementioned adjustment wire for fixing the free end 32 of the proximal clip 30 to the surface of the fixing base 10, and the adjustment wire extends to the outside of the patient through the cavity of the pushing catheter 95. Among them, the regulating wire can be made of metal or polymer materials such as PTFE.

It should be noted that the pushing component and the valve clamp can be delivered into the patient's body by using the existing adjustable curved sheath.

In other embodiments, the pushing assembly may not include the pushing catheter 95, and the connecting piece 60, the liner 90, and the mandrel 93 with a certain axial length can be directly delivered to the patient through the adjustable curved sheath, the adjustment line and the control line The 80, etc. can also be directly inserted into the adjustable curved sheath and extend back to the patient's body, which will not be repeated here.

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

Step 1: Set the adjusting member 40 on the outside of the connecting member 60, and pull the adjusting member 40 toward the proximal end through the control wire 80, so that the adjusting member 40 compresses the elastic member, and then the pusher assembly and the clamp of the valve clamp The main body 100 is detachably connected, and the free end 32 of the proximal clip 30 is bound to the surface of the fixing base 10 with an adjustment wire. Specifically, as described above, the buckle 65 at the distal end of the connecting member 60 is pushed outward by the liner 90, so that the buckle 65 is locked into the hole 113 of the fixing base 10, so that the fixing base 10 and the pusher The connecting piece 60 of the assembly is in a connected state; the mandrel 93 of the push assembly is rotated to make the mandrel 93 and the push rod 50 screwed and fixed; the mandrel 93 is moved in the proximal direction by the operating handle to drive the push rod 50 to the farther end in the axial direction Sliding in the end direction, the distal end clip 20 is driven to close relative to the fixing base 10, so that the clip body 100 is in a fully collapsed state. At this time, the proximal end clip 30 and the distal end clip 20 are both close to the fixing base 10 The surface, keep the closed state unchanged.

The second step: using the transatrial septum path, the valve clamp 100 connected to it is advanced from the left atrium through the pushing component, and then reaches the left ventricle through the mitral valve, as shown in FIG. 16.

The third step: adjust the relative position of the clip body 100 and the mitral valve, so that the clip body 100 is close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve.

Step 4: Move the mandrel 93 in the proximal direction by operating the handle, thereby driving the push rod 50 to slide in the proximal direction to drive the distal clip 20 to open relative to the fixing base 10 and adjust the direction of the clip body 100 , So that the distal clip 20 is perpendicular to the occlusal line of the mitral valve.

Step 5: Withdraw the entire clip body 100 proximally, so that the distal clip 20 supports the valve leaflet on the left ventricle side, as shown in FIG. 17.

Step 6: Release the restraint of the proximal clip 30 by the adjustment wire, the proximal clip 30 rebounds and expands relative to the holder 10, so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped in the corresponding Between the proximal clip 30 and the distal clip 20, as shown in FIG. 18.

Step 7: Observe through medical imaging such as ultrasound. For patients with a large distance between the front and rear valve leaflets, loosen the control line 80 of the control adjustment member 40 to release the tension on the adjustment member 40. Under the elastic force of the elastic member, the adjustment member 40 slides toward the distal end to be fixed on the fixing seat 10, and the protrusion 115 on the fixing seat 10 is clamped into the fixing hole 46 of the adjusting member 40, as shown in Fig. 19; for patients with a small distance between the front and rear leaflets, there is no need The adjusting member 40 is released, and the compressed state of the elastic member is maintained at this time to prevent the adjusting member 40 from being released.

Step 8: Move the mandrel 93 to the distal direction again, and the mandrel 93 drives the push rod 50 to axially slide to the distal end, thereby driving the distal clip 20 to close relative to the fixing seat 10, until the clip body 100 is completely closed , As shown in Figure 20;

Step 9: Control the rotation of the mandrel 93 by operating the handle to unlock the threaded connection between the mandrel 93 and the push rod 50, and then withdraw the liner 90 and the mandrel 93 to the proximal end until the distal end of the connector 60 is locked. The buckle 65 is unlocked and separated from the hole 115 of the fixing base 10, and the clip body 100 is completely separated from the pushing assembly. Finally, the pushing assembly is withdrawn from the patient's body. At this time, the clip body 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve toward each other to obtain a bi-foramen mitral valve, and complete the edge alignment of the mitral valve. Margin repair. In the case of releasing the adjusting member 40, the adjusting member 40 is released inside the clip body 100 and stays in the patient's body along with the clip body 100, as shown in FIG. 8; for the case where there is no need to release the adjusting member 40, the operator can The adjusting member 40 and the pushing assembly are pulled out of the patient's body together through the control wire 80, and only the clip body 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve.

It is understandable that the valve clamping system of the present application can also use a path such as transapex to deliver the valve clamp to the mitral valve.

The adjustable valve clamping system of the present application can clamp the valve leaflets through the cooperation of the proximal clip 30 and the distal clip 20, and has sufficient clamping force to prevent the clip body 100 from slipping; furthermore, according to The distance between the mitral valve leaflets of the patient can choose to release or not release the adjusting member 40, so as to treat the "mitral regurgitation" of patients with different leaflet distances. When the adjusting member 40 is released and fixed to the fixing seat 10 When the adjusting member 40 is inside the clip body 100 when it is folded, the adjusting member 40 is filled between the anterior and posterior leaflets of the clamped mitral valve, and abuts against the proximal clip 30, which is elastic The adjusting member 40 can be squeezed and deformed following the pulsation of the valve leaflet. The adjusting member 40 generates elastic force to push the part of the valve leaflet close to the adjusting member 40 in the direction away from the fixing seat 10, so that the anterior and posterior leaflets of the mitral valve are between The clamping angle is smaller than the opening angle between the distal clips 20, and the elastic adjustment member 40 has a cushioning effect on the pulsating valve leaflets, thereby reducing the pulling of the clip body 100 on the valve leaflets, so that the clamping The degree of traction of the valve leaflets by the device body 100 is always kept within a reasonable range, which can effectively treat the "mitral regurgitation" of patients with a large leaflet spacing and avoid excessive traction and damage to the valve leaflets; in addition, the adjustment member 40 can Buffers the direct flushing of the inside of the clip body 100 by blood flow, prevents the clip body 100 from being continuously washed off by blood, and also prevents blood from pooling in the dead corners between the proximal clips 30 of the clip body 100 Formation of thrombus.

Please refer to FIG. 21. The structure of the valve clamp provided by the second embodiment of the present application is similar to the structure of the valve clamp in the first embodiment, except that: in the second embodiment, the adjusting member 40, At least one of the proximal clip 30 and the distal clip 20 is covered with a film. Specifically, in this embodiment, the adjusting member 40, the proximal clip 30 and the distal clip 20 are respectively covered with a first film 410, a second covering film 420, and a third covering film 430.

The first covering film 410 completely covers the outer surface of the adjusting member 40, the second covering film 420 at least partially covers the first surface of the proximal clip 30, and the third covering film 430 at least partially covers the second surface of the distal clip 20. surface. Preferably, in this embodiment, the second covering film 420 completely covers the first surface of the proximal clip 30 and extends to completely cover the surface of the proximal clip 30 opposite to the first surface, so that only the proximal clip 30 The barb 37 penetrates the second covering film 420; the third covering film 430 completely covers the second surface of the distal clip 20 and extends to completely cover the surface of the distal clip 20 opposite to the second surface, and covers The third covering film 430 on the two distal clips 20 covers the outer surface of the connecting part of the two distal clips 20 (that is, the part where the connecting seat 55 and the connecting rod 57 are located).

Wherein, the first covering film 410, the second covering film 420, and the third covering film 430 are all fixed by stitching, dipping, bonding, fusion, or binding. In this embodiment, the first covering film 410 and the second covering film 420 are respectively bonded and fixed on the adjusting member 40 and the proximal clip 30, and the third covering film 430 is sutured and fixed on the distal clip 20.

Wherein, the first covering film 410, the second covering film 420, and the third covering film 430 are all made of at least one layer of biocompatible polymer material that is resistant to oxidation and dissolution, and the polymer material is selected from PET, At least one of polyester, PTFE, silicone, silica gel, or urethane. The materials of the first coating 410, the second coating 420, and the third coating 430 may be the same or different. In this embodiment, the first covering film 410, the second covering film 420, and the third covering film 430 are preferably single-layer PET covering films.

Further, the first covering film 410, the second covering film 420, and the third covering film 430 all adopt a two-dimensional sieve structure, a porous film body, a microporous structure, a woven or non-woven mesh structure, a foamed structure, etc. One or more than two structures. In this embodiment, the covering film adopts a mesh structure, the first covering film 410, the second covering film 420, and the third covering film 430 are all provided with multiple meshes, and the first covering film 410, the second covering film 420, and the The opening ratio of the third coating 430 (that is, the percentage of the opening area to the entire coating area) decreases successively. Further, the meshes of the first covering film 410 cannot pass blood and thrombus, and the meshes of the second covering film 420 and the third covering film 430 can pass blood and prevent thrombus from passing through.

In this embodiment, the first covering film 410 can not only increase the biocompatibility of the adjusting member 40, avoid tissue allergies and inflammation, and improve product safety. More importantly, the adjusting member 40 with the first covering film 410 can also It can form an artificial barrier on the atrial side of the valve leaflets to block thrombus in the blood, close the opening of the entire clip body 100 toward the atrial side, and avoid the repeated washing of blood at the internal dead corners of the clip body 100 to form thrombus, thereby avoiding thrombus formation. thrombus.

The second covering film 420 and the third covering film 430 can wrap the metal surface and/or metal sharp edges of the clip body 100, thereby avoiding damage to the clamped valve tissue; further, the second covering film 420 and the third covering The membrane 430 can increase the blocking force during blood circulation, thereby reducing the blood pressure difference between the left atrium and the left ventricle; in addition, the second membrane 420 can also increase the contact area between the proximal clip 30 and the blood, thereby reducing the blood pressure difference between the left atrium and the left ventricle. It buffers the inflowing blood, so as to avoid as far as possible from the inflowing blood impacting the clip body 100 and causing the proximal clip 30 to deform and cause slippage. The third covering film 430 can also enter a very small amount through the second covering film 420. The thrombus inside the clip body 100 is blocked and stays in the clip body 100, preventing the thrombus from entering the left ventricle and entering the blood circulation of the human body to induce stroke.

The opening rate of the third covering film 430 is relatively large, so that the third covering film 430 has good elasticity and elongation. When the distal end clip 20 covered with the third covering film 430 is opened and closed relative to the fixing seat 10, the first The three covering films 430 can follow the opening and closing of the distal end clip 20 to produce corresponding elastic deformations, and the third covering film 430 is always attached to the distal end clip 20.

Preferably, in this embodiment, the mesh holes of the third covering film 430 covering the proximal region (ie, the clamping section 22) of the distal clip 20 are relatively small, and the third covering film 430 in this area is highly dense. Therefore, it is not easy to be worn through by the proximal edge of the distal clip 20 and will not affect the opening and closing of the distal clip 20; and the third membrane covering the distal region of the distal clip 20 (ie the connecting section 21) The pore size of the mesh of the 430 is larger, and the third covering film 430 in this area has better elasticity and elongation. Even in some cases where the opening and closing angles are large, the third covering film 430 close to the fixing seat 10 can follow The opening and closing of the distal end clip 20 are deformed accordingly to ensure that the third covering film 430 is attached and fixed on the distal end clip 20.

Please refer to FIGS. 22 to 24 together. The structure of the valve clamp provided by the third embodiment of the present application is similar to the structure of the valve clamp in the first embodiment, except that: in the third embodiment The adjusting member 40c is a net cage structure made of a biocompatible metal material, and the metal material is selected from stainless steel, nickel-titanium alloy, or cobalt-chromium alloy with certain elasticity. It can also be understood that the adjusting member 40 may also be a net cage structure woven from elastic materials such as nickel-titanium wire, so as to increase the elasticity of the adjusting member 40, thereby improving the adaptability to the valve leaflets, and reducing the loss in the delivery state. Outer diameter. Specifically, the adjusting member 40c of the net cage structure includes a woven net 47, and a connecting pipe 48 and a fixing pipe 49 respectively connected to opposite ends of the woven net 47, and the fixing pipe 49 is used to detachably connect to the fixing base 10. In this embodiment, the fixing tube 49 is axisymmetrically provided with a set of fixing holes 491, and the fixing holes 491 cooperate with the protrusion 115 of the fixing base 10 to clamp the adjusting member 40c on the fixing base 10.

Among them, in order to prevent the adjustment member 40c from being fixed to the fixing seat 10 affecting the relative opening and closing between the proximal clip 30 and the distal clip 20 and the fixing seat 10, thereby affecting the clamping effect of the clip body 100, a mesh is woven. The diameter of the distal portion of 47 gradually decreases from the proximal end to the distal end. As shown in FIG. 22, in this embodiment, the middle of the woven mesh 47 is columnar, the opposite ends are cones, and the cone angles of the cones at both ends are the same. In other embodiments, the woven mesh 47 may have other reasonable shapes, for example, the spindle-shaped structure shown in FIG. 23 with the same taper angle at both ends, or the structure with different taper angles at both ends shown in FIG. 24, as long as the woven mesh 47 The diameter of the distal end portion of the clip is gradually reduced, which does not affect the clamping effect of the clip body 100.

Specifically, when making the adjusting member 40c in this embodiment, firstly, 12-36 nickel-titanium wires with a diameter of 0.05-0.08 mm are wound on the backing rod to form a cylindrical woven mesh 47, and the straight woven mesh One end of 47 is inserted into the connecting tube 48 made of stainless steel tube, and the nickel-titanium wire and the connecting tube 48 are connected by crimping or welding; then the open end of the straight woven mesh 47 is inserted into the shaping mold, and then The open end is wound into a bundle with stainless steel wire; put the woven mesh 47 and the shaping mold into an electric heating circulating air box furnace for shaping heat treatment at 450-650℃ (preferably 500℃) for 12-18 minutes; take it out and cool to room temperature Afterwards, the stainless steel wire is removed, and the shaping mold is taken out to obtain the shaping net; the nickel-titanium wire at the open end of the shaping net is stuffed into the fixed pipe 49 made of stainless steel, and crimping or welding is performed to obtain the adjusting member 40c of the net cage structure.

In this embodiment, the adjusting member 40c of the net cage structure has better elastic deformation ability, can better adapt to the anatomical structure of the mitral valve, and avoid valve leaflet damage caused by excessive pulling of the valve leaflet.

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

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

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

Claims

An adjustable valve clamping system, characterized in that it comprises a valve clamping device and a pushing device for conveying the valve clamping device, the valve clamping device comprising:

A clamp body, which is used to clamp valve tissue;

A clip adjusting mechanism, the clip adjusting mechanism is located between the pushing device and the clip main body, and the clip adjusting mechanism includes a clip that can be slid in an axial direction to be sleeved on the clip The adjusting member of the main body; when the clip main body is folded, the adjusting member presses against the clip main body to adjust the pulling degree of the valve tissue by the clip main body.
The adjustable valve clamping system according to claim 1, wherein the main body of the clamp comprises a fixing base detachably connected to the pushing device, and a distal clamp that can be opened and closed relative to the fixing base. Piece, and a proximal clip provided between the fixing seat and the distal clip, the distal clip cooperates with the proximal clip to clamp the valve tissue; the clip adjuster The mechanism is located between the pushing device and the fixing seat.
The adjustable valve clamping system according to claim 2, wherein a connecting piece is provided at the distal end of the pushing device, and the adjusting piece is provided with through holes extending through both ends in the axial direction, and the pushing device passes through the The connecting piece is detachably connected to the fixing seat, the adjusting piece is sleeved on the outside of the connecting piece, and the adjusting piece slides along the connecting piece to sleeve it on the fixing seat to abut the proximal end Clips.
The adjustable valve clamping system according to claim 3, wherein the clamping device adjustment mechanism further comprises a driving member, and the driving member is used to drive the adjustment member to slide in the axial direction.
The adjustable valve clamping system according to claim 4, wherein the clamping device adjustment mechanism further comprises a control line connected to the adjustment member, and the driving member is arranged between the pushing device and the The elastic member between the adjusting members; pulling the control wire toward the proximal end to drive the adjusting member to slide toward the proximal end in the axial direction, the elastic member is compressed; loosening the control wire, the elastic member extends And pushing the adjusting member to slide toward the distal end in the axial direction to be sleeved outside the proximal end of the fixing seat.
The adjustable valve clamping system according to claim 5, wherein the adjusting member includes a ferrule portion, a supporting portion and a fixing portion in sequence from the proximal end to the distal end, and the distal end of the elastic member is sleeved on The card sleeve part.
The adjustable valve clamping system according to claim 6, wherein the diameter of the ferrule portion is smaller than the diameter of the support portion, and a stepped surface is formed between the ferrule portion and the support portion, The distal end of the elastic member abuts against the step surface.
7. The adjustable valve clamping system according to claim 6, wherein the support portion is provided with at least one threading hole, and the control wire passes through the threading hole.
7. The adjustable valve clamping system of claim 6, wherein the diameter of the fixed portion gradually decreases from the proximal end to the distal end.
The adjustable valve clamping system of claim 6, wherein the fixing portion defines at least one fixing groove or at least one fixing hole penetrating the outer wall surface of the fixing portion on the inner wall of the through hole, and The outer wall of the fixing seat is provided with at least one protrusion, and the protrusion corresponds to the fixing groove or the fixing hole one-to-one to fix the adjusting member sleeved on the fixing seat.
The adjustable valve clamping system of claim 5, wherein the elastic member is sleeved on the outside of the connecting member, and the proximal end of the elastic member is connected to the pushing device.
The adjustable valve clamping system of claim 5, wherein the elastic member can be compressed or stretched along the axial direction of the pushing device.
The adjustable valve clamping system of claim 3, wherein the outer wall of the connecting member is provided with at least one slide rail along the axial direction, and the inner wall of the through hole of the adjusting member is provided corresponding to at least one of the slide rails. At least one chute.
The adjustable valve clamping system according to claim 3, wherein at least two connecting rods are arranged at the distal end of the connecting member, and the distal end of each connecting rod is arranged to be able to communicate with the fixing seat The connected buckle is disassembled, and a clamping hole corresponding to the buckle is opened at the proximal end of the fixing seat.
The adjustable valve clamping system according to claim 14, wherein the connecting rod is made of elastic material, and when the buckle of the connecting rod receives a thrust outward along the radial direction of the connecting member , The buckle of the connecting rod expands outward to be locked into the corresponding hole.
The adjustable valve clamping system of claim 1, wherein the adjusting member is an elastic structure made of a biocompatible polymer material or a metal material.
The adjustable valve clamping system according to claim 16, wherein the polymer material is selected from silica gel or sponge, and the metal material is selected from stainless steel, nickel-titanium alloy, or cobalt-chromium alloy.
The adjustable valve clamping system of claim 16, wherein the adjusting member is a mesh structure, and the mesh structure includes a woven mesh, and connecting pipes respectively connected to opposite ends of the woven mesh And a fixed tube, which is used to detachably connect the valve clamp.
The adjustable valve clamping system according to claim 2, wherein at least one of the adjusting member, the proximal clip and the distal clip at least partially covers the membrane.
The adjustable valve clamping system of claim 19, wherein the adjusting member, the proximal clip and the distal clip respectively cover the first membrane, the second membrane, and the third membrane. Laminated.
The adjustable valve clamping system according to claim 20, wherein the covering membrane adopts a mesh structure, and the opening ratio of the first covering membrane, the second covering membrane and the third covering membrane are successively reduced .