Valve clamping device

Abstract

The invention discloses a valve clamping device which comprises a main body part, a pair of clamping pieces and a clamping piece arranged between the main body part and the clamping pieces, and the clamping pieces are arranged on the outer side of the main body part in a surrounding mode and can be unfolded or closed relative to the main body part with one end as the center. The clamping piece comprises two clamping arms which can be operated to move relative to the clamping piece, the clamping piece and the clamping arms are respectively provided with a bending part, and the bending degree of the bending part of the clamping piece and the bending degree of the bending parts of the clamping arms are matched to clamp the valve leaflet of the valve.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a valve clamping device. Background Art

[0002] Atrioventricular valves such as the mitral valve and the tricuspid valve are one-way valves in the heart. A normal and healthy atrioventricular valve can control the blood flow from the atrium to the ventricle, while preventing the blood from flowing from the ventricle to the atrium. For example, the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, which can control the blood flow from the left atrium to the left ventricle, while preventing the blood from flowing from the left ventricle to the left atrium. Specifically, the mitral valve includes a pair of valve leaflets, namely the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet are opposed to each other, the mitral valve can be completely closed, preventing the blood from flowing from the left ventricle to the left atrium. When there are organic or functional changes in the valve leaflets or their related structures of the mitral valve, the anterior and posterior leaflets of the mitral valve do not oppose well. As a result, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, leading to blood reflux from the left ventricle to the left atrium, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Surgical procedures usually adopt surgical methods such as edge-to-edge suture of the valve to treat mitral regurgitation. However, such surgical procedures have defects such as complex surgical procedures, high surgical costs, high patient trauma, high risk of complications, long hospital stays, and painful patient recovery processes. The interventional valve clamping procedure refers to implanting a valve clamping device into the mitral valve to pull the two originally poorly opposed valve leaflets towards each other, reducing or eliminating the leaflet gap, thereby treating regurgitation.

[0004] In the existing valve clamping devices, the clamping arm structure for clamping the valve leaflets is usually a single straight structure. The clamping area of this structure of the clamping arm is limited by the length of the clamping arm in the axial direction. Therefore, the clamping effect is not ideal, and usually, long spines with a relatively long length need to be provided on the inner clamping arm to assist in anchoring the valve leaflets. The presence of the long spines can cause damage to the valve leaflets and increase the risk of postoperative complications. Summary of the Invention

[0005] In view of this, the present application provides a valve clamping device to solve the problems of stable clamping and reduced damage to the valve leaflets.

[0006] On the one hand, an embodiment of the present application provides a valve clamping device, which includes a main body, a pair of clamping members, and a clamping member disposed between the main body and the clamping members. The clamping members are disposed around the outside of the main body and can be unfolded or closed relative to the main body with one end as the center. The clamping member includes two clamping arms that can be manipulated to move relative to the clamping members. The clamping members and the clamping arms each have a zigzag portion, and the curvatures of the zigzag portions of the clamping members and the clamping arms cooperate to clamp the valve leaflets of the valve.

[0007] In a preferred embodiment, the bent portions of each of the clamping members or the clamping arms each include a convex section and a concave section, and the convex sections and the concave sections on the surfaces of the clamping members opposite to the clamping arms cooperate with each other.

[0008] In a preferred embodiment, the convex sections and the concave sections each include a plurality of them, and the plurality of convex sections and the plurality of concave sections are alternately and continuously arranged, and extend from one end of the clamping member and the clamping arm close to the main body portion in a direction away from the main body portion.

[0009] In a preferred embodiment, each of the convex sections and the concave sections is arc-shaped, and the curvature radii of the arcs of each set of cooperating convex sections and concave sections are the same.

[0010] In a preferred embodiment, the length of the arc of each convex section and concave section is 1 / 4 of the circle where it is located, and the range of the curvature radius of the arc of each convex section and concave section is from 1 / 8 to 1 / 5 of the length of the mating surface of the clamping member and the clamping arm.

[0011] In a preferred embodiment, the plurality of convex sections and concave sections of the clamping member and the clamping arm extend transversely from one width side of the clamping member and the clamping arm to the other side.

[0012] In a preferred embodiment, a friction element is provided on the side of the clamping arm facing the clamping member, and / or a friction element is provided on the side of the clamping member facing the clamping arm, and the height of the friction element in a direction away from the clamping arm or the clamping member is less than the height of the convex section protruding.

[0013] In a preferred embodiment, the clamping member includes a planar portion in the middle and edge portions on both sides of the planar portion, and a plurality of the convex sections and concave sections are provided on both the planar portion and the edge portions. The width of the clamping arm is less than or equal to the width of the planar portion of the clamping member, and the plurality of convex sections and concave sections of the clamping arm extend transversely from one width side of the clamping arm to the other side.

[0014] In a preferred embodiment, the edge portions are higher than the planar portion, so that the cross-section of the clamping member is concavely recessed approximately in a C shape.

[0015] In a preferred embodiment, the main body portion includes a plugging ball, and the side surface of the plugging ball facing the clamping member includes a bent portion cooperating with the clamping member.

[0016] In a preferred embodiment, each of the cooperating bent portions of the clamping member and the clamping arm includes at least one cooperating arc.

[0017] In a preferred embodiment, it further includes a driving part and a control line. The driving part is used to drive the clamping member to expand or close, and the control line is used to manipulate and control the movement of the clamping arm relative to the clamping member.

[0018] Compared with the prior art, the clamping member and the clamping arm of the present application each have a zigzag portion, and the curvatures of the zigzag portion of the clamping member and the zigzag portion of the clamping arm cooperate to clamp the leaflets of the valve. In this way, the soft leaflets can be adapted to be clamped between the zigzag portions, and the cooperating zigzag portions clamp the leaflets like anchoring elements. Thus, the long spines on the clamping arm in the prior art can be avoided, or the requirements for the long spines can be minimized. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0020] Figure 1 It is a schematic three-dimensional structure diagram of a valve clamping device provided by the first embodiment of the present invention.

[0021] Figure 2 is Figure 1 a front structure diagram of the valve clamping device in

[0022] Figure 3 is Figure 1 a schematic three-dimensional structure diagram of the clamping member in

[0023] Figure 4 is Figure 3 a side view of the clamping member in

[0024] Figure 5 is Figure 1 a schematic three-dimensional structure diagram of the clamping member in

[0025] Figure 6 is Figure 1 a schematic diagram of the effect of the valve clamping device in

[0026] Figure 7 is Figure 1 a schematic three-dimensional structure diagram of the clamping member with a friction element added in

[0027] Figure 8 It is a schematic three-dimensional structure diagram of the clamping member in another variant embodiment.

[0028] Figure 9Schematic perspective view of the clamping member of yet another modified embodiment.

[0029] Figure 10 Schematic perspective view of the clamping member of a further modified embodiment.

[0030] Figure 11 Is Figure 1 Schematic perspective view of the clamping member in with a friction element added to the clamping member.

[0031] Figure 12 Schematic perspective view of the clamping member of another modified embodiment.

[0032] Figure 13 Schematic perspective view of the clamping member of another embodiment.

[0033] Figure 14 Is Figure 1 Schematic view of a wire threading method of the clamping member of .

[0034] Figure 15 Is Figure 14 Schematic view of a wire threading method of the clamping member of another modified embodiment of .

[0035] Figure 16 Is Figure 1 Schematic view of another wire threading method of the clamping member of .

[0036] Figure 17 Schematic perspective view of the valve clamping device provided by the second embodiment of the present invention.

[0037] Figure 18 Is Figure 17 Schematic perspective view of the clamping member of .

[0038] Figure 19 Is Figure 18 Schematic view of the effect of the clamping member cross-section supporting the valve leaflet of .

[0039] Figure 20 Schematic perspective view of the valve clamping device provided by the third embodiment of the present invention.

[0040] Figure 21 Front view structure schematic of a modified embodiment of the valve clamping device.

[0041] Figure 22 Schematic view of the state when the valve clamping device provided by the embodiment of the present invention is applied to the treatment of mitral valve.

[0042] Figure 23 Is Figure 22 Schematic view of the state when the valve clamping device of closes to clamp the valve leaflet.

[0043] Figure 24 Yes Figure 23 Schematic diagram of the state where the valve clamping device is separated from the delivery device.

[0044] The following specific embodiments will further illustrate the present application in conjunction with the above-mentioned drawings. Specific Embodiments

[0045] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present application.

[0046] First of all, it should be noted that in the field of interventional medicine, along the delivery path of the instrument, the end of the instrument closer to the operator is usually referred to as the proximal end, and the end of the instrument farther from the operator is referred to as the distal end. Specifically, for a delivery device used to deliver and release an implantable device into a patient's body, the distal end refers to the end where the delivery device can be freely inserted into an animal or human body, and the proximal end refers to the end where the delivery device is operated by a user or a machine. The direction of the rotation center axis of a column, a tube, or the like is defined as the axial direction, the circumferential direction is the direction around the axis of a columnar object such as a column or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius), and the radial direction refers to the direction along the diameter or radius. Among them, the axial direction, the circumferential direction, and the radial direction together constitute three orthogonal directions of the columnar object. It should be noted that regardless of the "end" in words such as "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "both ends", "free end", "upper end", "lower end", etc., it not only refers to the end, the end point, or the end face, but also includes the part that extends a certain axial distance and / or radial distance on the element to which the end, the end point, or the end face belongs from the end, the end point, or the end face. The above definitions are only for convenience of description and should not be construed as a limitation to the present application.

[0047] It is understood that the terms in the description, claims and the above-mentioned drawings of this application are only for describing specific embodiments and are not intended to limit this application. The terms "first", "second", etc. in the description, claims and the above-mentioned drawings of this application are used to distinguish different objects and are not used to describe a specific order. Unless otherwise clearly stated in the context, the singular forms "a" and "the" are also intended to include the plural forms. The term "comprising" and any variation thereof are intended to cover non-exclusive inclusion. In addition, this application can be implemented in many different forms and is not limited to the embodiments described in this embodiment. The purpose of providing the following specific embodiments is to facilitate a clearer and more thorough understanding of the disclosed content of this application. The words indicating directions such as up, down, left, and right are only in terms of the positions of the shown structures in the corresponding drawings.

[0048] It should be noted that all the above-mentioned drawings are exemplary illustrations of this application, do not represent the actual size of the product, and the dimensional proportional relationships between the components in the drawings are not used as limitations on the actual products of this application. The subsequent description in the specification is the preferred embodiment for implementing this application. However, the above description is for the purpose of explaining the general principles of this application and is not used to limit the scope of this application. The protection scope of this application shall be determined by what is defined in the appended claims.

[0049] Please refer to Figure 1 and Figure 2 , the first embodiment of this application provides a valve clamping device 100, which includes a main body part 10, a pair of clamping parts 20, a clamping member 30 arranged between the main body part 10 and the clamping parts 20, and a driving part 40 for driving the clamping parts 20 to open and close. The clamping parts 20 surround the outside of the main body part 10 and can expand or close relative to the main body part 10 with one end as the center. The clamping member 30 includes two clamping arms 32 that can move relative to the clamping parts 20 under manipulation and control. The clamping arms 32 and the clamping parts 20 cooperate to clamp the valve leaflets of the valve. The left and right groups of clamping arms 32 and the clamping parts 20 pull the anterior leaflet and the posterior leaflet of the mitral valve towards each other (refer to Figure 23 ), obtaining a bicuspid mitral valve and realizing edge-to-edge repair of the mitral valve.

[0050] The main body part 10 includes a support base 11. Please refer to Figure 3, a pair of the clamping members 20 are each in a sheet shape. Each clamping member 20 has two opposite legs 22 and a sheet-shaped clamping area 24. The legs 22 are used to straddle the front and rear sides of the support base 11 and are respectively connected to the support base 11 by pins. In this embodiment, the legs 22 of a pair of the clamping members 20 straddling the front side of the support base 11 are connected to the front side of the support base 11 by the same pin; the legs 22 straddling the rear side of the support base 11 are connected to the rear side of the support base 11 by the same pin. This pair of clamping members 20 can rotate relative to each other to open or close around the pins. The driving part 40 includes a base 41, a driving shaft 42 connected to the base 41, and two connecting rods 43 respectively rotatably connected to the left and right sides of the base 41. The two connecting rods 43 are respectively connected to a pair of the clamping members 20, and the support base 11 has a central channel. The driving shaft 42 passes through the central channel of the support base 11 or is detachably connected to an external driving device, such as a conveying device, extending into the central channel within the central channel. When the driving shaft 42 is driven, the base 41 will be driven simultaneously, causing the connecting rods 43 to pull the clamping members 20 to make a pair of clamping members 20 expand relative to each other, or push the clamping members 20 to make a pair of clamping members 20 close relative to each other.

[0051] The clamping area 24 of the clamping member 20 serves as an area for capturing the clamping leaflets. Please refer to Figure 4 , the clamping area 24 of the clamping member 20 has a zigzag portion 24a. In this embodiment, the zigzag portion 24a extends from one end of the clamping member 20 close to the main body portion 10 to the end far from the main body portion 10.

[0052] Specifically, the zigzag portion 24a includes a raised section 24b and a sunken section 24c. In this embodiment, the raised sections 24b and the sunken sections 24c each include a plurality of them, and the plurality of raised sections 24b and the plurality of sunken sections 24c are arranged alternately and continuously. The plurality of raised sections 24b can be the same among them, and the plurality of sunken sections 24c can be the same among them; or the plurality of raised sections 24b can also be different among them, and the plurality of sunken sections 24c can also be different among them. For example, among the plurality of raised sections 24b or the plurality of sunken sections 24c, some of the raised sections 24b are only partial, or some of the sunken sections 24c are also partial, that is, some are incomplete raised sections 24b or incomplete sunken sections 24c. In a preferred embodiment, the plurality of raised sections 24b and the plurality of sunken sections 24c are both in a circular arc or quasi-circular arc shape, making the clamping area 24 of the clamping member 20 in a wavy shape.

[0053] In this embodiment, the clamping member 20 is rigid and can be made of materials such as stainless steel. The plurality of raised sections 20b and the sunken sections 20c extend transversely from one side of the width of the clamping member 20 to the other side.

[0054] See also Figure 5 The clamping member 30 is an integral member, which includes a connecting seat 32 which is substantially U-shaped in the middle, and clamping arms 34 extending from the connecting seat 32 to both sides, and one end of the clamping arm 34 away from the connecting seat 32 is a free end. The supporting seat 11 of the main body 10 is accommodated in the connecting seat 32, and the connecting seat 32 can be fixedly connected with the supporting seat 11.

[0055] The clamp 30 can be made of an elastic material or a material with shape memory function. It will deform when subjected to external force. After the external force disappears, the free end tends to restore its original shape and position due to its elasticity or shape memory ability. Therefore, during the delivery process, the free end can be tightened and closed, and after release, it will be opened to capture the leaflets of the valve. Common materials include nickel-titanium alloy.

[0056] The clamping arm 34 serves as an area for capturing and clamping the leaflet, and the clamping arm 34 has a curved portion 34a. In the present embodiment, the curved portion 34a extends from one end of the clamping arm 34 close to the connecting seat 32 to the end away from the main body 10, and the curved portion 34a also includes a plurality of raised sections 34b and a plurality of recessed sections 34c. The plurality of raised sections 34b and the recessed sections 34c are arranged alternately and continuously, and extend laterally from one side of the width of the clamping arm 34 to the other side. The plurality of raised sections 34b and the plurality of recessed sections 34c are all arc-shaped or quasi-arc-shaped curves, so that the clamping arm 34 is wavy.

[0057] The raised sections 20b, 34b and the recessed sections 20c, 34c of the surfaces opposite to the clamping arm 34 cooperate with each other, and the arc curvature radii of the matched raised sections 20b, 34b and recessed sections 20c, 34c of the surfaces opposite to the clamping arm 34 are the same, so that the curvatures of the curved portion 24a of the clamping member 20 and the curved portion 34a of the clamping arm 34 cooperate to clamp the leaflets of the valve.

[0058] In this embodiment, the arc length of the convex section 20b of the clamping member 20 facing the clamping arm 34 is greater than the arc length of the concave section 20c of the clamping member 20 facing the clamping arm 34; correspondingly, the arc length of the concave section 34c of the clamping arm 34 facing the clamping arm 34 is greater than the arc length of the convex section 34b of the clamping member 20 facing the clamping arm 34. In this way, the convex and concave parts with alternating lengths increase the anchoring force on the valve leaf. The length of the longer arc in the convex sections 20b, 34b and the concave sections 20c, 34c is about 6 mm - 10 mm, preferably 8 mm, and the length of the shorter arc is about 2 mm - 4 mm, preferably 3 mm. The length of each arc is about 1 / 4 of a complete circle where it is located. The arc curvature radius of each convex section 20b, 34b and concave section 20c, 34c is 1 / 8 to 1 / 5 of the overall length of the mating surfaces of the clamping member 20 and the clamping arm 34.

[0059] Please refer to Figure 6 , since the valve leaf of the valve, such as the anterior leaf 201 and posterior leaf 202 of the mitral valve, is soft, the valve leaf 201, 202 will be clamped between the two zigzag parts following the shape of the zigzag part. The cooperation of the convex sections 20b, 34b and the concave sections 20c, 34c holds the valve leaf 201, 202 in place just like an anchor point, but does not damage the valve leaf 201, 202.

[0060] Please refer to Figure 7 , in some embodiments, a friction element 342 is provided on the surface of the clamping arm 34 of the clamping member 30 facing the clamping member 20, so that the valve leaf is clamped more tightly between the clamping arm 34 and the clamping member 20. The friction element 342 can be provided in a partial section or the entire surface. In this embodiment, the friction element 342 is a hemispherical bump, and the radius of the bump is about 0.02 mm - 0.05 mm.

[0061] Please refer to Figure 8 , in some embodiments, a friction element 344 is provided on the surface of the clamping arm 34 facing the clamping member 20, and the friction element 344 is a strip-shaped semi-cylindrical protrusion. The radius of the protrusion can be about 0.02 mm - 0.05 mm, and the number of protrusions can be about 10 - 15.

[0062] Please refer to Figure 9, in some other embodiments, a friction element 346 is disposed on the surface of the clamping arm 34 facing the clamping member 20, and the friction element 346 is a barb with a relatively short length facing the clamping member 20. Due to the zigzag design of the clamping member 20 and the clamping arm 34, this barb only needs to play a role in enhancing the fixation by friction. The shape of this barb can be, for example, triangular or quasi-triangular, and it extends out at a certain angle with the surface of the clamping arm 34. Therefore, it has a strong anchoring force. Its head end can be a slightly pointed barb, or it doesn't have to be overly pointed to achieve a good effect of enhancing the fixation by friction.

[0063] Please refer to Figure 10 , in some other embodiments, the friction element 347 of the clamping arm 34 is in the shape of a barbed hook barb, which extends obliquely towards the connecting seat 32. The included angle between it and the surface of the clamping arm 34 can be between 25 - 55 degrees. This barbed hook barb can play a role in pulling the valve leaf towards the center to prevent the valve leaf from slipping off after being captured.

[0064] Please refer to Figure 11 , in some other embodiments, a friction element 302 is disposed on the surface of the clamping member 20 facing the clamping arm 34, so that the valve leaf is clamped more tightly between the clamping arm 34 and the clamping member 20. The friction element 302 can be disposed on a partial section or the entire surface. In this embodiment, the friction element 302 is a hemispherical bump.

[0065] Please refer to Figure 12 , in some other embodiments, a friction element 304 is disposed on the surface of the clamping member 20 facing the clamping arm 34, and the friction element 304 is a strip-shaped semi-cylindrical protrusion.

[0066] In some other embodiments, one of the clamping arm 34 and the clamping member 20 can have a friction element. Especially when the clamping arm 34 has barbs, since the barbs have a strong anchoring force, at this time, the clamping member 20 may not need to be provided with a friction element, or both the clamping arm 34 and the clamping member 20 have friction elements.

[0067] In the above embodiments, due to the cooperation of the protruding sections 20b, 34b and the recessed sections 20c, 34c, just like anchor points, the valve leaves 201, 202 are pressed, and the length requirements for the friction elements 346, 347, 302, 304 are minimized. The heights of the friction elements 346, 347, 302, 304 on the surface of the above clamping arm 34 or the clamping member 20 in the direction away from the clamping arm 34 or the clamping member 20 can be less than the heights of the protrusions of the protruding sections 20b, 34b.

[0068] Please refer to Figure 13, in a deformable embodiment, the zigzag portion 40a where the clamping member 40 and the clamping arm (not shown in the figure) cooperate has only one arc 42 respectively. The end of the arc 42 in the distal direction includes a transition section 43 and a flanging section 44. The length of the arc 42 accounts for 3 / 5 to 4 / 5 of the length of the surface where the clamping member 40 and the clamping arm cooperate, and the radius of curvature of the arc 42 is about 1 / 2 of the length of the surface where the clamping member 40 and the clamping arm cooperate. By using a larger arc, the contact area between the leaflet and the clamping member 40 and the clamping arm is increased, so that the soft leaflet can be smoothly received and clamped between the clamping member 40 and the clamping arm. The transition section 43 and the flanging section 44 can play a role in supporting the leaflet. The surface of the clamping member 40 opposite to the clamping arm can still be provided with the above-mentioned friction elements to enhance clamping.

[0069] Please refer to Figure 14 , in the drive control, the clamping member 30 can control the movement of the clamping arm 34 through the control line 38. A threading hole 36 can be provided at the free end of the clamping arm 34 away from the connecting seat 32. Then, each clamping arm 34 is passed through a control line 38 through the threading hole 36 and further extends to the control end of the operation handle of the doctor of the conveying device (refer to Figure 22 ) (not shown in the figure) to control each clamping arm 34 through the control line 38. In this embodiment, the number of threading holes 36 on each clamping arm 34 is two. In other embodiments, please refer to Figure 15 , the number of threading holes 36 on each clamping arm 34 can also be only one.

[0070] Please refer to Figure 16 , the two clamping arms 34 can also share a control line 38 so that the two clamping arms 34 are controlled simultaneously. The shared control line 38 passes through the two threading holes 36 on each clamping arm 34 respectively, and then the two ends extend to the control end of the operation handle of the doctor of the conveying device (see Figure 22 ).

[0071] Please refer to Figures 17 to 19 , the second embodiment of the present application provides a valve clamping device 200. The difference between the valve clamping device 200 and the above-mentioned valve clamping device 100 is that: the clamping member 60 includes an intermediate part 62, edge parts 64 on both sides of the intermediate part 62, and a flanging part 66 at the end. The intermediate part 62 and the edge parts 64 respectively have alternating convex segments 62a, 64a and concave segments 62b, 64b. The convex segment 62a of the intermediate part 62 corresponds to the convex segment 64a of the edge part 64, and the convex segment 64a of the edge part 64 corresponds to the convex segment 64b of the edge part 64. The intermediate part 62 is recessed inward relative to the edge parts 64, so that the whole clamping member 60 becomes a C shape with slightly higher sides and slightly lower middle.

[0072] The width of the clamping arm 45 is less than or equal to the planar portion 62 of the clamping member 60, and a plurality of protruding segments and recessed segments of the clamping arm 45 (refer to Figure 5 ) extend laterally from one side of the width of the clamping arm 45 to the other side.

[0073] In the above second embodiment, a plurality of protruding segments and recessed segments of the clamping member 60 and the clamping arm 45 act as anchoring elements to press the valve leaflets against the inwardly recessed space of the clamping member 60. The substantially C-shaped structure of the clamping member 60 wraps the valve leaflets, making the valve leaflets clamped more firmly. The edge portion 64 and the flanging portion 66 of the clamping member 60 can support the edges of the valve leaflets.

[0074] The thicknesses of the above clamping member and the clamping member are generally between 0.15 mm and 0.35 mm, and the thickness of the clamping member is slightly thicker than that of the clamping member. The clamping area of the clamping member and the clamping arm of the clamping member serve as the effective area length for capturing the valve leaflets. This effective area length L1 (see Figure 4 ) can be between 9 mm and 13 mm. Active drugs can be applied to the surfaces of the clamping member and the clamping member respectively, or a polymer film can be coated thereon to promote the endothelial cell crawling and growth on the surfaces of the clamping member and the clamping member, and reduce the rejection reaction caused by the direct contact between the metal parts and the valve. The thickness of the coated film is preferably between 0.1 mm and 0.15 mm.

[0075] Please refer to Figure 20 , a valve clamping device 300 is provided in the third embodiment of the present application. The difference between the valve clamping device 300 and the above valve clamping device 100 is that: a blocking ball 110 can be sleeved on the support seat 11 of the main body portion to strengthen the blocking of the blood reflux gap between the valve leaflets by the valve clamping device 300. The blocking ball 110 is made of an elastic material and can be compressed in accordance with the shape of the bending portion of the clamping arm 34.

[0076] Please refer to Figure 21 , in some embodiments, the side of the blocking ball 110a facing the clamping member 20 can also be provided with a bending portion 110b, and the bending portion 110b of the blocking ball 110a cooperates with the bending portion of the clamping arm (see Figure 17 ) or the clamping member 20 to achieve the closest fit, so as to reduce the gap between the clamping members 20 after the clamping members 20 are relatively closed, and form a better blocking reflux effect at the clamping place. In addition, the clamping member 20 can be C-shaped, and the clamping arm can be received in the clamping member 20. The cooperation between the blocking ball 110a and the bending portion of the clamping arm (see Figure 17 ) or the clamping member 20, and the C-shaped wrapping design of the clamping member 20 help the clamping members 20 to be highly matched with each other when the clamping members 20, the clamping arm and the blocking ring 110a are closed, thereby helping to prevent the clamping members 20 from being bounced open.

[0077] In addition, please refer to Figure 20 For the markings of Figure 20 , the valve clamping device of the present invention can be further provided with a locking piece 70 and an unlocking wire 72. The unlocking wire 72 is used to control the locking and unlocking of the locking piece on the drive shaft 42, thereby further preventing the adverse event of the clamping member 20 being bounced open.

[0078] In summary, the clamping member 20 and the clamping arm 34 of the present application each have a zigzag portion, and the curvatures of the zigzag portion of the clamping member 20 and the zigzag portion of the clamping arm 34 cooperate to clamp the leaflets of the valve. In this way, the soft leaflets can be accommodated and clamped between the zigzag portions. The cooperating zigzag portions act like anchoring elements to clamp the leaflets tightly, so that the long spines on the clamping arm 34 can be avoided or the requirements for the long spines can be minimized.

[0079] Based on the fact that the clamping member 20 and the clamping arm 34 each have a zigzag portion, the zigzag portion of the occlusion ball 110a can cooperate with the clamping member 20 and the clamping arm 34 to form the maximum degree of close contact, so that a better occlusion and anti-reflux effect can be achieved at the clamping position.

[0080] The valve clamping device of the present invention can be applied to the treatment of cardiac valve regurgitation, including mitral valve or tricuspid valve regurgitation. Please refer to Figure 1 、 Figures 22 to 24 Taking the repair process of the anterior and posterior leaflets of the mitral valve as an example, the valve repair system of the present invention includes a valve clamping device 100 and a delivery device 500. The operation method of the valve repair of the present invention mainly includes the following steps:

[0081] By means of trans-femoral vein puncture, the distal end of the delivery device 500 and the valve clamping device 100 are delivered to the left atrium through the inferior vena cava; then the valve clamping device 100 is controlled to approach the anterior and posterior leaflets of the mitral valve; the drive mandrel 520 is delivered distally, and the drive mandrel 520 drives the drive shaft 42 (see Figure 1 ), and the clamping member 20 (see Figure 1 ) is driven to expand. The direction of the clamping member 20 is adjusted. At this time, the relative positions of the clamping member 20 and the anterior and posterior leaflets of the mitral valve can be observed through a medical imaging or imaging device, so that the clamping member 20 is substantially perpendicular to the free edges of the anterior and posterior leaflets; then the valve clamping device 100 is pushed to the left ventricle through the delivery device 500, and the valve clamping device 100 is placed under the anterior and posterior leaflets, and the clamping member 20 is continuously opened to the capture position; at the same time, the two clamping arms 34 of the clamping member 30 are pulled (see Figure 1 ). At this time, a leaflet accommodation space is formed between each of the two clamping arms 34 and the clamping member 20;

[0082] Release the clamping arms 34 on both sides simultaneously or successively. The clamping arms 34 cooperate with the clamping member 20 to capture the anterior leaflet and the posterior leaflet. When it is observed that the leaflets are not clamped in the proper position, pull the drive mandrel 520 proximally to drive the drive shaft 50, thereby driving the clamping member 20 to close, so that the anterior leaflet and the posterior leaflet are clamped between the clamping arms 34 and the clamping member 20.

[0083] Release the threaded connection between the drive mandrel 520 and the drive shaft 50, and withdraw the drive mandrel 520 rearward. The delivery sheath 510 is separated from the valve clamping device 100, and the connection between the valve clamping device 100 and the delivery device 500 is released. Then, the delivery device 500 is withdrawn from the body to obtain the Figure 24 implantation state as shown. The valve clamping device 100 pulls the anterior leaflet and the posterior leaflet of the mitral valve towards each other and clamps them, completing the edge-to-edge repair of the anterior leaflet and the posterior leaflet.

[0084] The above valve repair system and valve clamping device are suitable for application in mitral or tricuspid valve clamping procedures. In addition to the above femoral vein - interatrial septum - atrioventricular path, it can also be the transapical approach. When applied to the tricuspid valve, since there are three leaflets, namely the anterior leaflet, the posterior leaflet, and the septal leaflet, another or multiple valve clamping devices 100 can be implanted when necessary for treatment.

[0085] The above has introduced the embodiments of the present application in detail. Specific examples are used in this article to elaborate on the principle and embodiments of the present application. The description of the above embodiments is only used to help understand the method and its core idea of the present application; at the same time, for those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific embodiments and application scopes. In summary, the content of this specification should not be construed as a limitation to the present application.

Claims

1. A valve clamping device, comprising: A main body portion; A pair of clamping members, which are disposed around the outside of the main body portion and can be expanded or closed relative to the main body portion with one end as the center; And A clamping member, which is disposed between the main body portion and the clamping members, and the clamping member includes two clamping arms that can be manipulated to move relative to the clamping members. The clamping members and the clamping arms respectively have bending portions, and the curvatures of the bending portions of the clamping members and the clamping arms are matched.

2. The valve clamping device according to claim 1, characterized in that, Each bending portion of the clamping member or the clamping arm includes a convex section and a concave section, and the convex sections and the concave sections on the surfaces of the clamping member and the clamping arm facing each other are matched.

3. The valve clamping device according to claim 2, wherein, The convex sections and the concave sections respectively include a plurality of them, and the plurality of convex sections and the plurality of concave sections are alternately and continuously arranged, and extend from the ends of the clamping members and the clamping arms close to the main body portion in a direction away from the main body portion.

4. The valve clamping device according to claim 3, wherein, Each convex section and concave section is arc-shaped, and the curvature radii of the arcs of each group of matched convex sections and concave sections are the same.

5. The valve clamping device according to claim 4, characterized in that, The length of the arc of each convex section and concave section is 1 / 4 of the circle where it is located, and the curvature radius range of the arc of each convex section and concave section is 1 / 8 to 1 / 5 of the length of the mating surface of the clamping member and the clamping arm.

6. The valve clamping device according to claim 4, wherein The plurality of convex sections and concave sections of the clamping member and the clamping arm extend transversely from one side of the width of the clamping member and the clamping arm to the other side.

7. The valve clamping device according to claim 6, wherein A friction element is provided on the side of the clamping arm facing the clamping member, and / or a friction element is provided on the side of the clamping member facing the clamping arm. The height of the friction element in the direction away from the clamping arm or the clamping member is less than the height of the convex section protruding.

8. The valve clamping device according to claim 2, characterized in that, The clamping member includes a planar portion in the middle and edge portions on both sides of the planar portion. The planar portion and the edge portions are both provided with a plurality of the convex sections and concave sections. The width of the clamping arm is less than or equal to the width of the planar portion of the clamping member. The plurality of convex sections and concave sections of the clamping arm extend transversely from one side of the width of the clamping arm to the other side.

9. The valve clamping device according to claim 8, wherein, The edge portion is higher than the planar portion, so that the cross-section of the clamping member is recessed approximately in a C shape.

10. The valve clamping device according to claim 9, wherein, The main body portion includes a blocking ball, and the side surface of the blocking ball facing the clamping member includes a bending portion that cooperates with the clamping member.

11. The valve clamping device according to claim 1, further comprising a driving portion and a control line. The driving portion is used to drive the clamping members to expand or close, and the control line is used to manipulate and control the movement of the clamping arms relative to the clamping members.

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