Tissue closure devices

Abstract

The present invention relates to a tissue closure device, comprising a first clamping portion and a second clamping portion, wherein the first clamping portion and the second clamping portion are used to clamp tissue; the first clamping portion comprises a first clamping arm and a support arm rotatably connected to the first clamping arm, the support arm comprising a curved section and a straight section, one end of the curved section being fixedly connected to the straight section, and the other end being rotatably connected to the first clamping arm; or, one end of the curved section being fixedly connected to the straight section, and the end of the straight section away from the curved section being rotatably connected to the first clamping arm, the first clamping arm and the support arm being movable between an open position and a closed position, and when the first clamping arm and the support arm are in the closed position, the first clamping arm and the second clamping portion are close to each other. The tissue closure device is relatively easy to open.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to a tissue closing device. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Mitral valve disease is a common condition among the elderly. It includes two common types: mitral regurgitation and mitral stenosis, with mitral regurgitation being the most common. According to statistics, the incidence of mitral regurgitation in people over the age of 75 is as high as 10%. Mild mitral regurgitation generally has no impact on normal life, while moderate to severe mitral regurgitation requires interventional treatment. Traditional surgical treatment involves open-chest surgery, where the heart is opened with the support of an extracorporeal circulation machine to repair or replace the valve, but high-risk patients cannot tolerate this. The rise of interventional therapy in recent years has brought hope to high-risk patients with mitral regurgitation. Interventional therapy generally involves delivering a device to the affected area via a catheter to repair or replace the valve. Currently, most transcatheter mitral valve replacement products are in the clinical research stage, while transcatheter mitral valve repair products are already on the market.

[0004] The principle of existing transcatheter mitral valve repair products is to use a clamping device to clamp the anterior and posterior leaflets of the mitral valve, reducing the valve opening area, thereby achieving the purpose of treating regurgitation. Among the existing products, some are mechanically locked clamping devices, which need to be unlocked during interventional procedures before the clamping operation can be performed, so the operation is complicated. Moreover, because they are mechanically locked, the clamping stress cannot be controlled, so the device causes greater damage to the leaflets. In order to avoid this problem, some use an elastic clamping method to clamp the leaflets between an elastic clamping arm and a flexible spacer to alleviate the stress of the leaflet clamping and reduce leaflet damage. However, when using an elastic clamping arm, a certain mechanism needs to be used to open the clamping arm before the leaflet is captured, and the clamping arm is opened by a support arm. A large force needs to be used during the opening process, which increases the risk of surgery. Summary of the Invention

[0005] Based on this, it is necessary to provide a tissue closing device that is easier to open.

[0006] A tissue closing device comprises a first clamping part and a second clamping part, wherein the first clamping part and the second clamping part are used to clamp tissue; the first clamping part comprises a first clamping arm and a support arm rotatably connected to the first clamping arm, the support arm comprises a curved section and a straight section, one end of the curved section is fixedly connected to the straight section, and the other end is rotatably connected to the first clamping arm; or, one end of the curved section is fixedly connected to the straight section, and the end of the straight section away from the curved section is rotatably connected to the first clamping arm, the first clamping arm and the support arm can move between an open position and a closed position, and when the first clamping arm and the support arm are in the closed position, the first clamping arm and the second clamping part are close to each other.

[0007] In one embodiment, in the closed position, the curved section is in a curved state, and when the first clamping arm and the support arm move from the closed position to the open position, the degree of curvature of the curved section increases.

[0008] In one embodiment, the arc length of the curved section is 1 / 5 to 1 / 3 of the length of the straight section.

[0009] In one embodiment, the angle of the curved section is 10° to 45°.

[0010] In one embodiment, the tissue closure device further comprises a first fixing seat and a second fixing seat, wherein the end of the first clamping arm away from the support arm is fixedly connected to the first fixing seat, and the end of the support arm away from the first clamping arm is rotatably connected to the second fixing seat.

[0011] In one embodiment, the support arm includes a support body and a connecting portion connected to the support body, an end of the connecting portion away from the support body is connected to the first clamping arm, and an end of the support body away from the connecting portion is rotatably connected to the second fixed seat.

[0012] In one embodiment, the second clamping portion includes a second clamping arm, one end of the second clamping arm is fixedly connected to the second fixing seat, and the other end is a free end.

[0013] In one embodiment, the tissue closing device further includes a spacer, one end of which is fixedly connected to the second fixing seat, and the other end of which extends axially in a direction away from the second fixing seat.

[0014] In one embodiment, the second clamping portion includes a second clamping arm, and one end of the second clamping arm is fixedly connected to an end of the support arm away from the first clamping arm.

[0015] In one embodiment, an anchor is provided on the second clamping arm.

[0016] During implantation, the first clamping arm and the support arm move from a closed position to an open position. After capturing tissue, the first clamping arm and the support arm move from the open position to the closed position, thereby bringing the first clamping arm and the second clamping portion closer together and clamping the tissue between the first clamping arm and the second clamping portion. Because the support arm of the tissue closure device includes a curved section and a straight section, the component force applied by the support arm to the first clamping arm in the opening direction is increased during the opening process, making the first clamping arm easier to open, thereby improving the safety of the operating system. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a schematic structural diagram of a tissue closing device in a closed state according to an embodiment;

[0018] Figure 2 This is a schematic structural diagram of a tissue closing device in an open state according to an embodiment;

[0019] Figure 3 This is a schematic diagram of the connection relationship between the first clamping arm and the support arm according to an embodiment;

[0020] Figure 4 This is a schematic diagram of the connection relationship between the first clamping arm and the support arm according to an embodiment;

[0021] Figure 5 is a schematic structural diagram of a first clamping arm according to an embodiment;

[0022] Figure 6 This is a schematic diagram of the positional relationship of two first clamping arms in a closed state according to an embodiment;

[0023] Figure 7 is a schematic structural diagram of a first clamping arm according to an embodiment;

[0024] Figure 8 for Figure 7 A schematic diagram of the positional relationship of the two first clamping arms at another angle is shown;

[0025] Figure 9 This is a schematic structural diagram of a first curved section of a first clamping arm according to an embodiment;

[0026] Figure 10 This is a schematic structural diagram of the second curved section of the first clamping arm according to an embodiment;

[0027] Figure 11 A schematic diagram of the connection relationship between the first clamping arm, the support arm, the first fixing seat and the second fixing seat in another embodiment;

[0028] Figure 12A schematic diagram of the connection relationship between the first clamping arm, the support arm, the first fixing seat and the second fixing seat of a tissue closing device according to another embodiment;

[0029] Figure 13 Schematic diagram of the structure of a support arm of a tissue closing device according to one embodiment;

[0030] Figure 14 This is a schematic structural diagram of a tissue closing device in an open state according to an embodiment;

[0031] Figures 15 to 18 Schematic diagram of the implantation process of a tissue closure device according to one embodiment;

[0032] Figure 19 This is a schematic diagram of the connection relationship between the first fixing base and the first clamping arm according to an embodiment;

[0033] Figure 20a Schematic diagram of force analysis of the first clamping arm and the support arm of the conventional structure;

[0034] Figure 20b to Figure 20d Schematic diagram of the first clamping arm and the support arm of the conventional structure in different degrees of opening. DETAILED DESCRIPTION

[0035] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in this specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0037] See also Figure 1 A tissue closure system according to one embodiment includes a tissue closure device 1 and a delivery device. The tissue closure device 1 includes a first clamping portion 10 and a second clamping portion 20, each of which is used to clamp tissue. Tissue is clamped between the first clamping portion 10 and the second clamping portion 20. The tissue includes, but is not limited to, mitral valve leaflets, tricuspid valve leaflets, and the like.

[0038] There are at least two first clamping parts 10 and at least two second clamping parts 20, and the number of first clamping parts 10 and second clamping parts 20 is equal. The tissue closure device 1 has a longitudinal central axis II. The two first clamping parts 10 are symmetrically arranged about the longitudinal central axis II, and the two second clamping parts 20 are symmetrically arranged about the longitudinal central axis II. It can be understood that the first clamping parts 10 and the second clamping parts 20 correspond one-to-one to clamp tissue.

[0039] Please also refer to Figure 2 The first clamping portion 10 includes a first clamping arm 110 and a support arm 120. The first clamping arm 110 is made of an elastic metal material, such as a nickel-titanium alloy, and provides clamping force through the elasticity of the material itself. The support arm 120 is made of metal or polymer material.

[0040] The first clamping arm 110 and the support arm 120 are rotatably connected. For example, one end of the first clamping arm 110 is pivotally connected to one end of the support arm 120, so that the support arm 120 can open the first clamping arm 110, so that the first clamping arm 110 and the support arm 120 can be in the open position (such as Figure 2 as shown) and closed position (as shown) Figure 1 In a natural state, the first clamping arm 110 and the support arm 120 are in a closed position. The support arm 120 should have a certain degree of rigidity and toughness so that when in the open position, it can prop open the first clamping arm 110 to maintain the open state.

[0041] The rotatable connection between one end of the first clamping arm 110 and one end of the support arm 120 can be achieved in various ways. For example, the first clamping arm 110 and the support arm 120 are connected via a rotating shaft, a pin shaft, or a movable hinge.

[0042] In one embodiment, if Figure 3As shown, the first clamping arm 110 is generally a wire loop structure with an opening. For example, the first clamping arm 110 can be a wire loop with an opening formed by winding nickel-titanium wire. The support arm 120 includes a support body 121 and a connecting portion 122 connected to the support body 121. The end of the connecting portion 122, which is away from the support body 121, is connected to the first clamping arm 110. In one embodiment, the connecting portion 122 and the support body 121 are integrally formed, with one end of the support body 121 being wound to form the connecting portion 122. The connecting portion 122 defines a receiving cavity, and the first clamping arm 110 passes through the receiving cavity of the connecting portion 122. The ends of the first clamping arm 110 are bent to form a wire loop with an opening. The first clamping arm 110 and the connecting portion 122 can pivot relative to each other. The structures of the support arm 120 and the first clamping arm 110 cooperate with each other, allowing the first clamping arm 110 and the connecting portion 122 to pivot relative to each other without the use of connecting members such as rotating shafts or pins. This pivot connection method reduces the use of parts such as shafts and pins, and can provide flexible rotation.

[0043] In one embodiment, if Figure 3 As shown, the support body 121 and the connecting portion 122 are an integrated structure. The support arm 120 including the support body 121 and the connecting portion 122 is formed integrally by weaving elastic metal wires.

[0044] In another embodiment, Figure 4 The support body 121 and the connecting portion 122 are not integrally formed. The connecting portion 122 is a machined metal part, connected to the support body 121 by welding, gluing, mortising, or sewing with metal wire. This arrangement prevents the support arm 120 from shifting during opening due to the constraints on both sides of the first clamping arm 110, ensuring smooth opening and closing of the first clamping arm 110.

[0045] Please return Figure 3 In one embodiment, the first clamping arm 110 includes two support segments 111 and a connecting segment 112. Both the support segments 111 and the connecting segment 112 are metal rods. The connecting segment 112 is connected to the two support segments 111 at both ends, and the ends of the two support segments 111 away from the connecting segments 112 are disconnected, forming an open wire loop structure. The end where the connecting segments 112 are located is the free end of the first clamping arm 110. The support arm 120 is rotatably connected to the connecting segment 112.

[0046] Please also refer to Figure 5 and Figure 6In one embodiment, each support segment 111 includes a curved segment 1112 and an extension segment 1114 connected to the curved segment 1112. The end of the curved segment 1112, which is distal to the extension segment 1114, is curved in a first direction, such that the end of the curved segment 1112, which is distal to the extension segment 1114, and the extension segment 1114 are not in the same plane. Furthermore, because the end of the curved segment 1112, which is distal to the extension segment 1114, is curved in the first direction, the connecting segment 112 of the first clamping arm 110 is distal to the longitudinal center axis II of the tissue closure device.

[0047] like Figure 6 As shown, in the natural state, the curved segment 1112 bends in the first direction, and the bending of the curved segment 1112 makes the end of the curved segment 1112 away from the extension section 1114 not in the same plane as the extension section 1114, so that the free ends of the two first clamping arms 110 are away from the longitudinal center axis II, that is, the two connecting sections 112 of the two first clamping arms 110 are away from the longitudinal center axis II and are in a state of being away from each other, making it easier to open the first clamping arms 110. The first direction, for example Figure 6 As shown, the bent segment 1112 may be bent in a direction away from the connecting segment 112 of the other first clamping arm 110 , and the end of the bent segment 1112 away from the extending segment 1114 is not in the same plane as the extending segment 1114 .

[0048] In one embodiment, the extension section 1114 is in the shape of a straight rod, and the portion where the extension section 1114 is connected to the curved segment 1112 is on the same plane as the extension section 1114 .

[0049] See also Figure 7 In one embodiment, the extension section 1114 includes a curved rod 1114A and a straight rod 1114B connected to the curved rod 1114A. The end of the curved rod 1114A away from the straight rod 11114B is connected to the curved segment 1112. Figure 6 and Figure 8 In one embodiment, in the natural state (also the clamping state), the curved rod 1114A bends in the second direction, so that the connection portion between the curved rod 1114A and the curved segment 1112 of one first clamping arm 110 and the connection portion between the curved rod 1114A and the curved segment 1112 of the other first clamping arm 110 (the circle portion indicated by VI in the figure) are more reliably abutted together to form a holding portion. At the holding portion, since the first clamping arms 110 are elastic, the two first clamping arms 110 provide mutually opposing holding forces, so that the two first clamping arms 110 are more reliably abutted together, which is beneficial to improve the reliability of the clamping, so as to avoid the tissue closure device 1 from falling off due to the contraction and relaxation movement of the heart. In the second direction, for example Figure 7As shown, it can be the direction outside the wire loop, that is, the center of the curved rod 1114A itself is located inside the wire loop.

[0050] In one embodiment, the connection portion between the curved rod 1114A and the curved segment 1112 of each clamping arm 110 is in the shape of a straight rod, so that the area of ​​the mutually abutting portion of the two clamping arms 110 is larger, and the abutment is more reliable.

[0051] See also Figure 9 In one embodiment, the angle α of the curved rod 1114A is between 5° and 15°, so that the connection between the extension section 1114 and the curved segment 1112 of the two first clamping arms 110 can be reliably abutted together. Angle α refers to the angle formed by the intersection of tangent line A and tangent line B of the curved rod 1114A, with the intersection point being a. Tangent line A intersects the connection between the curved rod 1114A and the straight rod 1114B, while tangent line B intersects the connection between the curved rod 1114A and the curved segment 1112.

[0052] See also Figure 10 In one embodiment, the angle β of the curved segment 1112 is between 10° and 60° to facilitate opening of the first clamping arm 110. Furthermore, when the length of the curved segment 1112 is constant, the portion of the curved segment 1112 connected to the curved rod 1114A (i.e., the portion of the curved segment 1112 coplanar with the curved rod 1114A) is sufficiently long to maintain the clamping effect. The angle β is the angle between the extension line C of the connection between the curved rod 1114A and the curved segment 1112 and the tangent line D of the curved segment 1112. The tangent line D intersects the extension line C at the intersection point b between the extension line C and the curved segment 1112.

[0053] In one embodiment, the support arm 120 is made of elastic metal, for example, a nickel-titanium alloy is used to make a spring, and one end of the spring is bent and shaped to form the connecting portion 122 .

[0054] In one embodiment, see Figure 11 The support body 121 includes a curved section 123 and a straight section 124. One end of the curved section 123 is fixedly connected to the straight section 124, and the other end is rotatably connected to the first clamping arm 110. In one embodiment, the connecting portion 122 is connected to the end of the curved section 123 away from the straight section 124, and the curved section 123 is rotatably connected to the first clamping arm 110 through the connecting portion 122. In another embodiment, Figure 12 As shown, one end of the connecting portion 122 is connected to one end of the straight section 124 away from the curved section 123 , and the straight section 124 is rotatably connected to the first clamping arm 110 through the connecting portion 122 .

[0055] See also Figure 13In one embodiment, the length of the straight section 124 is L1, and the arc length of the curved section 123 is L2 (not shown), with L2 / L1 = 1 / 5 to 1 / 3. This arrangement of the lengths of the straight section 124 and the curved section 123 prevents the curved section 123 from being too long, ensuring sufficient disengagement force is transmitted to the first clamping arm 110. This ensures that the support arm 120 can provide a sufficient disengagement force to disengage the first clamping arm 110 during the opening process. Furthermore, it prevents the curved section 123 from being too short, allowing it to further deform (bend) during the opening process, thereby alleviating the problem of excessive stress.

[0056] Please continue reading Figure 13 In one embodiment, the angle γ of the curved section 123 ranges from 10° to 45°. Within this angle range, under a certain force, the support arm 120 can transmit the expansion force to the first clamping arm 110, and the curved section 123 can deform to a certain extent to alleviate the problem of excessive stress. The angle γ is the angle between the extension line E of the straight section 124 and the tangent line F of the curved section 123. The tangent line F and the extension line E intersect at the intersection point C of the extension line E and the curved section 123.

[0057] When the length of the support body 121 is determined, the larger the angle γ of the curved section 123, the smaller the capture length of the support body 121, making it more difficult to capture tissue. When the angle γ of the curved section 123 is too small, it is difficult to easily open the first clamping arm 110. Therefore, in one embodiment, the length of the straight section 124 is L1, the arc length of the curved section 123 is L2, L2 / L1=1 / 5 to 1 / 3, and the angle γ of the curved section 123 ranges from 10° to 45°. This makes it easier to open the first clamping arm 110 and capture tissue, facilitates operation, ensures smooth operation, and helps reduce surgical time.

[0058] In one embodiment, the support body 121 may be an integrated structure made of metal wire or sheet material, and has a corresponding curved shape after heat setting treatment, forming a curved section 123 and a straight section 124 .

[0059] Please return Figure 11 In one embodiment, the tissue closing device 1 further includes a first fixing seat 130 and a second fixing seat 140. The first fixing seat 130 and the second fixing seat 140 are axially opposite, coaxial, and spaced apart.

[0060] The end of the first clamping arm 110 away from the support arm 120 is fixedly connected to the first fixing seat 130. The fixing connection method can be a method known to those skilled in the art, including but not limited to welding, gluing, mortising, metal wire suturing, etc. Specifically, the first clamping arm 110 is connected to the first fixing seat 130 through the support section 111. The end of the straight rod 1114B of the support section 111 away from the curved rod 1114A is fixedly connected to the first fixing seat 130, as shown in FIG. Figure 7 Please refer to Figure 11 The end of the support arm 120 away from the first clamping arm 110 is rotatably connected to the second fixing base 140. The support body 121 is connected to the second fixing base 140 via a rotating shaft, a pin, or a movable hinge. For example, the support body 121 and the second fixing base 140 are rotatably connected via a rotating shaft 150.

[0061] In one embodiment, if Figure 11 As shown, one end of the straight section 124 of the support body 121 away from the curved section 123 is rotatably connected to the second fixing seat 140 .

[0062] In one embodiment, if Figure 12 As shown, one end of the curved section 123 of the support body 121 away from the straight section 124 is rotatably connected to the second fixing seat 140 .

[0063] In one embodiment, a through hole is formed in the middle of each of the first fixing base 130 and the second fixing base 140 .

[0064] Please return Figure 2 In one embodiment, the second clamping portion 20 includes a second clamping arm 210. One end of the second clamping arm 210 is fixedly connected to the second fixing base 140, and the other end is free. When the first clamping arm 110 and the support arm 120 are in the closed position, the free end of the second clamping arm 210 is close to the support arm 120, thereby clamping the tissue located between the second clamping arm 210 and the support arm 120.

[0065] In another embodiment, one end of the second clamping arm 210 is not connected to the second fixing base 140 , but is fixedly connected to an end of the support arm 120 away from the first clamping arm 110 .

[0066] The second clamping arm 210 is made of an elastic material, giving it a resilient feel. Tissue positioned between the elastic first clamping arm 110 and the elastic second clamping arm 210 is elastically squeezed, resulting in a more stable clamping performance for the tissue closure device 1. In one embodiment, the second clamping arm 210 is made of nickel-titanium alloy.

[0067] In one embodiment, the second clamping portion 20 further includes an anchor 220. The anchor 220 is disposed on the surface of the second clamping arm 210 facing the support arm 120 and extends toward the support arm 120. The anchor 220 is used to capture tissue (e.g., leaflets). Furthermore, once the tissue is captured, the anchor 220 penetrates the tissue, and the first clamping arm 110, the second clamping arm 210, and the anchor 220 cooperate to securely clamp the tissue.

[0068] There can be one or more anchoring members 220 . When there are more than one anchoring members 220 , the anchoring members 220 are disposed on the second clamping arm 210 at intervals.

[0069] There are two first clamping parts 10 and two second clamping parts 20. The two first clamping parts 10 are symmetrically arranged on either side of the first fixing base 130, with the longitudinal center axis of the first fixing base 130 (coinciding with the longitudinal center axis II) as the center of symmetry. Specifically, the two first clamping arms 110 are symmetrically arranged on either side of the first fixing base 130, and the two support arms 120 are symmetrically located on either side of the second fixing base 140. Each support arm 120 has one end rotatably connected to the first clamping arm 110 and the other end rotatably connected to the second fixing base 140. The two second clamping arms 210 are symmetrically arranged on either side of the second fixing base 140, with the longitudinal center axis of the second fixing base 140 (coinciding with the longitudinal center axis II) as the center of symmetry.

[0070] Please continue reading Figure 2 The tissue closing device 1 further includes a spacer 160 . One end of the spacer 160 is connected to the second fixing seat 140 , and the other end thereof extends axially in a direction away from the second fixing seat 140 and the first fixing seat 130 .

[0071] Spacer 160 is a cage-like structure made of an elastic material, such as an elastic metal wire or an elastic polymer wire. In one embodiment, spacer 160 is a cage-like structure woven from nickel-titanium wire. In another embodiment, spacer 160 is made of elastic sponge or elastic silicone. In another embodiment, spacer 160 is an airbag structure made of a polymer material.

[0072] The spacer 160 can seal and fill the gap between the two tissues, further improving the sealing performance. Furthermore, because the spacer 160 is made of an elastic material, it has a certain degree of flexibility and deformability. After clamping, the spacer 160 can act as a buffer, preventing the two clamped tissues (e.g., two leaflets) from being pulled together, thereby reducing the clamping stress.

[0073] The shape of the spacer 160 is not limited, and any shape that can play a sealing and buffering role can be used. In one embodiment, the spacer 160 is cylindrical. In another embodiment, the spacer 160 is a structure with two axially opposite ends being smaller and a middle being larger.

[0074] In one embodiment, the shape of the spacer 160 matches the shape of the first clamping arm 110 , so that in the clamped state, the outer surface of the spacer 160 completely fills the wire loop of the first clamping arm 110 , thereby improving the sealing effect.

[0075] In one embodiment, a coating (not shown) is provided on the spacer 160 , and the coating covers the surface of the spacer 160 to further improve the sealing effect.

[0076] The delivery device is used to deliver the tissue closing instrument 1 to a target location and release the tissue closing instrument 1 to clamp the target tissue.

[0077] Please also refer to Figure 14 and Figure 15 The conveyor includes a handle (not shown), a conveying sheath 310 and an operating rod 320. The handle is connected to the proximal end of the conveying sheath 310, and a control member for operating the tissue closure device 1 is provided on the handle. The tissue closure device 1 after radial compression is accommodated in the conveying sheath 310 and reaches the target site along with the conveying sheath 310. The operating rod 320 is accommodated in the conveying sheath 310, the proximal end of the operating rod 320 is connected to the control member, and the distal end passes through the spacer 160 and the second fixing seat 140 and extends to the first fixing seat 130. The distal end of the operating rod 320 is detachably connected to the first fixing seat 130. The detachable connection method includes but is not limited to a threaded connection. For example, the through hole of the first fixing seat 130 is a threaded hole, and the distal outer wall of the operating rod 320 is provided with an external thread to achieve detachable connection.

[0078] The delivery device further includes a connector that is detachably connected to the distal end of the spacer 160. The connector can be any structure known to those skilled in the art that can be detachably connected to the spacer 160. For example, in one embodiment, the connector is a cannula having an internal thread at its distal end, which is received in the delivery sheath 310. The spacer 160 is provided with a threaded structure adapted to the cannula to achieve detachable connection.

[0079] like Figure 16 As shown, the delivery device further includes a control wire 330, which passes through the delivery sheath 310. The proximal end of the control wire 330 is connected to the control member, and the distal end of the control wire 330 is detachably connected to the second clamping arm 210. The control wire 330 controls the movement of the second clamping arm 210 to capture the target tissue.

[0080] In one embodiment, in order to facilitate the operation rod 320 to pass through the second fixing seat 140 and the first fixing seat 130 in sequence through the spacer 160, a guide tube 170 with an inner cavity is provided inside the spacer 160. Figure 14 The guide tube 170 extends axially from the distal end to the proximal end of the spacer 160 . The operating rod 320 passes through the inner cavity of the guide tube 170 , passes through the second fixing seat 140 , and extends to the first fixing seat 130 .

[0081] In one embodiment, if Figure 14 As shown, one end of the guide tube 170 close to the first fixing seat 130 extends to the outside of the second fixing seat 140 and extends axially toward the first fixing seat 130, which is beneficial to improving the pushing performance of the operating rod 320, so that an operating rod 320 with a smaller rod diameter can be used, which is beneficial to reducing the overall flexibility of the tissue closure system to facilitate passing through a curved vascular path.

[0082] At the same time, the guide tube 170 is provided to support the spacer 160 to maintain the structural stability of the spacer 160 .

[0083] The delivery, release and closing process of the tissue closing device 1 are described by taking the mitral valve leaflet as an example. Figure 15 , through the delivery sheath 310 through the femoral vein and inferior vena cava to the right atrium RA, and then puncture the atrial septum AS, the distal end of the delivery sheath 310 reaches the left atrium LA. By adjusting the distal end of the delivery sheath 310 to be located in the middle position above the mitral valve MV, and then using the control part on the operating handle, the tissue closure device 1 is pushed out of the delivery sheath 310, as shown in FIG. Figure 16 For further information, see Figure 17 , push the tissue closure instrument 1 to the position of the mitral valve MV, and adjust the position (if necessary) so that the first clamping arm 110 of the tissue closure instrument 1 is located on the side of the mitral valve leaflet close to the left ventricle LV. Through the control part on the operating handle, the operating rod 320 is moved axially, so that the first clamping arm 110 is in an open state to capture the leaflet. Then, the angle of the second clamping part 20 is controlled by the control wire 330 to capture the leaflet. After the second clamping part 20 captures the leaflet, the operating rod 320 is moved axially so that the support arm 120 and the second clamping part 20 are close to each other to clamp the leaflet. The two second clamping parts 20 and the two support arms 120 cooperate so that the anterior leaflet and the posterior leaflet of the mitral valve MV are clamped, as shown in FIG. Figure 18 After the clamping is completed, the control wire 330 is withdrawn, the connection between the operating rod 320 and the first fixing seat 130 is released, the connection between the connector and the spacer 160 is released, and the conveyor is withdrawn to complete the operation.

[0084] Please also refer to Figure 14 and Figure 19 In one embodiment, the tissue closure device 1 further includes a reinforcement tube 180. The reinforcement tube 180 is mounted on the first mounting base 130. The distal end of the operating rod 320 extends into the reinforcement tube 180 and is detachably connected to the first mounting base 130. The reinforcement tube 180 cooperates with the guide tube 170 extending from the second mounting base 140 to improve the pushing performance of the operating rod 320. This allows the use of an operating rod 320 with a smaller diameter, thereby reducing the overall compliance of the tissue closure system and facilitating navigation through tortuous vascular pathways.

[0085] In one embodiment, the operating rod 320 is detachably connected to the reinforcement tube 180 via threads.

[0086] In one embodiment, the outer diameter of the guide tube 170 is smaller than the inner diameter of the reinforcement tube 180. In the closed state, the guide tube 170 extends into the reinforcement tube 180, and the operating rod 320 passes through the guide tube 170 and the reinforcement tube 180 and is detachably connected (e.g., threadedly connected) to the first fixing seat 130. In this manner, the guide tube 170 and the reinforcement tube 180 guide the operating rod 320 axially and constrain the operating rod 320 radially. The mutual positioning and guiding effect between the guide tube 170 and the reinforcement tube 180 facilitates the stable transmission and uniform distribution of axial force, thereby preventing the first clamping arms 110 from deviating, thereby allowing the two first clamping arms 110 on both sides to open synchronously and stably.

[0087] When the tissue closing device 1 is to be opened, at the moment of opening, the radial force generated on the first clamping arm 110 is the largest, and the guide tube 170 extends into the reinforcing tube 180 and simultaneously plays a role in enhancing rigidity, further making it easier to open the first clamping arm 110.

[0088] During the opening process of the first clamping arm 110, when the support arm 120 is a conventional structure, the force analysis of the support arm 120 is as follows:

[0089] like Figure 20aAs shown, the first clamping arm 110 is opened by sliding the operating rod 320 and the guide tube 170 relative to each other. T is the force applied by the guide tube 170 on the rotating shaft 150, which generates two force components: a force component T1 parallel to the support arm 120 and a force component T2 perpendicular to the support arm 120. T1 is transmitted along the support arm 120 to the position where the support arm 120 and the first clamping arm 110 are rotatably connected, thereby driving the first clamping arm 110 to open. Assuming that there is no loss when the force is transmitted within the support arm 120, T1 = F. Where F is decomposed into two force components at the position where the support arm 120 and the first clamping arm 110 are rotatably connected: a force component F1 perpendicular to the first clamping arm 110 and a force component F2 parallel to the first clamping arm 110. F1 = F*Sinθ, and T1 = T*Cosθ, where θ is the angle between the support arm 120 and the first clamping arm 110. From this, it can be calculated that T=T1 / Cosθ=F / Cosθ=(F1 / Sinθ) / Cosθ=F1 / (Sinθ*Cosθ)=2*F1 / Sin 2θ.

[0090] It can be seen from the above formula that as the angle θ increases, the force required to be applied to the guide tube 170 becomes smaller and smaller. Figure 20b , θ is 20°. Figure 20c , θ is 40°. Figure 20d , θ is 65°. Figures 20b to 20d , the force that needs to be applied to the guide tube 170 becomes smaller and smaller. When the first clamping arm 110 and the support arm 120 are in the closed position, the angle θ is the smallest. When the opening force F1 is constant, the force that needs to be applied to the operating rod 320 is the largest. In the closed position, the angle θ is 1 to 10°. When θ = 10°, the force F1 to open the support arm 120 is 10N, then the calculated T1 is 58N, and the guide tube 170 needs to bear the force of the support arms 120 on both sides, so the actual force required on the guide tube 170 is 2*T1=116N. It can be seen from this that in the process of opening the first clamping arm 110, the force that the guide tube 170 and the operating rod 320 need to bear is very large. Therefore, the first clamping arm 110 needs to be driven by a large force to open. On the one hand, this requires the doctor to operate vigorously, which will increase the risk of surgery; on the other hand, it also increases the risk of failure of the various force-bearing components of the tissue closure device 1.

[0091] The support body 121 of the tissue closure device 1 includes a curved section 123 and a straight section 124. Specifically, in its natural state (the closed state, in which the first clamping arm 110 and the support arm 120 are in a closed position), one end of the support arm 120 is curved. Whether the curved section 123 is rotatably connected to the first clamping arm 110 or connected to the second fixing base 140, the presence of the curved section 123 increases the force component perpendicular to the first clamping arm 110 when the support arm 120 extends the first clamping arm 110. Consequently, the force applied to the operating rod 320 and the guide tube 170 is reduced, thereby saving effort, facilitating operation, easing control, and improving operational safety.

[0092] In one embodiment, as the first clamping arm 110 and support arm 120 move from a closed position to an open position, the degree of curvature of the curved section 123 increases. Specifically, when the force applied to the curved section 123 exceeds a certain limit, it can guide the support arm 120 toward the curved direction, thus providing a buffering effect. When the support arm 120 deforms to a certain degree, the first clamping arm 110 becomes easier to open.

[0093] During implantation, the first clamping arm 110 and the support arm 120 of the tissue closure device 1 change from a closed position to an open position. After capturing tissue, the first clamping arm 110 and the support arm 120 change from the open position to the closed position, thereby bringing the first clamping arm 110 and the second clamping portion closer together, so that the tissue is clamped between the first clamping arm 110 and the second clamping portion 20. Because the support arm 120 of the tissue closure device 1 includes a curved section 123 and a straight section 124, during the opening process, the component force applied by the support arm 120 to the first clamping arm 110 in the opening direction is increased, making the opening of the first clamping arm 110 easier, thereby improving the safety of the manipulation system.

[0094] Furthermore, due to the special structural design of the first clamping arm 110, the free ends of the two first clamping arms 110 are away from the longitudinal center axis II, making it easier to open the first clamping arm 110. A smaller force can be used to enable the support arm 120 to open the first clamping arm 110, so that the connecting section 112 of the first clamping arm 110 moves in a direction away from the longitudinal center axis II, thereby making the first clamping arm 110 in an open state.

[0095] Furthermore, since the end of the curved segment 1112 of the first clamping arm 110 close to the extension segment 1114 is located in the same plane as the extension segment 1114, in the closed position, the two first clamping arms 110 of the two second clamping parts 10 can reliably clamp the spacer 160 to prevent it from falling off and maintain the sealing performance.

[0096] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0097] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A tissue closing device, characterized in that: and a second clamping portion, wherein the first clamping portion and the second clamping portion are used to clamp tissue; the first clamping portion comprises a first clamping arm and a support arm located inside the first clamping arm and rotatably connected to the first clamping arm, the support arm comprises a support body and a connecting portion connected to the support body, one end of the connecting portion away from the support body is rotatably connected to the first clamping arm, the support body comprises a curved section and a straight section, one end of the curved section is fixedly connected to the straight section, and the other end is connected to the connecting portion; or, one end of the curved section is fixedly connected to the straight section, and the end of the straight section away from the curved section is connected to the connecting portion, the first clamping arm and the support arm can move between an open position and a closed position, and when the first clamping arm and the support arm are in the closed position, the first clamping arm and the second clamping portion are close to each other; In the closed position, the bending section is in a bent state, and when the first clamping arm and the support arm move from the closed position to the open position, the bending section can be further deformed and bent, so that the degree of bending of the bending section increases.

2. The tissue closing device according to claim 1, wherein: The arc length of the curved section accounts for 1 / 5 to 1 / 3 of the length of the straight section.

3. The tissue closing device according to claim 1, wherein: The angle of the bending section is 10°~45°.

4. The tissue closing device according to claim 1, wherein: The tissue closing device further comprises a first fixing seat and a second fixing seat, wherein one end of the first clamping arm away from the support arm is fixedly connected to the first fixing seat, and one end of the support arm away from the first clamping arm is rotatably connected to the second fixing seat.

5. The tissue closing device according to claim 4, wherein: The support arm includes a support body and a connecting portion connected to the support body, one end of the connecting portion away from the support body is connected to the first clamping arm, and one end of the support body away from the connecting portion is rotatably connected to the second fixing seat.

6. The tissue closing device according to claim 4, wherein: The second clamping portion includes a second clamping arm, one end of the second clamping arm is fixedly connected to the second fixing seat, and the other end is a free end.

7. The tissue closing device according to claim 4, wherein: The tissue closing device further includes a spacer, one end of which is fixedly connected to the second fixing seat, and the other end of which extends axially in a direction away from the second fixing seat.

8. The tissue closing device according to claim 1, wherein: The second clamping portion includes a second clamping arm, one end of which is fixedly connected to an end of the support arm away from the first clamping arm.

9. The tissue closing device according to claim 6 or 8, characterized in that: An anchor is provided on the second clamping arm.

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