Tip member of suturing device and suturing device

By designing the front end component of the suturing device, utilizing the movable connection between the first clamping member and the second clamping member to clamp the target tissue, and providing a second receiving groove on the second clamping member to simplify the puncture process, the problems of low suturing efficiency and leaflet displacement are solved, and efficient and stable suturing operation is achieved.

CN120788643APending Publication Date: 2025-10-17CAREFREE HEARTBEAT MEDICAL TECH (SHENZHEN) CO LTD
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Patent Information

Application Number
CN202510272396.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-07
Publication Date
2025-10-17

AI Technical Summary

Technical Problem

When suturing the mitral valve with existing suturing devices, it is difficult for the puncture needle to accurately puncture the valve leaflets, resulting in low suturing efficiency and easy displacement of the valve leaflets.

Method used

A front end component of a suturing device is designed, including a first clamping part and a second clamping part, which are movably connected to form a clamping space to clamp the target tissue, and a second receiving groove is provided on the second clamping part for inserting a puncture needle into a connector to simplify the puncture process.

Benefits of technology

The convenience and efficiency of suturing operation are improved, the mutual displacement of the suturing device and the target tissue is prevented, the difficulty of operation is reduced, and the accuracy and stability of suturing are ensured.

✦ Generated by Eureka AI based on patent content.

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Abstract

A tip part of a suturing device and the suturing device relate to the technical field of medical instruments, the tip part comprises a first clamping piece and second clamping pieces located on two opposite sides of the first clamping piece, the distal end of the first clamping piece is movably connected with the first ends of the second clamping pieces, and the distal end of the first clamping piece is movably connected with the second ends of the second clamping pieces. A clamping space which is located between the first clamping piece and the second clamping piece and used for clamping target tissue is formed; the first clamping piece is provided with a first containing groove used for assembling a suture line, a second containing groove is formed in the second end, opposite to the first end, of the second clamping piece, the second containing groove is used for containing a connector at the end of the suture line, and a notch of the second containing groove is used for allowing a puncture needle to be inserted into and connected with the connector. The target tissue is gripped when the second gripper moves in a direction approaching the first gripper, thereby preventing mutual displacement between the tip of the suturing device and the target tissue.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a tip component of a suturing device and the suturing device. BACKGROUND

[0002] The mitral valve is a one-way "valve" between the left atrium and the left ventricle, which can ensure the blood flow from the left atrium to the left ventricle. The mitral valve has an anterior leaflet and a posterior leaflet, and when the anterior leaflet and the posterior leaflet are closed well, the blood can flow from the left ventricle to the aorta. If the mitral valve is diseased, when the left ventricle is in a contraction state, the mitral valve cannot recover to the normal state that the anterior leaflet and the posterior leaflet are closed well, and the phenomenon of insufficiency occurs, causing blood reflux. When the reflux is severe, surgical treatment is needed. At present, one way of surgical treatment is to use a suturing device to suture the anterior leaflet and the posterior leaflet of the mitral valve, thereby solving the problem of reflux. However, when suturing, the puncture needle of the suturing device is easy to displace when puncturing the leaflet, which increases the difficulty of puncture and affects the surgical efficiency of suturing. SUMMARY

[0003] The present application provides a tip component of a suturing device and the suturing device, which can solve the problem of low surgical efficiency of suturing.

[0004] According to an aspect of the present application, a tip component of a suturing device is provided in one embodiment, which comprises a first clamping piece for connecting with a distal end of an insertion tube, and a second clamping piece located on opposite sides of the first clamping piece, the distal end of the first clamping piece is movably connected with a first end of the second clamping piece, forming a clamping space between the first clamping piece and the second clamping piece for clamping target tissue; the first clamping piece is provided with a first accommodating groove for assembling a suture, and a second end of the second clamping piece opposite to the first end is provided with a second accommodating groove, the second accommodating groove is used for accommodating a connector at an end of the suture, and a slot of the second accommodating groove is used for inserting a puncture needle connected with the connector.

[0005] In one embodiment, the first clamping piece is provided with a third accommodating groove, the third accommodating groove is used for assembling a flow resistance piece provided on the suture, the third accommodating groove is in communication with the first accommodating groove, and the first accommodating groove and the third accommodating groove are both provided with an opening, the opening is used for allowing the suture and the flow resistance piece to come out of the corresponding groove.

[0006] In one embodiment, the second clamping member is located on opposite sides of the first clamping member, and the first accommodating groove and the third accommodating groove are located on one of the other opposite sides of the first clamping member; the third accommodating groove is arranged at the proximal end of the first clamping member, and the first accommodating groove is located at the distal end side of the third accommodating groove; the opposite sides of the distal end of the first accommodating groove are provided with wire outlet holes, and the hole walls of the wire outlet holes are provided with notches for the suture to exit, and the notches are in communication with the opening of the first accommodating groove for the suture to exit.

[0007] In one embodiment, the distal end of the first clamping member is provided with a hinge seat, and the hinge seat and the first end are hingedly connected to form the movable connection; the wire outlet hole is C-shaped, and the opposite two ends of the C-shaped hole form a notch for the suture to exit; the wire outlet hole is located on the proximal side of the hinge seat, and the notch for the suture to exit is located on the side of the wire outlet hole close to the hinge seat.

[0008] In one embodiment, the proximal end of the first clamping member is provided with a connecting member for connecting an insertion tube, and the distal end surface of the connecting member is provided with a groove, and the groove opening is in communication with the proximal end of the third accommodating groove; the groove is used to cooperate with the end of the flow blocking piece to limit the flow blocking piece.

[0009] In one embodiment, the proximal end surface of the connecting member is provided with a filler groove for hot melt connection with an insertion tube, and the filler groove includes a main body part located at the middle of the connecting member, and at least two limiting parts extending from the main body part to the peripheral edge of the connecting member; the width of one end of the limiting part close to the edge is a first width, the width of one end of the limiting part close to the middle is a second width, and the first width of at least one of the limiting parts is greater than the second width; at least one of the limiting parts is a hole structure penetrating from the main body part to the peripheral side wall of the connecting member.

[0010] In one embodiment, the second accommodating groove is a blind hole arranged on the second end, the hole opening of the blind hole is the groove opening of the second accommodating groove, the hole opening of the blind hole is located on the end surface of the second end, and the hole wall of the blind hole close to one side of the first clamping member is provided with a wire passing notch penetratingly arranged, and the wire passing notch is in communication with the hole opening.

[0011] In one embodiment, the tip component further includes a driving mechanism, the driving mechanism includes a driving block for fixedly connecting with the distal end of the control rod, and push-pull arms arranged on the opposite sides of the driving block, one end of the push-pull arm is hingedly connected with the driving block, the other end is hingedly connected with the second clamping member on the corresponding side, the hinged part of the push-pull arm and the second clamping member is located between the first end and the second end, and the first end is hingedly connected with the distal end of the first clamping member to form the movable connection.

[0012] In one embodiment, opposite sides of the first clamping member are respectively provided with clamping notches, the second clamping member is located in the clamping notches on the corresponding sides, and a spacing between the first clamping member and the second clamping member forms an L-shaped clamping space; opposite sides of the first clamping member are respectively provided with through holes for assembling the puncture needle, the through holes correspond to the second accommodating grooves on the second clamping member on the corresponding sides, and are communicated with the clamping space on the corresponding sides.

[0013] In one embodiment, the first clamping member comprises a clamping section and a main body section, the clamping notches are located on opposite sides of the clamping section, the main body section is located on a proximal side of the clamping notches, and the through holes are provided on the main body section; a side wall of a distal end of the through hole is provided with a clearance opening penetrating to an outer side surface of the main body section, a width of the clearance opening is smaller than a hole diameter of the through hole, the clearance opening is communicated with a distal end aperture of the through hole, and the distal end aperture of the through hole is provided with a guide inclined surface.

[0014] According to another aspect of the present application, in one embodiment, a suture device is provided, comprising a handle, an insertion tube, a control rod, and the tip component as claimed in any one of claims 1-10, the tip component is connected to a distal end of the insertion tube, the handle is connected to a proximal end of the insertion tube, the insertion tube is provided with an inner cavity for the control rod, the suture line, and the puncture needle to pass through, a proximal end of the control rod is connected to the handle for controlling the second clamping member to move relative to the first clamping member to clamp or release the target tissue.

[0015] In one embodiment, the suture device further comprises a traction wire, the handle is connected to a proximal end of the traction wire for controlling the traction wire to reciprocate, and a distal end of the traction wire is connected to a proximal end of the first clamping member.

[0016] The tip component of the suture device and the suture device according to the above-mentioned embodiments comprise a first clamping member and a second clamping member, a distal end of the first clamping member is movably connected to a first end of the second clamping member, and a clamping space for clamping the target tissue is formed between the first clamping member and the second clamping member. When the second clamping member moves towards the first clamping member, the target tissue is clamped, thereby preventing mutual displacement between the tip of the suture device and the target tissue, and after clamping, the puncture needle is inserted into the second accommodating groove through the slot of the second accommodating groove and connected to the connector, and in the process of inserting the puncture needle, the puncture needle will pass through the target tissue, which is simple and fast, and is conducive to improving the efficiency of the suture operation. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 FIG. 1 is a structural schematic view of a tip component of a suture device according to one embodiment; Figure 2Structure diagram of a second end of a second clamping member of an embodiment provided with a second accommodating groove; Figure 3 Structure diagram of a proximal end of a first clamping member of an embodiment provided with a connecting member; Figure 4 Structure diagram of a suture provided with a flow blocking piece of an embodiment; Figure 5 Structure diagram of a connecting head and a puncture needle of an embodiment; Figure 6 Structure diagram of a first clamping member of an embodiment; Figure 7 Structure diagram of a cross section of a first clamping member of an embodiment; Figure 8 Structure diagram of a distal end of a first through hole of an embodiment provided with a clearance opening; Figure 9 Structure diagram of a second clamping member of an embodiment; Figure 10 Structure diagram of a connecting member of an embodiment provided with a recess; Figure 11 Structure diagram of a connecting member of an embodiment provided with a filler slot; Figure 12 Structure diagram of a suture device of an embodiment; Figure 13 Structure diagram of a tip part of a suture device of an embodiment extending between two suture objects; Figure 14 Structure diagram of a target tissue located between a first clamping member and a second clamping member when the second clamping member of an embodiment is opened; Figure 15 Structure diagram of a target tissue clamped in a clamping space when the second clamping member of an embodiment is closed; Figure 16 Structure diagram of a flow blocking piece of an embodiment being released from a third accommodating groove; Figure 17 Structure diagram of a target tissue released when the second clamping member of an embodiment is opened; Figure 18 Structure diagram of a suture device of an embodiment being withdrawn; Figure 19 Structure diagram of two ends of a suture fixed by a locking nail after suture of an embodiment is completed; Figure 20 Structure diagram of a flow blocking piece of an embodiment adhering to a suture site after suture is completed; Figure 21An exploded view of the tip component of the suturing device of one embodiment.

[0018] BRIEF DESCRIPTION OF DRAWINGS 1 - first clamping member; 101 - first accommodating groove; 102 - third accommodating groove; 103 - clamping notch; 104 - wire exit hole; 105 - first through hole; 106 - second guide slope; 107 - blind hole; 108 - clearance opening; 109 - hinged seat; 110 - notch; 111 - first guide slope; 112 - second through hole; 113 - guide slope; 2 - second clamping member; 201 - second accommodating groove; 202 - extension section; 203 - clamping section; 204 - protrusion structure; 205 - wire passing notch; 206 - tapered surface; 207 - first end; 208 - second end; 3 - suture; 4 - baffle; 5 - connecting member; 501 - groove; 502 - main body; 503 - limiting portion; 6 - driving mechanism; 601 - driving block; 602 - push-pull arm; 603 - control rod; 7 - insertion tube; 8 - clamping space; 9 - connecting head; 10 - fixing pin; 11 - traction wire; 12 - handle; 1201 - wire reel; 13 - target tissue; 14 - puncture needle; 15 - tip component; 16 - locking pin. DETAILED DESCRIPTION

[0019] The application will be further described in details through specific embodiments and with reference to the drawings. In different embodiments, similar elements are denoted by similar reference numerals. In the following embodiments, many details are described in order to make the application better understood. However, those skilled in the art can easily recognize that some features can be omitted in different cases, or can be replaced by other elements, materials or methods. In some cases, some operations related to the application are not shown or described in the specification in order to avoid the core of the application being overwhelmed by too many descriptions, and those skilled in the art can fully understand the related operations according to the description in the specification and the general technical knowledge in the art.

[0020] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various embodiments. Meanwhile, the steps or actions in the method description can also be sequentially adjusted or adjusted in a manner that is obvious to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing one embodiment, and do not mean that the sequence is necessary, unless otherwise stated that a certain sequence must be followed.

[0021] The serial numbers of components in this paper, such as "first", "second", etc., are only used to distinguish the described objects, and have no technical meaning. The "connection" and "coupling" in this application include direct and indirect connection (coupling) unless otherwise specified.

[0022] Please refer to Figures 1 to 21 The end part of the suturing device provided by the embodiments of the present application comprises a first clamping part 1, a second clamping part 2, and other functional parts as needed, which are connected to the distal end of the insertion tube 7. The specific description is as follows.

[0023] The first clamping part 1 in the embodiments is used to connect to the distal end of the insertion tube 7, and the second clamping part 2 is located on the opposite sides of the first clamping part 1. The distal end of the first clamping part 1 is movably connected to the first end 207 of the second clamping part 2, forming a clamping space 8 between the first clamping part 1 and the second clamping part 2 for clamping the target tissue. The first clamping part 1 is provided with a first accommodating groove 101 for assembling the suture 3. The second end 208 of the second clamping part 2 opposite to the first end 207 is provided with a second accommodating groove 201 for accommodating the connecting head 9 of the end of the suture 3. The groove of the second accommodating groove 201 is used for inserting the puncture needle 14 connected to the connecting head 9.

[0024] It can be understood that the opposite sides in the embodiments are the opposite sides on the peripheral sidewall between the two ends of the first clamping part 1. The two ends are the proximal end and the distal end. The proximal end is the end close to the handle 12 of the suturing device, and the distal end is the end away from the handle 12 of the suturing device. The handle 12 of the suturing device is exposed outside the body for operation and control. In some embodiments, such as Figure 1 , Figure 2The two second clamping members 2 can be symmetrically arranged on the opposite sides of the first clamping member 1, but are not limited thereto. In some embodiments, the two second clamping members 2 can be symmetrically arranged on the opposite sides of the first clamping member 1. The clamping space 8 in the present embodiment is located between the first clamping member 1 and the second clamping member 2, i.e., the first clamping member 1 and the second clamping member 2 can directly contact the target tissue to clamp the target tissue, and the clamping space 8 is also a space for accommodating the target tissue. The material of the first clamping member 1 and the second clamping member 2 in the present embodiment is not specifically limited, and can be metal, plastic or other materials. The second accommodating groove 201 is used to accommodate the connecting head 9 arranged at the end of the suture 3. During suturing, the target tissue enters the clamping space 8, and then the second clamping member 2 moves towards the first clamping member 1 to clamp the target tissue between the first clamping member 1 and the second clamping member 2. Then the puncture needle 14 passes through the target tissue from the proximal end to the distal end, and is inserted into the second accommodating groove 201 through the slot of the second accommodating groove 201 to connect with the connecting head 9. Then the connecting head 9 can be pulled out of the second accommodating groove 201 by the puncture needle 14, and the connecting head 9 and the suture 3 can pass through the target tissue from the distal end to the proximal end under the dragging of the puncture needle 14 to perform suturing. The second accommodating groove 201 is arranged at the second end 208 of the second clamping member 2. After the target tissue is clamped, the connecting head 9 is located on one side of the target tissue, and the puncture needle 14 is located on the other side of the target tissue. During puncture, the puncture needle 14 directly passes through the target tissue, so that the operation is simple and fast, and no additional device and step are needed during the operation to perform suturing, which reduces the operation difficulty and is beneficial to improving the surgical efficiency of suturing.

[0025] As Figure 2 , Figure 4 , Figure 5The connecting head 9 in the embodiment can be, but is not limited to, a fixing member fixed on the end of the suture 3, the distal end of the puncture needle 14 is inserted into and fixedly connected with the fixing member, and the connection between the fixing member and the puncture needle 14 can be, but is not limited to, clamping. Specifically, the fixing member can have an inner cavity for inserting the needle of the puncture needle 14, the needle of the puncture needle 14 is provided with a clamping flange structure, and the inner cavity wall of the fixing member is provided with a protruding structure for clamping the flange structure. The protruding structure in the embodiment can be, but is not limited to, an elastic clamping protrusion. When clamping, the needle of the puncture needle 14 is inserted into the inner cavity of the fixing member, so that the flange structure on the puncture needle 14 extrudes the protruding structure on the inner cavity wall, until the flange structure passes through the protruding structure, and the protruding structure is reset against the flange structure on the puncture needle 14 to form clamping. The embodiment does not limit the connection mode between the end of the suture 3 and the fixing member, for example, the end of the suture 3 can be connected by ring compression fastening. The connecting head 9 in the embodiment can also have other structures, for example, the connecting head 9 can be a connecting ring provided on the end of the suture 3, the needle of the puncture needle 14 is connected and fixed with the connecting ring through a hook-shaped structure or a clamping structure, or the connecting head 9 can be a knot provided on the end of the suture 3, and the puncture needle 14 is directly inserted into the knot to hook out the knot.

[0026] The first clamping member 1 in the embodiment is fixedly connected with the insertion tube 7, the first clamping member 1 is a structure that is fixed in the tip part, and the second clamping member 2 is a structure that can move in the tip part. The embodiment does not limit the specific structure of the second clamping member 2, and any structure that can move and clamp the target tissue is acceptable, for example, the second clamping member 2 can be a straight arm structure or a curved arm structure. The distal end of the first clamping member 1 is movably connected with the first end 207 of the second clamping member 2 in the embodiment, and the movable connection in the embodiment can be achieved by any one of hinging, nesting, and hinge connection. In the embodiment, the first clamping member 1 is provided with a first accommodating groove 101 for assembling the suture 3, so that the suture 3 does not need other devices or structures for assembly, simplifying the structure of the suturing device, and realizing clamping and suturing of the suturing device at the same time, which is more conducive to the operation of puncture suturing.

[0027] The tip part of the suturing device in the above embodiment includes the first clamping member 1 and the second clamping member 2, the distal end of the first clamping member 1 is movably connected with the first end 207 of the second clamping member 2, forming a clamping space 8 between the first clamping member 1 and the second clamping member 2 for clamping the target tissue. When the second clamping member 2 moves towards the first clamping member 1, the target tissue is clamped, thereby preventing mutual displacement between the tip of the suturing device and the target tissue, and after clamping, the puncture needle 14 is inserted into the second accommodating groove 201 through the slot of the second accommodating groove 201 and connected with the connecting head 9. During the insertion of the puncture needle 14, the puncture needle 14 will pass through the target tissue, which is simple and fast, and is conducive to improving the operation efficiency of suturing.

[0028] In one embodiment, as shown in Figure 1 , Figure 2 , Figure 6 , Figure 7 , the first clamping member 1 is provided with a third accommodating groove 102 for accommodating the flow resistance sheet 4 provided on the suture 3, the third accommodating groove 102 is in communication with the first accommodating groove 101, and the first accommodating groove 101 and the third accommodating groove 102 are each provided with an opening for the suture 3 and the flow resistance sheet 4 to be pulled out of the corresponding groove. The third accommodating groove 102 can accommodate the flow resistance sheet 4, which can provide the implementation condition for the flow resistance sheet 4 provided on the suture 3. After the suture 3 is provided with the flow resistance sheet 4, the flow resistance sheet 4 can be pre-assembled in the third accommodating groove 102 during assembly, and the suture 3 can be pulled out of the distal end of the first accommodating groove 101, and then the connecting head 9 at the end of the suture 3 can be placed in the second accommodating groove 201. During suturing, the leading end of the suturing device is inserted into the body, the target tissue is clamped by the first clamping member 1 and the second clamping member 2, and then the puncture needle 14 is inserted into the second accommodating groove 201 through the opening of the second accommodating groove 201 to connect with the connecting head 9. Then the suture 3 is pulled out, and at this time the flow resistance sheet 4 can be pulled out of the opening of the third accommodating groove 102, and the suture 3 can be pulled out of the opening of the first accommodating groove 101. The flow resistance sheet 4 can be fixed at the target suture site by continuing to pull the suture 3 for suturing. The flow resistance sheet 4 has the effect of resisting flow at the suture site, which is beneficial to achieve good closure of the suture site, and can prevent the leaflets of the mitral valve from being torn by the suture 3, thereby improving the surgical treatment effect. In the present embodiment, the first accommodating groove 101 can have a through structure from the proximal end to the distal end. In some embodiments, when the suture 3 of the suturing device is folded for assembly, the width or depth of the first accommodating groove 101 can be greater than or equal to twice the diameter of the suture 3. The depth refers to the height of the opening of the accommodating groove from the groove bottom. In the present embodiment, the openings of the first accommodating groove 101 and the third accommodating groove 102 are located on the side wall of the first clamping member 1 and are opposite to the groove bottom. The first accommodating groove 101 and the third accommodating groove 102 in the present embodiment can have a structure that penetrates from the proximal end to the distal end of the first clamping member 1. The specific shape of the third accommodating groove 102 is not limited in the present embodiment, and it can be used to assemble the flow resistance sheet 4. For example, the shape of the third accommodating groove 102 can be adapted to the shape of the flow resistance sheet 4 (including any shape that the flow resistance sheet 4 can deform), and the third accommodating groove 102 can limit the flow resistance sheet 4 by embedding. Alternatively, the shape of the third accommodating groove 102 can not be adapted to the shape of the flow resistance sheet 4, and the third accommodating groove 102 can limit the flow resistance sheet 4 by clamping.

[0029] In one embodiment, as shown in Figure 1 , Figure 7, the second clamping piece 2 is located on opposite sides of the first clamping piece 1, the first accommodating groove 101 and the third accommodating groove 102 are located on one of the other opposite sides of the first clamping piece 1; the third accommodating groove 102 is arranged at the proximal end of the first clamping piece 1, the first accommodating groove 101 is located at the distal end side of the third accommodating groove 102, the opposite sides of the distal end of the first accommodating groove 101 are provided with wire outlet holes 104, the hole wall of the wire outlet hole 104 is provided with a gap 110 for the suture 3 to exit, and the gap 110 is in communication with the opening of the first accommodating groove 101 for the suture 3 to exit. The first accommodating groove 101 in the embodiment is used to assemble the suture 3, the opposite sides of the distal end of the first accommodating groove 101 are provided with wire outlet holes 104, so that the suture 3 assembled in the first accommodating groove 101 can pass out through the wire outlet holes 104 on the two sides, which is more conducive to the separation of the suture 3 on the opposite sides when pulling the suture 3 after puncture, preventing the suture 3 on the opposite sides from being entangled and knotted with each other. The wire outlet hole 104 in the embodiment can be vertically through the first accommodating groove 101, that is, the extension direction of the wire outlet hole 104 is perpendicular to the extension direction of the first accommodating groove 101, for example, the extension direction of the first accommodating groove 101 can be the same as the axial extension direction of the insertion tube 7, and the extension direction of the wire outlet hole 104 can be perpendicular to the axial extension direction of the insertion tube 7. The gap 110 of the wire outlet hole 104 can make the suture 3 exiting from the first accommodating groove 101 continue to exit from the gap 110 of the wire outlet hole 104. Through the guidance of the wire outlet hole 104, the suture 3 can be stretched out from the side of the first clamping piece 1, and the suture 3 stretched out from the side is not easy to affect the insertion of the tip of the suturing device. In some embodiments, the length of the gap 110 can be the same as the length of the wire outlet hole 104, and the width of the gap 110 is not easy to be too large, so that the suture 3 can exit.

[0030] In one embodiment, the distal end of the first clamping member 1 is provided with a hinged seat 109, which is hingedly connected with the first end 207 to form a movable connection; the wire outlet hole 104 is in a C shape, and a gap 110 for the suture 3 to exit is formed between the two opposite ends of the C shape. The wire outlet hole 104 is located on the proximal side of the hinged seat 109, and the gap 110 for the suture 3 to exit is located on the side of the wire outlet hole 104 close to the hinged seat 109. In this embodiment, the wire outlet hole 104 is in a C shape, i.e., the cross section of the wire outlet hole 104 is in a C shape, which is the cross section of the wire outlet hole 104 perpendicular to the axis direction of the wire outlet hole 104. The gap 110 is located on the side of the wire outlet hole 104 close to the hinged seat 109, which is beneficial for the suture 3 to exit from the wire outlet hole 104. The wire outlet hole 104 is located on the proximal side of the hinged seat 109, which can avoid the influence of the extended suture 3 on the movable connection between the second clamping member 2 and the hinged seat 109 before the suture 3 exits. The two opposite ends of the C-shaped wire outlet hole 104 can form a certain limiting effect on the suture 3 that has not exited, preventing the suture 3 from exiting from the wire outlet hole 104 before the suture 3 is started to be sutured. At the same time, during the suture process, when the suture 3 is to be exited from the wire outlet hole 104, the suture 3 can be easily exited from the gap 110 when it is pulled by force. In some application scenarios, the wire outlet hole 104 can also not be provided according to needs, for example, when the suture 3 is not provided with the flow resistance piece 4, the suture 3 can be directly exited from the distal end of the first accommodating groove 101. In some embodiments, the second clamping member 2 can be located on the front and rear sides of the first clamping member 1, and the first accommodating groove 101 and the third accommodating groove 102 are both located on the upper side of the first clamping member 1. The left and right ends of the first clamping member 1 are respectively the distal end and the proximal end.

[0031] In some embodiments, as Figures 6 to 8, the opposite sides of the hinged seat 109 can protrude from the side wall surface adjacent to the first clamping member 1, the protruding portions on the opposite sides of the hinged seat 109 are provided with hinged through holes, and the first end 207 of the second clamping member 2 is hinged to the first end 207 through a pin passing through the corresponding hinged through hole. The opposite sides of the hinged seat 109 protrude from the side wall surface adjacent to the first clamping member 1, and the hinged through holes are arranged on the protruding portions on the opposite sides of the hinged seat 109, which is more conducive to the formation of the clamping space 8 and avoids the risk of the target tissue being clamped by the second clamping member 2 due to the small space between the second clamping member 2 and the first clamping member 1. In some embodiments, the second clamping member 2 can also be hinged at other positions of the first clamping member 1, and the hinging between the second clamping member 2 and the first clamping member 1 can be achieved. In the embodiment, the axis of the hinged through hole extends perpendicularly to the axial extension direction of the control rod 603, and in some embodiments, the approximate perpendicularity is equivalent to the perpendicularity in the embodiment. In some embodiments, in order to improve the fixing effect of the wire outlet hole 104 on the suture line 3 before the suture line 3 is pulled out, the central axis of the wire outlet hole 104 can be flush with or lower than the side surface of the corresponding side of the hinged seat 109, and the side surface of the corresponding side of the hinged seat 109 is the side surface of the hinged seat 109 corresponding to the first accommodating groove 101 and the wire outlet hole 104. The shape of the hinged seat 109 is not limited in the embodiment, and the hinged seat 109 can be used for active connection, for example, the hinged seat 109 can have a block structure. The wire outlet hole 104 is located on the proximal side of the hinged seat 109, the first end 207 of the second clamping member 2 is hinged to the hinged seat 109, and the second accommodating groove 201 is arranged on the second end 208 of the second clamping member 2. As shown in Figure 2 , after the suture line 3 extends out of the wire outlet hole 104, the suture line 3 can extend to the second accommodating groove 201 along the inner side surface of the second clamping member 2, the end portion of the suture line 3 is fixed to the second end 208 of the second clamping member 2 through the connecting head 9 in the second accommodating groove 201, and when the second clamping member 2 is opened, the suture line 3 also moves away from the first clamping member 1 with the second clamping member 2. At this time, the target tissue is located in the clamping gap 103 by moving the first end portion, and then the second clamping member 2 is closed. After the second clamping member 2 is closed, the suture line 3 is attached to one side of the target tissue, and then the suture line 3 is pulled from the other side of the target tissue by the connecting head 9 passing through the target tissue to achieve suture. The suture line 3 is attached to the inner side surface of the second clamping member 2, and the movement of the suture line 3 is more controllable.

[0032] In one embodiment, as Figure 2 , Figure 10The proximal end of the first clamping piece 1 is provided with a connecting piece 5 for connecting the insertion tube 7. The distal end surface of the connecting piece 5 is provided with a groove 501. The slot of the groove 501 is in communication with the proximal end of the third accommodating groove 102. The groove 501 is used for cooperating with the end of the baffle 4 to limit the baffle 4. In the embodiment, the proximal end of the third accommodating groove 102 is not provided with a groove wall, so that the groove 501 is in communication with the third accommodating groove 102. In the embodiment, the groove wall of the groove 501 limits the baffle 4. The groove 501 and the third accommodating groove 102 form a structure for pre-fixing the baffle 4. The part of the structure for fixing the baffle 4 is arranged on the connecting piece 5, and the part of the structure is arranged on the first clamping piece 1, which is beneficial to reduce the processing difficulty of the fixing structure of the baffle 4. In the embodiment, the depth of the groove 501 can be set according to the need. The baffle 4 can be limited to prevent the baffle 4 from being pulled out when not under stress, and the baffle 4 can be pulled out under stress. In some embodiments, the groove bottom of the groove 501 can be provided with a through hole in communication with the inner cavity in the insertion tube 7 for the suture 3 to pass through, so as to pass through the suture 3 extending from the end of the baffle 4 matched in the groove 501. In the embodiment, the connecting piece 5 can be fixed with the first clamping piece 1 by welding, but is not limited to welding. In some application scenarios, the connecting piece 5 and the first clamping piece 1 can also be directly manufactured as an integrated structure. In some embodiments, when the hole structure in communication with the inner cavities in the insertion tube 7 is arranged on the first clamping piece 1, the corresponding hole structure can also be arranged on the connecting piece 5.

[0033] In one embodiment, as Figure 2 、 Figure 3 、 Figure 11The proximal end surface of the connecting piece 5 is provided with a filler groove for heat melting connection with the insertion tube 7. The filler groove comprises a main body portion 502 located in the middle of the connecting piece 5, and at least two limiting portions 503 extending from the main body portion 502 to the peripheral edge of the connecting piece 5. The width of the limiting portion 503 near the edge is a first width, and the width of the limiting portion 503 near the middle is a second width. In the limiting portion 503, the first width of at least one limiting portion 503 is greater than the second width. At least one limiting portion 503 is a hole structure penetrating from the main body portion 502 to the peripheral side wall of the connecting piece 5. The connecting piece 5 is beneficial for the fixed connection between the first clamping piece 1 and the insertion tube 7. The filler groove provided on the connecting piece 5 can be heat melting connected with the insertion tube 7 through a heat melting process. At this time, the insertion tube 7 can be made of a material that can be heat melted. The filler groove in the embodiment has a main body portion 502 in the middle and limiting portions 503 around the periphery. The main body portion 502 can ensure the strength of the connection between the connecting piece 5 and the insertion tube 7. The limiting portions 503 around the periphery can form circumferential limiting, which is beneficial for improving the stability of the connection between the connecting piece 5 and the insertion tube 7. In the limiting portion 503, the first width of at least one limiting portion 503 is greater than the second width, so that radial limiting can be formed, which is beneficial for preventing the displacement of the connecting piece 5 in the radial direction of the insertion tube 7. At least one limiting portion 503 is a hole structure penetrating from the main body portion 502 to the peripheral side wall of the connecting piece 5. After heat melting connection, the material of the end portion of the insertion tube 7 is inserted into the hole structure, which prevents the insertion tube 7 from coming out and forms limiting in the axial direction of the insertion tube 7. That is, the filler groove can form circumferential, radial and axial limiting, which increases the connection stability between the insertion tube 7 and the connecting piece 5, and also ensures the strength of the connection between the connecting piece 5 and the insertion tube 7. In some embodiments, the connecting piece 5 can also be connected with the insertion tube 7 through other ways, such as adhesion.

[0034] In one embodiment, as Figure 2 、 Figure 9, the second accommodating groove 201 is a blind hole provided on the second end 208, the hole opening of the blind hole is the groove opening of the second accommodating groove 201, the hole opening of the blind hole is located on the end face of the second end 208, and the hole wall of the blind hole close to the first clamping piece 1 is provided with a wire passing gap 205 penetrating through the hole wall. The bottom of the blind hole can limit the connecting head 9, which is beneficial to the connection between the puncture needle 14 and the connecting head 9. In order to prevent the connecting head 9 from being mistakenly detached from the blind hole, the depth of the blind hole can be set to be relatively deep, for example, the depth of the blind hole can be greater than twice the length of the connecting head 9. The hole opening of the blind hole is located on the end face of the second end 208, that is, the proximal end face of the second clamping piece 2 when the second clamping piece 2 is in a closed state. After the second clamping piece 2 clamps the target tissue, the proximal end face of the second clamping piece 2 is opposite to the puncture needle 14, and the groove opening of the second accommodating groove 201 is located on the proximal end face of the second clamping piece 2, so that the puncture needle 14 can be directly inserted into the blind hole and connected with the connecting head 9 after passing through the target tissue. In the embodiment, when the second clamping piece 2 is closed, the extending direction of the axis of the blind hole can be parallel to the extending direction of the axis of the puncture needle 14, and in order to enable the puncture needle 14 to be smoothly inserted into the blind hole, the central axis of the blind hole can also coincide with the central axis of the hole in the first clamping piece 1 for assembling the puncture needle 14. In the embodiment, parallel and approximately parallel, and coincidence and approximately coincidence are equivalent replacements. In some application scenarios, the groove opening of the second accommodating groove 201 can also be arranged at other parts of the second clamping piece 2 according to needs. When the connecting head 9 is assembled, the connecting head 9 can be placed in the blind hole, and the wire passing gap 205 arranged therein forms a space for the suture 3 connected with the connecting head 9, so that the suture 3 can extend out of the blind hole away from the hole opening, which is beneficial to improving the stability of the connecting head 9 accommodated in the blind hole. In order to prevent the connecting head 9 from being detached from the wire passing gap 205, the width of the wire passing gap 205 needs to be slightly smaller than the connecting head 9 and greater than the width of the suture 3. The length of the wire passing gap 205 is not limited in the embodiment, for example, the length of the wire passing gap 205 can be the same as the depth of the blind hole, or can also be different. In some application scenarios, the wire passing gap 205 can also not be arranged, for example, the connecting head 9 can be arranged in the blind hole, so that the suture 3 connected with the connecting head 9 extends out of the hole opening through the side wall of the connecting head 9. In some embodiments, the hole opening of the blind hole is provided with a tapered surface 206 for guiding the puncture needle 14 to be inserted into the connecting head 9, and the tapered surface 206 can guide the puncture needle 14 to be smoothly inserted into the blind hole and connected with the connecting head 9. In some embodiments, the hole opening of the blind hole can also be provided with a guiding arc surface, or can also not be provided with a guiding surface. The second accommodating groove 201 in the embodiment is not limited to the structure of the blind hole, and can also be other structures, for example, the second accommodating groove 201 can be a through hole structure, a clamping structure is arranged in the through hole, and the connecting head 9 is fixed by a releasable clamping manner.

[0035] In one embodiment, asFigure 1 、 Figure 2 、 Figure 21 The tip component further comprises a driving mechanism 6, which comprises a driving block 601 fixedly connected with the distal end of the control rod 603, and a push-pull arm 602 arranged on the opposite sides of the driving block 601. One end of the push-pull arm 602 is hingedly connected with the driving block 601, and the other end is hingedly connected with the second clamping piece 2 on the corresponding side. The hinged part of the push-pull arm 602 and the second clamping piece 2 is located between the first end 207 and the second end 208, and the first end 207 is hingedly connected with the distal end of the first clamping piece 1 to form a movable connection. In the embodiment, the driving block 601 is connected with the control rod 603, and the axial movement of the control rod 603 can drive the axial movement of the driving block 601. The movement of the driving block 601 can pull the second clamping piece 2 to rotate around the distal end of the first clamping piece 1 through the push-pull arm 602, so as to realize the opening or closing of the second clamping piece 2. In use, the control rod 603 can be moved towards the proximal end to move the driving block 601 towards the proximal end and the second clamping piece 2. At this time, the first clamping piece 1 is closed, and the target tissue is clamped between the first clamping piece 1 and the second clamping piece 2. The control rod 603 is moved towards the distal end to push the driving block 601 towards the distal end and away from the first clamping piece 1. At this time, the second clamping piece 2 is opened, and the target tissue can be released. The specific connection mode between the driving block 601 and the control rod 603 is not limited in the embodiment, and any mode that can realize the transmission of movement can be used. For example, a through hole or a blind hole can be arranged on the driving block 601, the distal end of the control rod 603 is inserted into the through hole or the blind hole and is welded and fixed, or the driving block 601 can be fixed in the through hole or the blind hole through interference fit. The extension direction of the through hole or the blind hole on the driving block 601 is the same as the axial extension direction of the control rod 603.

[0036] In one embodiment, the driving mechanism 6 can also be other mechanisms that can realize the opening or closing of the second clamping piece 2, for example, the driving block can not be provided, and two control rods can be directly provided, the control rods have certain strength and bendability, the distal ends of the control rods are extended through the first clamping piece 1 and are hinged to the second clamping piece 2, the hinged positions of the control rods and the second clamping piece 2 are located between the first end 207 and the second end 208, the first end 207 of the second clamping piece 2 is hinged to the distal end of the first clamping piece 1, and in use, the two control rods are directly pushed to move to the distal end, so as to push the second clamping piece 2 to open, and the two control rods are pulled to move to the proximal end, so as to pull the second clamping piece 2 to close. In the embodiment, the hinge is a connection between two objects that can rotate relative to each other, for example, but is not limited to, a hinge is formed by a pin sequentially penetrating the hinged objects, in order to prevent the pin from falling out, a limiting structure can be provided at both ends of the pin, for example, an axial limiting end cap can be fixedly arranged at one end of the pin, and a limiting ring can be fixed by welding at the other end after penetrating the hinged objects, or a limiting pin can also be fixed by welding at the other end after penetrating the hinged objects, in order to improve the slip resistance of the outer wall surface of the end component, the outer surface of the end cap and the limiting ring at both ends of the pin can be provided as an arc surface. In the embodiment, the first end 207 and the second end 208 of the second clamping piece 2 can be the distal end and the proximal end of the second clamping piece 2 when the second clamping piece 2 is in the closed state.

[0037] In one embodiment, as Figure 9As shown, the second end 208 of the second clamping piece 2 is provided with a clamping section 203, and the inner side surface of the clamping section 203 is parallel to the side wall surface of the corresponding part of the first clamping piece 1. In this embodiment, the inner side surface of the clamping section 203 is the side surface of the second clamping piece 2 close to the first clamping piece 1 when the second clamping piece 2 is in the closed state, and the inner side surface of the clamping section 203 is parallel to the side wall surface of the corresponding part of the first clamping piece 1, which is beneficial to improve the clamping effect on the target tissue, can relatively increase the contact area with the target tissue, and reduce the probability of injury to the target tissue due to local contact. In this embodiment, the side wall surface of the corresponding part of the first clamping piece 1 is a clamping surface, and the inner side surface of the clamping section 203 and the side wall surface of the corresponding part of the first clamping piece 1 can be an arc surface, a plane or a combined surface. When the inner side surface of the clamping section 203 is a plane, the side wall surface of the corresponding part of the first clamping piece 1 is also a plane, and when the inner side surface of the clamping section 203 is an arc surface, the side wall surface of the corresponding part of the first clamping piece 1 is also an arc surface. In some embodiments, in order to effectively clamp and not to injure the target tissue and improve the clamping effect, an anti-skid rib structure 204 can be arranged on the inner side surface of the clamping section 203 or the side wall surface of the corresponding side of the first clamping piece 1, and the protruding end of the rib can be provided with an arc surface, but is not limited to this. The rib structure 204 of this embodiment can be any protruding shape, for example, it can be a triangular shape, a circular arc shape, etc., and when the cross section of the rib structure 204 is triangular, the included angle formed by the two edges of the protruding part can be 30°-80°, the rib structure 204 with this included angle range has good clamping effect and is not easy to injure the tissue, and specifically, the included angle formed by the two edges of the protruding part can be 60°. In some embodiments, in order to further improve the clamping effect, the rib structure 204 can be arranged on one of the inner side surface of the clamping section 203 and the side wall surface of the corresponding side of the first clamping piece 1, and the other surface is provided with a groove structure corresponding to the rib structure 204.

[0038] In one embodiment, the second clamping member 2 further includes an extension section 202, which is located on a side of the clamping member 203 near the first end 207. When the second clamping member 2 is closed, the distance between the inner side surface of the clamping member 203 and the side wall surface of the corresponding portion on the first clamping member 1 is a first distance, and the distance between the inner side surface of the extension section 202 and the side wall surface of the corresponding portion on the first clamping member 1 is a second distance, wherein the first distance is less than the second distance. In some embodiments, the length of the second clamping member 2 may be, but is not limited to, 4 mm to 10 mm, and its length may be equal to or approximately equal to the distance from the edge of the rough portion of the target tissue to the position to be sutured. The extension section 202 can extend the length of the second clamping member 2, allowing the clamping section 203 to clamp the tissue near the middle of the rough portion of the mitral valve leaflet (i.e., the position to be sutured), which helps to avoid the suture site being too close to the edge of the rough portion of the mitral valve or the transparent area of ​​the mitral valve, thereby avoiding the risk of tearing of the mitral valve leaflet during suturing. The first distance is smaller than the second distance, so that only the clamping section 203 can be in contact with the target tissue. The smaller the contact area, the greater the force per unit area, which helps to ensure a sufficiently large clamping force. At the same time, it can also ensure that only the target tissue near the location to be sutured is clamped, preventing the impact of clamping a large area of ​​the target tissue on hemodynamics. In some application scenarios, the extension section 202 can be omitted, and the length of the clamping section 203 on the second clamping member 2 can be relatively increased to achieve stable clamping of the target tissue by adjusting the clamping force.

[0039] In one embodiment, if Figure 1 、 Figure 6The first clamping member 1 has clamping notches 103 on opposite sides, with the second clamping member 2 positioned within the clamping notches 103 on the corresponding side. A gap is left between the first and second clamping members 1 and 2 to form an L-shaped clamping space 8. Through holes for receiving the puncture needle 14 are provided on opposite sides of the first clamping member 1. These through holes correspond to the second receiving grooves 201 on the corresponding second clamping member 2 and communicate through the corresponding clamping space 8. In this embodiment, the through hole for receiving the puncture needle 14 is a first through hole 105. The first through hole 105 corresponds to the second receiving groove 201 on the corresponding second clamping member 2, i.e., the positions of the first through hole 105 and the second receiving groove 201 correspond, allowing the puncture needle 14 to be inserted into the second receiving groove 201. In this embodiment, the first through hole 105 can communicate with the inner cavity of the insertion tube 7 for receiving the puncture needle 14, allowing the puncture needle 14 to pass through the corresponding inner cavity of the insertion tube 7 and the first through hole 105 on the first clamping member 1. In some embodiments, the first clamping member 1 can be made of a cylinder as the processing material, and clamping notches 103 are processed on two opposite sides of the cylinder. A clamping section is formed between the two clamping notches 103, and the portion without the clamping notches 103 forms a cylindrical main section. The clamping section can be located at the distal end of the main section. The second clamping member 2 is located in the clamping notches 103 on the corresponding side, which can reduce the distance between the two second clamping members 2, which is beneficial to reducing the external dimensions of the front end component and expanding the scope of application of the suturing device. In some embodiments, the outer side surface of the second clamping member 2 may not protrude from the outer wall surface of the main section. For example, the outer side surface of the second clamping member 2 may be lower than the outer wall surface of the main section. In this case, the suture 3 is not easily stuck between the second clamping member 2 and the insertion tube 7, which is more conducive to the suture 3 coming out. In this embodiment, the second end 208 of the second clamping member 2 is the end of the second clamping member 2 that is not connected to other components, and the first end 207 of the second clamping member 2 is the other end opposite to the second end 208. The clamping space 8 in this embodiment is the part of the front end component that accommodates the target tissue. The part of the L-shaped clamping space 8 corresponding to the inner side surface of the second clamping member 2 is used to clamp the target tissue. The part of the L-shaped clamping space 8 corresponding to the end surface of the second end 208 is used to limit the specific direction of the puncture surface of the target tissue. After clamping the target tissue, Figure 15, the target tissue in the clamping space 8 is in L shape, the part of the target tissue 13 adhering to the inner side of the second clamping piece 2 is tightly fixed by the second clamping piece 2, the part of the target tissue 13 adhering to the end face of the second end 208 of the second clamping piece 2 is positioned for puncture, and the part of the target tissue 13 adhering to the inner side of the second clamping piece 2 is relatively far away from the edge position of the suture object, which can improve the stability of the suture. The part of the target tissue 13 adhering to the end face of the second end 208 of the second clamping piece 2 is positioned vertically or approximately vertically to the puncture direction, which facilitates puncture. In some embodiments, an arc transition surface is provided between the inner side of the second clamping piece 2 and the end face of the second end 208, and the corresponding corner of the first clamping piece 1 can also be provided with an arc transition surface, which has a guiding effect on the turning of the target tissue 13.

[0040] In one embodiment, as shown in Figure 6 , Figure 8 , the first clamping piece 1 includes the clamping section, the main body section, the clamping notches 103 are located on the opposite sides of the clamping section, the main body section is located on the proximal side of the clamping notches 103, and the first through hole 105 is provided in the main body section; the side wall of the distal end of the first through hole 105 is provided with a displacement opening 108 penetrating to the outer side face of the main body section, the width of the displacement opening 108 is smaller than the hole diameter of the first through hole 105, the displacement opening 108 is in communication with the distal end aperture of the first through hole 105, and the distal end aperture of the first through hole 105 is provided with a guide inclined surface 113. The puncture needle 14 can directly extend out of the first through hole 105 to pass through the target puncture position, which is simple and fast. In the process of pulling the connecting head 9 by the puncture needle 14, the suture thread 3 will be pulled under the driving of the connecting head 9, after the puncture needle 14 pulls the connecting head 9 into the first through hole 105, the suture thread 3 will also be pulled into the first through hole 105, at this time, the suture thread 3 can move in the displacement opening 108, such as Figure 18 , that is, the suture thread 3 can pass into the first through hole 105 through the displacement opening 108, so that the angle of the suture thread 3 entering the first through hole 105 can be greater than 90 degrees, and the suture thread 3 is not easy to be stuck, which is beneficial to the withdrawal. In this embodiment, the guide inclined surface 113 provided at the distal end aperture of the first through hole 105 can guide the entry of the connecting head 9 when the puncture needle 14 pulls the connecting head 9 into the first through hole 105, which is also more conducive to the withdrawal.

[0041] In one embodiment, as shown in Figure 7As shown, the bottom of the third accommodating groove 102 can be lower than the bottom of the first accommodating groove 101, the bottom of the first accommodating groove 101 and the bottom of the third accommodating groove 102 are connected by the first guide slope 111, and the second guide slope 106 is arranged on the groove wall of the third accommodating groove 102 close to the first accommodating groove 101. The bottom of the third accommodating groove 102 is lower than the bottom of the first accommodating groove 101, that is, the distance between the bottom of the third accommodating groove 102 and the central axis of the first clamping piece 1 is greater than the distance between the bottom of the first accommodating groove 101 and the central axis of the first clamping piece 1, and the central axis of the first clamping piece 1 can be the same as the extending direction of the central axis of the insertion tube 7. The bottom of the third accommodating groove 102 is lower than the bottom of the first accommodating groove 101, so that when the anti-flow sheet 4 is pulled out of the third accommodating groove 102 by pulling the suture thread 3, the pulling direction of the suture thread 3 is an oblique upward force relative to the third accommodating groove 102, so that the anti-flow sheet 4 is more easily pulled out of the third accommodating groove 102. The first guide slope 111 can guide the movement of the suture thread 3, and the first guide slope 111 is also beneficial to reduce the wear of the suture thread 3. The second guide slope 106 can reduce the angle of the anti-flow sheet 4, which is more beneficial to the pulling out of the anti-flow sheet 4. In some embodiments, the first guide slope 111 and the second guide slope 106 can be planar or arc-shaped guide surfaces. In some embodiments, when the wire hole 104 is provided, the wire hole 104 can be lower than the bottom of the first accommodating groove 101, and a guide slope can also be arranged between the wire hole 104 and the bottom of the first accommodating groove 101. When the wire hole 104 is lower than the bottom of the first accommodating groove 101, it is beneficial to the separation of the suture thread 3 from the first clamping piece 1.

[0042] The tip component of the suture device in the above embodiment includes the first clamping piece 1 and the second clamping piece 2, the distal end of the first clamping piece 1 is movably connected with the first end 207 of the second clamping piece 2, and a clamping space 8 for clamping the target tissue is formed between the first clamping piece 1 and the second clamping piece 2. When the target tissue is clamped by the movement of the second clamping piece 2 towards the first clamping piece 1, the mutual displacement between the tip of the suture device and the target tissue can be prevented, and after clamping, the puncture needle 14 is inserted into the second accommodating groove 201 through the slot of the second accommodating groove 201 to be connected with the connector 9. During the insertion of the puncture needle 14, the puncture needle 14 will pass through the target tissue, which is simple and fast, and is beneficial to improve the efficiency of the suture operation.

[0043] Please refer to Figures 1 to 21 The suture device provided by the embodiment of the present application includes a handle 12, an insertion tube 7, a control rod 603, and the above-mentioned tip component 15, the tip component 15 is connected to the distal end of the insertion tube 7, the handle 12 is connected to the proximal end of the insertion tube 7, the insertion tube 7 is provided with an inner cavity for the control rod 603, the suture thread 3, and the puncture needle 14 to pass through, and the proximal end of the control rod 603 is connected with the handle 12 for controlling the movement of the second clamping piece 2 relative to the first clamping piece 1 to clamp or release the target tissue.

[0044] It can be understood that the suturing device in the embodiment can be applied to minimally invasive suturing repair of the mitral valve, and the target tissue 13 is the anterior leaflet and the posterior leaflet of the mitral valve, but is not limited thereto, and can be used for other minimally invasive suturing operations as required. The tip component 15 in the embodiment is the same as that in the above embodiment, and will not be described herein again. The handle 12 in the embodiment is exposed outside the body for operation control during the operation process, and a control button for controlling the opening and closing of the second clamping member 2 and a puncture button for controlling the puncture of the puncture needle 14 can be arranged on the handle 12. In some embodiments, a wire reel 1201 can also be arranged in the handle 12, and the proximal end of the suture 3 is wound on the wire reel 1201. When the flow blocking piece 4 is arranged on the suture 3, the flow blocking piece 4 can be made of a flexible material and has a certain deformation ability. The shape of the flow blocking piece 4 is not limited in the embodiment, for example, the flow blocking piece 4 can be a square implant. In some embodiments, as shown in FIG. 8, the flow blocking piece 4 is arranged on the suture 3, and the flow blocking piece 4 is arranged on the suture 3 in the form of a square implant. The flow blocking piece 4 is arranged on the suture 3 in the form of a square implant. Figure 4As shown, the flow blocker 4 can be folded in half and assembled in the third accommodating groove 102, the third accommodating groove 102 can be shaped to match the shape of the folded-in-half flow blocker 4, and the folded-in-half flow blocker 4 can be assembled with the end having the opening facing the distal end. The opposite ends of the flow blocker 4 are the third end and the fourth end, and the third end and the fourth end can overlap after being folded in half. The suture 3 in this embodiment can also be folded in half, and the end of the suture 3 having the thread end is located at the distal end after being folded in half, and the end of the suture 3 not having the thread end is located at the proximal end, and the proximal end of the suture 3 can be wound around the thread reel 1201 provided in the handle 12. The connection between the suture 3 and the flow blocker 4 in this embodiment can be that one end of the suture 3 passes through the third end and the other end of the suture 3 passes through the fourth end. When the flow blocker 4 has sufficient thickness, one end of the suture 3 can directly pass into the third end from the bent part of the flow blocker 4 folded in half, and pass out through the end of the third end, and the other end of the suture 3 can directly pass into the fourth end from the bent part of the flow blocker 4 folded in half, and pass out through the end of the fourth end. In some embodiments, the one end of the suture 3 passing through the third end in this embodiment can also be that the thread end of the suture 3 passes from the outside of the third end to the inside of the folded-in-half flow blocker 4, and the other end of the suture 3 passing through the fourth end can also be that the other thread end of the suture 3 passes from the outside of the fourth end to the inside of the folded-in-half flow blocker 4. In some embodiments, after passing from the outside to the inside, it can also pass out from the inside to the outside, at which time the fixation of the flow blocker 4 on the suture 3 is also stable. After one end of the suture 3 passes through the third end and the other end of the suture 3 passes through the fourth end, the flow blocker 4 can be opened under the pulling of the suture 3 under the driving of the two ends of the suture 3, and the third end and the fourth end of the flow blocker 4 can also be closed when the two ends of the suture 3 are gathered. The insertion tube 7 in this embodiment is provided with an inner cavity for the control rod 603, the suture 3, and the puncture needle 14 to pass through, and specifically, one inner cavity can be provided for the control rod 603, the suture 3, and the puncture needle 14, respectively, and in some application scenarios, one or two of the inner cavities can be combined into one inner cavity.

[0045] In one embodiment, as Figure 3 、 Figure 17, the suture device further comprises a traction wire 11, a handle 12 is connected with a proximal end of the traction wire 11 to control reciprocating movement of the traction wire 11, and a distal end of the traction wire 11 is fixedly connected with the proximal end of the first clamping member 1. In use, after the resistance plate 4 is pulled out of the third accommodating groove 102, the second clamping member 2 can be opened to release the target tissue 13, after the release, the traction wire 11 is axially and reciprocally pulled to make the front end member 15 vibrate, in the process of the vibration, the front end member 15 can be completely separated from the target tissue 13, after the separation, the suture device can be withdrawn from the body, and the setting of the traction wire 11 facilitates the withdrawal of the suture device, and is beneficial to improve the operation efficiency. In the embodiment, the traction wire 11 can be made of a material with certain strength, for example, a steel wire. In some embodiments, when the second clamping member 2 is completely opened, the second end 208 of the second clamping member 2 can be located on the distal end side of the first clamping member 1, and the connector 9 is located on the distal end side of the first clamping member 1 after assembly, at this time, it is beneficial to prevent the target tissue from being stuck by the second clamping member 2.

[0046] The embodiment does not limit the specific connection mode between the traction wire 11 and the proximal end of the first clamping member 1. For example, in one embodiment, as shown in Figure 3 、 Figure 7The proximal end of the first clamping member 1 can be provided with a blind hole 107 for assembling the traction wire 11, and a second through hole 112 vertically penetrating the blind hole 107, the diameter of the second through hole 112 is smaller than that of the blind hole 107, and the second through hole 112 is used for inserting the fixing pin 10 to limit the traction wire 11. The traction wire 11 can be wound around the fixing pin 10 after the fixing pin 10 is inserted to limit the traction wire 11. The specific position of the blind hole 107 in the embodiment is not limited, for example, it can be but not limited to the position between the two first through holes 105, and when the first clamping member 1 has other structures in the middle, the blind hole 107 can also be arranged at a position deviating from the middle of the first clamping member 1 between the two first through holes 105. At this time, the two first through holes 105 can be respectively located on the opposite sides of the first clamping member 1, and the third accommodating groove 102 and the blind hole 107 can be respectively located on the other opposite sides of the first clamping member 1. In some embodiments, a cylindrical plug can also be arranged at the end of the traction wire 11, the plug is inserted into the blind hole 107, the plug is provided with a limiting hole penetrating through, the traction wire 11 is limited by the fixing pin 10 penetrating through the second through hole 112 and the limiting hole of the plug, and the connection between the traction wire 11 and the first clamping member 1 can be formed at this time. However, it is not limited to this, and the traction wire 11 can also be connected to the first clamping member 1 in other ways as needed. In some embodiments, the above-mentioned blind hole can also be made into a through hole, and the traction wire 11 is inserted from the proximal end of the through hole during assembly, and then the traction wire 11 is inserted from the distal end of the through hole after passing through one side of the fixing pin 10 and then extending out from the proximal end of the through hole, and then the traction wire 11 is inserted from the distal end of the through hole again, and then the traction wire 11 extends out from the proximal end of the through hole after passing through the other side of the fixing pin 10. At this time, the traction wire 11 can still be limited by the fixing pin 10. In some embodiments, other ways except the traction wire 11 can also be used to separate the tip member 15 from the target tissue 13, or when there is no separation between the tip member 15 and the target tissue 13, the traction wire 11 can also not be arranged.

[0047] In an embodiment, the tip member 15 of the suturing device in the above-mentioned embodiment can be sutured by but not limited to the following steps: S1: the second clamping member 2 of the tip member 15 is in a closed state, and the tip member 15 of the suturing device is stretched between two suturing objects, as shown in FIG. 1, at this time, the two suturing objects are respectively located on the opposite sides of the tip member 15. In order to prevent the movement of the second clamping member 2 from interfering with the suturing objects, at this time, the two suturing objects can be located on the proximal side of the second clamping member 2, and the two suturing objects are the target tissue 13. Figure 13

[0048] S2: the control rod 603 is pushed to the distal end to make the control rod 603 move axially to the distal end, so that the control rod 603 pushes the driving block 601 to move to the distal end, and the driving block 601 drives the push-pull arm 602 to pull the second clamping member 2 to open, as shown in FIG. 2. Figure 14 ​As shown, the handle 12 is then used to control the entire device to move axially toward the proximal end until the two suture objects, namely the target tissues 13, are located between the first clamping member 1 and the second clamping member 2.

[0049] S3: Pull the control rod 603 toward the proximal end to make the control rod 603 move axially toward the proximal end, and the control rod 603 will pull the driving block 601 toward the proximal end, and the driving block 601 will drive the push-pull arm 602 to move the second clamping member 2 to close. Figure 15 As shown, the two objects to be sutured are clamped in the clamping space 8 after closing.

[0050] S4: Move the puncture needle 14 axially toward the distal end, so that the puncture needle 14 passes through the suture object on the corresponding side, and is inserted into the second receiving groove 201 on the corresponding side to connect with the corresponding connector 9; move the puncture needle 14 axially toward the proximal end to bring the connector 9 out of the second receiving groove 201, and while the puncture needle 14 retracts through the puncture portion on the target tissue, it brings the connector 9 from one side of the target tissue 13 to the other side; then continue to retract, and the connector 9 is brought into the first through hole 105 on the first clamping member 1 until the connector 9 is pulled out of the body. During the retraction process, the suture 3 is pulled by the connector 9, and the baffle 4 will fall out of the third receiving groove 102 driven by the suture 3, as shown in FIG. Figure 16 and Figure 17 As shown, the suture thread 3 will also fall out of the first receiving groove 101 .

[0051] S5: Move the control rod 603 axially to the distal end to open the second clamping member 2 and release the target tissue 13; Figure 17 As shown, the traction wire 11 is pulled to make it move back and forth, and the tip part 15 is shaken under the action of the traction wire 11. During the shaking process, the tip part 15 is completely separated from the target tissue 13, and the suture thread 3 is completely separated from the first clamping member 1.

[0052] In this step, pulling the traction wire 11 can solve the problem of the suture 3 being entangled, knotted, and stuck at the distal end of the first clamping member 1 in the distal end component. In some embodiments, if the second clamping member 2 can successfully release the target tissue 13 after opening, or the suture 3 is not entangled or knotted, or the distal end component can be successfully separated from the target tissue, the step of pulling the traction wire 11 can be omitted.

[0053] S6: As Figure 18 As shown, the control rod 603 is moved axially toward the proximal end to close the second clamping member 2 and cut the suture 3 at the distal end of the connector 9; the suture device is completely withdrawn from the patient's body, as shown in FIG. Figure 19 、 Figure 20 As shown, the locking nail 16 is then implanted to fit the baffle 4 between the two suture objects. The locking nail 16 fixes the two ends of the suture line 3 to complete the suture operation.

[0054] The suture device provided by the above embodiment comprises a first clamping member 1 and a second clamping member 2, the distal end of the first clamping member 1 is movably connected with the first end 207 of the second clamping member 2, forming a clamping space 8 between the first clamping member 1 and the second clamping member 2 for clamping the target tissue 13. When the second clamping member 2 moves towards the first clamping member 1, the target tissue 13 is clamped, thereby preventing the mutual displacement between the leading end of the suture device and the target tissue 13, and after clamping, the puncture needle 14 is inserted into the second accommodating groove 201 through the slot of the second accommodating groove 201 and connected with the connector 9, and in the process of insertion, the puncture needle 14 will pass through the target tissue 13, so that the puncture is simple and fast, and the operation efficiency of suture is improved.

[0055] The above application uses specific examples to illustrate the present application, which is only used to help understand the present application and does not limit the present application. For those skilled in the art to which the present application belongs, according to the idea of the present application, a number of simple deductions, deformations or substitutions can be made.

Claims

1. A distal end component of a suturing device, characterized in that: It includes a first clamping member for connecting to the distal end of the insertion tube, and second clamping members located on opposite sides of the first clamping member, the distal end of the first clamping member is movably connected to the first end of the second clamping member to form a clamping space for clamping the target tissue between the first clamping member and the second clamping member; the first clamping member is provided with a first accommodating groove for assembling a suture, and the second end of the second clamping member opposite to the first end is provided with a second accommodating groove, the second accommodating groove is used to accommodate a connector at the end of the suture, and the notch of the second accommodating groove is used for a puncture needle to be inserted and connected to the connector.

2. The distal end member of the suturing device according to claim 1, characterized in that: The first clamping member is provided with a third accommodating groove, and the third accommodating groove is used to assemble the baffle set on the suture line. The third accommodating groove is connected to the first accommodating groove. The first accommodating groove and the third accommodating groove are both provided with openings, and the openings are used to allow the suture line and the baffle to escape from the corresponding grooves.

3. The distal end member of the suturing device according to claim 2, characterized in that: The second clamping member is located on two opposite sides of the first clamping member, and the first accommodating groove and the third accommodating groove are both located on one of the other two opposite sides of the first clamping member; the third accommodating groove is provided at the proximal end of the first clamping member, and the first accommodating groove is located on the distal side of the third accommodating groove. Wire outlet holes are provided on the opposite sides of the distal end of the first accommodating groove, and the hole wall of the wire outlet hole is provided with a notch for the suture thread to escape, and the notch is connected to the opening on the first accommodating groove for the suture thread to escape.

4. The distal end member of the suturing device according to claim 3, characterized in that: The distal end of the first clamping member is provided with a hinged seat, and the hinged seat is hinged to the first end to form the movable connection; the wire outlet hole is C-shaped, and a gap for the suture thread to escape is formed between the two opposite ends of the C-shape, and the wire outlet hole is located on the proximal side of the hinged seat, and the gap for the suture thread to escape is located on the side of the wire outlet hole close to the hinged seat.

5. The distal end member of the suturing device according to claim 3, characterized in that: The proximal end of the first clamping member is provided with a connector for connecting to the insertion tube, and the distal surface of the connector is provided with a groove, the notch of the groove is connected to the proximal end of the third accommodating groove, and the groove is used to cooperate with the end of the baffle to form a limit for the baffle.

6. The distal end member of the suturing device according to claim 5, characterized in that: The proximal surface of the connector is provided with a filling groove for hot-melt connection with the insertion tube, and the filling groove includes a main body located in the middle of the connector, and at least two limiting parts extending from the main body to the four edges of the connector. The width of the limiting part close to one end of the edge is a first width, and the width of the limiting part close to one end of the middle is a second width. Among the limiting parts, the first width of at least one limiting part is greater than the second width, and at least one limiting part is a hole structure that passes through the main body to the four side walls of the connector.

7. The distal end component of the suturing device according to any one of claims 1 to 6, characterized in that: The second accommodating groove is a blind hole set on the second end, the opening of the blind hole is the slot of the second accommodating groove, the opening of the blind hole is located on the end face of the second end, and a wire notch is set through the hole wall of the blind hole close to the side of the first clamping member, and the wire notch is connected to the opening.

8. The distal end component of the suturing device according to any one of claims 1 to 6, characterized in that: The front end component also includes a driving mechanism, which includes a driving block for being connected and fixed to the distal end of the control rod, and push-pull arms arranged on opposite sides of the driving block, one end of the push-pull arm is hinged to the driving block, and the other end is hinged to the second clamping member on the corresponding side, the hinge portion of the push-pull arm and the second clamping member is located between the first end and the second end, and the first end is hinged to the distal end of the first clamping member to form the movable connection.

9. The distal end component of the suturing device according to any one of claims 1 to 6, characterized in that: The first clamping member is provided with a clamping notch on each of the opposite sides, and the second clamping member is located in the clamping notch on the corresponding side. A spacing is left between the first clamping member and the second clamping member to form the L-shaped clamping space; the first clamping member is provided with a through hole for assembling the puncture needle on each of the opposite sides, and the through hole corresponds to the second accommodating groove on the second clamping member on the corresponding side, and is connected through the clamping space on the corresponding side.

10. The distal end member of the suturing device according to claim 9, characterized in that: The first clamping member includes a clamping section and a main body section, the clamping notch is located on opposite sides of the clamping section, the main body section is located on the proximal side of the clamping notch, and the through hole is provided in the main body section; the side wall of the distal end of the through hole is provided with a clearance opening that passes through to the outer side surface of the main body section, the width of the clearance opening is smaller than the aperture of the through hole, the clearance opening is connected to the distal orifice of the through hole, and the distal orifice of the through hole is provided with a guide slope.

11. A suturing device, characterized in that: It includes a handle, an insertion tube, a control rod, and a tip component as described in any one of claims 1 to 10, wherein the tip component is connected to the distal end of the insertion tube, the handle is connected to the proximal end of the insertion tube, the insertion tube is provided with an inner cavity for the control rod, the suture, and the puncture needle to pass through, and the proximal end of the control rod is connected to the handle for controlling the movement of the second clamping member relative to the first clamping member to clamp or release the target tissue.

12. The suturing device according to claim 11, characterized in that The suturing device further comprises a traction wire, the handle is connected to the proximal end of the traction wire to control the reciprocating movement of the traction wire, and the distal end of the traction wire is connected to the proximal end of the first clamping member.