CN114432004A

CN114432004A - Tissue closure device

Info

Publication number: CN114432004A
Application number: CN202011209042.8A
Authority: CN
Inventors: 王刚
Original assignee: Shenzhen Jianxin Medical Technology Co ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2020-11-03
Filing date: 2020-11-03
Publication date: 2022-05-06

Abstract

The invention relates to a tissue closure device, comprising a first clamping part and a second clamping part, wherein the first clamping part and the second clamping part are used for clamping tissues; the first clamping part comprises a first clamping arm and a supporting arm which is rotatably connected with the first clamping arm, the supporting arm comprises a bending section and a straight extension section, one end of the bending section is fixedly connected with the straight extension section, and the other end of the bending section is rotatably connected with the first clamping arm; or one end of the bending section is fixedly connected with the straight extension section, one end of the straight extension section, which is far away from the bending section, is rotatably connected with the first clamping arm, the first clamping arm and the supporting arm can move between an opening position and a closing position, and when the first clamping arm and the supporting arm are located at the closing position, the first clamping arm and the second clamping part are close to each other. The tissue closure device is easier to open.

Description

Tissue closure device

Technical Field

The invention relates to the field of interventional medical instruments, in particular to a tissue closure instrument.

Background

This section provides background information related to the present disclosure only and is not necessarily prior art.

Mitral valve disease is a common disease in the elderly population, and includes two common types of mitral regurgitation and mitral stenosis, with mitral regurgitation being the most common. Statistically, the incidence of mitral regurgitation is as high as 10% in people older than 75 years of age. Mild mitral regurgitation generally has no effect on normal life, while moderate or severe mitral regurgitation requires interventional treatment. The traditional surgical treatment mode is open chest treatment, and the heart is opened to repair or replace the valve under the support of an external circulation machine, but the high-risk patient cannot tolerate the treatment. Recent emerging interventions have created a hope for high risk patients with mitral regurgitation. Interventional procedures typically involve the delivery of instruments through a catheter to the site of the lesion to repair or replace the valve. Most of the transcatheter mitral valve replacement products are in clinical research stage at present, and the transcatheter mitral valve repair products are on the market at present.

The principle of the existing transcatheter mitral valve repair product is that a clamping device is adopted to clamp the anterior leaflet and the posterior leaflet of the mitral valve, so that the opening area of the valve is reduced, and the purpose of treating regurgitation is achieved. Some existing products are mechanically locked clamping instruments, which need to be unlocked to perform clamping operation in intervention operation, so that the operation is complex, and clamping stress cannot be controlled due to the mechanical locking type clamping instrument, so that the instrument has great damage to valve leaflets. In order to avoid the problem, some of the valve leaflets are clamped between the elastic clamping arms and the flexible partition pieces in an elastic clamping mode, so that the clamping stress of the valve leaflets is relieved, and the damage of the valve leaflets is reduced.

Disclosure of Invention

Based on this, there is a need to provide a tissue closure device that is easier to open.

A tissue closure device comprising a first and a second clamping portion for clamping tissue; the first clamping part comprises a first clamping arm and a supporting arm which is rotatably connected with the first clamping arm, the supporting arm comprises a bending section and a straight extension section, one end of the bending section is fixedly connected with the straight extension section, and the other end of the bending section is rotatably connected with the first clamping arm; or one end of the bending section is fixedly connected with the straight extension section, one end of the straight extension section, which is far away from the bending section, is rotatably connected with the first clamping arm, the first clamping arm and the supporting arm can move between an opening position and a closing position, and when the first clamping arm and the supporting arm are located at the closing position, the first clamping arm and the second clamping part are close to each other.

In one embodiment, in the closed position, the curved section is curved and the degree of curvature of the curved section increases as the first clamping arm and the support arm move from the closed position to the open position.

In one embodiment, the arc length of the bent section accounts for 1/5-1/3 of the length of the straight section.

In one embodiment, the angle of the curved section is between 10 ° and 45 °.

In one embodiment, the tissue closure device further comprises a first fixing seat and a second fixing seat, wherein one end of the first clamping arm far away from the supporting arm is fixedly connected with the first fixing seat, and one end of the supporting arm far away from the first clamping arm is rotatably connected with the second fixing seat.

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 fixing base.

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 of the second clamping arm is a free end.

In one embodiment, the tissue closure device further comprises a spacer, one end of the spacer is fixedly connected with the second fixed seat, and the other end of the spacer axially extends in a direction away from the second fixed seat.

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

In one embodiment, an anchor is disposed on the second clamping arm.

During implantation, the first clamping arm and the support arm change from a closed position to an open position, and after tissue is captured, the first clamping arm and the support arm change from the open position to the closed position, so that the first clamping arm and the second clamping part are close to each other, and the tissue is clamped between the first clamping arm and the second clamping part. Because the supporting arm of the tissue closing instrument comprises the bending section and the straight extension section, in the opening process, the component force applied to the opening direction of the first clamping arm by the supporting arm is increased, so that the first clamping arm is easier to open, and the safety of a control system is improved.

Drawings

FIG. 1 is a schematic structural view of an embodiment of a tissue closure device in a closed state;

FIG. 2 is a schematic structural view of an embodiment of the tissue closure device in an open state;

FIG. 3 is a schematic view of a connection relationship between a first clamping arm and a supporting arm according to an embodiment;

FIG. 4 is a schematic view of a connection relationship between a first clamping arm and a supporting arm according to an embodiment;

FIG. 5 is a schematic view of a first clamping arm according to an embodiment;

FIG. 6 is a schematic diagram of the position relationship of two first clamping arms in a closed state according to an embodiment;

FIG. 7 is a schematic view of a first clamping arm according to an embodiment;

FIG. 8 is a schematic view of the two first clamping arms shown in FIG. 7 at another angular position;

FIG. 9 is a schematic view of a first curved section of a first clamping arm according to one embodiment;

FIG. 10 is a schematic view of a second curved section of the first clamping arm according to one embodiment;

FIG. 11 is a schematic view of a connection relationship between a first clamping arm, a supporting arm, a first fixing seat and a second fixing seat according to another embodiment;

FIG. 12 is a schematic view of the connection of a first clamping arm, a support arm, a first anchor, and a second anchor of another embodiment of a tissue closure device;

FIG. 13 is a schematic diagram of a support arm of the tissue closure device, according to one embodiment;

FIG. 14 is a schematic structural view of an embodiment of a tissue closure device in an open state;

FIGS. 15-18 are schematic views of an implantation procedure of a tissue closure device according to an embodiment;

FIG. 19 is a schematic view illustrating a connection relationship between a first fixing base and a first clamping arm according to an embodiment;

FIG. 20a is a force analysis diagram of the first clamping arm and the support arm of the conventional configuration;

fig. 20b to 20d are schematic views showing different degrees of opening states of the first clamping arm and the support arm of the conventional structure.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to FIG. 1, one embodiment of a tissue closure system includes a tissue closure device 1 and a delivery apparatus. The tissue closure device 1 comprises a first nip 10 and a second nip 20, the first nip 10 and the second nip 20 being for nipping tissue. The tissue is clamped between the first clamping portion 10 and the second clamping portion 20. Including, but not limited to, the leaflets of the mitral valve, the leaflets of the tricuspid valve, and the like.

At least two first clamping parts 10 and at least two second clamping parts 20 are provided, and the number of the first clamping parts 10 and the number of the second clamping parts 20 are equal. The tissue closure device 1 has a longitudinal central axis I-I, the two first clamping parts 10 are arranged symmetrically with respect to the longitudinal central axis I-I, and the two second clamping parts 20 are arranged symmetrically with respect to the longitudinal central axis I-I. It is understood that the first clamping portion 10 and the second clamping portion 20 correspond one to clamp tissues.

Referring to fig. 2, the first clamping portion 10 includes a first clamping arm 110 and a supporting arm 120. The first clamping arm 110 is made of a resilient metal material, for example, the first clamping arm 110 is made of a nickel-titanium alloy material, and the resilience of the material itself provides the clamping force. The support arm 120 is made of metal or polymer material.

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, thereby allowing the first clamping arm 110 and the support arm 120 to move between an open position (shown in fig. 2) and a closed position (shown in fig. 1). In the natural state, the first clamping arm 110 and the support arm 120 are in the closed position. The support arm 120 should have a certain rigidity and flexibility to be able to open the first clamping arm 110 when in the open position to maintain the open state.

The rotatable coupling of the one end of the first clamping arm 110 to the one end of the support arm 120 may be achieved in various ways. For example, the first clamping arm 110 and the support arm 120 are connected by a hinge, a pin, a living hinge, or the like.

In one embodiment, as shown in fig. 3, the first clamping arm 110 is substantially a wire loop structure having an opening. For example, the first clamping arm 110 may be a wire loop of nickel titanium wire wound with an opening. The supporting arm 120 includes a supporting body 121 and a connecting portion 122 connected to the supporting body 121, and one end of the connecting portion 122 away from the supporting body 121 is connected to the first clamping arm 110. In an embodiment, the connecting portion 122 and the supporting body 121 are an integral structure, and one end of the supporting body 121 is wound to form the connecting portion 122. The connecting portion 122 has a receiving cavity therein, the first clamping arm 110 penetrates through the receiving cavity of the connecting portion 122, and two 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 first clamping arm 110 and the connecting portion 122 can pivot relative to each other without using a rotating shaft, a pin, or other connecting member by the mutual cooperation of the structures of the support arm 120 and the first clamping arm 110. The pivot connection mode reduces the use of parts such as rotating shafts, pins and the like, and can provide flexible rotation.

In one embodiment, as shown in fig. 3, the supporting body 121 and the connecting portion 122 are a single-body structure. The support arm 120 including the support body 121 and the connection portion 122 is integrally formed by an elastic wire braid.

In another embodiment, as shown in fig. 4, the supporting body 121 and the connecting portion 122 are not of an integral structure. The connecting portion 122 is a machined metal part, and the connecting portion 122 is connected to the support body 121 by welding, gluing, crimping, or sewing with a metal wire. In this way, in the process of opening the supporting arm 120, the supporting arm 120 is not deviated due to the limitation of the two sides of the first clamping arm 110, and the smoothness of the opening and closing movement of the first clamping arm 110 is ensured.

Referring back to fig. 3, in an embodiment, the first clamping arm 110 includes two supporting sections 111 and a connecting section 112, and the supporting sections 111 and the connecting section 112 are metal rods. Two ends of the connecting section 112 are respectively connected to the two supporting sections 111, and one ends of the two supporting sections 111 far away from the connecting section 112 are not connected to form a wire loop structure with an opening. The end at which the connecting section 112 is located is the free end of the first clamping arm 110. The support arm 120 is rotatably coupled to the connecting section 112.

Referring to fig. 5 and 6 together, in one embodiment, each support segment 111 includes a curved segment 1112 and an extension segment 1114 connected to the curved segment 1112. Wherein an end of the bent segment 1112 distal to the extension segment 1114 is bent in a first direction such that the end of the bent segment 1112 distal to the extension segment 1114 and the extension segment 1114 are not in the same plane. Also, as the end of the curved segment 1112 distal to the extending segment 1114 is curved in a first direction, the connecting segment 112 of the first clamping arm 110 is distal to the longitudinal central axis I-I of the tissue closure instrument.

As shown in fig. 6, in a natural state, the bending section 1112 is bent toward the first direction, and the bending section 1112 makes an end of the bending section 1112 far from the extending section 1114 be not in the same plane as the extending section 1114, so that free ends of the two first clamping arms 110 are far from the longitudinal central axis I-I, that is, the two connecting sections 112 of the two first clamping arms 110 are far from the longitudinal central axis I-I to be in a mutually far state, so that the first clamping arms 110 are convenient to open. The first direction, for example as shown in fig. 6, may be a direction away from the connecting segment 112 of the other first clamping arm 110, and the end of the curved segment 1112 away from the extending segment 1114 is not in the same plane as the extending segment 1114.

In one embodiment, the extension 1114 is a straight rod, and the connection point between the extension 1114 and the bending segment 1112 is in the same plane as the extension 1114.

Referring to FIG. 7, in one embodiment, the extension 1114 includes a curved rod 1114A and a straight rod 1114B connected to the curved rod 1114A, and an end of the curved rod 1114A remote from the straight rod 11114B is connected to the curved segment 1112. Referring to fig. 6 and 8, in an embodiment, in a natural state (also in a clamping state), the bending rod 1114A is bent toward the second direction, so that a connection portion of the bending rod 1114A and the bending segment 1112 of one first clamping arm 110 and a connection portion (a circle portion indicated by VI in the figure) of the bending rod 1114A and the bending segment 1112 of the other first clamping arm 110 are reliably abutted together to form an abutting portion. At the abutting part, because the first clamping arms 110 have elasticity, the two first clamping arms 110 provide opposite abutting force, so that the two first clamping arms 110 are reliably abutted together, which is beneficial to improving the reliability of clamping, and the tissue closing device 1 is prevented from falling off due to the contraction and relaxation motions of the heart. The second direction, for example as shown in fig. 7, may be a direction outside the wire loop, i.e., the center of the bent rod 1114A itself is located inside the wire loop.

In one embodiment, the connecting portion of the curved rod 1114A and the curved segment 1112 of each clamping arm 110 is a straight rod, so that the two clamping arms 110 can be abutted with each other more reliably in a larger area.

Referring to fig. 9, in an embodiment, the angle α of the bent rod 1114A is 5 ° to 15 °, so that the connection portions of the extending segments 1114 and the bent segments 1112 of the two first clamping arms 110 can be reliably abutted together. Here, the angle α is an angle formed by intersecting the tangent line a and the tangent line B of the bent lever 1114A, and the intersection point is a. Tangent line a intersects the junction of curved bar 1114A and straight bar 1114B, and tangent line B intersects the junction of curved bar 1114A and curved segment 1112.

Referring to fig. 10, in one embodiment, the angle β of the curved segment 1112 is 10-60 ° to facilitate opening of the first clamping arm 110, and when the length of the curved segment 1112 is fixed, 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 long enough to maintain the clamping effect. The angle β is an angle between an extension line C of a connection portion of the bent rod 1114A and the bent segment 1112 and a tangent line D of the bent segment 1112, and the tangent line D and the extension line C intersect at an intersection point b of the extension line C and the bent segment 1112.

In one embodiment, the support arm 120 is made of a resilient metal, such as nitinol, and one end of the resilient metal is bent and shaped to form the connecting portion 122.

In one embodiment, referring to fig. 11, the supporting body 121 includes a curved section 123 and a straight section 124. One end of the bending section 123 is fixedly connected to the straight extending 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 an end of the curved section 123 far 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, as shown in fig. 12, one end of the connecting portion 122 is connected to one end of the straight extending portion 124 away from the curved portion 123, and the straight extending portion 124 is rotatably connected to the first clamping arm 110 through the connecting portion 122.

Referring to fig. 13, in an embodiment, the length of the straight section 124 is L1, the arc length of the curved section 123 is L2 (not shown), and L2/L1 is 1/5 to 1/3. The lengths of the straight extension section 124 and the curved section 123 are set in this way, on one hand, the length of the curved section 123 is prevented from being too large, so that enough distraction force is transmitted to the first clamping arm 110, that is, the supporting arm 120 can provide a certain distraction force, so that the first clamping arm 110 can be distracted in the opening process; on the other hand, it is avoided that the length of the bending section 123 is too small, so that during opening the bending section 123 can be further deformed (further bent) to alleviate the problem of too much stress.

Referring to fig. 13, in an embodiment, the angle γ of the bending section 123 is in a range of 10 ° to 45 °, and in the angle range, the supporting arm 120 can transmit the opening force to the first clamping arm 110 under a certain force, and the bending section 123 can deform to a certain extent to alleviate the problem of excessive stress. The angle γ is an angle between the extension line E of the straight extension section 124 and the tangent F of the bending section 123, and the tangent F intersects with the extension line E at the intersection point c of the extension line E and the bending section 123.

When the length of the support body 121 is determined, the larger the angle γ of the curved section 123 is, the smaller the capture length of the support body 121 is, and the more difficult it is to capture tissue. When the angle γ of the bent section 123 is too small, it is difficult to easily open the first clamping arm 110. Therefore, in an embodiment, the length of the straight section 124 is L1, the arc length of the curved section 123 is L2, and L2/L1 is 1/5 to 1/3, and the angle γ of the curved section 123 ranges from 10 ° to 45 °, so that the first clamping arm 110 is opened easily, and the tissue is captured easily, thereby facilitating the operation, and reducing the operation time.

In one embodiment, the supporting body 121 may be a one-piece structure made of metal wire or sheet, and has a corresponding curved shape after being subjected to a heat setting process, so as to form the curved section 123 and the straight section 124.

Referring back to fig. 11, in one embodiment, the tissue closure device 1 further comprises a first anchor 130 and a second anchor 140. The first fixing seat 130 and the second fixing seat 140 are axially opposite to each other, and are coaxially and alternately arranged.

One end of the first clamping arm 110 far away from the supporting arm 120 is fixedly connected to the first fixing base 130. The means of securing the connection may be any means known to those skilled in the art, including but not limited to welding, gluing, crimping, wire stitching, and the like. Specifically, the first clamping arm 110 is connected to the first fixing base 130 through the supporting section 111. One end of the straight rod 1114B of the support section 111, which is far away from the bent rod 1114A, is fixedly connected with the first fixed seat 130, as shown in fig. 7. Referring to fig. 11 again, an end of the supporting arm 120 away from the first clamping arm 110 is rotatably connected to the second fixing base 140. The supporting body 121 is connected to the second fixing base 140 by a rotating shaft, a pin, a living hinge, or the like. For example, the supporting body 121 and the second fixing base 140 are rotatably connected by a rotating shaft 150.

In one embodiment, as shown in fig. 11, an end of the straight section 124 of the supporting body 121 far from the curved section 123 is rotatably connected to the second fixing seat 140.

In one embodiment, as shown in fig. 12, an end of the curved section 123 of the supporting body 121 far from the straight section 124 is rotatably connected to the second fixing seat 140.

In an embodiment, the first fixing base 130 and the second fixing base 140 are both provided with a through hole in the middle.

Referring back to fig. 2, in an 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 a free end. 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 adjacent to the support arm 120, clamping the tissue between the second clamping arm 210 and the support arm 120.

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 supporting arm 120 far away from the first clamping arm 110.

The second clamping arm 210 is made of an elastic material, so that the second clamping arm 210 has elasticity. The tissue is positioned between the resilient first and second clamping

arms

110, 210 and is resiliently compressed, which results in a more stable clamping of the tissue closure device 1. In one embodiment, the material of the second clamping arm 210 is nitinol.

In one embodiment, the second nip 20 further comprises an anchor 220. Anchor 220 is disposed on a surface of second clamping arm 210 facing support arm 120 and extends toward support arm 120. Anchor 220 serves, on the one hand, to capture tissue (e.g., leaflets) and, on the other hand, when tissue is captured, anchor 220 penetrates the tissue, and first and

second arms

110, 210 and anchor 220 cooperate together to securely clamp the tissue.

The number of the anchor 220 may be one or more. When there are a plurality of anchors 220, the plurality of anchors 220 are disposed at intervals on the second clamping arm 210.

The number of the first clamping portions 10 and the second clamping portions 20 is two, and the two first clamping portions 10 are symmetrically arranged on two sides of the first fixing base 130 by taking a longitudinal central axis (coinciding with the longitudinal central axis I-I) of the first fixing base 130 as a symmetry center. Specifically, the two first clamping arms 110 are symmetrically disposed on two sides of the first fixing base 130, the two supporting arms 120 are symmetrically disposed on two sides of the second fixing base 140, and one end of each supporting arm 120 is rotatably connected to the first clamping arm 110, and the other end is rotatably connected to the second fixing base 140. The two second clamping arms 210 are symmetrically disposed on two sides of the second fixing base 140 with a longitudinal central axis (coinciding with the longitudinal central axis I-I) of the second fixing base 140 as a symmetry center.

With continued reference to fig. 2, the tissue closure device 1 further includes a spacer 160. One end of the spacer 160 is connected to the second fixing base 140, and the other end extends axially away from the second fixing base 140 and the first fixing base 130.

The 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, the spacer 160 is a cage-like structure woven from nickel titanium wires. In another embodiment, the spacer 160 is made of an elastic sponge or elastic silicone. In one embodiment, the spacer 160 is a balloon structure made of a polymer material.

The spacer 160 can seal and fill the gap between the two tissues, further improving the sealing performance. Moreover, because the spacer 160 is made of an elastic material, the spacer 160 has a certain flexibility and a deformation capability, and after the clamping, the spacer 160 can play a certain buffering role, so that two tissues (such as two valve leaflets) to be clamped cannot be pulled together firmly, and the clamping stress can be relieved.

The shape of the spacer 160 is not limited, and any shape may be used as long as it can perform the sealing and buffering functions. In one embodiment, the spacer 160 is cylindrical. In another embodiment, the spacer 160 is a structure with axially opposite ends small and the middle large.

In one embodiment, the shape of the spacer 160 matches the shape of the first clamping arm 110 such 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.

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

The transporter is used to transport the tissue closure device 1 to a target site and to release and cause the tissue closure device 1 to clamp the target tissue.

Referring to fig. 14 and 15 together, the delivery device includes a handle (not shown), a delivery sheath 310, and a lever 320. A handle is connected to the proximal end of the delivery sheath 310, the handle being provided with controls for operating the tissue closure device 1. The radially compressed tissue closure device 1 is received in the delivery sheath 310 and reaches the target site along with the delivery sheath 310. The operating rod 320 is accommodated in the delivery 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 base 130. The detachable connection manner includes, but is not limited to, a threaded connection, for example, the through hole of the first fixing base 130 is a threaded hole, and the outer wall of the distal end of the operating rod 320 is provided with an external thread to implement the detachable connection.

The delivery device also includes a connector that removably connects to the distal end of the spacer 160. The coupling member may take any structure that can be detachably coupled to the spacer 160 as will be appreciated by those skilled in the art. For example, in one embodiment, the connector is a sleeve with internal threads at its distal end, which is received within the delivery sheath 310, and the spacer 160 has a thread structure adapted to the sleeve for detachable connection.

As shown in fig. 16, the delivery device further includes a control wire 330, the control wire 330 is disposed through the delivery sheath 310, a proximal end of the control wire 330 is connected to the control member, and a 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.

In one embodiment, in order to facilitate the operation rod 320 to sequentially pass through the second fixing base 140 and the first fixing base 130 via the spacer 160, a guide tube 170 having an inner cavity is disposed inside the spacer 160, as shown in fig. 14. A guide tube 170 extends axially from the distal end of the spacer 160 to the proximal end. The operating rod 320 passes through the inner cavity of the guide tube 170, passes through the second fixing base 140, and extends to the first fixing base 130.

In one embodiment, as shown in fig. 14, the end of the guiding tube 170 near the first fixing seat 130 extends to the outside of the second fixing seat 140 and extends axially to the outside near the first fixing seat 130, which is beneficial to improve the pushing performance of the operation rod 320, so that the operation rod 320 with smaller rod diameter can be used, and thus the flexibility of the tissue closing system can be reduced, and the curved blood vessel path can be conveniently passed through.

Meanwhile, the guide tube 170 is provided to be able to support the spacer 160 to maintain the structural stability of the spacer 160.

The delivery, release and closure process of the tissue closure device 1 is illustrated by taking the tissue to be closed as mitral valve leaflets as an example. In one embodiment, the distal end of delivery sheath 310 is passed to the left atrium LA by passing delivery sheath 310 through the femoral vein, inferior vena cava to the right atrium RA, and then puncturing the interatrial septum AS, AS shown in fig. 15. The tissue closure device 1 is advanced out of the delivery sheath 310 by manipulating the distal end of the delivery sheath 310 to a neutral position over the mitral valve MV, and then by manipulating controls on the handle, as shown in fig. 16. Further, referring to fig. 17, the tissue closure device 1 is advanced to the mitral valve MV position and the position is adjusted (if necessary) such that the first clamping arm 110 of the tissue closure device 1 is located on the side of the mitral valve leaflets near the left ventricle LV. By operating the control on the handle, the operating rod 320 is moved in the axial direction, thereby causing the first clamping arm 110 to assume the open state to capture the valve leaflet. Then, the angle of the second clamping part 20 is controlled by the control wire 330 to catch the leaflet. After the second clamping portion 20 catches the leaflet, the operating rod 320 is moved in the axial direction so that the support arm 120 and the second clamping portion 20 approach each other to clamp the leaflet. The two second clamping portions 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. 18, thereby achieving a reduction in the opening area of the mitral valve MV. After the clamping is completed, the control wire 330 is withdrawn, the connection between the operating rod 320 and the first fixing base 130 is released, the connection between the connecting piece and the spacer 160 is released, and the transporter is withdrawn, thereby completing the operation.

Referring to fig. 14 and 19 together, in one embodiment, the tissue closure device 1 further includes a stiffening tube 180. The reinforced tube 180 is disposed on the first fixing base 130, and the distal end of the operation rod 320 extends into the reinforced tube 180 and is detachably connected to the first fixing base 130. The reinforcing tube 180 cooperates with the guide tube 170 extending from the second anchor block 140 to facilitate improved pushing performance of the operating rod 320, thereby allowing use of a smaller rod diameter operating rod 320 to facilitate reduced overall compliance of the tissue closure system to facilitate passage through a tortuous vascular pathway.

In one embodiment, the lever 320 is removably coupled to the reinforcement tube 180 via threads.

In one embodiment, the outer diameter of the guide tube 170 is smaller than the inner diameter of the reinforcement tube 180, and in the closed state, the guide tube 170 extends into the reinforcement tube 180, and the operation rod 320 passes through the guide tube 170 and the reinforcement tube 180 and is detachably connected (e.g., screwed) to the first fixing base 130. At this time, the guide tube 170 and the reinforcing tube 180 have a guiding function in the axial direction on the operation rod 320, and the guide tube 170 and the reinforcing tube 180 have a restraining function in the radial direction on the operation rod 320, so that the mutual positioning and guiding functions of the guide tube 170 and the reinforcing tube 180 contribute to stable transmission of axial force and uniform dispersion to both sides, and the first clamping arms 110 can be prevented from being deviated, so that the two first clamping arms 110 on both sides can be synchronously and stably opened.

When the tissue closure device 1 is to be opened, the radial force on the first clamping arm 110 is the greatest at the moment of just opening, and the guide tube 170 extends into the reinforcement tube 180 and simultaneously serves to increase the rigidity, further serving to make it easier to open the first clamping arm 110.

During the opening of the first clamping arm 110, when the support arm 120 is of a conventional structure, the force of the support arm 120 is analyzed as follows:

as shown in fig. 20a, the first clamping arm 110 is opened by sliding the operating lever 320 and the guide tube 170 relative to each other. T is the force exerted by the guide tube 170 on the shaft 150, and T generates two components: a component parallel to support arm 120, T1, and a component perpendicular to support arm 120, T2. T1 passes along the support arm 120 to the point where the support arm 120 is pivotally connected to the first clamping arm 110 to actuate the first clamping arm 110 to open. Assuming no loss of force is transmitted within the support arm 120, T1 is F. Where F is split into two force components at the location where the support arm 120 is rotatably connected to the first clamping arm 110, a force component F1 perpendicular to the first clamping arm 110 and a force component F2 parallel to the first clamping arm 110. Where F1 is F Sin θ, and T1 is T Cos θ, where θ is the angle between the support arm 120 and the first clamping arm 110. This can convert T to T1/Cos θ to F/Cos θ (F1/Sin θ)/Cos θ to F1/(Sin θ Cos θ) to 2F 1/Sin 2 θ.

As can be seen from the above equation, as the angle θ increases, less and less force needs to be applied to the guide tube 170. As in fig. 20b, θ is 20 °. As in fig. 20c, θ is 40 °. As in fig. 20d, θ is 65 °. From fig. 20b to 20d, less and less force needs to be applied to the guide tube 170. And the angle theta is minimized when the first clamping arm 110 and the support arm 120 are in the closed position. In the case where the expanding force F1 is constant, the force to be applied to the operation lever 320 is the largest. When in the closed position, the theta angle is 1-10 degrees. When θ is 10 °, the force F1 for spreading the support arm 120 is 10N, 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 force actually needed on the guide tube 170 is 2 × T1 is 116N. It can be seen that the force that the guide tube 170 and the operating lever 320 need to bear during the process of opening the first clamping arm 110 is very large. Therefore, the first clamping arm 110 needs to be driven to open by a large force, so that on one hand, a doctor needs to operate with a large force, and the surgical risk is increased; on the other hand, the risk of failure of the various force-bearing components of the tissue closure device 1 is also increased.

The support body 121 of the tissue closure device 1 includes a curved section 123 and a straight section 124. That is, in a natural state (a closed state in which the first clamping arm 110 and the support arm 120 are in the closed position), one end of the support arm 120 is curved. No matter the bending section 123 is rotatably connected with the first clamping arm 110 or the bending section 123 is connected with the second fixing seat 140, due to the bending section 123, when the supporting arm 120 is used for opening the first clamping arm 110, the component force of the supporting arm 120, which is decomposed to the direction perpendicular to the first clamping arm 110, is increased, so that the force applied to the operating rod 320 and the guide pipe 170 is reduced, the purpose of saving labor is achieved, the operation is convenient, the control is easy, and the operation safety is improved.

In one embodiment, the degree of curvature of the curved segment 123 increases as the first clamping arm 110 and the support arm 120 move from the closed position to the open position. That is, the bending section 123 can guide the support arm 120 to deform toward the bending direction when the force exceeds a certain limit, thereby playing a role of buffering. When the support arm 120 is deformed to a certain extent, the first clamping arm 110 is more easily opened.

During implantation, the first clamping arm 110 and the support arm 120 of the tissue closure device 1 are moved from the closed position to the open position, and after capturing tissue, the first clamping arm 110 and the support arm 120 are moved from the open position to the closed position, thereby bringing the first clamping arm 110 and the second clamping portion closer to each other so that the tissue is clamped between the first clamping arm 110 and the second clamping portion 20. Since the support arm 120 of the tissue closure device 1 includes the curved section 123 and the straight section 124, the component force applied to the opening direction of the first clamping arm 110 by the support arm 120 is increased during the opening process, so that the opening of the first clamping arm 110 is easier, thereby improving the safety of the manipulation system.

Further, due to the special structural design of the first clamping arm 110, the free ends of the two first clamping arms 110 are far away from the longitudinal central axis I-I, so that the first clamping arm 110 is easier to open, the support arm 120 can open the first clamping arm 110 with a small force, and the connecting section 112 of the first clamping arm 110 moves in the direction far away from the longitudinal central axis I-I, so that the first clamping arm 110 is in an open state.

Also, since the end of the bent segment 1112 of the first clamping arm 110 close to the extension 1114 is in the same plane as the extension 1114, the two first clamping arms 110 of the two second clamps 10 can reliably clamp the spacer 160 in the closed position to avoid dropping off and maintain the sealing performance.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A tissue closure device comprising a first clamping portion and a second clamping portion for clamping tissue; the first clamping part comprises a first clamping arm and a supporting arm which is rotatably connected with the first clamping arm, the supporting arm comprises a bending section and a straight extension section, one end of the bending section is fixedly connected with the straight extension section, and the other end of the bending section is rotatably connected with the first clamping arm; or one end of the bending section is fixedly connected with the straight extension section, one end of the straight extension section, which is far away from the bending section, is rotatably connected with the first clamping arm, the first clamping arm and the supporting arm can move between an opening position and a closing position, and when the first clamping arm and the supporting arm are located at the closing position, the first clamping arm and the second clamping part are close to each other.

2. The tissue closure device of claim 1, wherein in the closed position, the curved segment is curved and the degree of curvature of the curved segment increases as the first clamping arm and the support arm move from the closed position to the open position.

3. The tissue closure device of claim 1, wherein the curved section has an arc length that is 1/5-1/3 of the length of the straight section.

4. The tissue closure device of claim 1 wherein the angle of the curved section is between 10 ° and 45 °.

5. The tissue closure device of claim 1, further comprising a first anchor block and a second anchor block, wherein an end of the first clamping arm distal from the support arm is fixedly coupled to the first anchor block, and wherein an end of the support arm distal from the first clamping arm is rotatably coupled to the second anchor block.

6. The tissue closure device of claim 5, wherein the support arm comprises a support body and a connecting portion connected to the support body, wherein an end of the connecting portion distal from the support body is connected to the first clamping arm, and an end of the support body distal from the connecting portion is rotatably connected to the second fixed base.

7. The tissue closure device of claim 5, wherein the second clamping portion comprises a second clamping arm, one end of the second clamping arm is fixedly connected with the second fixed seat, and the other end of the second clamping arm is a free end.

8. The tissue closure device of claim 5, further comprising a spacer having one end fixedly connected to the second anchor block and another end extending axially away from the second anchor block.

9. The tissue closure device of claim 1, wherein the second clamping portion comprises a second clamping arm, an end of the second clamping arm fixedly connected to an end of the support arm distal from the first clamping arm.

10. The tissue closure instrument of claim 1, wherein an anchor is disposed on the second clamping arm.