Anchor, implant and implant system
By designing a sliding anchoring element with a self-locking structure, the problem of poor structural stability of nickel-titanium alloy anchoring elements was solved, and the stable expansion and continuous anchoring of the anchoring element under external force was achieved.
Patent Information
- Application Number
- CN202410745959.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-06-11
- Publication Date
- 2025-12-12
AI Technical Summary
Existing anchoring components are mainly made of nickel-titanium alloy, which has poor structural stability and is prone to deformation, resulting in poor anchoring effect and the risk of falling off.
Design an anchoring element including a puncture part and an anchoring part. The anchoring part has a fixed end and a movable end. The movable end can slide along the axial direction of the puncture part to an expanded state and is limited by a self-locking structure to increase the contact area with the tissue and provide a continuous anchoring effect.
It improves the stability and anchoring performance of the anchor, ensuring that the anchor can remain in an expanded state under external force, providing a continuous anchoring effect and reducing the risk of detachment.
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Figure CN121101807A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to an anchor, an implant and an implant system. BACKGROUND
[0002] This section provides background information only and can not necessarily be prior art.
[0003] Mitral regurgitation is a common heart valve disease. According to the development of the disease, mitral regurgitation is divided into acute (Acute MR) and chronic (Chronic MR), and chronic is further divided into organic (Degenerative MR, DMR / Primary MR) and functional (Functional MR, FMR / Secondary MR). Among them, one of the causes of functional mitral regurgitation is left ventricular dilation, which leads to incomplete closure of the anterior and posterior leaflets of the mitral valve, thereby causing regurgitation.
[0004] At present, many treatment methods for treating functional mitral regurgitation are being developed. For example, by implanting a plurality of anchors that can be slidably connected to a collection rope in the left ventricular wall, and then tightening the collection rope to shorten the distance between the plurality of anchors on the left ventricular wall to tighten the enlarged left ventricle in the circumferential direction, thereby reducing the mitral regurgitation.
[0005] However, the existing anchor is mainly a wire-shaped hook made of nickel-titanium alloy. Since the surface of the nickel-titanium alloy is relatively smooth and there is no other structure to cooperate, the structural stability is poor. When subjected to external force, the wire-shaped structure may be deformed and cannot provide stable anchoring effect, which has the risk of falling off, and may further cause the instrument to fail. SUMMARY
[0006] Therefore, it is necessary to provide an anchor with good anchoring performance.
[0007] Further, an implant with good anchoring performance is provided.
[0008] Still further, an implant system with good anchoring performance is provided.
[0009] An anchor for anchoring tissue, comprising a puncture part and an anchor part, the anchor part comprising a fixed end and a movable end, the fixed end being fixedly connected with the puncture part, the movable end being axially slidable along the puncture part to change the anchor part from a natural state to an expanded state, and in the expanded state, the movable end is limited.
[0010] In one of the embodiments, the anchor part comprises an anchor leaf, two ends of the anchor leaf are connected with the fixed end and the movable end respectively, and axial sliding of the movable end along the puncture part makes the end of the anchor leaf connected with the movable end radially away from the puncture part, so that the anchor part is in the expanded state.
[0011] In one of the embodiments, a plurality of hooks are arranged on two sides of the anchor leaf respectively, and the hooks are distributed along the axial direction, each of the hooks points to the fixed end in the natural state, and each of the hooks points to the outer surface of the puncture part in the expanded state.
[0012] In one of the embodiments, the anchor leaf forms an included angle greater than 0° with the longitudinal central axis of the puncture part in the natural state.
[0013] In one of the embodiments, the anchor part comprises two anchor leaves, the two anchor leaves are symmetrically arranged with the longitudinal central axis of the puncture part as the axis of symmetry, and the two anchor leaves are synchronously deformed with the axial sliding of the movable end, so that the ends of the two anchor leaves close to the movable end are radially away from each other, thereby the anchor part changes from the natural state to the expanded state.
[0014] In one of the embodiments, the anchor part comprises a first connecting ring, a second connecting ring and an anchor assembly, the first connecting ring is the fixed end, the second connecting ring is the movable end, the anchor assembly is arranged between the first connecting ring and the second connecting ring, and two ends of the anchor assembly are connected with the first connecting ring and the second connecting ring respectively, the first connecting ring and the second connecting ring are both sleeved on the puncture part, the first connecting ring is fixedly connected with the puncture part, and the second connecting ring can axially slide along the puncture part to make the anchor assembly change from the natural state to the expanded state.
[0015] In one of the embodiments, the anchor assembly comprises an anchor leaf, a first bending arm and a second bending arm, one end of the first bending arm is connected with the first connecting ring, the other end is connected with the anchor leaf, one end of the second bending arm is connected with the second connecting ring, the other end is connected with the anchor leaf, and when the second connecting ring axially slides relative to the puncture part, the first bending arm and the second bending arm can be bent to make the anchor leaf change from the natural state to the expanded state.
[0016] In one of the embodiments, a mounting groove is arranged on the anchor leaf, one end of the second bending arm extends into the mounting groove and is fixedly connected with the anchor leaf, and the end of the second bending arm connected with the anchor leaf is surrounded by the anchor leaf.
[0017] In one of the embodiments, the installation slot is provided with an anchoring arm, one end of the anchoring arm is connected with the bottom of the installation slot, the other end is a free end, and in the natural state, the free end extends towards the movable end, when the second bending arm is bent, the free end of the anchoring arm inclines outward.
[0018] In one of the embodiments, the second bending arm includes a main arm and two branch arms, one end of the main arm is connected with the movable end, the other end is connected with the two branch arms, one end of the two branch arms away from the main arm is connected with the bottom of the installation slot, and the anchoring arm is located between the two branch arms, when the main arm and the two branch arms are bent, the anchoring arm inclines outward.
[0019] In one of the embodiments, the anchoring part includes an anchoring assembly, the anchoring assembly includes an anchoring leaf, a first bending arm and a second bending arm, one end of the first bending arm is connected with the anchoring leaf, the other end extends as the fixed end, one end of the second bending arm is connected with the anchoring leaf, the other end is connected with the movable end.
[0020] In one of the embodiments, the puncture part is provided with a self-locking structure, when the movable end of the anchoring part axially slides along the puncture part to the anchoring part in the expanded state, the self-locking structure limits the axial sliding of the movable end.
[0021] In one of the embodiments, the self-locking structure includes a first self-locking member and a second self-locking member, the first self-locking member and the second self-locking member are spaced apart along the axial direction of the puncture part, and the space between the first self-locking member and the second self-locking member forms a self-locking space, when the movable end of the anchoring part axially slides along the puncture part to the self-locking space, the anchoring part is in the expanded state, and the movable end of the anchoring part is limited by the first self-locking member and the second self-locking member and cannot axially slide towards the proximal end and the distal end.
[0022] In one of the embodiments, the puncture part includes a side wall; the first self-locking member includes a first self-locking piece, one end of the first self-locking piece is connected with the side wall, the other end is a free end, in the natural state, the first self-locking piece inclines outward relative to the side wall, and the free end of the first self-locking piece points to the second self-locking member; the second self-locking member includes a second self-locking piece, one end of the second self-locking piece is connected with the side wall, the other end is a free end, in the natural state, the second self-locking piece inclines outward relative to the side wall, and the free end of the second self-locking piece points to the first self-locking member.
[0023] In one of the embodiments, the first self-locking piece is formed by cutting the side wall and shaping, and the second self-locking piece is formed by cutting the side wall and shaping.
[0024] In one of the embodiments, the side wall is provided with a first through hole and a second through hole, the first through hole extends from the side wall to the first self-locking piece, the part of the first through hole extending to the first self-locking piece is located within the edge of the first self-locking piece, the second through hole extends from the side wall to the second self-locking piece, the part of the second through hole extending to the second self-locking piece is located within the edge of the second self-locking piece.
[0025] In one of the embodiments, the piercing part comprises a side wall, the self-locking structure comprises a slide rail and a limiting area provided on the side wall, the slide rail extends along the axial direction of the piercing part, the limiting area is located on one side of the slide rail, and the limiting area is in communication with the slide rail, the movable end is provided with a cooperating structure, the movable end slides along the axial direction of the piercing part to drive the cooperating structure to slide along the slide rail, when the cooperating structure slides along the slide rail to the point that the cooperating structure enters the limiting area, the movable end is limited, and the anchoring part is in the expanded state.
[0026] In one of the embodiments, the cooperating structure comprises a connecting frame and a limiting piece, the connecting frame is connected with the movable end, the connecting frame is provided with a penetrating hole, one end of the limiting piece is connected with the side wall of the penetrating hole, and the other end is a free end, and in the natural state, the free end of the limiting piece bends towards the slide rail.
[0027] In one of the embodiments, the connecting frame and the limiting piece are in an integral structure, the cooperating structure is provided with an inner hole, the inner hole extends from the connecting frame to the limiting piece, and the part of the inner hole extending to the limiting piece is located within the edge of the limiting piece.
[0028] In one of the embodiments, the piercing part comprises a side wall; the self-locking structure comprises a locking piece, one end of the locking piece is connected with the side wall, and the other end is a free end, in the natural state, the locking piece is inclined outwardly relative to the side wall; the movable end of the anchoring part is provided with a limiting hole, in the process of the movable end of the anchoring part sliding along the axial direction of the piercing part, the locking piece can enter the limiting hole to limit the movable end.
[0029] An implant comprises a plurality of the above-mentioned anchoring pieces and a collection piece, the collection piece is used to connect the plurality of anchoring pieces in series, and each of the anchoring pieces can slide along the collection piece when the collection piece connects the plurality of anchoring pieces in series.
[0030] An implant system comprises the implant and a delivery device, the delivery device comprises a pushing member and a driving member, the pushing member is detachably connected with one end of the puncture part away from the fixed end of the anchor part, for piercing the anchor part into a target site, the driving member is detachably connected with the anchor part, for driving the movable end of the anchor part to slide along the puncture part in an axial direction.
[0031] In one of the embodiments, a first buckle is arranged on the pushing member, a second buckle is arranged on the puncture part, the first buckle and the second buckle are connected to connect the pushing member with the puncture part, a connecting area is arranged on the puncture part, a connecting hole is arranged on the connecting area, the connecting hole is used for the passing of the gathering member, the connecting area is radially opposite to the second buckle, and when the first buckle and the second buckle are connected, the first buckle is located between the second buckle and the connecting area.
[0032] In one of the embodiments, a clamping block is arranged on one end of the driving member close to the movable end, a clamping groove is arranged on the movable end, the driving member is sleeved on the puncture part, the clamping block and the clamping groove are matched to detachably connect the driving member with the anchor part, and the first buckle and the second buckle are radially limited by the driving member.
[0033] The anchor part comprises a puncture part and an anchor part, the fixed end of the anchor part is fixedly connected with the puncture part, the movable end can slide along the puncture part in an axial direction to change the anchor part from a natural state to an expanded state, in the expanded state, the contact area of the anchor part with the tissue is larger, and in the expanded state, the movable end is limited, so that even under the action of an external force, the anchor part is always in the expanded state to provide a continuous anchoring effect. Thus, the anchoring performance of the anchor part is better.
[0034] The implant and the implant system comprise the anchor part, and thus the anchoring performance is better. BRIEF DESCRIPTION OF DRAWINGS
[0035] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the following embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort.
[0036] In which:
[0037] Figure 1 It is a structural schematic view of the implant system of an embodiment (the anchor part of the anchor part is omitted in the figure);
[0038] Figure 2 It is a schematic view of the implant state of an embodiment of the implant.
[0039] Figure 3 This is a schematic diagram showing the anchoring element connected to the conveyor in its natural state, according to one embodiment.
[0040] Figure 4 for Figure 3 The diagram shows the anchor connected to the conveyor in the expanded state.
[0041] Figure 5 This is a schematic diagram of the anchoring part in the retracted state according to an embodiment;
[0042] Figure 6 for Figure 5 The plan view of the anchoring part shown;
[0043] Figure 7 A plan view of the movable end of the anchoring part according to another embodiment;
[0044] Figure 8 This is a planar development view of an anchoring leaf according to one embodiment;
[0045] Figure 9 This is a schematic diagram of the anchoring part in an expanded state according to an embodiment;
[0046] Figure 10 for Figure 9 Top view;
[0047] Figure 11 A plan view of the anchoring leaf according to another embodiment;
[0048] Figure 12 This is a schematic diagram of the puncture site in one embodiment;
[0049] Figure 13 This is a schematic diagram of a self-locking structure according to one embodiment;
[0050] Figure 14 This is a schematic diagram of the self-locking structure according to another embodiment;
[0051] Figure 15 This is a schematic diagram of the puncture site in another embodiment;
[0052] Figure 16 for Figure 15 A schematic diagram of the structure of the puncture site from another angle is shown;
[0053] Figure 17 This is a schematic diagram of the anchoring portion in an expanded state according to another embodiment;
[0054] Figure 18 for Figure 17 A plan view;
[0055] Figure 19 This is a schematic diagram of the structure of an anchoring member in an expanded state according to an embodiment;
[0056] Figure 20 This is a schematic diagram of the puncture site in another embodiment;
[0057] Figure 21 This is a planar unfolded schematic diagram of the anchoring part according to another embodiment;
[0058] Figure 22 This is a schematic diagram of the structure of a pusher component according to one embodiment;
[0059] Figure 23 for Figure 22 A schematic diagram of the connector of the pusher component is shown;
[0060] Figure 24 This is a schematic diagram of the structure of a driving component according to one embodiment;
[0061] Figure 25 This is a plan view of the anchoring part according to another embodiment. Detailed Implementation
[0062] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0063] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0064] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.
[0065] In the field of interventional medical devices, the end of a medical device that is closer to the operator is often referred to as the "proximal" end, and the end that is further from the operator is often referred to as the "distal" end, and this terminology is used to define the "proximal" and "distal" ends of any component of a medical device. The "axial" direction generally refers to the lengthwise direction of a medical device when it is being delivered, and the "radial" direction generally refers to a direction of a medical device that is non-parallel to its "axial" direction, and this terminology is used to define the "axial" and "radial" directions of any component of a medical device. The "circumferential" direction refers to the direction around the circumference of a lumen or the axis of a cylinder.
[0066] Referring to Figure 1 , an implant system 1 of an embodiment includes an implant 100 and a delivery device 200. The delivery device 200 is used to deliver and implant the implant 100 to a target site.
[0067] Referring to Figure 2 , an implant 100 of an embodiment includes a plurality of anchors 10 and a constriction member 30. The anchors 10 are used to be implanted in tissue. The constriction member 30 is an elongated strip structure. The constriction member 30 is used to connect the plurality of anchors 10 in series. When the plurality of anchors 10 are connected in series by the constriction member 30, each anchor 10 can slide along the constriction member 30. After the plurality of anchors 10 are anchored in the tissue at intervals, the constriction member 30 is tightened to reduce and lock the distance between adjacent anchors 10, thereby tightening the tissue and achieving the purpose of adjusting the size of the tissue. For example, the plurality of anchors 10 are implanted in the annulus of a valve to achieve the purpose of ring reduction. Or, the plurality of anchors 10 are implanted in the ventricle to achieve the purpose of ventricle volume reduction.
[0068] In an embodiment, the implant 100 further includes a plurality of spacers 50. The plurality of spacers 50 are connected to the constriction member 30, and each spacer 50 is located between two adjacent anchors 10. The spacer 50 is used to define the distance between the two adjacent anchors 10 to avoid excessive tightening of the constriction member 30 and causing damage to the tissue.
[0069] Referring to Figure 3 and Figure 4 In an embodiment, the anchor 10 includes an anchoring portion 110 and a piercing portion 120. Referring to Figure 5 , the anchoring portion 110 includes a fixed end 111 and a movable end 112. The fixed end 111 and the movable end 112 are opposite in the axial direction. One end of the piercing portion 120 has a sharp structure 121. In an embodiment, the anchoring portion 110 is sleeved on the piercing portion 120. The fixed end 111 is located at one end close to the sharp structure 121. The fixed end 111 is fixedly connected to the piercing portion 120. The movable end 112 can slide axially along the piercing portion 120 to change the anchoring portion 110 from a natural state Figure 3 to an expanded state.Figure 4 ) and is limited when the active end 112 is axially slid along the puncture part 120 to change the anchoring part 110 to the expanded state. In the process of changing from the natural state to the expanded state, the distance between the active end 112 and the fixed end 111 gradually decreases.
[0070] As shown in Figure 4 , in the expanded state, the anchoring part 110 has a larger contact area with the tissue; and in the expanded state, the active end 112 is limited, so that the anchoring part 110 is always in the expanded state to provide a sustained anchoring effect even under the action of external force. Thus, the anchoring performance of the anchor 10 is good.
[0071] The fixed connection of the fixed end 111 and the puncture part 120 can adopt the connection method mastered in the art, including but not limited to welding, bonding, etc.
[0072] Please refer to Figures 3 to 6 , the anchoring part 110 includes an anchoring leaf 113, both ends of the anchoring leaf 113 are connected with the fixed end 111 and the active end 112 respectively, and when the active end 112 is axially slid along the puncture part 120 to make the end of the anchoring leaf 113 connected with the active end 112 radially away from the puncture part 120, the anchoring part 110 is in the expanded state.
[0073] In an embodiment, a plurality of hooks 1131 are arranged on both sides of the anchoring leaf 113 respectively and are distributed in the axial direction. As shown in Figure 3 , in the natural state, each hook 1131 points to the fixed end 111. When the anchoring part 110 changes from the natural state to the expanded state, the angle between the anchoring leaf 113 and the puncture part 120 increases, and each hook 1131 is inclined to make the hook 1131 point to the outer surface of the puncture part 120 (as shown in Figure 4 ), so that the hook 1131 can be obliquely pierced into the tissue in contact with the anchoring leaf 113, and even when the puncture part 120 is subjected to an external force in the direction opposite to the piercing direction of the puncture part 120, the obliquely pierced hook 1131 still maintains the anchoring state with the tissue in the direction opposite to the direction of the external force. Even in the extreme state, when the active end 112 has a tendency to move away from the fixed end 111 under a larger external force, the anchoring leaf 113 has a tendency to change from the expanded state to the contracted state, and even in the contracted state, the hook 1131 still maintains the anchoring with the tissue, thereby providing a sustained anchoring effect.
[0074] It should be noted that the expansion degree of the contracted state is greater than that of the natural state and less than that of the expanded state.
[0075] Please refer to Figure 6In an embodiment, the two anchor leaves 113 are arranged symmetrically about the longitudinal central axis of the puncture portion 120, and the two anchor leaves 113 deforms synchronously with the axial sliding of the active end 112 so that the end of the two anchor leaves 113 close to the active end 112 moves away from each other in the radial direction. Thus, the anchoring portion 110 changes from the natural state to the expanded state.
[0076] In an embodiment, the two anchor leaves 113 are arranged symmetrically about the longitudinal central axis of the puncture portion 120, and the two anchor leaves 113 deforms synchronously with the axial sliding of the active end 112 so that the end of the two anchor leaves 113 close to the active end 112 moves away from each other in the radial direction. Thus, the anchoring portion 110 changes from the natural state to the expanded state.
[0077] The two anchor leaves 113 are arranged symmetrically, so that when the active end 112 slides in the axial direction, the two anchor leaves 113 deform synchronously, so that the anchoring portion 110 can expand uniformly, avoiding uneven expansion that causes local excessive stress and breaks or improper bending that makes it difficult to penetrate the tissue, etc., improving the stability of the structure, thereby facilitating the provision of sustained anchoring performance. Moreover, the two anchor leaves 113 deform synchronously, and when subjected to adverse forces, the two anchor leaves 113 can collectively resist the adverse forces, avoiding slipping from the tissue, and the anchoring performance is good.
[0078] In an embodiment, the fixed end 111 is a ring structure, named the first connecting ring. The active end 112 is also a ring structure, named the second connecting ring. The anchoring portion 110 includes the first connecting ring, the second connecting ring, and an anchoring assembly. The anchoring assembly is arranged between the first connecting ring and the second connecting ring. The anchoring assembly includes the anchor leaves 113. The two ends of the anchor leaves 113 are connected to the first connecting ring and the second connecting ring, respectively.
[0079] The first connecting ring and the second connecting ring are both sleeved on the puncture portion 120, the first connecting ring is fixedly connected to the puncture portion 120, and the second connecting ring can slide axially along the puncture portion 120 so that the anchoring assembly changes from the natural state to the expanded state.
[0080] The fixed end 111 is arranged as a ring structure, so that the fixed end 111 has a larger contact area with the puncture portion 120, thereby improving the reliability of the fixed connection between the two.
[0081] The active end 112 is arranged as a ring structure to be sleeved on the puncture portion 120, so that the active end 112 slides more stably along the axial direction of the puncture portion 120, which is conducive to reliably changing the anchoring assembly to the expanded state, thereby avoiding the risk of local rupture caused by improper expansion.
[0082] In an embodiment, the movable end 112 is provided with a clamping groove 1121 for cooperating with the conveyor 200. In an embodiment, the clamping groove 1121 is a V-shaped groove, as shown in Figure 5 and Figure 6 In other embodiments, the clamping groove 1121 is not limited to a V-shaped groove, but can also be in other forms, for example, as shown in Figure 7 the clamping groove 1121 is a wide-narrow buckle structure connected by a trapezoidal part.
[0083] Please refer back to Figure 6 In an embodiment, the anchoring assembly further comprises a first bending arm 114 and a second bending arm 115. One end of the first bending arm 114 is connected to the first connecting ring, and the other end is connected to the anchoring leaf 113. One end of the second bending arm 115 is connected to the second connecting ring, and the other end is connected to the anchoring leaf 113. The width of the first bending arm 114 and the second bending arm 115 is less than the width of the anchoring leaf 113. When the second connecting ring slides axially along the puncture part 120, it can drive the first bending arm 114 and the second bending arm 115 to bend, thereby changing the anchoring part 110 from the natural state to the expanded state. The first bending arm 114 and the second bending arm 115 are provided to facilitate the bending of the anchoring leaf 113 when the movable end 112 slides axially, so that the anchoring part 110 can smoothly change from the natural state to the expanded state.
[0084] In an embodiment, the first bending arm 114 has a first bending area 1141, and the second bending arm 115 has a second bending area 1151 and a third bending area 1152. When the movable end 112 slides in the axial direction of the puncture part 120 towards the fixed end 111, the first bending arm 114 bends at the first bending area 1141, and the second bending arm 115 bends at the second bending area 1151 and the third bending area 1152, so that the anchoring part 110 changes from the natural state to the expanded state.
[0085] Please refer back to Figure 3 In the natural state, the anchoring leaf 113 forms an angle greater than 0° with the longitudinal axis of the puncture part 120. That is, in the natural state, the anchoring part 110 exhibits a certain degree of radial expansion relative to the puncture part 120, but the degree of radial expansion in this state is less than that in the expanded state, and greater than that in the contracted state. By so arranging, when the movable end 112 slides in the axial direction of the puncture part 120 towards the fixed end 111, the anchoring part 110 expands radially, avoiding the anchoring part 110 changing in an undesirable direction and failing to achieve anchoring or anchoring being not firm. The undesirable direction, for example, the first bending arm 114 and / or the second bending arm 115 bend inwardly, causing the anchoring part 110 to fail to change to the expanded state.
[0086] The anchoring part 110 can be formed by pre-molding, as shown in Figure 5The anchoring part 110 in the contracted state is shaped to the natural state. That is, as Figure 5 The first bending arm 114 and the second bending arm 115 in the contracted state are subjected to a certain degree of bending shaping treatment, so that the anchoring part 110 is shaped to the natural state.
[0087] Please refer to Figure 8 In an embodiment, an end of the anchoring leaf 113 close to the movable end 112 is provided with a mounting slot 1132, and the mounting slot 1232 is a notch provided in the middle of the end of the anchoring leaf 113 close to the movable end 112. One end of the second bending arm 115 extends into the mounting slot 1132 and is fixedly connected with the anchoring leaf 113, and the end of the second bending arm 115 connected with the anchoring leaf 113 is surrounded by the anchoring leaf 113, that is, the end of the second bending arm 115 connected with the anchoring leaf 113 extends into the anchoring leaf 13. In this way, on the one hand, the outward bending of the second bending arm 115 at the third bending area 1152 can smoothly drive the anchoring leaf 113 to expand radially; on the other hand, under the condition that the distance between the fixed end 111 and the movable end 112 remains unchanged, the length of the anchoring leaf 113 and the length of the second bending arm 115 can be increased as much as possible, thereby correspondingly increasing the number of the hooks 1131 on both sides of the anchoring leaf 113 and providing a sufficient bending radius to improve the expansion degree of the anchoring leaf 110, thereby increasing the anchoring length and the anchoring area and improving the anchoring performance.
[0088] Please refer to Figures 8 to 10 In an embodiment, the mounting slot 1132 is further provided with an anchoring arm 1133, one end of the anchoring arm 1133 is connected with the slot bottom of the mounting slot 1132, and the other end is a free end, and under the natural state, the free end extends in the direction close to the movable end 112. The second bending arm 115 includes a main arm 1153 and two branch arms 1154 connected with the main arm 1153, one end of the main arm 1153 is connected with the movable end 112, and the other end is connected with the two branch arms 1154. The two branch arms 1154 are located in the mounting slot 1132 and are fixedly connected with the slot bottom of the mounting slot 1132, and the anchoring arm 1133 is located between the two branch arms 1154. The third bending area 1152 of the second bending arm 115 is located on the branch arm 1154. When the first bending arm 114 is bent at the first bending area 1141, and the second bending arm 115 is bent at the second bending area 1151 and the third bending area 1152, the free end of the anchoring arm 1133 is inclined outward so as to penetrate into the tissue. The anchoring arm 1133 and the plurality of hooks 1131 jointly act to increase the action points of the anchoring leaf 113 with the target tissue, thereby improving the anchoring performance. Moreover, the penetration direction of the anchoring arm 1133 is opposite to the penetration direction of the hook 1131, thereby further increasing the difficulty of the anchoring part 10 slipping out of the tissue, that is, improving the anchoring performance.
[0089] Please refer toFigure 11 In another embodiment, the second bending arm 115 is not a cantilever structure, and the width of the connection part of the second bending arm 115 to the mounting slot 1132 is greater than the width of each cantilever 1154 to the mounting slot 1132, so that the strength is higher.
[0090] Please refer to Figure 12 The puncture part 120 includes a side wall 122, which forms a hollow structure with a substantially cylindrical profile, and a sharp structure 121 at the distal end. The puncture part 120 is provided with a self-locking structure 123, which limits the axial displacement of the movable end 112 when the movable end 112 of the anchoring part 110 is axially slid along the puncture part 120 to the expanded state of the anchoring part 110, so that the anchoring part 110 remains in the expanded state, as shown in Figure 4 .
[0091] In an embodiment, the self-locking structure 123 includes a first self-locking member 1231 and a second self-locking member 1232. The first self-locking member 1231 and the second self-locking member 1232 are spaced apart along the axial direction of the side wall 122, and the space between the first self-locking member 1231 and the second self-locking member 1232 forms a self-locking space 1233. And, before the movable end 112 is axially slid along the puncture part 120, the movable end 112 is located at the proximal end of the first self-locking member 1231, as shown in Figure 3 . When the movable end 112 is axially slid along the puncture part 120, it passes through the first self-locking member 1231 and enters the self-locking space 1233, and the anchoring part 110 is in an expanded state. And, the movable end 112 located in the self-locking space 1233 is limited by the first self-locking member 1231 and the second self-locking member 1232 and cannot slide axially to both ends, so that the anchoring part 110 remains in the expanded state, as shown in Figure 4 .
[0092] Please refer to Figure 13 In an embodiment, the first self-locking member 1231 includes a first self-locking piece 12311, one end (connection end 12312) of which is connected to the side wall 122, and the other end is a free end 12313. In the natural state, the first self-locking piece 12311 is inclined outward relative to the side wall 122, and the free end 12313 of the first self-locking piece 12311 points to the second self-locking member 1232, so that the connection part of the first self-locking piece 12311 to the side wall 122 forms a first abutting part. The first self-locking piece 12311 can be radially inwardly abutted to fit on the surface of the side wall 122 or smoothly transition with the side wall 122, so that the movable end 112 can pass through the first self-locking piece 12311 and enter the self-locking space 1233. The first abutting part limits the axial sliding of the movable end 112 located in the self-locking space 1233 away from the second self-locking member 1232.
[0093] In an embodiment, the second self-locking member 1232 comprises a second self-locking piece 12321, one end (connecting end 12322) of which is connected to the side wall 122, and the other end is a free end 12323. In the natural state, the second self-locking piece 12321 is inclined outward relative to the side wall 122, and the free end 12323 of the second self-locking piece 12321 points to the first self-locking member 1231, so that the connecting part of the second self-locking piece 12321 and the side wall 122 forms a second abutting part. The second abutting part limits the axial sliding of the movable end 112 in the self-locking space 1233 away from the first self-locking member 1231. The second self-locking piece 12321 can be radially abutted to the surface of the side wall 122 or smoothly transitioned with the side wall 122, so that the movable end 112 or the fixed end 111 can pass through the second self-locking piece 12321 to facilitate the assembly of the anchoring part 110 and the puncture part 120.
[0094] In an embodiment, the first self-locking piece 12311 is formed by cutting and shaping the side wall 122, and the first self-locking piece 12311 and the side wall 122 are an integral structure, so that the connecting part of the first self-locking piece 12311 and the side wall 122 is smoothly transitioned, so that the movable end 112 can smoothly pass through the first self-locking piece 12311 and enter the self-locking space 1233.
[0095] In an embodiment, the second self-locking piece 12321 is formed by cutting and shaping the side wall 122, and the second self-locking piece 12321 and the side wall 122 are an integral structure, so that the connecting part of the second self-locking piece 12321 and the side wall 122 is smoothly transitioned, so that the movable end 112 or the fixed end 111 can smoothly pass through the second self-locking piece 12321 to facilitate the assembly of the anchoring part 110 and the puncture part 120.
[0096] In an embodiment, a first through hole 1221 is formed in the side wall 122, the first through hole 1221 extends from the part of the side wall 122 close to the connecting end 12312 of the first self-locking piece 12311 to the first self-locking piece 12311, and the part of the first through hole 1221 extending to the first self-locking piece 12311 is located in the edge of the first self-locking piece 12311. Thus, without reducing the width of the first self-locking piece 12311, the bending resistance of the connecting part of the first self-locking piece 12311 and the side wall 122 can be reduced, so that in the natural state, the first self-locking piece 1231 is more inclined outward relative to the side wall 122, and the movable end 112 of the anchoring part 110 is more easily entered into the self-locking space 1233.
[0097] The second through hole 1222 extends from the part of the side wall 122 close to the connecting end 12322 of the second self-locking piece 12321 to the second self-locking piece 12321, and the part of the second through hole 1222 extending to the second self-locking piece 12321 is located in the edge of the second self-locking piece 12321. Thus, without reducing the width of the second self-locking piece 12321, the bending resistance at the connection between the second self-locking piece 12321 and the side wall 122 can be reduced, so that the second self-locking piece 12321 is more likely to tilt outward relative to the side wall 122 in the natural state, and the assembly of the anchoring part 110 and the puncture part 120 is facilitated.
[0098] Please refer to Figure 14 In another embodiment, the self-locking structure 123 includes a first self-locking member 1231 and a second self-locking member 1232. The first self-locking member 1231 is the same as the structure shown in Figure 12 and Figure 13 The second self-locking member 1232 is different from the structure shown in Figure 12 and Figure 13 In this embodiment, the second self-locking member 1232 is a protruding structure arranged on the side wall 122. The protruding structure and the first self-locking member 1231 are spaced apart in the axial direction of the side wall 122 to form a self-locking space 1233. When the movable end 112 slides into the self-locking space 1233, the movable end 112 is limited in the axial direction by the first self-locking member 1231 and the protruding structure and cannot slide in the axial direction to both ends.
[0099] Correspondingly, in this embodiment, in order to facilitate assembly, the anchoring part 110 can be sleeved on the puncture part 120. The fixed end 111 is not a continuous annular structure, but has an opening with a width greater than that of the protruding structure, so that the fixed end 111 can pass through the protruding structure and be sleeved on the puncture part 120.
[0100] It can be understood that in other embodiments, when the fixed end 111 is not an annular structure, the second self-locking member 1231 can be in other forms, for example, the second self-locking member 1231 is an annular protrusion sleeved on the puncture part 120, as long as the annular protrusion does not hinder the assembly of the anchoring part 110 and the puncture part 120.
[0101] In an embodiment, no matter what structure the first self-locking member 1231 and the second self-locking member 1232 are, the self-locking structure 123 is two, and the two self-locking structures 123 are symmetrically arranged with the longitudinal center axis of the side wall 122 as the axis of symmetry, which is beneficial to the relatively reliable sliding of the movable end 112 of the anchoring part 110 along the axial direction of the side wall 122 and avoids slipping. Moreover, when the movable end 112 slides to the expanded state of the anchoring part 110, the two self-locking structures 123 are respectively matched with the two matching structures 116, which can relatively reliably lock the anchoring part 110 in the expanded state.
[0102] It can be understood that in other embodiments, the self-locking structure 123 can be only one, and only one self-locking structure 123 is arranged, which can also better lock the position of the movable end 112.
[0103] Please refer to Figure 15 and Figure 16 In another embodiment, the puncture part 120 includes a side wall 122, and the puncture part 120 is provided with a self-locking structure 123. Different from the self-locking structure 123 in the above-mentioned embodiment, the self-locking structure 123 in the present embodiment includes a sliding rail 1234 and a limiting area 1235. The sliding rail 1234 extends along the axial direction of the puncture part 120, and the limiting area 1235 is located on one side of the sliding rail 1234, and the limiting area 1235 is in communication with the sliding rail 1234.
[0104] Please refer to Figure 17 In the present embodiment, the movable end 112 of the anchoring part 110 is provided with a matching structure 116, which is used for cooperating with the self-locking structure 123 to limit the movable end 112 after the anchoring part 110 is in the expanded state, so as to keep the anchoring part 110 in the expanded state.
[0105] Please refer to Figure 17 and Figure 18 In an embodiment, the matching structure 116 includes a connecting frame 1161 and a limiting sheet 1162. The connecting frame 1161 is connected with the movable end 112, and a penetrating hole 11611 is formed in the connecting frame 1161. One end of the limiting sheet 1162 is connected with the side wall of the penetrating hole 11611, and the other end extends along the circumferential direction of the puncture part 120 and forms a free end. In the natural state, the free end of the limiting sheet 1162 is bent towards the longitudinal center axis of the puncture part 120. That is, the free end of the limiting sheet 1162 is closer to the longitudinal center axis of the puncture part 120 in the radial direction than the connecting end of the limiting sheet 1162 with the connecting frame 1161.
[0106] In the initial assembly state, the movable end 112 of the anchoring portion 110 is located above the self-locking structure 123, that is, in the initial assembly state, in the axial direction, the self-locking structure 123 is located between the sharp structure 121 of the puncture portion 120 and the movable end 112. When the movable end 112 is driven to slide in the axial direction of the puncture portion 120 towards the sharp structure 121, the free end of the limiting sheet 1162 slides along the slide rail 1234, and when the limiting sheet 1162 slides to the limiting area 1235, the limiting sheet 1162 is limited by the limiting area 1235, so that the movable end 112 cannot continue to slide in the axial direction of the puncture portion 120. In this state, the anchoring portion 110 is in an expanded state and remains in the expanded state, as shown in Figure 19
[0107] In an embodiment, the slide rail 1234 is a through hole formed in the side wall 122, and the limiting area 1235 is also a through hole or a groove formed in the side wall 122.
[0108] In another embodiment, the slide rail 1234 can be a groove formed in the side wall 122, and correspondingly, the limiting area 1235 is a through hole or a groove formed in the side wall 122.
[0109] Please refer back to Figure 15 and Figure 16 In an embodiment, the self-locking structure 123 is two, and the two self-locking structures 123 are symmetrically arranged with the longitudinal center axis of the side wall 122 as the axis of symmetry. Correspondingly, the matching structure 116 on the anchoring portion 110 is also two. The arrangement of the two self-locking structures 123 and the matching structure 116 corresponding to each other is beneficial to the more reliable sliding of the movable end 112 of the anchoring portion 110 in the axial direction of the side wall 122, avoiding slipping. And when the movable end 112 slides to the expanded state of the anchoring portion 110, the two self-locking structures 123 cooperate with the two matching structures 116 respectively, which can more reliably lock the anchoring portion 110 in the expanded state.
[0110] In an embodiment, the slide rail 1234 can be omitted, and when the slide rail 1234 is omitted, the limiting area 1235 is a through hole formed in the side wall 121. When the movable end 112 slides in the axial direction of the puncture portion 120 towards the sharp structure 121 to the limiting area 1235, the free end of the limiting sheet 1162 is bent towards the longitudinal center axis of the puncture portion 120, and the limiting sheet 1162 is resisted by the inner wall of the limiting area 1235, so that the movable end 112 is limited. Therefore, omitting the slide rail 1234 can also achieve the limitation or locking of the movable end 112 to keep the anchoring portion 110 in the expanded state.
[0111] However, the slide rail 1234 is arranged such that when the movable end 112 slides along the axial direction, the free end of the limiting piece 1162 always slides within the slide rail 1234 in the region where the slide rail 1234 extends axially, thereby avoiding the limiting piece 1162 from sliding off and ensuring that the limiting piece 1162 can be limited by the limiting region 1235.
[0112] Referring to Figure 18 In an embodiment, the connecting frame 1161 and the limiting piece 1162 are integrated. The cooperating structure 116 is provided with an inner hole 1163 extending from the connecting frame 1161 to the limiting piece 1162, and the portion of the inner hole 1163 extending to the limiting piece 1162 is located within the edge of the limiting piece 1162. The inner hole 1163 can reduce the bending resistance of the limiting piece 1162 without reducing the width of the limiting piece 1162.
[0113] Referring to Figure 20 In another embodiment, the self-locking structure 123 is different from the self-locking structure 123 of the above-mentioned embodiment. In this embodiment, the self-locking structure 123 includes a locking piece 1236, one end of the locking piece 1236 is connected to the side wall 122, and the other end is a free end and points to the pointed structure 121 of the puncture part 120. In the natural state, the locking piece 1236 is inclined outward relative to the side wall 122. Accordingly, as shown in Figure 21 The movable end 112 is provided with a limiting hole 1122, and during the axial sliding of the movable end 112, the outwardly inclined locking piece 1236 can penetrate into the limiting hole 1122, so that the movable end 112 is limited by the locking piece 1236, and at this time, the anchoring part 110 is in the expanded state.
[0114] In this embodiment, the self-locking structure 123 is also two, and the two self-locking structures 123 are symmetrically arranged with respect to the longitudinal center axis of the puncture part 120. In other embodiments, the self-locking structure 123 can be one.
[0115] Referring to Figure 12 , Figure 15 , Figure 16 , Figure 19 and Figure 20 In an embodiment, the end of the puncture part 120 away from the pointed structure 121 is provided with a connecting region 124, and the connecting region 124 is used to connect with the constriction member 30, so that the anchoring member 10 is slidably connected to the constriction member 30. In an embodiment, the connecting region 124 is provided with a connecting hole 1241, and the constriction member 30 can pass through the connecting hole 1241, thereby connecting a plurality of anchoring members 10 in series.
[0116] Referring back to Figure 1In an embodiment, the delivery device 200 comprises an outer sheath 20, an inner sheath 40, a pusher 60 and a driver 80. The outer sheath 20 is used to establish an implantation path, the inner sheath 40 is used to deliver the anchor 10 through the inner lumen of the outer sheath 20 to the target site, the pusher 60 is used to pierce the anchor 10 into the tissue, and the driver 80 is used to drive the movable end 112 of the anchor portion 110 to slide along the axis of the puncture portion 120.
[0117] The inner sheath 40 is axially slidably received in the inner lumen of the outer sheath 20. The driver 80 is axially slidably threaded through the inner sheath 40, and the distal end of the driver 80 is detachably connected to the proximal end of the movable end 112. The pusher 60 is axially slidably threaded through the driver 80, and the distal end of the pusher 60 is detachably connected to the proximal end of the puncture portion 120. The side opening 410 is formed on the distal end side wall of the inner sheath 40, so as to allow the constraining member 30 to enter the inner sheath 40 and be connected to the puncture portion 120.
[0118] Please refer to Figure 22 The pusher 60 comprises a joint 610 and a push rod 620, the proximal end of the joint 610 is fixedly connected to the distal end of the push rod 620, and the distal end is detachably connected to the proximal end of the puncture portion 120.
[0119] Please refer to Figure 23 In an embodiment, the joint 610 is provided with a first buckle 611. Correspondingly, the puncture portion 120 is provided with a second buckle 125 (see Figure 12 、 Figure 15 、 Figure 16 、 Figure 19 and Figure 20 ), and the second buckle 125 is located at one end of the puncture portion 120 away from the sharp structure 121. The first buckle 611 and the second buckle 125 are buckled to detachably connect the pusher 60 and the puncture portion 120.
[0120] In an embodiment, the first buckle 611 is an S-shaped buckle, and the second buckle 125 is also an S-shaped buckle.
[0121] Please refer to Figure 22 In an embodiment, the joint 610 further comprises a connecting portion 612, one end of the connecting portion 612 is connected to the first buckle 611, and the other end is connected to the push rod 620. The connecting portion 612 is provided to facilitate the connection of the joint 610 and the push rod 620. The connecting portion 612 and the first buckle 611 are an integral structure, for example, formed by cutting a hollow tube body, or the connecting portion 612 and the first buckle 611 are a split structure, and connected to form the joint 610.
[0122] Please refer to Figure 24In an embodiment, the driving member 80 comprises a connecting ring 810 and a driving rod 820 connected to the connecting ring 810. The driving member 80 is sleeved on the puncture part 120, and an end of the connecting ring 810 close to the anchoring part 110 is provided with a clamping block 811. Adjacent two clamping blocks 811 form a gap 812 therebetween.
[0123] Please refer back to Figure 3 The clamping block 811 cooperates with the clamping groove 1121 on the movable end 112, so that the driving member 80 can reliably abut against the movable end 112, so that the driving member 80 can drive the movable end 112 to slide along the axial direction of the puncture part 120.
[0124] When the first clasp 611 and the second clasp 125 are clamped, and the driving member 80 is sleeved on the puncture part 120, the first clasp 611 and the second clasp 125 are surrounded by the driving member 80, thereby limiting the radial movement of the first clasp 611 and the second clasp 125, so that the first clasp 611 and the second clasp 125 remain in the clamped state.
[0125] As shown in Figure 12 , Figure 15 , Figure 16 , Figure 19 and Figure 20 , in an embodiment, the connecting region 124 is radially opposite to the second clasp 125. When the first clasp 611 and the second clasp 125 are clamped, the first clasp 611 is located between the connecting region 124 and the second clasp 125. The first clasp 611 is clamped by the connecting region 124 and the second clasp 125, so that the connection of the first clasp 611 and the second clasp 125 is more reliable, so as to smoothly abut against the puncture part 120 to stab the puncture part 120 into the tissue. When the connecting ring 810 is sleeved on the distal end of the puncture part 120 (as shown in Figure 3 ), the connecting region 124 is radially opposite to the gap 812, so as to connect the bunching member 30 in series with a plurality of anchoring members 10.
[0126] In the implantation process, first, the second clasp 125 of the puncture part 120 of the anchoring member 10 is clamped with the first clasp 611 of the pushing member 60, the connecting ring 810 of the driving member 80 is sleeved on the first clasp 611 and the second clasp 125, and the clamping block 811 of the connecting ring 810 extends into the clamping groove 1121 of the movable end 112, as shown in Figure 3 Then, the anchoring member 10 is accommodated in the distal end of the inner sheath 40, and the pushing rod 620 of the pushing member 60 and the driving rod 820 of the driving member 80 are both extended from the proximal end of the inner sheath 40. The side opening 410 of the inner sheath 40 is radially opposite to the connecting region 124 of the puncture part 120. The bunching member 30 is inserted into the connecting hole 1241. Please refer back to Figure 2The distal end of the constraining member 30 is provided with a blocking member 310, and the proximal end of the constraining member 30 is inserted into the connecting hole 1241, and the blocking member 310 is used to prevent the anchor 10 from sliding off the constraining member 30. Then, the outer sheath 20 is implanted into the body to establish a target path. The inner sheath 40, the constraining member 30, the anchor 10 accommodated in the inner sheath 40, and the push member 60 and the driving member 80 penetrating the inner sheath 40 are sent into the body through the outer sheath 20, as shown in Figure 1 The constraining member 30 extends axially between the outer wall of the inner sheath 40 and the inner wall of the outer sheath 20, and the proximal end of the constraining member 30 is located outside the body. When the anchor 10 is accommodated in the distal end of the inner sheath 40, the anchoring portion 110 is in a contracted state, as shown in Figure 5 The anchoring portion 110 is in a contracted state.
[0127] Then, the distal end of the inner sheath 40 is abutted against the target tissue, the push member 60 is slid towards the target tissue, so that the distal end of the puncturing portion 120 and the anchoring portion 110 in the contracted state are simultaneously pierced into the tissue, and the puncturing portion 120 is pierced to a sufficient depth, and at least the self-locking structure 123 is pierced into the tissue. After the anchoring portion 110 is pierced into the tissue, the anchoring portion 110 returns to a natural state, that is, the two anchoring leaves 113 are in a state of radial expansion to a certain extent. Further, the driving member 80 is moved towards the target tissue to drive the movable end 112 to slide along the axis of the puncturing portion 120, and when the movable end 112 is limited and cannot continue to move, the two anchoring leaves 113 are further expanded, so that the anchoring portion 110 is in an expanded state.
[0128] Further, the inner sheath 40, the push member 60 and the driving member 80 are withdrawn, and the next anchor 10 is installed, the constraining member 30 with the proximal end located outside the body penetrates the connecting hole 1241 of the anchor 10, and a plurality of anchors 10 are sequentially and spacedly implanted into the target tissue in the same way. It should be noted that when the spacer 50 is arranged between the two adjacent anchors 10, after the first anchor 10 is implanted, the spacer 50 is sent in, and then the next anchor 10 is installed, and then another spacer 50 is implanted, and then the next anchor 10 is installed, and a plurality of anchors 10 and a plurality of spacers 50 are alternately implanted in the corresponding order.
[0129] Finally, the constraining member 30 is tightened and locked, and then the constraining member 30 is cut off, and the outer sheath 20, the inner sheath 40, the push member 60 and the driving member 80 are withdrawn, and the operation is completed.
[0130] It should be noted that the locking manner is adopted by those skilled in the art, including but not limited to, knotting the collection member 30 so that the collection member 30 cannot pass through the connecting hole 1241 to achieve locking. The cutting manner of the collection member 30 is also adopted by those skilled in the art, including but not limited to, sending a cutting mechanism from the outer sheath 20 into and cutting the collection member 30.
[0131] The sharp structure 121 of the puncture part 120 can be a single-sided sharp structure, a double-sided sharp structure, or a multi-sided sharp structure.
[0132] In an embodiment, the sharp structure 121 is a single-sided sharp structure formed by cutting the distal end of the side wall 122, and the radial width of the sharp structure 121 gradually increases from the distal end to the proximal end, so that the penetration resistance is small, and it is convenient to penetrate into the tissue.
[0133] Please refer to Figure 21 In an embodiment, the distal end of the fixed end 111 has a sharp head 1111 towards the distal end, which is arranged to facilitate reducing the resistance in the puncture process, so as to facilitate the anchor part 110 to penetrate into the tissue together with the puncture part 120.
[0134] Please refer to Figure 25 In an embodiment, the fixed end 111 of the anchor part 110 is not a ring structure, the first connecting ring is omitted, the first bending arm 114 is extended, and the distal end part of the first bending arm 114 is used as the fixed end 111 for fixed connection with the puncture part 120. In this way, it is convenient to reduce the resistance in the process of penetrating into the tissue and facilitate penetration.
[0135] In an embodiment, the distal end of the first bending arm 114 has a sharp head part 1141, which is arranged to further reduce the penetration resistance.
[0136] When the distal end part of the first bending arm 114 is used as the fixed end 111, it is also convenient to fixedly connect the fixed end 111 with the puncture part 120, and the form of the second self-locking member 1232 of the self-locking structure 123 is more flexible, which is not easy to hinder the assembly of the anchor part 110 and the puncture part 120.
[0137] The puncture function of the anchor 10 is borne by the puncture part 120, and the anchoring function is borne by the anchor part 110, so that a sharp structure 120 with a smaller radial size can be arranged to facilitate puncture, and the anchoring performance will not be affected by reducing the anchoring area. The anchor part 110 is brought into the tissue during the puncture process of the puncture part 120, and the anchor part 110 can be deformed independently to increase the anchoring area. Therefore, the anchor 10 has higher anchoring performance compared with the existing puncture and anchoring function integrated filamentous structure.
[0138] The anchoring performance of the anchor 10 is good, so that the implant 100 can be stably and reliably implanted into the target tissue, thereby achieving good curative effect.
[0139] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, but as long as the combinations of the technical features do not exist contradictions, they should be considered as the scope of the present disclosure.
[0140] The above only discloses the preferred embodiments of the present application, and of course cannot limit the scope of the right of the present application, so the equivalent changes made according to the claims of the present application still belong to the scope covered by the present application.
Claims
1. An anchoring element for anchoring tissue, characterized in that, It includes a puncture part and an anchoring part. The anchoring part includes a fixed end and a movable end. The fixed end is fixedly connected to the puncture part. The movable end can slide along the axial direction of the puncture part to change the anchoring part from a natural state to an expanded state. In the expanded state, the movable end is limited.
2. The anchoring element according to claim 1, characterized in that, The anchoring part includes an anchoring leaf, the two ends of which are connected to the fixed end and the movable end, respectively. The movable end slides along the axial direction of the puncture part, causing the end of the anchoring leaf connected to the movable end to move radially away from the puncture part, thereby causing the anchoring part to be in an expanded state.
3. The anchoring element according to claim 2, characterized in that, The anchoring leaf has multiple hooks spaced apart along the axial direction on both sides. In its natural state, each hook points towards the fixed end; in its expanded state, each hook points towards the outer surface of the puncture part.
4. The anchoring element according to claim 2, characterized in that, In its natural state, the anchoring leaf forms an angle greater than 0° with the longitudinal central axis of the puncture portion.
5. The anchoring element according to claim 2, characterized in that, There are two anchoring leaves, which are symmetrically arranged about the longitudinal central axis of the puncture part. The two anchoring leaves deform synchronously with the axial sliding of the movable end, so that the ends of the two anchoring leaves closest to the movable end move away from each other in the radial direction, thereby changing the anchoring part from a natural state to an expanded state.
6. The anchoring element according to claim 1, characterized in that, The anchoring part includes a first connecting ring, a second connecting ring, and an anchoring component. The first connecting ring is the fixed end, and the second connecting ring is the movable end. The anchoring component is disposed between the first connecting ring and the second connecting ring, and both ends of the anchoring component are connected to the first connecting ring and the second connecting ring, respectively. The first connecting ring and the second connecting ring are both sleeved on the puncture part. The first connecting ring is fixedly connected to the puncture part, and the second connecting ring can slide along the axial direction of the puncture part to change the anchoring component from a natural state to an expanded state.
7. The anchoring element according to claim 6, characterized in that, The anchoring assembly includes an anchoring leaf, a first bending arm, and a second bending arm. One end of the first bending arm is connected to the first connecting ring, and the other end is connected to the anchoring leaf. One end of the second bending arm is connected to the second connecting ring, and the other end is connected to the anchoring leaf. When the second connecting ring slides axially relative to the puncture part, it can drive the first bending arm and the second bending arm to bend, thereby changing the anchoring leaf from its natural state to its expanded state.
8. The anchoring element according to claim 7, characterized in that, The anchoring leaf has an installation groove, one end of the second bending arm extends into the installation groove and is fixedly connected to the anchoring leaf, and the end of the second bending arm connected to the anchoring leaf is surrounded by the anchoring leaf.
9. The anchoring element according to claim 8, characterized in that, An anchoring arm is provided in the mounting groove. One end of the anchoring arm is connected to the bottom of the mounting groove, and the other end is a free end. In its natural state, the free end extends towards the movable end. When the second bending arm bends, the free end of the anchoring arm tilts outward.
10. The anchoring element according to claim 9, characterized in that, The second bending arm includes a main arm and two support arms. One end of the main arm is connected to the movable end, and the other end is connected to the two support arms. The ends of the two support arms that are away from the main arm are connected to the bottom of the mounting groove. The anchoring arm is located between the two support arms. When the main arm and the two support arms are bent, the anchoring arm tilts outward.
11. The anchoring element according to claim 1, characterized in that, The anchoring part includes an anchoring assembly, which includes an anchoring leaf, a first bending arm, and a second bending arm. One end of the first bending arm is connected to the anchoring leaf, and the other end extends distally as the fixed end. One end of the second bending arm is connected to the anchoring leaf, and the other end is connected to the movable end.
12. The anchoring element according to claim 1, characterized in that, The puncture portion is provided with a self-locking structure. When the movable end of the anchor portion slides along the axial direction of the puncture portion until the anchor portion is in an expanded state, the self-locking structure restricts the axial sliding of the movable end.
13. The anchoring element according to claim 12, characterized in that, The self-locking structure includes a first self-locking component and a second self-locking component. The first and second self-locking components are spaced apart along the axial direction of the puncture portion, and the space between the first and second self-locking components forms a self-locking space. When the movable end of the anchoring portion slides along the axial direction of the puncture portion into the self-locking space, the anchoring portion is in an expanded state, and the movable end of the anchoring portion is limited by the first and second self-locking components and cannot slide axially towards the proximal and distal ends.
14. The anchoring element according to claim 13, characterized in that, The puncture site includes a sidewall; the first self-locking member includes a first self-locking piece, one end of which is connected to the sidewall and the other end is a free end. In its natural state, the first self-locking piece is inclined outward relative to the sidewall, and the free end of the first self-locking piece points towards the second self-locking member; the second self-locking member includes a second self-locking piece, one end of which is connected to the sidewall and the other end is a free end. In its natural state, the second self-locking piece is inclined outward relative to the sidewall, and the free end of the second self-locking piece points towards the first self-locking member.
15. The anchoring element according to claim 14, characterized in that, The first self-locking piece is formed by cutting and shaping the sidewall, and the second self-locking piece is formed by cutting and shaping the sidewall.
16. The anchoring element according to claim 15, characterized in that, The sidewall has a first through hole and a second through hole. The first through hole extends from the sidewall to the first self-locking piece, and the portion of the first through hole extending to the first self-locking piece is located within the edge of the first self-locking piece. The second through hole extends from the sidewall to the second self-locking piece, and the portion of the second through hole extending to the second self-locking piece is located within the edge of the second self-locking piece.
17. The anchoring element according to claim 12, characterized in that, The puncture portion includes a sidewall, and the self-locking structure consists of a slide rail and a limiting area formed on the sidewall. The slide rail extends axially along the puncture portion, and the limiting area is located on one side of the slide rail and communicates with the slide rail. A mating structure is provided on the movable end. The movable end can slide along the axial direction of the puncture portion to drive the mating structure to slide along the slide rail. When the mating structure slides along the slide rail until it enters the limiting area, the movable end is limited, and the anchoring portion is in an expanded state.
18. The anchoring element according to claim 17, characterized in that, The mating structure includes a connecting frame and a limiting piece. The connecting frame is connected to the movable end and has a through hole. One end of the limiting piece is connected to the side wall of the through hole, and the other end is a free end. In its natural state, the free end of the limiting piece bends toward the slide rail.
19. The anchoring element according to claim 18, characterized in that, The connecting frame and the limiting piece are an integral structure. The mating structure has an inner hole that extends from the connecting frame to the limiting piece, and the portion of the inner hole extending to the limiting piece is located within the edge of the limiting piece.
20. The anchoring element according to claim 12, characterized in that, The puncture portion includes a sidewall; the self-locking structure includes a locking piece, one end of which is connected to the sidewall and the other end is a free end. In its natural state, the locking piece is inclined outward relative to the sidewall; a limiting hole is provided on the movable end of the anchoring portion. During the process of the movable end of the anchoring portion sliding along the axial direction of the puncture portion, the locking piece can pass into the limiting hole to limit the movable end.
21. An implant, characterized in that, It includes a converging member and a plurality of anchoring members as described in any one of claims 1 to 20, wherein the converging member is used to connect the plurality of anchoring members in series, and each of the anchoring members can slide along the converging member when the converging member connects the plurality of anchoring members in series.
22. An implantation system, characterized in that, The device includes a delivery unit and the implant as described in claim 21. The delivery unit includes a pusher and a drive unit. The pusher is detachably connected to one end of the puncture portion away from the fixed end for inserting the anchor into the target site. The drive unit is detachably connected to the anchor portion for driving the movable end of the anchor portion to slide axially along the puncture portion.
23. The implantation system according to claim 22, characterized in that, The pusher is provided with a first buckle, and the puncture part is provided with a second buckle. The first buckle and the second buckle are engaged to connect the pusher to the puncture part. The puncture part is provided with a connecting area, and the connecting area is provided with a connecting hole for the converging member to pass through. The connecting area is radially opposite to the second buckle. When the first buckle and the second buckle are engaged, the first buckle is located between the second buckle and the connecting area.
24. The implantation system according to claim 23, characterized in that, A locking block is provided on one end of the driving member near the movable end, and a locking groove is provided on the movable end. The driving member is sleeved on the puncture part. The locking block and the locking groove cooperate to make the driving member detachably connected to the anchoring part, and the first buckle and the second buckle are radially limited by the driving member.