Suture and suture system

Abstract

The application relates to the technical field of medical devices, and discloses a suturing device and a suturing system. The suturing device comprises a first arc segment, a second arc segment and a third arc segment. The first arc segment comprises a first main arc segment, the two ends of the first main arc segment are a first end and a second end respectively, the second arc segment is curved and extended from the first end and forms a first puncture part, the third arc segment is curved and extended from the second end and forms a second puncture part, the second arc segment and the third arc segment are located on the same side of the first main arc segment, and the second arc segment and the third arc segment are arranged in an overlapping and intersecting mode to form an intersection site. The intersection site is located between the first end and the first puncture part, and the intersection site is located between the second end and the second puncture part. The suturing device has a simple structure, no large protruding structure, is not prone to thrombosis, and is easier to be fully endothelialized. After the suturing is completed, the device left in the body is small, large device residues do not occur, and the burden of the suturing device on the heart is reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a suture device and suture system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] PFO (perforamen ovale not necessarily) refers to a condition in humans where the foramen ovale remains open throughout life without closing after birth. PFO occurs in approximately 25% of the general population, and most people do not require treatment. However, research suggests a link between PFO and certain types of neurocutaneous decompression sickness (DCS). Furthermore, some believe that adults with PFO may have a higher risk of certain types of stroke, specifically stroke caused by embolism.

[0004] If someone has a symptom-related patent foramen ovale (PFO), medication can be used to prevent thrombosis, depending on the specific circumstances. Alternatively, interventional treatments can be used, such as percutaneous catheterization to deliver an occlusion device to the PFO site to close it.

[0005] Interventional treatment has the advantages of being minimally invasive and simple to perform. However, the mainstream PFO occluders are currently made of nickel-titanium woven double-disc structure. After implantation, large, non-degradable devices remain in the heart, which increases the burden on the heart. Summary of the Invention

[0006] The purpose of this application is to at least address the problem that existing interventional PFO occluders leave large, non-biodegradable device fragments in the heart, placing a significant burden on the heart. This objective is achieved through the following technical solution:

[0007] The first aspect of this application provides a suture device, comprising a first arc segment, a second arc segment, and a third arc segment. The first arc segment includes a first main arc segment, with a first end and a second end at its two ends, respectively. The second arc segment extends from the first end in a curved manner to form a first puncture portion. The third arc segment extends from the second end in a curved manner to form a second puncture portion. The second arc segment and the third arc segment are located on the same side of the first main arc segment, and the second arc segment and the third arc segment overlap and intersect to form an intersection point. The intersection point is located between the first end and the first puncture portion, and the intersection point is located between the second end and the second puncture portion.

[0008] According to the suture device of this application, the tissues on both sides of the foramen ovale (i.e., the atrial septum tissue) can be cross-sutured through the combined action of the first arc segment, the second arc segment and the third arc segment. The entire structure is achieved by using arc segments. Compared with existing PFO occlusion devices, the suture device of this application has a simple structure, no large protruding structure, is less likely to form thrombi, and is easier to achieve complete endothelialization. After suturing, the device left in the body is small, and there will be no large device residue, which reduces the burden on the heart brought by the suture device.

[0009] In addition, the suture device according to this application may also have the following additional technical features:

[0010] In some embodiments of this application, under natural conditions, the included angle α formed by the bending of the first arc segment and the second arc segment at the first end satisfies: 0°<α≤20°;

[0011] And / or, the angle β formed by the bending of the first arc segment and the third arc segment at the second end is greater than 0 degrees and less than 20 degrees.

[0012] In some embodiments of this application, the second arc segment includes a second main arc segment, which is located between the first arc segment and the first puncture portion, and the first puncture portion is inclined relative to the second main arc segment toward a side away from the first main arc segment;

[0013] And / or, the third arc segment includes a third main arc segment, the third main arc segment being located between the first arc segment and the second puncture portion, the second puncture portion being inclined relative to the third main arc segment toward a side away from the first main arc segment.

[0014] In some embodiments of this application, the second main arc segment includes a first sub-arc segment and a second sub-arc segment, the first sub-arc segment being connected between the first arc segment and the second sub-arc segment, and the second sub-arc segment being connected between the first sub-arc segment and the first puncture site; the third main arc segment includes a third sub-arc segment and a fourth sub-arc segment, the third sub-arc segment being connected between the first arc segment and the fourth sub-arc segment, and the fourth sub-arc segment being connected between the first sub-arc segment and the second puncture site, wherein the first sub-arc segment and the third sub-arc segment overlap and intersect at the intersection point;

[0015] The second sub-arc segment is inclined relative to the first sub-arc segment toward the side closer to the first main arc segment; and / or, the fourth sub-arc segment is inclined relative to the third sub-arc segment toward the side closer to the first main arc segment.

[0016] In some embodiments of this application, the first puncture portion is tilted relative to the second main arc segment toward a side away from the first main arc segment, thereby forming a first inflection point between the second sub-arc segment and the first puncture portion. The axial distance between the first inflection point and the first main arc segment is L1, and the axial distance between the intersection point and the first main arc segment is L2. L1 and L2 satisfy L1≤L2.

[0017] And / or, the second puncture portion is inclined relative to the third main arc segment toward the side away from the first main arc segment, thereby forming a second inflection point between the fourth sub-arc segment and the second puncture portion. The axial distance between the second inflection point and the first main arc segment is L3, and the axial distance between the intersection point and the first main arc segment is L2. L3 and L2 satisfy L3≤L2.

[0018] In some embodiments of this application, the radial cross-sectional area of ​​the first puncture portion gradually decreases along the direction away from the first main arc segment;

[0019] And / or, the radial cross-sectional area of ​​the second puncture portion gradually decreases in the direction away from the first main arc segment.

[0020] In some embodiments of this application, the axial line passing through the midpoint of the first main arc segment is the central axis, and the suture device is symmetrically arranged relative to the central axis.

[0021] A second aspect of this application provides a suture system including a pushing device, comprising a delivery sheath and a pushing member disposed within the delivery sheath, wherein a loading space is provided at the distal end of the delivery sheath;

[0022] The first aspect of this application provides a suture device that can be loaded into the loading space, wherein the distal end of the pusher is fixedly connected to the first arc segment;

[0023] The pusher is used to drive the suture to rotate about the central axis of the pusher, and to push the suture out of the delivery sheath.

[0024] In some embodiments of this application, the pushing member includes a pushing rod, a fixing seat, and a fixing member. The fixing seat includes a connecting part and a fixing part. The proximal end of the connecting part is provided with a fixing groove along the axial direction. The distal end of the pushing rod is fixed to the proximal end of the fixing seat through the fixing groove. The distal end of the fixing part is provided with a through groove. The fixing member can fix the first arc segment in the through groove. The fixing member extends from the distal end of the pushing rod toward the proximal end. By acting on the proximal end of the fixing member, the fixing seat can be released from the first arc segment.

[0025] In some embodiments of this application, the fixing part is arc-shaped, and the central angle corresponding to the arc is less than or equal to 180°; the fixing member includes a fixing line, one end of the fixing line includes a loop, the fixing line extends from the loop from one axial side of the fixing part around the fixing part to the other axial side, and extends along the push rod toward the proximal end, so that the first main arc segment can be tied in the through groove of the fixing part.

[0026] In some embodiments of this application, the fixing part is provided with a relief groove along its arc direction, and the fixing line is wound in the relief groove. Attached Figure Description

[0027] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0028] Figure 1 The diagram schematically illustrates the structure of a suture according to some embodiments of the present application;

[0029] Figure 2 schematically shown Figure 1 Another perspective view;

[0030] Figure 3 The diagram schematically illustrates the structure of a suture according to some embodiments of the present application;

[0031] Figure 4 A schematic diagram of the first puncture site according to some embodiments of the present application is shown.

[0032] Figure 5 schematically shown Figure 4 Enlarged view of the end of the first puncture site;

[0033] Figure 6 A schematic diagram illustrating the assembly of a suture and a pusher according to some embodiments of the present application is shown.

[0034] Figure 7 A schematic diagram illustrating the assembly of the first arc segment and the pusher according to an embodiment of this application is shown.

[0035] Figure 8 schematically shown Figure 7 A cross-sectional view;

[0036] Figure 9 A schematic diagram of a suturing system according to an embodiment of this application is shown;

[0037] Figure 10 A schematic diagram of the suturing system according to an embodiment of this application during the suturing process is shown;

[0038] Figure 11 schematically shown Figure 10 A schematic diagram of the subsequent suturing process;

[0039] Figure 12 schematically shown Figure 11 A schematic diagram showing the twisting of the suture device during subsequent suturing;

[0040] Figure 13 schematically shown Figure 12 The diagram shows the process of the suture device returning to its natural state during subsequent suturing.

[0041] Figure 14 schematically shown Figure 13 A schematic diagram showing the interaction between the suture system and the tissue after suturing is completed;

[0042] Figure 15 The diagram schematically illustrates the suture state of the suture device and the tissue.

[0043] The attached figures are labeled as follows:

[0044] 100. Suture device; 110. First arc segment; 111. First main arc segment; 112. First end; 113. Second end; 120. Second arc segment; 121. First inflection point; 1211. First sub-arc segment; 1212. Second sub-arc segment; 1213. First extension line; 122. First puncture site; 1221. Blunt inverted structure; 130. Third arc segment; 131. Second inflection point; 1311. Third sub-arc segment; 1312. Fourth sub-arc segment; 1313. Second extension line; 132. Second puncture site; 140. Crossover point; 150. Central axis;

[0045] 200. Pushing device; 210. Conveying sheath; 220. Pushing component; 221. Pushing rod; 222. Fixing base; 2221. Connecting part; 2222. Fixing part; 2223. Through groove; 2224. Clearance groove; 223. Fixing line; 2231. Loose collar; 230. Limiting rod;

[0046] 300. Organization. Detailed Implementation

[0047] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0048] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0049] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0050] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0051] like Figures 1 to 15 As shown, according to an embodiment of this application, a suture device 100 is proposed, including a first arc segment 110, a second arc segment 120, and a third arc segment 130. The first arc segment 110 includes a first main arc segment 111, with a first end 112 and a second end 113 at its two ends. The second arc segment 120 extends from the first end 112 and forms a first puncture portion 122. The third arc segment 130 extends from the second end 113 and forms a second puncture portion 132. The second arc segment 120 and the third arc segment 130 are located on the same side of the first main arc segment 111, and the second arc segment 120 and the third arc segment 130 overlap and intersect to form an intersection point 140. The intersection point 140 is located between the first end 112 and the first puncture portion 122, and the intersection point 140 is located between the second end 113 and the second puncture portion 132.

[0052] In this embodiment, the structural description of the suture 100 is based on the suture 100 being in its natural state, such as... Figure 1 , Figure 2 and Figure 3 As shown, the first arc segment 110, the second arc segment 120, and the third arc segment 130 of the suture device 100 in its natural state form a roughly "∝"-shaped structure, or roughly an "α"-shaped structure. The first arc segment 110 is usually located in the right atrium. When the suture device 100 is applied to a patient's body, and the patient's left and right sides are described, the first arc segment 110 is a slightly inwardly curved right arc segment, and the second arc segment 120 and the third arc segment 130 are two slightly inwardly curved left arc segments that overlap and intersect each other.

[0053] Among them, the two ends of the first main arc segment 111 are the stitchers 100. Figure 1 and Figure 3The highest and lowest points in the vertical direction shown, that is, the two ends of the first main arc segment 111, are the two reversal inflection points of the suture 100, and these two reversal inflection points are located on the side of the intersection point 140 away from the puncture site. The first end 112 of the first arc segment 110 of the suture 100 is connected to the second arc segment 120 as a whole, and the second arc segment 120 is located on one side of the first arc segment 110 (refer to...). Figure 1 and Figure 3 (As shown on the right), and the second arc segment 120 extends from the first end 112 of the first main arc segment 111 towards the second end 113 of the first main arc segment 111, and has a tendency to gradually move away from the first main arc segment 111. The second end 113 of the first arc segment 110 is connected to the third arc segment 130 as a whole, and the third arc segment 130 and the second arc segment 120 are located on the same side of the same arc segment (refer to the right side). Figure 1 and Figure 3 (As shown on the right), and the third arc segment 130 extends from the second end 113 of the first main arc segment 111 towards the first end 112 of the first main arc segment 111, and has a tendency to gradually move away from the first main arc segment 111. The second arc segment 120 and the third arc segment 130 overlap and intersect but are not fixedly connected. Specifically, the second arc segment 120 can abut against one side of the third arc segment 130. Through the action of external force, the second arc segment 120 and the third arc segment 130 can be separated, that is, the intersection is released.

[0054] The first puncture portion 122 and the second puncture portion 132 are used to pass through the tissue 300 to be sutured, combined with Figure 12-15 As shown. The suture device 100 of this embodiment should have deformable elasticity so that it can be twisted and deformed, so that the first arc segment 110 and the second arc segment 120 of the suture device 100 can be de-crossed or restored to overlap, thereby realizing the suturing of the tissue 300 (e.g., the tissue 300 on both sides of the foramen ovale, i.e., the interatrial septum tissue between the left and right atria) by the suture device 100. The suture device 100 can be made of metal wire, specifically a metal wire made of shape memory metal, for example, integrally formed of nickel-titanium material, that is, the first arc segment 110, the second arc segment 120 and the third arc segment 130 are formed by bending and shaping a single nickel-titanium wire. The suture 100, formed by bending metal wire, can undergo elastic deformation and torsion under external force. For example, when the second arc segment 120 and the third arc segment 130 are in an overlapping and crossing state, fixing the end of the second arc segment 120 away from the first arc segment 110 (first puncture part 122) and the end of the third arc segment 130 away from the first arc segment 110 (second puncture part 132), and twisting the first arc segment 110 from the first end 112 to the second end 113 and from the second end 113 to the first end 112 around the axis of symmetry of the suture, can release the overlapping and crossing of the second arc segment 120 and the third arc segment 130. Figure 1The situation where the third arc segment 130 overlaps the second arc segment 120 needs to be reversed in a counterclockwise direction when viewed from left to right in the figure in order to release the overlap and intersection of the second arc segment 120 and the third arc segment 130.

[0055] The natural state of the stapler 100 is a stable state, or in other words, the stapler 100 tends to return to its natural state after deformation. Specifically, the second arc segment 120 and the third arc segment 130 of the stapler 100 are in an overlapping and crossing state in their natural state. During the suturing operation, the second arc segment 120 and the third arc segment 130 are adjusted and twisted to release the overlapping and crossing. The stapler 100 has an elastic force generated by the twisting. This elastic force can restore the second arc segment 120 and the third arc segment 130 to the overlapping and crossing state while fixing the first arc segment 110 and not being restrained at the original crossing point. Specifically, the stapler 100 can have superelasticity so that it can automatically return to its original shape after a large degree of deformation.

[0056] In this embodiment, the first puncture portion 122 and the second puncture portion 132 of the suture device 100 can pass through the same plane or through two adjacent planes (the plane refers to the tissue surface to be sutured).

[0057] The following example illustrates the suturing process of the suturer 100, using the example of passing through two adjacent planes (for ease of description, we will define the two adjacent planes as plane A and plane B). First, as... Figure 11 The combination shown Figure 1-3 The first puncture part 122 of the suture device 100 passes through plane A, and the second puncture part 132 passes through plane B. When the intersection point approaches the punctured surfaces (plane A and plane B) during the puncture process, puncture cannot continue due to the presence of the intersection point 140. At this time, the first puncture part 122 and the second puncture part 132 are fixed by plane A and plane B in the direction of parallel planes. Under the action of external torsional force, the first arc segment 110 is twisted, which can release the overlapping and crossing of the second arc segment 120 and the third arc segment 130 (the upper and lower positions of the second arc segment and the third arc segment are exchanged in the figure, as shown). Figures 11 to 12 (the state), forming a superimposed cross release state, such as Figure 12 As shown; continuing forward, since most of the second arc segment 120 and the third arc segment 130 pass through the other side of plane A and plane B, and the first arc segment 110 is held by torsional force, the second arc segment 120 and the third arc segment 130 return to their overlapping and intersecting state on the other side of plane A and plane B, as shown. Figure 12-14 As shown.

[0058] It should be noted that, in order to ensure that the suture 100 can be in a relatively stable state between the second arc segment 120 and the third arc segment 130 after twisting, and to avoid the suture 100 remaining in a state between the second arc segment 120 and the third arc segment 130 being in a state of unoverlapping or overlapping, the suture 100 in this embodiment, being a planar structure, can reach a stable state after twisting 180°. In its natural state, the second arc segment 120 and the third arc segment 130 of the suture 100 are in an overlapping state; this state is the initial state of the suture 100 after twisting. Figure 1-3 As shown, when the suture 100 is twisted 180° to reach another relatively stable state, the second arc segment 120 and the third arc segment 130 are completely de-overlapped; the second arc segment 120 and the third arc segment 130 generate an elastic force due to the twisting of the first arc segment 110, which restores the suture to a stable state by returning it to the overlapped state. The suture 100 can be twisted and, in the de-overlapped state after twisting, the first arc segment 110 can be stabilized by the restraining action of the pushing device 200.

[0059] The suture device 100 of this embodiment can be used as a suture instrument for PFO (patent foramen ovale), and can also be used to suture structures such as the ventricular septum. It can be implanted through an interventional device (i.e., a pusher device 200) that enters the blood vessels. Taking the suture of the foramen ovale as an example, during the suture process, the suture device 100 is pushed by the pusher device 200 as follows: Figure 9 The procedure, as shown, is delivered to the right atrium, and then the first puncture section 122 and the second puncture section 132 are pushed to protrude from the distal end of the delivery device, as indicated. Figure 10 As shown, the tissue 300 passes through both sides of the foramen ovale. By twisting the pushing device 200 by 180°, the first arc segment 110 is rotated by the fixing seat 222 fixed to the first arc segment 110, thus releasing the overlapping and crossing of the second arc segment 120 and the third arc segment 130. The puncture tissue 300 is then pushed forward. Figure 11-12 As shown, the second arc segment 120 and the third arc segment 130 ultimately overlap and cross on one side of the left atrium of tissue 300 (foramen ovale tissue), while the first arc segment 110 is located on one side of the right atrium, as shown. Figure 13-14As shown, the foramen ovale is closed by overlapping and cross-suturing of the tissues 300 on both sides of the foramen ovale through the combined action of the first arc segment 110, the second arc segment 120, and the third arc segment 130. The entire structure of the suture device 100 is realized by using arc segments. The suture device 100 of this embodiment has a simple structure and a light overall weight. After suturing, the instrument left in the body is small, and there will be no large instrument residue, which reduces the burden on the heart caused by the suture device 100. Compared with existing PFO occlusion devices (existing PFO occlusion devices have a thrombus with gathered braided wires in the center of the occlusion disc in the left atrium, which forms a protruding structure and is prone to thrombosis), the suture device 100 of this embodiment has no large protruding structure, is less prone to thrombosis, and is easier to achieve complete endothelialization.

[0060] It should be noted that the suture device 100 can also be placed in the left atrium before suturing, and the overlapping and cross-suturing of the tissues on both sides of the foramen ovale can be achieved by suturing from the left atrium to the right atrium, which will not be elaborated here.

[0061] In this embodiment, the suture device 100 is mainly used as a PFO suture instrument to illustrate the suture process and effect. However, it should be noted that the suture device 100 is not limited to use as a PFO suture instrument, and it can also be applied to the suturing of other tissues as needed.

[0062] like Figures 1 to 3 as well as Figure 6 As shown, in one embodiment of this implementation, in the natural state, the included angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112 satisfies: 0°<α≤20°; and / or, the included angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 satisfies: 0°<β≤20°.

[0063] In one specific implementation, the angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 is not limited. For example, the angle β can be greater than 20 degrees, specifically 21° or 22°. In the natural state, the angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112 satisfies: 0°<α≤20°. Specifically, the angle α can be 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19° or 20°.

[0064] After the suture is completed by the suturer 100, the sutured tissue 300 will be placed between the second arc segment 120 and the first arc segment 110 and between the third arc segment 130 and the first arc segment 110. The smaller the angle between the first arc segment 110 and the second arc segment 120, and the smaller the angle between the first arc segment 110 and the third arc segment 130, the better the suturer restricts the sutured tissue, the less likely the sutured tissue 300 will move on the suturer 100, that is, the better the suture stability of the tissue 300, and the better the fit between the tissue 300 and the suturer 100. In this specific implementation, the included angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112 is set to be greater than 0 degrees and less than or equal to 20 degrees. This makes the bending radius between the first arc segment 110 and the second arc segment 120 smaller, reducing the distance between the two arc segments. This helps to enhance the fit between the first arc segment 110 and the second arc segment 120 and the tissue 300, ensuring that the tissue 300 between the second arc segment 120 and the first arc segment 110 has good suture stability after the suture is completed by the suturer 100.

[0065] In one specific implementation, the angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112 is not limited. For example, the angle α can be greater than 20 degrees, specifically 21° or 22°. In the natural state, the angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 satisfies: 0°<β≤20°. Specifically, the angle β can be 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19° or 20°.

[0066] In this specific implementation, the included angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 is set to be greater than 0 degrees and less than or equal to 20 degrees. This makes the bending radius between the first arc segment 110 and the third arc segment 130 smaller, reducing the distance between the two arc segments. This helps to enhance the fit between the first arc segment 110 and the third arc segment 130 and the tissue 300. It can ensure that after the suture is completed by the suturer 100, the tissue 300 between the first arc segment 110 and the third arc segment 130 has good suture stability.

[0067] In one specific implementation, under natural conditions, the included angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112 satisfies: 0° < α ≤ 20°, and the included angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 satisfies: 0° < β ≤ 20°. Specifically, the included angles α and β can be the same or different, and can be 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19°, or 20° respectively.

[0068] In this specific implementation, the included angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112 is set to be greater than 0 degrees and less than or equal to 20 degrees, and the included angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 is set to be greater than 0 degrees and less than or equal to 20 degrees. This helps to enhance the fit between the first arc segment 110 and the third arc segment 130 and the tissue (plane B), the fit between the first arc segment 110 and the second arc segment 120 and the tissue (plane A), and the fit between the tissue 300 punctured by the third arc segment 130 and the tissue punctured by the second arc segment 120. This ensures that after the suture is completed by the suturer 100, the tissue 300 between the second arc segment 120 and the first arc segment 110 and the tissue 300 between the first arc segment 110 and the third arc segment 130 are all attached to the first arc segment 110 and close to each other, thus having better suture stability.

[0069] It should be noted that in the above specific implementation, the angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112, and the angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113 are both given as integer degrees. However, in actual production, they can be non-integer degrees, which can be approximately a certain degree and do not require high precision, such as around 10 degrees.

[0070] like Figure 3 and Figure 6 As shown, in one embodiment of this implementation, the second arc segment 120 includes a second main arc segment, which is located between the first end 112 of the first arc segment 110 and the first puncture portion 122. The first puncture portion 122 is inclined relative to the second main arc segment towards the side opposite to the first main arc segment 111. And / or, the third arc segment 130 includes a third main arc segment, which is located between the second end 113 of the first arc segment 110 and the second puncture portion 132. The second puncture portion 132 is inclined relative to the third main arc segment towards the side opposite to the first main arc segment 111.

[0071] The first puncture portion 122 is inclined relative to the second main arc segment towards the side opposite to the first main arc segment 111, which can be understood as the first puncture portion 122 bending outward; the second puncture portion 132 is inclined relative to the third main arc segment towards the side opposite to the first main arc segment 111, which can be understood as the second puncture portion 132 bending outward, such as... Figure 3 As shown.

[0072] In one specific implementation, refer to Figure 3 and Figure 6 As shown, the first puncture portion 122 is inclined relative to the second main arc segment toward the side away from the first main arc segment 111, the first puncture portion 122 is bent outward, and the second puncture portion 132 is inclined relative to the third main arc segment toward the side away from the first main arc segment 111.

[0073] Reference Figure 3 and Figure 6 The first puncture portion 122 is inclined relative to the second main arc segment towards the side opposite to the first main arc segment 111, such that the end of the first puncture portion 122 (the end refers to the end away from the second main arc segment) faces the side opposite to the first main arc segment 111 (with... Figure 3 In other words, the side that deviates from the first main arc segment 111 is the right side. Figure 6 In other words, the side opposite to the first main arc segment 111 (that is, the left side) curves outward. Thus, during the suturing process, the first puncture portion 122 extends relative to the extension direction of the second main arc segment (the extension direction of the first puncture portion 122 along the extension direction of the second main arc segment can be referred to...). Figure 1 and Figure 2 The end of the first puncture portion 122 curves towards the tissue 300 to be sutured, making it easier for the first puncture portion 122 to pass through the tissue 300 to be sutured. Similarly, continue referring to... Figure 3 and Figure 6 The second puncture portion 132 is inclined relative to the third main arc segment toward the side opposite to the first main arc segment 111, such that the end of the second puncture portion 132 (the end refers to the end away from the third main arc segment) is inclined toward the side opposite to the first main arc segment 111 (towards...). Figure 3 In other words, the side that deviates from the first main arc segment 111 is the right side. Figure 6 In other words, the side opposite to the first main arc segment 111 (that is, the left side) curves outward. Thus, during suturing, the second puncture portion 132 extends in the direction of the third main arc segment relative to the extension of the second puncture portion 132 (the extension of the first puncture portion 122 along the direction of the second main arc segment can be referred to...). Figure 1 and Figure 2 The end of the second puncture part 132 is curved toward the tissue 300 that needs to be sutured, making it easier for the second puncture part 132 to pass through the tissue 300 that needs to be sutured.

[0074] In this specific implementation, during the suturing process, the ends of both the first puncture part 122 and the second puncture part 132 face the tissue 300 to be sutured. This makes it easier for both the first puncture part 122 and the second puncture part 132 to pass through the tissue 300 to be sutured, thus optimizing the puncture effect of the suturer 100 and making the suturing operation of the suturer 100 more convenient.

[0075] It should be noted that in this embodiment, the suture device 100 may only have the first puncture portion 122 tilted relative to the second main arc segment towards the side away from the first main arc segment 111, while the extension direction of the second puncture portion 132 relative to the third main arc segment is not limited. For example, the second puncture portion 132 may continue to extend along the extension direction of the third main arc segment, as long as it facilitates puncturing the tissue when it is just pushed out of the delivery device. In this way, the end of the first puncture portion 122 faces the tissue 300 to be sutured, and the first puncture portion 122 can more easily pass through the tissue 300 to be sutured. Compared to the method where neither the first puncture portion 122 nor the second puncture portion 132 is tilted away from the first main arc segment 111, the puncture operation of the first puncture portion 122 is more convenient, and the puncture effect of the suture device 100 can be optimized, making the suture operation of the suture device 100 more convenient.

[0076] In this embodiment, the suture device 100 can also have the second puncture portion 132 tilted relative to the third main arc segment towards the side away from the first main arc segment 111. The extension direction of the first puncture portion 122 relative to the second main arc segment is not limited. For example, the first puncture portion 122 can continue to extend along the extension direction of the second main arc segment, as long as it facilitates puncturing the tissue when it is just pushed out of the pusher device. In this way, the end of the second puncture portion 132 faces the tissue 300 to be sutured, and the second puncture portion 132 can more easily pass through the tissue 300 to be sutured. Compared with the method where neither the first puncture portion 122 nor the second puncture portion 132 is tilted away from the first main arc segment 111, the puncture operation of the second puncture portion 132 is more convenient, which optimizes the puncture effect of the suture device 100 and makes the overall suture operation of the suture device 100 more convenient.

[0077] Continue to refer to Figure 3 and Figure 6As shown, in one embodiment of this implementation, the second main arc segment includes a first sub-arc segment 1211 and a second sub-arc segment 1212. The first sub-arc segment 1211 connects the first end 112 of the first arc segment 110 and the second sub-arc segment 1212, and the second sub-arc segment 1212 connects the first sub-arc segment 1211 and the first puncture portion 122. The third main arc segment includes a third sub-arc segment 1311 and a fourth sub-arc segment 1312. The third sub-arc segment 1311 connects the second end 113 of the first arc segment 110 and the fourth sub-arc segment 1312, and the fourth sub-arc segment 1312 connects the third sub-arc segment 1311 and the second puncture portion 132. The first sub-arc segment 1211 and the third sub-arc segment 1311 overlap and intersect at the intersection point 140, as shown. Figure 3 As shown. The second sub-arc segment 1212 is inclined relative to the first sub-arc segment 1211 toward the side closer to the first main arc segment 111; and / or, the fourth sub-arc segment 1312 is inclined relative to the third sub-arc segment 1311 toward the side closer to the first main arc segment 111.

[0078] The first sub-arc segment 1211 and the second sub-arc segment 1212 are integrally constructed, and the third sub-arc segment 1311 and the fourth sub-arc segment 1312 are integrally constructed. That is, the entire sewing machine 100 can be formed by bending and shaping a single metal wire.

[0079] The second sub-arc segment 1212 is inclined relative to the first sub-arc segment 1211 towards the side closer to the first main arc segment 111. This can be understood as the second sub-arc segment 1212 being located on the side of the extension line of the first sub-arc segment 1211 closer to the first main arc segment 111. Furthermore, from the end connected to the first sub-arc segment 1211 to the end connected to the first puncture part 122, the second sub-arc segment 1212 is gradually positioned closer to the first main arc segment 111 relative to the extension line (first extension line 1213) of the first sub-arc segment 1211, such that the angle formed between the second sub-arc segment 1212 and the first main arc segment 111 is smaller than the angle formed between the first sub-arc segment 1211 and the first main arc segment 111 (the angle formed between the first sub-arc segment 1211 and the first main arc segment 111 is also the angle α formed by the bending of the first arc segment 110 and the second arc segment 120 at the first end 112). (Refer to...) Figure 3 and Figure 6 As shown, the second sub-arc segment 1212 is equivalent to bending inward, that is, the second sub-arc segment 1212 is folded inward relative to the first sub-arc segment 1211, which helps to improve the fit between the first arc segment 110 and the second arc segment 120. After the suturer 100 has finished suturing the tissue 300 and it is completely released, it helps to make the tissue 300 on both sides of the foramen ovale fit more tightly.

[0080] Similarly, the fourth sub-arc segment 1312 is inclined towards the side closer to the first main arc segment 111 relative to the third sub-arc segment 1311. This can be understood as the fourth sub-arc segment 1312 being located on the side of the extension line of the third sub-arc segment 1311 closer to the first main arc segment 111. Furthermore, from the end connected to the third sub-arc segment 1311 to the end connected to the second puncture part 132, the fourth sub-arc segment 1312 gradually gets closer to the first main arc segment 111 relative to the extension line of the third sub-arc segment 1311 (the second extension line 1313), such that the angle formed between the fourth sub-arc segment 1312 and the first main arc segment 111 is smaller than the angle formed between the third sub-arc segment 1311 and the first main arc segment 111 (the angle formed between the third sub-arc segment 1311 and the first main arc segment 111 is also the angle β formed by the bending of the first arc segment 110 and the third arc segment 130 at the second end 113). (Refer to...) Figure 3 and Figure 6 As shown, the fourth sub-arc segment 1312 is equivalent to bending inward, that is, the fourth sub-arc segment 1312 is folded inward relative to the third sub-arc segment 1311, which helps to improve the fit between the first arc segment 110 and the third arc segment 130. After the suturer 100 has finished suturing the tissue 300 and it is completely released, it helps to make the tissue 300 on both sides of the foramen ovale fit more tightly.

[0081] Reference Figure 3 and Figure 6 As shown, in one specific implementation, the suture device 100 is configured such that the second sub-arc segment 1212 is inclined relative to the first sub-arc segment 1211 towards the side closer to the first main arc segment 111, and the fourth sub-arc segment 1312 is inclined relative to the third sub-arc segment 1311 towards the side closer to the first main arc segment 111. The degree of inclination of the second sub-arc segment 1212 relative to the first sub-arc segment 1211 can be the same as or different from the degree of inclination of the fourth sub-arc segment 1312 relative to the third sub-arc segment 1311; no restriction is imposed here.

[0082] By setting the second sub-arc segment 1212 to be tilted relative to the first sub-arc segment 1211 towards the side closer to the first main arc segment 111, and setting the fourth sub-arc segment 1312 to be tilted relative to the third sub-arc segment 1311 towards the side closer to the first main arc segment 111, it is beneficial to improve the fit between the first arc segment 110 and the second arc segment 120 and between the first arc segment 110 and the third arc segment 130. After the suturer 100 has finished suturing the tissue 300 and has been completely released, the tissues 300 on both sides of the foramen ovale fit more tightly. Furthermore, the second arc segment 120 includes a continuously bent first sub-arc segment 1211, a second sub-arc segment 1212, and a first puncture portion 122, and the third arc segment 130 includes a continuously bent third sub-arc segment 1311, a fourth sub-arc segment 1312, and a second puncture portion 132, so that both the second arc segment 120 and the third arc segment 130 form three bends. The middle part of both the second arc segment 120 and the third arc segment 130 is set to be inward and the end is set to be outward, which improves the fit and optimizes the puncture effect.

[0083] It should be noted that the stapler 100 can also be configured such that the second sub-arc segment 1212 is tilted relative to the first sub-arc segment 1211 towards the side closer to the first main arc segment 111, and the fourth sub-arc segment 1312 is not tilted relative to the third sub-arc segment 1311 towards the side closer to the first main arc segment 111; or, the stapler 100 can also be configured such that the second sub-arc segment 1212 is not tilted relative to the first sub-arc segment 1211 towards the side closer to the first main arc segment 111, and the fourth sub-arc segment 1312 is tilted relative to the third sub-arc segment 1311 towards the side closer to the first main arc segment 111. Both of these configurations, after the stapler 100 has finished suturing the tissue 300 and is completely released, also have the effect of making the tissue 300 on both sides of the foramen ovale adhere more tightly.

[0084] Furthermore, such as Figure 3 As shown, the first puncture portion 122 is inclined relative to the second main arc segment towards the side away from the first main arc segment 111, thus forming a first inflection point 121 between the second sub-arc segment 1212 and the first puncture portion 122. The axial distance between the first inflection point 121 and the first main arc segment 111 is L1, and the axial distance between the intersection point 140 and the first main arc segment 111 is L2. L1 and L2 satisfy the condition that L1 ≤ L2. The second puncture portion 132 is inclined relative to the third main arc segment towards the side away from the first main arc segment 111, thus forming a second inflection point 131 between the fourth sub-arc segment 1312 and the second puncture portion 132. The axial distance between the second inflection point 131 and the first main arc segment 111 is L3, and the axial distance between the intersection point 140 and the first main arc segment 111 is L2. L3 and L2 satisfy the condition that L3 ≤ L2.

[0085] Wherein, the axial direction of the suture 100 refers to the direction perpendicular to the first arc segment 110 on the plane containing the suture formed by the first arc segment 110, the second arc segment 120, and the third arc segment 130, such as... Figure 3 As shown. When the suture device 100 is built into the pusher device 200, the axial direction of the suture device 100 is aligned with the axial direction of the pusher device 200.

[0086] By setting L1 to be less than or equal to L2, the second sub-arc 1212 of the second arc segment 120 achieves a better inward curling effect based on the three curved arc segments. By setting L3 to be less than or equal to L2, the fourth sub-arc 1312 of the third arc segment 130 achieves a better inward curling effect based on the three curved arc segments, resulting in a better stitching effect.

[0087] It should be noted that in some specific embodiments, L1 can be set to be less than or equal to L2, and L3 can be set to be greater than L2; or, L1 can be set to be greater than L2, and L3 can be set to be less than or equal to L2.

[0088] like Figures 1 to 6 As shown, in some embodiments of this implementation, the radial cross-sectional area of ​​the first puncture portion 122 gradually decreases in the direction away from the first main arc segment 111 to facilitate puncture.

[0089] The radial cross-sectional area of ​​the first puncture portion 122 is typically circular. The radial cross-sectional area of ​​the first puncture portion 122 gradually decreases in the direction away from the first main arc segment 111. This can be understood as the diameter of the first puncture portion 122 gradually decreasing in the direction away from the first main arc segment 111; that is, the first puncture portion 122 gradually tapers from the end near the first main arc segment 111 to the end away from the first main arc segment 111. The first puncture portion 122 is equivalent to a sharpening treatment at the end of the second arc segment 120 to form a first puncture portion 122 with a thinner end, thereby making it easier for the first puncture portion 122 to puncture the interatrial septum tissue 300.

[0090] It is understood that in some embodiments of this implementation, the radial cross-sectional area of ​​the second puncture portion 132 gradually decreases in the direction away from the first main arc segment 111.

[0091] The radial cross-sectional area of ​​the second puncture portion 132 is typically circular. The radial cross-sectional area of ​​the second puncture portion 132 gradually decreases in the direction away from the first main arc segment 111. This can be understood as the diameter of the second puncture portion 132 gradually decreasing in the direction away from the first main arc segment 111; that is, the second puncture portion 132 gradually tapers from the end near the first main arc segment 111 to the end away from the first main arc segment 111. The second puncture portion 132 is equivalent to a sharpening treatment at the end of the third arc segment 130 to form a thinner second puncture portion 132, thereby making it easier for the second puncture portion 132 to puncture the interatrial septum tissue 300.

[0092] Furthermore, the end of the first puncture portion 122 can form a blunted structure 1221, that is, as shown in the figure. Figure 4 and Figure 5 As shown, the end face of the first puncture portion 122 is arc-shaped. By blunting the end of the first puncture portion 122, the probability of the first puncture portion 122 causing damage to other parts can be reduced.

[0093] The end of the second puncture portion 132 can also form a blunt structure 1221, that is, as shown in the image. Figure 4 and Figure 5 As shown, the end face of the second puncture portion 132 is arc-shaped. By blunting the end of the second puncture portion 132, the probability of the second puncture portion 132 causing damage to other parts can be reduced.

[0094] In some embodiments of this implementation, the axial line passing through the midpoint of the first main arc segment 111 is the central axis 150, and the suture 100 is symmetrically arranged relative to the central axis 150.

[0095] In its natural state, the central axis 150 passes through the intersection point 140 between the second arc segment 120 and the third arc segment 130. Since the suture device 100 is symmetrically arranged relative to the central axis 150, the second arc segment 120 and the third arc segment 130 have the same length and shape. The angle α formed by the bending of the second arc segment 120 and the first arc segment 110 between their first ends 112 is the same as the angle β formed by the bending of the first arc segment 110 and the third arc segment 130 between their second ends 113. The outward curvature angle of the first puncture portion 122 is the same as the outward curvature angle of the second puncture portion 132. Thus, by connecting the position of the first arc segment 110 of the suture device 100 corresponding to the central axis 150 to the pushing device 200, the suture device 100 can be symmetrically housed within the pushing device 200. Figure 9 As shown, this facilitates the loading of the suture device 100 into the loading space of the pushing device 200. Furthermore, the suture devices 100 are symmetrically arranged within the pushing device 200. During puncture operations, the puncture control of the first puncture section 122 and the second puncture section 132 can be specifically controlled based on the angle of one of them, thus simplifying the puncture operation.

[0096] like Figures 7 to 14 As shown, this embodiment also provides a suturing system, including a pushing device 200 and a suturer 100 provided in any of the above embodiments of this embodiment.

[0097] The pushing device 200 includes a delivery sheath 210 and a pushing member 220 disposed within the delivery sheath 210. A loading space is provided at the distal end of the delivery sheath 210. The suture 100 can be loaded into the loading space. The distal end of the pushing member 220 is fixedly connected to the first arc segment 110. The pushing member 220 is used to drive the suture 100 to rotate about the central axis of the pushing member 220 and to push the suture 100 out of the delivery sheath 210.

[0098] The distal end of the delivery sheath 210 can be delivered from the human body to the right atrium, while the proximal end of the delivery sheath 210 is located outside the body for the operator to perform corresponding release or twisting operations. The proximal end of the pusher 220 corresponds to the proximal end of the delivery sheath 210, and the pusher 220 can be operated by acting on its proximal end. The distal end of the pusher 220 extends along the axial direction of the delivery sheath 210 to the distal end of the delivery sheath 210 and is connected to the suture device 100 within the loading space.

[0099] The pushing device 200 may also include a handle connected to the proximal end of the delivery sheath 210 and the proximal end of the pusher 220. By operating the handle, the pusher 220 and the delivery sheath 210 can be moved relative to each other in the axial direction of the delivery sheath 210.

[0100] In one implementation, such as Figures 6 to 8 As shown, the pusher 220 includes a push rod 221, a fixing seat 222, and a fixing member. The fixing seat 222 includes a connecting part 2221 and a fixing part 2222. The proximal end of the connecting part 2221 is provided with a fixing groove along the axial direction. The distal end of the push rod 221 is fixed to the proximal end of the fixing part 2222 through the fixing groove. The distal end of the fixing part 2222 is provided with a through groove 2223. The fixing member can fix the first arc segment 110 in the through groove 2223. The fixing member extends from the distal end of the push rod 221 toward the proximal end, so that the fixing seat 222 can be fixed or unfixed to the first arc segment 110.

[0101] The push rod 221 can be a steel cable, with its proximal end corresponding to the proximal end of the conveying sheath 210. The proximal end of the steel cable is connected to the handle, and the steel cable passes through the conveying sheath 210 along its axial direction. The distal end of the steel cable passes through the fixing groove and is fixedly connected to the proximal end of the fixing part 2222. The proximal end of the fixing part can be connected to the handle so that the movement of the fixing part can be controlled by operating the handle.

[0102] Furthermore, a guide wire (not shown in the figure) can be provided axially inside the push rod 221, which can guide the conveying direction of the conveying sheath 210.

[0103] In one embodiment of this invention, the fixing part 2222 has an arcuate surface, and the angle of the central angle corresponding to the arc is less than or equal to 180°. The fixing member includes a fixing line 223, one end of which includes a loop 2231. The fixing line 223 extends from the loop 2231 from one axial side of the fixing part 2222, around the fixing part 2222, to the other axial side, and extends proximally along the push rod 221, thereby allowing the first arc segment 110 to be secured within the through groove 2223 of the fixing part 2222. Figure 8 Combination Figure 7 As shown.

[0104] Reference Figure 7-8 As shown, the arc-shaped opening of the fixing part 2222 forms the opening of the through groove 2223. The arc-shaped through groove 2223 is connected at both ends along the vertical axis so that the first arc segment 110 can pass through the through groove 2223. The central angle corresponding to the arc is less than or equal to 180°, so the arc opening will be greater than or equal to 180°. This facilitates the first arc segment 110 entering the through groove 2223 through the opening and easily exiting the through groove 2223 when the fixing line 223 is released. The specific angle of the central angle corresponding to the arc can be 90°, 120°, 150°, 180°, etc., as long as it facilitates fixing the first arc segment and facilitating its exit from the through groove.

[0105] Combination Figure 7-8 As shown, the fixing thread 223 can be a silk thread, specifically a multi-strand nickel-titanium alloy thread. Before the suture device 100 is fully released, the loop 2231 of the fixing thread 223 can cooperate with the limiting rod 230, so that the distal end of the fixing thread 223 passes through the loop 2231 and fixes the loop end, thereby binding the first main arc segment 111 into the through groove 2223. Specifically, the push rod 221 is provided with a first cavity extending along the axial direction of the push rod 221, and the fixing seat 222 is provided with a second cavity communicating with the first cavity. Before the suture device 100 is fully released, the loop 2231 is placed in the second cavity, the proximal end of the limiting rod 230 corresponds to the proximal end of the delivery sheath 210, and the distal end of the limiting rod 230 enters the second cavity along the first cavity and passes through the loop 2231 before abutting against the fixing part 2222, thereby fixing the loop 2231. After the suture is completed by the suturer 100, the limiting rod 230 is pulled out from the loop 2231. At this time, the loop 2231 is no longer restricted by the limiting rod 230. Pull the end of the fixing line 223 located at the proximal end (this end is the end without the loop 2231) to move the fixing line 223 to the proximal end, and finally make the fixing line 223 detach from the fixing part 2222. At this time, pulling the push rod 221 backward can make the first main arc segment 111 of the suturer 100 detach from the through groove 2223, thus completing the release of the suturer 100.

[0106] It should be noted that, in order to ensure the stability of the limiting rod 230 in fixing the loose ring 2231, a limiting hole can also be provided on the fixing part 2222, and the far end of the limiting rod 230 passes through the limiting ring and abuts in the limiting hole.

[0107] Furthermore, referring to Figure 7 As shown, the fixing part 2222 is provided with a relief groove 2224 along its arc direction, and the fixing line 223 is wound in the relief groove 2224.

[0108] Specifically, the clearance groove 2224 can be provided around the arc of the fixing part 2222, or it can be provided only on one or both sides of the opening of the fixing part 2222. The clearance groove 2224 allows the fixing wire 223 to be embedded, preventing the fixing wire 223 from moving along the surface of the fixing part 2222, thereby increasing the fixing reliability of the suture 100.

[0109] Before implantation, the suture system of this embodiment pre-installs or installs the suture device 100 onto the fixation part 2222. Specifically, during the installation of the suture device 100, the end of the fixation suture 223 without the slip loop 2231 passes through the proximal end of the push rod 221 along the axial direction of the push rod 221, and the first arc segment 110 of the suture device 100 is inserted into the through groove 2223 of the fixation part 2222; the slip loop 2231 of the fixation suture 223 is bypassed around the opening of the through groove 2223, so that the fixation suture 223 is wound around the fixation part 2222; the limiting rod 230 is then... The needle passes through the slip ring 2231 and abuts against the fixing part 2222. At this time, the fixing line 223 fixes the first arc segment 110 in the through groove 2223. Then, the push rod 221 is pulled proximally, causing the suture 100, push rod 221, and fixing seat 222 to move together towards the proximity of the delivery sheath 210. This causes the suture 100 to be radially compressed and deformed before entering the loading space of the push device 200. The loading process can be facilitated by a flared loader. The state of the suture 100 loaded in the push device 200 is as follows: Figure 9 As shown.

[0110] The operation of the suture system in this embodiment during interventional surgery is roughly as follows: The delivery sheath 210 is inserted into the heart region via a pre-placed guidewire, reaching the right atrium. At this point, the suture system is in the following state: Figure 9 As shown. Then, under DSA (Digital Subtraction Angiography) imaging, the push rod 221 is pushed, which drives the fixation base 222 and the suture device 100 on the fixation base 222 to move distally, pushing the suture device 100 to the end of the delivery sheath 210, exposing the first puncture part 122 and the second puncture part 132. The ends of the first puncture part 122 and the ends of the second puncture part 132 are further opened apart, as shown. Figure 10The following steps are illustrated. After determining the suture site, the delivery sheath 210 and the push rod 221 are simultaneously pushed, causing the ends of the first puncture portion 122 and the second puncture portion 132 of the suture device 100 to pierce the tissue 300 on both sides of the soft round hole, respectively. Then, the delivery sheath 210 is fixed, and the push rod 221 is pushed further, causing more than one-quarter of the length of the second arc segment 120 and the third arc segment 130 of the suture device 100 to pass through the tissue 300. That is, the tissue 300 passes through the first puncture portion 122 to the second sub-arc segment 1212, and through the second puncture portion 132 to the fourth sub-arc segment 1312. At this time, the third sub-arc segment 1311 and the first sub-arc segment 1211 are still located within the loading space of the delivery sheath 210, and the intersection point 140 is also located within the loading space. Figure 11 As shown; the push rod 221 is twisted about its central axis, causing the push rod 221 to drive the fixing seat 222 and the first arc segment 110 fixed on the fixing seat 222 to twist. At this time, since the first puncture part 122 and the second puncture part 132 are fixed by the tissue 300, the intersection point 140 of the third arc segment 130 and the second arc segment 120 is released from overlapping and crossing. Refer to Figure 12 As shown; during or after the torsion, pushing the push rod 221 further distally can continue to advance the suture 100 towards the tissue 300 (if the overlapping and crossing are released, it can continue to be pushed forward), causing the first arc segment 110 to move towards the tissue 300. When the tissue 300 passes the second sub-arc segment 1212 onto the first sub-arc segment 1211, and then passes the fourth sub-arc segment 1312 onto the third sub-arc segment 1311, and exceeds the original crossing point, or after the suture 100 is pushed out of the loading space by the pusher, because the first arc segment 110 is held by the torsional force, and the suture 100 has a tendency to return to a stable state (a stable state includes a natural state and a state that has been flipped 180° from the initial natural state; here, returning to the natural state is a state that has been flipped 180° from the initial natural state), the second arc segment 120 and the third arc segment 130, under the elastic action of the suture 100 itself, return to the overlapping and crossing state from the other side of the tissue 300 (the left atrium side), and suture the two tissues 300 together, as shown. Figure 13 and Figure 14 As shown. Then, pull the limiting rod 230 out of the loose ring 2231, and then loosen the fixing wire so that the first arc segment 110 disengages from the through groove 2223 of the fixing part 2222, thus completing the release of the suture device 100. Finally, remove the delivery sheath 210 and the pusher 220 from the body. The suture state of the suture device 100 and the tissue 300 in the body is as follows. Figure 15 As shown.

[0111] The suture device 100 can be configured to reach a stable state every 180° of rotation. Any angle between 0° and 180°, excluding the end angle, is in an unstable state. Thus, when the suture device 100 is twisted, it will only reach a relatively stable state after twisting 180°, under the fixing action of the delivery sheath 210. When the first arc segment 110 is in the loading space and the suture device 100 is twisted, the first arc segment 110 is connected to the push rod 221. The operator keeps the push rod 221 stationary, so the first arc segment 110 is always in a state of 180° twist. In this way, the second arc segment 120 and the third arc segment 130 have a tendency to return from the un-overlapping and cross-over state to the overlapping and cross-over state. As the suture device 100 moves to the distal end, when the limiting effect of the delivery sheath 210 has basically no effect on the second arc segment 120 and the third arc segment 130, the tissue 300 also passes through the original cross-over point 140. Therefore, when the second arc segment 120 and the third arc segment 130 return to the overlapping and cross-over state on the left atrium side, the cross-over point 140 can be transferred from the side of the tissue 300 to the side of the tissue 300 away from the first arc segment 110, that is, from the right atrium side to the left atrium side, thereby completing the suturing of the suture device.

[0112] The above description is merely a preferred embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A suture device, characterized in that, The device includes a first arc segment, a second arc segment, and a third arc segment. The first arc segment includes a first main arc segment, with a first end and a second end at its two ends. The second arc segment extends from the first end in a curved manner to form a first puncture portion. The third arc segment extends from the second end in a curved manner to form a second puncture portion. The second arc segment and the third arc segment are located on the same side of the first main arc segment, and the second arc segment and the third arc segment overlap and intersect to form an intersection point. The intersection point is located between the first end and the first puncture portion, and the intersection point is located between the second end and the second puncture portion.

2. The suture device according to claim 1, characterized in that, In its natural state, the angle α formed by the bending of the first arc segment and the second arc segment at the first end satisfies: 0°<α≤20°; And / or, the angle β formed by the bending of the first arc segment and the third arc segment at the second end satisfies: 0°<β≤20°.

3. The suture device according to claim 1, characterized in that, The second arc segment includes a second main arc segment, which is located between the first end and the first puncture portion, and the first puncture portion is inclined relative to the second main arc segment toward a side away from the first main arc segment; And / or the third arc segment includes a third main arc segment, the third main arc segment being located between the first arc segment and the second puncture portion, the second puncture portion being inclined relative to the third main arc segment toward a side away from the first main arc segment.

4. The suture device according to claim 3, characterized in that, The second main arc segment includes a first sub-arc segment and a second sub-arc segment, wherein the first sub-arc segment is connected between the first arc segment and the second sub-arc segment, and the second sub-arc segment is connected between the first sub-arc segment and the first puncture part; The third main arc segment includes a third sub-arc segment and a fourth sub-arc segment. The third sub-arc segment is connected between the first arc segment and the fourth sub-arc segment. The fourth sub-arc segment is connected between the first sub-arc segment and the second puncture part. The first sub-arc segment and the third sub-arc segment overlap and intersect at the intersection point. The second sub-arc segment is inclined relative to the first sub-arc segment toward the side closer to the first main arc segment; And / or, the fourth sub-arc segment is tilted relative to the third sub-arc segment toward the side closer to the first main arc segment.

5. The suture device according to claim 4, characterized in that, The first puncture portion is inclined relative to the second main arc segment toward the side away from the first main arc segment, thereby forming a first inflection point between the second sub-arc segment and the first puncture portion. The axial distance between the first inflection point and the first main arc segment is L1, and the axial distance between the intersection point and the first main arc segment is L2. L1 and L2 satisfy L1≤L2. And / or, the second puncture portion is inclined relative to the third main arc segment toward the side away from the first main arc segment, thereby forming a second inflection point between the fourth sub-arc segment and the second puncture portion. The axial distance between the second inflection point and the first main arc segment is L3, and the axial distance between the intersection point and the first main arc segment is L2. L3 and L2 satisfy L3≤L2.

6. The suture device according to claim 1, characterized in that, The radial cross-sectional area of ​​the first puncture portion gradually decreases in the direction away from the first main arc segment; And / or, the radial cross-sectional area of ​​the second puncture portion gradually decreases in the direction away from the first main arc segment.

7. The suture device according to claim 1, characterized in that, The axial line passing through the midpoint of the first main arc segment is the central axis, and the suture device is symmetrically arranged relative to the central axis.

8. A suture system, characterized in that, include: A pushing device includes a conveying sheath and a pushing member disposed within the conveying sheath, wherein a loading space is provided at the distal end of the conveying sheath; The suture device according to any one of claims 1-7, wherein the suture device can be loaded in the loading space, and the distal end of the pusher is fixedly connected to the first arc segment; The pusher is used to drive the suture to rotate about the central axis of the pusher, and to push the suture out of the delivery sheath.

9. The suture system according to claim 8, characterized in that, The pushing component includes a pushing rod, a fixing seat, and a fixing member. The fixing seat includes a connecting part and a fixing part. The proximal end of the connecting part has a fixing groove along the axial direction. The distal end of the pushing rod is fixed to the proximal end of the fixing part through the fixing groove. The distal end of the fixing part has a through groove. The fixing member can fix the first arc segment in the through groove, and the fixing member extends from the distal end of the pushing rod toward the proximal end, so that the fixing seat can fix or release the first arc segment.

10. The suture system according to claim 9, characterized in that, The fixing part is arc-shaped, and the angle of the central angle corresponding to the arc is less than or equal to 180°; the fixing member includes a fixing line, one end of the fixing line includes a loop, the fixing line passes around the fixing part from one side of the axial direction of the fixing part to the other side of the axial direction from the loop, and extends along the push rod towards the proximal end, so that the first main arc segment can be tied in the through groove of the fixing part.

11. The suture system according to claim 10, characterized in that, The fixing part is provided with a relief groove along its arc direction, and the fixing line is wound in the relief groove.

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