CN116509468B - Blocking system and knotting method of tightening parts - Google Patents

Abstract

The embodiment of the present application provides a sealing system and a knotting method of tightening parts, which relate to the field of interventional medical equipment. The sealing system is used to seal defects in the vascular system, and includes: a first sealing disk and a second sealing disk. The blocking disk is used to cover different openings of the defect; the tightening member includes an adjusting wire loop, an adjusting section, a locking section and a wire knot. The adjusting section and the locking section are connected to the proximal side of the wire knot, and the adjusting wire loop is connected to The distal side of the wire knot; the wire knot includes at least one wire loop, the adjustment section passes through the wire knot and at least two wire loops in the adjustment wire loop; the locking section is used to drive the wire loop in the wire knot to shrink, and the wire knot is locked and adjusted end of segment.

Description

Blocking system and knotting method of tightening parts

Technical field

The invention relates to the field of interventional medical equipment, and mainly relates to a blocking system and a knotting method of tightening parts.

Background technique

The foramen ovale is an open area in the middle of the septum between the left and right ventricles, located at the junction of the primary septum and the secondary septum during the embryonic period. The foramen ovale is usually covered by a thin sheet of septum primum. Before birth, the foramen ovale remains open because blood flow is from right to left. After birth, normal pulmonary circulation is established. The increase in intra-atrial pressure forces the lamellae of the primary atrial septum to press against the surface of the foramen ovale, causing the foramen ovale to close and gradually forming a permanent atrial septum. However, if the fusion is not complete after 3 years of age, the remaining cleft-like channel is called PFO. The length of PFO ranges from 3 to 18 mm, and increases with age. In order to seal the foramen ovale, the PFO sealing system was invented.

The existing PFO sealing system includes a first sealing disk and a second sealing disk. The first sealing disk and the second sealing disk are connected through a wire loop, and the two ends of the wire loop are fixed together through a wire knot. In some cases, because the knots at both ends of the wire loop are not strong enough, the wire knots on the wire loop may easily become loose, and the first sealing disk and the second sealing piece may fall off from the wire body, and the safety of the device cannot be guaranteed.

Contents of the invention

In view of the shortcomings of the above-mentioned prior art, the purpose of this application is to provide a method for tying a blocking system and a tightening member to improve the firmness of the knots in the blocking system and ensure the safety of the equipment of the blocking system.

In order to achieve the above objectives, the implementation of this application adopts the following technical solutions:

A sealing system for sealing defects in the vascular system, including: a first sealing disk and a second sealing disk, used to cover different openings of the defect; the tightening member includes an adjustment wire ring, an adjustment section, locking section and wire knot, the adjustment section and the locking section are connected to the proximal side of the wire knot, the adjustment wire loop is connected to the distal side of the wire knot, the adjustment section, the The locking section and the wire knot are arranged on the side of the second blocking disk away from the first blocking disk, and part of the adjustment wire loop is connected between the first blocking disk and the second blocking disk. Between the blocking discs, the adjustment wire loop is used to penetrate into the defect; the wire knot includes at least one wire loop, and the adjustment section passes through the wire knot and at least two of the adjustment wire loops. A wire loop; the locking section is used to drive the wire loop in the wire knot to shrink, and the wire knot locks the end of the adjustment section.

A method for knotting the tightening parts in the above-mentioned sealing system, including the following steps:

The wire knot is formed by winding a wire-shaped member, and the adjusting wire loop is connected to the distal side of the wire knot, and the wire-shaped member forms two sections including ends on the proximal side of the wire knot, They are the adjusting section and the locking section respectively.

Beneficial effects: The blocking system provided by the embodiment of the present application includes a first blocking disk, a second blocking disk, and a tightening piece for connecting the first blocking disk and the second blocking disk. The tightening piece includes an adjustment line. ring, adjustment section, locking section and wire knot, the adjustment section and locking section are connected to the proximal side of the wire knot, the adjustment wire loop is connected to the distal side of the wire knot, the adjustment section, locking section and wire knot are arranged on the second On the side of the blocking disk away from the first blocking disk, part of the adjustment wire loop is connected between the first blocking disk and the second blocking disk. By pulling the locking section, the locking section drives the wire knot. The wire loop shrinks, and the wire knot locks the end of the adjusting section. Therefore, in the blocking system of the present application, the adjusting section passes through the wire knot and at least two wire loops in the adjusting wire loop, so that after the wire knot is locked , the end of the adjusting section can be locked by at least two wire loops in the wire knot, or one adjusting wire loop and at least one wire loop in the wire knot. The locking knot is stronger and it is not easy for the first sealing disk to be connected with the second wire loop. The movement of the second sealing disk, or the loosening of the adjustment section and the locking section when pulling, improves the locking ability of the tightening piece to the adjustment section (end), as well as the first sealing disk and the second sealing disk. The locking performance of the distance between them ensures the safety and reliability of the blocking system.

Description of the drawings

Figure 1 is a schematic structural diagram of a blocking system in an embodiment of the present application.

FIG. 2 is a schematic diagram of one structure of the tightening member provided in Embodiment 1 of the present application.

Figure 3 is a schematic diagram of another structure of the tightening member provided in Embodiment 1 of the present application.

Figure 4 is a schematic diagram of another structure of the tightening member provided in Embodiment 1 of the present application.

Figure 5 is a schematic diagram of another structure of the tightening member provided in Embodiment 1 of the present application.

Figure 6 is a schematic diagram of another structure of the tightening member provided in Embodiment 1 of the present application.

Figure 7 is a schematic diagram of another structure of the tightening member provided in Embodiment 1 of the present application.

Figure 8 is a schematic diagram of another structure of the tightening member provided in Embodiment 1 of the present application.

Figure 9 is a schematic diagram of one structure of the tightening member provided in Embodiment 2 of the present application.

Figure 10 is a schematic diagram of another structure of the tightening member provided in Embodiment 2 of the present application.

Figure 11 is a schematic diagram of another structure of the tightening member provided in Embodiment 2 of the present application.

Figure 12 is a schematic diagram of another structure of the tightening member provided in Embodiment 2 of the present application.

Figure 13 is a schematic structural diagram of a tightening member provided in Embodiment 3 of the present application.

Figure 14 is a schematic structural diagram of a tightening member provided in Embodiment 4 of the present application.

Description of main component symbols: 1-first sealing disk; 2-second sealing disk; 3-tightening piece; 31-adjusting wire ring; 32-adjusting section; 33-locking section; 34-wire knot; 341 -Basic wire loop; 342-locking wire loop; 343-first connecting section; 344-second connecting section; 345-reinforced wire loop; 346-locking space; 4-conveying device; 41-handle; 42-nickel Titanium tube.

Detailed ways

The embodiment of the present application provides a blocking system and a knotting method of tightening parts. In order to make the purpose, technical solutions and effects of the present application clearer and clearer, the present application will be further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described here are only used to explain the present application and are not used to limit the protection scope of the present application.

First of all, it needs to be explained that in the field of interventional medicine, along the delivery path of the instrument, the end/side of the instrument close to the operator is usually called the proximal end/side, and the end/side of the instrument away from the operator is called the distal end/side. . With respect to a delivery device used to deliver and release an implantable device into a patient, the distal end/side refers to the end/side of the delivery device that is freely insertable into an animal or organism, and the proximal end/side refers to the end/side of the delivery device that is freely insertable into an animal or organism. The end/side for user or machine operation.

The blocking system provided by the embodiments of the present application is used to block defects in the vasculature system. The defects include but are not limited to foramen ovale, ductus arteriosus, atrial septal defect, ventricular septal defect, etc., as described in this application. Taking the defect as the foramen ovale as an example illustrates the advantages of the blocking system for treating patent foramen ovale. It is understandable that the defect can also be other defects mentioned above.

Referring to Figure 1, the sealing system includes a first sealing disk 1, a second sealing disk 2, a tightening member 3 and a conveying device 4. The first sealing disk 1 and the second sealing disk 2 are used to cover the defect. Different openings, the tightening member 3 is used to pass through the defect and connect the first sealing disk 1 and the second sealing disk 2. After the sealing system is implanted into the organism, the first sealing disk 1 and the second sealing disk 2 cover the different openings of the defect, and the first sealing disk 1 and the second sealing disk 1 are sealed by the tightening member 3 The distance between the discs 2 is locked to achieve the sealing of the defect by the sealing system.

That is to say, after the sealing system is implanted into the living body, the first sealing disk 1 and the second sealing disk 2 cover different openings of the defect respectively. In this embodiment, as shown in Figure 1, the first sealing disk 1 and the second sealing disk 2 respectively cover the openings on both sides of the defect, that is, the first sealing disk 1 and the second sealing disk 2 respectively cover the area adjacent to the primary septum and secondary septum adjacent to the foramen ovale. The blocking disc 1 is used to be released in the left atrium and is used to block the opening of the defect towards the left atrium. The second blocking disc 2 is used to be released in the right atrium and is used to block the opening of the defect towards the right atrium. The tightening piece 3 passes through the defect and can be connected to the first sealing disk 1 and the second sealing disk 2 at the same time. After the tightening member 3 is tightened, the first sealing disk 1 and the second sealing disk 2 are respectively attached to the periphery on both sides of the defect to achieve sealing of the defect; moreover, the sealing system is fixed to the sealing vascular system. location of the defect.

Referring to Figure 2, the tightening member 3 is formed of a linear member, is flexible, and can be made of degradable or non-degradable materials. The material of the tightening member 3 includes, but is not limited to, at least one of polytetrafluoroethylene, polyglycolide, polyglycolide, polylactic acid, collagen, nylon suture, and polyester suture. Preferably, the tightening member 3 is a suture made of polytetrafluoroethylene. Due to the high mechanical strength of the polytetrafluoroethylene material, the toughness of the tightening part 3 is improved.

The tightening member 3 includes an adjustment wire loop 31 , an adjustment section 32 , a locking section 33 and a wire knot 34 . The adjustment section 32 and the locking section 33 each include an end, which is also the end of the tightening member 3. The ends of the adjustment section 32 and the locking section 33 are connected to the proximal side of the wire knot 34 for tightening the wire knot. The proximal side of 34 extends and is further connected to the delivery device 4 (as shown in Figure 1). The adjusting wire loop 31 is connected to the distal side of the wire knot 34 , and the adjusting section 32 , the locking section 33 and the wire knot 34 are located on the proximal side of the second blocking disk 2 . The adjusting wire loop 31 is in the shape of a U-shaped ring. Both ends of the adjusting wire loop 31 are connected to the wire knot 34 and are located on the proximal side of the second blocking disk 2. The portion between the two ends of the adjusting wire loop 31 is relative to its two ends. Extends toward the distal direction of both ends and connects the first sealing disk 1 and the second sealing disk 2 . Specifically, the part between the two ends of the adjusting wire loop 31 passes through the second blocking disk 2 and extends distally and is connected to the first blocking disk 1. Part of the adjusting wire loop 31 is connected between the first blocking disk 1 and the first blocking disk 1. The second sealing disc is between 2. After the sealing system is implanted into the living body, the portion of the adjustment wire loop 31 located between the first sealing disk 1 and the second sealing disk 2 passes through the defect. Among them, the side of the second sealing disk 2 facing away from the first sealing disk 1 is the proximal side of the second sealing disk 2 and the first sealing disk 1, and the side of the first sealing disk 1 facing away from the second sealing disk 2 One side is the far side of the first sealing disk 1 and the second sealing disk 2. The side where the first sealing disk 1 and the second sealing disk 2 face each other is the proximal side of the first sealing disk 1. 2. Block the far side of disk 2.

The wire knot 34 is a sliding knot. During the assembly process of the tightening member 3 with the first blocking disk 1 and the second blocking disk 2, one end of the adjusting wire loop 31 is connected to the wire knot 34, and the other end of the adjusting wire loop 31 Connect the adjusting section 32. The end of the adjusting section 32 passes through the second blocking disk 2, connects to the first blocking disk 1, passes through the second blocking disk 2 again and then penetrates into the wire knot 34. The adjusting section 32 is connected from Pass out the proximal side of knot 34.

When the wire knot 34 is not tightened, the adjustment section 32 can drive one end of the adjustment wire loop 31 connected thereto to slide into the wire knot 34 and slide out from the proximal side of the wire knot 34 , thereby shortening the axis of the adjustment wire loop 31 To the length, the length of the adjustment section 32 is increased, that is, part of the section in the adjustment wire loop 31 is converted into an adjustment section 32 to adjust the adjustment wire loop 31 between the first blocking disk 1 and the second blocking disk 2 length; pulling the locking section 33 can tighten the wire knot 34, so that the wire knot 34 tightens a part of the adjustment wire loop 31 located therein to fix the adjustment between the first blocking disk 1 and the second blocking disk 2 The length of the wire loop 31.

In the above, the length of the linear member between the first blocking disk 1 and the second blocking disk 2 is adjusted by pulling the adjustment section 32, thereby controlling the distance between the first blocking disk 1 and the second blocking disk 2. The distance is adapted to the anatomical structure of the patient and is conducive to improving the degree of fit between the first sealing disk 1 and the second sealing disk 2 and the tissue around the foramen ovale, thereby sealing the foramen ovale stably.

After the first sealing disk 1 and the second sealing disk 2 are released respectively, by adjusting the distance between the first sealing disk 1 and the second sealing disk 2, it is ensured that the primary interval and secondary separation after the device is implanted are ensured. The degree of deformation of the septum is small, which does not affect the endothelialization of the two diaphragms toward the sealing disk, reduces the occurrence of residual shunt, avoids the trouble of customizing the sealing device due to the specific structure of the foramen ovale in individual patients, and effectively expands the scope of PFO sealing. The scope of application of the occluder allows more patients to benefit from minimally invasive surgery.

In the embodiment where the defect has more than two openings, the occluder is also used to block multiple openings located on different sides or on the same side of the defect.

As shown in Figure 1, the second blocking disk 2 is provided with at least two holes for passing through the tightening member 3. The tightening member 3 passes through one of the holes on the second blocking disk 2 and is connected to the first The blocking disk 1 passes through another hole on the second blocking disk 2 to connect the tightening member 3 with the first blocking disk 1 and the second blocking disk 2, and makes the two ends of the tightening member 3 Located on the side (proximal side) of the second blocking disk 2 away from the first blocking disk 1, a U-shaped adjusting wire ring 31 is formed at the distal end of the wire knot 34, and the opening of the U-shaped adjusting wire ring 31 is formed. Toward knot 34.

As shown in FIGS. 2 to 14 , the wire knot 34 includes at least one wire loop. The adjustment section 32 passes through the wire knot 34 and at least two wire loops in the adjustment wire loops 31 . The end of the adjustment section 32 is connected to the end of the adjustment wire loop 31 . The ends are connected to each other. When the adjustment section 32 is pulled, the end of the adjustment wire loop 31 can be driven to move proximally through the wire knot 34 to adjust the distance between the first blocking disk 1 and the second blocking disk 2 . The locking section 33 is connected to the wire loop of the wire knot 34. The locking section 33 is used to drive the wire loop in the wire knot 34 to shrink. That is, when the operator (or the conveyor) pulls the locking section 33, the lock section 33 will lock. The tight section 33 can drive the wire loop of the wire knot 34 to shrink, thereby causing the wire knot 34 to lock the end of the adjustment section 32 . After the wire knot 34 locks the adjustment section 32, the distance between the first sealing disk 1 and the second sealing disk 2 is locked.

Simply put, the linear members used to make the tightening member 3 are surrounded by multiple wire loops. The section between one end of the linear member and the wire loop is the locking section 33; the other end passes through After the first sealing disk 1, the second sealing disk 2 and the wire loop of the wire knot 34, it passes through the proximal side of the wire knot 34. The section located near the wire knot 34 is the adjustment section 32, which is located at the wire knot. The distal section 34 forms an adjusting wire loop 31 . Therefore, pulling the adjustment section 32 can drive the end (specifically one end) of the adjustment wire loop 31 to move toward the proximal side of the wire knot 34 to achieve the distance between the first blocking disk 1 and the second blocking disk 2 adjustment.

In this application, the adjustment section 32 passes through the wire knot 34 and at least two wire loops in the adjustment wire loop 31. In some embodiments, the two wire loops are at least two wire loops in the wire knot 34. In some embodiments, the two wire loops include at least one wire loop in the wire knot 34 and an adjustment wire loop 31 outside the wire knot 34 . After the locking section 33 is pulled to shrink multiple wire loops (including the wire loops in the wire knot 34 and the adjusting wire loop 31 outside the wire knot 34), the adjusting section 32 or the end of the adjusting section 32 can be wire-knotted. At least two wire loops in 34, or one adjustment wire loop 31 and at least one wire loop in the wire knot 34 are locked, and at least two wire loops are provided to lock the adjustment section 32, adding a function for locking the adjustment section 32 With the number of wire loops, the locking knot is more secure and is not easily knotted 34 due to the movement of the first blocking disk 1 and the second blocking disk 2 or the conveying device 4 pulling the adjusting section 32 and the locking section 33 Loosening improves the locking ability of the tightening piece 3 to the adjustment section 32 and the locking performance of the distance between the first sealing disk 1 and the second sealing disk 2, thus ensuring the safety and reliability of the sealing system.

For a blocking system in which the length of the adjustment wire ring 31 is preset, there is no need to adjust the distance between the first blocking disk 1 and the second blocking disk 2. The adjustment section 32 can be adjusted by pulling the locking section 33. Carry out locking. That is, the adjustment section 32 has a set locking position, and the wire knot 34 is located at the set locking position. After the blocking system is released, the adjustment section 32 can be locked by simply pulling the locking section 33 .

Among them, in the sealing system of the present application, the wire knot 34 can pull the locking section 33 during the assembly process, so that the wire loop of the wire knot 34 locks the adjustment section 32, so that the first sealing disk 1 and the second sealing plate The blocking disk 2 and the tightening member 3 form an integral body to prevent the first blocking disk 1 and the second blocking disk 2 from being separated from the adjusting wire ring 31 . In the process of releasing the blocking system into the living body, it is sufficient to directly release the whole body composed of the first blocking disk 1, the second blocking disk 2 and the tightening member 3 into the living body.

The blocking system of the present application can also adjust the distance between the first blocking disk 1 and the second blocking disk 2 according to the anatomical structure of the living body during the process of being released into the living body, and then pull the locking section 33 Therefore, the wire loop of the wire knot 34 locks the adjustment section 32 to fix the length of the adjustment wire loop 31 between the first blocking disk 1 and the second blocking disk 2 . In the description of this article, this method is used as an example.

The proximal end of the locking section 33 is connected to the delivery device 4 , and the locking section 33 can be pulled by the delivery device 4 so that the wire loop of the wire knot 4 contracts to lock the adjustment section 32 .

In one embodiment, the proximal end of the adjustment section 32 is also connected to the delivery device 4. When the wire loop of the wire knot is in an untightened state, the transport device 4 can pull the adjustment section to drive the adjustment wire loop through the wire knot, thereby achieving Adjust the distance between the first sealing disk 1 and the second sealing disk 2.

In some embodiments, the proximal end of the adjustment section 32 and the proximal end of the locking section 33 are controlled manually by the operator, and are not connected and pulled through the delivery device 4 The proximal end of 33.

In some embodiments, the proximal end of the adjustment section 32 or the proximal end of the locking section 33 is connected to the delivery device 4; in an embodiment where the delivery device 4 is connected to the proximal end of the adjustment section 32, the wire loop of the wire knot is in the unfinished position. In the tightened state, the conveying device 4 can pull the adjusting section to drive the adjusting wire loop through the wire knot to adjust the distance between the first sealing disk 1 and the second sealing disk 2; when the conveying device 4 is connected to the lock In the embodiment of the tight section 33, the conveying device 4 can be controlled to pull the locking section 33, so that the wire loop of the wire knot 4 contracts to lock the adjustment section 32.

Since the adjusting section 32 and the locking section 33 are both movable lines connected to the blocking disk, operating the adjusting section 32 and the locking section 33 separately will cause the blocking disk to move, resulting in poor operability; preferably, the conveying device 4 It is also connected to the second blocking disk 2. Specifically, after the first blocking disk 1 and the second blocking disk 2 are released and before the delivery device 4 is withdrawn from the atrium, the second blocking disk 2 is fixed to the delivery device 4 distal end, thereby preventing the two blocking disks from shaking simultaneously when pulling the adjustment section 32 and the locking section 33, so as to adjust the length of the adjustment wire loop 31 and lock the adjustment section 32 with the wire knot 34.

Specifically, in the blocking system shown in Figure 1, both the first blocking disk 1 and the second blocking disk 2 have a single-layer mesh disk structure, and each mesh disk is made of woven nickel-titanium wire. The sealing disk is in the shape of a sheet. Each sealing disc consists of a nitinol wire braided skeleton and a covering attached to the skeleton. In other embodiments, the specific structure of each blocking disk is not limited. Each blocking disk may be a double-layer mesh disk, or may be columnar or claw-shaped.

The delivery device 4 includes a handle 41 and a nickel-titanium tube 42 disposed at the distal end of the handle 41. The distal end of the nickel-titanium tube 42 is connected to the second blocking disk 2. The adjustment section 32 penetrates into the nickel-titanium tube 42 and is connected with the handle 41. The driving mechanism is connected, and the other end is knotted on the nickel-titanium tube 42 to form a wire knot 34. The wire knot 34 tied on the nickel-titanium tube 42 is a sliding knot, and the two ends of the tightening member 3 pass through the handle 41 The cavity in is connected to the driving mechanism in the handle 41. The driving mechanism can adjust the distance between the two blocking disks by pulling the adjustment section 32 of the tightening member 3. The driving mechanism can pull the locking section 33 to make the wire knot 34 Lock so that the distance between the two blocking disks is locked.

Example 1:

Referring to FIG. 2 , the wire knot 34 includes a basic wire loop 341 and a locking wire loop 342 . That is, the multiple wire loops included in the wire knot 34 include a basic wire loop 341 and a locking wire loop 342 . The locking section 33 is connected to one end of the locking wire loop 342, the adjusting section 32 is connected to one end of the adjusting wire loop 31, and the base wire loop 341 is connected between the end of the locking wire loop 342 and the end of the adjusting wire loop 31 . Therefore, when the locking section 33 is pulled, the locking wire loop 342 and the base wire loop 341 will shrink. The adjustment section 32 passes through at least one of the basic wire loop 341 and the locking wire loop 342. In this embodiment, the adjustment section 32 passes through the basic wire loop 341 and the locking wire loop 342. Therefore, it is pulled and locked. After section 33, both the locking wire loop 342 and the basic wire loop 341 can lock the adjustment section 32. In an alternative embodiment, the adjustment section 32 passes through one of the basic wire loop 341 and the locking wire loop 342, and passes through at least one reinforcing wire loop 345 (the reinforcing wire loop 345 is described in other embodiments).

In the embodiment shown in FIG. 2 , the base wire loop 341 is disposed proximally of the locking wire loop 342 . In the blocking system of the present application, the wire knot 34 is locked by pulling the locking section 33 proximally. During the entire locking process of the wire knot 34, the wire knot 34 is locked under the drive of the locking section 33. The wire loop 342 first moves proximally for locking. Among the multiple wire loops that the adjustment section 32 passes through, the locking wire loop 342 is located on the distal side of the basic wire loop 341 or at least one other wire loop to facilitate locking the wire loop. When 342 moves proximally and locks, the other wire loops passed by the adjusting section 32 are pushed to gather proximally. Then, after the locking section 33 is tightened, the position of the wire loop passed by the adjusting section 32 in the wire knot 34 is Relatively concentrated, it is convenient for the wire loops to shrink in one place and play a locking role in the adjustment section 32; it avoids that after the locking section 33 is tightened, the multiple wire loops passed through the adjustment section 32 cannot be gathered together and cause The adjustment section 32 can slide in the multiple wire loops it passes through, and there is a problem that the adjustment section 32 cannot be locked.

In other embodiments, the basic wire loop 341 can also be disposed on the distal side of the locking wire loop 342. The basic wire loop 341 is pulled by an end connected to the locking wire loop 342 and gathered with the locking wire loop 342. In some embodiments, the basic wire loop 341 and the locking wire loop 342 are arranged side by side, that is, the basic wire loop 341 and the locking wire loop 342 are disposed at substantially the same axial position.

The wire knot 34 also includes a first connecting section 343, which is connected between the basic wire loop 341 and the locking wire loop 342. In this embodiment, the two ends of the first connecting section 343 are respectively connected to the ends of the basic wire loop 341 and the locking wire loop 342 that are away from each other. Therefore, during the process of locking the wire knot 34, the locking section 33 drives The locking wire loop moves proximally, and the locking wire loop 342 pulls the proximal part and the entire base wire loop 341 through the first connecting section 343 to move toward the locking wire loop 342, thereby locking the wire loop 342 and the basic wire. The rings 341 move toward each other to facilitate the locking wire ring 342 and the base wire ring 341 to come together and lock the adjustment section 32 . In some embodiments, the two ends of the first connecting section 343 are not connected to the ends of the basic wire loop 341 and the locking wire loop 342 that are away from each other, but can be connected to the two ends of the basic wire loop 341 and the locking wire loop 342 that are close to each other. end, or one end of the first connecting section 343 is connected to any end of the basic wire loop 341, and the other end of the first connecting section 343 is connected to any end of the locking wire loop 342.

The adjacent first connecting section 343 of the wire knot 34 , part of the basic wire loop 341 , part of the locking wire loop 342 , and the part of the adjustment section 32 that passes through the wire knot 34 form a locking space 346 . The wire knot 34 also includes a second connecting section 344. One end of the second connecting section 344 is connected to the basic wire loop 341, and the other end is connected to the adjusting wire loop 31. In this embodiment, the second connecting section 344 passes through the locking space 346, so that when the locking section 33 is pulled, the locking space 346 shrinks and tightens the end of the second connecting section 344, thereby locking the adjustment wire loop. 31 end.

The locking space 346 is a wire loop formed by different adjacent sections of the wire knot 34 and the section of the adjustment section 32 that passes through the wire knot 34 . It is defined that when the wire knot 34 is loose, the section where the adjustment wire loop 31 and the adjustment section 32 are adjacent to each other and pass through the wire knot 34 is a part of the adjustment section 32 . When the wire knot 34 is locked, the end of the adjustment section 32 and the end of the adjustment wire loop 31 are locked in the wire knot 34 .

As shown in FIG. 2 , the adjacent different sections of the wire knot 34 surrounding the locking space 346 include the first connecting section 343 , a partial basic wire loop 341 connected to the end of the first connecting section 343 , The other end of the connecting section 343 partially locks the wire ring 342. The wire bodies of these three sections are adjacent to each other and form a C-shaped open ring. The opening of the C-shaped open ring faces upward in Figure 2, and the adjusted section 32 The part passing through the knot 34 is blocked. Further, one end of the section of the basic wire loop 341 that surrounds the locking space 346 is connected to the first connecting section 343, and the other end is connected (specifically, wound) to the adjustment section 32; the locking wire loop 342 that surrounds the locking space 346 One end of the section is connected to the first connecting section 343, and the other end is connected (specifically, wound) to the adjusting section 32.

During the process of pulling the locking section 33 to tighten the wire knot 34, after the basic wire loop 341 and the locking wire loop 342 shrink, the area of the locking space 346 also becomes smaller, and the end of the second connecting section 344 is locked. tight. That is to say, after the adjusting section 32 is locked by the wire knot 34, the end of the second connecting section 344 is clamped by the basic wire loop 341, the locking wire loop 342, the first connecting section 343 and the adjusting section 32, thereby locking Tightening the two ends of the adjusting wire loop 31 improves the locking strength of the wire knot 34 to the adjusting wire loop 31 .

Preferably, as shown in Figure 2, the locking section 33 also passes through the locking space 346. Therefore, after the adjustment section 32 is locked by the wire knot 34, the end of the locking section 33 is also locked by the basic wire loop 341 and the wire knot 34. The tight wire loop 342, the first connecting section 343 and the adjusting section 32 are tightened, thereby improving the locking strength of the wire knot 34 to the adjusting wire loop 31.

Referring to FIG. 6 , in a further embodiment, the locking section 33 passes through the locking space 346 and also passes through the adjustment wire loop 31 . After the locking space 346 contracts, the wire knot 34 presses against it from the proximal side to the distal side. The second sealing disk 2 reaches the tissue surface. In addition to being clamped by the basic wire loop 341, the locking wire loop 342, the first connecting section 343 and the adjusting section 32, the locking section 33 is also clamped by the wire knot 34 and the second blocking section. The disc 2 is clamped, which improves the locking strength of the wire knot 34 to the adjusting wire ring 31.

Referring to Figures 3-5 and 7-8, the wire knot 34 further includes at least one reinforcing wire loop 345, and the adjustment section 32 passes through at least one reinforcing wire loop 345. By strengthening the arrangement of the wire loops 345, the number of wire loops that the adjustment section 32 passes through is increased, and the locking performance of the wire knot 34 is improved.

Among them, in Figures 3-5 and 7-8, the adjustment section 32 not only passes through the basic wire loop 341 and the locking wire loop 342, but also passes through all the reinforcing wire loops 345. It can be understood that the adjustment section 32 can choose to pass through any number of the basic wire loops 341, the locking wire loops 342 and all the reinforcing wire loops 345. For example, the adjustment section 32 can pass through the basic wire loops 341 and the lock. At least one of the tight wire loops 342 can optionally pass through at least one reinforcing wire loop 345 on this basis, thereby satisfying the condition that the adjustment section 32 passes through at least two wire loops; or as described in the previous embodiment, the adjustment section 32 passes through the basic wire loop 341 and the locking wire loop 342, and does not pass through the reinforcing wire loop 345 (the reinforcing wire loop 345 is not set in the wire knot 34, or the reinforcing wire loop 345 is set in the wire knot 34 and the adjustment section 32 does not pass through it. over reinforced wire loops 345); or the wire knot 34 includes multiple reinforced wire loops 345, the adjustment section 32 passes through at least two reinforced wire loops 345, and does not pass through the basic wire loop 341 and the locking wire loop 342.

The greater the number of reinforcing wire loops 345 that the adjusting section 32 passes through, the greater the locking strength of the wire knot 34 to the adjusting section 32. However, if the number of reinforcing wire loops 345 is too large, it will only pull the locking section 33. Some of the reinforcing wire loops 345 can be tightened, but all the reinforcing wire loops 345 cannot be tightened. For example, in the embodiment shown in FIGS. 3-5 , multiple reinforcing wire loops 345 are wound around the adjustment section 32 and arranged in a spiral shape, and are connected in sequence. Preferably, each reinforcing wire loop 345 circles the adjustment section 32 once (360 degrees). It can be understood that in some embodiments, some of the reinforcing wire loops 345 circle around the axial direction more than one circle or less than one circle. . One of the plurality of reinforcing wire loops 345 that is close to the locking wire loop 342 is connected to the end of the locking wire loop 342 . During the process of pulling the locking section 33, after tightening the locking wire loop 342, the locking wire loop 342 will sequentially drive and tighten the reinforcing wire loops 345 connected to it. If the number of the reinforcing wire loops 345 is too much, it may cause In the process of continuing to pull the locking section 33 to lock the unlocked reinforcing wire loop 345, a large friction force is generated between the locked locking wire loop 342 and part of the reinforcing wire loop 345 and the adjusting section 32. The locking section 33 cannot continue to move proximally, so that the partial reinforcing wire loop 345 cannot be locked. The embodiment shown in FIGS. 7 and 8 also has the same problem as mentioned above.

Preferably, the number of reinforcing wire loops 345 is preferably 4-8. On the one hand, it is convenient for the operator to operate. On the other hand, the locking force can reach between 5N-40N to avoid the locking wire knot 34 in the left and right atria. They are released due to the pressure difference between them, thereby improving the reliability and safety of the locking of the wire knot 34. In the embodiments shown in FIGS. 3 , 5 and 7 , the number of reinforcing wire loops 345 is two. In the embodiments shown in FIGS. 4 and 8 , the number of reinforcing wire loops 345 is four.

In detail, the reinforcing wire loop 345 may be formed by winding the first connecting section 343, as shown in Figures 3-5. The reinforcing wire loop 345 can also be formed by winding the second connecting section 344, as shown in Figures 7-8.

Preferably, as shown in Figures 3-5 and 7-8, the reinforcing wire loop 345, the basic wire loop 341 and the locking wire loop 342 are arranged in the axial direction, so that during the locking process of the wire knot 34 , it is convenient for the locking wire loop 342 to push/pull multiple wire loops together in sequence along the axial direction, and the wire loops passed through the adjustment section 32 in the wire knot 34 are relatively concentrated, so that the wire loops can be contracted in one place. at the position, it plays a locking role on the adjusting section 32; it avoids that after the locking section 33 is tightened, the multiple wire loops passed by the adjusting section 32 cannot be gathered together in the axial direction, and the adjusting section 32 can pass through The problem occurs that the adjustment section 32 cannot be locked due to sliding among multiple wire loops.

Among them, the setting methods of the reinforcing wire loop 345 include:

The first way: between two adjacent reinforcing wire loops 345, the distal end of the proximal reinforcing wire loop 345 is connected to the proximal end of the distal reinforcing wire loop 345 to facilitate smooth pulling of the locking section 33. Each reinforcing wire loop 345 is convenient for shrinking to lock the adjustment section 32, as shown in Figures 3, 4, 7 and 8.

The second way: between two adjacent reinforcing wire loops 345, the proximal end of the proximal reinforcing wire loop 345 is connected to the distal end of the distal reinforcing wire loop 345, that is, connecting the two reinforcing wire loops 345. They are connected at one end away from each other, so that two adjacent reinforcing wire loops 345 are locked with each other, thereby improving the locking strength of the wire knot 34, as shown in Figure 5.

In other embodiments, the above two ways of setting the reinforcing wire loops 345 can also be mixed. For example, the reinforcing wire loops 345 close to the locking wire loop 342 are arranged in the second way, and the reinforcing wires close to the basic wire loop 341 are arranged in the second way. Ring 345 is configured in the first manner.

The arrangement sequence of the reinforcing wire loop 345, the locking wire loop 342 and the basic wire loop 341 in the axial direction can be: the reinforcing wire loop 345, the locking wire loop 342 and the basic wire loop 341 are arranged in order from far to near, as shown in the figure 3 and 4, correspondingly, the adjustment section 32 passes through the reinforcing wire loop 345, the locking wire loop 342 and the basic wire loop 341 in sequence, so that the adjustment section 32 can be pulled smoothly.

The arrangement sequence of the reinforcing wire loop 345, the locking wire loop 342 and the basic wire loop 341 in the axial direction can also be: the locking wire loop 342, the reinforcing wire loop 345 and the basic wire loop 341 are arranged in order from far to near, such as In the embodiment shown in Figures 5, 7 and 8, accordingly, the adjustment section 32 passes through the locking wire loop 342, the reinforcing wire loop 345 and the basic wire loop 341 in sequence.

In some embodiments, the locking wire loop 342 and the reinforcing wire loop 345 and the reinforcing wire loop 345 and the basic wire loop 341 can be connected in a first manner, that is, the proximal end of the locking wire loop 342 is connected to the distal end of the locking wire loop 342 . The distal end of the reinforcing wire loop 345 is connected, and the distal end of the basic wire loop 341 is connected to the proximal end of the reinforcing wire loop 345 located proximally, as shown in Figures 3, 4, 7 and 8. In some embodiments, the locking wire loop 342 and the reinforcing wire loop 345 and the reinforcing wire loop 345 and the basic wire loop 341 can also be connected in a second manner, that is, the distal end of the locking wire loop 342 and the distal end of the locking wire loop 342 can be connected to each other. The proximal end of the reinforcing wire loop 345 is connected, and the proximal end of the basic wire loop 341 is connected to the distal end of the reinforcing wire loop 345 located on its proximal side, as shown in FIG. 5 .

In other embodiments, the arrangement sequence of the reinforcing wire loop 345, the locking wire loop 342 and the basic wire loop 341 in the axial direction can also be: the reinforcing wire loop 345, the basic wire loop 341 and the locking wire loop 342 are arranged from far away. They are arranged in order from near to near, or the basic wire loop 341, the reinforcing wire loop 345 and the locking wire loop 342 are arranged in order from far to near.

Example 2:

Referring to Figures 9 to 12, the wire knot 34 includes a basic wire loop 341, a locking wire loop 342 and a second connecting section 344. The locking section 33 is connected to one end of the locking wire loop 342, and the adjusting section 32 is connected to the adjusting wire loop 31. At one end, the base wire loop 341 is connected between the end of the locking wire loop 342 and the end of the adjustment wire loop 31 .

The difference between the tightening piece 3 in the second embodiment and the first embodiment mainly lies in the following aspects:

One end of the second connecting section 344 is connected to the basic wire loop 341, and the other end is connected to the adjusting wire loop 31. In this embodiment, the second connecting section 344 at least passes through the locking wire loop 342, so that the locking wire loop 342 shrinks , and simultaneously lock the ends of the second connecting section 344 and the adjusting section 32 , that is, lock both ends of the adjusting wire loop 31 at the same time, thereby improving the locking strength of the wire knot 34 .

In the embodiment shown in FIG. 9 , the locking section 33 passes out from the side of the locking wire loop 342 away from the adjustment wire loop 31 , that is, it passes between the locking wire loop 342 and the base wire loop 341 , and the locking section 33 is locked. The section 33 passes through the locking wire loop 342 but does not pass through the base wire loop 341; the adjustment section 32 passes through the locking wire loop 342 and the basic wire loop 341. After the wire knot is locked, the locking section 33 can be clamped on Between the locking wire loop 342 and the basic wire loop 341, the end of the adjustment section 32 can be tightened and bound in the locking wire loop 342 and the basic wire loop 341, ensuring the locking strength of the wire knot.

In the embodiment shown in FIGS. 10 and 11 , the adjustment section 32 passes through the locking wire loop 342 and the basic wire loop 341 , so the adjustment section 32 is simultaneously locked by the locking wire loop 342 and the basic wire loop 341 . Among them, the locking section 33 passes through the basic wire loop 341. In a modified embodiment, the locking section 33 can also pass between the basic wire loop 341 and the locking wire loop 342, so that after the wire knot is tightened, the locking section 33 can be locked. The end of the tight section 33 is locked to prevent the wire knot 34 from loosening.

Further, as shown in Figure 12, the adjustment section 32 can also pass through the adjustment wire loop 31, that is, pass through the adjustment wire loop 31 at a position proximal to the second blocking disk 2, so that after the wire knot 34 is tightened, the adjustment section In addition to being locked by the wire knot 34, the end of the adjustment section 32 is also clamped by the wire knot 34 and the second blocking disk 2 to improve the locking strength of the end of the adjustment section 32.

In one embodiment, as shown in FIGS. 11 and 12 , at least one reinforcing wire loop 345 is formed between the basic wire loop 341 and the locking wire loop 342 to increase the number of wire loops of the wire knot 34 . The tight sections 33 all pass through the reinforcing wire loop 345 to improve the locking strength of the wire knot 34 to the adjusting section 32 and the locking section 33 to prevent them from loosening. Among them, the locking section 33 passes through at least one of the reinforcing wire loop 345 and the basic wire loop 341, so that after the locking section 33 is pulled, the locking section 33 is passed through at least one of the reinforcing wire loop 345 and the basic wire loop 341. The wire loop is locked to ensure that the wire knot 34 will not loosen.

Embodiment three:

As shown in Figure 13, the wire knot 34 includes a basic wire loop 341, an adjustment wire loop 31 and a second connecting section 344. The locking section 33 is connected to one end of the locking wire loop 342, and the adjustment section 32 is connected to one end of the adjustment wire loop 31. The basic wire loop 341 is connected between the end of the locking wire loop 342 and the end of the adjusting wire loop 31 . One end of the second connecting section 344 is connected to the basic wire loop 341 and the other end is connected to the adjusting wire loop 31 . Among them, the locking wire loop 342 is sleeved on the basic wire loop 341, specifically the end of the locking section 33 connected to the locking wire loop 342 passes through the basic wire loop 341; the locking wire loop 342 and the adjustment wire loop 31 are sleeved on each other. It is assumed that the locking wire loop 342 passes through the adjusting wire loop 31 .

The second connecting section 344 is wound around the locking wire loop 342 to form at least one reinforcing wire loop 345 , that is, the second connecting section 344 passes through the locking wire loop 342 , and the adjusting section 32 passes through the basic wire loop 341 and the reinforcing wire loop 345 . In some embodiments, the adjustment section 32 can pass through at least one of the base wire loop 341 and the reinforcing wire loop 345 so that the end of the adjustment section 32 can be locked after the wire knot 34 is locked.

In some embodiments, the locking wire loop 342 and the adjusting wire loop 31 are not nested with each other.

In this embodiment, the adjustment section 32 does not pass through the locking wire loop 342, but is locked by the basic wire loop 341 and the reinforcing wire loop 345. After the locking section 33 is pulled, the locking wire loop 342 shrinks so that the basic wire loop 341 and the reinforcing wire loop 345 gather, and the basic wire loop 341 and the reinforcing wire loop 345 shrink to lock the adjustment section 32 . In this embodiment, the locking wire loop 342 is sleeved on the basic wire loop 341 and the adjustment wire loop 31. In the process of pulling the locking section 33 to tighten the locking wire loop 342, the locking wire loop 342 gradually shrinks. , and then pull the adjustment wire loop 31 and the basic wire loop 341 together during the contraction process, thereby improving the efficiency and reliability of wire knot locking.

Embodiment 4:

As shown in Figure 14, the wire knot 34 includes a locking wire loop 342. The locking wire loop 342 is located on the proximal side of the adjusting wire loop 31. One end of the adjusting wire loop 31 is connected to the locking wire loop 342, and the other end is connected to the adjusting section 32. , the adjusting section 32 passes through the locking wire loop 342 and the adjusting wire loop 31 . In this embodiment, during the process of forming the wire knot 34, the adjusting section 32 first passes through the locking wire loop 342 (specifically, the end of the adjusting section 32 passes through the locking wire loop 342), and then passes through the adjusting wire loop. 31. Therefore, when the locking section 33 is pulled, the locking wire loop 342 contracts to lock the adjusting section 32. At the same time, the locking wire loop 342 and the second blocking disk 2 clamp the adjusting section 32, thereby improving the control of the adjusting wire loop. 31 locking performance.

The embodiment of the present application provides a method for knotting the tightening member 3 in the above-mentioned blocking system, which includes the following steps:

The linear member is wound to form a wire knot 34, and an adjustment wire loop 31 is connected to the distal side of the wire knot 34. The linear member forms two sections including ends on the proximal side of the wire knot 34, namely the adjustment section 32 and the locking section. Paragraph 33. In detail, the linear member includes a locking section 33, a first section, a second section and an adjustment section 32 connected in sequence. The first section is used to be wound into a wire knot 34, and the second section is used to form an adjustment line. Ring 31.

In one embodiment, a wire-shaped member is wound to form a wire knot 34, and an adjustment wire loop 31 is connected to the distal side of the wire knot 34. The wire-shaped member forms two sections with ends proximal to the wire knot 34, respectively. The steps of adjusting the section 32 and the locking section 33 specifically include: S11: winding the first section to form a wire knot 34, which includes a plurality of wire loops; S12: guiding the adjustment section 32 through the wire knot 34 At least two wire loops among the plurality of wire loops are used so that the second section forms an adjusting wire loop 31 to obtain the tightening member 3 .

Wherein, in step S12, at least two wire loops through which the guide adjustment section 32 passes may include a basic wire loop 341 and a locking wire loop 342, such as the tightening member 3 shown in Figures 2, 6 and 9 ; It may also include a reinforcing wire loop 345, such as the tightening member 3 shown in Figures 3-5 and 7-8; it may also include a basic wire loop 341 and a reinforcing wire loop 345, but does not pass through the locking wire loop 342, such as the tightening member 3 shown in Figure 13. In alternative embodiments, multiple reinforcing wire loops 345 may be passed through without passing through the base wire loop 341 and/or the locking wire loop 342 .

In another embodiment, a wire-shaped member is wound to form a wire knot 34, and an adjustment wire loop 31 is connected to the distal side of the wire knot 34, and the wire-shaped member forms a section with two ends proximal to the wire knot 34, The steps of adjusting section 32 and locking section 33 respectively include: S21: winding the first section to form a wire knot 34, which includes at least one wire loop; S22: guiding the adjustment section 32 to at least pass through the wire. A wire loop in the knot 34 allows the second section to form an adjustment wire loop 31 on the far side of the wire knot 34; S23: guide the adjustment section 32 through the adjustment wire loop 31 to obtain the tightening member 3.

Among them, in step S22, the adjusting section 32 can only pass through the locking wire loop 342 and the adjusting wire loop 31 to obtain the tightening member 3 as shown in Figure 14, in which the wire knot 34 only includes one wire loop. It is the locking wire ring 342. In other embodiments, the adjustment section 32 can also pass through the adjustment wire loop 31 and multiple wire loops in the wire knot 34, such as the locking wire loop 342 and other wire loops in the wire knot 34, for example, in Figure 12, In addition to passing through the locking wire loop 342 and the adjusting wire loop 31 , the adjusting section 32 also passes through the basic wire loop 341 and the reinforcing wire loop 345 in the wire knot 34 .

It should be noted that the above-mentioned labels S11, S12, S21, S22, and S23 are only used to distinguish different steps and are not used to limit the order of execution of the steps.

The above-mentioned blocking system needs to be used in conjunction with guide wires, dilators, etc. during use. For example: transport the delivery device to the middle of the left atrium through the guide wire; then withdraw the guide wire, and use the delivery device to transport the occlusion system into the atrium, so that the two occlusion discs of the occlusion system are released on both sides of the defect respectively. side, and then pull the end of the adjustment section 32 proximally through the delivery device, so that the length of the adjustment wire loop is reduced and the two blocking disks are respectively attached to both sides of the defect; then the locking section is pulled proximally through the delivery device 33, causing the wire knot 34 to shrink to lock the adjustment section 32; finally, the excess wire segment is cut off by a wire cutter, and the delivery device and the wire cutter are withdrawn to complete the implantation of the blocking system.

It should be noted that the specific technical solutions in each embodiment/mode of the present application can be applicable to each other as long as the technical principles are not inconsistent, that is, the specific technical features in each embodiment/mode are applicable to each other as long as the technical principles are not inconsistent. The following can be combined with each other, and the technical solution obtained by combining the technical features with each other also belongs to the protection scope of this application.

It can be understood that, for those of ordinary skill in the art, equivalent substitutions or changes can be made based on the technical solutions and application concepts of the present application, and all such changes or substitutions should fall within the protection scope of the present application.

Claims (8)

1. A sealing system for sealing defects in the vascular system, which is characterized in that it includes: a first sealing disk and a second sealing disk for covering different openings of the defect; The tightening member includes an adjustment wire loop, an adjustment section, a locking section and a wire knot. The adjustment section and the locking section are connected to the proximal side of the wire knot, and the adjustment wire loop is connected to the wire knot. On the far side, the adjusting section, the locking section and the wire knot are arranged on the side of the second blocking disk away from the first blocking disk, and part of the adjusting wire loop is connected to the Between the first sealing disk and the second sealing disk, the adjustment wire loop is used to penetrate the defect; The wire knot includes at least one wire loop, and the adjustment section passes through the wire knot and at least two wire loops in the adjustment wire loop; the wire knot includes a basic wire loop and a locking wire loop; the lock The tight section is connected to one end of the locking wire loop, the adjustment section is connected to one end of the adjustment wire loop, and the basic wire loop is connected to the end of the locking wire loop and the end of the adjustment wire loop. between; the wire knot includes a second connection section, one end of the second connection section is connected to the base wire loop, and the other end is connected to the adjustment wire loop, and the second connection section at least passes through the Locking wire loop; the adjustment section passes through the locking wire loop and the base wire loop; the adjustment section also passes through the adjustment wire loop; and The locking section is used to drive the wire loop in the wire knot to shrink, so that the wire knot locks the end of the adjustment section. 2. The plugging system according to claim 1, characterized in that the plugging system includes a conveying device, the conveying device is connected to the proximal end of the adjusting section and is used to pull the adjusting section to drive the The adjustment wire loop moves proximally through the wire knot to adjust the distance between the first blocking disk and the second blocking disk; and/or The delivery device is connected to the proximal end of the locking section and is used to pull the locking section. 3. The occlusion system according to claim 1, wherein the basic wire loop is disposed proximal to the locking wire loop. 4. The plugging system according to claim 1, characterized in that, The locking section passes through the base wire loop. 5. The plugging system according to claim 1, characterized in that, At least one reinforcing wire loop is formed between the basic wire loop and the locking wire loop, and the locking section passes through at least one of the reinforcing wire loops and the basic wire loop. 6. A method for knotting tightening members in the blocking system according to any one of claims 1 to 5, characterized in that it includes the following steps: The wire knot is formed by winding a wire-shaped member, and the adjusting wire loop is connected to the distal side of the wire knot, and the wire-shaped member forms two sections including ends on the proximal side of the wire knot, They are the adjusting section and the locking section respectively. 7. The knotting method of the tightening member according to claim 6, wherein the linear member includes the locking section, the first section, the second section and the adjusting section connected in sequence. ; The linear member is wound to form the wire knot and the adjustment wire loop is connected to the distal side of the wire knot. The linear member forms two ends including ends on the proximal side of the wire knot. sections, respectively the steps of the adjustment section and the locking section, specifically include: winding the first section to form the wire knot, the wire knot including a plurality of wire loops; The tightening member is obtained by guiding the adjustment section through at least two of the plurality of wire loops of the wire knot so that the second section forms the adjustment wire loop. 8. The knotting method of the tightening member according to claim 6, wherein the linear member includes the locking section, the first section, the second section and the adjustment section connected in sequence. ; The linear member is wound to form the wire knot and the adjustment wire loop is connected to the distal side of the wire knot. The linear member forms two ends including ends on the proximal side of the wire knot. sections, respectively the steps of the adjustment section and the locking section, specifically include: The first section is wound to form the wire knot, the wire knot including at least one wire loop, guiding the adjustment section through at least one wire loop in the wire knot such that the second section forms the adjustment wire loop distally of the wire knot; The adjusting section is guided through the adjusting wire loop to obtain the tightening piece.