WO2020052016A1

WO2020052016A1 - Defect closure device assembly and intervention method therefor

Info

Publication number: WO2020052016A1
Application number: PCT/CN2018/112649
Authority: WO
Inventors: 潘湘斌; 谭雄进
Original assignee: 谭雄进
Priority date: 2018-09-11
Filing date: 2018-10-30
Publication date: 2020-03-19
Also published as: CN109044427B; CN109044427A

Abstract

A defect closure device assembly and an intervention method therefor, the defect closure device assembly comprising a closure device and a puncture needle (10); the closure device comprises: a rod body (20), a head portion thereof being bendable, an exit of a first channel (21) at the interior of the rod body (20) being located at an inner side when the head portion of the rod body (20) is bent, and an exit of a second channel (22) at the interior of the rod body (20) being located below the exit of the first channel (21); a lead structure, which is movably disposed at the exit of the first channel (21); a suture line (30), which penetrates into the first channel (21) and which is connected to the lead structure. The closure device may enter the human body by means of a blood vessel or other means; once the closure device is inserted into an organ defect hole (50), the head portion of the rod body (20) bends, and the puncture needle (10) passes through the second channel (22) as well as tissue surrounding the organ defect hole (50), and then connects to the lead structure; when the puncture needle (10) is withdrawn, the puncture needle (10) drives the lead structure to move together so that the suture line (30) passes through the tissue surrounding the organ defect hole (50) along the path by which the puncture needle (10) is withdrawn. The defect closure device assembly may solve the problem wherein metal occluder implantation in interventional occlusion and the long term retention thereof cause many risks.

Description

Defect closure device and its intervention method

Technical field

The present invention relates to the technical field of biomedical devices, and in particular, to a defect obturator assembly and an intervention method thereof, which are mainly due to the treatment of unobstructed oval foramen and atrial septal defect.

Background technique

Foramen ovale closure is an earlier treatment for interventional congenital heart disease. At present, it has accumulated mature experience in China. In the existing oval hole occlusion technique, an umbrella-shaped metal occluder is usually used to clamp the tissue around the defect, so as to achieve occlusion of the defect site. However, the occluder is a large foreign body, which not only has the risk of falling off, but also forms blood clots after implantation. Patients need to take aspirin for at least half a year. Even so, some patients have poor endothelialization and continue to produce blood clots. On the other hand, the metal occluder will remain in the patient's body for a long time, and there is a risk of abrading the surrounding tissue in the long term, causing complications such as cardiac perforation.

Summary of the Invention

The main purpose of the present invention is to provide a defect obturator assembly and an intervention method thereof, in order to solve the problem that the prior art interventional occlusion requires implantation of a metal occluder and persists for a long time, which will bring a lot of risks.

In order to achieve the above object, according to an aspect of the present invention, there is provided a defect closure device comprising a closure device and a puncture needle. The closure device includes a rod body, the rod body has a first channel and a second channel inside, and the head of the rod body may be Bend, the inlet of the first channel and the inlet of the second channel are located at the tail of the rod body, the outlet of the first channel is located inside when the head of the rod is bent, and the outlet of the second channel is located below the outlet of the first channel; The lead structure can be movably arranged at the exit of the first channel; the suture is an absorbable or non-absorbable suture, and the suture passes from the entrance of the first channel into the first channel and is connected with the lead structure After the obturator is inserted into the organ defect hole, the head of the rod is bent, and the puncture needle passes through the second channel, the tissue around the organ defect hole and is connected to the lead structure. When the puncture needle is withdrawn, the puncture needle drives the lead structure. Move together so that the suture passes through the tissue around the organ defect hole along the path that the puncture needle exits.

Further, a bending section is provided at a position near the exit of the first passage and a position near the exit of the second passage, so that when the head of the rod body is bent, the exit of the second passage can be aligned with the lead structure.

Further, the lead structure is a buckle, the buckle has a groove, and a barb is provided on the inner wall of the groove. When the head of the puncture needle extends into the groove, the barb hooks the head of the puncture needle to make puncture The needle can move the buckle together.

Further, the longitudinal section of the barb is triangular, the head of the puncture needle has a pointed tip, and the head of the puncture needle protrudes from the rest of the puncture needle along its radial direction.

Further, both the head of the puncture needle and the lead structure have a metal part, and a bubble structure is provided in the metal part. The bubble structure enables the metal part to be clearly developed under ultrasound, so that it can be positioned under ultrasound guidance without using radiation.

Further, the lead structure is cloth filled at the exit of the first channel, and the head of the puncture needle has barbs. When the head of the puncture needle is inserted into the cloth, the barbs hook the cloth so that the puncture needle can move the cloth together. .

Further, the lead structure is a first magnet, and the head of the puncture needle has a second magnet. When the head of the puncture needle approaches the first magnet, the first magnet and the second magnet are attracted to each other so that the puncture needle can drive the first magnet. A magnet moves together; or, the defect closer assembly further includes a third magnet and a metal part capable of being attracted by the third magnet, one of the third magnet and the metal part forms a lead structure, and the other of the third magnet and the metal part It is arranged on the head of the puncture needle. When the head of the puncture needle is close to the lead structure, the third magnet attracts the metal part, so that the puncture needle can move the lead structure together.

Further, the rod body includes a rod body and a bent rod rotatably disposed on the rod body, the bent rod forms a head of the rod body, and an outlet of the second channel is located on a side wall of the rod body.

Further, the first channel includes a main channel section and a sub channel section. The main channel section is disposed in the rod body, the sub channel section is disposed in the bending rod, and the diameter of the end of the sub channel section near the rod body is smaller than that of the main channel section near the bend. The diameter of one end of the folding rod, during the rotation of the bending rod, the auxiliary channel section rotates with the bending rod, and the auxiliary channel section and the main channel section are always connected.

Further, the rod body further includes a connection structure connected between the rod body and the bending rod. The connection structure can be rotatably connected with the rod body and the bending rod. The connection structure includes at least one connecting rod. When the connecting rod has multiple sections, each The adjacent two sections of the connecting rod can be rotatably connected.

Further, the rod body also has a third channel inside, the inlet of the third channel is located at the tail of the rod body, the outlet of the third channel is located at the head of the rod body, and the third channel is used to pass through the guide wire so that the closure can be guided along the guide. The silk is fed into the body and inserted into an organ defect hole.

According to another aspect of the present invention, there is provided an intervention method for a defect obturator assembly, which in turn includes the following steps:

Puncture the femoral vein, send the catheter and guide wire into the body, and enter the organ defect hole, exit the catheter, retain the guide wire; thread the guide wire into the third channel inside the rod body of the closer, and the closer is guided along the guide wire. Into the body and insert the organ defect hole, withdraw the guide wire; bend the bending rod of the rod to the side of the organ defect hole, pass the puncture needle through the second channel, pierce the tissue around the organ defect hole, and bend The lead structure connection inside the folding rod; exit the puncture needle, the puncture needle drives the lead structure to move together, so that the suture connected to the lead structure passes the tissue around the organ defect hole along the path of the puncture needle exit, exits the closure, and sutures Thread the tissue on one side of the organ defect hole; repeat the above steps to thread the suture on the tissue on the other side of the organ defect hole; tie the sutures on both sides of the organ defect hole with a knotter 60 Tighten the organ defect hole to close.

With the technical solution of the present invention, after the closure is inserted into the organ defect hole, the head of the rod is first bent to one side of the organ defect hole, and then the puncture needle is passed through the second channel to pierce the tissue around the organ defect hole. Connect with the lead structure, and then withdraw the puncture needle. When the puncture needle is withdrawn, the puncture needle drives the lead structure to move together to make the suture pass through the tissue around the organ defect hole along the path of the puncture needle withdraw. After that, the head of the rod was straightened and the retractor was withdrawn, and the suture thread was put on the tissue on the side of the organ defect hole. Insert a new suture into the obturator or use a new obturator, repeat the above operation, and thread the suture over the tissue on the other side of the organ defect hole. The knots on the two sides of the organ defect hole are tied and tied by a knotter, so that the organ defect hole is closed. For atrial septal defect, the above operation can be repeated multiple times, after multiple sutures are inserted, and then knotted, the defect can be completely closed. With the above-mentioned defect obturator assembly, only the defect site needs to be sutured with sutures, and no metal occluder is implanted, thereby avoiding various risks brought by the metal occluder. In addition, repair and closure of organ defect holes of different sizes can also be performed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which constitute a part of this application, are used to provide a further understanding of the present invention. The schematic embodiments of the present invention and the descriptions thereof are used to explain the present invention, and do not constitute an improper limitation on the present invention. In the drawings:

FIG. 1 is a schematic cross-sectional view of a closer of a first embodiment of a defect closer assembly according to the present invention; FIG.

FIG. 2 shows an enlarged schematic view of A of the closer of FIG. 1; FIG.

3 is a schematic cross-sectional view of the bender of the closer of FIG. 1 when it is bent;

Figure 4 shows a schematic sectional view of the closure of Figure 3 with the puncture needle;

FIG. 5 shows a schematic structural diagram when the atrial septal defect hole (oval hole) is repaired by using the defect closer component of FIG. 1; FIG.

FIG. 6 shows an enlarged schematic view at B of the defect closer assembly and atrial septal defect hole of FIG. 5; and

FIG. 7 is a schematic structural diagram of a knotter of the defect closer assembly of FIG. 1.

The above drawings include the following reference signs:

10, puncture needle; 20, rod body; 21, first channel; 22, second channel; 23, rod body; 24, bending rod; 25, third channel; 30, suture; 40, buckle; 41, Barbs; 50, organ defect holes; 60, knots; 61, hooks; 70, bubble structure.

detailed description

It should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the drawings and embodiments.

As shown in FIG. 1 to FIG. 7, the defect closure device of the first embodiment is used for closing and repairing an oval hole (or atrial septal defect). Specifically, the defect closure device described above includes a closure device and a puncture needle 10. The closer includes a rod body 20, a lead structure, and a suture 30. The rod body 20 has a first channel 21 and a second channel 22 inside. The head of the rod body 20 can be bent. The inlet of the first channel 21 and the inlet of the second channel 22 are both located at the tail of the rod body 20. The outlet of the first channel 21 is located on a side wall of the head of the rod body 20, and the outlet of the first channel 21 is located on the inner side when the head of the rod body 20 is bent. The exit of the second passage 22 is located below the exit of the first passage 21. The lead structure is movably disposed at the exit of the first channel 21. The suture thread 30 penetrates into the first channel 21 from the entrance of the first channel 21 and is connected to the lead structure. In addition, the rod body 20 also has a third channel 25 inside. The entrance of the third channel 25 is located at the tail of the rod body 20. The exit of the third channel 25 is located at the head of the rod body 20. The third channel 25 is used to pass through the guide wire so that the obturator can be introduced into the body along the guide wire and inserted into the organ defect hole 50.

Using the defect closure device of this embodiment, the femoral vein is punctured, the catheter and the guide wire are introduced into the body, and the organ and the guide wire are passed into the organ defect hole 50. The catheter is withdrawn and the guide wire is retained. The guide wire is then inserted into the third channel 25, and the obturator is sent into the body along the guide wire and inserted into the organ defect hole 50, and exits the guide wire. After the closure is inserted into the organ defect hole 50, the head of the rod body 20 is first bent toward one side of the organ defect hole 50, and then the puncture needle 10 is passed through the second channel 22 to pierce the tissue around the organ defect hole 50 and Connect to the lead structure and then withdraw the puncture needle 10. When the puncture needle 10 is withdrawn, the puncture needle 10 drives the lead structure to move together, so that the suture 30 passes through the tissue around the organ defect hole 50 along the path with which the puncture needle 10 exits. Thereafter, the head of the rod body 20 is straightened, and the guide wire is re-entered along the third channel 25, the guide wire is retained in the body, the closure device is withdrawn, and the suture thread 30 is put on the tissue of one side of the organ defect hole 50. Insert the closure into a new suture 30 or use a new closure to insert the retained guide wire into the organ defect hole 50, repeat the above operation, and thread the suture 30 into the tissue on the other side of the organ defect hole 50 on. The sutures 30 on both sides of the organ defect hole 50 are tied and tied by the knotter 60, so that the organ defect hole 50 (oval hole) is closed. By adopting the above-mentioned defect closure device assembly, the defect site only needs to be sutured through the suture 30, and no metal occluder needs to be implanted, thereby avoiding various risks brought by the metal occluder. In addition, it is also possible to repair and close organ defect holes 50 of different sizes.

It should be noted that, in this embodiment, the defect closure device is used to repair the oval hole. Of course, in other embodiments, the defect closer component can be used for other types of defects, for example, it can be used to repair the atrial septal defect. When the atrial septal defect is repaired, the above operation can be repeated multiple times to insert multiple sutures. After that, the knot can be closed completely. In addition, in this embodiment, the suture thread 30 is an absorbable thread, and the thread is absorbed by the human body after endothelialization, so that there is no residual treatment of heart disease. Of course, the suture thread 30 may be a non-absorbable thread.

As shown in FIG. 3 and FIG. 4, in the defect closer assembly of the first embodiment, the first channel 21 is located near its exit and the second channel 22 is near its exit. When the head is bent, the outlet of the second channel 22 can be aligned with the lead structure. That is, at this time, the center line of the exit of the second channel 22 and the center line of the lead structure are located on a straight line. The above structure can prevent the puncture needle 10 from going out of the second channel 22 when it is pushed forward, and can accurately enter the lead structure of the first channel 21 without damaging other tissues.

As shown in FIGS. 2 and 6, in the defect closer assembly of the first embodiment, the lead structure is a buckle 40. The buckle 40 has a groove, and an inner wall of the groove is provided with a barb 41. In this embodiment, the barb 41 extends one turn in the circumferential direction of the groove, and the barb 41 can be regarded as being formed by the inner wall of the groove protruding inward. The vertical cross section of the barb 41 is triangular. The head of the puncture needle 10 has a pointed tip (in this embodiment, the longitudinal section of the head of the puncture needle 10 also has a triangular shape, that is, the head of the puncture needle 10 has a triangular pyramid shape), Its radial direction projects beyond the rest of the puncture needle 10. When the head of the puncture needle 10 has just reached into the groove, the triangular tapered surface of the head of the puncture needle 10 contacts the slant surface of the barb 41. After the head of the puncture needle 10 is fully extended, the bottom surface of the barb 41 is stuck. The bottom surface of the head of the puncture needle 10 is held, so that the head of the puncture needle 10 is hooked, so that the puncture needle 10 can drive the buckle 40 to move together.

The lead structure is set as a buckle 40 with a barb 41, and the head of the puncture needle 10 is hooked by the barb 41, the structure is simple, and the connection between the lead structure and the puncture needle 10 can be made more reliable. The barb 41 is arranged in a circle to further ensure the connection reliability and effectively prevent the buckle 40 and the head of the puncture needle 10 from falling off. Similarly, the head of the puncture needle 10 protrudes from the rest of the puncture needle 10 in the radial direction, so as to be able to match the bottom surface of the protruding portion of the puncture needle 10 with the barb 41 to further ensure For connection reliability. In addition, the head of the puncture needle 10 has a triangular cone shape, and the longitudinal cross-section of the barb 41 is triangular. In this way, the triangular cone surface of the puncture needle 10 and the inclined surface of the barb 41 can slide in contact with each other, and play a guiding role, thereby making the puncture The head of the needle 10 more easily protrudes into the U-shaped groove of the buckle 40.

It should be noted that the specific form of the lead structure is not limited to this. In other embodiments not shown in the figure, the lead structure may be other structures that can be connected to the head of the puncture needle. In this embodiment, the buckle 40 has a cylindrical shape as a whole, and a groove is provided in the center thereof. The barb 41 is arranged in a circle along the circumferential side wall of the groove. Of course, the structure of the buckle 40 and the number of the barb 41 The shape and shape are not limited to this. In other embodiments not shown in the drawings, the buckle may be U-shaped as a whole, and barbs are provided on the inside, and the barbs are two symmetrically arranged. The barbs may be bar-shaped barbs arranged obliquely, and the number of barbs may be only one or three or more, as long as they can hook the head of the puncture needle. In addition, the head of the puncture needle 10 is not limited to a triangular pyramid shape. In other embodiments not shown in the figure, the shape of the head of the puncture needle may be similar to the combined shape of a triangular pyramid and a cylinder as a whole, as long as it can The head of the puncture needle protrudes beyond the rest of the puncture needle in its radial direction.

As shown in FIG. 2, FIG. 4, and FIG. 6, in the defect closer assembly of the first embodiment, both the head and the lead structure of the puncture needle 10 have a metal portion, and a bubble structure 70 is provided in the metal portion. The metal part is clearly developed under ultrasound, so that it can be positioned under ultrasound guidance without using radiation. Specifically, during the manufacturing process, micro-bubbles are mixed in the metal, so that a bubble structure 70 is formed in the formed metal portion. This can enhance the echo of the head of the puncture needle 10 and the lead structure under ultrasound, and on the ultrasound image The bright spots appear as highlights, which can be used to locate and keep the puncture point away from important tissues.

It should be noted that, in this embodiment, the entire head of the puncture needle 10 and the entire lead structure are made of a metal material, that is, the entire head of the puncture needle 10 and the entire lead structure are formed of metal. unit. Of course, the method of forming the metal portion is not limited to this. In other embodiments, the metal portion may be only a metal structure such as a metal block or a metal sheet provided on the head of the puncture needle or the lead structure.

As shown in FIGS. 1, 3 and 4, in the defect closer assembly of the first embodiment, the rod body 20 includes a rod body 23 and a bending rod 24 rotatably disposed on the rod body 23. The bending rod 24 forms a head of the rod body 20. An outlet of the second channel 22 is located on a side wall of the rod body 23. In this embodiment, the bending rod 24 is connected to the rod body 23 through a rotating shaft, and the bending rod 24 can be pivoted in a setting plane of the rod body 23. The length of the bending rod 24 is 1 to 10 cm, and preferably 2 cm. The included angle between the closer rod main body 23 and the bending rod 24 is 10 to 160 degrees, preferably 60 degrees. The closer also includes a rotation control portion provided at the tail portion of the rod body 23, through which the rotation of the bending rod 24 can be controlled (the specific implementation manners are many in the prior art, for example, through the combination of a knob, a wire, and a rotating shaft Control the shaft rotation). The first channel 21 includes a main channel section and a sub channel section. The main channel section is provided in the rod body 23, and the sub channel section is provided in the bending rod 24. The diameter of the end of the sub channel section near the rod body 23 is smaller than that of the main channel section. The diameter of one end of the bending rod 24. When the bending lever 24 rotates, the auxiliary passage section rotates with the bending lever 24, but the port of the auxiliary passage section near the rod body 23 must always be maintained corresponding to the port of the main passage section near the bending lever 24, so that the auxiliary passage section The channel segment and the main channel segment are always connected.

It should be noted that the rotational connection between the bending rod 24 and the rod body 23 is not limited to being connected through a rotating shaft. In other embodiments not shown in the figure, the bending rod and the rod body can be connected by other connection structures. (For details, please refer to the fifth embodiment); the bending rod 24 is not limited to pivot in the installation plane of the rod body 23, and in other embodiments, the bending rod can also rotate in any direction relative to the rod body. In addition, the specific form of the rod body 20 is not limited to this. In other embodiments not shown in the figure, the rod body may also be an integral flexible rod, and the head thereof can be bent.

The main difference between the defect closer device assembly (not shown in the figure) and the first embodiment is that the lead structure is cloth filled at the exit of the first channel, and the head of the puncture needle has barbs. When the head of the puncture needle is inserted into the fabric, the barb hooks the fabric so that the puncture needle can move the fabric together. In addition, other structures and working principles of the second embodiment are basically the same as those of the first embodiment, and details are not described herein again.

The main difference between the defect closer assembly (not shown in the figure) and the first embodiment is that the lead structure is a first magnet, and the head of the puncture needle has a second magnet. When the head of the puncture needle is close to the first magnet, the first magnet and the second magnet are attracted and connected to each other, so that the puncture needle can move the first magnet together. In addition, other structures and working principles of the third embodiment are basically the same as those of the first embodiment, and details are not described herein again.

The main difference between the defect closer assembly of the fourth embodiment (not shown) and the first embodiment lies in that the defect closer assembly further includes a third magnet and a metal part capable of being attracted by the third magnet, and the third magnet and the metal part One of them forms a lead structure, and the other of the third magnet and the metal part is provided on the head of the puncture needle. When the head of the puncture needle is close to the lead structure, the third magnet attracts the metal part, so that the puncture needle can move the lead structure together. In addition, other structures and working principles of the fourth embodiment are basically the same as those of the first embodiment, and details are not described herein again.

The main difference between the defect closer assembly of the fifth embodiment (not shown in the figure) and the first embodiment is that the rod body further includes a connection structure connected between the rod body and the bending rod. The connecting structure can be rotatably connected with the main body of the rod body and the bending rod. The connecting structure includes one or more connecting rods. When the connecting rod has multiple sections, two adjacent sections of the connecting rods can be rotatably connected. The above-mentioned connection structure can play a role similar to a joint, so that the rotation range of the bending rod is larger. In addition, other structures and working principles of the fifth embodiment are basically the same as those of the first embodiment, and details are not described herein again.

The main difference between the defect closer device of the sixth embodiment and the first embodiment is that the defect closer device of the first embodiment is used for closing and repairing the oval hole, while the defect closer device of the sixth embodiment is compared with the existing occluder. Combined to achieve closed repair of large atrial septal defects. Specifically, for large atrial septal defects, sufficient margins around the atrial septal defect can be used to occlude with the existing occluder. If the atrial septal defect has insufficient edges, the occluder will be affected by the supporting force of the part. Not enough to fall off. Therefore, such patients can first implant two symmetrical non-absorbable sutures through the defect closer component of this embodiment in a sufficient portion of the defect margin, and tie and tighten the two sutures. Although the atrial septal tissue on both sides cannot be connected by two sutures due to the large defect, the suture is transverse to the defect and divides the defect into two smaller defects, one of which is assisted by the suture. The lower perimeter has sufficient edges and supporting force, and can be implanted into existing ordinary occluders. Because the umbrella plate of the ordinary occluder is 14mm larger than the waist diameter, the umbrella plate of the occluder can cover the atrial septal defect suture. The other part of the separation, the combined application of the two devices, can enable patients who have not been able to intervene in the past to receive minimally invasive treatment.

The present application also provides an intervention method for a defect obturator assembly, and an embodiment of the intervention method according to the application includes the following steps in order:

Puncture the femoral vein, send the catheter and guide wire into the body, and enter the organ defect hole 50, exit the catheter, and retain the guide wire;

Pass the guide wire into the third channel 25 inside the rod body 20 of the closer, and the closer is sent into the body along the guide wire and inserted into the organ defect hole 50, and exits the guide wire;

The bending rod 24 of the rod body 20 is bent toward one side of the organ defect hole 50, and the puncture needle 10 is passed through the second channel 22, piercing the tissue around the organ defect hole 50, and the lead structure inside the bending rod 24 connection;

The puncture needle 10 is withdrawn, and the lead structure is driven by the puncture needle 10 to move together, so that the absorbable suture 30 connected to the lead structure passes the tissue around the organ defect hole 50 along the path of the puncture needle 10 exit. Straighten the head, re-enter the guide wire along the third channel 25, keep the guide wire in the body, exit the obturator, and thread the suture 30 on the tissue on the side of the organ defect hole 50;

Insert the closure into a new suture 30 or use a new closure to insert the remaining guide wire into the organ defect hole 50. Repeat the above steps to thread the suture 30 into the tissue on the other side of the organ defect hole 50 on;

The knots 60 are used to tie and tie the sutures 30 on both sides of the organ defect hole 50 to close the organ defect hole 50.

Among them, as shown in FIG. 7, the head of the knotter 60 has a hook portion 61. In specific operations, the free ends of the sutures 30 located on both sides of the organ defect hole 50 are extended outside the body, and then The tied knot is pushed into the body and fastened by the hook portion 61 of the knotter 60. Of course, the specific form of the knotter 60 is not limited to this. In other embodiments not shown in the figure, the knotter may also have a thread trimming function.

The above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

A defect obturator assembly, comprising an obturator and a puncture needle (10), the obturator comprises:

A rod body (20), the rod body (20) has a first channel (21) and a second channel (22) inside, the head of the rod body (20) can be bent, and the entrance of the first channel (21) And the inlet of the second channel (22) are both located at the tail of the rod body (20), the outlet of the first channel (21) is located inside when the head of the rod body (20) is bent, the The exit of the second channel (22) is located below the exit of the first channel (21);

A lead structure is movably disposed at the exit of the first channel (21); a suture (30), the suture is an absorbable suture or a non-absorbable suture, and the suture (30) is from The inlet of the first channel (21) penetrates into the first channel (21) and is connected to the lead structure. When the closer is inserted into the organ defect hole (50), the head of the rod body (20) Part of the body is bent, the puncture needle (10) is passed through the second channel (22), the tissue around the organ defect hole (50) in sequence and connected with the lead structure, and when the puncture needle (10 ) When exiting, the puncture needle (10) drives the lead structure to move together, so that the suture (30) passes through the organ defect hole (50) along the path where the puncture needle (10) exits. The surrounding organization.
The defect closer assembly according to claim 1, characterized in that the position of the first channel (21) near its exit and the position of the second channel (22) near its exit are provided with curved sections, so that When the head of the rod body (20) is bent, the outlet of the second channel (22) can be aligned with the lead structure.
The defect closer assembly according to claim 1, wherein the lead structure is a buckle (40), the buckle (40) has a groove, and an inner wall of the groove is provided with a barb (41) When the head of the puncture needle (10) extends into the groove, the barb (41) hooks the head of the puncture needle (10) to make the puncture needle (10) The buckle (40) can be driven to move together.
The defect closer assembly according to claim 3, wherein a longitudinal section of the barb (41) is triangular, a head of the puncture needle (10) has a pointed tip, and the puncture needle (10) The head of the bulge protrudes beyond the rest of the puncture needle (10) in its radial direction.
The defect closer assembly according to any one of claims 1 to 4, characterized in that both the head of the puncture needle (10) and the lead structure have a metal part, and a bubble structure is provided in the metal part (70) The bubble structure (70) enables the metal portion to be clearly developed under ultrasound, so that positioning can be performed under ultrasound guidance without using radiation.
The defect closer assembly according to claim 1, wherein the lead structure is cloth filled at an outlet of the first channel, and a head of the puncture needle has a barb, and when the puncture needle is After the head is inserted into the cloth, the barbs hook the cloth so that the puncture needle can drive the cloth to move together.
The defect closer assembly according to claim 1, wherein the lead structure is a first magnet, a head of the puncture needle has a second magnet, and when the head of the puncture needle is close to the first magnet In the case of a magnet, the first magnet and the second magnet are attracted and connected to each other, so that the puncture needle can drive the first magnet to move together; or the defect closer assembly further includes a third magnet and can be The third magnet and one of the metal parts form the lead structure, and the other of the third magnet and the metal part is provided on the puncture needle Head, when the head of the puncture needle is close to the lead structure, the third magnet attracts the metal part so that the puncture needle can drive the lead structure to move together.
The defect closer assembly according to claim 1, wherein the rod body (20) comprises a rod body (23) and a bending rod (24) rotatably disposed on the rod body (23), The bent rod (24) forms a head of the rod body (20), and an outlet of the second channel (22) is located on a side wall of the rod body (23).
The defect closer assembly according to claim 8, characterized in that the first channel (21) comprises a main channel section and a sub-channel section, and the main channel section is disposed in the rod body (23), so that The auxiliary passage section is disposed in the bending rod (24), and a diameter of an end of the auxiliary passage section near the rod body (23) is smaller than an end of the main passage section near the bending rod (24). Diameter, during the rotation of the bending rod (24), the auxiliary channel section rotates with the bending rod (24), and the auxiliary channel section and the main channel section are always in communication.
The defect closer assembly according to claim 8, wherein the rod body further comprises a connection structure connected between the rod body and the bent rod, and the connection structure and the rod body, The bending rods can be rotatably connected. The connecting structure includes at least one connecting rod. When the connecting rod has multiple sections, two adjacent connecting rods are rotatably connected.
The defect closer assembly according to claim 1, wherein the rod body (20) further has a third channel (25) inside, and the entrance of the third channel (25) is located in the rod body (20) At the tail, the outlet of the third channel (25) is located at the head of the rod body (20), and the third channel (25) is used to pass through a guide wire so that the closer can be guided along the guide The silk is fed into the body and inserted into the organ defect hole (50).
A method for intervention of a defect closure device comprises the following steps in sequence: puncturing a femoral vein, sending a catheter and a guide wire into the body, and passing into the organ defect hole (50), exiting the catheter, and retaining the Descend wire

The guide wire is inserted into a third channel (25) inside the rod body (20) of the closer, and the closer is sent into the body along the guide wire and inserted into the organ defect hole (50), exiting the Descend wire

Bend the bending rod (24) of the rod body (20) to one side of the organ defect hole (50), pass the puncture needle (10) through the second channel (22), and pierce the organ defect The tissue around the hole (50) is connected with the lead structure inside the bending rod (24);

Withdrawing the puncture needle (10), the puncture needle (10) drives the lead structure to move together, so that the suture (30) connected to the lead structure follows the exit path of the puncture needle (10) Through the tissue around the organ defect hole (50), exiting the obturator, and the suture (30) is threaded on one side of the organ defect hole (50);

Repeating the above steps, threading the suture (30) on the other tissue of the organ defect hole (50);

The suture thread (30) on both sides of the organ defect hole (50) is tied and tied by a knotter 60, thereby closing the organ defect hole (50).