A device for closing tissue

Abstract

The application belongs to the technical field of medical devices, and discloses a device for closing tissue, which comprises a closure device, the closure device comprising a first support body, a second support body and a suture, the first support body and the second support body being oppositely arranged, the first support body comprising a first connecting portion and a plurality of first support rods arranged along the circumference of the first connecting portion at intervals, the second support body comprising a second connecting portion and a plurality of second support rods arranged along the circumference of the second connecting portion at intervals, and the suture being arranged through the first connecting portion and the second connecting portion and used for connecting the first support body and the second support body. The device for closing tissue provided by the application can fix the first support body and the second support body through the suture, so that the first support rods and the second support rods abut against the atrial septum to complete the operation, and can effectively reduce the content of implanted metal and further reduce the risk of complications.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a device for closing tissue. BACKGROUND

[0002] The foramen ovale is a passageway between the left and right ventricles of the heart during fetal development. Blood from the mother's umbilical vein also enters the left heart cavity of the fetus through this passageway, and then distributes to the whole body to provide oxygen and nutrients required for fetal development. Without the foramen ovale, the fetus cannot develop normally, so the foramen ovale is a necessary and normal physiological structure. After the child is born, the child can establish normal pulmonary circulation, and the mission of the foramen ovale is accomplished. With the first cry, the left atrial pressure rises, causing the left primary septum oval fossa valve to partially adhere to the right secondary septum oval fossa edge, resulting in functional closure, and complete anatomical closure generally occurs 5-7 months after birth. About 77.6% of newborns' foramen ovale will close within 1 year. There are also people whose foramen ovale is always not closed. If the foramen ovale is not normally closed until 3 years old, it is considered to be a true patent foramen ovale.

[0003] The pressure of the left atrium of most people is greater than that of the right atrium, so even if there is a patent foramen ovale, the left-to-right shunt through the foramen ovale is very small and will not cause obvious symptoms. The flow of blood from the foramen ovale to the left atrium and then to the whole body during the fetal period is for the normal development of the fetus, and such blood flow after the baby grows up can cause some problems.

[0004] "atrial septal defect" is similar to patent foramen ovale, but it is a congenital heart malformation. Atrial septal defect is caused by abnormalities during embryonic development, and usually has symptoms such as shortness of breath, palpitations, and fatigue. Patent foramen ovale and atrial septal defect are both residual patent foramen ovale between the left and right atria, which can cause blood to flow between the two atria.

[0005] However, the size of the hole in patent foramen ovale is generally smaller than that of atrial septal defect (about 4mm for patent foramen ovale and about 8mm for atrial septal defect), and the valve defect hole does not extend vertically to the valve wall, i.e. the left atrial valve defect hole and the right atrial valve defect hole are not concentric. Patent foramen ovale with a diameter of 4mm or more can cause significant harm to the body, and in the prior art, a closure device is placed to close the foramen ovale to achieve the purpose of treatment.

[0006] At present, most of the closure devices on the market are disc-shaped, and the structure contains a large amount of metal. Long-term implantation in the heart may cause the closure device to gradually corrode and release toxic substances due to corrosion of blood and friction caused by heartbeats, which may increase the risk of complications. SUMMARY

[0007] One object of the present application is to provide a device for tissue closure, which can effectively reduce the amount of metal implantation.

[0008] To achieve the above object, the present application adopts the following technical solutions:

[0009] A device for tissue closure, comprising a closure device, the closure device comprising:

[0010] a first support body, the first support body comprising a first connecting portion and a plurality of first support rods arranged along the circumference of the first connecting portion, each of the first support rods having a first connecting end and a first free end arranged opposite to the first connecting end, and the first connecting end of each of the first support rods being connected to the first connecting portion;

[0011] a second support body, the second support body being arranged opposite to the first support body, the second support body comprising a second connecting portion and a plurality of second support rods arranged along the circumference of the second connecting portion, each of the second support rods having a second connecting end and a second free end arranged opposite to the second connecting end, and the second connecting end of each of the second support rods being connected to the second connecting portion;

[0012] a suture, the suture being arranged through the first connecting portion and the second connecting portion, and the suture being used to connect the first support body and the second support body.

[0013] Optionally, a flow resistance film is arranged between the plurality of first support rods, and / or a flow resistance film is arranged between the plurality of second support rods.

[0014] Optionally, a first threading hole is arranged on the first connecting portion, and a second threading hole is arranged on the second connecting portion, and the suture is arranged through the first threading hole and the second threading hole.

[0015] Optionally, the suture has a first end and a second end arranged opposite to the first end, the second end of the suture is formed with a fixing loop, the fixing loop is arranged through the first threading hole and the second threading hole, and the fixing loop is configured to be able to adjust the clamping space between the first support body and the second support body, and when the first end of the suture is pulled, the fixing loop tightens and fixes the first support body and the second support body.

[0016] Optionally, the device for tissue closure further comprises a catheter and a delivery guide wire, the delivery guide wire is detachably connected to the second support body, and the delivery guide wire can drive the second support body and the first support body to move in the catheter.

[0017] Optionally, the device for closing tissue further comprises a connecting member, the connecting member is provided with a first through hole, the distal end of the delivery guide wire is connected with the second support body detachably through the first through hole, and the delivery guide wire is in sliding connection with the first through hole.

[0018] Optionally, the connecting member is further provided with a second through hole and a third through hole; and the device further comprises:

[0019] a first push wire tube, the first push wire tube is arranged in the second through hole and is detachably connected with the connecting member, and the suture is arranged in the first push wire tube;

[0020] a second push wire tube, the second push wire tube is arranged in the third through hole and is detachably connected with the connecting member, and the suture is arranged in the second push wire tube.

[0021] Optionally, the first free end of the first support rod is capable of being bent towards the proximal end of the first connecting part and arranged in the catheter; and / or the second free end of the second support rod is capable of being bent towards the distal end of the second connecting part and arranged in the catheter.

[0022] Optionally, the first connecting end of the first support rod is connected with the distal end of the first connecting part, in the expanded state, the first support rod extends along the distal end to the proximal end of the first connecting part, and is bent towards the proximal end of the first connecting part near the proximal end of the first connecting part, the bending angle is greater than or equal to 90 degrees and less than 180 degrees.

[0023] Optionally, the second connecting end of the second support rod is connected with the distal end of the second connecting part, in the expanded state, the second free end of the second support rod is bent towards the distal end of the second connecting part, the bending angle is greater than or equal to 90 degrees and less than 180 degrees.

[0024] Optionally, the number of the first support rods and the second support rods is 3-6.

[0025] Optionally, the device further comprises a wire cutter for cutting the suture.

[0026] Beneficial effects: the device for closing tissue provided by the application comprises a blocking device with oppositely arranged first support body and second support body, wherein the first support body comprises a first connecting part and a plurality of first support rods arranged along the circumference of the first connecting part, the second support body comprises a second connecting part and a plurality of second support rods arranged along the circumference of the second connecting part, and the first support body and the second support body are connected and fixed by a suture, which can effectively reduce the content of implanted metal and further reduce the risk of complications. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 is a structure schematic view of the first support body and the second support body fixed on both sides of the target tissue provided by the present application;

[0028] Figure 2 is a structure schematic view of the first support body and the second support body from one perspective provided by the present application;

[0029] Figure 3 is a structure schematic view of the first support body and the second support body from another perspective provided by the present application;

[0030] Figure 4 is a structure schematic view of the first support body and the second support body placed on both sides of the target tissue provided by the present application;

[0031] Figure 5 is a structure schematic view of the device for closing the tissue provided by the embodiment one of the present application;

[0032] Figure 6 is a structure schematic view of the delivery guide wire provided by the embodiment one of the present application;

[0033] Figure 7 is a structure schematic view of the connecting piece provided by the embodiment one of the present application;

[0034] Figure 8 is a structure schematic view of the first push wire tube and the second push wire tube from one perspective provided by the embodiment one of the present application;

[0035] Figure 9 is a structure schematic view of the first push wire tube and the second push wire tube from another perspective provided by the embodiment one of the present application;

[0036] Figure 10 is a structure schematic view of the pull-back suture provided by the embodiment one of the present application;

[0037] Figure 11 is a flow chart of the use method of the device for closing the tissue provided by the embodiment two of the present application;

[0038] Figure 12 is another flow chart of the use method of the device for closing the tissue provided by the embodiment two of the present application.

[0039] In the figure:

[0040] 100, the first support body; 110, the first connecting part; 111, the first threading hole; 120, the first support rod;

[0041] 200, the second support body; 210, the second connecting part; 211, the second threading hole; 212, the connecting hole; 220, the second support rod;

[0042] 300, suture; 310, fixed wire loop; 320, locking knot;

[0043] 400, atrial septum;

[0044] 510, delivery guide wire; 520, connector; 521, first through hole; 522, second through hole; 523, third through hole; 530, first push wire tube; 531, first through hole; 540, second push wire tube; 541, second through hole. DETAILED DESCRIPTION

[0045] The application will be further described below in conjunction with the drawings and embodiments. It should be understood that the specific embodiments described herein are intended to be merely illustrative of the application and not in limitation thereof. It should also be noted that, for the purpose of clarity, only those structures related to the application are shown in the drawings.

[0046] In the description of the application, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the application can be understood according to the specific circumstances.

[0047] In the present application, unless otherwise explicitly specified and limited, the "upper" or "lower" of the first feature to the second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the "upper", "above" and "on" of the first feature to the second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The "below", "below" and "below" of the first feature to the second feature includes that the first feature is directly below and obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.

[0048] In the description of the present embodiment, the terms "upper", "lower", "right", and other orientation or position relationships are based on the orientation or position relationship shown in the drawings, and are only for the convenience of description and simplification of operation, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the application. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0049] In the description of the present application, when describing the device, "proximal" refers to the direction toward the end of the device that is manipulated by the user outside the patient's body, and "distal" refers to the direction toward the working end of the device at the treatment site and away from the user.

[0050] Referring to Figures 1 to 3 As shown in the drawings, the embodiment of the present application provides a device for closing tissue, comprising a closure device, the closure device comprising a first support body 100, a second support body 200 and a suture 300, the first support body 100 comprising a first connecting portion 110 and a plurality of first support rods 120 spaced apart along the circumference of the first connecting portion 110, each first support rod 120 having a first connecting end and a first free end opposite to the first connecting end, the first connecting end of each first support rod 120 being connected with the first connecting portion 110, and the first free end extending away from the first connecting portion 110; the second support body 200 is arranged opposite to the first support body 100, the second support body 200 comprising a second connecting portion 210 and a plurality of second support rods 220 spaced apart along the circumference of the second connecting portion 210, each second support rod 220 having a second connecting end and a second free end opposite to the second connecting end, the second connecting end of each second support rod 220 being connected with the second connecting portion 210, and the second free end extending away from the second connecting portion 210; the first connecting portion 110 and the second connecting portion 210 are arranged opposite to each other, and the suture 300 is arranged through the first connecting portion 110 and the second connecting portion 210, the suture 300 being used to connect the first support body 100 and the second support body 200.

[0051] In the embodiment, the occluder is arranged on both sides of the target tissue, for example, on both sides of the patent foramen ovale on the atrial septum, the first support body 100 is arranged on the distal side of the atrial septum 400, the second support body 200 is arranged on the proximal side of the atrial septum 400, and the first support body 100 and the second support body 200 are connected by the suture 300, so that the first free end of the first support rod 120 of the first support body 100 and the second free end of the second support rod 220 of the second support body 200 abut on the atrial septum 400 to complete the operation and prevent the generation of intracardiac shunt. The first support body 100 comprises the first connecting portion 110 and a plurality of first support rods 120 arranged circumferentially and spaced apart along the first connecting portion 110, the second support body 200 comprises the second connecting portion 210 and a plurality of second support rods 220 arranged circumferentially and spaced apart along the second connecting portion 210, and the first support body 100 and the second support body 200 are connected and fixed by the suture 300, which can effectively reduce the metal content of implantation and further reduce the risk of complications. In addition, the patent foramen ovale is a valvular opening between the first atrial septum 400 (SP) and the second atrial septum 400 (SS) at the position of the oval fossa, and fixing the first support body 100 and the second support body 200 can adhere the first atrial septum 400 (SS) and the second atrial septum 400 (SP) to further close the patent foramen ovale and prevent shunt between the two atria.

[0052] Preferably, the distal side of the atrial septum 400 can be the right atrial side, and the proximal side of the atrial septum 400 can be the left atrial side.

[0053] Preferably, the material of the first support body 100 and the second support body 200 is nickel-titanium alloy. The nickel-titanium alloy has good biocompatibility and can be implanted in the human body, and it has unique superelasticity and can be deformed greatly. In the embodiment, the first support body 100 and the second support body 200 are integrally formed by laser cutting a nickel-titanium tube and then heat setting, the production process is simple, the metal weight of the first support body 100 and the second support body 200 is lighter than that of the traditional occluder, and complications can be avoided, which is conducive to the puncture of the atrial septum 400. Of course, the material of the first support body 100 and the second support body 200 can also be other materials, and the first support body 100 and the second support body 200 can also be non-integrally formed, which is not limited here.

[0054] Specifically, the number of the first support rods 120 of the first support body 100 and the number of the second support rods 220 of the second support body 200 can be equal, so as to equalize the pressure of each first support rod 120 and second support rod 220 on the atrial septum 400, thereby ensuring that the first support body 100 and the second support body 200 are stably fixed on both sides of the atrial septum 400. Of course, the number of the first support rods 120 of the first support body 100 and the number of the second support rods 220 of the second support body 200 can also be unequal, and can be customized according to the patient's condition, which will not be limited here.

[0055] Specifically, the number of the first support rods 120 of the first support body 100 and the number of the second support rods 220 of the second support body 200 are both 3-6, which can reduce the amount of metal implanted while stably fixing the first support body 100 and the second support body 200 on both sides of the atrial septum 400. Preferably, the number of the first support rods 120 of the first support body 100 and the number of the second support rods 220 of the second support body 200 are both 4. In other embodiments of the present application, the number of the first support rods 120 and / or the second support rods 220 can also be greater than 6.

[0056] In the present embodiment, the first support body 100 and / or the second support body 200 is provided with a flow-blocking film. Specifically, the flow-blocking film (not shown in the figure) is wrapped between the plurality of first support rods 120, and / or the flow-blocking film is wrapped between the plurality of second support rods 220. Preferably, the flow-blocking film is wrapped between the plurality of first support rods 120 and the plurality of second support rods 220, achieving double protection and effectively preventing blood from flowing from the left atrium into the right atrium, thereby preventing the generation of intracardiac shunt.

[0057] Preferably, the material of the flow-blocking film can be a high polymer material, and the flow-blocking film can be wrapped on the first support rods 120 and the second support rods 220 by heat melting or sewing. Of course, the material of the flow-blocking film can also be other materials, which will not be limited here.

[0058] Further, the lengths of all the first support rods 120 of the first support body 100 are equal, and the lengths of all the second support rods 220 of the second support body 200 are equal. In some embodiments of the present application, the lengths of all the first support rods 120 and the lengths of all the second support rods 220 are equal. The flow-blocking film of the first support body 100 and the second support body 200 after being unfolded is substantially circular or umbrella-shaped, so that the edges of the flow-blocking film are evenly distributed on both sides of the atrial septum 400. Of course, the flow-blocking film of the first support body 100 and the second support body 200 after being unfolded can also be other shapes, which will not be limited here.

[0059] Further, according to the size of the un-closed atrial hole on the atrial septum of the patient, the diameter of the first support body 100 and the second support body 200 after being deployed can be set to 8mm-16mm. Preferably, the diameter of the first support body 100 and the second support body 200 after being deployed is 8mm, 10mm, 12mm, 14mm or 16mm.

[0060] In this embodiment, continuing to refer to Figures 2 to 3 As shown in the figure, the first connecting part 110 is provided with a first threading hole 111, and the second connecting part 210 is provided with a second threading hole 211. The suture 300 is threaded through the first threading hole 111 and the second threading hole 211, so that the suture 300 can connect the first connecting part 110 and the second connecting part 210 together.

[0061] Specifically, the first connecting part 110 is tubular in shape, and the first threading hole 111 penetrates the side wall of the first connecting part 110. Further, the second connecting part 210 is tubular in shape, and the second threading hole 211 penetrates the side wall of the second connecting part 210.

[0062] Further, the suture 300 has a first end and a second end opposite to the first end, and the second end of the suture 300 forms a fixed loop 310. In this embodiment, the first end of the suture 310 is the proximal end of the suture 310, and the second end is the distal end of the suture 310. The proximal end of the fixed loop 310 is formed with a lock 320, which is located on the proximal end side of the second support part 200 and close to the second support part 200. The fixed loop 310 is configured to allow the clamping space between the first support body 100 and the second support body 200 to be adjustable. Specifically, the suture 300 can move relative to the lock 320 to tighten and fix the first support body 100 and the second support body 200.

[0063] In this embodiment, before the operation, the fixed loop 310 on the suture 300 connects the first support body 100 and the second support body 200 together, and the clamping space between the first support body 100 and the second support body 200 is adjustable. First, the first support body and the second support body are respectively placed on both sides of the atrial septum; then, the positions of the first support body 100 and the second support body 200 relative to the un-closed atrial hole on the atrial septum 400 are adjusted, so that the first support body 100 and the second support body 200 accurately correspond to the un-closed atrial hole; finally, by pulling the proximal end of the suture 300 to move relative to the lock 320 to tighten and fix the fixed loop 310 at the distal end of the first support body 100 and the second support body 200, the operation is completed.

[0064] Specifically, the distal end of the suture 300 is sequentially threaded through the second threading hole 211, the first threading hole 111 and re-threaded through the second threading hole 211 to form a fixed wire loop 310, and the distal end of the suture 300 is re-threaded through the second threading hole 211 to form a lock knot 320. In this embodiment, the distal end of the suture 300 is sequentially threaded through the second threading hole 211, the first threading hole 111 and re-threaded through the second threading hole 211, when the proximal end of the suture 300 is pulled back to move the distal end of the suture 300 relative to the lock knot 320, the lock knot 320 can be fixed to the end of the second connecting portion 210, thereby avoiding the lock knot 320 from being offset, preventing the lock knot 320 from contacting or entering the second threading hole 211. If the lock knot 320 contacts or enters the second threading hole 211, it may cause the lock knot 320 to be stuck in the second threading hole 211, thereby causing the distal end of the suture 300 to move relative to the lock knot 320 to be not smooth, and in severe cases, it may cause the first support body 100 and the second support body 200 to be not firmly fixed. In this embodiment, the lock knot 320 is fixed to the end of the second connecting portion 210, i.e. the lock knot 320 is fixed to the hollow position of the second connecting portion 210, thereby avoiding the lock knot 320 from contacting the second connecting portion 210, when the suture 300 is pulled back to move the suture 300 relative to the lock knot 320, because the lock knot 320 does not contact the second connecting portion 210, the distal end of the suture 300 can move relative to the lock knot 320 smoothly, which can effectively avoid the force of pulling back the suture 300 to be too large to cause other accidental risks, and after the operation, the lock knot 320 does not contact the second connecting portion 210, which can avoid the lock knot 320 from being loosened due to the extrusion and friction of the second connecting portion 210, so that the suture 300 can firmly fix the first support body 100 and the second support body 200.

[0065] In this embodiment, with reference to Figures 4 to 6As shown, the device for closing tissue further comprises a catheter and a delivery guide wire 510 (not shown in the figure), the delivery guide wire 510 is detachably connected with the second support body 200, and the delivery guide wire 510 can drive the second support body 200 and the first support body 100 to move in the catheter. In this embodiment, the catheter is arranged to ascend along the femoral vein, the inferior vena cava, the right atrium, and then through the unsealed atrial hole of the atrial septum to the left atrium, and the delivery guide wire 510, the first support body 100 and the second support body 200 are arranged in the catheter. The second connecting part 210 is pushed by the delivery guide wire 510 to drive the first support body 100 and the second support body 200 to move in the catheter. After the first support body 100 is separated from the catheter and reaches the left atrium, the first free end of the first support rod 120 of the first support body 100 is unfolded. The catheter is withdrawn to the right atrium, and the second connecting part 210 is pushed by the delivery guide wire 510. After the second support body 200 is separated from the catheter and enters the right atrium, the second free end of the second support rod 220 of the second support body 200 is unfolded. The delivery guide wire 510 is disconnected from the second connecting part 210. The suture 300 is pulled back to tighten and fix the first support body 100 and the second support body 200. The surgical process is simple and convenient. In addition, pulling the delivery guide wire 510 can adjust the position of the first support body 100 and the second support body 200 relative to the atrial septum 400, so that the first support body 100 and the second support body 200 accurately correspond to the unsealed atrial hole.

[0066] Specifically, the first support body 100 has an expanded state and a compressed state. In the expanded state, the first connecting end of the first support rod 120 is connected with the distal end of the first connecting part 110 and extends towards the proximal end of the first connecting part 110. The first support rod 120 extends along the direction from the distal end to the proximal end of the first connecting part 110, and bends towards the proximal end of the first connecting part 110 near the proximal end of the first connecting part 110. The bending angle is Figure 2The angle 'a' in the diagram is greater than or equal to 90 degrees and less than 180 degrees, for example, it can be 90 degrees, 100 degrees, 110 degrees, 115 degrees, 120 degrees, 130 degrees, 150 degrees, 170 degrees, etc. During delivery, the first free end of the first support rod 120 can be bent towards the proximal end of the first connecting part 110 and placed inside the catheter. At this time, the first support body 100 is in a compressed state, facilitating its placement inside the catheter for delivery to the target tissue. Furthermore, as the first support body 100 detaches from the catheter and reaches the left atrium, the first free end of the first support rod 120 will not contact the interatrial septum 400, facilitating surgical operation and ensuring surgical safety. In addition, the first free end of the first support rod 120 will not interfere with the second support body 200 inside the catheter, thus avoiding the first support body 100 and the second support body 200 from getting stuck inside the catheter due to interference when the guide wire 510 pushes them, and also avoiding the situation where the first support body 100 is difficult to separate from the second support body 200 when it leaves the catheter.

[0067] Furthermore, the second support 200 has an extended state and a compressed state. In the extended state, the second connecting end of the second support rod 220 is connected to the distal end of the second connecting portion 210, the second support rod 220 extends in a direction away from the second connecting portion 210, and the second free end of the second support rod 220 bends toward the distal end of the second connecting portion 210 at a bending angle of [value missing]. Figure 2 The angle b in the figure is greater than or equal to 90 degrees and less than 180 degrees, for example, it can be 90 degrees, 100 degrees, 110 degrees, 115 degrees, 120 degrees, 130 degrees, 150 degrees, 170 degrees, etc. During delivery, the second free end of the second support rod 220 can be bent toward the distal end of the second connecting part 210 and placed inside the catheter. Here, the second support body 200 is in a compressed state, facilitating its placement inside the catheter for delivery to the target tissue. Furthermore, when the second support body 200 detaches from the catheter and enters the right atrium, the second free end of the second support rod 220 will not contact the interatrial septum 400, facilitating surgical operation and ensuring surgical safety. In addition, the second free end of the second support rod 220 will not interfere with the first support 100 inside the catheter, which more effectively avoids the guide wire 510 from getting stuck inside the catheter due to interference when pushing the first support 100 and the second support 200, and also more effectively avoids the situation where the first support 100 is difficult to separate from the second support 200 when it leaves the catheter.

[0068] Preferably, the delivery guidewire 510 can be a flexible medical guidewire, which facilitates the delivery of the guidewire 510 into the catheter to push the first support 100 and the second support 200.

[0069] Specifically, continue to refer to Figure 6As shown, one end of the delivery guide wire 510 is threadedly connected with the second connecting part 210. Specifically, the proximal end of the second connecting part 210 is provided with a connecting hole 212, which is internally threaded, and the distal end of the delivery guide wire 510 is provided with external threads that match the internal threads of the connecting hole 212, facilitating the disassembly and assembly of the delivery guide wire 510 and the second connecting part 210.

[0070] In this embodiment, the device for closing tissue further comprises a connecting member 520, which is provided with a first through hole 521, and the distal end of the delivery guide wire 510 is threadedly connected with the second support 200 after passing through the first through hole 521, and the delivery guide wire 510 is slidably connected with the first through hole 521. Figures 7 to 10

[0071] Further, the connecting member 520 is further provided with a second through hole 522 and a third through hole 523, and the device for closing tissue further comprises a first push wire tube 530 and a second push wire tube 540, the first push wire tube 530 is arranged in the second through hole 522 and is detachably connected with the connecting member 520, and the second push wire tube 540 is arranged in the third through hole 523 and is detachably connected with the connecting member 520, the suture 300 is arranged in the first push wire tube 530 and the second push wire tube 540, and the two free ends of the suture 300 pass through the proximal ends of the first push wire tube 530 and the second push wire tube 540, respectively.

[0072] Further, the locking knot 320 is arranged on the first side of the connecting member 520, and the first push wire tube 530 and the second push wire tube 540 are arranged on the second side of the connecting member 520, which is the opposite side of the first side of the connecting member 520. In this embodiment, the first side of the connecting member 520 is the distal end side, and the second side is the proximal end side.

[0073] Further, the inner diameter of the through hole 521 of the connecting member 520 is equal to or slightly larger than the outer diameter of the delivery guide wire 510, and the fit between the through hole 521 and the delivery guide wire 510 can be a shaft hole gap fit.

[0074] Further, the length of the internal threads in the connecting hole 212 is less than the length of the external threads of the delivery guide wire 510, and when the one end of the delivery guide wire 510 is arranged in the through hole 521 and connected with the second support 200, the external threads of the delivery guide wire 510 are exposed at the end of the connecting member 520 that faces the second support 200, and the surgeon can observe the external threads of the delivery guide wire 510 to determine whether the second support 200 has been completely pushed out of the catheter by the delivery guide wire 510, so as to prevent the delivery guide wire 510 from being excessively exposed in the right atrium and affecting the operation.

[0075] ​Further, the first push wire tube 530 is detachably connected with the connecting piece 520, and the second push wire tube 540 is detachably connected with the connecting piece 520, which is convenient for preparation in the process and effectively saves the process cost when making corresponding size adjustment.

[0076] Further, continuing to refer to Figures 8 to 9 As shown, the first push wire tube 530 is threadedly connected with the connecting piece 520. The connecting piece 520 is provided with a second through hole 522, and the second through hole 522 is provided with an internal thread. One end of the first push wire tube 530 is provided with an external thread matched with the internal thread of the second through hole 522, which is convenient for disassembly and assembly between the first push wire tube 530 and the connecting piece 520. Specifically, the first push wire tube 530 is provided with a first through hole 531, and one free end of the suture 300 can extend out of the first through hole 531.

[0077] Further, continuing to refer to Figures 8 to 9 As shown, the second push wire tube 540 is threadedly connected with the connecting piece 520. Specifically, the connecting piece 520 is provided with a third through hole 523, and the third through hole 523 is provided with an internal thread. One end of the second push wire tube 540 is provided with an external thread matched with the internal thread of the third through hole 523, which is convenient for disassembly and assembly between the second push wire tube 540 and the connecting piece 520. Specifically, the second push wire tube 540 is provided with a second through hole 541, and the other free end of the suture 300 can extend out of the second through hole 541.

[0078] In this embodiment, after the connected delivery guide wire 510, the connecting piece 520, the first push wire tube 530 and the second push wire tube 540, the first support body 100 and the second support body 200 are placed in the catheter, the delivery guide wire 510, the first push wire tube 530 and the second push wire tube 540 are pushed together, the connecting piece 520, the first support body 100 and the second support body 200 are moved along the catheter, when the first support body 100 reaches the end of the catheter located in the left atrium, the surgeon keeps the first push wire tube 530 and the second push wire tube 540 still, and pushes the first support body 100 out of the catheter to the left atrium through the delivery guide wire 510 and then unfolds it; similarly, after the catheter is withdrawn to the right atrium, the second support body 200 is also pushed out of the catheter to the right atrium through the delivery guide wire 510 and then unfolds it. The cooperation of the delivery guide wire 510, the connecting piece 520, the first push wire tube 530 and the second push wire tube 540 facilitates the pushing of the first support body 100 and the second support body 200. In addition, the connecting piece 520 can be used as a support to assist the delivery guide wire 510 in adjusting the position of the first support body 100 and the second support body 200 relative to the atrial septum 400 during the process of pulling the delivery guide wire 510 to adjust the position of the first support body 100 and the second support body 200 relative to the atrial septum 400, which facilitates the accurate correspondence of the first support body 100 and the second support body 200 with the unsealed atrial hole on the atrial septum.

[0079] Further, continuing to refer to Figure 10 to facilitate the surgeon to distinguish the two free ends of the suture 300, the surgeon pulls the proximal end of the suture 300 on the proximal side of the second push wire tube 540 to tighten and fix the first support body 100 and the second support body 200, which can effectively prevent the suture 300 from being entangled with the guide wire and affecting the operation. In addition, the cooperation of the connector 520, the first push wire tube 530 and the second push wire tube 540 can adjust the position of the lock knot 320 relative to the second connecting part 210, effectively avoiding the offset of the lock knot 320.

[0080] In this embodiment, the device for closing the tissue further comprises a line cutter (not shown in the figure) for cutting the suture 300. Specifically, the line cutter can adopt existing line cutter technology, which will not be described in detail here.

[0081] The use method of the above-mentioned device for closing the tissue, referring to Figure 11 as shown, comprises the following steps:

[0082] S100, respectively placing the first support body 100 and the second support body 200 on both sides of the atrial septum 400;

[0083] S200, adjusting the relative position of the first support body 100 and the second support body 200;

[0084] S300, fixing the first support body 100 and the second support body 200 by the suture 300.

[0085] In this embodiment, the clamping space between the first support body 100 and the second support body 200 is adjustable, the relative position of the first support body 100 and the second support body 200 is adjusted, the first support body 100 is accurately corresponded to the oval hole of the atrial septum 400, which effectively prevents blood from flowing from the left atrium into the right atrium and prevents the generation of intracardiac shunt.

[0086] Figure 12 is a detailed step flow chart of the use method of the device for closing the tissue provided in this embodiment, according to Figure 12 the use method of the device for closing the tissue is described in detail.

[0087] The use method of the device for closing the tissue comprises the following steps:

[0088] Step one, the first push wire tube 530, the second push wire tube 540, the guide wire, the connecting piece 520, the first support body 100, the second support body 200 and the suture 300 are assembled into an integrated assembly.

[0089] Specifically, step one specifically includes the following steps:

[0090] S110, the first push wire tube 530 is screwed with the second through hole 522 of the connecting piece 520, and a free end of the suture 300 is extended from the first push wire tube 530.

[0091] S120, the second push wire tube 540 is screwed with the third through hole 523 of the connecting piece 520, and the other free end of the suture 300 is extended from the second push wire tube 540.

[0092] S130, the end of the guide wire provided with external threads is arranged in the through hole 521 of the connecting piece 520 and is screwed with the second connecting part 210 of the second support body 200.

[0093] In this embodiment, the step S110, the step S120 and the step S130 are not in sequence.

[0094] Step two, the catheter is arranged along the femoral vein, the inferior vena cava to the right atrium and then through the oval foramen to the left atrium.

[0095] Specifically, during the operation, the skin around the right femoral vein is first anesthetized, the guide wire is inserted into the sleeve after the sleeve is inserted into the right femoral vein, and then the guide wire is arranged along the femoral vein, the inferior vena cava to the right atrium and then through the oval foramen to the left atrium (the guide wire is not shown in the figure, and the whole process needs to be completed under the guidance of an X-ray imaging instrument), the catheter is inserted along the guide wire, the contrast agent is injected after the catheter reaches the right atrium to confirm the position of the oval foramen, and the guide wire is withdrawn after the catheter passes through the oval foramen.

[0096] Step three, the assembled integrated assembly is arranged in the catheter, and the first support body 100 and the second support body 200 are arranged on the two sides of the atrial septum 400 respectively.

[0097] Specifically, step three specifically includes the following steps:

[0098] S310, the delivery guide wire 510, the first push wire tube 530 and the second push wire tube 540 are pushed together, the connecting piece 520, the first support body 100 and the second support body 200 are moved along the catheter, and the first support body 100 reaches the end of the catheter in the left atrium.

[0099] S320, the first push wire tube 530 and the second push wire tube 540 are kept stationary, and the first support body 100 is pushed out of the catheter to the left atrium and then unfolded through the delivery guide wire 510.

[0100] S330, the catheter is withdrawn back to the right atrium.

[0101] Specifically, the delivery guide wire 510, the first push wire tube 530, the second push wire tube 540 and the catheter are pulled back together, so that the second support body 200 is kept in the catheter.

[0102] S340, the delivery guide wire 510 is pulled to adjust the position of the first support body 100, so that the first support body 100 is accurately positioned corresponding to the oval foramen of the interatrial septum 400.

[0103] S350, the first push wire tube 530 and the second push wire tube 540 are kept still, and the second support body 200 is pushed out of the catheter to the right atrium by the delivery guide wire 510 and then is unfolded.

[0104] Step four, the first support body 100 and the second support body 200 are fixed.

[0105] Step four specifically includes the following steps:

[0106] S410, the delivery guide wire 510 is pulled to adjust the position of the second support body 200, so that the second support body 200 is accurately positioned corresponding to the oval foramen of the interatrial septum 400.

[0107] S420, the delivery guide wire 510 is rotated to be separated from the second connecting part 210 of the second support body 200 and is withdrawn from the catheter.

[0108] S430, the suture 300 is pulled back to tighten the fixing wire ring 310 and fix the first support body 100 and the second support body 200.

[0109] Step five, the suture 300 is cut short.

[0110] Specifically, step five specifically includes the following steps:

[0111] S510, the first push wire tube 530, the second push wire tube 540, the connecting part 520 and the catheter are withdrawn from the body together.

[0112] S520, the tail of the suture 300 is placed in the slot of the suture cutter outside the body, the suture 300 is pulled tight, and the suture cutter is pushed along the femoral vein to the right atrium to cut the suture 300 short.

[0113] S530, the suture cutter is withdrawn.

[0114] In the embodiment, the whole operation of the surgery is simple, and the first support body 100 and the second support body 200 can be accurately pressed on both sides of the oval foramen, effectively preventing the generation of atrial blood shunt, and the metal content is less, effectively reducing the risk of complications.

[0115] Obviously, the above embodiments of the present application are merely exemplary but not intended to limit the embodiments of the present application. Various obvious changes, re-adjustments and substitutions can be made by those skilled in the art without departing from the scope of the present application. It is not necessary or possible to enumerate all the embodiments. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the claims of the present application.

Claims

1. A device for closing tissue, characterized in that, Includes a plugging device, the plugging device comprising: A first support body (100) includes a first connecting portion (110) and a plurality of first support rods (120) spaced circumferentially along the first connecting portion (110). Each first support rod (120) has a first connecting end and a first free end disposed opposite to the first connecting end. The first connecting end of each first support rod (120) is connected to the first connecting portion (110). The second support body (200) is disposed opposite to the first support body (100). The second support body (200) includes a second connecting part (210) and a plurality of second support rods (220) disposed circumferentially spaced along the second connecting part (210). Each second support rod (220) has a second connecting end and a second free end disposed opposite to the second connecting end. The second connecting end of each second support rod (220) is connected to the second connecting part (210). A suture (300) is provided through the first connecting part (110) and the second connecting part (210), and the suture (300) is used to connect the first support (100) and the second support (200). The first connecting part (110) is provided with a first thread hole (111), and the second connecting part (210) is provided with a second thread hole (211). The suture (300) passes through the first thread hole (111) and the second thread hole (211). The suture (300) has a first end and a second end opposite to the first end. The second end of the suture (300) forms a fixing loop (310). The fixing loop (310) passes through the first thread hole (111) and the second thread hole (211). The fixing loop (310) is configured to allow the clamping space between the first support (100) and the second support (200) to be adjustable. When the first end of the suture (300) is pulled, the fixing loop (310) tightens and fixes the first support (100) and the second support (200). A flow-blocking membrane is wrapped between a plurality of the first support rods (120), and / or a flow-blocking membrane is wrapped between a plurality of the second support rods (220).

2. The device for closing tissue according to claim 1, characterized in that, The device further includes: catheter; The delivery guide wire (510) is detachably connected to the second support body (200), and the delivery guide wire (510) can drive the second support body (200) and the first support body (100) to move within the catheter.

3. The device for closing tissue according to claim 2, characterized in that, The device also includes a connector (520), which has a first through hole (521). The distal end of the conveying guide wire (510) passes through the first through hole (521) and is detachably connected to the second support body (200). The conveying guide wire (510) is slidably connected to the first through hole (521).

4. The device for closing tissue according to claim 3, characterized in that, The connector (520) also has a second through hole (522) and a third through hole (523); and, The device further includes: The first push-suture tube (530) passes through the second through hole (522) and is detachably connected to the connector (520), and the suture (300) passes through the first push-suture tube (530); The second push tube (540) passes through the third through hole (523) and is detachably connected to the connector (520). The suture (300) passes through the second push tube (540).

5. The device for closing tissue according to claim 2, characterized in that, The first free end of the first support rod (120) can be bent toward the proximal end of the first connecting part (110) and placed inside the conduit; and / or the second free end of the second support rod (220) can be bent toward the distal end of the second connecting part (210) and placed inside the conduit.

6. The device for closing tissue according to claim 1, characterized in that, The first connecting end of the first support rod (120) is connected to the distal end of the first connecting portion (110). In the extended state, the first support rod (120) extends from the distal end to the proximal end of the first connecting portion (110) and bends toward the proximal end of the first connecting portion (110) near the proximal end of the first connecting portion (110). The bending angle is greater than or equal to 90 degrees and less than 180 degrees.

7. The device for closing tissue according to claim 1, characterized in that, The second connecting end of the second support rod (220) is connected to the far end of the second connecting part (210). In the extended state, the second free end of the second support rod (220) is bent toward the far end of the second connecting part (210) at an angle greater than or equal to 90 degrees and less than 180 degrees.

8. The device for closing tissue according to claim 1, characterized in that, The number of the first support rod (120) and the second support rod (220) is 3-6.

9. The device for closing tissue according to claim 1, characterized in that, The device also includes a suture cutter for cutting the suture (300).

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