Heart diaphragm patent foramen ovale stitching instrument and stitching system

Abstract

The invention discloses a heart diaphragm patent foramen ovale suturing instrument and suturing system, comprising an outer tube in which a suture, a stent assembly and a puncture assembly are arranged in a penetrating manner; the suture is provided with a first section, a second section and a third section, a pre-tightening knot is arranged between the first section and the second section, and a plugging section is arranged between the second section and the third section; the support assembly comprises a control rod and a bearing arm, the bearing arm is driven by the control rod to extend out of the far end opening of the outer pipe and then extends in the first direction, and the far end of the bearing arm is detachably connected with an anchoring base connected with the third subsection. The puncture assembly comprises a puncture guide wire, and the far end of the puncture guide wire can stretch out of the far end opening of the outer tube and then is bent to form an arc-shaped needle. An anchoring buckle is arranged at the far end of the puncture guide wire and can be connected with the anchoring base in a matched mode. According to the invention, few or no implants exist, a tunnel with an unclosed foramen ovale is not twisted, the contact area at a suture plugging point can be increased, and a better suture plugging treatment effect is achieved.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a cardiac septum patent foramen ovale suture device and a suture system. Background Art

[0002] A patent foramen ovale (PFO) is a flap-like opening between the atrial septum primum (SP) and the atrial septum secundum (SS) at the location of the fossa ovale that continues to develop within the first year and a half of life. In utero, the foramen ovale serves as a physiological conduit for right-to-left shunting of blood within the fetal heart. After birth, as pulmonary circulation is established, increased left atrial blood flow and pressure press the atrial septum primum (SP) against the wall of the atrial septum secundum (SS), covering the foramen ovale and resulting in functional closure of the foramen ovale. Following this closure, anatomical closure of the foramen ovale usually occurs as the atrial septum primum (SP) fuses to the atrial septum secundum (SS).

[0003] When anatomical closure of the foramen ovale does not occur, a patent foramen ovale (PFO) is caused. A patent foramen ovale is a persistent, usually flap-like opening between the atrial septum primum (SP) and the atrial septum secundum (SS) of the heart. Patent foramen ovale occurs when the atrial septum primum (SP) partially fuses to or does not fuse to the atrial septum secundum (SS). In the case of partial fusion or non-fusion, a persistent channel (PFO path) exists between the atrial septum primum (SP) and the atrial septum secundum (SS). This opening or channel is parallel to the plane of the atrial septum primum and has a mouth that is generally in the shape of the foramen ovale. Generally, the opening is relatively long, but quite narrow. The opening can remain closed due to the average pressure in the left atrium (LA) being higher than that in the right atrium (RA). In this way, the atrial septum primum (SP) acts as a one-way valve, thereby preventing fluid communication between the right atrium and the left atrium through the PFO path. However, sometimes the pressure in the right atrium may be temporarily higher, thereby causing the PFO path to open to allow a small amount of blood to pass from the right atrium to the left atrium. While the PFO path is generally kept closed, the endothelialized surface of the tissue forming the PFO path prevents the tissue from healing together and permanently closing the PFO path.

[0004] Studies have shown that a relatively large percentage of adults have a patent foramen ovale (PFO). It is believed that embolism through a PFO may be the cause of a considerable number of ischemic strokes, particularly in relatively young patients. It is estimated that in 50% of hidden strokes, a PFO is present. A blood clot that forms in the venous circulation (e.g., in the legs) may embolize and may enter the arterial circulation through a PFO and subsequently into the cerebral circulation, resulting in an embolic stroke. A blood clot may also form near a PFO and embolize into the arterial circulation and into the cerebral circulation. Patients with a PFO who have a hidden stroke or transient ischemic attack (TIA) should consider receiving medical treatment to reduce the risk of recurrence of an embolic event.

[0005] Medical treatment usually includes oral anticoagulants or antiplatelets. These therapies may cause certain side effects, such as bleeding. If medical treatment is not appropriate, surgery can be performed to close the PFO with sutures. Similar to other open surgical treatments, this surgery is horizontally invasive, risky, requires general anesthesia, and may result in a long recovery.

[0006] The PFO can be closed non-surgically using umbrella-like devices developed for percutaneous closure of atrial septal defects (ASDs) where there is no well-formed septum primum (SP). However, many of these conventional devices for ASDs are technically complex, bulky, and difficult to deploy in a precise location. In addition, such devices may be difficult or impossible to retract and / or reposition if initial positioning is unsatisfactory. Furthermore, these devices are specifically designed for use with ASDs and therefore may not be suitable for closing and sealing PFOs, particularly because the septum primum (SP) overlaps the septum secundum (SS).

[0007] Currently, there are occluders designed specifically for patent foramen ovale on the market. Most of the existing devices for treating patent foramen ovale are traditional double-disc occluders. The above occluders are usually large in size and are generally made of nickel-titanium. They may increase the risk of complications in the short and long term. In addition, the waist of the traditional double-disc structure will distort the tunnel of the patent foramen ovale, causing thicker tissue hyperplasia and affecting subsequent re-puncture treatment. Summary of the invention

[0008] In order to overcome the shortcomings of the prior art, the present invention provides a cardiac septum patent foramen ovale suture device and suture system, which has fewer or no implants, will not distort the patent foramen ovale tunnel, can increase the contact area at the suture occlusion point, and achieve better suture occlusion treatment effect.

[0009] The first aspect of the present invention is to provide a cardiac septum patent foramen ovale suture device, comprising an outer tube, wherein a suture, a stent assembly and a puncture assembly are inserted into the outer tube;

[0010] The suture has a first segment, a second segment and a third segment. A pre-tightening knot is provided between the first segment and the second segment. A pre-tightening channel is provided in the pre-tightening knot. The pre-tightening channel can be tightened under the pulling of the suture. A blocking segment is provided between the second segment and the third segment. The blocking segment can expand radially.

[0011] The support assembly includes a control rod, a receiving arm is connected to the distal end of the control rod, and the receiving arm can be extended from the distal end of the outer tube under the drive of the control rod; the receiving arm extends in a first direction after losing the constraint of the outer tube, and the first direction forms an angle with the axis of the outer tube; the distal end of the receiving arm is detachably connected to an anchoring base, and the anchoring base is connected to the third segment of the suture;

[0012] The puncture assembly includes a puncture guide wire, the distal end of which passes through the pre-tightening channel and can slide relative to the pre-tightening knot, and the distal end of the puncture guide wire can extend from the distal end of the outer tube; after the distal end of the puncture guide wire loses the constraint of the outer tube, it bends to form an arc-shaped needle head, and the arc-shaped needle head is used to puncture heart tissue; the distal end of the puncture guide wire is provided with an anchoring buckle, and the anchoring buckle passes through the heart tissue under the guidance of the arc-shaped needle head and is connected with the anchoring base.

[0013] In the first aspect of the present invention, as a preferred embodiment, a limiting guide block is provided at the distal end of the outer tube; the outer side of the limiting guide block is fixed to the inner wall of the outer tube, and the limiting guide block is formed with a control rod accommodating cavity, a puncture guide wire accommodating cavity, and a first suture accommodating cavity along the axial direction; the control rod accommodating cavity is used for allowing the control rod to pass through, and the control rod can move axially relative to the limiting guide block; the puncture guide wire accommodating cavity is used for allowing the puncture guide wire to pass through, and the puncture guide wire can move axially relative to the limiting guide block; the first suture accommodating cavity is used for allowing the first segment of the suture to pass through.

[0014] In the first aspect of the present invention, as a preferred embodiment, the inner wall of the control rod accommodating cavity is formed with a first limiting surface, and the circumferential surface of the control rod is formed with a second limiting surface, and the first limiting surface cooperates with the second limiting surface to limit the rotation of the control rod in the control rod accommodating cavity;

[0015] A third limiting surface is formed on the inner wall of the puncture guidewire accommodating cavity, and a fourth limiting surface is formed on the circumferential surface of the puncture guidewire. The third limiting surface cooperates with the fourth limiting surface to limit the rotation of the puncture guidewire in the puncture guidewire accommodating cavity.

[0016] In the first aspect of the present invention, as a preferred embodiment, a second suture accommodating cavity is formed on the limiting guide block; the second suture accommodating cavity is used to accommodate the second segment of the suture.

[0017] In the first aspect of the present invention, as a preferred embodiment, the receiving arm is made of memory metal, and after the receiving arm is freed from the constraint of the outer tube, it returns to the memory shape and tilts to one side; a supporting portion is formed on the side of the receiving arm, and the supporting portion is used to resist the position of the oval fossa;

[0018] The two ends of the receiving arm are respectively formed with a connecting end and a receiving end; the connecting end is used to be connected to the control rod, and the receiving end is provided with a buckle groove, and the buckle groove is used to be buckled with the anchor base;

[0019] The receiving arm is provided with a receiving groove, which is used to receive the blocking section of the suture and provide radial restraint force for the blocking section.

[0020] In the first aspect of the present invention, as a preferred embodiment, the blocking segment is a woven mesh structure, which is made of a plurality of strands of degradable polymer filaments. The filaments are woven into a mesh tube and then heat-formed into a flat block. The wires at both ends are twisted into cables and respectively connected to the second segment and the third segment of the suture.

[0021] In the first aspect of the present invention, as a preferred embodiment, the blocking section is a cutting grid structure, and the cutting grid structure is made of a degradable material; a plurality of diamond-shaped or elliptical holes are arranged in an array inside the cutting grid structure; and a layer of blocking film is fixed on the surface of the cutting grid structure.

[0022] In the first aspect of the present invention, as a preferred embodiment, the end of the anchoring base forms a fixed end, and the fixed end is used to be fixedly connected to the third segment of the suture; the outer side of the anchoring base has a clamping portion, and the clamping portion is clamped in the buckle groove; the inside of the anchoring base forms a through hole for the arc-shaped needle to pass through, and a limiting groove is formed in the through hole;

[0023] A fixing hole is provided inside the anchor buckle, and the fixing hole allows the puncture guide wire to pass through, and the anchor buckle is sleeved on the distal end of the puncture guide wire through the fixing hole;

[0024] A guide portion is formed at the end of the anchoring buckle, and a plurality of first cards are connected to the edge of the guide portion. The first cards have elastic force, and the first cards can shrink or expand in the radial direction; the anchoring buckle is driven to penetrate the anchoring base by the arc-shaped needle head, and the first card radially shrinks and penetrates the through hole under the guidance of the guide portion, and the first card radially expands in the limiting groove to realize the connection between the anchoring buckle and the anchoring base.

[0025] In the first aspect of the present invention, as a preferred embodiment, the number of the stent assembly, the puncture assembly and the suture are all 2;

[0026] After losing the constraint of the outer tube, the connecting arms of the two bracket assemblies extend in a first direction and a second direction respectively, and the first direction is arranged opposite to the second direction;

[0027] A limiting guide block is provided at the distal end of the outer tube, a first limiting guide portion is formed on the outer side of the limiting guide block, and a second limiting guide portion is formed on the inner side; the outer side of the first limiting guide portion is fixed to the inner wall of the outer tube;

[0028] A limiting guide groove is formed between the first limiting guide part and the second limiting guide part, and a support control tube is slidably connected in the limiting guide groove, so that the support control tube can move relative to the limiting guide block in the axial direction; a fifth limiting surface is formed in the limiting guide groove, and a sixth limiting surface is formed on the support control tube, and the support control tube is limited to rotate in the limiting guide groove through the cooperation of the fifth limiting surface and the sixth limiting surface; the control rods of the two support assemblies are respectively fixed on the opposite sides of the support control tube;

[0029] Two puncture guide wire accommodating cavities and two first suture accommodating cavities are formed in the second limiting guide portion; the two puncture guide wire accommodating cavities are respectively used for allowing the puncture guide wires of the two puncture assemblies to pass through, and the two first suture accommodating cavities are respectively used for allowing the two sutures to pass through.

[0030] The second aspect of the present invention provides a suturing system, comprising the patent foramen ovale suture device for the cardiac septum as described in any one of the first aspect of the present invention; and also comprising a regulating handle, the regulating handle and a wire cutting assembly; the regulating handle is installed at the proximal end of the outer tube, and is used to drive the control rod and the puncture guide wire to move axially relative to the outer tube; the wire cutting assembly is arranged at the distal end of the outer tube, and is used to cut the suture.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] The suture device and suture system for the patent foramen ovale of the heart septum of the present invention do not require implantation of an instrument for occlusion, and can effectively avoid complications caused by implantation of the occluder. In addition, the PFO tunnel will not be distorted, and excessive endothelialization can be prevented from affecting subsequent re-puncture treatment. By providing an occluding segment on the suture, the contact area at the suture is increased, and the suture closure effect of the foramen ovale is better. The effect of the asymmetric elliptical start-stop limiter is utilized, and the relative position of the arc needle and the receiving arm is pre-positioned in combination with the arc needle of shape memory alloy material, so as to achieve positioning during the puncture process, greatly improving the alignment rate of the anchor buckle and the anchor base, ensuring the success rate of hooking the line, and the operation is simple, convenient and fast. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a schematic structural diagram of the cardiac septum patent foramen ovale suture device of Example 1;

[0034] Figure 2 It is a structural schematic diagram of the cardiac septum patent foramen ovale suture device of Example 1 in a state where the receiving arm is extended;

[0035] Figure 3 It is a schematic structural diagram of the puncture guide wire of the cardiac septum patent foramen ovale suture device of Example 1 when the puncture guide wire is extended;

[0036] Figure 4 This is a schematic diagram of the structure of the suture of the cardiac septum patent foramen ovale suture device of Example 1;

[0037] Figure 5 It is a structural schematic diagram of the receiving arm of the cardiac septum patent foramen ovale suture device of Example 1;

[0038] Figure 6 It is a structural schematic diagram of the receiving arm of the cardiac septum patent foramen ovale suture device of Example 1 at another angle;

[0039] Figure 7 It is a structural schematic diagram of the memory state of the receiving arm of the cardiac septum patent foramen ovale suture device of Example 1;

[0040] Figure 8 This is a schematic diagram of the internal structure of the cardiac septum patent foramen ovale suture device of Example 1;

[0041] Fig. 9 It is an enlarged cross-sectional view of section AA of the cardiac septum patent foramen ovale suture device of Example 1;

[0042] Fig.10 It is a cross-sectional schematic diagram of the limiting guide block of the cardiac septum patent foramen ovale suture device of Example 1;

[0043] Fig.11 This is a schematic structural diagram of an anchor buckle of a suture device for patent foramen ovale of a cardiac septum according to Example 1;

[0044] Fig.12 This is a schematic structural diagram of an anchoring base of a suture device for patent foramen ovale of a cardiac septum according to Example 1;

[0045] Fig.13 This is a schematic diagram of the cardiac septum patent foramen ovale suture device in use according to Example 1;

[0046] Fig.14 This is a schematic diagram of another use state of the cardiac septum patent foramen ovale suture device of Example 1;

[0047] Fig.15 This is a schematic diagram of the cardiac septum patent foramen ovale suture device of Example 1 after use;

[0048] Fig.16It is a schematic structural diagram of a cardiac septum patent foramen ovale suture device according to Example 2;

[0049] Fig.17 It is a structural schematic diagram of the cardiac septum patent foramen ovale suture device of Example 2 in a state where the receiving arm is extended;

[0050] Fig.18 It is an enlarged cross-sectional view of section BB of the cardiac septum patent foramen ovale suture device of Example 2;

[0051] Fig.19 This is a schematic diagram of the cardiac septum patent foramen ovale suture device in use according to Example 2;

[0052] Fig. 20 This is a schematic diagram of another use state of the cardiac septum patent foramen ovale suture device of Example 2;

[0053] Fig.21 This is a schematic diagram of the cardiac septum patent foramen ovale suture device of Example 2 after use;

[0054] Fig. 22 It is a schematic structural diagram of a cardiac septum patent foramen ovale suture device according to Example 4;

[0055] Fig.23 It is a schematic diagram of the connection relationship between the anchoring base and the anchoring buckle of the cardiac septum patent foramen ovale suture device of Example 4;

[0056] Fig.24 It is a structural schematic diagram of an anchoring base of a suture device for patent foramen ovale of a heart septum according to Example 4;

[0057] Fig.25 This is a schematic diagram of the connection relationship between the suture and the anchoring base of the cardiac septum patent foramen ovale suture device of Example 4.

[0058] In the figure: 10, suture; 11, first segment; 12, second segment; 13, third segment; 14, pre-tightening knot; 15, blocking segment; 20, bracket assembly; 21, receiving arm; 211, connecting end; 212, receiving end; 213, abutting portion; 214, receiving groove; 215, buckle groove; 22, anchoring base; 221, fixed end; 222, snap-fitting portion; 223, through hole; 224, limiting groove; 225, fixed portion; 226, second card; 23, control rod; 24 , stent control tube; 30, puncture assembly; 31, puncture guide wire; 32, curved needle; 33, anchor buckle; 331, fixing hole; 332, guide part; 333, first card; 334, puncture end; 335, hook part; 40, limit guide block; 41, control rod accommodating chamber; 42, puncture guide wire accommodating chamber; 43, first suture accommodating chamber; 44, second suture accommodating chamber; 45, first limit guide part; 46, second limit guide part; 91, secondary septum; 92, primary septum. DETAILED DESCRIPTION

[0059] Below, in conjunction with the accompanying drawings and specific embodiments, the invention is further described. It should be noted that, under the premise of no conflict, the various embodiments described below or the various technical features can be arbitrarily combined to form a new embodiment. Except as otherwise specified, the materials and equipment used in this embodiment can be purchased from the market. Examples of the embodiments are shown in the accompanying drawings, in which the same or similar reference numerals throughout represent the same or similar elements or elements with the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application, and cannot be understood as limiting the present application.

[0060] In the description of the present application, it should be understood that the terms "upper", "lower", "front", "back", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as a limitation on the present application. In the description of the present application, "plurality" means two or more, unless otherwise precisely and specifically specified.

[0061] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "connected", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, or it can be connected through an intermediary medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0062] The terms "first", "second", etc. in the specification and claims of this application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0063] Embodiment 1:

[0064] Please refer to Figure 1-15 As shown, this embodiment provides a cardiac septum patent foramen ovale suture device, comprising an outer tube, and a suture 10, a support assembly 20 and a puncture assembly 30 that are inserted into the outer tube.

[0065] The outer tube of this embodiment has a proximal end and a distal end, the proximal end is the end closer to the operator when in use, and the distal end is the end farther from the operator when in use. The outer tube has a central axis, and the central axis is a line connecting the center of the distal end of the outer tube and the center of the proximal end of the outer tube in a natural state; the proximal end of the outer tube of this embodiment is used for installing a stress relief tube and a regulating handle, and the distal end is used for access.

[0066] The outer tube of this embodiment can be a slender tube made of stainless steel, nickel-titanium alloy, polymer tubing or composite materials. The distal end of the outer tube is formed with a hollow structure by laser engraving and other processes, so that it is soft in its natural state and can better conform to the blood vessels, so as to achieve high-precision use of the outer tube in the blood vessels. The outer tube is cut in stages according to the route and curvature of the access route, so that it has different hardness segments and better positioning. The outer diameter of the outer tube of this embodiment is preferably 2.64 to 3.96 mm, the inner diameter is preferably 2.4 to 3.7 mm, and the length is 1000 to 2000 mm. The outer tube can provide radial restraint force to the suture 10, the stent assembly 20 and the puncture assembly 30 in the tube.

[0067] The suture 10 of this embodiment is formed into a first segment 11, a second segment 12 and a third segment 13 in sequence from the proximal end to the distal end, a pre-tightening knot 14 is provided between the first segment 11 and the second segment 12, and a blocking segment 15 is provided between the second segment 12 and the third segment 13. Specifically, the pre-tightening knot 14 has a pre-tightening channel, and the pre-tightening channel can be used for the suture 10 at the distal end of the puncture assembly 30 and the third segment 13 to pass through. The pre-tightening channel can be tightened under the pulling of the sutures 10 at both ends, thereby fixing the suture 10 of the third segment 13 therein; optionally, the pre-tightening knot 14 of this embodiment is a fisherman's knot formed by the suture 10 at the distal end of the first segment 11 being wound around the distal end of the puncture assembly 30. The pre-tightening knot 14 can reduce the difficulty of the doctor's operation and improve the stability of the connection between the sutures 10. The occluding segment 15 of the present embodiment is contracted at the distal end of the stent assembly 20, and is slender when contracted, and can pass through the cardiac tissue driven by the suture 10 at the distal end of the puncture assembly 30 and the third segment 13; the occluding segment 15 can radially expand from a slender shape to a flat block after losing the radial restraint force, and is used to seal the heart tissue, increase the contact area between the suture 10 and the suture occlusion point, improve the stability between the suture and the heart tissue, and achieve a better suture occlusion treatment effect.

[0068] The support assembly 20 includes a control rod 23, which can be made of stainless steel, nickel-titanium alloy, cable and other materials. The cross section of the control rod 23 is an ellipse. The ratio of the long side to the short side of the ellipse can be 10:9 to 10:3. The distal end of the control rod 23 is connected to a receiving arm 21, which can move in the axial direction of the outer tube under the drive of the control rod 23, and extend or withdraw from the distal end of the outer tube;

[0069] After the receiving arm 21 extends from the distal end of the outer tube, it loses the radial restraint of the outer tube and extends in the first direction. The first direction forms an angle with the axis of the outer tube, that is, the receiving arm 21 bends toward the side of the outer tube after extending from the distal end of the outer tube. The distal end of the receiving arm 21 is detachably connected to an anchoring base 22, and the anchoring base 22 is connected to the third segment 13 of the suture 10; the initial state of the anchoring base 22 is to be clamped to the distal end of the receiving arm 21, and after being fixed with the anchoring buckle 33 disposed at the distal end of the puncture assembly 30, it is separated from the receiving arm 21, and the third segment 13 is driven to pass through the heart tissue in sections as the puncture assembly 30 is withdrawn.

[0070] The puncture assembly 30 of this embodiment includes a puncture guide wire 31, which is made of shape memory alloy. The cross section of the puncture guide wire 31 is elliptical, and the ratio of the long side to the short side of the ellipse can be 10:9 to 10:3. Through the heat setting process, the puncture guide wire 31 is bent in the direction where the ellipse is wider. The distal end of the puncture guide wire 31 passes through the pre-tightening channel and can slide relative to the pre-tightening knot 14. The distal end of the puncture guide wire 31 can extend from the distal end of the outer tube; after the distal end of the puncture guide wire 31 loses the constraint of the outer tube, it bends to form an arc needle 32, and the arc needle 32 is used to puncture cardiac tissue; specifically, the arc needle 32 of this embodiment is a round needle with a chord length of 3 to 20 mm (puncture width) and a 1 / 2 arc at the distal end of the puncture guide wire 31. An anchor buckle 33 is provided at the distal end of the puncture guide wire 31 . The anchor buckle 33 passes through the heart tissue under the guidance of the arc-shaped needle 32 and is connected with the anchor base 22 .

[0071] Furthermore, it also includes a limiting guide block 40. The limiting guide block 40 of this embodiment is arranged at the distal end of the outer tube, and is mainly used to support and guide the suture 10, the stent assembly 20 and the puncture assembly 30 in the outer tube, so as to avoid the suture 10, the stent assembly 20 and the puncture assembly 30 from interfering with each other and cross-knotting in the tube. The limiting guide block 40 can be made of polymer tubing or composite materials, such as acrylic, which has good supporting capacity. The outer side of the limiting guide block 40 is fixed to the inner wall of the outer tube by welding and bonding. The limiting guide block 40 of this embodiment is formed with three accommodating chambers along the axial direction, namely, the control rod accommodating chamber 41, the puncture guide wire accommodating chamber 42 and the first suture accommodating chamber 43.

[0072] The control rod accommodating cavity 41 is used for the control rod 23 to pass through, and the control rod 23 can move axially relative to the limiting guide block 40; further, a first limiting surface is formed on the inner wall of the control rod accommodating cavity 41, and a second limiting surface is formed on the circumferential surface of the control rod 23, and the first limiting surface cooperates with the second limiting surface to limit the rotation of the control rod 23 in the control rod accommodating cavity 41.

[0073] The puncture guidewire accommodating cavity 42 is used for the puncture guidewire 31 to pass through, and the puncture guidewire 31 can move axially relative to the limiting guide block 40; the inner wall of the puncture guidewire accommodating cavity 42 is formed with a third limiting surface, and the circumferential surface of the puncture guidewire 31 is formed with a fourth limiting surface, and the third limiting surface cooperates with the fourth limiting surface to limit the rotation of the puncture guidewire 31 in the puncture guidewire accommodating cavity 42.

[0074] The first limiting surface and the second limiting surface, the third limiting surface and the fourth limiting surface can be mutually adapted elliptical surfaces, or can be other anti-rotation surfaces, whose main purpose is to limit the rotation of the control rod 23 in the control rod accommodating cavity 41 and the puncture guide wire 31 in the puncture guide wire accommodating cavity 42.

[0075] The first suture accommodating cavity 43 is used for passing the first segment 11 of the suture 10. In this way, one end of the suture 10 is left at the proximal end of the outer tube and connected to the regulating handle.

[0076] Furthermore, a second suture accommodating cavity 44 is formed on the limiting guide block 40 ; the second suture accommodating cavity 44 is used to accommodate the second segment 12 of the suture 10 to prevent the suture 10 from being cross-knotted.

[0077] Specifically, the receiving arm 21 of this embodiment is made of memory metal, and the receiving arm 21 returns to the memory shape and tilts to one side after being freed from the constraint of the outer tube; a supporting portion 213 is formed on the side of the receiving arm 21, and the supporting portion 213 is used to support the position of the oval fossa;

[0078] The two ends of the receiving arm 21 are respectively formed with a connecting end 211 and a receiving end 212; the connecting end 211 is sleeved outside the control rod 23, and the connecting end 211 and the control rod 23 can be fixedly connected by welding or bonding. The receiving end 212 is provided with a buckle groove 215, and the buckle groove 215 is used to be buckled with the anchor base 22; the receiving arm 21 is provided with a receiving groove 214, and the receiving groove 214 is used to receive the blocking section 15 of the suture 10 and provide radial restraint for the blocking section 15; so that the blocking section 15 can extend out of the outer tube with the receiving arm 21 under the push of the control rod 23, and tilt to one side with the receiving arm 21, and at this time, the blocking section 15 is gathered into a slender shape in the receiving groove 214.

[0079] The blocking section 15 may be made of a suture or a metal rod, or a suture braided structure, or a cutting structure, or a combination of a cutting skeleton and a braided mesh connection structure.

[0080] Optionally, the occluding segment 15 is a woven mesh structure, which is made of several strands of wire. The material of the wire can be non-degradable polymer wire, such as nylon, polypropylene, etc.; or degradable polymer wire, such as PGA / PLA / PDS / PDO wire, etc.; or mixed with nickel-titanium wire, platinum-tungsten wire, etc.; by weaving multiple strands of wire into a mesh tube and then heat-setting it into a flat block, the wires at both ends are twisted into cables and respectively connected to the second segment 12 and the third segment 13 of the suture 10.

[0081] Optionally, the blocking section 15 is a cutting grid structure, which is made of biodegradable polymer materials, biodegradable metals, nickel titanium and other materials as a base material; a plurality of diamond or elliptical holes are arranged in an array inside the cutting grid structure, and the whole is cut into a flat structure of a diamond or ellipse; a layer of blocking film is fixed on the surface of the cutting grid structure to increase the contact area with the heart tissue and improve the blocking effect.

[0082] In this embodiment, the anchor base 22 has a fixed end 221 at its end, and the fixed end 221 is used to be fixedly connected to the third segment 13 of the suture 10; the anchor base 22 has a snap-fitting portion 222 on its outer side; the snap-fitting portion 222 is snap-fitted into the snap-fitting groove 215 by elastic force, and when the anchor base 22 is connected to the anchor snap 33, the snap-fitting portion 222 is disengaged from the snap-fitting groove 215. A through hole 223 is formed inside the anchor base 22 for the arc-shaped needle head 32 to pass through, and a limiting groove 224 is formed inside the through hole 223.

[0083] A fixing hole 331 is provided inside the anchoring buckle 33, through which the puncture guide wire 31 can pass. The anchoring buckle 33 is sleeved on the distal end of the puncture guide wire 31 through the fixing hole 331, and the anchoring buckle 33 is fixedly connected to the puncture guide wire 31 by bonding and welding.

[0084] A guide portion 332 is formed at the end of the anchor buckle 33, and a plurality of first cards 333 are cut out at the edge of the guide portion 332. The first cards 333 have elastic force, and the first cards 333 can shrink or expand in the radial direction; the number of first cards 333 can be 2 to 4, and the shrunk outer diameter is smaller than the diameter of the through hole 223, so that it can smoothly enter the through hole 223, and the maximum outer diameter after full expansion should be larger than the diameter of the through hole 223, so that it can be stuck in the limiting groove 224.

[0085] The anchor buckle 33 is driven by the arc-shaped needle head 32 to penetrate into the anchor base 22, and the first card 333 radially shrinks and penetrates into the through hole 223 under the guidance of the guide part 332, and the first card 333 radially expands in the limiting groove 224 to realize the connection between the anchor buckle 33 and the anchor base 22.

[0086] Please refer to Figure 13-15 As shown, the method for using the cardiac septum patent foramen ovale suture device of this embodiment comprises the following steps:

[0087] S11 Arrival step: delivering the patent foramen ovale suture device for the heart septum from the blood vessel to the target position, i.e., the oval fossa.

[0088] S12 Positioning step: by applying a thrust in the distal direction to the control rod 23, the receiving arm 21 connected to the distal end of the control rod 23 is pushed out of the distal end of the outer tube, and the receiving arm 21 bends to the side after losing the constraint of the outer tube; by applying torque to the outer tube, the extending direction of the receiving arm 21 is adjusted to extend it in the direction of the primary septum 92. Further push the control rod 23 forward to make the receiving arm 21 completely extend out of the outer tube, and then rotate the receiving arm 21 by slightly twisting or moving the outer tube and the control rod 23 to adjust a better operating position. At the same time, the outer tube and the receiving arm 21 are slightly pushed forward so that the side support portion 213 of the receiving arm 21 can resist the position of the oval fossa.

[0089] S13 puncture step: after fixing the positions of the outer tube and the stent assembly 20, gently push the puncture guide wire 31 in the distal direction so that the puncture guide wire 31 extends from the distal end of the outer tube. After the distal end of the puncture guide wire 31 loses the constraint of the outer tube, it bends to form an arc-shaped needle head 32. The arc-shaped needle head 32 punctures the secondary septum 91 and the primary septum 92 in turn and then reaches the distal position of the receiving arm 21. Then the puncture guide wire 31 is pushed forward so that the anchoring buckle 33 is embedded in the anchoring base 22. At this time, the anchoring buckle 33 is fixedly connected to the anchoring base 22.

[0090] S14 suturing step: pull back the puncture guide wire 31, the puncture guide wire 31 and the anchoring base 22 are withdrawn into the outer tube, the anchoring base 22 drives the suture 10 to pass through the primary septum 92 and the secondary septum 91 in sequence, and one end of the third segment 13 of the suture 10 is received into the outer tube.

[0091] S15 tightening and knotting step: tighten the suture 10 by the first segment 11, continue to withdraw the puncture guide wire 31, so that the third segment 13 of the suture 10 connected to the buckle base also passes through the fisherman's knot structure, and at the same time, the occluding segment 15 passes through the primary septum 92 driven by the suture 10, and is sealed at the position of the oval fossa after radial expansion; the outer tube and the puncture guide wire 31 are pushed and pulled together to push the fisherman's knot out of the outer tube, tighten the suture 10 and the puncture guide wire 31, draw the primary septum 92 and the secondary septum 91 closer, and tighten the fisherman's knot, so that the fisherman's knot is fixed to the third segment 13 of the suture 10.

[0092] S16: Wire cutting step: the suture 10 is cut by the wire cutting assembly arranged on the outer tube, and then the patent foramen ovale suture device for the cardiac septum is withdrawn.

[0093] Embodiment 2:

[0094] Please refer to Figure 16-21 As shown, this embodiment provides a cardiac septum patent foramen ovale suture device based on the embodiment 1, and the difference between this embodiment and the embodiment 1 is that the number of the stent assembly 20, the puncture assembly 30 and the suture 10 in this embodiment are all 2;

[0095] The two stent assemblies 20, the two puncture assemblies 30 and the two sutures 10 are symmetrically arranged in the outer tube; and the connecting arms of the two groups of stent assemblies 20 extend in the first direction and the second direction respectively after losing the constraint of the outer tube, and the first direction and the second direction are arranged opposite to each other.

[0096] In this embodiment, a limiting guide block 40 is provided at the distal end of the outer tube. A first limiting guide portion 45 is formed on the outer side of the limiting guide block 40, and a second limiting guide portion 46 is formed on the inner side. The outer side of the first limiting guide portion 45 is fixed to the inner wall of the outer tube.

[0097] A limiting guide groove is formed between the first limiting guide portion 45 and the second limiting guide portion; a support control tube 24 is slidably connected in the limiting guide groove, so that the support control tube 24 can move relative to the limiting guide block 40 in the axial direction; a fifth limiting surface is formed in the limiting guide groove, and a sixth limiting surface is formed on the support control tube 24, and the support control tube 24 is limited to rotate in the limiting guide groove through the cooperation of the fifth limiting surface and the sixth limiting surface; the control rods 23 of the two support assemblies 20 are respectively fixed on the opposite sides of the support control tube 24; the cooperation of the fifth limiting surface and the sixth limiting surface can be through the cooperation of elliptical surfaces, that is, the support control tube 24 is an elliptical tube, the ratio of the long side to the short side of the ellipse can be 10:9 to 10:3, and the limiting guide groove is an elliptical tube groove adapted thereto, which is used to limit the support control tube 24 from rotating in the limiting guide groove; of course, the fifth limiting surface and the sixth limiting surface can also be other anti-rotation matching surfaces, and those skilled in the art can implement it according to actual needs.

[0098] Two puncture guide wire accommodating cavities 42 and two first suture accommodating cavities 43 are formed in the second limiting guide portion 46; the two puncture guide wire accommodating cavities 42 are respectively used for allowing the puncture guide wires 31 of the two puncture assemblies 30 to pass through, and the two first suture accommodating cavities 43 are respectively used for allowing the two sutures 10 to pass through.

[0099] Please refer to Figure 19-22 As shown, the method for using the cardiac septum patent foramen ovale suture device of this embodiment comprises the following steps:

[0100] S21 Arrival step: delivering the patent foramen ovale suture device for the heart septum from the blood vessel to the target position, i.e., the oval fossa.

[0101] S22 Positioning step: The two control rods 23 are pushed out synchronously by the support control tube 24, and the two receiving arms 21 are pushed out of the distal end of the outer tube. After losing the constraint of the outer tube, the receiving arms 21 extend to opposite sides respectively; by applying torque to the outer tube, the extension direction of the receiving arms 21 is adjusted so that the two receiving arms 21 extend toward the primary septum 92 and the secondary septum 91 respectively. The support control tube 24 is further pushed forward so that the receiving arms 21 are completely extended out of the outer tube, and then the receiving arms 21 are rotated by slightly twisting or moving the outer tube and the control rod 23 to adjust a better operating position. At the same time, the outer tube and the two receiving arms 21 are slightly pushed forward so that the side support portion 213 of the receiving arm 21 can resist the position of the oval fossa.

[0102] S23 puncture step: after fixing the positions of the outer tube and the stent assembly 20, gently push the puncture guide wire 31 in the distal direction so that the two puncture guide wires 31 extend synchronously from the distal end of the outer tube. After the distal ends of the two puncture guide wires 31 lose the constraints of the outer tube, they bend in the dorsal direction to form two arc-shaped needles 32. The two arc-shaped needles 32 puncture the secondary septum 91 and the primary septum 92 in turn and then reach the corresponding distal position of the receiving arm 21. Then push the puncture guide wire 31 forward so that the two anchor buckles 33 are respectively embedded in the corresponding anchor bases 22. At this time, the anchor buckles 33 are fixedly connected to the anchor base 22.

[0103] S24 suturing step: pull back the puncture guide wire 31, and the two puncture guide wires 31 respectively withdraw into the outer tube with the corresponding anchoring bases 22, and the two anchoring bases 22 drive the suture 10 to pass through the primary septum 92 and the secondary septum 91 in turn, and one end of the third segment 13 of the suture 10 is received in the outer tube.

[0104] S25 tightening and knotting step: tighten the suture 10 by the first segment 11, continue to withdraw the puncture guide wire 31, so that the third segment 13 of the suture 10 connected to the buckle base also passes through the fisherman's knot structure, and at the same time, the two blocking segments 15 pass through the primary septum 92 driven by the suture 10, and after radial expansion, they are blocked at the oval fossa and the position on one side of it; the outer tube and the puncture guide wire 31 are pushed and pulled together to push the two fisherman's knots out of the outer tube, tighten the suture 10 and the puncture guide wire 31, draw the primary septum 92 and the secondary septum 91 closer, and tighten the fisherman's knots, so that the two fisherman's knots are respectively fixed to the third segments 13 of the suture 10 corresponding to them.

[0105] S26: Wire cutting step: the two sutures 10 are cut by the wire cutting assembly arranged on the outer tube, and then the patent foramen ovale suture device for the heart septum is withdrawn.

[0106] Embodiment 3:

[0107] This embodiment provides a suture device for patent foramen ovale of a heart septum, which is a further improvement on the basis of the embodiment 2. The difference between this embodiment and the embodiment 2 is that the number of the stent assembly 20, the puncture assembly 30 and the suture 10 in this embodiment are all 3 or more groups;

[0108] Three groups of stent assemblies 20, two puncture assemblies 30 and two sutures 10 are arranged in the outer tube; and the connecting arms of the three groups of stent assemblies 20 extend in different directions respectively after losing the constraints of the outer tube.

[0109] Embodiment 4:

[0110] Please refer to Figure 22-25 As shown, this embodiment is another implementation of the anchor base 22 and the anchor buckle 33.

[0111] The distal end of the anchor buckle 33 of this embodiment forms a sharp puncture end 334, and the proximal end of the anchor buckle 33 is connected to the puncture guide wire 31, and a hook portion 335 is formed at the connection. The anchor buckle 33 of this embodiment can be integrally formed at the distal end of the puncture guide wire, or can be independently formed and connected to the puncture guide wire by hot melting, gluing or welding.

[0112] A fixing portion 225 is formed at one end of the anchoring base 22 of the present embodiment. The fixing portion 225 is used to be fixedly connected to the third segment 13 of the suture 10. A clamping portion 222 is provided on the outer side of the fixing portion 225. The clamping portion 222 is clamped in the clamping groove 215 by elastic force. When the anchoring base 22 is connected to the anchoring buckle 33, the clamping portion 222 is separated from the clamping groove 215. A through hole 223 is formed inside the fixing portion 225 for the anchoring buckle 33 to pass through.

[0113] A plurality of second cards 226 are cut out at the edge of the fixing portion, and the second cards 226 have elastic force, and the second cards 226 can shrink or expand in the radial direction; the number of second cards 226 can be 2 to 4, and the second cards 226 are normally in a contracted state. In the contracted state, the gap between the ends of each second card 226 is smaller than the diameter of the hook portion of the anchor buckle 33, so that it can limit the withdrawal of the anchor buckle 33; after being fully expanded, the gap between the second cards 226 should be larger than the diameter of the anchor buckle 33, so that the anchor buckle 33 can pass smoothly.

[0114] The anchor buckle 33 is driven to penetrate the anchor base 22 by the arc-shaped needle 32, and the puncture end 334 of the anchor buckle 33 penetrates through the through hole 223 of the fixed part 225 of the anchor base 22, squeezing the second cards 226 on the edge of the fixed part 225 from the inside to the outside. The second cards 226 are elastically deformed and unfolded under the force to allow the anchor buckle 33 to pass smoothly. After the anchor buckle 33 passes, the second cards 226 return to the contracted state under the action of the elastic force, so that the end of the second card 226 abuts against the hook part 335 of the anchor buckle 33, thereby realizing the connection between the anchor buckle 33 and the anchor base 22. In this embodiment, the anchor buckle 33 can be directly formed at the distal end of the puncture guide wire 31 to reduce the puncture resistance; the anchor base 22 and the anchor buckle 33 are connected by the contraction of the second card 226 and the hook part 335, thereby improving the accuracy of hooking the line.

[0115] Embodiment 5:

[0116] The present embodiment provides a suturing system, comprising the patent foramen ovale suture device for the cardiac septum as described in any one of Embodiments 1-4; further comprising an adjusting handle, the adjusting handle and a wire cutting assembly; the adjusting handle is installed at the proximal end of the outer tube, and is used to drive the control rod 23 and the puncture guide wire 31 to move axially relative to the outer tube; the wire cutting assembly is arranged at the distal end of the outer tube, and is used to cut the suture 10.

[0117] The foramen ovale defect is closed by the cardiac septum patent foramen ovale suture device and suture system of this embodiment, and there is no need to implant an instrument for occlusion, which can effectively avoid complications after the implantation of the occluder. In addition, the PFO tunnel will not be distorted, and excessive endothelialization can be prevented from affecting subsequent re-puncture treatment. By providing a closure segment 15 on the suture 10, the contact area at the suture is increased, and the effect of suturing and closing the foramen ovale is better. The effect of the asymmetric elliptical start-stop limiter is utilized, and the relative position of the arc needle 32 and the receiving arm 21 is pre-positioned in combination with the arc needle 32 of the shape memory alloy material, so as to achieve positioning during the puncture process, greatly improve the alignment rate of the anchor buckle 33 and the anchor base 22, ensure the success rate of hooking the line, and the operation is simple, convenient and fast.

[0118] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. A cardiac septum patent foramen ovale suture device, characterized in that: It comprises an outer tube, wherein a suture, a stent assembly and a puncture assembly are inserted into the outer tube; The suture has a first segment, a second segment and a third segment, a pre-tightening knot is arranged between the first segment and the second segment, a pre-tightening channel is arranged in the pre-tightening knot, and the pre-tightening channel can be tightened under the pulling of the suture; a blocking segment is arranged between the second segment and the third segment, and the blocking segment can expand radially; The support assembly includes a control rod, a receiving arm is connected to the distal end of the control rod, and the receiving arm can be extended from the distal end of the outer tube under the drive of the control rod; the receiving arm extends in a first direction after losing the constraint of the outer tube, and the first direction forms an angle with the axis of the outer tube; the distal end of the receiving arm is detachably connected to an anchoring base, and the anchoring base is connected to the third segment of the suture; The puncture assembly includes a puncture guide wire, the distal end of which passes through the pre-tightening channel and can slide relative to the pre-tightening knot, and the distal end of the puncture guide wire can extend from the distal end of the outer tube; after the distal end of the puncture guide wire loses the constraint of the outer tube, it bends to form an arc-shaped needle head, and the arc-shaped needle head is used to puncture heart tissue; the distal end of the puncture guide wire is provided with an anchoring buckle, and the anchoring buckle passes through the heart tissue under the guidance of the arc-shaped needle head and is connected with the anchoring base.

2. A cardiac septum patent foramen ovale suture device according to claim 1, characterized in that: A limiting guide block is provided at the distal end of the outer tube; the outer side of the limiting guide block is fixed to the inner wall of the outer tube, and the limiting guide block is formed with a control rod accommodating chamber, a puncture guide wire accommodating chamber and a first suture accommodating chamber along the axial direction; the control rod accommodating chamber is used for allowing the control rod to pass through, and the control rod can move axially relative to the limiting guide block; the puncture guide wire accommodating chamber is used for allowing the puncture guide wire to pass through, and the puncture guide wire can move axially relative to the limiting guide block; the first suture accommodating chamber is used for allowing the first segment of the suture to pass through.

3. A cardiac septum patent foramen ovale suture device according to claim 1, characterized in that: The inner wall of the control rod accommodating cavity is formed with a first limiting surface, and the circumferential surface of the control rod is formed with a second limiting surface, and the first limiting surface cooperates with the second limiting surface to limit the rotation of the control rod in the control rod accommodating cavity; A third limiting surface is formed on the inner wall of the puncture guidewire accommodating cavity, and a fourth limiting surface is formed on the circumferential surface of the puncture guidewire. The third limiting surface cooperates with the fourth limiting surface to limit the rotation of the puncture guidewire in the puncture guidewire accommodating cavity.

4. A cardiac septum patent foramen ovale suture device according to claim 3, characterized in that: A second suture accommodating cavity is formed on the limiting guide block; the second suture accommodating cavity is used to accommodate the second segment of the suture.

5. The cardiac septum patent foramen ovale suture device according to claim 1, characterized in that: The receiving arm is made of memory metal, and after being released from the constraint of the outer tube, the receiving arm returns to the memory shape and tilts to one side; a supporting portion is formed on the side of the receiving arm, and the supporting portion is used to support the position of the oval fossa; The two ends of the receiving arm are respectively formed with a connecting end and a receiving end; the connecting end is used to be connected to the control rod, and the receiving end is provided with a buckle groove, and the buckle groove is used to be buckled with the anchor base; The receiving arm is provided with a receiving groove, which is used to receive the blocking section of the suture and provide radial restraint force for the blocking section.

6. A cardiac septum patent foramen ovale suture device according to claim 1, characterized in that: The blocking section is a woven mesh structure, which is made of a plurality of strands of degradable polymer filaments. The filaments are woven into a mesh tube and then heat-set into a flat block. The two ends of the filaments are twisted into cables and respectively connected to the second segment and the third segment of the suture.

7. A cardiac septal patent foramen ovale suture device according to claim 1, characterized in that: The blocking section is a cutting grid structure, which is made of degradable materials; a plurality of diamond or elliptical holes are arranged in an array inside the cutting grid structure; and a layer of blocking film is fixed on the surface of the cutting grid structure.

8. The cardiac septum patent foramen ovale suture device according to claim 1, characterized in that: The end of the anchoring base forms a fixed end, and the fixed end is used to be fixedly connected to the third segment of the suture; the outer side of the anchoring base has a clamping portion, and the clamping portion is clamped in the buckle groove; the inside of the anchoring base forms a through hole for the arc-shaped needle to pass through, and a limiting groove is formed in the through hole; A fixing hole is provided inside the anchor buckle, and the fixing hole allows the puncture guide wire to pass through, and the anchor buckle is sleeved on the distal end of the puncture guide wire through the fixing hole; A guide portion is formed at the end of the anchoring buckle, and a plurality of first cards are connected to the edge of the guide portion. The first cards have elastic force, and the first cards can shrink or expand in the radial direction; the anchoring buckle is driven to penetrate the anchoring base by the arc-shaped needle head, and the first card radially shrinks and penetrates the through hole under the guidance of the guide portion, and the first card radially expands in the limiting groove to realize the connection between the anchoring buckle and the anchoring base.

9. A cardiac septum patent foramen ovale suture device according to claim 1, characterized in that: The number of the stent assembly, puncture assembly and suture is 2; After losing the constraint of the outer tube, the connecting arms of the two bracket assemblies extend in a first direction and a second direction respectively, and the first direction is arranged opposite to the second direction; A limiting guide block is provided at the distal end of the outer tube, a first limiting guide portion is formed on the outer side of the limiting guide block, and a second limiting guide portion is formed on the inner side; the outer side of the first limiting guide portion is fixed to the inner wall of the outer tube; A limiting guide groove is formed between the first limiting guide part and the second limiting guide part, and a support control tube is slidably connected in the limiting guide groove, so that the support control tube can move relative to the limiting guide block in the axial direction; a fifth limiting surface is formed in the limiting guide groove, and a sixth limiting surface is formed on the support control tube, and the support control tube is limited to rotate in the limiting guide groove through the cooperation of the fifth limiting surface and the sixth limiting surface; the control rods of the two support assemblies are respectively fixed on the opposite sides of the support control tube; Two puncture guide wire accommodating cavities and two first suture accommodating cavities are formed in the second limiting guide portion; the two puncture guide wire accommodating cavities are respectively used for allowing the puncture guide wires of the two puncture assemblies to pass through, and the two first suture accommodating cavities are respectively used for allowing the two sutures to pass through.

10. A suturing system, characterized in that: It comprises the patent foramen ovale suture device of any one of claims 1 to 9; it also comprises a regulating handle, the regulating handle and a wire cutting assembly; the regulating handle is mounted at the proximal end of the outer tube, and is used to drive the control rod and the puncture guide wire to move axially relative to the outer tube; the wire cutting assembly is arranged at the distal end of the outer tube, and is used to cut the suture.

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