A cardiac septum patent foramen ovale suture device and suture system

Abstract

The present invention discloses a cardiac septum patent foramen ovale suture device and suturing system, comprising an outer tube, in which a suture, a stent assembly and a puncture assembly are provided; the suture has a first segment, a second segment and a third segment, a pre-tightened knot is provided between the first segment and the second segment, and a blocking segment is provided between the second segment and the third segment; the stent assembly comprises a control rod and a receiving arm, the receiving arm extends from the distal end of the outer tube under the drive of the control rod and then extends in a first direction, the distal end of the receiving arm is detachably connected to an anchoring base connected to the third segment; the puncture assembly comprises a puncture guide wire, the distal end of the puncture guide wire can be bent to form an arc-shaped needle after extending from the distal end of the outer tube; the distal end of the puncture guide wire is provided with an anchoring buckle, which can be connected in conjunction with the anchoring base. The present invention has fewer or no implants, will not distort the tunnel of the patent foramen ovale, can increase the contact area at the suture blocking point, and achieve better suture blocking treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a cardiac septal patent foramen ovale suture device and a suturing 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 site of the fossa ovale that continues to develop during the first year and a half of life. In utero, the foramen ovale serves as a physiological conduit for right-to-left blood flow within the fetal heart. After birth, with the establishment of pulmonary circulation, 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 leading to its functional closure. Following this closure, anatomical closure of the foramen ovale typically occurs due to fusion of the atrial septum primum (SP) to the atrial septum secundum (SS).

[0003] When anatomical closure of the foramen ovale does not occur, a patent foramen ovale (PFO) results. A PFO is a persistent, typically flap-like opening between the heart's atrial septum primum (SP) and atrial septum secundum (SS). A PFO occurs when the atrial septum primum (SP) partially fuses to the atrial septum secundum (SS), or fails to fuse. In the event of partial fusion or failure to fuse, a persistent passageway (the PFO path) exists between the atrial septum primum (SP) and atrial septum secundum (SS). This opening or passageway is parallel to the plane of the atrial septum primum and has an opening that is generally shaped like the foramen ovale. Typically, the opening is relatively long but quite narrow. The opening can remain closed because the average pressure in the left atrium (LA) is higher than that in the right atrium (RA). In this way, the atrial septum primum (SP) acts as a one-way valve, preventing fluid communication between the right and left atria through the PFO path. However, sometimes the pressure in the right atrium may temporarily become higher, causing the PFO path to open, allowing 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 cryptic strokes, a PFO is present. A blood clot that forms in the venous circulation (e.g., in the legs) may embolize and may pass through a PFO into the arterial circulation and subsequently into the cerebral circulation, resulting in an embolic stroke. Blood clots may also form near a PFO and embolize into the arterial circulation and into the cerebral circulation. Patients with a PFO who have had a cryptic stroke or transient ischemic attack (TIA) should consider receiving medical treatment to reduce the risk of recurrence of the embolic condition.

[0005] Medical treatment typically includes oral anticoagulants or antiplatelet agents. These therapies may cause certain side effects, such as bleeding. If medical treatment is inadequate, surgery to close the PFO with sutures may be performed. Similar to other open surgical treatments, this procedure is horizontally invasive, carries risks, requires general anesthesia, and can result in a long recovery.

[0006] PFOs 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 position. In addition, such devices may be difficult or impossible to retract and / or reposition if the initial positioning is not satisfactory. 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 with the septum secundum (SS).

[0007] While there are currently occluders specifically designed for PFO closure on the market, the majority of existing devices used for PFO closure are traditional double-disc occluders. These devices are typically large and made of nickel-titanium, which can increase the risk of both short-term and long-term complications. Furthermore, the waist of the traditional double-disc structure can distort the PFO tunnel, leading to tissue thickening and compromising subsequent re-puncture treatment. Summary of the Invention

[0008] In order to overcome the shortcomings of the existing technology, the present invention provides a cardiac septal 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] A first aspect of the present invention is to provide a cardiac septal 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. The pre-tightening knot has a pre-tightening channel therein. The pre-tightening channel can be tightened when the suture is pulled. A blocking segment is provided between the second segment and the third segment. The blocking segment can expand radially.

[0011] The stent assembly includes a control rod, a receiving arm connected to a distal end of the control rod, and the receiving arm can be extended from a 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 anchor base, and the anchor 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 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, a first limiting surface is formed on the inner wall of the control rod accommodating cavity, and a second limiting surface is formed on the circumferential surface of the control rod, 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 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 abut against the position of the oval fossa;

[0018] The receiving arm is provided with a connecting end and a receiving end at both ends; the connecting end is used to connect with 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 several strands of degradable polymer filaments. The filaments are woven into a mesh tube and then heat-set 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 interior 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 anchoring buckle, through which the puncture guide wire can pass, and the anchoring 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 can shrink or expand radially. 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. 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 the first direction and the second direction respectively, and the first direction and the second direction are arranged opposite to each other;

[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 of the limiting guide block; 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 portion and the second limiting guide portion, a support control tube is slidably connected in the limiting guide groove, so that the support control tube can move in the axial direction relative to the limiting guide block; 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 fifth limiting surface cooperates with the sixth limiting surface to limit the support control tube from rotating in the limiting guide groove; the control rods of the two support assemblies are respectively fixed on 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 cardiac septum patent foramen ovale suture device described in any one of the first aspects 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, for driving 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, for cutting the suture.

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

[0032] The cardiac septal patent foramen ovale suture device and suture system of the present invention do not require implantation of instruments for occlusion, and can effectively avoid complications caused by implantation of the occluder. In addition, it will not distort the PFO tunnel, and can avoid excessive endothelialization affecting subsequent re-puncture treatment. By providing an occluding segment on the suture, the contact area at the suture site is increased, and the suture effect of closing the foramen ovale is better. By utilizing the effect of the asymmetric elliptical start-stop limiter, and coordinating with the arc needle of shape memory alloy material, the relative position of the arc needle and the receiving arm is pre-positioned, and positioning during the puncture process is achieved, which greatly improves the alignment rate of the anchor buckle and the anchor base, ensures the success rate of hooking the line, and is simple, convenient and fast to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Schematic diagram of the structure of the cardiac septum patent foramen ovale suture device of Example 1;

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

[0035] Figure 3 This is a schematic structural diagram of the patent foramen ovale suture device for the cardiac septum according to Example 1, with the puncture guide wire extended;

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

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

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

[0039] Figure 7 Schematic diagram of the structure of the memory state of the receiving arm of the cardiac septum patent foramen ovale suture device of Example 1;

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

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

[0042] Figure 10 Schematic cross-sectional view of the limiting guide block of the cardiac septum patent foramen ovale suture device of Example 1;

[0043] Figure 11 Schematic diagram of the structure of the anchor buckle of the cardiac septum patent foramen ovale suture device of Example 1;

[0044] Figure 12 This is a schematic structural diagram of the anchoring base of the cardiac septum patent foramen ovale suture device of Example 1;

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

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

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

[0048] Figure 16Schematic diagram of the structure of the cardiac septum patent foramen ovale suture device according to Example 2;

[0049] Figure 17 This is a structural schematic diagram of the cardiac septum patent foramen ovale suture device according to Example 2, with the receiving arm in an extended state;

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

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

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

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

[0054] Figure 22 Schematic diagram of the structure of the cardiac septum patent foramen ovale suture device according to Example 4;

[0055] Figure 23 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] Figure 24 This is a schematic structural diagram of the anchoring base of the cardiac septum patent foramen ovale suture device of Example 4;

[0057] Figure 25 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, supporting portion; 214, receiving slot; 215, snap slot; 22, anchor base; 221, fixed end; 222, snap-fit ​​portion; 223, through hole; 224, limiting slot; 225, fixed portion; 226, second card; 23, control lever; 24 , stent control tube; 30, puncture assembly; 31, puncture guide wire; 32, curved needle; 33, anchoring buckle; 331, fixing hole; 332, guide part; 333, first card; 334, puncture end; 335, hook part; 40, limiting 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 limiting guide part; 46, second limiting guide part; 91, secondary septum; 92, primary septum. DETAILED DESCRIPTION

[0059] Below, the invention is further described in conjunction with the accompanying drawings and specific embodiments. 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. Unless 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 this application, it should be understood that the terms "upper," "lower," "front," "back," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended only to facilitate the description of this application and simplify the description. They do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting this application. In the description of this application, "plurality" means two or more, unless otherwise specifically specified.

[0061] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "connected," "connected," and "connected" should be understood in a broad sense. For example, they may refer to a fixed connection, a connection through an intermediary medium, internal communication between two components, or an interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0062] The terms "first," "second," and the like in the specification and claims of this application and the accompanying drawings are used to distinguish similar objects and are not necessarily used to describe a particular order or sequential sequence. In addition, the terms "including," "comprising," and "having," and any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or apparatus that includes a series of steps or elements is not necessarily limited to those steps or elements explicitly listed, but may include other steps or elements not explicitly listed or inherent to the process, method, product, or apparatus.

[0063] Example 1:

[0064] Please refer to Figure 1-15 As shown, this embodiment provides a cardiac septal patent foramen ovale suture device, comprising an outer tube, and a suture 10, a stent assembly 20 and a puncture assembly 30 arranged inside the outer tube.

[0065] The outer tube of this embodiment has a proximal end and a distal end, the proximal end being the end closer to the operator when in use, and the distal end being the end farther away from the operator when in use. The outer tube has a central axis, which is the 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 control 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 that the outer tube can be used in a high-position 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 for 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 to the suture 10, stent assembly 20 and 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, a pre-tightening channel is provided in the pre-tightening knot 14, and the pre-tightening channel can be used for the sutures 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 pull 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 this embodiment is contracted at the distal end of the stent assembly 20, and is slender when contracted, and can pass through the heart tissue under the drive of the suture 10 at the distal end of the puncture assembly 30 and the third segment 13; the occluding segment 15 can be radially expanded 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 better suture occlusion treatment effect.

[0068] The stent assembly 20 includes a control rod 23, which can be made of materials such as stainless steel, nickel-titanium alloy, or cable. The cross-section of the control rod 23 is elliptical. The ratio of the long side to the short side of the ellipse can be 10:9 to 10:3. A receiving arm 21 is connected to the distal end of the control rod 23. Driven by the control rod 23, the receiving arm 21 can move axially along the outer tube, extending or retracting from the distal end of the outer tube.

[0069] After extending from the distal end of the outer tube, the receiving arm 21 loses the radial restraint of the outer tube and extends in a 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 anchor base 22, which is connected to the third segment 13 of the suture 10. The anchor base 22 is initially clamped to the distal end of the receiving arm 21. After being fixed with the anchor buckle 33 provided at the distal end of the puncture assembly 30, it is separated from the receiving arm 21. As the puncture assembly 30 is withdrawn, the third segment 13 is driven to pass through the cardiac tissue in sections.

[0070] The puncture assembly 30 of this embodiment includes a puncture guidewire 31, which is made of a shape memory alloy. The cross-section of the puncture guidewire 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 a heat setting process, the puncture guidewire 31 is bent toward the wider side of the ellipse. The distal end of the puncture guidewire 31 passes through the preload passage and can slide relative to the preload knot 14. The distal end of the puncture guidewire 31 can extend from the distal end of the outer tube. After the distal end of the puncture guidewire 31 loses the restraint of the outer tube, it bends to form an arc-shaped needle head 32, which is used to puncture cardiac tissue. Specifically, the arc-shaped needle head 32 of this embodiment is a round needle head with a chord length of 3 to 20 mm (puncture width) and a 1 / 2 arc. 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 bracket assembly 20 and the puncture assembly 30 in the outer tube, so as to prevent the suture 10, the bracket 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 cavities along the axial direction, namely the control rod accommodating cavity 41, the puncture guide wire accommodating cavity 42 and the first suture accommodating cavity 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. 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 allowing 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 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. After being released from the constraint of the outer tube, the receiving arm 21 returns to the memory shape and tilts to one side. A supporting portion 213 is formed on the side of the receiving arm 21, and the supporting portion 213 is used to abut against the position of the oval fossa.

[0078] The receiving arm 21 has a connecting end 211 and a receiving end 212 at each end. The connecting end 211 is sleeved on the outside of the control rod 23 and can be fixedly connected to the control rod 23 by welding or bonding. The receiving end 212 has a snap-fit ​​groove 215, which is used to snap into the anchor base 22. The receiving arm 21 has a receiving groove 214, which is used to receive the blocking section 15 of the suture 10 and provide radial restraint for the blocking section 15. This allows the blocking section 15 to extend out of the outer tube under the push of the control rod 23 and tilt to one side with the receiving arm 21. At this time, the blocking section 15 is gathered into a slender shape within the receiving groove 214.

[0079] The occluding section 15 may be made of a suture or a metal rod, or may be a suture braided structure, or a cutting structure, or may be 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 a non-degradable polymer wire, such as nylon, polypropylene, etc.; or a 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 elliptical shape; 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, which is used to securely connect to the third segment 13 of the suture 10. The anchor base 22 has a snap-fit ​​portion 222 on its outer side. The snap-fit ​​portion 222 is elastically snapped into the snap groove 215. Once the anchor base 22 is connected to the anchor snap 33, the snap-fit ​​portion 222 disengages from the snap groove 215. A through hole 223 is formed within the anchor base 22, through which the curved needle 32 passes. A limiting groove 224 is formed within 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 using processes such as bonding and welding.

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

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

[0086] Please refer to Figure 13-15 As shown, the method for using the patent foramen ovale suture device of the present embodiment includes 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 fossa ovalis.

[0088] S12 Positioning step: By applying a distal thrust 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. After losing the restraint of the outer tube, the receiving arm 21 bends laterally. By applying torque to the outer tube, the extension direction of the receiving arm 21 is adjusted so that it extends toward the primary septum 92. The control rod 23 is further pushed forward to allow the receiving arm 21 to fully extend out of the outer tube. Then, by slightly twisting or moving the outer tube and the control rod 23, the receiving arm 21 is rotated to adjust the 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 abut the oval fossa.

[0089] S13 puncture step: After fixing the position 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 reaches the distal position of the receiving arm 21. Then push the puncture guide wire 31 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, and the puncture guide wire 31 withdraws into the outer tube with the anchoring base 22. 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 from 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: cutting step: cutting the suture 10 by the cutting assembly arranged on the outer tube, and then withdrawing the patent foramen ovale suture device for the cardiac septum.

[0093] Example 2:

[0094] Please refer to Figure 16-21 As shown, this embodiment provides a cardiac septal patent foramen ovale suture device based on the embodiment 1. 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 after losing the constraints of the outer tube, the connecting arms of the two groups of stent assemblies 20 extend in the first direction and the second direction respectively, 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 within the limiting guide groove, allowing the support control tube 24 to move axially relative to the limiting guide block 40. A fifth limiting surface is formed within the limiting guide groove, and a sixth limiting surface is formed on the support control tube 24. The fifth limiting surface cooperates with the sixth limiting surface to limit rotation of the support control tube 24 within the limiting guide groove. The control rods 23 of the two support assemblies 20 are respectively fixed to opposite sides of the support control tube 24. The cooperation between the fifth limiting surface and the sixth limiting surface can be achieved by cooperation of elliptical surfaces, that is, the support control tube 24 is an elliptical tube with a ratio of the long side to the short side of the ellipse of 10:9 to 10:3. The limiting guide groove is an elliptical tube groove adapted thereto to limit rotation of the support control tube 24 within the limiting guide groove. Of course, the fifth limiting surface and the sixth limiting surface can also be other anti-rotation mating 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 to allow 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 to allow the two sutures 10 to pass through.

[0099] Please refer to Figure 19-22 As shown, the method for using the patent foramen ovale suture device of the present embodiment includes 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 fossa ovalis.

[0101] S22 Positioning Step: The stent control tube 24 drives the two control rods 23 to be pushed out synchronously, pushing the two receiving arms 21 out of the distal end of the outer tube. After losing the restraint of the outer tube, the receiving arms 21 extend to opposite sides. 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 stent control tube 24 is further pushed forward to allow the receiving arms 21 to fully extend out of the outer tube. Then, by slightly twisting or moving the outer tube and control rods 23, the receiving arms 21 are rotated to adjust the optimal operating position. At the same time, the outer tube and the two receiving arms 21 are slightly pushed forward so that the side support portions 213 of the receiving arms 21 can abut the fossa ovalis.

[0102] S23 puncture step: After fixing the position 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 from the distal end of the outer tube simultaneously. After the distal ends of the two puncture guide wires 31 lose the constraint of the outer tube, they bend in the back 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 reach the corresponding distal position of the receiving arm 21. Then push the puncture guide wire 31 forward so that the two anchoring buckles 33 are respectively embedded in the corresponding anchoring base 22. At this time, the anchoring buckle 33 is fixedly connected to the anchoring base 22.

[0103] S24 suturing step: pull back the puncture guide wire 31, and the two puncture guide wires 31 respectively withdraw the corresponding anchoring bases 22 into the outer tube. 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 from 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, block the oval fossa and the position on one side of it; the outer tube and the puncture guide wire 31 push and pull together to push the two fisherman's knots out of the outer tube, tighten the suture 10 and the puncture guide wire 31, pull the primary septum 92 and the secondary septum 91 closer, and tighten the fisherman's knot, so that the two fisherman's knots are respectively fixed to their corresponding third segments 13 of the suture 10.

[0105] S26: cutting step: cutting the two sutures 10 by the cutting assembly arranged on the outer tube, and then withdrawing the patent foramen ovale suture device for the cardiac septum.

[0106] Example 3:

[0107] This embodiment provides a cardiac septal patent foramen ovale suture device, which is a further improvement on the basis of Example 2. The difference between this embodiment and Example 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 after losing the constraints of the outer tube.

[0109] Example 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 anchoring clip 33 of this embodiment forms a sharp puncture tip 334, and the proximal end of the anchoring clip 33 is connected to the puncture guidewire 31, with a hook portion 335 formed at the connection. The anchoring clip 33 of this embodiment can be integrally formed with the distal end of the puncture guidewire, or it can be independently formed and then connected to the puncture guidewire through a process such as hot melt, gluing, or welding.

[0112] In this embodiment, the anchor base 22 has a fixing portion 225 formed at one end. The fixing portion 225 is used to securely connect to the third segment 13 of the suture 10. The fixing portion 225 has a snap-fitting portion 222 on its outer side. The snap-fitting portion 222 is elastically snapped into the snap-fitting groove 215. When the anchor base 22 is connected to the anchor snap 33, the snap-fitting portion 222 is released from the snap-fitting groove 215. A through hole 223 is formed within the fixing portion 225, through which the anchor snap 33 passes.

[0113] A number of second cards 226 are cut out on 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 curved needle 32 drives the anchor buckle 33 to penetrate the anchor base 22, and the puncture end 334 of the anchor buckle 33 penetrates the through hole 223 of the fixed portion 225 of the anchor base 22, squeezing the second cards 226 on the edge of the fixed portion 225 from the inside to the outside. The second cards 226 are elastically deformed and expanded 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 retracted state under the action of the elastic force, so that the end of the second card 226 abuts against the hook portion 335 of the anchor buckle 33, thereby achieving the connection between the anchor buckle 33 and the anchor base 22. In this embodiment, by directly forming the anchor buckle 33 on the distal end of the puncture guide wire 31, the puncture resistance can be reduced; the anchor base 22 and the anchor buckle 33 are connected by the second cards 226 contracting and cooperating with the hook portion 335, thereby improving the accuracy of the line hooking.

[0115] Example 5:

[0116] This embodiment provides a suturing system, comprising the cardiac septum patent foramen ovale suture device described in any one of Examples 1-4; further 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, for driving 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, for cutting 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. No implantation of an instrument is required for occlusion, which can effectively avoid complications after implantation of the occluder. In addition, the PFO tunnel will not be distorted, and excessive endothelialization can be avoided to affect subsequent re-puncture treatment. By providing a closure segment 15 on the suture 10, the contact area at the suture site is increased, and the suture closure effect of the foramen ovale is better. By utilizing the effect of the asymmetric elliptical start-stop limiter, and coordinating with the arc needle 32 of the shape memory alloy material, the relative position of the arc needle 32 and the receiving arm 21 is pre-positioned, and positioning during the puncture process is achieved, which greatly improves the alignment rate of the anchor buckle 33 and the anchor base 22, ensures the success rate of hooking the line, and is simple, convenient and fast to operate.

[0118] The above 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 replacements made by technicians in this field on the basis of the present invention fall within the scope of protection required by the present invention.

Claims

1. A cardiac septal patent foramen ovale suture device, characterized in that: It comprises an outer tube, wherein a suture, a stent assembly and a puncture assembly are passed through the outer tube; 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. The pre-tightening knot has a pre-tightening channel therein. The pre-tightening channel can be tightened when the suture is pulled. A blocking segment is provided between the second segment and the third segment. The blocking segment can expand radially. The stent assembly includes a control rod, a receiving arm connected to a distal end of the control rod, and the receiving arm can be extended from a 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 anchor base, and the anchor 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 cardiac tissue; the distal end of the puncture guide wire is provided with an anchoring buckle, and the anchoring buckle, under the guidance of the arc-shaped needle head, passes through the cardiac tissue and is connected with the anchoring base; 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; A first limiting surface is formed on the inner wall of the control rod accommodating cavity, and a second limiting surface is formed on the circumferential surface of the control rod, 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.

2. A cardiac septal patent foramen ovale suture device according to claim 1, 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.

3. The cardiac septal 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 abut against the position of the oval fossa; The receiving arm is provided with a connecting end and a receiving end at both ends; the connecting end is used to connect with 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.

4. The cardiac septal patent foramen ovale suture device according to claim 1, characterized in that: The blocking section is a woven mesh structure made of several 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 and third segments of the suture.

5. The cardiac septal patent foramen ovale suture device according to claim 1, characterized in that: The blocking section is a cutting grid structure made of degradable material; 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.

6. The cardiac septal patent foramen ovale suture device according to claim 3, 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 is formed with 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 anchoring buckle, through which the puncture guide wire can pass, and the anchoring 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 can shrink or expand radially. 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. The first card radially expands in the limiting groove to realize the connection between the anchoring buckle and the anchoring base.

7. The cardiac septal 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 the first direction and the second direction respectively, and the first direction and the second direction are arranged opposite to each other; 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 of the limiting guide block; 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 portion and the second limiting guide portion, a support control tube is slidably connected in the limiting guide groove, so that the support control tube can move in the axial direction relative to the limiting guide block; 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 fifth limiting surface cooperates with the sixth limiting surface to limit the support control tube from rotating in the limiting guide groove; the control rods of the two support assemblies are respectively fixed on 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.

8. A suturing system, characterized in that: It comprises the cardiac septum patent foramen ovale suture device according to any one of claims 1 to 7; 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, for driving 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, for cutting the suture.

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