Closure device for tissue defect

Abstract

The present invention relates to the field of medical devices, and particularly to a closure device for tissue defects. The closure device includes a locking unit and a release unit located in the proximal region of the locking unit; the locking unit includes at least one or more locking members; by operating the release unit, the locking members are driven to rotate, the locking members approach each other and achieve self-locking, thereby realizing the closure of the tissue defect; the locking unit and the release unit are of an integral structure, and when the locking members achieve self-locking, further operating the release unit causes the release unit to break away from the locking unit.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to a closure device for tissue defects, and more particularly to a closure device for intracardiac tissue defects. Background Art

[0002] Patent Foramen Oval (PFO) is the most common congenital heart anomaly in adults. In the normal population, about 1 in 4 people can be detected with this disease. There are 1.5 million patients with congenital heart disease in China. The annual prevalence of congenital heart disease is 6.78%, and the number of newly born children with congenital heart disease is as high as 100,000 - 150,000 cases per year. Among them, simple patent foramen ovale accounts for about 10% of congenital heart disease.

[0003] This common problem of patent foramen ovale may lead to potentially serious complications. In recent years, many studies have shown that there is a close link between patent foramen ovale and patients with cryptogenic stroke. For patients with patent foramen ovale, the remaining slit-like abnormal channel between the primary septum and the secondary septum is similar to a functional valve. Since the blood pressure in the left atrium of the heart is higher than that in the right atrium, blood may flow from the left atrium through the patent foramen ovale into the right atrium. Long-term blood flow from the left atrium to the right atrium leads to an increase in the blood volume of the right atrium, causing right ventricular hypertrophy and an increase in pulmonary circulation blood volume. When the right atrial pressure is higher than the left atrial pressure, the weak primary septum on the left side is pushed open, resulting in a right-to-left shunt of blood. In addition, the following emboli may enter the left heart system to cause corresponding clinical symptoms: thrombi in the deep veins of the lower extremities or pelvic veins, air emboli caused by decompression sickness or diving, and fat emboli formed after surgery or trauma. For patients with patent foramen ovale who have had a thromboembolic event, the risk of recurrence is still very high. At the same time, it has also been found that the long-term presence of patent foramen ovale can cause diseases such as migraine, cerebral ischemia, stroke, decompression sickness, platypnea-orthodeoxia syndrome, and altitude sickness.

[0004] The traditional treatment method for patent foramen ovale is surgical operation. For the surgical treatment method, the patient needs to undergo thoracotomy through surgery. The main disadvantages of surgical operation are as follows: cardiopulmonary bypass is required during the operation, and the operation may cause complications and lead to death; the surgical trauma is large, and there is a scar left after the operation; the surgical cost is expensive. With the development and improvement of interventional treatment technology, the method of treating PFO through minimally invasive interventional technology is now very mature. Minimally invasive interventional treatment has the advantages of not requiring surgery, small trauma, few complications, fast recovery, good effect, wide range of indications, and relatively low surgical cost.

[0005] The current mainstream products in clinical practice are traditional double-disk patent foramen ovale occluders. The traditional double-disk patent foramen ovale occluder has a double-disk structure, with a left disk and a right disk that are symmetric left and right, as well as a short waist connecting the left disk and the right disk. There is a protruding collecting end in the middle of the left side of the left disk, and a protruding collecting end in the middle of the right side of the right disk. However, there are more or less problems with the above-mentioned traditional double-disk patent foramen ovale occluders in clinical use. If the patent foramen ovale is relatively close to the superior or inferior vena cava or the main pulmonary artery, the edge of the occluder may wear the blood vessels, resulting in occlusion failure; if an occluder with a smaller size of the left and right disk surfaces is selected, the anchoring effect of the occluder is not good, resulting in poor occlusion stability. In addition, the fossa ovalis is the puncture point for atrial septum puncture in cardiac interventional surgery. For patients with patent foramen ovale who have potential interventional cardiac treatment, after occluding the patent foramen ovale with the above-mentioned traditional occluder, they will face the situation of being unable to perform secondary interventional treatment due to difficult atrial septum puncture, and having to switch to a treatment method with a higher risk.

[0006] Patent CN112244902A provides a patent foramen ovale occluder with adjustable disk surface, belonging to the technical field of medical devices; the occluder with a reticular structure includes an upper disk surface, a waist, a lower disk surface, an adjusting rod and an adjusting wire; a waist is provided between the upper disk surface and the lower disk surface; the upper disk surface is provided with an intermediate section on the same central axis and an edge section with an adjustable cross-section perpendicular to the central axis; the upper disk surface of the occluder is a splicing design of the intermediate section and the edge section, and an adjusting wire is provided between the edge section and the adjusting rod. The size of the upper disk surface can be freely adjusted by rotating the adjusting rod and changing the length of the adjusting wire. The occluder with adjustable disk surface reduces the probability of replacing the occluder during the operation; improves the fitting degree of the occluder; the upper disk surface of the occluder adopts a two-section design of the intermediate section and the edge section, and the edge section is softer than the intermediate section, which is beneficial to the adjustment of the disk surface size of the occluder and reduces the wear of the tissue in contact with it. However, the existing treatment method for the above diseases is to use an occlusion operation to place an occluder made mostly or entirely of metal materials in the body. The above-mentioned occluders are usually large in size, and due to the complex structure in the heart and placing the occluder in the heart, many patients are not easy to accept, and the risk of complications may increase both in the short term and in the long term, and it is difficult to achieve repeated release and recovery.

[0007] Patent CN211934140U provides an interventional defect suture device, including a sheath, a suture assembly disposed at the distal end of the sheath, and at least two puncture needles inserted into the sheath. The suture assembly includes a main body fixedly connected to the sheath and a movable part rotatably connected to the main body, and the movable part is provided with at least one connecting cylinder connected to the suture on both sides of its rotation axis. After the movable part rotates into place relative to the main body, one of the connecting cylinders is correspondingly located on the moving path of the distal end of the puncture needle, and the at least two puncture needles are respectively docked with a corresponding connecting cylinder after puncturing the tissue around the defect. When the puncture needle moves toward the proximal end, it drives the corresponding connecting cylinder and suture connected thereto to move toward the proximal end, so that the suture is implanted into the tissue around the defect, thereby realizing at least two suture points formed by one intervention, reducing the number of instrument interventions and shortening the operation time. However, the suture device is difficult to operate, complicated in workmanship, and cannot achieve precise positioning. It is difficult for the puncture needle to achieve precise docking with the connecting cylinder when the needle is removed.

[0008] Patent ZL201822027543.9 provides a patent foramen ovale suture device, which relates to the field of medical suturing technology and solves the technical problems that it is difficult to position and suture the existing patent foramen ovale surgery and that complications are prone to occur when using an occluder for implantation; the device includes a pushing part and an extender connected to the pushing part, the head of the extender is provided with a metal suture and two clamping arms, the two ends of the metal suture are respectively pulled through the fixing grooves on the clamping arms, a push rod is provided on the pushing part, and the two clamping arms can pull the metal suture out and inward by pushing the push rod; two puncture needles can be inserted into the guide groove, the guide groove runs through the inside of the extender, and the traction needle is pushed, which can pull the two ends of the metal suture and pass through the septum to fix the two septa; the present application is used to achieve minimally invasive closure of patent foramen ovale or atrial septal defect, ensure suturing in the exact position, and reduce the risk of complications after implantation of the occluder. However, since the suture is unfolded in the heart by pushing the clamping arm and then hooked and pulled back by the hooked needle of the traction needle, metal sutures are preferably used during actual surgical operations to facilitate angiographic observation. The suture device has the following main disadvantages: 1. Metal sutures are relatively sharp. Using metal sutures as the main material for closure cannot disperse the pulling force on the tissue when the metal sutures pull the tissue, which may cause tearing damage to the suture site and even form a hole structure, artificially forming an additional defect; 2. The positioning and needle removal operations are complicated and require very high precision, and the doctor has a long learning curve; 3. The defect closure is achieved by the entanglement of the metal sutures, but the release mechanism of the metal sutures is not designed, and there may be a risk of metal suture breakage or unclear release position, resulting in closure failure.

[0009] Therefore, how to solve the problem of patent foramen ovale during the operation, reduce postoperative complications, avoid some drawbacks brought by the traditional occluder interventional treatment surgery, and achieve simple, rapid closure and detachment, while retaining the possibility of carrying out secondary interventional surgery at the future atrial septum puncture point or area has become an urgent problem to be solved at present. Summary of the Invention

[0010] In view of the above and others, the object of the present invention is to overcome the deficiencies of the prior art.

[0011] According to an embodiment in the application of the patent foramen ovale treatment surgery, the present invention can provide a closure device for tissue defects for patients with structural heart disease who need interventional treatment, which can solve some drawbacks brought by using an occluder to treat patent foramen ovale during the interventional treatment surgery, such as poor anchoring effect of the occluder resulting in poor occlusion stability, or the large metal content of the occluder being likely to cause damage to human tissues, etc. It can also solve the problem that it is impossible to perform atrial septum puncture to carry out secondary interventional surgery after occluding the patent foramen ovale with a traditional occluder, and avoid the situation of switching to a treatment method with a higher risk; in addition, it can also achieve precise positioning and suture during the patent foramen ovale surgery, reducing postoperative complications.

[0012] According to one aspect of the present invention, the closure device includes a locking unit and a release unit located in the proximal region of the locking unit; the locking unit includes at least one or more locking members; operating the release unit drives the locking members to rotate, the locking members approach each other and achieve self-locking, thereby realizing the closure of the tissue defect; the locking unit and the release unit are of an integral structure. When the locking members achieve self-locking and locking, further operating the release unit causes the release unit to break and separate from the locking members. The advantages of such a design are as follows: simple structure, low risk, few components, convenient manufacturing, high production efficiency, low cost and short cycle required for the whole set of products; the metal implantation amount can be limited to the greatest extent, less irritation to tissues, and good biocompatibility; at the same time, it is convenient to release. By further rotating the release unit and preferentially selecting the rotational release method, the release unit can be broken and separated from the locking unit. The operation action is simple, and after breaking, there will be a good tactile feedback at the locking transmission rod, which can immediately evaluate whether it is completely broken and released, without the need for additional operating instruments for detection, short operation time during the operation, and short learning curve for doctors; in addition, the delivery sheath has a small diameter, little damage to human blood vessels, and is especially suitable for special populations such as underage patients with small blood vessels.

[0013] In one embodiment, when the locking members achieve self-locking and locking, further operating the release unit causes the proximal region of the locking unit to rotate further; before the locking unit and the release unit break and separate, the two are of a gradually narrowing structure from the distal end to the proximal end.

[0014] In one embodiment, the locking unit includes one or more fixing members located in the distal region of the locking member and connected to the locking member. Part or all of the fixing members are attached or anchored to the inner or distal outer surface of the target tissue; an enhanced connection structure is provided between the fixing members, and the enhanced connection structure connects a plurality of the fixing members; the enhanced connection structure is a flexible metal material or a polymer material.

[0015] In one embodiment, the enhanced connection structure can prevent the fixing members from detaching and falling into the left atrium after the fixing members and the locking member are broken.

[0016] In one embodiment, the enhanced connection structure does not participate in the self-locking process of the locking member, nor does it participate in the process of the release unit breaking away from and separating from the locking unit.

[0017] In one embodiment, the enhanced connection structure is free outside the proximal region or the entire region of the locking member. After the local parts of the enhanced connection structure and the locking member are connected by a fixing structure and are in a parallel structure, the proximal region of the locking unit and / or the release unit is connected to the delivery system, so as to ensure that the enhanced connection structure can participate in the self-locking process of the locking member and play a certain fixing role.

[0018] In one embodiment, the closing device includes a delivery system located in the proximal region of the release unit or the locking unit; the locking unit or the release unit is connected to the delivery system; the enhanced connection structure is not connected to the delivery system and is independently free outside the proximal region of the locking member.

[0019] In one embodiment, before the tissue defect is closed, when the release unit is operated to drive the locking unit to rotate, the locking force F of the release unit 01 , the locking force F of the locking unit 02 , the critical breaking force F1 of the release unit, the critical breaking force F2 of the locking unit, and the critical breaking force F7 of the enhanced connection structure satisfy: F 01 < F1, F 01 = F 02 , F1 < F2 < F7; when the locking unit is gradually locked, the F 01 and the F 02 gradually increase. When the locking unit is completely locked and the release unit is further operated, the F 01 reaches the critical breaking force F1, and the release unit breaks away and separates.

[0020] In one embodiment, F 01 , F02 The values of F1, F2, and F7 are all between 0.1 N and 100 N.

[0021] In a preferred embodiment, F 01 、F 02 The values of, F, F1, and F2 are all between 0.1 N and 10 N.

[0022] In one embodiment, the locking unit tangles and self-locks in the concentrated area to form a cable structure or a twist structure, and the cable structure or the twist structure has at least one turn.

[0023] In one embodiment, the conveying system includes a locking mechanism, and the locking mechanism includes a locking power source, a locking transmission rod, and a locking transmission structure fixedly connected to the distal end of the locking transmission rod; the conveying system includes a releasing mechanism, and the releasing mechanism includes a releasing power source and a releasing transmission medium; the releasing mechanism is the locking mechanism, and the releasing transmission medium is the locking transmission rod; during pre-installation, the proximal area of the releasing unit is connected to the locking transmission structure and forms a concentrated area; when the locking power source takes effect, the locking member is linear and in a taut state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod and then drives the locking transmission structure to twist forward, thereby causing the releasing unit to drive the locking member to rotate, and the locking unit tangles and self-locks in the concentrated area.

[0024] In one embodiment, the closing instrument includes a locking unit and a releasing unit located in the proximal area of the locking unit; the locking unit includes at least one or more locking members; the releasing unit includes an auxiliary fracture structure; operating the releasing unit causes the auxiliary fracture structure to drive the locking members to rotate, the locking members approach each other and achieve self-locking, thereby achieving the closing of the tissue defect; when the locking members achieve self-locking, further operating the releasing unit causes the auxiliary fracture structure to be further rotated, so that the auxiliary fracture structure fractures and separates from the locking members. The advantages of this design are as follows: By adopting the design of the auxiliary fracture structure, the fracture position of the instrument after tissue closing can be further limited, making the fracture position safe and reliable, and the fracture position can be accurately limited at the auxiliary fracture structure, ensuring that the implanted part of the closing instrument is in the best state; at the same time, the locking members apply force evenly during the closing process of the tissue defect, avoiding additional local tissue defects caused by uneven force at the tissue defect; in addition, the sheath diameter of the delivery sheath is small, causing little damage to the human blood vessels, and is especially suitable for special populations such as minor patients with small blood vessels.

[0025] In one embodiment, the locking unit includes one or more fixing members located in the distal region of the locking member and connected to the locking member, and part or all of the fixing members are attached or anchored to the inner or distal outer surface of the target tissue; an enhanced connection structure is provided between the fixing members, and the enhanced connection structure connects multiple fixing members; the closing instrument includes a delivery system located in the proximal region of the release unit, and the enhanced connection structure is not connected to the delivery system; wherein, after the enhanced connection structure is connected to the proximal region of the auxiliary breaking mechanism in a parallel structure, a twisted structure or a braided structure with the locking member, the distal region of the auxiliary breaking structure is connected to the delivery system; or, the enhanced connection structure is independently free outside the proximal region or the entire region of the locking member.

[0026] In one embodiment, after part or all of the enhanced connection structure and the locking member are connected through a fixing structure, they are in a parallel structure and then connected to the distal region of the auxiliary breaking structure, and then the proximal region of the auxiliary breaking structure is connected to the delivery system, so as to ensure that the enhanced connection structure can participate in the self-locking process of the locking member and play a certain fixing role.

[0027] In one embodiment, before closing the tissue defect, when operating the auxiliary breaking structure to drive the locking unit to rotate, the locking force F received by the auxiliary breaking structure 03 、the locking force F received by the locking unit 04 、the critical breaking force F3 of the auxiliary breaking structure, the critical breaking force F4 of the locking unit, and the critical breaking force F8 of the enhanced connection structure satisfy: F 03 <F3, F 03 =F 04 , F3<F4<F8; when the locking unit is gradually locked, the F 03 and the F 04 gradually increase, when the locking unit is completely locked, and further operating the auxiliary breaking structure, the F 03 reaches the F3, realizing the fracture separation of the auxiliary breaking structure. The advantage of this design is that during the process of ensuring that the locking members approach each other and achieve self-locking, the locking force is in a relatively low state, reducing the stimulation to the tissue. At the same time, as the locking process progresses, the critical breaking force of the release unit is lower than that of the locking unit, ensuring that fracture occurs at the release unit after complete locking, further limiting the fracture position. At the same time, the use of the enhanced connection structure can further ensure that the locking unit will not break prematurely, improving safety.

[0028] In one embodiment, the auxiliary breaking structure is connected to the locking member in one of the ways of penetration, sliding loop, and fixed loop.

[0029] In one embodiment, the locking unit and the enhanced connection structure are entangled and self-locked in the concentrated area to form a cable structure or a twisted structure, and the cable structure or the twisted structure has at least one turn.

[0030] In one embodiment, the enhanced connection structure is a polymer wire. After the free end of the polymer wire is connected to the fixing member by means of gluing, entanglement, knotting, mechanical connection, welding, etc.; the locking unit is a soft metal wire. The locking unit includes two locking members. After each locking member is connected to the fixing member by means of gluing, mechanical connection, welding, etc., it is twisted with the polymer wire; the release unit is operated to drive the locking member to rotate, and the locking members approach each other and achieve self-locking, thereby realizing the closure of the tissue defect; when the locking members achieve self-locking, the release unit is further operated, and the auxiliary fracture structure is further rotated, so that the auxiliary fracture structure is broken and separated from the locking member.

[0031] In one embodiment, the closing instrument includes a locking unit and a release unit located in the proximal region of the locking unit; the locking unit includes at least one or more locking members; the release unit includes an auxiliary operation structure; the release unit is operated to drive the locking members to rotate, and the locking members approach each other and achieve self-locking, thereby realizing the closure of the tissue defect; the locking unit and the release unit are connected. The auxiliary operation structure is operated to separate the release unit from the locking member. The advantages of such a design are as follows: The non-fracture release of the auxiliary operation structure is adopted, and the release operation does not damage the original structural components. The release method reaches an ideal state. The locking amplitude of the locking unit can be adjusted according to the anatomical shape of the defective tissue, so as to ensure that the defective tissue is in a relatively perfect closed state and the release mechanism is released and separated. The safety is high; the sheath tube can be controlled between 10Fr and 20Fr, which is suitable for the vast majority of patients.

[0032] In one embodiment, the auxiliary operation structure includes a fusible connection structure, a cryogenic brittle fracture connection structure, a cuttable connection structure, and a detachable connection structure provided in the proximal region of the release unit.

[0033] In one embodiment, the locking unit includes one or more fixing members located in the distal region of the locking member and connected to the locking member, and part or all of the fixing members are attached or anchored to the inner or distal outer surface of the target tissue; an enhanced connection structure is provided between the fixing members, and the enhanced connection structure connects multiple fixing members; the closing instrument includes a delivery system located in the proximal region of the release unit, and the enhanced connection structure is not connected to the delivery system; wherein, after the enhanced connection structure is connected to the proximal region of the release unit in a parallel structure, a twisted structure or a braided structure with the locking member, the distal region of the release unit is connected to the delivery system; or, the enhanced connection structure is independently free outside the proximal region or the entire region of the locking member.

[0034] In one embodiment, after part or all of the enhanced connection structure and the locking member are connected through a fixing structure to form a parallel structure and then connected to the distal region of the release unit, the proximal region of the release unit is connected to the delivery system, so as to ensure that the enhanced connection structure can participate in the self-locking process of the locking member and play a certain fixing role.

[0035] In one embodiment, before the tissue defect is closed, when the release unit is operated to drive the locking unit to rotate, the locking force F of the release unit 05 and the locking force F of the locking unit 06 , the critical breaking force F5 of the release unit, the critical breaking force F6 of the locking unit, and the critical breaking force F9 of the enhanced connection structure satisfy: F 05 <F5, F 05 =F 06 , F5<F6<F9. The advantage of this design is that when ensuring that the locking members approach each other and achieve the self-locking process, the locking force is in a relatively low state, reducing the stimulation to the tissue. At the same time, as the locking process progresses, the critical breaking force of the release unit is lower than that of the locking unit, ensuring that no fracture occurs at the locking unit after complete locking, further limiting the release position, so as to ensure that the release unit and the locking unit can be separated through the auxiliary operation structure. At the same time, the use of the enhanced connection structure can further ensure that the locking unit will not break prematurely, improving safety.

[0036] In one embodiment, the delivery system includes a locking mechanism, which includes a locking power source, a locking transmission rod, and a locking transmission structure fixedly connected to the distal end of the locking transmission rod; the delivery system includes a releasing mechanism, which includes a releasing power source and a releasing transmission medium; the locking mechanism is different from the releasing mechanism. After operating the locking power source to rotate the locking member to close the tissue defect, operate the releasing power source to separate the locking member from the releasing unit.

[0037] During pre-installation, the proximal region of the releasing unit is connected to the locking transmission structure and forms a concentrated region; when the locking power source is in operation, the locking member is linear and in a taut state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod, and then drives the locking transmission structure to twist forward, so that the releasing unit drives the locking member to rotate, and the locking unit is entangled and self-locked in the concentrated region.

[0038] In one embodiment, the locking unit and / or the enhanced connection structure are entangled and self-locked in the concentrated region to form a cable structure or a twisted structure, and the cable structure or the twisted structure has at least one turn.

[0039] In one embodiment, the fixing member includes a housing structure and / or an inner support structure from the outside to the inside; wherein, the fixing member is strip-shaped; one end or both ends of the fixing member are provided with a buffer structure, and the buffer structure includes one or more of a flexible variable diameter structure, a flexible small branch structure, a local thickening structure, an S-shaped structure, a corrugated structure, a spring structure, a ring, and a ball head, which can reduce the irritation or damage to the target tissue; when the fixing member includes an inner support structure, along the axial direction of the fixing member, the inner support structure is located in the middle section region or the entire section region of the housing structure; wherein, the inner support structure has a higher rigidity or bending modulus than the housing structure; the housing structure defines the relative positions of the distal end of the locking member and the inner support structure.

[0040] In one embodiment, the fixing member includes an inner support structure, the enhanced connection structure is a polymer wire, and the free end of the polymer wire is connected to the fixing member by means of gluing, entanglement, mechanical connection, welding, etc.; the locking unit is a soft metal wire, and the locking unit includes two locking members, and each locking member is connected to the inner support structure by means of gluing, mechanical connection, welding, etc. and then twisted with the polymer wire to form a shape.

[0041] In one embodiment, the fixing member or the housing structure is a plastic pipe or wire piece, which has good biocompatibility and can reduce the amount of metal implantation.

[0042] In a preferred embodiment, the fixing member or the housing structure is made of a special plastic, which mainly includes one or more of PEEK, PI, PPS, PSF, PAR, LCP, and PPSU.

[0043] In one embodiment, the special plastic is an implantable material.

[0044] In one embodiment, the inner support structure can improve the supportability of the housing structure.

[0045] In one embodiment, the inner support structure is located in the middle section area of the housing structure, and the two end areas of the housing structure are soft structures to prevent scratching of tissues.

[0046] In one embodiment, the fixing member is a circular tube or a circular rod, the material of the circular tube or the circular rod is an implantable metal material, and buffer structures are provided at both ends of the fixing member.

[0047] In one embodiment, the inner support structure is a metal wire with a diameter of 0.1 mm to 1 mm, and the metal wire includes one or more of nickel-titanium alloy, magnesium-based alloy, cobalt-chromium alloy, zinc-based alloy, iron-based alloy, titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, pure gold, pure tantalum, pure magnesium, and pure zinc.

[0048] In one embodiment, the fixing member includes an inner support structure, the inner support structure is formed by twisting multiple strands of metal wires, the two ends of the inner support structure are arc-shaped structures, and the arc-shaped structures are located at both ends of the fixing member as buffer structures. The enhanced connection structure and the locking unit are twisted together to form a fixed connection, where the enhanced connection structure and the locking unit are twisted together with the inner support structure inside the fixing member to form a fixed connection.

[0049] In one embodiment, an anchoring structure extending outside the locking member is provided on the locking member; wherein, the anchoring structure includes one or more combinations of micro-spike structures, local protrusion structures, and local flattening structures, which increases the anchoring effect and improves the friction force.

[0050] In one embodiment, a posture adjustment structure is provided between the fixing member and the locking member; when the fixing member and the locking member are stretched in the tissue defect area, the posture adjustment structure adjusts the angle between the fixing member and the locking member to make the fixing member contact the tissue to the greatest extent; wherein, the posture adjustment structure is a rotating structure, and the rotating mechanism includes one or more combinations of a chain structure, a hinge structure, and the elastic and / or plastic deformation of the material itself; or the posture adjustment structure is a sliding structure, and the sliding mechanism includes one or more combinations of a slider and a pulley.

[0051] In one embodiment, the locking member is connected to the release unit after being in a parallel structure, a twisted structure, or a braided structure.

[0052] In one embodiment, the locking unit tangles and self-locks in the centralized area to form a cable structure or a twisted structure, and the cable structure or the twisted structure has at least one turn.

[0053] In one embodiment, when the locking unit is locked, after the locking unit is in a closed state, it is connected to the release unit.

[0054] In one embodiment, the fixing member has a microporous structure; or the fixing member and / or the locking unit includes a covering member, and the covering member includes one of a coating, a polymer film, a polymer sheet, and a drug sustained-release structure.

[0055] In one embodiment, the delivery system includes a puncture needle. When the closing device is located within the delivery system, the locking unit includes a first free end located in the distal region of the locking member and a second free end located in the proximal region of the locking member. The first free end is provided with an abutting member, and the second free end is provided with a hooking member. The puncture needle has a preset shape. When the closing device is released, after the puncture needle passes through the secondary septum and then reversely passes through the primary septum, the puncture needle is retracted, the abutting member is released, and the locking transmission rod is operated to make the hooking member hook the abutting member; the release unit is operated to drive the locking member to rotate, and the locking members approach each other and self-lock, thereby closing the tissue defect; when the locking unit locks at the tissue defect, the locking unit is in a closed state as a whole and then connected to the release unit, and further operating the release unit causes the release unit to break and separate from the locking unit.

[0056] In one embodiment, the anchoring structure and the locking member have one or more combined structures of integral braiding, integral laser engraving, and post-processing connection.

[0057] In one embodiment, the closing of the tissue defect includes closing of the patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, etc.

[0058] In one embodiment, the locking unit is connected to the release unit. The proximal end of the locking unit includes a three-dimensional structure. When the locking power source drives the three-dimensional structure to rotate to lock the locking members, further operating the release unit causes the release unit to break and separate from the locking member.

[0059] In one embodiment, the locking unit is connected to the release unit. The auxiliary operating structure is a spherical structure and a rod-shaped structure passing through the spherical structure. After the proximal end of the locking member tangles and self-locks, the rod-shaped structure is removed to separate the locking unit from the release unit.

[0060] In one embodiment, the auxiliary operating structure is a shearer.

[0061] In one embodiment, the auxiliary operation structure is an electrolytic extractor.

[0062] In one embodiment, each locking member includes 1 - 20 filaments; wherein, each locking member is formed by parallel laying of multiple filaments, or each locking member is formed by twisting or braiding multiple filaments into a cable structure or a twist structure.

[0063] In one embodiment, the puncture needle has a substantially sharp distal end.

[0064] In one embodiment, the number and positions of the locking members and the fixing members correspond one by one; wherein, each locking member is composed of one filament.

[0065] In one embodiment, when the fixing member and the locking member are within the delivery system, the enhanced connection structure is in a "U" shape or a folded shape.

[0066] In one embodiment, the locking unit and the release unit are of an integral structure. The locking unit located in the centralized area self - locks to close the tissue defect. Further operating the release unit causes the release unit to break and separate from the locking unit. When the locking unit self - locks, it has the number of entanglement turns. The position with the densest number of entanglement turns is the first position, and the position when the locking unit and the release unit break and separate is the second position. The first position and the second position are not the same, and the second position is outside the proximal end of the first position.

[0067] In one embodiment, the release unit is provided with a detachable connection structure that cooperates with the delivery system.

[0068] In one embodiment, the delivery system includes at least a traction part and a pushing part. The traction part includes one or more puncture needles which have inner cavities, and the pushing part includes a push pin. First, the fixing member and the push pin are located within the inner cavity. The pushing part abuts against the proximal end of the fixing member through the push pin and drives the fixing member to extend out within the inner cavity, thereby ensuring that the configuration of the closing instrument within the delivery system has a very small cross - section, which is convenient for storage and accommodation. Second, the puncture needle penetrates the tissue wall, and the pushing of the push pin drives the fixing member to be released from the puncture needle. Finally, the release unit drives the locking member and then drives the fixing member to close the tissue defect, realizing the flexible connection between the fixing member and the locking member while improving the connection compliance, thereby ensuring complete closure of the foramen ovale.

[0069] In one embodiment, the traction part further includes a plurality of needle - controlling guide rails arranged outside the puncture needle, and the needle - controlling guide rails control the movement trajectory of the puncture needle and the piercing position on the tissue.

[0070] In one embodiment, after the fixing member is released from the inner cavity, the distal region of the locking member is connected to the fixing member through an attitude adjustment structure. The attitude adjustment structure adjusts the included angle between the fixing member and the locking member to maximize the contact between the fixing member and the tissue.

[0071] In one embodiment, the wire and the fixing member form an attitude adjustment structure through a rotating mechanism. The rotating mechanism includes one or more combinations of a chain structure, a hinge structure, and elastic and / or plastic deformation of the material itself.

[0072] In one embodiment, the locking member is connected to the fixing member through a hole groove or a limiting member to form an attitude adjustment structure.

[0073] In one embodiment, each fixing member is provided with an axial through hole and a groove connected to the through hole. The free end of the wire is fixedly connected to the distal region of the through hole and then extends out from the groove to form an attitude adjustment structure.

[0074] In one embodiment, the fixing member is provided with an axial U-shaped through hole, and the locking member passes through the U-shaped through hole in a ring shape to form an attitude adjustment structure.

[0075] In one embodiment, a through hole is provided in the middle of the fixing member, and the locking member and / or the enhanced connection structure can converge, tangle, and wind at the through hole to be fixedly connected to the fixing member to form an attitude adjustment structure.

[0076] In one embodiment, the free end of the wire and the fixing member form an attitude adjustment structure through a sliding mechanism. The sliding mechanism includes one or more combinations of a slider and a pulley.

[0077] In one embodiment, the fixing member and the locking member form an attitude adjustment structure through an elastic element.

[0078] In one embodiment, the locking transmission structure can cooperate with at least one puncture needle to control the action of the puncture needle passing through the tissue; or the locking transmission structure can cooperate with at least one fixing member to control the action of the fixing member fixing the tissue.

[0079] In one embodiment, the puncture needle and the needle control guide rail are both formed with corresponding side openings. The side openings allow the locking member to extend out and be connected to the locking transmission structure. The side openings provide a quick channel for the connection of the locking member, the fixing member, and the locking transmission structure, facilitating the release process of the closing instrument and simplifying the surgical operation process.

[0080] In one embodiment, the puncture needle is preferably made of a metal material, which has both rigidity and a certain degree of flexibility to facilitate piercing the tissue.

[0081] In one embodiment, the locking unit is a metal wire, and the material of the metal wire is an implantable flexible metal material.

[0082] In one embodiment, the closing device has a very low metal content.

[0083] In one embodiment, the locking transmission rod is made of a metal material or a polymer material and has good torsional properties.

[0084] In one embodiment, the auxiliary operation structure separates the release unit from the locking member through a hook.

[0085] In one embodiment, the tapered structure can be formed by gradually narrowing a single wire.

[0086] In another embodiment, the tapered structure can be formed by reducing the number of multiple filaments from more to less or by changing the number of multiple filaments in an interlaced manner from thick to thin and tightening.

[0087] In one embodiment, the maximum outer diameter of the thimble is 0.1 mm to 1 mm. The thimble has a certain rigidity, axial compression resistance, and certain mechanical support.

[0088] In one embodiment, the delivery system includes a delivery outer sheath and a control handle.

[0089] In one embodiment, the inner support structure can improve the strength of the fixing member, play a certain supporting role, ensure that the fixing member can complete compliant deformation with the wire twisting action, and prevent it from breaking.

[0090] In one embodiment, the anti-release force of the enhanced connection structure and the locking member in a parallel structure, a twisted structure, or a braided structure is increased by several times to dozens of times compared to the anti-release force of only the locking unit. With the continuous beating of the heart and the influence of blood pressure on the locking unit, the locking unit can be prevented from self-releasing; in addition, the anti-release force can be adjusted according to the proportion of the enhanced connection structure, the twisting method, and the braiding method of the enhanced connection structure and the locking member, so that the anti-release force can reach different levels.

[0091] In one embodiment, the delivery outer sheath is an adjustable bending sheath. By operating the control handle, the bending angle of the distal end of the delivery outer sheath can be adjusted, and the adjustment angle is 0 - 180°. Further, the control needle guide rail is provided with internal grooves, which can change compliantly with the angle change of the distal end of the delivery outer sheath to realize the bending function of the adjustable bending sheath for the instrument.

[0092] In one embodiment, a passage needs to be established in advance to ensure the smooth entry of the closing device.

[0093] In one embodiment, the delivery system is provided with a traction mechanism and a traction wire. By pulling the traction wire, the angle of the control needle guide rail can be further adjusted.

[0094] In one embodiment, after the tissue defect is closed, the fixing members are all located on the surface of the primary septum and the surface of the secondary septum within the left atrium.

[0095] In another embodiment, after the tissue defect is closed, the fixing members are all located on the surface of the primary septum within the left atrium.

[0096] In one embodiment, the puncture needle includes a lumen configured to allow the fixing member to slide therethrough.

[0097] In one embodiment, the distal portion of the needle control guide rail has a preset shape with a curved arc that can adjust the release angle of the puncture needle and is curved away from the central axis of the delivery system.

[0098] In one embodiment, the distal portion of the needle control guide rail has a cavity into which a curved mandrel can be inserted, and the distal portion of the needle control guide rail is bent in a desired manner by pulling a traction wire to adjust the release angle of the puncture needle.

[0099] In one embodiment, the delivery system is provided with an auxiliary positioning assembly that can assist in positioning the puncture needle, assist the puncture needle in positioning and passing through the defective tissue, improving the positioning reference and the surgical operation efficiency.

[0100] In one embodiment, the locking power source mainly includes a gear control device and a motor control device.

[0101] In one embodiment, the auxiliary positioning assembly includes a positioning disk or a positioning umbrella.

[0102] In one embodiment, the twist-like structure is helical.

[0103] Compared with the prior art, the advantages of the present invention are as follows:

[0104] 1. Taking the patent foramen ovale treatment surgery as an example, during the interventional treatment surgery, using a closure device to treat patent foramen ovale will bring some disadvantages. For example, the poor anchoring effect of the closure device leads to poor closure stability, or the high metal content of the closure device is likely to cause damage to human tissues. In addition, after the traditional closure device closes the patent foramen ovale, it faces the problem that transseptal puncture of the atrial septum cannot be treated by interventional methods. In an embodiment of the present invention, the release unit is operated to drive the locking member to rotate. The locking members approach each other and achieve self-locking, thereby realizing the closure of the tissue defect; the locking unit and the release unit are of an integral structure. When the locking members achieve self-locking, the release unit is further operated to cause the release unit to break and separate from the locking unit; or when the locking members achieve self-locking, the release unit is further operated, and the auxiliary fracture structure is further rotated, so that after the auxiliary fracture structure breaks, it separates from the locking member; or the proximal end of the locking unit is connected to the distal end of the release unit, and the auxiliary operation structure is operated to separate the release unit from the locking member; the operation is simple and convenient, and can achieve simple, rapid closure and release, improving the surgical efficiency, avoiding tying knots outside the body and then transporting them to the position of the patent foramen ovale in the body to complete the suture of the patent foramen ovale, improving the surgical efficiency and reducing the surgical risk.

[0105] 2. Different from the prior art, in an embodiment of the present invention, the fixing member includes a housing structure and / or an inner support structure from the outside to the inside. The fixing member or the housing structure is a plastic pipe or wire piece, which has good biocompatibility and can reduce the amount of metal implantation; the inner support plays a supporting role, improving the support strength and preventing the housing structure from deflecting and failing when being pulled.

[0106] 3. Different from the prior art, in an embodiment of the present invention, when the locking power source plays a role, while the locking power source drives the locking transmission rod to rotate, as the number of entanglement and self-locking turns of the locking members increases, the locking power source drives the locking transmission rod and then drives the locking transmission structure to twist forward, so that the locking members approach each other radially from the proximal end to the distal end. After that, the locking transmission rod will move distally relative to the control handle and can adapt to the rotation process of the locking members. During the whole process, the locking members are linear and in a straightened state, the locking transmission rod is in a straight state, and the locking power source can control the rotation and movement speed of the locking transmission rod, so as to ensure that the locking transmission rod can adaptively change according to the distance from the puncture needle, thereby improving the cooperation degree between the locking power source and the locking members, and better enabling the locking unit to exert the entanglement and self-locking effect in the concentrated area.

[0107] 4. Different from the prior art, in an embodiment of the present invention, before the tissue defect is closed, when the release unit is operated to drive the locking unit to rotate, the locking force F 01 received by the release unit and the locking force F 02, the critical breaking force F1 of the release unit, the critical breaking force F2 of the locking unit, and the critical breaking force F7 of the enhanced connection structure satisfy: F 01 <F1, F 01 =F 02 , F1<F2<F7; when the locking unit is gradually locked, the F 01 and the F 02 gradually increase; when the locking unit is completely locked, further operate the release unit, and the F 01 reaches the F1, realizing the fracture separation of the release unit. The advantage of this design is that it ensures that during the process of the locking parts approaching each other and achieving self-locking, the locking force is in a relatively low state, reducing the stimulation to the tissue. At the same time, as the locking process progresses, the critical breaking force of the release unit is lower than that of the locking unit, ensuring that the fracture occurs at the release unit after the defective tissue is completely locked, further limiting the fracture position. At the same time, the enhanced connection structure can further ensure that the locking unit does not break prematurely, improving safety.

[0108] 5. Different from the prior art, in an embodiment of the present invention, when the locking part realizes self-locking, further operate the release unit, and the proximal region of the locking unit is further rotated; before the locking unit and the release unit are fractured and separated, the two have a gradually narrowing structure from the distal end to the proximal end; or, in another embodiment of the present invention, the auxiliary operation structure includes a fusible connection structure, a low-temperature brittle fracture connection structure, a shear connection structure, and a detachable connection structure provided in the proximal region of the release unit. Both embodiments can accurately locate the fracture separation position of the locking part and the release unit, making the disconnection self-locking position closer to the locking transmission structure and farther away from the fixing part, so as to better play the fixing role of the implant on the closure of the foramen ovale.

[0109] 6. Different from the prior art, in an embodiment of the present invention, the locking unit and / or the enhanced connection structure are entangled in the concentrated area to form a cable structure or a twist structure. The operation is simple, avoiding the traditional problem that because the metal suture is very thin, it is difficult to see clearly under the cardiac angiography state, resulting in difficulty in hooking the puncture needle and easy to cause difficult surgical operations. In addition, the entanglement self-locking action increases the friction force, improves the contact degree with the tissue, reduces the damage to the tissue, improves the fatigue resistance, and plays a self-breaking and complementary effect, reducing the risk of the fixing part falling into the left atrium.

[0110] 7. Different from the prior art, in an embodiment of the present invention, an enhanced connection structure is provided between several fixing members, and the enhanced connection structure connects all the fixing members; when the closing device is in the first form, the enhanced connection structure is a "U" - shaped structure or a folded structure, and the enhanced connection structure has an anti - detachment effect, which can prevent the fixing member and the locking member from disconnecting during the percutaneous closure of the patent foramen ovale, or prevent the self - locking force between the locking members from being insufficient after the release unit and the locking unit are fractured and separated, thus avoiding the risk of the closing device falling into the left atrium, and improving the safety and reliability of the surgical operation process.

[0111] 8. Different from the prior art, in an embodiment of the present invention, the attitude adjustment structure adjusts the angle between the fixing member and the locking member to maximize the contact of the fixing member with the tissue, providing additional clinical benefits.

[0112] 9. Different from the prior art, in an embodiment of the present invention, the enhanced connection structure is a polymer wire, which is twisted together with the locking member and used in cooperation with an auxiliary fracture structure. The auxiliary fracture structure is connected to the proximal end of the locking unit. On the one hand, the enhanced connection structure provides a twisting axis for twisting and participates in the twisting, which can increase the connection force of the locking unit and reduce the risk of the fixing member falling off into the left atrium due to the premature fracture of the locking unit. When the locking member realizes self - locking, further operating the release unit, the auxiliary fracture structure is further rotated, so that after the auxiliary fracture structure is fractured, it is separated from the locking member, which can ensure that the fracture and separation occur at the position of the auxiliary fracture structure with accurate positioning.

[0113] 10. Different from the prior art, in an embodiment of the present invention, a covering member is provided outside the fixing member, and the covering member includes one of a coating, a polymer film, a polymer sheet, and a drug - slow - release structure. The covering member can increase the contact area between the fixing member and the tissue, promote the crawling of the inner epidermis, and prevent the tissue from being damaged.

[0114] 11. Different from the prior art, in an embodiment of the present invention, the enhanced connection structure and the locking member are in a parallel structure, a twisted structure or a braided structure. Compared with the case where there is only the locking member, the anti - release force of the locking unit is greatly improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0115] Figure 1a It is a schematic diagram of the state where the closing device in the first embodiment of the present invention is loaded and restricted within the delivery system.

[0116] Figure 1b It is a schematic diagram of the state where the locking member in the second embodiment of the present invention is provided with an anchoring structure.

[0117] Figure 1c and Figure 1dSchematic diagram of the state when the locking unit is connected to the release unit in a gradually narrowing structure from the distal end to the proximal end in various embodiments of the present invention.

[0118] Figure 1e Schematic diagram of the state when a reinforcement connection structure is provided between the fixing members in an embodiment of the present invention.

[0119] Figures 2a - 2e Schematic diagram of the process of the release unit breaking away from the locking unit after the locking units approach each other to achieve self-locking in Embodiment 1 of the present invention.

[0120] Figure 2f Schematic diagram of the state when the locking member has a parallel structure in an embodiment of the present invention.

[0121] Figure 2g Schematic diagram of the state when the locking member is twisted or braided into a cable structure or a twisted structure in Embodiment 1 of the present invention.

[0122] Figure 3 Schematic diagram of the state when the auxiliary operation structure is a detachable connection structure in Embodiment 2 of the present invention.

[0123] Figures 4a - 4l Schematic diagram of the state of the attitude adjustment structure in various embodiments of the present invention.

[0124] Figure 5a Schematic diagram of the state when the closing instrument is in the first form in various embodiments of the present invention.

[0125] Figures 5b - 5c Schematic diagram of the state when the needle control guide rail is angle-adjusted by the traction mechanism in Embodiment 2 of the present invention.

[0126] Figures 6a - 6i Schematic diagram of the steps in the surgical operation process in Embodiment 1 of the present invention.

[0127] Figure 7 Schematic diagram of the positional relationship between the locking power source and the delivery system in various embodiments of the present invention.

[0128] Figures 8a - 8f Schematic diagram of the state of the auxiliary operation structure in various embodiments of the present invention.

[0129] Figure 9 Schematic diagram of the state when the release unit includes an auxiliary fracture structure in an embodiment of the present invention.

[0130] Figure 10 Schematic diagram of the state when the release unit includes an auxiliary fracture structure in another embodiment of the present invention.

[0131] Figure 11a and Figure 11bSchematic diagram of the process when the locking unit is in a closed state in Embodiment 3 of the present invention.

[0132] Figures 12a - 12c Schematic diagram of the process of the puncture needle puncturing the primary septum and the secondary septum in Embodiment 3 of the present invention.

[0133] Figures 13a - 13d Schematic diagram of the process state when the enhanced connection structure and the locking unit are twisted together and cooperate with the auxiliary fracture structure in Embodiment 4 of the present invention.

[0134] Figures 14a - 14b Schematic diagram of various connection methods between the enhanced connection structure and the locking unit in Embodiment 4 of the present invention.

[0135] Figure 14c Schematic diagram of the state of the inner support structure in an embodiment of the present invention.

[0136] The names of the parts referred to by the numbers in the drawings are as follows:

[0137] 11 - locking unit, 12 - locking member, 121 - hooking member, 122 - abutting member, 13 - release unit, 14 - attitude adjustment structure, 15 - anchoring structure, 16 - enhanced connection structure, 17 - fixing member, 21 - locking power source, 22 - locking transmission rod, 23 - locking transmission structure, 24 - hook, 25 - concentrated area, 31 - puncture needle, 32 - thimble, 33 - needle control guide rail, 34 - traction mechanism, 35 - traction wire, 4 - delivery outer sheath, 5 - control handle, 6 - tapered structure, 7 - auxiliary operation structure, 8 - auxiliary fracture structure, 9 - inner support structure, 91 - buffer structure. Detailed implementation manners

[0138] The present invention will be further described in detail below in conjunction with the drawings and embodiments.

[0139] In the present invention, the term "proximal end" refers to the end close to the surgeon when the implantable device is compressed and loaded in the delivery system during pre - installation, and the "distal end" refers to the end far from the surgeon when the implantable device is compressed and loaded in the delivery system during pre - installation.

[0140] Embodiment 1:

[0141] In this embodiment, the closing device includes a locking unit 11 and a releasing unit 13 located in the proximal region of the locking unit 11; the locking unit 11 includes at least one or more locking members 12; by operating the releasing unit 13, the locking members 12 are driven to rotate, and the locking members 12 approach each other and achieve self-locking, thereby closing the tissue defect; the locking unit 11 and the releasing unit 13 are of an integral structure. When the locking members 12 achieve self-locking, by further operating the releasing unit 13, the releasing unit 13 is broken and separated from the locking unit 11, as Figures 2a - 2e shown. The advantages of such a design are as follows: simple structure, low risk, few components, convenient manufacturing, high production efficiency, low cost and short cycle for the whole set of products; the amount of metal implantation can be limited to the greatest extent, with less tissue irritation and good biocompatibility; at the same time, it is convenient to release. By further rotating the releasing unit 13 and preferentially selecting the rotational release method, the releasing unit 13 can be broken and separated from the locking unit 11. The operating action is simple, and after breaking, there will be a good tactile feedback at the locking transmission rod 22, and it can be immediately evaluated whether it is completely broken and released, without the need for additional operating instruments for detection, short intraoperative operation time, and short doctor learning curve; in addition, the delivery sheath has a small diameter, causing little damage to human blood vessels, and is especially suitable for special populations such as underage patients with small blood vessels.

[0142] In another embodiment, each locking member 12 includes 1-20 filaments; wherein, each locking member 12 is formed by parallel laying of multiple filaments, or each locking member 12 is formed by twisting or braiding multiple filaments into a cable structure or a twist structure, as Figure 2f shown.

[0143] In this embodiment, as Figure 1c or Figure 1d shown, when the locking members 12 achieve self-locking, by further operating the releasing unit 13, the proximal region of the locking unit 11 is further rotated; before the locking unit 11 and the releasing unit 13 are broken and separated, the two are of a gradually narrowing structure 6 from the distal end to the proximal end.

[0144] In this embodiment, the locking unit 11 includes one or more fixing members 17, the fixing members 17 are located in the distal region of the locking members 12 and are connected to the locking members 12, and part or all of the fixing members 17 are attached or anchored to the inside or the distal outer surface of the target tissue.

[0145] In this embodiment, the closing device includes a delivery system, the delivery system is located in the proximal region of the releasing unit 13 or the locking unit 11; the locking unit 11 or the releasing unit 13 is connected to the delivery system.

[0146] In this embodiment, before the tissue defect is closed, when the release unit 13 is operated to drive the locking unit 11 to rotate, the locking force F of the release unit 13 01 and the locking force F of the locking unit 11 02 , the critical fracture force F1 of the release unit 13, and the critical fracture force F2 of the locking unit 11 satisfy: F 01 <F1, F 01 =F 02 , F1<F2; when the locking unit 11 is gradually locked, the F 01 and the F 02 gradually increase. When the locking unit 11 is completely locked and the release unit 13 is further operated, the F 01 reaches the F1, and the release unit 13 is fractured and separated.

[0147] In this embodiment, the values of F 01 , F 02 , F1, and F2 are all between 0.1 N and 10 N.

[0148] In this embodiment, the conveying system includes a locking mechanism. The locking mechanism includes a locking power source 21, a locking transmission rod 22, and a locking transmission structure 23 fixedly connected to the distal end of the locking transmission rod 22; the conveying system includes a release mechanism. The release mechanism includes a release power source and a release transmission medium; during pre-installation, the proximal region of the release unit 13 is connected to the locking transmission structure 22 to form a concentrated region 25; when the locking power source 21 functions, the locking member 12 is in a linear and taut state, the locking transmission rod 22 is in a straight state, the locking power source 21 drives the locking transmission rod 22 and then drives the locking transmission structure 22 to twist forward, so that the release unit 13 drives the locking member 12 to rotate, and the locking unit 11 is entangled and self-locked in the concentrated region 25.

[0149] In this embodiment, the locking mechanism is the release mechanism, the locking power source 21 is the release power source, and the locking unit 11 or the release unit 13 is entangled and self-locked in the concentrated region 25 to form a cable structure or a twisted structure, and the cable structure or the twisted structure has at least one turn.

[0150] In this embodiment, as Figure 1a shown, the locking unit 11 includes two locking members 12; the numbers and positions of the locking members 12 and the fixing members 17 correspond one by one.

[0151] In this embodiment, as Figure 1a shown, the two locking members 12 are respectively formed by three wire materials into a twisted structure or a braided structure.

[0152] In this embodiment, the locking members 12 together form a twisted structure.

[0153] In this embodiment, during preloading, as Figure 1a shown, the closing device is linearly loaded and restricted within the delivery system.

[0154] In this embodiment, the fixing member 17 and the locking members 12 are stretched in the tissue defect area, and the attitude adjustment structure 14 adjusts the angle between the fixing member 17 and the locking members 12.

[0155] In this embodiment, the locking members 12 are connected to the fixing member through holes or limit members to form the attitude adjustment structure 14, as Figures 4a - 4b shown.

[0156] In another embodiment, each fixing member 17 is provided with an axial through hole and a groove connected to the through hole. The free end of the wire is fixedly connected to the distal region of the through hole and then extends out from the groove to form the attitude adjustment structure 14, as Figures 4c - 4d shown.

[0157] In another embodiment, the fixing member 17 is provided with an axial U-shaped through hole, and the locking members 12 pass through the U-shaped through hole in a ring shape to form the attitude adjustment structure 14, as Figures 4e - 4f shown.

[0158] In another embodiment, a through hole is provided in the middle of the fixing member 17, and the locking members 12 and / or the enhanced connection structure 16 can converge, tangle, and wind at the through hole to achieve a fixed connection with the fixing member 17 to form the attitude adjustment structure 14, as Figures 4g - 4h shown.

[0159] In another embodiment, the free end of the wire and the fixing member 17 form the attitude adjustment structure 14 through a sliding mechanism, and the sliding mechanism includes one or a combination of a slider and a pulley, as Figures 4i - 4j shown.

[0160] In another embodiment, the fixing member 17 and the locking members 12 form the attitude adjustment structure 14 through an elastic element, as Figures 4k - 4l shown.

[0161] In this embodiment, the tissue defect closure is for the closure of the foramen ovale defect.

[0162] In this embodiment, the delivery system includes a delivery outer sheath 4 and a control handle 5.

[0163] In this embodiment, the locking transmission rod 22 connects the locking power source 21 and the control handle 5.

[0164] In this embodiment, the locking unit 11 located in the concentrated area 25 can be tangled and self-locked and then disconnected.

[0165] In this embodiment, as shown in Figure 5, the delivery system includes a traction part and a pushing part. The traction part includes two puncture needles 31, and the puncture needles 31 have inner cavities. The pushing part includes a push pin 32. When the closing instrument is in the first form, the fixing member 17 and the push pin 32 are located within the inner cavity. The pushing part abuts against the proximal end of the fixing member 17 through the push pin 32 and drives the fixing member 17 to extend out within the inner cavity. When the closing instrument is in the second form, the puncture needles 31 penetrate the tissue wall, and the push pin 32 is pushed to drive the fixing member 17 to be released from the puncture needles. When the closing instrument is in the third form, the release unit 13 drives the locking member 12, and further drives the fixing member 17 to close the tissue defect.

[0166] In this embodiment, the traction part further includes a plurality of needle control guides 33 arranged outside the puncture needles 31, and the needle control guides 33 control the movement trajectory of the puncture needles 31 and the piercing positions on the tissue.

[0167] In this embodiment, the puncture needles 31 have substantially sharp distal ends.

[0168] In this embodiment, after the fixing member 17 is released from the inner cavity, the distal region of the locking member 12 is connected to the fixing member 17 through the attitude adjustment structure 14. The attitude adjustment structure 14 adjusts the angle between the fixing member 17 and the locking member 12 and enables the fixing member 17 to contact the tissue to the greatest extent. Among them, the locking member 12 and the fixing member 17 form the attitude adjustment structure 14 through a rotating mechanism, and the rotating mechanism includes one or a combination of a chain structure, a hinge structure, the elastic and / or plastic deformation of the material itself.

[0169] In this embodiment, a through hole is provided in the middle of the fixing member 17, and the locking member can converge, entangle, and wind around the through hole to form a fixed connection with the fixing member 17 to form the attitude adjustment structure 14, as Figures 4g - 4h shown.

[0170] In this embodiment, the puncture needles 31 are preferably made of nitinol tube alloy material.

[0171] In this embodiment, the locking transmission rod 22 has good torsional and transmission properties. When the operation control handle 5 rotates the locking transmission rod 22 to drive the locking member 12 to complete the self-locking of the locking member 12, the locking transmission rod 22 further drives the release unit 13, so that the release unit 13 is broken and separated from the locking unit 11.

[0172] In this embodiment, the puncture needles 31 are preferably made of nitinol tube alloy material and have good flexibility to facilitate the needle-out movement.

[0173] In this embodiment, the fixing member 17 is a round tube or a round bar, and the material of the round tube or the round bar is an implantable metal material. Buffer structures are provided at both ends of the fixing member 17, and the buffer structures include one or more of a flexible diameter-changing structure, a flexible thin-branch structure, a locally thickened structure, an S-shaped structure, a corrugated structure, a spring structure, a ring, and a ball head.

[0174] In this embodiment, the locking member 12 is a metal wire, and the material of the metal wire is an implantable flexible metal material.

[0175] In this embodiment, the metal content of the fixing member 17 and the locking member 12 is very small.

[0176] In this embodiment, the locking transmission rod 22 is made of a metal material or a polymer material and has good torsional properties.

[0177] In this embodiment, the tapered structure 6 of each locking unit 11 is formed by tightening three strands of wire materials with the number decreasing from more to less.

[0178] In this embodiment, after the locking member 12 is in a twisted structure, it is connected to the release unit 13.

[0179] In this embodiment, the locking units 11 are entangled and self-locked in the concentrated area 25 to form a cable structure or a twisted structure, and the cable structure or the twisted structure is at least one turn.

[0180] In this embodiment, the locking unit 11 and the release unit 13 are of an integral structure. The locking unit 11 located in the concentrated area 25 is self-locked to close the tissue defect. By further operating the release unit 13, the release unit 13 is broken and separated from the locking unit 11. Among them, when the locking unit 11 is self-locked, it has a number of entanglement turns. The position with the densest number of entanglement turns is the first position, and the position when the locking unit 11 and the release unit 13 are broken and separated is the second position. The first position and the second position are not the same, and the second position is located outside the proximal end of the first position.

[0181] In this embodiment, after the release unit 13 drives the locking member 12 and then drives the fixing member 17 to close the tissue defect, the fixing members 17 are all located on the surface of the primary septum and the secondary septum in the left atrium.

[0182] In this embodiment, the maximum outer diameter of the thimble 32 is 0.1 mm to 1 mm. The thimble has a certain rigidity, has axial compression resistance, and has a certain mechanical support.

[0183] In this embodiment, the delivery system at least includes a traction part and a pushing part. The traction part includes one or more puncture needles 31 which have inner cavities, and the pushing part includes a thimble 32. First, the fixing member 17 and the thimble 32 are located inside the inner cavity. The pushing part abuts against the proximal end of the fixing member 17 through the thimble and drives the fixing member 17 to extend out inside the inner cavity, so as to ensure that the configuration of the closing instrument in the delivery system has a very small cross-section, which is convenient for storage and accommodation. Secondly, the puncture needle 31 penetrates the tissue wall, and the pushing thimble 32 drives the fixing member 17 to be released from the puncture needle 31. Finally, the release unit 13 drives the locking member 12 and then drives the fixing member 17 to close the tissue defect, realizing the flexible connection between the fixing member 17 and the locking member 12 while improving the connection compliance, so as to ensure that the foramen ovale is completely closed.

[0184] In this embodiment, the traction part further includes a plurality of needle control guides 33 arranged outside the puncture needle 31, and the needle control guides 33 control the movement trajectory of the puncture needle 31 and the piercing position on the tissue.

[0185] In this embodiment, the puncture needle 31 and the needle control guides 33 are both formed with corresponding side openings. The side openings allow the locking member 12 to extend out and be connected to the locking transmission structure 23. The side openings provide a quick channel for the connection of the locking member 12, the fixing member 17 and the locking transmission structure 23, facilitating the release process of the closing instrument and simplifying the surgical operation process.

[0186] In this embodiment, the locking transmission structure 22 can cooperate with at least one fixing member to complete the control of the action of the fixing member for fixing the tissue.

[0187] In this embodiment, the puncture needle 31 is preferably made of a metal material, which has both rigidity and a certain degree of flexibility to facilitate piercing the tissue.

[0188] In this embodiment, the delivery system includes a delivery outer sheath 4 and a control handle 5.

[0189] In this embodiment, the puncture needle 31 includes an inner cavity, and the inner cavity is configured to enable the fixing member to slide inside it.

[0190] In this embodiment, the distal part of the needle control guide 33 has a preset shape, which has a bending arc and can adjust the release angle of the puncture needle 31, and it bends in a direction away from the central axis of the delivery system.

[0191] The operation process steps of this embodiment during the operation are as follows (as Figures 6a - 6i shown):

[0192] (1)Percutaneously puncture, reserve a guide wire at the tissue defect site, deliver the closing device along the guide wire through the femoral vein to the right atrium, and then to the unclosed patent foramen ovale between the secondary septum and the primary septum near the atrial septum, and make the end of the guiding head at the distal end of the closing device pass through the patent foramen ovale to limit its position;

[0193] (2)Operate the control handle 5, slowly withdraw the delivery outer sheath 4 and push the needle control guide rail 33 through the control handle 5 to expose the two needle control guide rails 33, and make the two needle control guide rails 33 located on both sides of the patent foramen ovale respectively. Operate the control handle 51 to make the puncture needle 31 penetrate the tissue wall;

[0194] (3)After the puncture needle 31 completes the needle exit action, operate the thimble 32 to release the fixing member 17 from the needle control guide rail 33. Withdraw the needle control guide rail 33 and the puncture needle 31, and then withdraw the guiding head. Operate the control handle 5 to make the locking transmission rod 22 drive the locking transmission structure 23 to achieve the disconnection and self-locking of the locking unit 11, and then withdraw the delivery system to complete the surgical procedure.

[0195] Embodiment 2:

[0196] The difference from Embodiment 1 is that:

[0197] In this embodiment, as Figure 3 shown, the locking unit 11 includes two locking members 12, and the release unit 13 and the locking transmission structure 23 form a detachable connection structure.

[0198] In this embodiment, each locking unit 11 is composed of a wire.

[0199] In this embodiment, the release unit 13 includes an auxiliary operation structure 7. The auxiliary operation structure 7 is a detachable connection structure formed by the hook 24 and the proximal region of the release unit 13. The advantage of this design is that: the non-breaking release of the auxiliary operation structure 7 is adopted, and the release operation does not damage the original structural components. The release method reaches an ideal state, and the locking amplitude of the locking unit 11 can be adjusted according to the anatomical shape of the defect tissue, so as to ensure that the defect tissue is in a relatively perfect closed state to realize the release and separation of the release mechanism, with high safety; the sheath tube can be controlled between 10Fr - 20Fr, which is suitable for the vast majority of patients.

[0200] In another embodiment, the locking unit 11 is connected to the release unit 13. The proximal end of the locking unit 11 includes a three-dimensional structure. When the locking power source 21 drives the three-dimensional structure to rotate to make the locking member 12 achieve self-locking, further operate the release unit 13 to make the release unit 13 break and separate from the locking member 12. As Figure 8a shown.

[0201] In another embodiment, the locking unit 11 is connected to the releasing unit 13. The auxiliary operation structure 7 is a spherical structure and a rod-shaped structure passing through the spherical structure. After the proximal end of the locking member 12 is entangled and self-locked, the rod-shaped structure is removed to separate the locking unit 11 from the releasing unit 13, as Figure 8b shown.

[0202] In another embodiment, the auxiliary operation structure 7 is a shearer, as Figure 8c and 8d shown.

[0203] In another embodiment, the auxiliary operation structure 7 is an electrolytic release device, as Figure 8e and 8f shown.

[0204] In this embodiment, the conveying system is provided with a traction mechanism 34 and a traction wire 35. By pulling the traction wire 35, the angle of the needle control guide rail 33 can be further adjusted, as Figure 5b and 5c shown.

[0205] In this embodiment, as Figure 1b shown, an anchoring structure is provided on the locking member 12; wherein, the anchoring structure is an anchor barb, which increases the anchoring effect and improves the friction force.

[0206] In this embodiment, as Figures 4i - 4j shown, the locking member 12 and the fixing member 17 form an attitude adjustment structure 14 through a sliding mechanism, and the sliding mechanism includes one of a slider and a pulley.

[0207] The operation process steps of this embodiment during the operation are as follows:

[0208] (1) Percutaneous puncture, leaving a guide wire reserved at the tissue defect site, and conveying the closing instrument along the guide wire through the femoral vein to the right atrium, and then to the unclosed foramen ovale between the secondary septum and the primary septum near the atrial septum, and making the end of the guiding head at the distal end of the closing instrument pass through the foramen ovale to limit its position;

[0209] (2) Operating the control handle 5, the bending angle adjustment of the distal end of the conveying outer sheath 4 can be realized. Slowly withdraw the conveying outer sheath 4 and push the needle control guide rail 33 through the control handle 5 to expose the two needle control guide rails 33, and make the two needle control guide rails 33 located on both sides of the foramen ovale respectively. Operate the control handle 51 to make the puncture needle penetrate the tissue;

[0210] (3) After the puncture needle 31 completes the needle-out action, operate the thimble 32 to release the fixing member 17 from the needle control guide rail 33. Withdraw the needle control guide rail 33 and the puncture needle 31 and then withdraw the guiding head. Operate the control handle 5 to release the detachable connection structure between the releasing unit 13 and the hook 24, and withdraw the conveying system to complete the operation process.

[0211] Example 3:

[0212] The difference from Example 1 is that:

[0213] In this embodiment, the delivery system includes a puncture needle 31. When the closing device is located within the delivery system, the locking unit 11 includes a first free end located in the distal region of the locking member and a second free end located in the proximal region of the locking member. The first free end is provided with an abutting member 122, and the second free end is provided with a hooking member 121. The puncture needle 31 has a preset shape, such as Figures 12a - 12c as shown. When the closing device is released, after the puncture needle 31 passes through the secundum and then reversely passes through the primum, the puncture needle 31 is retracted, the abutting member is released, and the locking transmission rod 22 is operated to make the hooking member 121 hook the abutting member 122; the release unit 13 is operated to drive the locking member 12 to rotate, and the locking members 12 approach each other and self-lock, thereby realizing the closure of the tissue defect; when the locking unit 11 locks at the tissue defect, the locking unit 11 is integrally in a closed state and then connected to the release unit 13, and further operating the release unit 13 causes the release unit 13 to break away from the locking unit 11, as Figures 11a - 11b shown.

[0214] In this embodiment, as Figure 11b shown, when the locking unit 11 locks, the locking unit 11 is in a closed state and then connected to the release unit 13.

[0215] Example 4:

[0216] The difference from Example 1 is that:

[0217] In this embodiment, the closing instrument includes a locking unit 11 and a release unit 13 located in the proximal region of the locking unit 11; the locking unit 11 includes at least one or more locking members 12; the release unit 13 includes an auxiliary fracture structure 8, and the distal end of the auxiliary fracture structure 8 is connected to the proximal end of the locking member 12; operating the release unit 13 causes the auxiliary fracture structure 8 to drive the locking member 12 to rotate, and the locking members 12 approach each other and achieve self-locking to lock, thereby achieving the closure of the tissue defect; when the locking members 12 achieve self-locking, further operating the release unit 13, the auxiliary fracture structure 8 is further rotated, so that the auxiliary fracture structure 8 breaks and separates from the locking member 12. The advantages of this design are as follows: With the design of the auxiliary fracture structure 8, the fracture position of the instrument after tissue closure can be further defined, making the fracture position safe and reliable. The fracture position can be accurately defined at the auxiliary fracture structure 8, ensuring that the implanted part of the closing instrument is in the best state; at the same time, the locking members 12 apply force evenly during the closure of the tissue defect, avoiding additional local tissue defects caused by uneven force at the tissue defect; in addition, the delivery sheath has a small diameter and causes little damage to the human blood vessels, especially suitable for special populations such as underage patients with small blood vessels.

[0218] In another embodiment, the auxiliary fracture structure 8 is connected to the locking member 12 in one of the ways of penetration, sliding ring sleeve, and fixed ring sleeve, such as Figure 9 or Figure 10 shown.

[0219] In this embodiment, an enhanced connection structure 16 is provided between the fixing members 17, and the enhanced connection structure 16 connects all the fixing members 17; and the locking member 12 is connected to the delivery system; the enhanced connection structure 16 is not connected to the delivery system; after the enhanced connection structure 16 and the locking member 12 form a twisted structure and are connected to the proximal region of the auxiliary fracture structure 8, the distal region of the auxiliary fracture structure 8 is connected to the delivery system, such as Figure 13a shown.

[0220] In this embodiment, before the tissue defect is closed, when operating the auxiliary fracture structure 8 to drive the locking unit 11 to rotate, the locking force F 03 received by the auxiliary fracture structure 8, the locking force F 04 received by the locking unit 11, the critical fracture force F3 of the auxiliary fracture structure 8, the critical fracture force F4 of the locking unit 11, and the critical fracture force F8 of the enhanced connection structure 16 satisfy: F 03 < F3, F 03 = F 04 , F3 < F4 < F8; when the locking unit 11 is gradually locked, the F03 and the F 04 gradually increases. When the locking unit 11 is fully locked and the auxiliary fracture structure 8 is further operated, the F 03 reaches the critical fracture force F3, and the auxiliary fracture structure 8 is fractured and separated.

[0221] In this embodiment, the locking unit 11 and the enhanced connection structure 16 are entangled and self-locked in the concentrated area to form a cable structure or a twisted structure, and the cable structure or the twisted structure has at least one turn.

[0222] In this embodiment, as Figure 14b shown, the fixing member 17 includes a housing structure and an inner support structure 9 from outside to inside; wherein, the fixing member 17 is strip-shaped; one end or both ends of the fixing member 17 are provided with a buffer structure, and the buffer structure includes one or more of a flexible diameter-changing structure, a flexible thin branch structure, a local thickening structure, an S-shaped structure, a corrugated structure, a spring structure, a ring, a ball head, etc., which can reduce the irritation or damage to the target tissue; when the fixing member 17 includes the inner support structure 9, along the axial direction of the fixing member 17, the inner support structure 9 is located in the entire area of the housing structure; wherein, the inner support structure 9 has a higher rigidity or bending modulus than the housing structure; the housing structure defines the relative positions of the distal end of the locking member 12 and the inner support structure 9.

[0223] In another embodiment, the enhanced connection structure 16 is a polymer wire. After the free end of the polymer wire is connected to the fixing member 17 by means of adhesion, entanglement, knotting, mechanical connection, welding, etc.; the locking unit 11 is a soft metal wire, and the locking unit 11 includes two locking members 12. After each locking member 12 is connected to the fixing member 17 by means of adhesion, mechanical connection, welding, etc., it is twisted and formed with the polymer wire, as Figure 14a shown

[0224] In another embodiment, the fixing member 17 includes an inner support structure 9, and the inner support structure 9 is formed by twisting multiple strands of metal wires. Both ends of the inner support structure 9 are arc-shaped structures, and the arc-shaped structures are located at both ends of the fixing member 17 as buffer structures 91. The enhanced connection structure 16 and the locking unit 11 are twisted and formed together. Among them, the enhanced connection structure 16 and the locking unit 11 are twisted and fixedly connected with the inner support structure 9 in the fixing member 17, as Figure 14c shown.

[0225] In another embodiment, as Figure 1e shown, when the fixing member 17 and the locking member 12 are in the delivery system, the enhanced connection structure 16 is in a "U" shape structure or a folded shape structure.

[0226] In this embodiment, the housing structure is made of special plastics, which mainly includes one or more of PEEK, PI, PPS, PSF, PAR, LCP, and PPSU.

[0227] In this embodiment, the inner support structure 9 can improve the supportability of the housing structure.

[0228] In this embodiment, the inner support structure 9 is located in the entire region of the housing structure, and the two end regions of the housing structure are soft structures to prevent scratching of tissues.

[0229] In this embodiment, the inner support structure 9 is a metal wire with a diameter of 0.1 mm to 1 mm, and the metal wire includes one or more of nitinol alloy, magnesium-based alloy, cobalt-chromium alloy, zinc-based alloy, iron-based alloy, titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, pure gold, pure tantalum, pure magnesium, and pure zinc.

[0230] In this embodiment, the enhanced connection structure 16 is a polymer wire. After the free end of the polymer wire is connected to the fixing member 17 by means of adhesion, entanglement, knotting, mechanical connection, welding, etc.; the locking unit 11 is a soft metal wire, and the locking unit 11 includes two locking members 12. After each locking member 12 is connected to the fixing member 17 by means of adhesion, mechanical connection, welding, etc., it is twisted with the polymer wire, as Figure 14a shown; operating the release unit 13 causes the auxiliary fracture structure 8 to drive the locking member 12 to rotate, and the locking members 12 approach each other and achieve self-locking, thereby realizing the closure of the tissue defect; when the locking members 12 achieve self-locking, further operating the release unit 13 causes the auxiliary fracture structure 8 to be further rotated, so that the auxiliary fracture structure 8 fractures and separates from the locking members 12, as Figures 13a - 13d shown.

[0231] The above content is only a preferred embodiment of the present invention. For those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manner and application scope. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. Closure device for atrial septal defect, characterized in that: The closing device includes a locking unit and a release unit located in the proximal region of the locking unit; the locking unit includes at least one or more locking members; operating the release unit drives the locking members to rotate, the locking members approach each other and achieve self-locking to lock, thereby achieving the closure of the atrial septal defect; the locking unit and the release unit are of an integral structure, when the locking members achieve self-locking, further operating the release unit causes the release unit to break and separate from the locking unit; before the locking unit and the release unit break and separate, the two are of a gradually narrowing structure from the distal end to the proximal end; when the locking members achieve self-locking, further operating the release unit, the proximal region of the locking unit is further rotated, causing the release unit to break and separate from the locking unit; the locking unit includes one or more fixing members, the fixing members are located in the distal region of the locking members and are connected to the locking members, and part or all of the fixing members are attached or anchored to the inside or the distal outer surface of the target tissue; an enhanced connection structure is provided between the fixing members, and the enhanced connection structure connects multiple fixing members; the enhanced connection structure is a flexible metal material or a polymer material; the closing device includes a delivery system, the delivery system is located in the proximal region of the release unit or the locking unit; the locking unit or the release unit is connected to the delivery system; the enhanced connection structure is not connected to the delivery system and is independently free outside the proximal region or the entire region of the locking members.

2. The closure device for atrial septal defect according to claim 1, characterized in that: Before the atrial septal defect is closed, when operating the release unit to drive the locking unit to rotate, the locking force F01 on the release unit, the locking force F02 on the locking unit, the critical breaking force F1 of the release unit, the critical breaking force F2 of the locking unit, and the critical breaking force F7 of the enhanced connection structure satisfy: F01 < F1, F01 = F02, F1 < F2 < F7; when the locking unit gradually locks, the F01 and the F02 gradually increase; when the locking unit is fully locked, further operating the release unit, the F01 reaches the F1, achieving the breaking and separation of the release unit.

3. The closure device for atrial septal defect according to claim 1, characterized in that: The delivery system includes a locking mechanism, the locking mechanism includes a locking power source, a locking transmission rod, and a locking transmission structure fixedly connected to the distal end of the locking transmission rod; the delivery system includes a release mechanism, the release mechanism includes a release power source and a release transmission medium; the release mechanism is the locking mechanism, and the release transmission medium is the locking transmission rod; during pre-installation, the proximal region of the release unit is connected to the locking transmission structure and forms a concentrated region; when the locking power source functions, the locking members are in a linear shape and in a taut state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod and then drives the locking transmission structure to twist forward, thereby causing the release unit to drive the locking members to rotate, and the locking unit tangles and self-locks in the concentrated region.

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