CN216777122U

CN216777122U - Closure device for tissue defects

Info

Publication number: CN216777122U
Application number: CN202122231207.8U
Authority: CN
Inventors: 李彪; 邵烨; 李刚
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2021-09-15
Filing date: 2021-09-15
Publication date: 2022-06-21
Anticipated expiration: 2031-09-15

Abstract

The invention relates to the field of medical instruments, in particular to a closing instrument for tissue defects, which comprises a locking unit, a releasing unit and a locking unit, wherein the releasing unit is positioned at the proximal region of the locking unit; the locking unit comprises at least one or more locking members; operating the releasing unit to drive the locking pieces to be rotated, enabling the locking pieces to approach each other and realize self-locking and locking, and further realizing the closure of the tissue defect; the locking unit and the releasing unit are of an integrated structure, and when the locking piece realizes self-locking and locking, the releasing unit is further operated, so that the releasing unit and the locking unit are separated in a breaking mode.

Description

Closure device for tissue defects

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a tissue defect closing instrument, in particular to an intracardiac tissue defect closing instrument.

Background

Patent Foramen Ovale (PFO) is the most common congenital heart abnormality in adults, and 1 in about 4 of normal people can be detected. 150 million patients with congenital heart disease exist in China, the morbidity of the congenital heart disease is 6.78% every year, up to 10-15 thousands of infants suffering from the congenital heart disease are born every year, and the patent number of a single foramen ovale accounts for about 10% of the congenital heart disease.

Patent foramen ovale, a common problem, can lead to potentially serious complications. Many studies in recent years have shown that patent foramen ovale is closely related to stroke patients of unknown origin. For a patient with patent foramen ovale, the slit-like abnormal channel remained in the primary compartment and the secondary compartment is similar to a functional valve, and because the blood pressure in the left atrium of the heart is higher than that in the right atrium, blood can flow into the right atrium from the left atrium through the patent foramen ovale, and the long-term left atrium flows to the right atrium, so that the blood volume in the right atrium is increased, the right ventricle is hypertrophied, and the pulmonary circulation blood volume is increased. When the right atrial pressure is higher than the left atrial pressure, the weak primary septum on the left side is pushed away, a right-to-left shunting of blood occurs, and in addition, the following emboli may enter the left cardiac system causing the corresponding clinical symptoms: the risk of recurrence for patients with patent foramen ovale, who have had a thrombotic event, is still high with respect to thrombosis of the deep veins of the lower extremities or pelvic veins, air emboli caused by caisson's disease or decompression sickness, fatty emboli formed after surgery or trauma. Meanwhile, the long-term existence of patent foramen ovale is also found to cause symptoms such as migraine, cerebral ischemia, cerebral apoplexy, decompression sickness, decubitus respiratory upright hypoxia syndrome, altitude sickness and the like.

The traditional treatment mode for patent foramen ovale is surgical operation. The treatment method of surgery is that the patient needs to be opened by surgery. The main drawbacks of surgery are: extracorporeal circulation is needed during the operation, which may cause complications and death; the surgical operation has large wound and scars are left after the operation; the surgery is expensive. With the development and improvement of interventional therapy technology, methods for treating PFO through minimally invasive interventional techniques are now well established. The minimally invasive interventional therapy has the advantages of no operation, small wound, less complication, quick recovery, good effect, wide range of indications, relatively low operation cost and the like.

The mainstream product in clinical at present is traditional two dishes foramen ovale plugging device, and traditional two dishes foramen ovale plugging device is two dishes of structure, has bilateral symmetry's left side dish and right side dish and connects the short waist portion between left side dish and right side dish, and the department has outstanding collection end in the middle of the left side of left side dish, and the department has outstanding collection end in the middle of the right side of right side dish. However, the above-mentioned conventional double-disc foramen ovale occluder has more or less problems in clinical use. If the oval hole is close to the superior and inferior vena cava or the main pulmonary artery, the edge of the occluder can abrade the blood vessel, resulting in failure of occlusion; if the occluder with the smaller specifications of the left disc surface and the right disc surface is selected, the anchoring effect of the occluder is poor, so that the occlusion stability is poor, in addition, the oval fossa is a puncture point for atrial septal puncture in the heart interventional operation, and for patients with potential patent foramen ovale for interventional heart treatment, after the traditional occluder is used for occluding the patent foramen ovale, the situation that secondary interventional treatment cannot be performed due to difficulty in atrial septal puncture and a higher risk treatment method is changed into can be met.

Patent CN112244902A provides a patent foramen ovale patent occluder with adjustable disc surface, belonging to the technical field of medical apparatus and instruments; the plugging device with the net structure comprises an upper disc surface, a waist part, a lower disc surface, an adjusting rod and an adjusting wire; a waist part is arranged between the upper disc surface and the lower disc surface; the upper disc surface is provided with a middle section with the same central shaft and an edge section with an adjustable cross section vertical to the central shaft; the upper disc surface of the plugging device is designed by splicing a middle section and an edge section, an adjusting wire is arranged between the edge section and an adjusting rod, and the size of the upper disc surface can be freely adjusted by rotating the adjusting rod and changing the length of the adjusting wire. The occluder with the adjustable disc surface reduces the probability of replacing the occluder during operation; the fitting degree of the plugging device is improved; the middle section is adopted on the disc surface of the occluder, the edge section is designed in two sections, and the edge section is softer than the middle section, so that the disc surface size adjustment of the occluder is facilitated, and the tissue abrasion attached to the disc surface is reduced. However, the existing way to treat the above diseases is to use an occlusion operation to place an occluder made of a metallic material mostly or entirely in the body. The occluder is usually large in size, and due to the fact that the structure in the heart is complex, the occluder is placed in the heart and is not easily accepted by many patients, risks of complications can be increased in the near term and the long term, and repeated release and recovery are difficult to achieve.

Patent CN211934140U provides an interventional defect suturing device, which comprises a sheath tube, a suturing component arranged at the distal end of the sheath tube, and at least two puncture needles arranged in the sheath tube in a penetrating manner. The suture assembly comprises a main body piece fixedly connected with the sheath tube and a movable piece rotatably connected with the main body piece, and the two sides of the axis of rotation of the movable piece are respectively provided with at least one connecting cylinder connected with a suture. After the movable piece rotates in place relative to the main body piece, one connecting cylinder is correspondingly located on a moving path of the far end of the puncture needle, at least two puncture needles are respectively butted with one corresponding connecting cylinder after puncturing tissues around defects, when the puncture needle moves towards the near end, the connecting cylinder and a suture correspondingly connected with the puncture needle are driven to move towards the near end, so that the suture is implanted into the tissues around the defects, at least two suture points are formed through one-time intervention, the intervention times of instruments are reduced, and the operation time is shortened.

Patent ZL 201822027543.9 provides a patent foramen ovale suturing device, relates to the technical field of medical suturing, and solves the technical problems that the existing patent foramen ovale surgery is difficult to position and suture, and complications are easy to occur when the existing patent foramen ovale suturing device is implanted; the device comprises a pushing part and an extender connected with the pushing part, wherein the head part of the extender is provided with a metal suture and two clamping arms, two ends of the metal suture are respectively pulled through fixing grooves on the clamping arms, the pushing part is provided with a push rod for pushing the push rod, and the two clamping arms can pull the metal suture to extend out and retract; the two puncture needles can extend into the guide grooves, the guide grooves penetrate through the inside of the extender to push the traction needles, and the two puncture needles can pull the two ends of the metal suture and penetrate through the diaphragms to fix the two diaphragms; the suture device is used for realizing minimally invasive closure of patent foramen ovale or atrial septal defect, ensures suture at an accurate position, reduces complications caused by implantation of the occlusion device, but because the suture is hooked and pulled back by pushing the hook-shaped needle of the traction needle after the clamping arm is unfolded in the heart, the suture device preferentially adopts a metal suture for facilitating radiography observation during actual operation, and the suture device mainly has the following defects: 1. the metal suture is sharp, and the metal suture is used as a main closed material, so that the dragging force generated by the metal suture when the metal suture is used for dragging the tissue cannot be dispersed, the suture part can be torn and damaged, even a hole structure is formed, and extra defects are artificially formed; 2. the positioning and needle withdrawing operations are complex, very high precision is required, and the learning curve of a doctor is long; 3. defect closure is achieved by entanglement of the metal suture, but without the design of a metal suture release mechanism, there may be a risk of the metal suture breaking or the release location being ambiguous, thereby causing closure failure.

Therefore, how to solve the problem of patent foramen ovale and reduce postoperative complications in the operation process, avoiding some disadvantages brought by the traditional occluder interventional therapy operation, realizing simple and rapid closure and release, and simultaneously keeping the possibility of developing secondary interventional operation at the future interatrial puncture point or area becomes the problem to be solved urgently at present.

Disclosure of Invention

In view of the above and other, it is an object of the present invention to overcome the deficiencies of the prior art.

According to an embodiment in the application aspect of the patent foramen ovale treatment operation, the patent foramen ovale treatment device can provide a tissue defect closing instrument for patients with structural heart disease and needing interventional therapy, can solve some defects caused by adopting the occluder to treat patent foramen ovale in the interventional therapy operation process, such as poor occlusion stability caused by poor anchoring effect of the occluder, or the problems that the metal content of the occluder is large and damages are easily caused to human tissues, and the like, can also solve the problem that the atrial septal puncture cannot be carried out after the patent foramen ovale is occluded by the traditional occluder to carry out secondary interventional operation, and avoids the situation of using a higher risk treatment method; in addition, the accurate positioning and suturing in the patent foramen ovale operation can be realized, and postoperative complications are reduced.

According to an aspect of the invention, the closure instrument comprises a locking unit, a release unit located in the proximal region of the locking unit; the locking unit at least comprises one or more locking pieces; operating the releasing unit to drive the locking pieces to be rotated, enabling the locking pieces to approach each other and realize self-locking, and further realizing the closure of the tissue defect; the locking unit with release unit formula structure as an organic whole, work as when the retaining member realizes auto-lock locking, further operation release the unit, make release the unit with the retaining member fracture separation, the advantage of design like this lies in: the structure is simple, the existing risk is low, the number of components is small, the manufacture is convenient, the production efficiency is high, the cost required by the whole set of products is low, and the period is short; the metal implantation amount can be limited to the maximum extent, the stimulation to the tissues is less, and the biocompatibility is good; meanwhile, the releasing unit is convenient to release, the releasing unit and the locking unit can be separated by breaking through further rotating the releasing unit and preferentially selecting a rotating releasing mode, the operation action is simple, after the releasing unit breaks, the locking transmission rod has better tactile feedback, whether the releasing unit completely breaks or not can be immediately evaluated, an additional operation instrument is not needed for detection, the operation time in the operation is short, and the learning curve of a doctor is short; in addition, the sheath diameter of the conveying sheath is small, the damage to blood vessels of a human body is small, and the conveying sheath is particularly suitable for special crowds such as minor blood vessels and minor immature patients.

In one embodiment, when the locking member achieves self-locking, the releasing unit is further operated, and the proximal end region of the locking unit is further rotated; before the locking unit and the releasing unit are not broken and separated, the locking unit and the releasing unit are in a tapered structure from the far end to the near end.

In one embodiment, the locking unit comprises one or more fixing members, the fixing members are positioned at the distal end region of the locking member and connected with the locking member, and part or all of the fixing members are attached or anchored to the inside or the outer surface of the distal end of the target tissue; a reinforced connecting structure is arranged between the fixing pieces and is connected with a plurality of fixing pieces; the reinforced connecting structure is made of flexible metal materials or high polymer materials.

In one embodiment, the reinforced attachment structure prevents the anchor from falling out of the left atrium after the anchor is broken away from the retaining member.

In one embodiment, the reinforced connecting structure does not participate in the self-locking process of the locking member, nor does the reinforced connecting structure participate in the breaking and separating process of the releasing unit and the locking unit.

In one embodiment, the reinforcing connecting structure is free outside the proximal end area or the whole area of the locking piece, and the reinforcing connecting structure and the locking piece are partially connected through the fixing structure, so that after the reinforcing connecting structure and the locking piece are in parallel structures, the proximal end area of the locking unit and/or the releasing unit is connected with the conveying system, the reinforcing connecting structure can be ensured to participate in the self-locking and locking process of the locking piece, and a certain fixing effect is achieved.

In one embodiment, the closure device comprises a delivery system located at a proximal region of the disengagement unit or the locking unit; the locking unit or the releasing unit is connected with the conveying system, and the reinforced connecting structure is not connected with the conveying system and is independent and free outside the proximal end area of the locking piece.

In one embodiment, the release unit locking force F is a release unit locking force when the release unit is manipulated to rotate the locking unit prior to closure of the tissue defect₀₁Locking force F of the locking unit₀₂Critical breaking force F of said disengagement unit₁Critical breaking force F of the locking unit₂Critical breaking force F of the reinforced connection structure₇Satisfies the following conditions: f₀₁＜F₁，F₀₁=F₀₂，F₁＜F₂＜F₇(ii) a When the locking unit is gradually locked, F₀₁And said F₀₂Gradually increasing, when the locking unit is fully locked, and further operating the releasing unit, the F₀₁Reach the critical breaking force F₁And realizing the fracture separation of the releasing unit.

In one embodiment, F₀₁、F₀₂、F₁、F₂、F₇The values of (A) are all between 0.1N and 100N.

In a preferred embodiment, F₀₁、F₀₂、F₁、F₂The values of (A) are all between 0.1N and 10N.

In one embodiment, the locking unit is self-locking entangled in the concentrated area to form a cable structure or a twist-like structure having at least one turn.

In one embodiment, the delivery system comprises a locking mechanism comprising a locking power source, a locking drive rod, a locking drive structure fixedly attached to a distal end of the locking drive rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises 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; when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area; when the locking power source acts, the locking piece is linear and is in a stretched state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod to further drive the locking transmission structure to twist and advance, the releasing unit drives the locking piece to rotate, and the locking unit is tangled in the concentration area to be locked in a self-locking mode.

In one embodiment, the closure instrument comprises a locking unit, a disengagement unit located in a proximal region of the locking unit; the locking unit at least comprises one or more locking pieces; the releasing unit comprises an auxiliary breaking structure; operating the releasing unit to enable the auxiliary breaking structure to drive the locking pieces to rotate, enabling the locking pieces to approach each other and realize self-locking, and further realizing the closure of the tissue defect; when the retaining member realizes auto-lock locking, further operation the disengagement unit, supplementary fracture structure is further rotated, makes after supplementary fracture structure fracture with the retaining member separation, the advantage of design like this lies in: by adopting the design of the auxiliary fracture structure, the fracture position of the closed tissue instrument can be further limited, so that the fracture position is safe and reliable, the fracture position can be accurately limited at the auxiliary fracture structure, and the implanted part of the closed tissue instrument is ensured to be in the best state; meanwhile, the force of the locking piece is uniformly applied in the tissue defect closing process, so that the extra local tissue defect caused by uneven stress at the tissue defect position is avoided; in addition, the sheath diameter of the conveying sheath is small, the damage to blood vessels of a human body is small, and the conveying sheath is particularly suitable for special crowds such as minor blood vessels and minor immature patients.

In one embodiment, the locking unit comprises one or more fixing members, the fixing members are positioned at the distal end region of the locking member and connected with the locking member, and part or all of the fixing members are attached or anchored to the inside or the outer surface of the distal end of the target tissue; a reinforced connecting structure is arranged between the fixing pieces and is connected with a plurality of fixing pieces; the closure device includes a delivery system located at a proximal region of the detachment unit, the reinforced attachment structure not being connected to the delivery system; wherein after the reinforced connecting structure and the locking piece are connected with the proximal end region of the auxiliary breaking structure in a parallel structure or a twisted structure or a braided structure, the distal end region of the auxiliary breaking structure is connected with the conveying system; alternatively, the reinforcing attachment structure is free of the retaining member from the proximal region or from the entire region.

In one embodiment, after the reinforcing connecting structure and the retaining member are partially or completely connected through the fixing structure, the reinforcing connecting structure and the retaining member are connected with the distal end region of the auxiliary breaking structure after being in a parallel structure, and then the proximal end region of the auxiliary breaking structure is connected with the conveying system, so that the reinforcing connecting structure can be ensured to participate in the self-locking and locking process of the retaining member and play a certain fixing role.

In one embodiment, the auxiliary rupturing structure is subjected to a locking force F when the auxiliary rupturing structure is manipulated to rotate the locking unit before the tissue defect is closed₀₃Locking force F that the locking unit receives₀₄Critical breaking force F of the auxiliary breaking structure₃Critical breaking force F of the locking unit₄Critical breaking force F of the reinforced connection structure₈Satisfies the following conditions: f₀₃＜F₃，F₀₃=F₀₄，F₃＜F₄＜F₈(ii) a When the locking unit is gradually locked, F₀₃And said F₀₄Gradually increasing, when the locking unit is fully locked, and further operating the auxiliary breaking structure, the F₀₃To said F₃The realization supplementary rupture structure fracture separation, the advantage of this kind of design lies in, ensures that the retaining member is close to each other and realizes the auto-lock in-process, and locking force is in relatively lower state, reduces the stimulation to the tissue production, and simultaneously along with going on of locking process, the critical rupture force of disengagement unit is less than the critical rupture force of locking unit, ensures to lock and breaks off unit department emergence after completely, further prescribes a limit to the fracture position, adopts reinforcing connection structure can further ensure simultaneously that the locking unit can not break in advance, has promoted the security.

In one embodiment, the secondary rupture structure is connected to the retaining member by one of penetrating, sliding, and securing the collar.

In one embodiment, the locking unit and the reinforcing attachment structure are self-locking intertwined at the concentrated area to form a cable structure or a twist-like structure, the cable structure or twist-like structure having at least one turn.

In one embodiment, the reinforced connecting structure is a polymer thread, and the free end of the polymer thread is connected to the fixing piece through gluing, tangling, knotting, mechanical connection, welding and the like; the locking unit is a soft metal wire and comprises two locking pieces, and each locking piece is connected to the fixing piece in a gluing mode, a mechanical connection mode, a welding mode and the like and then twisted and formed with the high-molecular wire; operating the releasing unit to enable the auxiliary breaking structure to drive the locking pieces to rotate, enabling the locking pieces to approach each other and realizing self-locking, and further realizing the closing of the tissue defect; when the retaining member realizes self-locking and locking, the releasing unit is further operated, and the auxiliary breaking structure is further rotated, so that the auxiliary breaking structure is separated from the retaining member in a breaking way.

In one embodiment, the closure instrument comprises a locking unit, a disengagement unit located in a proximal region of the locking unit; the locking unit at least comprises one or more locking pieces; the disengagement unit comprises an auxiliary operating structure; the releasing unit is operated to drive the locking pieces to rotate, the locking pieces are close to each other and realize self-locking and locking, and further the closing of the tissue defect is realized; the locking unit with the disengagement unit is connected, operates the auxiliary operation structure, makes the disengagement unit with the retaining member separation, and the advantage of design like this lies in: the non-fracture type releasing of the auxiliary operation structure is adopted, the original structural components are not damaged by the releasing operation, the releasing mode reaches an ideal state, and the locking amplitude of the locking unit can be regulated and controlled according to the anatomical form of the defective tissue, so that the releasing and the separating of the releasing mechanism are realized under the condition that the defective tissue is in a perfect closed state, and the safety is high; the sheath tube can be controlled between 10Fr and 20Fr, and is suitable for most patients.

In one embodiment, the secondary operation structure comprises a fusible link structure, a cryo-breakable link structure, a severable link structure, a detachable link structure disposed at a proximal region of the detachment unit.

In one embodiment, the locking unit comprises one or more fixing members, the fixing members are positioned at the distal end region of the locking member and connected with the locking member, and part or all of the fixing members are attached or anchored to the inside or the outer surface of the distal end of the target tissue; a reinforced connecting structure is arranged between the fixing pieces and is connected with a plurality of fixing pieces; the closure device includes a delivery system located at a proximal region of the detachment unit, the reinforced attachment structure not being connected to the delivery system; after the reinforcing connecting structure and the locking piece are connected with the proximal end area of the releasing unit in a parallel structure or a twisted structure or a braided structure, the distal end area of the releasing unit is connected with the conveying system; alternatively, the reinforcing attachment structure is free of the proximal region or the entire region of the retaining member.

In one embodiment, after the reinforcing connecting structure and the retaining member are partially or completely connected through the fixing structure, the reinforcing connecting structure and the retaining member are connected with the distal end region of the releasing unit after being in a parallel structure, and then the proximal end region of the releasing unit is connected with the conveying system, so that the reinforcing connecting structure can be ensured to participate in the self-locking and locking process of the retaining member and play a certain fixing role.

In one embodiment, the locking force F of the release unit is greater than the locking force F of the release unit when the release unit is operated to rotate the locking unit prior to closure of the tissue defect₀₅Locking force F of the locking unit₀₆Critical breaking force F of said disengagement unit₅Critical breaking force F of the locking unit₆Critical breaking force F of the reinforced connection structure₉Satisfies the following conditions: f₀₅＜F₅，F₀₅=F₀₆，F₅＜F₆＜F₉The advantage of this kind of design lies in, ensure that the retaining member is close to each other and realize the auto-lock in-process, the locking force is in relatively lower state, reduce the stimulation to the tissue production, simultaneously along with going on of locking process, the critical rupture force of disengagement unit is less than the critical rupture force of locking unit, guarantee that locking can not take place the fracture in locking unit department after completely, further inject the disengagement position, thereby can guarantee to make disengagement unit and locking unit separation through auxiliary operation structure, adopt reinforcing connection structure can further ensure simultaneously that the locking unit can not break in advance, the security has been promoted.

In one embodiment, the delivery system comprises a locking mechanism comprising a locking power source, a locking drive rod, a locking drive structure fixedly attached to a distal end of the locking drive rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium; the locking mechanism is different from the releasing mechanism, the locking power source is operated, the locking member is rotated to close the tissue defect, the releasing power source is operated, and the locking member is separated from the releasing unit;

when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area; when the locking power source plays a role, the locking piece is linear and in a stretched straight state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod to further drive the locking transmission structure to twist and advance, the releasing unit drives the locking piece to rotate, and the locking unit is entangled in the concentration area for self-locking.

In one embodiment, the locking unit and/or the reinforcing connection structure are self-entangled at the concentration area to form a cable structure or a twist-like structure having at least one turn.

In one embodiment, the fixture comprises, from the outside to the inside, an outer shell structure and/or an inner support structure; wherein, the fixing piece is strip-shaped; one end or two ends of the fixing piece are provided with buffer structures, each buffer structure comprises one or more of a flexible reducing structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring and a ball head, and stimulation or damage to target tissues can be reduced; when the fixing piece comprises the inner supporting structure, the inner supporting structure is positioned in a middle section area or a whole section area of the shell structure along the axial direction of the fixing piece; wherein the inner support structure is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defines the relative positions of the distal end of the retaining member and the inner support structure.

In one embodiment, the fixing member comprises an inner supporting structure, the reinforcing connection structure is a polymer wire, and the free end of the polymer wire is connected to the fixing member by gluing, tangling, mechanical connection, welding and the like; the locking unit is soft metal wire, and the locking unit includes two retaining members, and every retaining member is connected inner support structure through modes such as gluing, mechanical connection, welding and is twisted with the polymer line and take shape again.

In one embodiment, the fixing member or the housing structure is a tube or a wire made of plastic, which has good biocompatibility and can reduce the implantation amount of metal.

In a preferred embodiment, the fixture or housing structure is a specialty plastic consisting essentially of one or more of PEEK, PI, PPS, PSF, PAR, LCP, PPSU.

In one embodiment, the specialty plastic is an implantable material.

In one embodiment, the internal support structure can improve the support of the shell structure.

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

In one embodiment, the fixing member is a round tube or a round rod, the round tube or the round rod is made of an implantable metal material, and the two ends of the fixing member are provided with buffer structures.

In one embodiment, the inner support structure is a 0.1mm to 1mm wire comprising 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, pure zinc.

In one embodiment, the fixing piece comprises an inner supporting structure, the inner supporting structure is formed by twisting a plurality of strands of metal wires, two ends of the inner supporting structure are arc-shaped structures, the arc-shaped structures are located at two ends of the fixing piece and are used as buffer structures, the reinforcing connecting structure and the locking unit are twisted together to form a fixed connection, and the reinforcing connecting structure and the locking unit are twisted together with the inner supporting structure in the fixing piece to form a fixed connection.

In one embodiment, the retaining member is provided with an anchoring structure extending outside the retaining member; the anchoring structure comprises one or more combinations of a micro-thorn structure, a local protruding structure and a local flattening structure, the anchoring effect is improved, and the friction force is improved.

In one embodiment, an attitude adjustment structure is arranged between the fixing member and the locking member; when the fixing piece and the retaining piece are unfolded in the tissue defect area, the posture adjusting structure adjusts an included angle between the fixing piece and the retaining piece, so that the fixing piece can contact the tissue to the maximum extent; the posture adjusting structure is a rotating structure, and the rotating structure comprises a chain structure, a hinge structure and one or more combinations of elastic and/or plastic deformation of materials; or the posture adjusting structure is a sliding structure, and the sliding mechanism comprises one or more combinations of a sliding block and a pulley.

In one embodiment, the locking member is connected to the releasing unit in a parallel structure or a twisted structure or a braided structure.

In one embodiment, when the locking unit is locked, the locking unit is connected with the releasing unit after being in a closed state.

In one embodiment, the fastener has a microporous structure; or the fixing piece and/or the locking unit comprise a coating piece, and the coating piece comprises one of a coating layer, a polymer film, a polymer sheet and a drug slow-release structure.

In one embodiment, the delivery system comprises a puncture needle, when the closure device is positioned in the delivery system, the locking unit comprises a first free end positioned at the far end area of the locking part and a second free end positioned at the near end area of the locking part, the first free end is provided with a butting piece, the second free end is provided with a hooking piece, the puncture needle has a preset shape, when the closure device is released, the puncture needle passes through the secondary septum and then reversely passes through the primary septum, the puncture needle is withdrawn, the butting piece is released, and the locking transmission rod is operated to enable the hooking piece to hook the butting piece; operating the releasing unit to drive the locking pieces to rotate, wherein the locking pieces are close to each other and realize self-locking, and further realize the closure of the tissue defect; when the locking unit is locked at the tissue defect part, the locking unit is integrally connected with the releasing unit after being in a closed state, and the releasing unit is further operated, so that the releasing unit and the locking unit are separated in a breaking way.

In one embodiment, the anchoring structure and retaining member have one or more of a combination of integrally woven, integrally laser engraved, post-machined attachment.

In one embodiment, closure of the tissue defect comprises closure of an foramen ovale defect, closure of an atrial septal defect, closure of a ventricular septal defect, closure of a patent ductus arteriosus, or the like.

In one embodiment, the locking unit is connected with the releasing unit, the proximal end of the locking unit comprises a three-dimensional structure, and when the locking power source drives the three-dimensional structure to rotate so as to enable the locking member to realize self-locking, the releasing unit is further operated, so that the releasing unit and the locking member are separated in a breaking manner.

In one embodiment, the locking unit is connected with the releasing unit, the auxiliary operating structure is a spherical structure and a rod-shaped structure penetrating through the spherical structure, and after the proximal end of the locking member is tangled and self-locked, the rod-shaped structure is withdrawn to separate the locking unit from the releasing unit.

In one embodiment, the secondary operation structure is a cutter.

In one embodiment, the secondary operation structure is an electrolytic stripper.

In one embodiment, each retaining member comprises 1-20 wires; wherein, every retaining member is laid by many silks of silk material parallel and is formed, perhaps every retaining member is twisted or is woven into cable structure or twist structure by many silks of silk material.

In one embodiment, the needle has a substantially sharp distal end.

In one embodiment, the locking members and the fixing members correspond in number and position one to one; wherein each locking member is composed of one wire.

In one embodiment, the reinforcing attachment structure is in a "U" or accordion configuration when the securing member and retaining member are within the delivery system.

In one embodiment, the locking unit and the releasing unit are of an integral structure, the locking unit located in the concentrated area is locked in a self-locking mode to close the tissue defect, and the releasing unit is further operated to enable the releasing unit and the locking unit to be separated in a breaking mode, wherein the locking unit has the winding number when locked in the self-locking mode, the position where the winding number is the most dense is the first position, the position where the locking unit and the releasing unit are separated in the breaking mode is the second position, the first position is not consistent with the second position, and the second position is located outside the proximal end of the first position.

In one embodiment, the disengagement unit is provided with a detachable connection that interacts with the delivery system.

In one embodiment, the delivery system includes at least a traction portion including one or more puncture needles having an inner lumen, a pushing portion including a spike; firstly, the fixing piece and the ejector pin are positioned in the inner cavity, the pushing part abuts against the near end of the fixing piece through the ejector pin and drives the fixing piece to extend out of the inner cavity, and therefore the configuration of the closing instrument in the conveying system is guaranteed to have a small cross section, and the closing instrument is convenient to store and accommodate; secondly, the puncture needle penetrates through the tissue wall, and the thimble is pushed to drive the fixing piece to be released from the puncture needle; finally, the releasing unit drives the locking piece and then drives the fixing piece to close the tissue defect, so that the flexible connection between the fixing piece and the locking piece is realized, and meanwhile, the connection compliance is improved, and the fact that the foramen ovale is completely closed is guaranteed.

In one embodiment, the traction portion further comprises a plurality of needle control rails disposed outside the puncture needle, the needle control rails controlling the motion trajectory of the puncture needle and the puncture location on the tissue.

In one embodiment, the distal region of the retaining member is connected to the securing member by an attitude adjustment structure that maximizes tissue contact of the securing member by adjusting the angle between the securing member and the securing member after the securing member is released from the lumen.

In one embodiment, the filament and the fixture form an attitude adjustment structure by a rotation mechanism comprising one or more combinations of a chain structure, a hinge structure, elastic and/or plastic deformation of the material itself.

In one embodiment, the locking member is connected with the fixing member through the hole slot or the limiting member to form the posture adjusting structure.

In one embodiment, each of the fixing members is provided with a through hole in an axial direction and a groove connected to the through hole, and a free end of the wire fixedly connected to a distal end region of the through hole is protruded from the groove to form an attitude adjusting structure.

In one embodiment, the fixing member is provided with an axial U-shaped through hole, and the locking member annularly penetrates through the U-shaped through hole to form the posture adjusting structure.

In one embodiment, the middle part of the fixing piece is provided with a through hole, and the locking piece and/or the reinforced connecting structure can be gathered, intertwined and wound at the through hole to be fixedly connected with the fixing piece to form the posture adjusting structure.

In one embodiment, the free end of the filament and the fixed member form an attitude adjustment structure via a sliding mechanism, the sliding mechanism including one or more combinations of a slider and a pulley.

In one embodiment, the fixing member and the locking member form the posture adjustment structure by the elastic member.

In one embodiment, the locking transmission structure can be matched with at least one puncture needle to control the motion of the puncture needle passing through tissues; or the locking transmission structure can be matched with at least one fixing piece to complete the control of the action of fixing the tissues by the fixing piece.

In one embodiment, the puncture needle and the needle control guide rail are respectively provided with a corresponding side opening, the side openings allow the locking piece to be connected with the locking transmission structure after extending out, and the side openings provide quick channels for the connection of the locking piece, the fixing piece and the locking transmission structure, so that the release process of a closed instrument is facilitated, and the operation process of the operation is simplified.

In one embodiment, the needle is preferably a metal material that has both rigidity and some flexibility to facilitate piercing of tissue.

In one embodiment, the locking unit is a wire made of an implantable flexible metal material.

In one embodiment, the metal content of the closure device is very low.

In one embodiment, the lock transmission rod is made of a metal material or a high polymer material and has good torsion performance.

In one embodiment, the auxiliary operating structure separates the release unit from the locker by the hook.

In one embodiment, the tapered structure may be formed by a strand of wire that is tapered.

In another embodiment, the tapered structure may be formed from multiple filaments with multiple tapers or multiple filaments with alternating tapers from coarse to fine.

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

In one embodiment, a delivery system includes a delivery sheath and a control handle.

In one embodiment, the internal support structure can improve the strength of the fixing part, play a certain supporting role, and ensure that the fixing part can complete the compliant deformation along with the action of the stranded wire, so as to prevent the breakage of the fixing part.

In one embodiment, the anti-releasing force of the reinforced connecting structure and the locking piece in a parallel structure or a twisted structure or a braided structure is improved by a plurality of times to a plurality of times compared with the anti-releasing force of only the locking unit, and the locking unit can be prevented from being released automatically along with the continuous beating of the heart and the influence of blood pressure on the locking unit; in addition, the anti-releasing force can be adjusted according to the proportion of the reinforced connecting structure, the twisting mode and the weaving mode of the reinforced connecting structure and the locking piece, so that the anti-releasing force can reach different levels.

In one embodiment, the delivery sheath is an adjustable bending sheath, and the bending angle of the distal end of the delivery sheath can be adjusted by operating the control handle, wherein the adjustment angle is 0-180 degrees, and further, the needle control guide rail is provided with internal cutting lines, so that the compliance change can be generated along with the angle change of the distal end of the delivery sheath, and the bending function of the adjustable bending sheath on the instrument is realized.

In one embodiment, the access needs to be established in advance to ensure smooth access of the closure device.

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

In one embodiment, the anchors are both positioned on the primary septal surface and the secondary septal surface within the left atrium after the tissue defect is closed.

In another embodiment, the anchors are positioned on the surface of the septum primum within the left atrium after the tissue defect is closed.

In one embodiment, the needle includes a lumen configured to slidably extend the securing member therein.

In one embodiment, the distal portion of the needle control rail has a predetermined shape with an arc of curvature that allows adjustment of the angle of release of the needle, which is curved away from the central axis of the delivery system.

In one embodiment, the distal portion of the needle control rail has a cavity into which the curved core can be inserted, and the release angle of the needle is adjusted by pulling on the pull wire to cause the distal portion of the needle control rail to bend in a desired manner.

In one embodiment, the conveying system is provided with an auxiliary positioning assembly, the auxiliary positioning assembly can assist the puncture needle in positioning and penetrating through the defective tissue, the positioning reference is improved, and the operation efficiency is improved.

In one embodiment, the locking power source consists essentially of a gear control and a motor control.

In one embodiment, the secondary positioning assembly includes a positioning plate or positioning umbrella.

In one embodiment, the twisted structure is helical.

Compared with the prior art, the invention has the advantages that:

1. by taking a patent foramen ovale treatment operation as an example, the patent foramen ovale treatment operation adopting an occluder in an interventional treatment operation process brings some defects, such as poor occlusion stability caused by poor anchoring effect of the occluder, or more metal content of the occluder easily causes damage to human tissues, and the like, and in addition, the difficult problem that the interventional treatment cannot be adopted when the traditional occluder is used for atrial septal puncture after occlusion of the patent foramen ovale is solved; the locking unit and the releasing unit are of an integrated structure, and when the locking piece realizes self-locking and locking, the releasing unit is further operated to enable the releasing unit and the locking unit to be separated in a breaking way; or when the locking piece realizes self-locking and locking, the releasing unit is further operated, and the auxiliary breaking structure is further rotated, so that the auxiliary breaking structure is separated from the locking piece after being broken; or the proximal end of the locking unit is connected with the distal end of the releasing unit, and the auxiliary operation structure is operated to separate the releasing unit from the locking piece; the operation is simple and convenient, simple and quick closing and releasing can be realized, the operation efficiency is improved, the phenomenon that the oval hole is sewn and closed by knotting from the outside and then conveying the oval hole to the inside is avoided, the operation efficiency is improved, and the operation risk is reduced.

2. Different from the prior art, in one embodiment of the invention, the fixing part comprises a shell structure and/or an inner support structure from outside to inside, and the fixing part or the shell structure is a pipe or a wire part made of plastic, so that the biocompatibility is good, and the implantation amount of metal can be reduced; the inner support plays a supporting role, so that the supporting strength is improved, and the deflection failure when the shell structure is pulled is avoided.

3. Different from the prior art, in one embodiment of the invention, when the locking power source acts, the locking power source drives the locking transmission rod to rotate, and simultaneously, as the locking member is tangled and has more and more self-locking turns, the locking power source drives the locking transmission rod to drive the locking transmission structure to twist forward so as to enable the locking members to mutually and radially approach each other from the proximal end to the distal end, the locking transmission rod can move towards the far end relative to the control handle and can adapt to the rotating process of the locking part, the locking part is linear and in a stretched straight state in the whole process, the locking transmission rod is in a straight state, the locking power source can control the rotating speed and the moving speed of the locking transmission rod, thereby guarantee that the locking transfer line can take place the adaptability according to the distance with the pjncture needle and change to improve the degree of cooperation of locking power supply and retaining member, better messenger locking unit is in the regional performance of concentrating and is tangled the auto-lock effect.

4. In contrast to the prior art, in one embodiment of the present invention, the tissue defect is pre-closureWhen the releasing unit is operated to drive the locking unit to rotate, the locking force F borne by the releasing unit₀₁Locking force F that the locking unit receives₀₂Critical breaking force F of said disengagement unit₁Critical breaking force F of the locking unit₂Critical breaking force F of the reinforced connection structure₇Satisfies the following conditions: f₀₁＜F₁，F₀₁=F₀₂，F₁＜F₂＜F₇(ii) a When the locking unit is gradually locked, F₀₁And said F₀₂Gradually increasing; when the locking unit is fully locked, the releasing unit is further operated, F₀₁To said F₁The utility model discloses a release unit fracture separation, the realization the advantage of this kind of design lies in, ensures that the retaining member is close to each other and realizes the auto-lock in-process, and locking force is in lower state relatively, reduces the stimulation to the tissue production, simultaneously along with going on of locking process, the critical rupture force of release unit is less than the critical rupture force of locking unit, ensures that the fracture takes place in release unit department after defect tissue locking is complete, further prescribes a limit to the fracture position, adopts reinforcing connection structure can further ensure simultaneously that the locking unit can not break in advance, has promoted the security.

5. Different from the prior art, when the locking piece realizes self-locking, the releasing unit is further operated, and the proximal end area of the locking unit is further rotated; before the locking unit and the releasing unit are not broken and separated, the locking unit and the releasing unit are in a tapered structure from the far end to the near end; or, in another embodiment of the invention, the auxiliary operation structure comprises a fusible connecting structure, a low-temperature brittle connecting structure, a shearable connecting structure and a detachable connecting structure which are arranged at the proximal end region of the releasing unit, and both embodiments can accurately position the position of the broken separation of the locking member and the releasing unit, so that the broken self-locking position is closer to the locking transmission structure and is far away from the fixing member, thereby better playing the fixing role of the implant on the closing of the foramen ovale.

6. Different from the prior art, in one embodiment of the invention, the locking unit and/or the reinforced connecting structure are/is intertwined in the concentrated area to form a cable structure or a twisted structure, the operation is simple, the problem that the traditional operation is difficult to cause because a metal suture is thin and is easy to be seen in an angiographic state, so that a puncture needle is difficult to hook and the operation is difficult to cause is solved, in addition, the intertwining self-locking action increases friction force, the contact degree with tissues is improved, the damage to the tissues is reduced, the fatigue resistance is improved, the self-breaking complementary effect is achieved, and the risk that the fixing piece falls into the left atrium is reduced.

7. Different from the prior art, the reinforced connecting structure is arranged among the plurality of fixing pieces in one embodiment of the invention and is connected with all the fixing pieces; when the closing appliance is in the first form, the reinforcing connection structure is of a U-shaped structure or a folded structure, the reinforcing connection structure has an anti-falling effect, the fixing part and the locking part are prevented from being disconnected in the process of suturing through intervention of the oval hole, or the releasing unit and the locking unit are separated after fracture, the locking unit is free of factors such as insufficient self-locking force between the locking parts, the risk that the closing appliance falls into the left atrium is caused, and the safety and the reliability of the operation process are improved.

8. Different from the prior art, the posture adjusting structure in one embodiment of the invention enables the fixing piece to contact tissues to the maximum extent by adjusting the included angle between the fixing piece and the locking piece, thereby supplementing clinical benefits.

9. Different from the prior art, in one embodiment of the invention, the reinforced connection structure is a polymer wire, the polymer wire is twisted together with the locking piece and is matched with the auxiliary fracture structure for use, and the auxiliary fracture structure is connected with the near end of the locking unit.

10. Different from the prior art, in one embodiment of the invention, the wrapping member is arranged outside the fixing member and comprises one of a coating, a polymer film, a polymer sheet and a drug slow-release structure, and the wrapping member can increase the contact area of the fixing member and tissues, promote the inner epidermis to climb and cover and prevent the tissues from being damaged.

11. Different from the prior art, in one embodiment of the invention, the reinforced connecting structure and the locking piece are in a parallel structure or a twisted structure or a braided structure, so that compared with the case of only the locking piece, the anti-releasing force of the locking unit is greatly improved.

Drawings

FIG. 1a is a schematic view of a closure device loaded and restrained within a delivery system in accordance with one embodiment of the present invention.

Fig. 1b is a schematic view of a state in which the locking member is provided with an anchoring structure according to the second embodiment of the present invention.

Fig. 1c and 1d are schematic views showing the locking unit being connected to the releasing unit in a tapered configuration from the distal end to the proximal end in various embodiments of the present invention.

FIG. 1e is a schematic view of a reinforced connection structure between the fastening members according to an embodiment of the present invention.

Fig. 2a to 2e are schematic diagrams illustrating a process of breaking and separating the releasing unit and the locking unit after the locking units approach each other to realize self-locking and locking according to an embodiment of the present invention.

FIG. 2f is a schematic view of the parallel configuration of the locking members according to one embodiment of the present invention.

FIG. 2g is a schematic diagram of a locking member twisted or braided into a cable or twisted structure according to an embodiment of the invention.

Fig. 3 is a schematic diagram illustrating a state in which the auxiliary operation structure is a detachable connection structure in the second embodiment of the present invention.

Fig. 4a to 4l are schematic views illustrating states of the posture adjustment structure according to various embodiments of the present invention.

FIG. 5a is a schematic view of a closure device in a first configuration according to various embodiments of the present invention.

Fig. 5b to 5c are schematic views illustrating the state of the control needle guide rail during angle adjustment by the traction mechanism according to the second embodiment of the present invention.

FIGS. 6 a-6 i are schematic views illustrating the steps of a surgical procedure according to one embodiment of the present invention.

FIG. 7 is a schematic illustration of the positional relationship of the locking power source and the delivery system in various embodiments of the present invention.

FIGS. 8 a-8 f are schematic views of auxiliary operating configurations according to various embodiments of the present invention.

Fig. 9 is a schematic diagram illustrating a state in which the releasing unit includes an auxiliary rupture structure according to an embodiment of the present invention.

Fig. 10 is a schematic view of a state in which the releasing unit includes an auxiliary rupture structure according to another embodiment of the present invention.

Fig. 11a and 11b are schematic views illustrating a process of the locking unit in a closed state according to a third embodiment of the present invention.

Fig. 12a to 12c are schematic diagrams illustrating the process of puncturing the primary septum and the secondary septum by the puncture needle in the third embodiment of the invention.

Fig. 13a to 13d are schematic views illustrating the process states of the fourth embodiment of the present invention when the reinforced connecting structure and the locking unit are twisted together and engaged with the auxiliary breaking structure.

Fig. 14a to 14b are schematic diagrams illustrating various connection manners of the reinforced connection structure and the locking unit in the fourth embodiment of the present invention.

FIG. 14c is a schematic view of the state of the inner support structure in one embodiment of the present invention.

The names of the parts indicated by the numbers in the drawings are as follows:

11-locking unit, 12-locking piece, 121-hooking piece, 122-abutting piece, 13-releasing unit, 14-attitude adjusting structure, 15-anchoring structure, 16-reinforced connecting structure, 17-fixing piece, 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 sheath, 5-control handle, 6-narrowing structure, 7-auxiliary operation structure, 8-auxiliary breaking structure, 9-inner supporting structure and 91-buffering structure.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples.

The term "proximal" as used herein refers to the end of the delivery system that is proximal to the operator when the device is compression loaded during pre-loading, and "distal" refers to the end of the delivery system that is distal to the operator when the device is compression loaded during pre-loading.

The first embodiment is as follows:

in this embodiment, the closure device comprises a locking unit 11, a release unit 13 located in the proximal region of the locking unit 11; the locking unit 11 comprises at least one or more locking members 12; the releasing unit 13 is operated to drive the locking piece 12 to be rotated, the locking pieces 121 are close to each other and realize self-locking, and further, the closing of the tissue defect is realized; the locking unit 11 and the releasing unit 13 are of an integrated structure, when the locking member 12 realizes self-locking and locking, the releasing unit 13 is further operated, so that the releasing unit 13 and the locking unit 11 are separated in a breaking way, as shown in fig. 2 a-2 e, and the design has the advantages that: the structure is simple, the existing risk is low, the number of components is small, the manufacture is convenient, the production efficiency is high, the cost required by the whole set of products is low, and the period is short; the metal implantation amount can be limited to the maximum extent, the stimulation to the tissues is less, and the biocompatibility is good; meanwhile, the releasing unit 13 is convenient to release, the releasing unit 13 and the locking unit 11 can be separated in a breaking way by further rotating the releasing unit 13 and preferentially selecting a rotating releasing mode, the operation action is simple, after the releasing unit is broken, the locking transmission rod 22 has better tactile feedback, whether the releasing unit is completely broken or not can be immediately evaluated, an additional operation instrument is not needed for detection, the operation time in the operation is short, and the learning curve of a doctor is short; in addition, the sheath diameter of the conveying sheath is small, the damage to blood vessels of a human body is small, and the conveying sheath is particularly suitable for special crowds such as minor blood vessels and minor immature patients.

In another embodiment, each retaining member 12 includes 1-20 filaments; wherein each locking member 12 is formed by laying a plurality of filaments in parallel, or each locking member 12 is twisted or woven into a cable structure or a twisted structure by a plurality of filaments, as shown in fig. 2 f.

In this embodiment, as shown in fig. 1c or fig. 1d, when the locking member 12 realizes self-locking, the releasing unit 13 is further operated, and the proximal end region of the locking unit 11 is further rotated; before the locking unit 11 and the releasing unit 13 are separated without fracture, the locking unit and the releasing unit are in a tapered structure 6 from the far end to the near end.

In this embodiment, the locking unit 11 comprises one or more fixing members 17, the fixing member 17 is located at the distal end region of the locking member 12 and connected with the locking member 12, and part or all of the fixing member 17 is attached or anchored to the inside or the outer surface of the distal end of the target tissue.

In this embodiment, the closure device comprises a delivery system located in the proximal region of the disengagement unit 13 or the locking unit 11; the locking unit 11 or the releasing unit 13 is connected to the conveying system.

In this embodiment, before the tissue defect is closed, when the releasing unit 13 is operated to drive the locking unit 11 to rotate, the locking force F of the releasing unit 13 is₀₁Locking force F of the locking unit 11₀₂Critical breaking force F of said disengagement unit 13₁Critical breaking force F of said locking unit 11₂Satisfies the following conditions: f₀₁＜F₁，F₀₁=F₀₂，F₁＜F₂(ii) a When the locking unit 11 is gradually locked, F₀₁And said F₀₂Gradually increased, when the locking unit 11 is fully locked, and the releasing unit 13 is further operated, the F₀₁To said F₁And the breaking separation of the releasing unit 13 is realized.

In this example, F₀₁、F₀₂、F₁、F₂The values of (A) are all between 0.1N and 10N.

In this embodiment, the conveying system includes a locking mechanism, and 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 comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium; when preassembling, the proximal region of the releasing unit 13 is connected with the locking transmission structure 22 to form a concentrated region 25; when the locking power source 21 acts, the locking member 12 is linear and in a stretched state, the locking transmission rod 22 is in a straight state, the locking power source 21 drives the locking transmission rod 22 to further drive the locking transmission structure 22 to twist and advance, the releasing unit 13 drives the locking member 12 to rotate, and the locking unit 11 is entangled in the concentration area 25 for self-locking.

In this embodiment, the locking mechanism is a releasing mechanism, the locking power source 21 is a releasing power source, and the locking unit 11 or the releasing unit 13 is entangled and self-locked in the concentration area 25 to form a cable structure or a twist-like structure, where the cable structure or the twist-like structure is at least one turn.

In this embodiment, as shown in fig. 1a, the locking unit 11 includes two locking members 12; the number and the positions of the locking members 12 and the fixing members 17 correspond one to one.

In this embodiment, as shown in fig. 1a, two locking members 12 are formed with a twisted structure or a braided structure by three filaments, respectively.

In this embodiment, the locking members 12 together have a twisted structure.

In this embodiment, when pre-loaded, as shown in FIG. 1a, the closure device is loaded linearly and confined within the delivery system.

In this embodiment, the securing member 17 and retaining member 12 are spread over the tissue defect area and the attitude adjustment structure 14 adjusts the angle between the securing member 17 and retaining member 12.

In this embodiment, the locking member 12 is connected to the fixing member through the hole or the limiting member to form the posture adjusting structure 14, as shown in fig. 4a to 4 b.

In another embodiment, each of the fixing members 17 is provided with a through hole in the axial direction and a groove connected to the through hole, and the free end of the wire is fixedly connected to the distal end region of the through hole and then protruded from the groove to form the posture adjusting structure 14, as shown in FIGS. 4c to 4 d.

In another embodiment, the fixing member 17 is provided with an axial U-shaped through hole, and the locking member 12 is annularly inserted through the U-shaped through hole to form the posture adjustment structure 14, as shown in fig. 4e to 4 f.

In another embodiment, the middle of the fixing member 17 is provided with a through hole, and the locking member 12 and/or the reinforced connecting structure 16 can be gathered, intertwined, wound around the through hole to be fixedly connected with the fixing member 17 to form the posture adjustment structure 14, as shown in fig. 4g to 4 h.

In another embodiment, the free end of the filament and the fixture 17 form the attitude adjustment structure 14 by a sliding mechanism comprising one or more combinations of a slider, a pulley, as shown in FIGS. 4 i-4 j.

In another embodiment, the fixing member 17 and the locking member 12 form the posture adjustment structure 14 by an elastic member, as shown in fig. 4k to 4 l.

In this embodiment, the closure of the tissue defect is a closure of the foramen ovale defect.

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

In this embodiment, the lock transmission rod 22 connects the lock power source 21 and the control handle 5.

In this embodiment, the locking unit 11 located in the concentration area 25 can be disconnected after being entangled and self-locked.

In this embodiment, as shown in fig. 5, the delivery system comprises a traction part and a pushing part, wherein the traction part comprises two puncture needles 31, the puncture needles 31 have inner cavities, and the pushing part comprises a thimble 32; when the closing instrument is in the first shape, the fixing piece 17 and the thimble 32 are positioned in the inner cavity, and the pushing part abuts against the near end of the fixing piece 17 through the thimble 32 and drives the fixing piece 17 to extend out of the inner cavity; when the closing apparatus is in the second shape, the puncture needle 31 penetrates through the tissue wall, and the thimble 32 is pushed to drive the fixing piece 17 to release from the puncture needle; when the closure device is in the third configuration, the releasing unit 13 drives the locking member 12 and thus the fixing member 17 to close the tissue defect.

In this embodiment, the traction unit further includes a plurality of needle control rails 33 disposed outside the puncture needle 31, and the needle control rails 33 control the movement trajectory of the puncture needle 31 and the puncture position on the tissue.

In this embodiment, the needle 31 has a substantially sharp distal end.

In this embodiment, after the fixing member 17 is released from the inner cavity, the distal end region of the retaining member 12 is connected to the fixing member 17 through the posture adjustment structure 14, and the posture adjustment structure 14 adjusts the included angle between the fixing member 17 and the retaining member 12, and makes the fixing member 17 contact the tissue to the maximum extent; wherein the locking member 12 and the fixing member 17 form the posture adjusting structure 14 by a rotating mechanism including one or more combinations of a chain structure, a hinge structure, and elastic and/or plastic deformation of the material itself.

In this embodiment, a through hole is formed in the middle of the fixing member 17, and the locking member can be gathered, intertwined, wound around the through hole and fixedly connected with the fixing member 17 to form the posture adjustment structure 14, as shown in fig. 4g to 4 h.

In this embodiment, the puncture needle 31 is preferably made of nitinol.

In this embodiment, the locking transmission rod 22 has good torsion and transmission properties, and when the operation control handle 5 rotates the locking transmission rod 22 to further drive the locking member 12 to complete the self-locking and locking of the locking member 12, the locking transmission rod 22 further drives the releasing unit 13, so that the releasing unit 13 and the locking unit 11 are separated by fracture.

In this embodiment, the puncture needle 31 is preferably made of nitinol, and has good flexibility to facilitate the needle withdrawing action.

In this embodiment, the fixing member 17 is a circular tube or a circular rod, the circular tube or the circular rod is made of an implantable metal material, and two ends of the fixing member 17 are provided with buffer structures, each buffer structure includes one or more of a flexible diameter-variable structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring, and a ball head.

In this embodiment, the locking member 12 is a wire made of an implantable flexible metal material.

In this embodiment, the metal content of the securing member 17 and retaining member 12 is very low.

In this embodiment, the lock transmission rod 22 is made of a metal material or a polymer material, and has a good torsion property.

In this embodiment, the tapered structure 6 of each locking unit 11 is formed by tightening three strands of wire with variable reductions.

In this embodiment, the locking member 12 is connected to the releasing unit 13 after being twisted.

In this embodiment, the locking unit 11 is self-twisted in the concentrated area 25 to form a cable structure or a twist-like structure, and the cable structure or the twist-like structure has at least one turn.

In this embodiment, the locking unit 11 and the releasing unit 13 are of an integral structure, the locking unit 11 located in the concentration region 25 is self-locked and locked to close the tissue defect, and the releasing unit 13 is further operated to break and separate the releasing unit 13 from the locking unit 11, wherein the locking unit 11 has a winding number during self-locking and locking, the position with the most winding number is a first position, the position during breaking and separating the locking unit 11 and the releasing unit 13 is a second position, the first position is not consistent with the second position, and the second position is located outside the proximal end of the first position.

In this embodiment, after the releasing unit 13 drives the locking member 12 and further drives the fixing member 17 to close the tissue defect, the fixing member 17 is located on the primary septal surface and the secondary septal surface in the left atrium.

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

In this embodiment, the delivery system at least comprises a traction part and a pushing part, wherein the traction part comprises one or more puncture needles 31, the puncture needles 31 are provided with inner cavities, and the pushing part comprises a thimble 32; firstly, the fixing piece 17 and the thimble 32 are positioned in the inner cavity, and the pushing part abuts against the near end of the fixing piece 17 through the thimble and drives the fixing piece 17 to extend out of the inner cavity, so that the configuration of the closing instrument in the conveying system is ensured to have a small cross section, and the closing instrument is convenient to store and contain; secondly, the puncture needle 31 penetrates through the tissue wall, and the thimble 32 is pushed to drive the fixing piece 17 to release from the puncture needle 31; finally, the releasing unit 13 drives the locking member 12 and further drives the fixing member 17 to close the tissue defect, so that the flexible connection between the fixing member 17 and the locking member 12 is realized, and meanwhile, the connection compliance is improved, thereby ensuring that the foramen ovale is completely closed.

In this embodiment, the puncture needle 31 and the needle control guide rail 33 are both formed with corresponding side openings, the side openings allow the locking member 12 to extend out and then be connected with the locking transmission structure 23, and the side openings provide quick channels for the connection of the locking member 12, the fixing member 17 and the locking transmission structure 23, so that the release process of a closing instrument is facilitated, and the operation process is simplified.

In this embodiment, the locking actuator 22 is adapted to cooperate with at least one fastener to control the tissue fastening action of the fastener.

In this embodiment, the puncture needle 31 is preferably made of metal, which has both rigidity and flexibility to facilitate puncturing tissue.

In this embodiment, needle 31 includes a lumen configured to slidably extend a fastener therein.

In this embodiment, the distal portion of needle control guide 33 has a predetermined shape with an arc of curvature that allows adjustment of the angle of release of needle 31, which is curved away from the central axis of the delivery system.

The operation procedure steps in the operation of the present embodiment are as follows (as shown in fig. 6a to 6 i):

(1) percutaneous puncture, reserving a guide wire at a tissue defect part, conveying a closing instrument to the right atrium through femoral veins along the guide wire, further conveying the closing instrument to a position of an patent foramen ovale between a secondary septum and a primary septum close to an interatrial septum, and enabling the end part of a guide head at the far end of the closing instrument to penetrate through the foramen ovale to limit the position of the guide head;

(2) operating the control handle 5, slowly withdrawing the delivery sheath 4, pushing the two needle control guide rails 33 through the control handle 5 to expose the two needle control guide rails 33, respectively positioning the two needle control guide rails 33 at two sides of the foramen ovale, and operating the control handle 51 to enable the puncture needle 31 to penetrate through the tissue wall;

(3) after the needle withdrawing action of the puncture needle 31 is completed, the thimble 32 is operated to release the fixing piece 17 from the needle control guide rail 33, the guide head is retracted after the needle control guide rail 33 and the puncture needle 31 are retracted, the control handle 5 is operated to enable the locking transmission rod 22 to drive the locking transmission structure 23 to realize the disconnection self-locking of the locking unit 11, and then the conveying system is retracted to complete the operation process.

Example two:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 3, the locking unit 11 includes two locking members 12, and the releasing unit 13 and the lock transmission structure 23 are formed as a detachable connection structure.

In this embodiment, each locking unit 11 is composed of one wire.

In this embodiment, the releasing unit 13 includes the auxiliary operating structure 7, and the auxiliary operating structure 7 is a detachable connecting structure formed by the hook 24 and the proximal end region of the releasing unit 13, and the design has the advantages that: the non-fracture type releasing of the auxiliary operation structure 7 is adopted, the original structural components are not damaged by releasing operation, the releasing mode reaches an ideal state, and the locking amplitude of the locking unit 11 can be regulated and controlled according to the anatomical morphology of the defective tissue, so that the releasing and the separating of the releasing mechanism are realized under the condition that the defective tissue is in a perfect closed state, and the safety is high; the sheath tube can be controlled between 10Fr and 20Fr, and is suitable for most patients.

In another embodiment, the locking unit 11 is connected with the releasing unit 13, the proximal end of the locking unit 11 includes a three-dimensional structure, and when the locking power source 21 drives the three-dimensional structure to rotate so as to enable the locking member 12 to realize self-locking, the releasing unit 13 is further operated, so that the releasing unit 13 is separated from the locking member 12 by breaking. As shown in fig. 8 a.

In another embodiment, the locking unit 11 is connected with the releasing unit 13, the auxiliary operating structure 7 is a spherical structure and a rod-like structure penetrating the spherical structure, and after the proximal end of the locking member 12 is entangled for self-locking, the rod-like structure is withdrawn to separate the locking unit 11 from the releasing unit 13, as shown in fig. 8 b.

In another embodiment, the secondary operation structure 7 is a cutter, as shown in fig. 8c and 8 d.

In another embodiment, the auxiliary operating structure 7 is an electrodeionization device, as shown in fig. 8e and 8 f.

In this embodiment, the delivery system is provided with a pull mechanism 34 and a pull wire 35, and the angle of the control needle guide 33 can be further adjusted by pulling the pull wire 35, as shown in FIGS. 5b and 5 c.

In this embodiment, as shown in fig. 1b, the locking member 12 is provided with an anchoring structure; wherein, add anchor structure and be the anchor thorn, increased anchoring effect, improved frictional force.

In this embodiment, as shown in fig. 4i to 4j, the locking member 12 and the fixing member 17 form the posture adjustment structure 14 by a sliding mechanism including one of a slider and a pulley.

The operation procedure of the present embodiment in the operation is as follows:

(2) the control handle 5 is operated to realize the adjustment of the bending angle of the far end of the delivery sheath 4, the delivery sheath 4 is slowly withdrawn, the two needle control guide rails 33 are exposed by pushing the needle control guide rails 33 through the control handle 5, the two needle control guide rails 33 are respectively positioned at two sides of the foramen ovale, and the puncture needle passes through tissues by operating the control handle 51;

(3) after the needle 31 is taken out, the thimble 32 is operated to release the fixing piece 17 from the needle control guide rail 33, the guide head is withdrawn after the needle control guide rail 33 and the puncture needle 31 are withdrawn, the control handle 5 is operated to release the detachable connecting structure between the releasing unit 13 and the hook 24, and the conveying system is withdrawn, thereby completing the operation process.

Example three:

the difference from the first embodiment is that:

in this embodiment, the delivery system comprises a puncture needle 31, when the closure device is located in the delivery system, the locking unit 11 comprises 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 abutment 122, the second free end is provided with a catch 121, the puncture needle 31 has a predetermined shape, as shown in fig. 12a to 12c, when the closure device is released, after the puncture needle 31 passes through the secondary septum and then passes through the primary septum in the reverse direction, the puncture needle 31 is withdrawn, the abutment is released, and the locking transmission rod 22 is operated to cause the catch 121 to catch the abutment 122; operating the releasing unit 13 to drive the locking pieces 12 to rotate, wherein the locking pieces 12 are close to each other and realize self-locking, and further, the closing of the tissue defect is realized; when the locking unit 11 is locked at the tissue defect, the locking unit 11 is integrally closed and then connected to the releasing unit 13, and the releasing unit 13 is further operated, so that the releasing unit 13 is separated from the locking unit 11 by breaking, as shown in fig. 11a to 11 b.

In this embodiment, as shown in fig. 11b, when the locking unit 11 is locked, the locking unit 11 is connected to the releasing unit 13 after being in a closed state.

Example four:

the difference from the first embodiment is that:

in this embodiment, the closure device comprises a locking unit 11, a release unit 13 located in the proximal region of the locking unit 11; the locking unit 11 comprises at least one or more locking members 12; the releasing unit 13 comprises an auxiliary breaking structure 8, and the distal end of the auxiliary breaking structure 8 is connected with the proximal end of the locking member 12; operating the releasing unit 13 to enable the auxiliary breaking structure 8 to drive the locking pieces 12 to rotate, enabling the locking pieces 12 to approach each other and realize self-locking and locking, and further realizing the closing of the tissue defect; when retaining member 12 realizes auto-lock locking, further operation disengagement unit 13, supplementary fracture structure 8 is rotated further for supplementary fracture structure 8 fracture back with retaining member 12 separates, and the advantage of design like this lies in: the auxiliary fracture structure 8 is adopted, so that the fracture position of the instrument after tissue closure can be further limited, the fracture position is safe and reliable, the fracture position can be accurately limited at the auxiliary fracture structure 8, and the implanted part of the closure instrument is ensured to be in the best state; meanwhile, the force application of the locking piece 12 is uniform in the tissue defect closing process, so that the extra local tissue defect caused by uneven stress at the tissue defect position is avoided; in addition, the sheath diameter of the conveying sheath is small, the damage to blood vessels of a human body is small, and the conveying sheath is particularly suitable for special crowds such as minor blood vessels and minor immature patients.

In another embodiment, the secondary breaking structure 8 is connected to the locking member 12 by one of a through-going, sliding collar and a securing collar, as shown in fig. 9 or fig. 10.

In this embodiment, a reinforced connecting structure 16 is disposed between the fixing members 17, and the reinforced connecting structure 16 connects all the fixing members 17; and the retaining member 12 is connected to the delivery system, the reinforced connecting structure 16 is not connected to the delivery system; after the reinforcing connecting structure 16 and the locking member 12 are connected to the proximal end region of the auxiliary breaking structure 8 in a twisted structure, the distal end region of the auxiliary breaking structure 8 is connected to the delivery system, as shown in fig. 13 a.

In this embodiment, before the tissue defect is closed, when the auxiliary breaking structure 8 is operated to drive the locking unit 11 to rotate, the locking force F applied to the auxiliary breaking structure 8 is₀₃The locking force F to which the locking unit 11 is subjected₀₄Critical breaking force F of the auxiliary breaking structure 8₃Critical breaking force F of said locking unit 11₄Critical breaking force F of said reinforced connection structure 16₈Satisfies the following conditions: f₀₃＜F₃，F₀₃=F₀₄，F₃＜F₄＜F₈(ii) a When the locking unit 11 is gradually locked, F₀₃And said F₀₄Gradually increases, and when the locking unit 11 is completely locked, the auxiliary breaking structure 8 is further operated, and the F is gradually increased₀₃Reach the critical breaking force F₃And realizing the fracture separation of the auxiliary fracture structure 8.

In this embodiment, the locking unit 11 and the reinforced connecting structure 16 are intertwined and self-locked at the concentrated area to form a cable structure or a twist-like structure, and the cable structure or the twist-like structure has at least one turn.

In this embodiment, as shown in fig. 14b, the fixing member 17 comprises, from the outside to the inside, a housing structure and an inner support structure 9; wherein, the fixing piece 17 is strip-shaped; one end or two ends of the fixing piece 17 are provided with buffer structures, and the buffer structures comprise one or more of flexible reducing structures, flexible fine branch structures, local thickening structures, S-shaped structures, wave structures, spring structures, circular rings and ball heads, so that stimulation or damage to target tissues can be reduced; when the fixture 17 comprises the inner support structure 9, the inner support structure 9 is located in the whole area of the outer shell structure along the axial direction of the fixture 17; wherein the inner support structure 9 is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defines the relative positions of the distal end of the retaining member 12 and the inner support structure 9.

In another embodiment, the reinforced connecting structure 16 is a polymer wire, and the free end of the polymer wire is connected to the fixing member 17 by gluing, twisting, knotting, mechanical connection, welding, etc.; the locking unit 11 is a soft metal wire, the locking unit 11 comprises two locking members 12, each locking member 12 is connected to the fixing member 17 by gluing, mechanical connection, welding, etc. and then twisted and formed with the polymer wire, as shown in fig. 14a

In another embodiment, the fixing member 17 includes an inner supporting structure 9, the inner supporting structure 9 is formed by twisting a plurality of metal wires, two ends of the inner supporting structure 9 are arc structures, the arc structures are located at two ends of the fixing member 17 and are used as buffer structures 91, the reinforcing connection structure 16 and the locking unit 11 are twisted together to form a fixed connection, wherein the reinforcing connection structure 16 and the locking unit 11 are twisted together with the inner supporting structure 9 in the fixing member 17 to form a fixed connection, as shown in fig. 14 c.

In another embodiment, as shown in FIG. 1e, reinforcing attachment structure 16 is in a "U" or accordion configuration when securing member 17 and retaining member 12 are in the delivery system.

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

In this embodiment, the inner support structure 9 can improve the support of the outer shell structure.

In this embodiment, the inner supporting structure 9 is located in the whole section of the outer shell structure, and the two end regions of the outer shell structure are soft structures to prevent scratching the tissue.

In this embodiment, the inner support structure 9 is a 0.1mm to 1mm metal wire, 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.

In this embodiment, the reinforced connection structure 16 is a polymer wire, and the free end of the polymer wire is connected to the fixing member 17 by gluing, twisting, knotting, mechanical connection, welding, or the like; the locking unit 11 is a soft metal wire, the locking unit 11 comprises two locking pieces 12, each locking piece 12 is connected to the fixing piece 17 by gluing, mechanical connection, welding and the like, and then twisted and formed with a high molecular wire, as shown in fig. 14 a; operating the releasing unit 13 to enable the auxiliary breaking structure 8 to drive the locking pieces 12 to rotate, enabling the locking pieces 12 to approach each other and realize self-locking and locking, and further realizing the closing of the tissue defect; when the locking member 12 realizes self-locking and locking, the releasing unit 13 is further operated, and the auxiliary breaking structure 8 is further rotated, so that the auxiliary breaking structure 8 is broken and separated from the locking member 12 after being broken, as shown in fig. 13a to 13 d.

The above description is only a preferred embodiment of the present invention, and for those skilled in the art, the present invention should not be limited by the description of the present invention, which should be interpreted as a limitation.

Claims

1. A closure device for a tissue defect, comprising: the closing instrument comprises a locking unit and a releasing unit positioned at the proximal end region of the locking unit; the locking unit at least comprises one or more locking pieces; the releasing unit is operated to drive the locking pieces to rotate, the locking pieces are close to each other and realize self-locking and locking, and further the closing of the tissue defect is realized; the locking unit and the releasing unit are of an integrated structure, and when the locking piece realizes self-locking and locking, the releasing unit is further operated, so that the releasing unit and the locking unit are separated in a breaking mode.

2. The closure instrument for a tissue defect of claim 1, wherein: before the locking unit and the releasing unit are not broken and separated, the locking unit and the releasing unit are in a tapered structure from the far end to the near end; when the locking piece realizes self-locking and locking, the releasing unit is further operated, and the proximal end area of the locking unit is further rotated, so that the releasing unit and the locking unit are separated in a breaking way.

3. The closure instrument for a tissue defect of claim 1, wherein: the locking unit comprises one or more fixing pieces, the fixing pieces are positioned at the distal end area of the locking pieces and are connected with the locking pieces, and part or all of the fixing pieces are attached or anchored to the inside or the outer surface of the distal end of the target tissue; a reinforced connecting structure is arranged between the fixing pieces and is connected with a plurality of fixing pieces; the reinforced connecting structure is made of flexible metal materials or high polymer materials; the closure device comprises a delivery system located in a proximal region of the disengagement unit or the locking unit; the locking unit or the releasing unit is connected with the conveying system; the reinforcing connection structure is not connected with the conveying system and is independent from the proximal end area or the whole area of the locking member.

4. The closure instrument for a tissue defect of claim 3, wherein: before the tissue defect is closed, when the releasing unit is operated to drive the locking unit to rotate, the locking force F borne by the releasing unit₀₁Locking force F that the locking unit receives₀₂Critical breaking force F of said disengagement unit₁The critical breaking force F2 of the locking unit and the critical breaking force F7 of the reinforced connection structure satisfy: f01 < F1, F01= F02, F1 < F2 < F7; when the locking unit is gradually locked, F₀₁And said F₀₂Gradually increasing; when the locking unit is fully locked, the releasing unit is further operated, F₀₁To said F₁And realizing the fracture separation of the releasing unit.

5. The closure instrument for a tissue defect of claim 3, wherein: the conveying system comprises a locking mechanism, wherein the locking mechanism comprises a locking power source, a locking transmission rod and a locking transmission structure fixedly connected to the far end of the locking transmission rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises 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; when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area; when the locking power source plays a role, the locking piece is linear and in a stretched straight state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod to further drive the locking transmission structure to twist and advance, the releasing unit drives the locking piece to rotate, and the locking unit is entangled in the concentration area for self-locking.

6. A closure device for a tissue defect, comprising: the closing instrument comprises a locking unit and a releasing unit positioned at the proximal end region of the locking unit; the locking unit at least comprises one or more locking pieces; the releasing unit comprises an auxiliary breaking structure, and the distal end of the auxiliary breaking structure is connected with the proximal end of the locking piece; operating the releasing unit to enable the auxiliary breaking structure to drive the locking pieces to rotate, enabling the locking pieces to approach each other and realizing self-locking and locking, and further realizing the closing of the tissue defect; when the retaining member realizes self-locking and locking, the releasing unit is further operated, and the auxiliary breaking structure is further rotated, so that the auxiliary breaking structure is separated from the retaining member after being broken.

7. The closure instrument for a tissue defect of claim 6, wherein: the locking unit comprises one or more fixing pieces, the fixing pieces are positioned at the distal end area of the locking pieces and are connected with the locking pieces, and part or all of the fixing pieces are attached or anchored to the inside or the outer surface of the distal end of the target tissue; a reinforced connecting structure is arranged between the fixing pieces and is connected with a plurality of fixing pieces; the closure device includes a delivery system located at a proximal region of the detachment unit, the reinforced attachment structure not being connected to the delivery system; wherein after the reinforced connecting structure and the locking member are in a parallel structure or a twisted structure or a braided structure and are connected with the distal end region of the auxiliary breaking structure, the proximal end region of the auxiliary breaking structure is connected with the delivery system; or the reinforced connecting structure is independent from the proximal end area or the whole area of the locking member.

8. The closure instrument for a tissue defect of claim 7, wherein: before the tissue defect is closed, when the auxiliary fracture structure is operated to drive the locking unit to rotate, the locking force F borne by the auxiliary fracture structure₀₃Locking force F that the locking unit receives₀₄Critical breaking force F of the auxiliary breaking structure₃Critical breaking force F of the locking unit₄Critical breaking force F of the reinforced connection structure₈Satisfies the following conditions: f₀₃＜F₃，F₀₃=F₀₄，F₃＜F₄＜F₈(ii) a When the locking unit is gradually locked, F₀₃And said F₀₄Gradually increasing, when the locking unit is fully locked, and further operating the auxiliary breaking structure, the F₀₃To said F₃Realize the assistance ofAnd (4) fracture separation of the fracture-assisting structure.

9. The closure instrument for a tissue defect of claim 6, wherein: the auxiliary breaking structure is connected with the locking piece in one or more combination modes of penetration, sliding ring sleeves and fixing ring sleeves.

10. The closure instrument for a tissue defect of claim 7, wherein: the conveying system comprises a locking mechanism, wherein the locking mechanism comprises a locking power source, a locking transmission rod and a locking transmission structure fixedly connected to the far end of the locking transmission rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises 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; when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area; when the locking power source plays a role, the locking piece is linear and in a stretched straight state, the locking transmission rod is in a straight state, the locking power source drives the locking transmission rod to further drive the locking transmission structure to twist and advance, the releasing unit drives the locking piece to rotate, and the locking unit is entangled in the concentration area for self-locking.

11. The closure device for a tissue defect of claim 10, wherein: the locking unit and the reinforced connecting structure are intertwined and self-locked in the concentration area to form a cable structure or a twist-shaped structure, and the cable structure or the twist-shaped structure is at least one circle.

12. A closure device for a tissue defect, comprising: the closing instrument comprises a locking unit and a releasing unit positioned at the proximal end region of the locking unit; the locking unit comprises at least one or more locking members; the disengagement unit comprises an auxiliary operating structure; the releasing unit is operated to drive the locking pieces to rotate, the locking pieces are close to each other and realize self-locking and locking, and further the closing of the tissue defect is realized; the proximal end of the locking unit is connected with the distal end of the releasing unit, and the auxiliary operation structure is operated to separate the releasing unit from the locking member.

13. The closure instrument for a tissue defect of claim 12, wherein: the auxiliary operation structure comprises a fusible link structure, a low-temperature breakable link structure, a breakable link structure and a detachable link structure which are arranged at the proximal end area of the releasing unit.

14. The closure instrument for a tissue defect of claim 12, wherein: the locking unit comprises one or more fixing pieces, the fixing pieces are positioned at the distal end area of the locking pieces and are connected with the locking pieces, and part or all of the fixing pieces are attached or anchored to the inside or the outer surface of the distal end of the target tissue; a reinforced connecting structure is arranged between the fixing pieces and is connected with a plurality of fixing pieces; the closure device includes a delivery system located at a proximal region of the detachment unit, the reinforced attachment structure not being connected to the delivery system; wherein after the reinforced connecting structure and the locking member are in a parallel structure or a twisted structure or a braided structure and are connected with the distal end region of the releasing unit, the proximal end region of the releasing unit is connected with the conveying system; alternatively, the reinforcing attachment structure is free of the retaining member from the proximal region or from the entire region.

15. The closure instrument for a tissue defect of claim 14, wherein: before the tissue defect is closed, when the releasing unit is operated to drive the locking unit to rotate, the locking force F of the releasing unit₀₅Locking force F of the locking unit₀₆Critical breaking force F of said disengagement unit₅Critical breaking force F of the locking unit₆Critical breaking force F of the reinforced connection structure₉Satisfies the following conditions: f₀₅＜F₅，F₀₅=F₀₆，F₅＜F₆＜F₉。

16. The closure instrument for a tissue defect of claim 14, wherein:

the conveying system comprises a locking mechanism, wherein the locking mechanism comprises a locking power source, a locking transmission rod and a locking transmission structure fixedly connected to the far end of the locking transmission rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium; the locking mechanism is different from the releasing mechanism, the locking power source is operated, the locking member is rotated to close the tissue defect, the releasing power source is operated, and the locking member is separated from the releasing unit;

17. The closure instrument for a tissue defect of claim 16, wherein: the locking unit and/or the reinforced connecting structure are/is self-twisted in the concentrated area to form a cable structure or a twist-shaped structure, and the cable structure or the twist-shaped structure is at least one circle.

18. A closure instrument for a tissue defect according to claim 3 or 7 or 14, wherein: the fixing piece comprises an outer shell structure and/or an inner support structure from outside to inside; wherein, the fixing piece is strip-shaped; one end or two ends of the fixing piece are provided with buffer structures, and each buffer structure comprises one or more of a flexible reducing structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring and a ball head; when the fixing piece comprises the inner supporting structure, the inner supporting structure is positioned in a middle section area or a whole section area of the shell structure along the axial direction of the fixing piece; wherein the inner support structure is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defines the relative positions of the retaining member distal end and the inner support structure.

19. The closure device for a tissue defect of claim 1, 6 or 12, wherein: the locking part is provided with an anchoring structure extending out of the locking part; wherein the anchoring structure comprises one or more of a micro-thorn structure, a local protrusion structure and a local flattening structure.

20. A closure instrument for a tissue defect according to claim 3 or 7 or 14, wherein: an attitude adjusting structure is arranged between the fixing piece and the locking piece; when the fixing piece and the retaining piece are unfolded in the tissue defect area, the posture adjusting structure adjusts an included angle between the fixing piece and the retaining piece, so that the fixing piece contacts the tissue to the maximum extent; the posture adjusting structure is a rotating structure, and the rotating structure comprises a chain structure, a hinge structure and one or more combinations of elastic deformation and/or plastic deformation of materials; or the posture adjusting structure is a sliding structure, and the sliding structure comprises one or more of a sliding block and a pulley.

21. The closure device for a tissue defect of claim 1, 6 or 12, wherein: the locking piece is of a parallel structure or a twisted structure or a braided structure.

22. A closure instrument for a tissue defect according to claim 3 or 7 or 14, wherein: the fixing piece is provided with a micropore structure; or the fixing piece and/or the locking unit comprise a coating piece, and the coating piece comprises one of a coating layer, a polymer film, a polymer sheet and a drug slow-release structure.