CN113827285A - Closure device for tissue defects - Google Patents

Abstract

Translated fromChinese

本发明涉及医疗器械领域，尤其涉及组织缺损的闭合器械，所述闭合器械包括锁紧单元、位于所述锁紧单元近端区域的解脱单元；所述锁紧单元至少包括一个或多个锁紧件；操作所述解脱单元，带动所述锁紧件被转动，所述锁紧件相互靠近并实现自锁锁紧，进而实现所述组织缺损的闭合；所述锁紧单元和所述解脱单元为一体式结构，当所述锁紧件实现自锁锁紧时，进一步操作所述解脱单元，使得所述解脱单元与所述锁紧单元断裂分离。

The present invention relates to the field of medical devices, in particular to a closure device for tissue defects, the closure device comprises a locking unit and a release unit located at the proximal end region of the locking unit; the locking unit at least includes one or more locking units operating the release unit to drive the locking piece to be rotated, the locking pieces approach each other and realize self-locking locking, thereby realizing the closure of the tissue defect; the locking unit and the releasing unit With an integrated structure, when the locking member achieves self-locking locking, the disengaging unit is further operated, so that the disengaging unit is broken and separated from the locking unit.

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 the normal population is 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 patent with patent foramen ovale, the remaining slit-like abnormal channels of the primary compartment and the secondary compartment are 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, the blood can flow from the left atrium to the right 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 enlarged, and the lung circulation blood volume is increased. When right atrial pressure is higher than left atrial pressure, the weak primary septum on the left side is pushed open, a right-to-left shunting of blood occurs, and in addition, the following emboli may enter the left cardiac system causing 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 of the 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 rotating axis line 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 curve for the doctor to learn 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 unit makes release 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 in a breaking way by further rotating the releasing unit and preferentially selecting a rotating releasing mode, the operation action is simple, after the releasing unit is broken, the locking transmission rod 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 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 connection structure is free outside the proximal end region of the locking member or outside the whole region, and the reinforcing connection structure and the locking member are partially connected through the fixing structure, so that after the reinforcing connection structure and the locking member are of parallel structures, the proximal end region of the locking unit and/or the releasing unit is connected with the conveying system, and therefore the reinforcing connection structure can be guaranteed to participate in the locking and locking process of the locking member and play a certain fixing role.

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 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 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 supplementary fracture structure fracture back 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 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 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 auxiliary fracture structure fracture separation is realized, and the design has the advantages that the locking pieces are ensured to be close to each other and realize the self-locking process, the locking force is in a relatively low state, the stimulation to the tissue is reduced, and meanwhile, along with the locking process, the critical fracture force of the releasing unit is lower than the critical fracture force of the locking unit, so that the locking is ensuredBreaking occurs at the releasing unit after the locking unit breaks completely, the breaking position is further limited, meanwhile, the locking unit can be further prevented from breaking in advance by the aid of the reinforced connecting structure, and safety is improved.

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

In one embodiment, the locking unit and the reinforcing attachment structure are self-entangled at the concentrated area to form a cable structure or a 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 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 retaining member distal end 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 fixture or housing structure is a tube or wire made of plastic, which is biocompatible and reduces the amount of metal implanted.

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, 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, 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 position, 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 mount form an attitude adjustment structure via 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 both provided with corresponding side openings, the side openings allow the locking pieces to be connected with the locking transmission structures after extending out, the side openings provide quick channels for the connection of the locking pieces, the fixing pieces and the locking transmission structures, the releasing process of the closing instrument is facilitated, and the operation process 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. Different from the prior art, in one embodiment of the present invention, before the tissue defect is closed, when the releasing unit is operated to drive the locking unit to rotate, the releasing unit is subjected to the locking force F₀₁Locking 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 and 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 entangled in the concentrated area to form a cable structure or a twist-shaped structure, so that the operation is simple, the problem that the operation is difficult to operate due to the fact that a puncture needle is difficult to hook because a metal suture is thin and is easy to be seen in an angiographic state in the prior art is solved, in addition, the entanglement self-locking action increases friction, 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 an 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 preloaded in the delivery system, and "distal" refers to the end of the delivery system that is distal to the operator when the device is preloaded in the delivery system.

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 rotate, the locking pieces 121 approach to each other and realize self-locking and locking, and further, the tissue defect is closed; 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 retainingmember 12 includes 1-20 filaments; wherein each lockingmember 12 is formed by laying a plurality of filaments in parallel, or each lockingmember 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 lockingmember 12 realizes self-locking, the releasingunit 13 is further operated, and the proximal end region of the lockingunit 11 is further rotated; before the lockingunit 11 and the releasingunit 13 are separated without fracture, the locking unit and the releasing unit are in atapered structure 6 from the far end to the near end.

In this embodiment, the lockingunit 11 comprises one ormore fixing members 17, the fixingmember 17 is located at the distal end region of the lockingmember 12 and connected with the lockingmember 12, and part or all of the fixingmember 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 thedisengagement unit 13 or thelocking unit 11; the lockingunit 11 or the releasingunit 13 is connected to the conveying system.

In this embodiment, before the tissue defect is closed, when the releasingunit 13 is operated to drive the lockingunit 11 to rotate, the locking force F of the releasingunit 13 is₀₁Locking force F of the lockingunit 11₀₂Critical breaking force F of saiddisengagement unit 13₁Critical breaking force F of said lockingunit 11₂Satisfies the following conditions: f₀₁＜F₁，F₀₁=F₀₂，F₁＜F₂(ii) a When the lockingunit 11 is gradually locked, F₀₁And said F₀₂Gradually increased, when the lockingunit 11 is fully locked, and the releasingunit 13 is further operated, the F₀₁To said F₁And the breaking separation of the releasingunit 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 lockingpower source 21, a lockingtransmission rod 22, and a lockingtransmission structure 23 fixedly connected to the distal end of the lockingtransmission 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 releasingunit 13 is connected with the lockingtransmission structure 22 to form aconcentrated region 25; when the lockingpower source 21 acts, the lockingmember 12 is linear and in a stretched state, the lockingtransmission rod 22 is in a straight state, the lockingpower source 21 drives the lockingtransmission rod 22 to further drive the lockingtransmission structure 22 to twist and advance, the releasingunit 13 drives the lockingmember 12 to rotate, and the lockingunit 11 is entangled in theconcentration area 25 for self-locking.

In this embodiment, the locking mechanism is a releasing mechanism, the lockingpower source 21 is a releasing power source, and the lockingunit 11 or the releasingunit 13 is entangled and self-locked in theconcentration 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 lockingunit 11 includes two lockingmembers 12; the number and the positions of the lockingmembers 12 and the fixingmembers 17 correspond one to one.

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

In this embodiment, the lockingmembers 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 securingmember 17 and retainingmember 12 are spread over the tissue defect area and theattitude adjustment structure 14 adjusts the angle between the securingmember 17 and retainingmember 12.

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

In another embodiment, each of the fixingmembers 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 theposture adjusting structure 14, as shown in FIGS. 4c to 4 d.

In another embodiment, the fixingmember 17 is provided with an axial U-shaped through hole, and the lockingmember 12 is annularly passed through the U-shaped through hole to form theposture adjustment structure 14, as shown in fig. 4e to 4 f.

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

In another embodiment, the free end of the filament and thefixture 17 form theattitude 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 fixingmember 17 and the lockingmember 12 form theposture 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 adelivery sheath 4 and acontrol handle 5.

In this embodiment, thelock transmission rod 22 connects thelock power source 21 and thecontrol handle 5.

In this embodiment, the lockingunit 11 located in theconcentration 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 athimble 32; when the closing instrument is in the first shape, the fixingpiece 17 and thethimble 32 are positioned in the inner cavity, and the pushing part abuts against the near end of the fixingpiece 17 through thethimble 32 and drives the fixingpiece 17 to extend out of the inner cavity; when the closing apparatus is in the second shape, thepuncture needle 31 penetrates through the tissue wall, and thethimble 32 is pushed to drive the fixingpiece 17 to release from the puncture needle; when the closure device is in the third configuration, the releasingunit 13 drives the lockingmember 12 and thus the fixingmember 17 to close the tissue defect.

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

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

In this embodiment, after the fixingmember 17 is released from the inner cavity, the distal end region of the retainingmember 12 is connected to the fixingmember 17 through theposture adjustment structure 14, and theposture adjustment structure 14 adjusts the included angle between the fixingmember 17 and the retainingmember 12, and makes the fixingmember 17 contact the tissue to the maximum extent; wherein the lockingmember 12 and the fixingmember 17 form theposture 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 fixingmember 17, and the locking member can be gathered, intertwined, wound around the through hole and fixedly connected with the fixingmember 17 to form theposture adjustment structure 14, as shown in fig. 4g to 4 h.

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

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

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

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

In this embodiment, the metal content of the securingmember 17 and retainingmember 12 is very low.

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

In this embodiment, the taperedstructure 6 of each lockingunit 11 is formed by tightening three strands of wire with variable reductions.

In this embodiment, the lockingmember 12 is connected to the releasingunit 13 after being twisted.

In this embodiment, the lockingunit 11 is self-twisted in theconcentrated 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 lockingunit 11 and the releasingunit 13 are of an integral structure, the lockingunit 11 located in theconcentration region 25 is self-locked and locked to close the tissue defect, and the releasingunit 13 is further operated to break and separate the releasingunit 13 from the lockingunit 11, wherein the lockingunit 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 lockingunit 11 and the releasingunit 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 releasingunit 13 drives the lockingmember 12 and further drives the fixingmember 17 to close the tissue defect, the fixingmember 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 thethimble 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 athimble 32; firstly, the fixingpiece 17 and thethimble 32 are positioned in the inner cavity, and the pushing part abuts against the near end of the fixingpiece 17 through the thimble and drives the fixingpiece 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, thepuncture needle 31 penetrates through the tissue wall, and thethimble 32 is pushed to drive the fixingpiece 17 to release from thepuncture needle 31; finally, the releasingunit 13 drives the lockingmember 12 and further drives the fixingmember 17 to close the tissue defect, so that the flexible connection between the fixingmember 17 and the lockingmember 12 is realized, and meanwhile, the connection compliance is improved, thereby ensuring that the foramen ovale is completely closed.

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

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

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

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

In this embodiment, the delivery system includes adelivery sheath 4 and acontrol handle 5.

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

In this embodiment, the distal portion ofneedle control guide 33 has a predetermined shape with an arc of curvature that allows adjustment of the angle of release ofneedle 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 thecontrol handle 5, slowly withdrawing thedelivery sheath 4, pushing the two needlecontrol guide rails 33 through the control handle 5 to expose the two needlecontrol guide rails 33, respectively positioning the two needlecontrol guide rails 33 at two sides of the foramen ovale, and operating the control handle 51 to enable thepuncture needle 31 to penetrate through the tissue wall;

(3) after the needle withdrawing action of thepuncture needle 31 is completed, thethimble 32 is operated to release the fixingpiece 17 from the needlecontrol guide rail 33, the guide head is retracted after the needlecontrol guide rail 33 and thepuncture needle 31 are retracted, the control handle 5 is operated to enable the lockingtransmission rod 22 to drive the lockingtransmission structure 23 to realize the disconnection self-locking of the lockingunit 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 lockingunit 11 includes two lockingmembers 12, and the releasingunit 13 and thelock transmission structure 23 are formed as a detachable connection structure.

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

In this embodiment, the releasingunit 13 includes theauxiliary operating structure 7, and theauxiliary operating structure 7 is a detachable connecting structure formed by thehook 24 and the proximal end region of the releasingunit 13, and the design has the advantages that: the non-fracture type releasing of theauxiliary 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 lockingunit 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 lockingunit 11 is connected with the releasingunit 13, the proximal end of the lockingunit 11 includes a three-dimensional structure, and when the lockingpower source 21 drives the three-dimensional structure to rotate so as to enable the lockingmember 12 to realize self-locking, the releasingunit 13 is further operated, so that the releasingunit 13 is separated from the lockingmember 12 by breaking. As shown in fig. 8 a.

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

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

In another embodiment, theauxiliary 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 apull wire 35, and the angle of thecontrol needle guide 33 can be further adjusted by pulling thepull wire 35, as shown in FIGS. 5b and 5 c.

In this embodiment, as shown in fig. 1b, the lockingmember 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 lockingmember 12 and the fixingmember 17 form theposture 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:

(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) the control handle 5 is operated to realize the adjustment of the bending angle of the far end of thedelivery sheath 4, thedelivery sheath 4 is slowly withdrawn, the two needlecontrol guide rails 33 are exposed by pushing the needlecontrol guide rails 33 through thecontrol handle 5, the two needlecontrol 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 theneedle 31 is taken out, thethimble 32 is operated to release the fixingpiece 17 from the needlecontrol guide rail 33, the guide head is withdrawn after the needlecontrol guide rail 33 and thepuncture needle 31 are withdrawn, the control handle 5 is operated to release the detachable connecting structure between the releasingunit 13 and thehook 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 apuncture needle 31, when the closure device is located in the delivery system, the lockingunit 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 anabutment 122, the second free end is provided with acatch 121, thepuncture needle 31 has a predetermined shape, as shown in fig. 12a to 12c, when the closure device is released, after thepuncture needle 31 passes through the secondary septum and then passes through the primary septum in the reverse direction, thepuncture needle 31 is withdrawn, the abutment is released, and the lockingtransmission rod 22 is operated to cause thecatch 121 to catch theabutment 122; operating the releasingunit 13 to drive the lockingpieces 12 to rotate, wherein the lockingpieces 12 are close to each other and realize self-locking, and further, the closing of the tissue defect is realized; when the lockingunit 11 is locked at the tissue defect, the lockingunit 11 is integrally closed and then connected to the releasingunit 13, and the releasingunit 13 is further operated, so that the releasingunit 13 is separated from the lockingunit 11 by breaking, as shown in fig. 11a to 11 b.

In this embodiment, as shown in fig. 11b, when the lockingunit 11 is locked, the lockingunit 11 is connected to the releasingunit 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, thesecondary breaking structure 8 is connected to the lockingmember 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 connectingstructure 16 is disposed between the fixingmembers 17, and the reinforced connectingstructure 16 connects all the fixingmembers 17; and the retainingmember 12 is connected to the delivery system, the reinforced connectingstructure 16 is not connected to the delivery system; after the reinforcing connectingstructure 16 and the lockingmember 12 are connected to the proximal end region of theauxiliary breaking structure 8 in a twisted structure, the distal end region of theauxiliary 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 theauxiliary breaking structure 8 is operated to drive the lockingunit 11 to rotate, the locking force F applied to theauxiliary breaking structure 8 is₀₃The locking force F to which thelocking unit 11 is subjected₀₄Critical breaking force F of theauxiliary breaking structure 8₃Critical breaking force F of said lockingunit 11₄Critical breaking force F of said reinforcedconnection structure 16₈Satisfies the following conditions: f₀₃＜F₃，F₀₃=F₀₄，F₃＜F₄＜F₈(ii) a When the lockingunit 11 is gradually locked, F₀₃And said F₀₄Gradually increases, and when the lockingunit 11 is completely locked, theauxiliary breaking structure 8 is further operated, and the F is gradually increased₀₃Reach the critical breaking force F₃And realizing the fracture separation of theauxiliary fracture structure 8.

In this embodiment, the lockingunit 11 and the reinforced connectingstructure 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 fixingmember 17 comprises, from the outside to the inside, a housing structure and aninner support structure 9; wherein, the fixingpiece 17 is strip-shaped; one end or two ends of the fixingpiece 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 thefixture 17 comprises theinner support structure 9, theinner support structure 9 is located in the whole area of the outer shell structure along the axial direction of thefixture 17; wherein theinner 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 retainingmember 12 and theinner support structure 9.

In another embodiment, the reinforced connectingstructure 16 is a polymer wire, and the free end of the polymer wire is connected to the fixingmember 17 by gluing, twisting, knotting, mechanical connection, welding, etc.; the lockingunit 11 is a soft metal wire, the lockingunit 11 comprises two lockingmembers 12, each lockingmember 12 is connected to the fixingmember 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 fixingmember 17 includes aninner supporting structure 9, the inner supportingstructure 9 is formed by twisting a plurality of metal wires, two ends of the inner supportingstructure 9 are arc structures, the arc structures are located at two ends of the fixingmember 17 and are used asbuffer structures 91, the reinforcingconnection structure 16 and the lockingunit 11 are twisted together to form a fixed connection, wherein the reinforcingconnection structure 16 and the lockingunit 11 are twisted together with the inner supportingstructure 9 in the fixingmember 17 to form a fixed connection, as shown in fig. 14 c.

In another embodiment, as shown in FIG. 1e, reinforcingattachment structure 16 is in a "U" or accordion configuration when securingmember 17 and retainingmember 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, theinner support structure 9 can improve the support of the outer shell structure.

In this embodiment, the inner supportingstructure 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, theinner 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 reinforcedconnection structure 16 is a polymer wire, and the free end of the polymer wire is connected to the fixingmember 17 by gluing, twisting, knotting, mechanical connection, welding, or the like; the lockingunit 11 is a soft metal wire, the lockingunit 11 comprises two lockingpieces 12, each lockingpiece 12 is connected to the fixingpiece 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 releasingunit 13 to enable theauxiliary breaking structure 8 to drive the lockingpieces 12 to rotate, enabling the lockingpieces 12 to approach each other and realize self-locking and locking, and further realizing the closing of the tissue defect; when the lockingmember 12 realizes self-locking and locking, the releasingunit 13 is further operated, and theauxiliary breaking structure 8 is further rotated, so that theauxiliary breaking structure 8 is broken and separated from the lockingmember 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 (22)

Translated fromChinese

1.组织缺损的闭合器械，其特征在于：所述闭合器械包括锁紧单元、位于所述锁紧单元近端区域的解脱单元；所述锁紧单元至少包括一个或多个锁紧件；操作所述解脱单元，带动所述锁紧件转动，所述锁紧件相互靠近并实现自锁锁紧，进而实现所述组织缺损的闭合；所述锁紧单元和所述解脱单元为一体式结构，当所述锁紧件实现自锁锁紧时，进一步操作所述解脱单元，使得所述解脱单元与所述锁紧单元断裂分离。1. A closure device for tissue defects, characterized in that: the closure device comprises a locking unit and a release unit located in the proximal region of the locking unit; the locking unit at least includes one or more locking members; operation The releasing unit drives the locking member to rotate, and the locking members approach each other and realize self-locking locking, thereby realizing the closure of the tissue defect; the locking unit and the releasing unit have an integrated structure , when the locking member realizes self-locking locking, further operate the disengaging unit, so that the disengaging unit is broken and separated from the locking unit.2.根据权利要求1所述的组织缺损的闭合器械，其特征在于：所述锁紧单元和所述解脱单元未断裂分离前，二者由远端到近端呈渐窄式结构；当所述锁紧件实现自锁锁紧时，进一步操作所述解脱单元，所述锁紧单元的近端区域被进一步转动，使得所述解脱单元与所述锁紧单元断裂分离。2 . The device for closing tissue defects according to claim 1 , characterized in that: before the locking unit and the releasing unit are not broken and separated, the two are in a gradually narrowing structure from the distal end to the proximal end; When the locking member realizes self-locking locking, the release unit is further operated, and the proximal end region of the locking unit is further rotated, so that the release unit is broken and separated from the locking unit.3.根据权利要求1所述的组织缺损的闭合器械，其特征在于：所述锁紧单元包括一个或多个固定件, 所述固定件位于所述锁紧件远端区域，且与所述锁紧件连接，所述固定件的部分或全部贴附或锚定于目标组织内部或远端外表面；所述固定件之间设置有增强连接结构，所述增强连接结构连接多个所述固定件；所述增强连接结构为柔性金属材料或高分子材料；所述闭合器械包括输送系统，所述输送系统位于所述解脱单元或所述锁紧单元的近端区域；所述锁紧单元或所述解脱单元与所述输送系统连接；所述增强连接结构不与所述输送系统连接，且独立游离于所述锁紧件的近端区域外或整个区域外。3 . The device for closing tissue defects according to claim 1 , wherein the locking unit comprises one or more fixing pieces, and the fixing pieces are located in the distal region of the locking piece and are connected with the locking piece. 4 . A locking piece is connected, and part or all of the fixing piece is attached or anchored to the inner surface of the target tissue or the outer surface of the distal end; a reinforced connection structure is arranged between the fixing pieces, and the reinforced connection structure connects a plurality of the Fixing piece; the reinforced connection structure is a flexible metal material or a polymer material; the closure device includes a delivery system, and the delivery system is located in the proximal region of the release unit or the locking unit; the locking unit Or the release unit is connected with the delivery system; the reinforcing connection structure is not connected with the delivery system, and is independent from the proximal end region or the entire region of the locking member.4.根据权利要求1或3所述的组织缺损的闭合器械，其特征在于：所述组织缺损闭合前，操作所述解脱单元带动所述锁紧单元转动时，所述解脱单元受到的锁紧力F₀₁、所述锁紧单元受到的锁紧力F₀₂、所述解脱单元的临界断裂力F₁、所述锁紧单元的临界断裂力F₂、所述增强连接结构的临界断裂力F₇满足：F₀₁＜F₁，F₀₁=F₀₂，F₁＜F₂＜F₇；当所述锁紧单元逐渐锁紧时，所述F₀₁和所述F₀₂逐渐增大；当所述锁紧单元完全锁紧时，进一步操作所述解脱单元，所述F₀₁达到所述F₁，实现所述解脱单元断裂分离。4 . The device for closing a tissue defect according to claim 1 or 3 , wherein: before the tissue defect is closed, when the releasing unit is operated to drive the locking unit to rotate, the locking unit received by the releasing unit is locked. 5 . Force F₀₁ , locking force F₀₂ received by the locking unit, critical fracture force F₁ of the release unit, critical fracture force F₂ of the locking unit, critical fracture force F of the reinforcing connection structure₇ Satisfy: F₀₁ <F₁ , F₀₁ =F₀₂ , F₁ <F₂ <F₇ ; when the locking unit is gradually locked, the F₀₁ and the F₀₂ gradually increase; When the locking unit is completely locked, the disengaging unit is further operated, the F₀₁ reaches the F₁ , and the disengaging unit is broken and separated.5.根据权利要求1或3所述的组织缺损的闭合器械，其特征在于：所述输送系统包括锁紧机构，所述锁紧机构包括锁紧动力源、锁紧传动杆、固定连接于所述锁紧传动杆远端的锁紧传动结构；所述输送系统包括解脱机构，所述解脱机构包括解脱动力源、解脱传递介质；所述解脱机构即为所述锁紧机构，所述解脱传递介质即为所述锁紧传动杆；预装时，所述解脱单元近端区域和所述锁紧传动结构连接并形成集中区域；当所述锁紧动力源发挥作用时，所述锁紧件呈线状且处于绷直状态，所述锁紧传动杆处于直态，所述锁紧动力源带动所述锁紧传动杆进而带动所述锁紧传动结构扭转前进，进而使所述解脱单元带动所述锁紧件转动，所述锁紧单元在所述集中区域缠结自锁。5. The device for closing tissue defects according to claim 1 or 3, wherein the delivery system comprises a locking mechanism, and the locking mechanism comprises a locking power source, a locking transmission rod, and a locking mechanism that is fixedly connected to the The locking transmission structure at the distal end of the locking transmission rod; the conveying system includes a release mechanism, and the release mechanism includes a release power source and a release transmission medium; the release mechanism is the locking mechanism, and the release transmission The medium is the locking transmission rod; during pre-installation, the proximal end area of the disengaging unit and the locking transmission structure are connected to form a concentrated area; when the locking power source functions, the locking piece It is linear and in a straight state, the locking transmission rod is in a straight state, and the locking power source drives the locking transmission rod and then drives the locking transmission structure to twist forward, so that the release unit drives The locking member is rotated, and the locking unit is tangled and self-locked in the concentrated area.6.组织缺损的闭合器械，其特征在于：所述闭合器械包括锁紧单元、位于所述锁紧单元近端区域的解脱单元；所述锁紧单元至少包括一个或多个锁紧件；所述解脱单元包括辅助断裂结构，所述辅助断裂结构的远端与所述锁紧件的近端连接；操作所述解脱单元使得所述辅助断裂结构带动所述锁紧件转动，所述锁紧件相互靠近并实现自锁锁紧，进而实现所述组织缺损的闭合；当所述锁紧件实现自锁锁紧时，进一步操作所述解脱单元，所述辅助断裂结构被进一步转动，使得所述辅助断裂结构断裂后与所述锁紧件分离。6. A closure device for tissue defects, characterized in that: the closure device comprises a locking unit and a release unit located at the proximal end region of the locking unit; the locking unit at least comprises one or more locking pieces; The release unit includes an auxiliary breaking structure, and the distal end of the auxiliary breaking structure is connected with the proximal end of the locking member; the release unit is operated so that the auxiliary breaking structure drives the locking member to rotate, and the locking member rotates. The parts approach each other and realize self-locking locking, thereby realizing the closure of the tissue defect; when the locking parts realize self-locking locking, the disengaging unit is further operated, and the auxiliary breaking structure is further rotated, so that all the The auxiliary breaking structure is separated from the locking member after being broken.7. 根据权利要求6所述的组织缺损的闭合器械，其特征在于：所述锁紧单元包括一个或多个固定件, 所述固定件位于所述锁紧件远端区域，且与所述锁紧件连接，所述固定件的部分或全部贴附或锚定于目标组织内部或远端外表面；所述固定件之间设置有增强连接结构，所述增强连接结构连接多个所述固定件；所述闭合器械包括输送系统，所述输送系统位于所述解脱单元的近端区域，所述增强连接结构不与所述输送系统连接；其中，所述增强连接结构与所述锁紧件呈平行结构或加捻结构或编织结构并与所述辅助断裂结构的远端区域连接后，所述辅助断裂结构的近端区域与所述输送系统连接；或者所述增强连接结构独立游离于所述锁紧件的近端区域外或整个区域外。7. The device for closing tissue defects according to claim 6, wherein the locking unit comprises one or more fixing pieces, and the fixing pieces are located at the distal end region of the locking piece and are connected with the locking piece. A locking piece is connected, and part or all of the fixing piece is attached or anchored to the inner surface of the target tissue or the outer surface of the distal end; a reinforced connection structure is arranged between the fixing pieces, and the reinforced connection structure connects a plurality of the a fastener; the closure device includes a delivery system, the delivery system is located in the proximal region of the disengagement unit, the reinforced connection structure is not connected with the delivery system; wherein the reinforcement connection structure and the locking After the piece is in a parallel structure or a twisted structure or a braided structure and is connected with the distal region of the auxiliary breaking structure, the proximal region of the auxiliary breaking structure is connected with the delivery system; or the reinforcing connecting structure is independent from the Outside the proximal region of the locking element or outside the entire region.8.根据权利要求6或7所述的组织缺损的闭合器械，其特征在于：所述组织缺损闭合前，操作所述辅助断裂结构带动所述锁紧单元转动时，所述辅助断裂结构受到的锁紧力F₀₃、所述锁紧单元受到的锁紧力F₀₄、所述辅助断裂结构的临界断裂力F₃、所述锁紧单元的临界断裂力F₄、所述增强连接结构的临界断裂力F₈满足：F₀₃＜F₃，F₀₃=F₀₄，F₃＜F₄＜F₈；当所述锁紧单元逐渐锁紧时，所述F₀₃和所述F₀₄逐渐增大，当所述锁紧单元完全锁紧时，进一步操作所述辅助断裂结构时，所述F₀₃达到所述F₃，实现所述辅助断裂结构断裂分离。8. The device for closing tissue defects according to claim 6 or 7, wherein before the tissue defect is closed, when the auxiliary breaking structure is operated to drive the locking unit to rotate, the auxiliary breaking structure receives The locking force F₀₃ , the locking force F₀₄ received by the locking unit, the critical breaking force F₃ of the auxiliary breaking structure, the critical breaking force F₄ of the locking unit, the critical breaking force of the reinforcing connection structure The breaking force F₈ satisfies: F₀₃ <F₃ , F₀₃ =F₀₄ , F₃ <F₄ <F₈ ; when the locking unit is gradually locked, the F₀₃ and the F₀₄ gradually increase , when the locking unit is completely locked and the auxiliary fracture structure is further operated, the F₀₃ reaches the F₃ , and the fracture separation of the auxiliary fracture structure is realized.9.根据权利要求6所述的组织缺损的闭合器械，其特征在于：所述辅助断裂结构与所述锁紧件通过贯穿、滑动环套、固定环套中的一种方式或多种组合方式连接。9 . The device for closing tissue defects according to claim 6 , wherein the auxiliary breaking structure and the locking member pass through one or more combinations of penetrating, sliding ring, and fixing ring. 10 . connect.10.根据权利要求6或7所述的组织缺损的闭合器械，其特征在于：所述输送系统包括锁紧机构，所述锁紧机构包括锁紧动力源、锁紧传动杆、固定连接于所述锁紧传动杆远端的锁紧传动结构；所述输送系统包括解脱机构，所述解脱机构包括解脱动力源、解脱传递介质；所述解脱机构即为所述锁紧机构，所述解脱传递介质即为所述锁紧传动杆；预装时，所述解脱单元近端区域和所述锁紧传动结构连接并形成集中区域；当所述锁紧动力源发挥作用时，所述锁紧件呈线状且处于绷直状态，所述锁紧传动杆处于直态，所述锁紧动力源带动所述锁紧传动杆进而带动所述锁紧传动结构扭转前进，进而使所述解脱单元带动所述锁紧件转动，所述锁紧单元在所述集中区域缠结自锁。10. The device for closing tissue defects according to claim 6 or 7, wherein the delivery system comprises a locking mechanism, and the locking mechanism comprises a locking power source, a locking transmission rod, and a locking mechanism that is fixedly connected to the The locking transmission structure at the distal end of the locking transmission rod; the conveying system includes a release mechanism, and the release mechanism includes a release power source and a release transmission medium; the release mechanism is the locking mechanism, and the release transmission The medium is the locking transmission rod; during pre-installation, the proximal end area of the disengaging unit and the locking transmission structure are connected to form a concentrated area; when the locking power source functions, the locking piece It is linear and in a straight state, the locking transmission rod is in a straight state, and the locking power source drives the locking transmission rod and then drives the locking transmission structure to twist forward, so that the release unit drives The locking member is rotated, and the locking unit is tangled and self-locked in the concentrated area.11.根据权利要求10所述的组织缺损的闭合器械，其特征在于：所述锁紧单元和所述增强连接结构在所述集中区域缠结自锁形成缆绳结构或麻花状结构，所述缆绳结构或所述麻花状结构至少为一圈。11. The device for closing tissue defects according to claim 10, wherein the locking unit and the reinforcing connection structure are tangled and self-locked in the concentrated area to form a cable structure or a twist-like structure, and the cable The structure or said twist-like structure is at least one loop.12.组织缺损的闭合器械，其特征在于：所述闭合器械包括锁紧单元、位于所述锁紧单元近端区域的解脱单元；所述锁紧单元至少包括一个或多个锁紧件；所述解脱单元包括辅助操作结构；操作所述解脱单元，带动所述锁紧件转动，所述锁紧件相互靠近并实现自锁锁紧，进而实现所述组织缺损的闭合；所述锁紧单元近端和所述解脱单元远端连接，操作所述辅助操作结构，使得所述解脱单元与所述锁紧件分离。12. A closure device for tissue defects, characterized in that: the closure device comprises a locking unit and a release unit located at the proximal end region of the locking unit; the locking unit at least comprises one or more locking pieces; The disengagement unit includes an auxiliary operation structure; the disengagement unit is operated to drive the locking piece to rotate, the locking pieces approach each other and realize self-locking locking, thereby realizing the closure of the tissue defect; the locking unit The proximal end is connected with the distal end of the release unit, and the auxiliary operation structure is operated to separate the release unit from the locking member.13.根据权利要求12所述的组织缺损的闭合器械，其特征在于：所述辅助操作结构包括设置在所述解脱单元近端区域的可熔断连接结构、可低温脆断连接结构、可切断连接结构、可拆卸连接结构。13 . The device for closing tissue defects according to claim 12 , wherein the auxiliary operation structure comprises a fusible connection structure, a low temperature brittle connection structure, and a severable connection provided in the proximal end region of the release unit. 14 . Structure, detachable connection structure.14. 根据权利要求12所述的组织缺损的闭合器械，其特征在于：所述锁紧单元包括一个或多个固定件, 所述固定件位于所述锁紧件远端区域，且与所述锁紧件连接，所述固定件的部分或全部贴附或锚定于目标组织内部或远端外表面；所述固定件之间设置有增强连接结构，所述增强连接结构连接多个所述固定件；所述闭合器械包括输送系统，所述输送系统位于所述解脱单元的近端区域，所述增强连接结构不与所述输送系统连接；其中所述增强连接结构与所述锁紧件呈平行结构或加捻结构或编织结构并与所述解脱单元的远端区域连接后，所述解脱单元的近端区域与所述输送系统连接；或者，所述增强连接结构独立游离于所述锁紧件的近端区域外或整个区域外。14. The device for closing tissue defects according to claim 12, wherein the locking unit comprises one or more fixing pieces, and the fixing pieces are located at the distal end region of the locking piece and are connected with the locking piece. A locking piece is connected, and part or all of the fixing piece is attached or anchored to the inner surface of the target tissue or the outer surface of the distal end; a reinforced connection structure is arranged between the fixing pieces, and the reinforced connection structure connects a plurality of the a fixation piece; the closure device comprises a delivery system, the delivery system is located at the proximal end region of the disengagement unit, the reinforced connection structure is not connected with the delivery system; wherein the reinforced connection structure is connected with the locking member After being in a parallel structure or a twisted structure or a braided structure and connected to the distal region of the disentanglement unit, the proximal end region of the disentanglement unit is connected to the delivery system; or, the reinforcing connecting structure is independent and dissociated from the Outside the proximal area of the locking element or outside the entire area.15.根据权利要求12或14所述的组织缺损的闭合器械，其特征在于：所述组织缺损闭合前，操作所述解脱单元带动所述锁紧单元转动时，所述解脱单元的锁紧力F₀₅、所述锁紧单元的锁紧力F₀₆、所述解脱单元的临界断裂力F₅、所述锁紧单元的临界断裂力F₆、所述增强连接结构的临界断裂力F₉满足：F₀₅＜F₅，F₀₅=F₀₆，F₅＜F₆＜F₉。15. The device for closing tissue defects according to claim 12 or 14, characterized in that: before the tissue defect is closed, when the disengaging unit is operated to drive the locking unit to rotate, the locking force of the disengaging unit F₀₅ , the locking force F₀₆ of the locking unit, the critical breaking force F₅ of the release unit, the critical breaking force F₆ of the locking unit, and the critical breaking force F₉ of the reinforcing connection structure satisfy : F₀₅ <F₅ , F₀₅ =F₀₆ , and F₅ <F₆ <F₉ .16.根据权利要求12或14所述的组织缺损的闭合器械，其特征在于：16. The device for closing tissue defects according to claim 12 or 14, wherein:所述输送系统包括锁紧机构，所述锁紧机构包括锁紧动力源、锁紧传动杆、固定连接于所述锁紧传动杆远端的锁紧传动结构；所述输送系统包括解脱机构，所述解脱机构包括解脱动力源、解脱传递介质；所述锁紧机构不同于所述解脱机构，操作所述锁紧动力源，所述锁紧件被转动使所述组织缺损闭合之后，操作所述解脱动力源，所述锁紧件与所述解脱单元分离；The conveying system includes a locking mechanism, the locking mechanism includes a locking power source, a locking transmission rod, and a locking transmission structure fixedly connected to the distal end of the locking transmission rod; the conveying system includes a release mechanism, The release mechanism includes a release power source and a release transmission medium; the locking mechanism is different from the release mechanism, the locking power source is operated, and after the locking member is rotated to close the tissue defect, the operation is performed. the release power source is described, and the locking member is separated from the release unit;预装时，所述解脱单元近端区域和所述锁紧传动结构连接并形成集中区域；当所述锁紧动力源发挥作用时，所述锁紧件呈线状且处于绷直状态，所述锁紧传动杆处于直态，所述锁紧动力源带动所述锁紧传动杆进而带动所述锁紧传动结构扭转前进，进而使所述解脱单元带动所述锁紧件转动，所述锁紧单元在所述集中区域缠结自锁。During pre-installation, the proximal end area of the release unit and the locking transmission structure are connected to form a concentrated area; when the locking power source is functioning, the locking piece is linear and in a straight state, so The locking transmission rod is in a straight state, and the locking power source drives the locking transmission rod and then drives the locking transmission structure to rotate forward, so that the release unit drives the locking member to rotate, and the lock The tight cells are tangled and self-locked in the concentrated area.17.根据权利要求16所述的组织缺损的闭合器械，其特征在于：所述锁紧单元和/或所述增强连接结构在所述集中区域缠结自锁形成缆绳结构或麻花状结构，所述缆绳结构或所述麻花状结构至少为一圈。17. The device for closing tissue defects according to claim 16, wherein the locking unit and/or the reinforcing connecting structure are tangled and self-locked in the concentrated area to form a cable structure or a twist-like structure, so The cable structure or the twist-like structure is at least one loop.18.根据权利要求3或7或14所述的组织缺损的闭合器械，其特征在于：所述固定件由外往内包括外壳结构和/或内支撑结构；其中，所述固定件呈条状；所述固定件的一端或两端设置有缓冲结构，所述缓冲结构包括柔性变径结构、柔性细小分支结构、局部增粗结构、S形结构、波形结构、弹簧结构、圆环、球头中的一种或多种；当所述固定件包括内支撑结构时，沿所述固定件的轴向方向上，所述内支撑结构位于所述外壳结构的中间段区域或整段区域；其中，所述内支撑结构比所述外壳结构的刚性或弯曲模量高；所述外壳结构限定所述锁紧件远端与所述内支撑结构二者的相对位置。18. The device for closing tissue defects according to claim 3, 7 or 14, wherein the fixing member comprises a shell structure and/or an inner support structure from outside to inside; wherein, the fixing member is in the shape of a strip ; One end or both ends of the fixing member is provided with a buffer structure, and the buffer structure includes a flexible variable diameter structure, a flexible small branch structure, a local thickening structure, an S-shaped structure, a wave structure, a spring structure, a ring, a ball head One or more of; when the fixing member includes an inner support structure, along the axial direction of the fixing member, the inner support structure is located in the middle section area or the whole section area of the outer shell structure; wherein , the inner support structure has a higher rigidity or flexural modulus than the outer shell structure; the outer shell structure defines the relative position of the distal end of the locking member and the inner support structure.19.根据权利要求1或6或12所述的组织缺损的闭合器械，其特征在于：所述锁紧件上设置有延伸于所述锁紧件外的加锚结构；其中，所述加锚结构包括微刺结构、局部突起结构、局部扁化结构中的一种或多种组合。19. The device for closing tissue defects according to claim 1, 6 or 12, wherein the locking member is provided with an anchoring structure extending outside the locking member; wherein the anchoring member is The structures include one or more combinations of micro-thorn structures, local protruding structures, and local flattening structures.20.根据权利要求3或7或14所述的组织缺损的闭合器械，其特征在于：所述固定件与所述锁紧件之间设置有姿态调整结构；当所述固定件和所述锁紧件在所述组织缺损区域得到舒展时，所述姿态调整结构调整所述固定件和所述锁紧件之间的夹角，使所述固定件最大程度接触所述组织；其中，所述姿态调整结构为转动结构，所述转动机构包括链条结构、铰链结构、材料自身的弹性和/或塑性形变的一种或多种组合；或者所述姿态调整结构为滑动结构，所述滑动机构包括滑块、滑轮中的一种或多种组合。20. The device for closing tissue defects according to claim 3, 7 or 14, wherein a posture adjustment structure is arranged between the fixing member and the locking member; when the fixing member and the locking member are When the tightening member is stretched in the tissue defect area, the posture adjustment structure adjusts the angle between the fixing member and the locking member, so that the fixing member contacts the tissue to the greatest extent; wherein, the The attitude adjustment structure is a rotating structure, and the rotating mechanism includes one or more combinations of a chain structure, a hinge structure, and the elastic and/or plastic deformation of the material itself; or the attitude adjustment structure is a sliding structure, and the sliding mechanism includes One or more combinations of sliders and pulleys.21.根据权利要求1或6或12所述的组织缺损的闭合器械，其特征在于：所述锁紧件呈平行结构或加捻结构或编织结构。21. The device for closing tissue defects according to claim 1, 6 or 12, wherein the locking member is in a parallel structure, a twisted structure, or a braided structure.22.根据权利要求3或7或14所述的组织缺损的闭合器械，其特征在于：所述固定件具有微孔结构；或者所述固定件和/或所述锁紧单元包括包覆件，所述包覆件包括涂层、高分子膜、高分子片、药物缓释结构中的一种。22. The device for closing tissue defects according to claim 3, 7 or 14, wherein the fixing member has a microporous structure; or the fixing member and/or the locking unit comprises a covering member, The covering member includes one of a coating, a polymer film, a polymer sheet, and a drug sustained-release structure.

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