CN113827284B - Tissue defect's closure apparatus - Google Patents
Tissue defect's closure apparatus Download PDFInfo
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- CN113827284B CN113827284B CN202111079433.7A CN202111079433A CN113827284B CN 113827284 B CN113827284 B CN 113827284B CN 202111079433 A CN202111079433 A CN 202111079433A CN 113827284 B CN113827284 B CN 113827284B
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00663—Type of implements the implement being a suture
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Abstract
The invention relates to the field of medical instruments, in particular to a tissue defect closing instrument which comprises a closing unit and a releasing unit, wherein the closing unit comprises a connecting unit and a locking unit connected with the connecting unit, the locking unit is positioned in the proximal end area of the connecting unit, and the releasing unit is positioned in the proximal end area of the locking unit; the connecting unit at least comprises one or more connecting pieces; the locking unit comprises at least one or more locking members; the releasing unit is operated to drive the locking pieces to rotate, the connecting unit is tensioned, the locking pieces are close to each other and realize self-locking and locking, and further, the closing of the tissue defect is realized; the locking unit and the releasing unit are of an integrated structure, when the locking piece realizes self-locking and locking, the releasing unit is further operated, so that the releasing unit and the locking unit are separated in a breaking way.
Description
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 thousands of patients with congenital heart diseases exist in China, the prevalence rate of the congenital heart diseases is 6.78% every year, and the number of the children with the congenital heart diseases born every year is up to 10-15 thousands, wherein the patent foramen ovale is about 10% of that of the congenital heart diseases.
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: 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, the risk of recurrence for patent foramen ovale with thrombotic episodes is still high. 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 foramen is close to the superior vena cava, the inferior vena cava or the main pulmonary artery, the edge of the occluder can abrade the blood vessel, which leads to the 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 cardiac intervention operation, and for patent patients with potential patent foramen ovale for interventional cardiac therapy, after the patent foramen ovale is occluded by the traditional occluder, the situation that interventional therapy cannot be adopted due to the difficulty in atrial septal puncture and the risk is higher can be met.
Patent CN112244902A provides a disc-surface-adjustable patent foramen ovale patent occluder, belonging to the technical field of medical 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 of the same central shaft and an edge section with adjustable cross section perpendicular 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 disk-adjustable occluder reduces the probability of replacing the occluder during the 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 ZL 201822027543.9 provides a patent foramen ovale suturing device, relates to the technical field of medical suturing, and solves the technical problems that existing patent foramen ovale surgery is difficult to position and suture, and complications are easy to occur when an occluder 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, a push rod is arranged on the pushing part and pushes 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 device is used for realizing the minimally invasive closure of the patent foramen ovale or the atrial septal defect, ensuring the suture at the accurate position and reducing the complications caused by the implantation of the occluder, but because the suture is hooked and pulled back by using the hook-shaped needle head of the traction needle after the clamping arm is pushed to be unfolded in the heart, the metal suture is preferentially adopted for facilitating the observation of radiography in the actual operation,
the suturing 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. the defect closure is achieved by entanglement of the metal suture, but without designing a releasing mechanism of the metal suture, there may be a risk that the metal suture is broken or the releasing position is unclear, thereby causing the 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 invention can provide a tissue defect closing apparatus for patients with structural heart disease and need interventional therapy, can solve some defects brought by adopting an occluder to treat patent foramen ovale operation 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 damage is easily caused to human tissues, and the like, can also solve the problem that atrial septal puncture cannot be performed to carry out secondary interventional operation after the patent foramen ovale is occluded by using the traditional occluder, 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 one aspect of the present invention, a closure device for a tissue defect, the closure device comprising a closure unit, a release unit, the closure unit comprising a connection unit, a locking unit connected to the connection unit, the locking unit being located at a proximal region of the connection unit, the release unit being located at a proximal region of the locking unit; the connecting unit at least comprises one or more connecting pieces; the locking unit at least comprises one or more locking pieces; operating the releasing unit to drive the locking pieces to rotate and tension the connecting unit, wherein the locking pieces are close to each other and realize self-locking and locking, so that the tissue defect is closed; 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 separation of locking unit fracture, the advantage of design like this lies in: the structure is simple, the existing risk is low, the number of components is small, the manufacturing 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, tissue defect closure includes a closing of a foramen ovale defect, an atrial septal defect, a ventricular septal defect, a patent ductus arteriosus, and the like.
In one embodiment, before the locking unit and the releasing unit are separated without fracture, the locking unit and the releasing unit are in a tapered structure from the far end to the near end; when the locking piece realizes self-locking and locking, the releasing unit is further operated, and the proximal end area of the locking unit is further rotated, so that the releasing unit and the locking unit are separated in a breaking way.
In one embodiment, the closing unit comprises one or more fasteners, the fasteners are positioned at the distal end region of the connecting element and connected with the connecting element, and part or all of the fasteners are attached or anchored to the inner or outer surface of the distal end of the target tissue; the number and the positions of the connecting pieces and the fixing pieces are in one-to-one correspondence; the closure device comprises a delivery system located in the proximal region of the release unit or the locking unit; the closure unit comprises a reinforced connection structure that is not connected to the delivery system; wherein the reinforcing connecting structure is connected with a plurality of fixing pieces and is independently free from the proximal end region or the whole region of the locking piece and/or the connecting piece; or the reinforced connecting structure is connected with a plurality of connecting units and is independently free from the area outside the proximal end area or the whole area of the locking member and/or the connecting member; or the reinforced connecting structure is connected to a part of the locking unit and is independently free from the outside of the proximal end area or the whole area of the locking member and/or the connecting member; the reinforced connecting structure is made of flexible metal materials or high polymer materials.
In one embodiment, the release unit is operated to rotate the locking unit before the tissue defect is closed, and the release unit is subjected to a locking force F 01 Locking force F borne by the locking unit 02 Critical breaking force F of said disengagement unit 1 Critical breaking force F of the locking unit 2 Critical breaking force F of said connection unit 10 Critical breaking force F of the reinforced connection structure 7 Satisfies the following conditions: f 01 ＜F 1 ，F 01 =F 02 ，F 1 ＜F 2 ＜F 10 ，F 1 ＜F 2 ＜F 7 (ii) a When the locking unit is gradually locked, the connection unit is gradually tightened, and F 01 And said F 02 Gradually increase; when the locking unit is fully locked, the releasing unit is further operated, F 01 To said F 1 And realizing the fracture separation of the releasing unit.
In one embodiment, F 01 、F 02 、F 1 、F 2 、F 10 、F 7 The values of (A) are all between 0.1N and 100N.
In a preferred embodiment, F 01 、F 02 、F 1 、F 2 The numerical values of (A) are all between 0.1N and 10N, F 10 The numerical value of (2) is 5 to 100N.
In one embodiment, the delivery system comprises a locking mechanism comprising a locking power source, a locking drive rod, a locking drive structure fixedly attached to a distal end of the locking drive rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium; the releasing mechanism is the locking mechanism, and the releasing transmission medium is the locking transmission rod; when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area; when the locking power source acts, the locking piece and the connecting piece are 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 concentrated area to be self-locked.
In one embodiment, the closure device comprises a closure unit comprising a connection unit, a locking unit connected to the connection unit, the locking unit being located in the proximal region of the connection unit, and a release unit located in the proximal region of the locking unit; the connecting unit at least comprises one or more connecting pieces; the locking unit at least comprises one or more locking pieces; the releasing unit comprises an auxiliary breaking structure, and the distal end of the auxiliary breaking structure is connected with the proximal end of the locking piece; operating the releasing unit to enable the auxiliary breaking structure to drive the locking pieces to rotate and enable the connecting unit to be tensioned, 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 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 delivery sheath is small, the damage to blood vessels of a human body is small, and the delivery sheath is particularly suitable for special crowds such as immature patients with small blood vessels.
In one embodiment, the closing 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 connecting members, and part or all of the fixing members are attached or anchored to the inner surface or the outer surface of the distal end of the target tissue; the number and the positions of the connecting pieces and the fixing pieces are in one-to-one correspondence; the closure device comprises a delivery system located in a proximal region of the disengagement unit or the locking unit; the locking unit or the releasing unit is connected with the conveying system, and the closing unit comprises an enhanced connecting structure which is not connected with the conveying system; wherein the reinforcing connecting structure is connected with a plurality of fixing pieces and is independently free from the area outside the proximal end area or the whole area of the locking piece and/or the connecting piece; or the reinforced connecting structure is connected with a plurality of connecting units and is independently free from the outer area of the proximal end area or the whole outer area of the locking member and/or the connecting member; or, the reinforced connecting structure is connected to part or all of the locking unit; the reinforced connecting structure is made of a flexible metal material or a high polymer material; when the reinforcing connecting structure is connected to part or all of the locking units, the reinforcing connecting structure and the locking piece are in a parallel structure or a twisted structure or a braided structure and are connected with the far end region of the auxiliary breaking structure, and then the near end region of the auxiliary breaking structure is connected with the conveying system.
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 closed 03 Locking force F that the locking unit receives 04 Critical breaking force F of the auxiliary breaking structure 3 The locking unit is arranged atInterfacial fracture force F 4 Critical breaking force F of said connection unit 11 Critical breaking force F of the reinforced connection structure 8 Satisfies the following conditions: f 03 ＜F 3 ，F 03 =F 04 ，F 3 ＜F 4 ＜F 11 , F 3 ＜F 4 ＜F 8 (ii) a When the locking unit is gradually locked, the connection unit is gradually tightened, and F 03 And said F 04 Gradually increasing, when the locking unit is fully locked, and further operating the auxiliary breaking structure, the F 03 To said F 3 The utility model discloses a supplementary fracture structure fracture separation, the 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 breaking force of disengagement unit is less than the critical breaking force of locking unit, and the critical breaking force of disengagement unit and the critical breaking force of locking unit all are less than the critical breaking force of linkage unit, ensure to lock complete back breaking occur in disengagement unit department, and can not be in linkage unit department fracture, further inject fracture position, adopt reinforcing connection structure can further ensure simultaneously that the locking unit can not fracture in advance, the security has been promoted.
In one embodiment, the secondary rupture structure is connected to the retaining member by one or more of a through-penetration, a sliding collar, and a securing collar.
In one embodiment, the delivery system comprises a locking mechanism comprising a locking power source, a locking drive rod, a locking drive structure fixedly attached to a distal end of the locking drive rod; the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium; the releasing mechanism is the locking mechanism, and the releasing transmission medium is the locking transmission rod; when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area; when the locking power source acts, the locking piece and the connecting piece are 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 concentrated area to be self-locked.
In one embodiment, the connection unit, the auxiliary breaking structure are made of materials of different properties; or the locking unit and the auxiliary breaking structure are made of materials with different properties; wherein the connecting unit is made of a high polymer material or a degradable metal material; the locking unit and the auxiliary breaking structure are made of a metal material.
In one embodiment, the locking unit is self-locking entangled with the reinforcing connection structure and/or the connection unit at the concentrated area to form a cable structure or a twist-like structure having at least one turn.
In one embodiment, the closure device comprises a closure unit comprising a connection unit, a locking unit connected to the connection unit, the locking unit being located in the proximal region of the connection unit, and a release unit located in the proximal region of the locking unit; the connecting unit at least comprises one or more connecting pieces; the locking unit at least comprises one or more locking pieces; the disengagement unit comprises an auxiliary operating structure; operating the releasing unit to drive the locking pieces to rotate and tighten the connecting units, wherein the locking pieces are close to each other and realize self-locking and locking, so that the tissue defect is closed; 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-breaking 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, the locking amplitude of the locking unit can be regulated and controlled according to the anatomical form of the defective tissue, 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 low temperature frangible link structure, a severable link structure, a detachable link structure disposed at a proximal region of the detachment unit.
In one embodiment, the closing 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 connecting members, and part or all of the fixing members are attached or anchored to the inner surface or the outer surface of the distal end of the target tissue; the number and the positions of the connecting pieces and the fixing pieces are in one-to-one correspondence; the closure device comprises a delivery system located in a proximal region of the disengagement unit or the locking unit; the locking unit or the releasing unit is connected with the conveying system, and the closing unit comprises an enhanced connecting structure which is not connected with the conveying system; wherein the reinforcing connecting structure is connected with a plurality of fixing pieces and is independently free from the proximal end region or the whole region of the locking piece and/or the connecting piece; or the reinforced connecting structure is connected with a plurality of connecting units and is independently free from the proximal end region or the whole region of the locking member and/or the connecting member; or, the reinforced connecting structure is connected to part or all of the locking unit; the reinforced connecting structure is made of flexible metal materials or high polymer materials. When the reinforced connecting structure is connected to part or all of the locking unit, the reinforced connecting structure and the locking piece are in a parallel structure or a twisted structure or a braided structure and are connected with the far end region of the releasing unit, and then the near end region of the releasing unit is connected with the conveying system.
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 defect 05 Locking force F of the locking unit 06 Critical breaking force F of said disengagement unit 5 Critical breaking force F of the locking unit 6 Critical breaking force F of said connection unit 12 Critical breaking force F of the reinforced connection structure 9 Satisfies the following conditions: f 05 ＜F 5 ，F 05 =F 06 ，F 5 ＜F 6 ＜F 12 , F 5 ＜F 6 ＜F 9 The 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, and, the critical rupture force of disengagement unit and the critical rupture force of locking unit all are less than the critical rupture force of linkage unit, guarantee that locking can not take place the fracture in locking unit department after complete, and can not be in linkage unit department fracture, 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, and 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, then 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 acts, the locking piece and the connecting piece are 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 concentrated area to be self-locked.
In one embodiment, the locking unit, and/or the reinforcing connection structure, and/or the connection unit are self-locking intertwined in the concentration area to form a cable structure or a twist-like structure, the cable structure or the 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, and each buffer structure comprises one or more of a flexible reducing structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring and a ball head; when the fixing piece comprises the inner supporting structure, the inner supporting structure is positioned in a middle section area or a whole section area of the shell structure along the axial direction of the fixing piece; wherein the inner support structure is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defines the relative positions of the distal end of the retaining member and the inner support structure.
In one embodiment, the connecting member or the locking member is provided with an anchoring structure extending outside the connecting member or the locking 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, the retaining member is in a parallel configuration or a twisted configuration or a braided configuration.
In one embodiment, the fastener has a microporous structure; or the fixing piece, and/or the connecting unit, and/or the locking unit comprises 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 proximal region of the connection unit and the distal region of the locking unit form a fixed connection structure or a limit connection structure by one or more combination of buckling, knotting and mechanical clamping; the connecting unit is partially or completely connected with the tissue; the locking unit is connected with the connecting unit through the fixed connecting structure or the limiting connecting structure; wherein the connection unit located in the proximal region of the tissue defect is in a non-occluded state.
In one embodiment, when the closing unit only comprises the connecting unit and the locking unit, the proximal end region of the connecting unit is connected with the distal end region of the locking unit through the fixed connecting structure or the spacing connecting structure; when the locking unit is locked, the connecting unit and the locking unit are integrally in a closed structure and then are connected with the distal end area of the releasing unit; and each two of the retaining members share a common one of the attachment members.
In one embodiment, the connection unit has a first fixed position and a second fixed position with respect to the tissue defect when the tissue defect is closed, and a linear distance between the first fixed position and the second fixed position is defined as L 1 (ii) a The total length of the connecting unit in the proximal region of the tissue defect is defined as L in the natural state 2 (ii) a And L is 1 、L 2 The mathematical relationship is satisfied: l is a radical of an alcohol 2 ≤L 1 。
In one embodiment, the connection unit and the locking unit are made of materials of different properties; wherein the connecting unit is made of a high polymer material or a degradable metal material; the locking unit is made of a metal material.
In one embodiment, the outer shell structure, the inner support structure, the connection unit and the locking unit are all made of degradable material; wherein the shell structure and/or the connection unit are made of a high molecular degradable material; the connecting unit has flexibility and extensibility resistance; the inner support structure and/or the locking unit are/is made of one or more combined materials of zinc-based alloy degradable materials, magnesium-based alloy degradable materials and iron-based alloy degradable materials.
In one embodiment, the connection unit is more flexurally compliant than the locking unit.
In one embodiment, the portion of the connection unit in contact with the tissue is provided with a local buffer structure comprising a local thickening structure, a self-expanding structure.
In one embodiment, an attitude adjusting structure is arranged between the fixing piece and the connecting piece; when the fixing piece and the connecting piece are unfolded in the tissue defect area, the posture adjusting structure adjusts an included angle between the fixing piece and the connecting 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 reinforced attachment structure prevents the anchor from falling out of the left atrium after the anchor is separated from the attachment element.
In one embodiment, the reinforced connection structure can prevent the connection unit or the locking unit itself from being broken when the locking unit is self-locked.
In one embodiment, the reinforcing connection does not participate in the self-locking process of the locking member, nor does the reinforcing connection participate in the breaking and separation process of the releasing unit from the locking unit.
In one embodiment, the reinforcing connection structure is independent to be dissociated outside the proximal end region or the whole region of the locking member and/or the connecting member, and after the reinforcing connection structure and the locking member are connected locally through the fixing structure, the reinforcing connection structure and the locking member are in parallel structures, the proximal end region of the locking unit and/or the releasing unit is connected with the conveying system, so that the reinforcing connection structure can be guaranteed to participate in the locking and locking process of the locking member, and a certain fixing effect is achieved.
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 reinforced connecting structure is a polymer thread, and the free end of the polymer thread is connected to the fixing member or the connecting unit or the locking unit by gluing, tangling, knotting, mechanical connection, welding, or the like.
In one embodiment, the connecting unit is a polymer wire, the locking unit is a soft metal wire, the locking unit comprises two locking pieces, and each locking piece is connected to the connecting piece in a gluing mode, a mechanical connection mode, a welding mode and the like and is twisted and formed with the connecting piece; operating the releasing unit to enable the auxiliary breaking structure to drive the locking pieces to rotate, enabling the locking pieces to approach each other and realizing self-locking and locking, and further realizing the closing of the tissue defect; work as when the retaining member realizes auto-lock locking, further operation the disengagement unit, supplementary fracture structure is further rotated, makes supplementary fracture structure with retaining member fracture separation, connecting piece and retaining member are twisted together to the supplementary fracture structure of cooperation uses, and supplementary fracture structure and locking unit near-end are connected, and the connecting piece is when providing the twisting axle for the twisting and participate in the twisting on the one hand, can increase the engaging force of locking unit, reduces the risk that the locking unit breaks in advance and leads to the mounting to drop into left room, works as 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 can guarantee again that supplementary fracture structure position breaks apart, and the location is accurate.
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 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 used as buffer structures, and the reinforcing connecting structure and the connecting unit are twisted together to form a fixed connection, wherein 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 connection unit is more flexurally compliant than the locking unit.
In one embodiment, the delivery system comprises a puncture needle, when the closure device is positioned in the delivery system, the connecting unit comprises a first free end positioned at the far end area of the connecting unit and a second free end positioned at the near end area of the locking unit, the first free end is provided with a leaning piece, the second free end is provided with a hooking piece, the puncture needle has a preset shape, after the puncture needle passes through the secondary septum and reversely passes through the primary septum, the puncture needle is withdrawn and the thimble is pushed to release the leaning piece, the locking transmission rod is operated to hook the hooking piece to the leaning piece, when the locking unit is locked, the connecting unit and the locking unit are integrally in a closed state and then connected with the releasing unit, and then the releasing unit is operated to enable the releasing unit and the locking unit to be separated in a breaking way.
In one embodiment, the locking unit is connected with the releasing unit, the proximal end of the locking unit comprises a three-dimensional structure, the releasing unit is operated to drive the locking member to rotate, the connecting unit is tensioned, the tissue defect is closed, and the releasing unit is further operated, so that the releasing unit and the locking member are separated in a breaking mode.
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 when the locking unit is tangled and self-locked, the rod-shaped structure is drawn out 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 and/or attachment member comprises 1-20 wires; each locking piece and/or each connecting piece is formed by laying a plurality of wires in parallel, or each locking piece is twisted or woven into a cable structure or a twisted structure by the plurality of wires.
In one embodiment, the delivery system includes an introducer needle having a substantially sharp distal end.
In one embodiment, the polymeric material is a permanently implanted polymeric material.
In one embodiment, the self-expansion structure is a water-absorbing expansion structure coated on the surface of the connecting piece, so that certain buffering can be formed, stress can be dispersed, and the self-expansion structure has the effect of local plugging after water absorption expansion.
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 near end of the first position.
In one embodiment, the disengagement unit is provided with a detachable connection that interacts with the transport system.
In one embodiment, the reinforcing connecting structure and the locking member are in a parallel structure or a twisted structure or a braided structure, and the anti-releasing force of the locking unit is greatly improved compared with that of the locking member alone.
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, and 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, 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 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 to further drive the connecting piece and the fixing piece to close the tissue defect, so that the flexible connection of the fixing piece and the connecting 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 posture adjustment structure maximizes tissue contact of the anchor by adjusting the angle between the anchor and the locking element when the anchor is released from the lumen.
In one embodiment, the posture adjustment structure is a rotating mechanism comprising one or more combinations of chain structures, hinge structures, elastic and/or plastic deformation of the material itself.
In one embodiment, the connecting member is connected with the fixing member through the hole slot or the limiting member to form the posture adjusting structure.
In one embodiment, the fixing member is provided with a through hole in the middle, and the connecting unit can be gathered, intertwined and wound at the through hole to be fixedly connected with the fixing member to form the posture adjusting structure.
In one embodiment, the posture adjustment structure is a sliding mechanism, and the sliding mechanism comprises one or more combinations of a sliding block and a pulley.
In one embodiment, the locking transmission structure can be matched with at least one puncture needle to complete the control of the motion of the puncture needle passing through the 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, and the side openings provide quick channels for the connection of the locking pieces, the connecting pieces, the fixing pieces and the locking transmission structures, so that the release process of a 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 configuration may be formed from multiple filaments in varying amounts tightened with multiple tapers or from thick to thin tightenings with alternating amounts of multiple filaments.
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 degree 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.
In one embodiment, the access needs to be established in advance to ensure that the closure device is successfully accessed.
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 the patent foramen ovale treatment operation as an example, the patent foramen ovale treatment operation adopting the occluder in the 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 traditional occluder has the problem that the interventional treatment cannot be adopted when the atrial septal puncture is near behind the patent foramen ovale; 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, in another embodiment of the present invention, the releasing unit is operated to make the auxiliary breaking structure drive the locking member to rotate, and the connecting unit is tensioned, and the locking members approach each other and realize self-locking and locking, so as to realize the closure of the tissue defect; 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 in another embodiment of the invention, the releasing unit is operated to drive the locking piece to rotate and tension the connecting unit, and the locking pieces approach to each other and realize self-locking and locking so as to realize the closure of the tissue defect; the locking unit is connected with the releasing unit, and the auxiliary operation structure is operated to separate the releasing unit from the locking piece; the homoenergetic guarantees its biocompatibility of the better performance of linkage unit, reduces the metal volume of closed apparatus and tissue contact, and in addition, easy operation is convenient, and simple quick closure and the disengagement are realized to the homoenergetic, have improved operation efficiency, have avoided knoing from the external and have accomplished the oval hole seam closure to carry internal oval hole position again, have improved operation efficiency, have reduced the operation risk.
2. Different from the prior art, the closing unit comprises a connecting unit, firstly, the connecting unit is in contact with the tissue and has good biocompatibility, the through hole is formed in the middle of the fixing piece, the connecting unit can be collected, tangled and wound at the through hole and is fixedly connected with the fixing piece to form an attitude adjusting structure, and the attitude adjusting structure can adjust an included angle between the fixing piece and the connecting piece, so that the connecting unit can be ensured to better exert the advantage of attitude adjustment, the fixing piece can be exerted to the greatest extent to contact the tissue, the tissue shearing area is reduced, and the releasing unit and the locking unit can be ensured to be released without breaking at the connecting unit.
3. Different from the prior art, in an embodiment of the present invention, the reinforced connection structure is made of a flexible metal material or a polymer material; the connecting unit and the locking unit are made of materials with different properties; wherein the connecting unit is made of a high polymer material or a degradable metal material; the locking unit is made of a metal material; alternatively, in another embodiment of the present invention, the outer shell structure, the inner support structure, the connection unit and the locking unit are all made of degradable material; wherein the shell structure and/or the connection unit are made of a high molecular degradable material; the inner support structure and/or the locking unit are/is made of one or more combined materials of zinc-based alloy degradable materials, magnesium-based alloy degradable materials and iron-based alloy degradable materials, so that good biocompatibility can be guaranteed, and stimulation damage to tissues is reduced.
4. 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 part is tangled and the number of self-locking turns increases, the locking power source drives the locking transmission rod to drive the locking transmission structure to twist forward so as to enable the locking part to mutually and radially approach from the near end to the far end, the locking transmission rod moves towards the far end relative to the control handle and can adapt to the rotating process of the locking part, the locking part and the connecting part are linear and in a stretched straight state in the whole process, the locking transmission rod is in a straight state, and the locking power source can control the rotation and moving speed of the locking transmission rod, so that the locking transmission rod can be adaptively changed according to the distance between the locking transmission rod and the puncture needle, the matching degree of the locking power source and the locking part is improved, and the locking unit can better exert the entanglement self-locking effect in a concentrated area.
5. In contrast to the prior art, in an embodiment of the present invention, the connecting unit is made of a flexible material, and when the tissue defect is closed, the connecting unit and the tissue defect have a first fixing position and a second fixing position, and a linear distance between the first fixing position and the second fixing position is defined as L 1 (ii) a The total length of the connecting unit is defined as L in a natural state 2 (ii) a And, L 1 、L 2 The mathematical relationship is satisfied: l is 2 ≤L 1 When part of connecting pieces participate in the entanglement and self-locking process of the locking unit, the releasing unit and the locking unit are broken and separated, and when L is 2 ≤L 1 In the process, even if the connecting piece is loosened and rebounded, the connecting piece can still be attached to the tissue defect under the action of the elastic force.
6. Different from the prior art, in one embodiment of the invention, the locking unit and/or the connecting unit and/or the reinforced connecting structure are/is entangled and self-locked in a concentrated area to form a cable structure or a twist-shaped structure, the operation is simple, the entanglement and self-locking actions increase the friction force, the contact degree with tissues is improved, the damage to the tissues is reduced, the fatigue resistance is improved, the self-breaking complementary effect is achieved, and the risk that the fixing piece falls into the left atrium is reduced.
7. Different from the prior art, the reinforced connecting structure in one embodiment of the invention has an anti-falling function, namely, the risk that the closing instrument falls into the left atrium due to the fact that the fixing member and the locking member are disconnected in the process of inserting the foramen ovale into the suture or the locking member is unlocked automatically by factors such as insufficient self-locking force after the releasing unit and the locking unit are separated and broken is prevented, and the safety and the reliability of the operation process are improved.
8. Different from the prior art, in an embodiment of the present invention, the fixing element, and/or the connecting element, and/or the locking element includes a covering element, the covering element includes one of a coating, a polymer film, a polymer sheet, and a drug sustained release structure, and the covering element can increase a contact area between the fixing element and/or the connecting element and a tissue, promote the inner epidermis to cover, and prevent the tissue from being damaged.
9. 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 only plays a role in supporting, so that the supporting strength is improved, and deflection failure when the shell structure is pulled is avoided.
10. In an embodiment of the present invention, before the tissue defect is closed, when the releasing unit is operated to rotate the locking unit, the releasing unit is subjected to a locking force F 01 Locking force F that the locking unit receives 02 Critical breaking force F of said disengagement unit 1 Critical breaking force F of the locking unit 2 Critical breaking force F of said connection unit 10 Critical breaking force F of the reinforced connection structure 7 Satisfies the following conditions: f 01 ＜F 1 ，F 01 =F 02 ，F 1 ＜F 2 ＜F 10 ，F 1 ＜F 2 ＜F 7 (ii) a When the locking unit is gradually locked, the connection unit is gradually tightened,said F 01 And said F 02 Gradually increasing; when the locking unit is fully locked, the releasing unit is further operated, F 01 To said F 1 The utility model discloses a release unit fracture separation, the realization the 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 lower state relatively, reduce 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, and the critical rupture force of release unit and locking unit all is less than the critical rupture force of linkage unit, can ensure that the fracture takes place in release unit department after defective tissue locking is complete, and can not be at linkage unit department fracture, further inject the fracture position, adopt reinforcing connection structure can further ensure simultaneously that the locking unit can not break in advance, the security has been promoted.
Drawings
FIG. 1a is a schematic view of an unreleased state of a closure device in accordance with one embodiment of the present invention.
Fig. 1b to 1c are schematic views illustrating a process in which the connecting unit and the locking unit are integrally closed according to a first embodiment of the present invention.
Fig. 2a to 2c are schematic diagrams illustrating a process of puncturing a primary septum and a secondary septum by a puncture needle according to an embodiment of the invention.
FIGS. 3 a-3 b are schematic illustrations of the various positional relationships of the linkage unit and the locking unit in a closure device in accordance with various embodiments of the present invention.
FIGS. 4 a-4 b are schematic views illustrating the relationship between the first and second fixation positions during closure of a second foramen ovale tissue defect in accordance with an embodiment of the present invention.
FIG. 5 is a schematic view of a second embodiment of the closure device of the present invention.
FIGS. 6 a-6 h are schematic views illustrating the operation steps of a second embodiment of the present invention.
Fig. 7 is a schematic view of the state of the inner support structure in an embodiment of the present invention.
FIG. 8 is a schematic view of the state of the control handle in various embodiments of the present invention.
Fig. 9a to 9g are schematic views illustrating states of the posture adjustment structure according to various embodiments of the present invention.
FIGS. 10 a-10 d are schematic views illustrating the state of the reinforced connection structure according to various embodiments of the present invention.
Fig. 11a to 11d 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 achieve self-locking and locking according to a fourth embodiment of the present invention.
The names of the parts indicated by the numbers in the drawings are as follows:
11-connecting unit, 111-connecting piece, 12-locking unit, 121-locking piece, 123-fixed connecting structure, 124-hooking piece, 125-abutting piece, 13-releasing unit, 14-posture adjusting structure, 15-reinforced connecting structure, 16-fixing piece, 161-inner supporting structure, 162-buffering structure, 21-locking power source, 22-locking transmission rod, 23-locking transmission structure, 24-hook, 25-concentrated area, 31-puncture needle, 32-puncture needle, 33-control needle guide rail, 34-traction mechanism, 35-traction wire, 4-ejector rod, 5-delivery sheath, 51-control handle, 6-tapered structure, 7-auxiliary operation structure, 8-auxiliary breaking structure, 91-first fixed position and 92-second fixed position.
Detailed Description
The invention is described in further detail below with reference to the figures and examples.
The term "proximal" as used herein refers to the end of the closure device that is proximal to the operator when the closure device is loaded into the delivery system during pre-loading, and "distal" refers to the end of the closure device that is distal to the operator when the closure device is loaded into the delivery system during pre-loading.
The first embodiment is as follows:
in this embodiment, as shown in fig. 1a to 1c, the closure device includes a closure unit and a release unit 13, the closure unit includes a connection unit 11 and a locking unit 12 connected to the connection unit 11, the locking unit 12 is located at a proximal region of the connection unit 11, and the release unit 13 is located at a proximal region of the locking unit 12; the connection unit 11 includes only one connection member 111; the locking unit 12 includes two locking members 121; the releasing unit 13 is operated to drive the locking pieces 121 to rotate, the connecting unit 11 is tensioned, the locking pieces 121 are close to each other and realize self-locking and locking, and then the tissue defect is closed, and the closing unit is connected with the tissue; locking unit 12 and the formula structure as an organic whole of disengaging unit 13, when retaining member 121 realizes the auto-lock locking, further operation disengaging unit 13 for disengaging unit 13 and locking unit 12 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 manufacturing 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 is convenient, the releasing unit 13 and the locking unit 12 can be separated by further rotating the releasing unit 13, the rotating releasing mode is preferentially selected, 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 delivery sheath is small, the damage to blood vessels of a human body is small, and the delivery sheath is particularly suitable for special crowds such as immature patients with small blood vessels.
In this embodiment, each two locking members 121 share a single attachment member 111.
In this embodiment, as shown in fig. 1a to 1c, when the closing unit only includes the connecting unit 11 and the locking unit 12, the proximal region of the connecting unit 11 is connected with the distal region of the locking unit 12 through the fixed connecting structure 123; when the locking unit 12 is locked, the connecting unit 11 and the locking unit 12 are integrally in a closed structure and then connected with the distal end region of the releasing unit 13.
In another embodiment, when the closing unit only comprises the connecting unit 11 and the locking unit 12, the proximal end region of the connecting unit 11 is connected with the distal end region of the locking unit 12 through a limit connection structure; when the locking unit 12 is locked, the connecting unit 11 and the locking unit 12 are integrally in a closed structure and then are connected with the distal end region of the releasing unit 13; and each two of the locking members 121 share one of the connecting members 111 as shown in fig. 3 a.
In this embodiment, the connecting unit 11 and the locking unit 12 are made of materials with different properties; wherein, the connecting unit 11 is made of high molecular material or degradable metal material; the locking unit 12 is made of a metal material.
In this embodiment, the portion of the connection unit 11 in contact with the tissue is provided with a local buffer structure, and the local buffer structure includes one of a local thickening structure and a self-expanding structure.
In this embodiment, as shown in fig. 1b, the connecting unit 11 and the locking unit 12 form a fixed connecting structure 123 by a buckle.
In this embodiment, the self-expansion structure is a water-absorbing expansion structure coated on the surface of the connecting piece, so that certain buffering and stress dispersion can be formed, and the self-expansion structure has the effect of local plugging after water absorption expansion.
In this embodiment, a delivery system is provided at the proximal end of the closure device, the delivery system includes a locking mechanism, the locking mechanism includes a locking power source 21, a locking transmission rod 22, and a locking transmission structure 23 fixedly connected to the distal end of the locking transmission rod 22; the conveying system comprises a releasing mechanism, and the releasing mechanism comprises a releasing power source and a releasing transmission medium; when preassembling, the proximal region of the releasing unit 13 is connected with the locking transmission structure 23 to form a concentration region 25; when the locking power source 21 acts, the locking member 121 and the connecting member 111 are in a linear stretched state, the locking transmission rod 22 is in a straight state, the locking power source 21 drives the locking transmission rod 22 to further drive the locking transmission structure 23 to twist and advance, the releasing unit 13 drives the locking member 121 to rotate, and the locking unit 12 is entangled and self-locked in the concentration area 25.
In this embodiment, before the locking unit 12 and the releasing unit 13 are separated without breaking, the locking unit and the releasing unit are in a tapered structure from the distal end to the proximal end; when the locking member 121 achieves self-locking, the proximal end region of the locking unit 12 is further rotated by further operating the releasing unit 13; so that the releasing unit 13 is rupture-separated from the locking unit 12.
In this embodiment, before the tissue defect is closed, when the releasing unit 13 is operated to drive the locking unit 12 to rotate, the releasing unitThe locking force F to which the element 13 is subjected 01 The locking force F to which the locking unit 12 is subjected 02 Critical breaking force F of said disengagement unit 13 1 Critical breaking force F of said locking unit 12 2 Critical breaking force F of said connection unit 10 And satisfies the following conditions: f 01 ＜F 1 ，F 01 =F 02 ，F 1 ＜F 2 ＜F 10 ；
In this embodiment, when the locking unit 12 is gradually locked, F is set 01 And said F 02 Gradually increased, when the locking unit 12 is fully locked, and the releasing unit 13 is further operated, the F 01 To F 1 And the breaking separation of the releasing unit 13 is realized.
In this example, F 01 、F 02 、F 1 、F 2 The numerical values of the components are all between 0.1N and 10N, and F 10 The value of (b) is between 5 and 100N.
In this embodiment, the locking unit 12 is self-locking twisted at the concentrated area 25 to form a cable structure or a twist-like structure, which has at least one turn.
In this embodiment, the releasing mechanism is a locking mechanism, and the releasing transmission medium is a locking transmission rod 22.
In this embodiment, as shown in fig. 1a, two locking members 13 are formed by three filaments to form a twisted or braided structure.
In this embodiment, the closure of the tissue defect is a closure of the foramen ovale defect.
In this embodiment, the delivery system comprises a delivery sheath 5 and a control handle 51.
In this embodiment, as shown in fig. 8, the lock transmission rod 22 connects the lock power source 21 and the control handle 51.
In this embodiment, as shown in fig. 1b to 1c, the delivery system comprises a puncture needle 31, when the closure device is located in the delivery system, the connection unit 11 comprises a first free end located at the distal region of the connection unit 11 and a second free end located at the proximal region of the locking unit 12, the first free end is provided with an abutment 125, the second free end is provided with a catch 124, and the puncture needle 31 has a predetermined shape.
In this embodiment, as shown in fig. 2a to 2c, after the puncture needle 31 passes through the secondary septum and then passes through the primary septum in the reverse direction, the puncture needle 31 is withdrawn and the ejector rod 4 is pushed to release the abutting member 125.
The operation procedure of this embodiment in operation is as follows (as shown in fig. 1a to 1 c):
(1) After the puncture needle 31 passes through the secondary septum and then reversely passes through the primary septum, the puncture needle 31 is withdrawn and the ejector rod 4 is pushed to release the abutting piece 125;
(2) After the lock transmission rod 22 is operated to make the hook member 124 hook the abutting member 125, the connecting unit 11 and the locking unit 12 are integrally closed;
(3) Operating the releasing unit 13 to drive the locking pieces 121 to rotate and tighten the connecting unit 11, enabling the locking pieces 121 to approach each other and realize self-locking and locking, further realizing the closure of the tissue defect, and connecting part or all of the connecting units are connected with the tissue;
(4) When the locking member 121 realizes self-locking, the releasing unit 13 is further operated, so that the releasing unit 13 is separated from the locking unit 12.
The second embodiment:
the difference from the first embodiment is that:
in this embodiment, as shown in fig. 3b, the closing unit comprises a connection unit 11, one or more fixation members 16 at the distal end area of the connection unit 11; the number and position of the connecting elements 111 and the fixing elements 16 are in one-to-one correspondence, the fixing elements 16 are arranged at the distal end area of the connecting elements 111 and connected with the connecting elements 111, and part or all of the fixing elements 16 are attached or anchored to the inner surface or the outer surface of the distal end of the target tissue.
In this embodiment, as shown in fig. 3b, when the connecting unit 11 located at the proximal region of the tissue defect is in the non-closed state, the locking unit 12 and the connecting unit 11 are connected by the fixed connecting structure 123.
In this embodiment, the locking unit 12 includes two locking members 121, and each locking member 121 includes three wires.
In this embodiment, the fixing member 16 and the connecting member 111 are stretched in the tissue defect region, and the posture adjustment structure 14 adjusts the included angle between the fixing member 16 and the connecting member 111, as shown in fig. 9 g.
In another embodiment, the fixing member 16 includes an inner supporting structure 161, the inner supporting structure 161 is formed by twisting a plurality of metal wires, two ends of the inner supporting structure 161 are arc-shaped structures, the arc-shaped structures are located at two ends of the fixing member 16 as buffer structures 162, the reinforced connecting structure 15 and the connecting unit 11 are twisted together to form a fixed connection, wherein the reinforced connecting structure 15 and the locking unit 12 are twisted together with the inner supporting structure 161 in the fixing member 16 to form a fixed connection, as shown in fig. 7.
In another embodiment, the connecting member 111 is connected to the fixing member through a hole or a stopper to form the posture adjusting structure 14, as shown in fig. 9a to 9 b.
In another embodiment, the fixing member 16 is provided with a through hole at the middle thereof, and the connecting unit 11 can be gathered, intertwined, wound around and fixedly connected with the fixing member 16 at the through hole to form the posture adjustment structure 14, as shown in fig. 9c to 9d and 9 g.
In another embodiment, the posture adjustment structure 14 is a sliding mechanism including one or more combinations of a slider and a pulley, as shown in fig. 9e to 9 f.
In this embodiment, as shown in fig. 4a to 4b, the connection unit 11 is made of a polymer flexible material; when the tissue defect is closed, the connecting unit 11 and the tissue defect have a first fixing position 91 and a second fixing position 92, and a straight-line distance between the first fixing position 91 and the second fixing position 92 is defined as L1; the total length of said connecting element 11 in the proximal region of the tissue defect is naturally defined as L 2 (ii) a And, L 1 、L 2 The mathematical relationship is satisfied: l is 2 ≤L 1 。
In this embodiment, the connection unit 11 and the locking unit 12 are both made of degradable material; and the connection unit 11 is made of a high molecular degradable material; the locking unit 12 is made of one or more of zinc-based alloy degradable materials, magnesium-based alloy degradable materials and iron-based alloy degradable materials.
In another embodiment, the reinforced connecting structure 15 connects a plurality of the fixing members 16 and is independently free from the proximal region or the entire region of the locking member 121 and/or the connecting member 111, as shown in FIG. 10 a; alternatively, the reinforced connecting structure 15 connects a plurality of connecting units 11 and is independent from the locking member 121 and/or the connecting member 111 except the proximal region or the whole region, as shown in fig. 10 b; alternatively, the reinforcing connecting structure 15 is connected to a part of the locking unit 12 and is independent from the locking member 121 and/or the connecting member 111 except for the proximal end region or the whole region, as shown in fig. 10 d; the reinforced connecting structure 15 is made of flexible metal material or high polymer material; alternatively, when the reinforced connecting structure 15 is connected to a part or all of the locking units 12, the proximal end region of the auxiliary breaking structure 8 is connected to the delivery system after the reinforced connecting structure 15 is connected to the distal end region of the auxiliary breaking structure 8 in a parallel structure or a twisted structure or a braided structure with the locker 121, as shown in fig. 10 c.
In this embodiment, as shown in fig. 6e, the delivery system comprises a traction part and a pushing part, the traction part comprises two puncture needles 31, the puncture needles 31 have inner cavities, and the pushing part comprises a thimble 32; when the closing instrument is in the first shape, the fixing piece 16 and the thimble 32 are located in the inner cavity of the puncture needle 31, and the pushing part abuts against the proximal end of the fixing piece 16 through the thimble 32 and drives the fixing piece 16 to extend out in the inner cavity; when the closing instrument is in the second shape, the puncture needle 31 penetrates through the tissue wall, and the thimble 32 is pushed to drive the fixing piece 16 to release from the puncture needle 31; when the closure device is in the third configuration, disengagement unit 13 drives locking member 121 and thus connecting member 111 and fastener 16 to close the tissue defect.
In this embodiment, the traction unit further includes a plurality of needle control rails 33 disposed outside the puncture needle 31, and the needle control rails 33 control the movement trajectory of the puncture needle 31 and the puncture position on the tissue.
In this embodiment, the needle 31 has a substantially sharp distal end.
In this embodiment, after the fixing member 16 is released from the inner cavity, the distal end region of the connecting member 111 is connected to the fixing member 16 through the posture adjustment structure 14, and the posture adjustment structure 14 adjusts the included angle between the fixing member 16 and the connecting member 111, and makes the fixing member 16 contact the tissue to the maximum extent; wherein the connecting member 111 and the fixing member 16 form the posture adjusting structure 14 by a rotating mechanism including one or more combinations of a chain structure, a hinge structure, and elastic and/or plastic deformation of the material itself.
In this embodiment, the puncture needle 31 is preferably made of metal, and has both rigidity and a certain flexibility to facilitate puncturing of tissue.
In this embodiment, the lock transmission rod 22 has good torsion and transmission properties.
In this embodiment, the fastener 16 is an implantable polymeric material.
In this embodiment, the fastener 16 has a microporous structure to facilitate tissue draping and endothelialization; or the fixing member 16, the connecting member 111 and the locking member 121 comprise coating members, and the coating members comprise one of a coating layer, a polymer film, a polymer sheet and a drug sustained-release structure.
In this embodiment, the lock transmission rod 22 is made of metal or polymer, and has good torsion property.
In this embodiment, after the tissue defect is closed, the anchor 16 is positioned on both the primary septal surface and the secondary septal surface within the left atrium.
In this embodiment, the maximum outer diameter of the thimble 32 is 0.1mm to 1mm, and the thimble 32 has a certain rigidity, axial compression resistance, and a certain mechanical support.
The operation procedure steps in the operation of the present embodiment are as follows (as shown in fig. 6a to 6 h):
(1) Percutaneous puncture, reserving a guide wire at a tissue defect part, conveying a closing instrument to the right atrium through femoral veins along the guide wire, further conveying the closing instrument to a position of an patent foramen ovale between a secondary septum and a primary septum close to an interatrial septum, and enabling the end part of a guide head at the far end of the closing instrument to penetrate through the foramen ovale to limit the position of the guide head;
(2) Operating the control handle 51, slowly withdrawing the delivery sheath 5, pushing the two needle control guide rails 33 through the control handle 51 to expose the two needle control guide rails 33, respectively positioning the two needle control guide rails 33 at two sides of the foramen ovale, and operating the control handle 51 to enable the puncture needle 31 to penetrate through the tissue wall;
(3) After the needle withdrawing action of the puncture needle 31 is finished, the thimble 32 is operated to release the fixing piece 16 from the needle control guide rail 33, and the guide head is retracted after the needle control guide rail 33 and the puncture needle 31 are retracted;
(4) Operating the releasing unit 13 to drive the locking member 121 to rotate and pull the connecting unit 11 tightly, enabling the locking members 111 to approach each other and realize self-locking, further realizing the closure of the tissue defect, and enabling part or all of the closing units to be connected with the tissue;
(5) When the locking piece realizes self-locking, the releasing unit 13 is further operated, so that the releasing unit 13 and the locking unit 12 are separated in a breaking way, the conveying system is retracted, and the operation process is completed.
Example three:
the difference from the first embodiment is that:
in this embodiment, as shown in fig. 11a to 11d, the connection unit 11 is a polymer wire, the locking unit 12 is a soft metal wire, the locking unit 12 includes two locking members 121, and each locking member 121 is connected to the connection member by gluing, mechanical connection, welding, etc. and twisted with the connection member 111.
In this embodiment, the releasing unit 13 is operated to make the auxiliary breaking structure 8 drive the locking member 121 to rotate, so that the locking members 121 approach each other and realize self-locking and locking, thereby realizing the closure of the tissue defect; when retaining member 121 realizes auto-lock locking, further operation disengagement unit 13, supplementary fracture structure 8 is rotated further, make supplementary fracture structure 8 with retaining member 121 fracture separation, as shown in fig. 11a 11d, connecting piece 111 and retaining member 121 twist together, and cooperation supplementary fracture structure 8 uses, supplementary fracture structure 8 and the near-end connection of locking unit 12, on the one hand connecting piece 111 provides the twisting axle and participates in the twisting for the twisting simultaneously, can increase the connecting force of locking unit 12, reduce locking unit 12 and break in advance and lead to the risk that mounting 16 drops into left room, when retaining member 121 realizes auto-lock locking, further operation disengagement unit 13, supplementary fracture structure 8 is further rotated, make behind the supplementary fracture structure 8 fracture with the retaining member separation, can guarantee again that supplementary fracture structure 8 position breaks again and separates, the location is accurate, the advantage of design like this: the design of the auxiliary fracture structure 8 is adopted, the fracture position of the instrument after the tissue is closed 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 closed instrument is ensured to be in the best state; meanwhile, the force of the locking piece 12 is uniformly applied in the tissue defect closing process, so that the additional local tissue defect caused by nonuniform stress at the tissue defect position is avoided; in addition, the sheath diameter of the delivery sheath is small, the damage to blood vessels of a human body is small, and the delivery sheath is particularly suitable for special crowds such as immature patients with small blood vessels.
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 (23)
1. A closure device for a tissue defect, comprising:
the closure device comprises a closure unit, a release unit and a delivery system, wherein the closure unit comprises a connection unit and a locking unit connected with the connection unit, the locking unit is positioned in the proximal region of the connection unit, the release unit is positioned in the proximal region of the locking unit, and the delivery system is positioned in the proximal region of the release unit or the locking unit;
the connecting unit at least comprises one or more connecting pieces; the locking unit at least comprises one or more locking pieces, and the locking pieces are in a parallel structure or a twisted structure or a braided structure;
the closing unit comprises a fixing member, the fixing member is positioned at the distal end area of the connecting member and is connected with the connecting member, and part or all of the fixing member is attached or anchored to the inside or the outer surface of the distal end of the target tissue; the number and the positions of the connecting pieces and the fixing pieces correspond to one another, and the fixing pieces comprise outer shell structures and/or inner support structures from outside to inside; wherein, the fixing piece is strip-shaped; one end or two ends of the fixing piece are provided with buffer structures, and each buffer structure comprises one or more of a flexible reducing structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring and a ball head; when the fixing piece comprises the inner supporting structure, the inner supporting structure is positioned in a middle section area or a whole section area of the shell structure along the axial direction of the fixing piece; wherein the inner support structure is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defining the relative positions of both the retaining member distal end and the inner support structure;
and, the closure unit further comprises a reinforced connection structure, which is not connected to the delivery system; the reinforcing connecting structure is connected with a plurality of fixing pieces and is independently free from the proximal end area or the whole area of the locking piece and/or the connecting piece; or the reinforced connecting structure is connected with a plurality of connecting units and is independently free from the proximal end region or the whole region of the retaining member and/or the connecting member; or the reinforced connecting structure is connected to a part of the locking unit and is independent from the proximal end area or the whole area of the locking member and/or the connecting member; the reinforced connecting structure is made of a flexible metal material or a high polymer material;
operating the releasing unit to drive the locking pieces to rotate and tension the connecting unit, wherein the locking pieces are close to each other and realize self-locking and locking, so that the tissue defect is closed;
the locking unit with release unit formula structure as an organic whole, when retaining member realized auto-lock locking, further operation release unit makes release unit with the separation of locking unit fracture.
2. A closure device for a tissue defect according to claim 1, wherein:
before the locking unit and the releasing unit are not broken and separated, the locking unit and the releasing unit are in a tapered structure from the far end to the near end; when the locking piece realizes self-locking and locking, the releasing unit is further operated, and the proximal end area of the locking unit is further rotated, so that the releasing unit and the locking unit are separated in a breaking way.
3. A closure device for a tissue defect according to claim 1, wherein:
before the tissue defect is closed, when the releasing unit is operated to drive the locking unit to rotate, the locking force F01 borne by the releasing unit, the locking force F02 borne by the locking unit, the critical breaking force F1 borne by the releasing unit, the critical breaking force F2 borne by the locking unit, the critical breaking force F10 borne by the connecting unit and the critical breaking force F7 borne by the reinforced connecting structure meet the following requirements: f01 < F1, F01= F02, F1 < F2 < F10, F1 < F2 < F7;
when the locking unit is gradually locked, the connecting unit is gradually tensioned, and the F01 and the F02 are gradually increased; when the locking unit is completely locked, the releasing unit is further operated, and F01 reaches F1, so that the releasing unit is broken and separated.
4. A closure device for a tissue defect according to claim 1, wherein:
the conveying system comprises a locking mechanism, wherein the locking mechanism comprises a locking power source, a locking transmission rod and a locking transmission structure fixedly connected to the far end of the locking transmission rod;
the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium; the releasing mechanism is the locking mechanism, and the releasing transmission medium is the locking transmission rod;
when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area;
when the locking power source acts, the locking piece and the connecting piece are 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 concentrated area to be self-locked.
5. A tissue defect closure device as defined in claim 1, wherein: the connecting piece or the locking piece is provided with an anchoring structure extending out of the connecting piece or the locking piece; wherein the anchoring structure comprises one or more of a micro-thorn structure, a local protrusion structure and a local flattening structure.
6. A closure device for a tissue defect according to claim 1, wherein: the fixing piece is provided with a micropore structure; or the fixing piece, and/or the connecting unit, and/or the locking unit comprises 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.
7. A tissue defect closure device as defined in claim 1, wherein: the proximal end region of the connecting unit and the distal end region of the locking unit form a fixed connecting structure or a limiting connecting structure in one or more combination modes of ring buckling, knotting and mechanical clamping; the connecting unit is partially or completely connected with the tissue; the locking unit is connected with the connecting unit through the fixed connecting structure or the limiting connecting structure; wherein the connection unit located in the proximal region of the tissue defect is in a non-occluded state.
8. A closure device for a tissue defect according to claim 7, wherein: when the closing unit only comprises the connecting unit and the locking unit, the proximal region of the connecting unit is connected with the distal region of the locking unit through the fixed connecting structure or the limiting connecting structure; when the locking unit is locked, the connecting unit and the locking unit are integrally in a closed structure and then are connected with the distal end area of the releasing unit; and each two of the retaining members share a common one of the attachment members.
9. A tissue defect closure device as defined in claim 1, wherein: when the tissue defect is closed, the connecting unit and the tissue defect have a first fixing position and a second fixing position, and the straight-line distance between the first fixing position and the second fixing position is defined as L1; naturally, the total length of the connecting unit in the proximal region of the tissue defect is defined as L2; and L1, L2 satisfy the mathematical relationship: l2 is less than or equal to L1.
10. A tissue defect closure device as defined in claim 1, wherein: the connecting unit and the locking unit are made of materials with different properties; wherein the connecting unit is made of a high polymer material or a degradable metal material; the locking unit is made of a metal material.
11. A closure device for a tissue defect according to claim 1, wherein: the part of the connecting unit, which is in contact with the tissue, is provided with a local buffer structure, and the local buffer structure comprises one of a local thickening structure and a self-expansion structure.
12. A closure device for a tissue defect, comprising:
the closure device comprises a closure unit, a release unit and a delivery system, wherein the closure unit comprises a connection unit, a locking unit connected with the connection unit, a fixing part and a reinforced connection structure, the locking unit is positioned at the proximal end region of the connection unit, the release unit is positioned at the proximal end region of the locking unit, and the delivery system is positioned at the proximal end region of the release unit or the locking unit; the locking unit or the releasing unit is connected with the conveying system;
the connecting unit at least comprises one or more connecting pieces; the locking unit at least comprises one or more locking pieces, and the locking pieces are in a parallel structure or a twisted structure or a braided structure; the releasing unit comprises an auxiliary breaking structure, and the distal end of the auxiliary breaking structure is connected with the proximal end of the locking piece;
wherein the fixing element is positioned at the distal end area of the connecting element and is connected with the connecting element, part or all of the fixing element is attached or anchored to the inner surface or the distal surface of the target tissue, and the fixing element comprises a shell structure and/or an inner support structure from outside to inside; wherein, the fixing piece is strip-shaped; one end or two ends of the fixing piece are provided with buffer structures, and each buffer structure comprises one or more of a flexible reducing structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring and a ball head; when the fixing piece comprises the inner supporting structure, the inner supporting structure is positioned in a middle section area or a whole section area of the shell structure along the axial direction of the fixing piece; wherein the inner support structure is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defining the relative positions of both the retaining member distal end and the inner support structure; the number and the positions of the connecting pieces and the fixing pieces are in one-to-one correspondence; wherein the reinforced connection structure is not connected to the delivery system; wherein the reinforcing connecting structure is connected with a plurality of fixing pieces and is independently free from the proximal end region or the whole region of the locking piece and/or the connecting piece; or the reinforced connecting structure is connected with a plurality of connecting units and is independently free from the proximal end region or the whole region of the locking member and/or the connecting member; or, the reinforced connecting structure is connected to part or all of the locking unit; the reinforced connecting structure is made of a flexible metal material or a high polymer material;
operating the releasing unit to enable the auxiliary breaking structure to drive the locking pieces to rotate and enable the connecting unit to be tensioned, enabling the locking pieces to approach each other and realizing self-locking and locking, and further realizing the closing of the tissue defect;
when the retaining member realizes self-locking and locking, the releasing unit is further operated, and the auxiliary breaking structure is further rotated, so that the auxiliary breaking structure is separated from the retaining member after being broken.
13. A tissue defect closure device as defined in claim 12, wherein: when the reinforcing connecting structure is connected to part or all of the locking units, the reinforcing connecting structure and the locking piece are in a parallel structure or a twisted structure or a braided structure and are connected with the far end region of the auxiliary breaking structure, and then the near end region of the auxiliary breaking structure is connected with the conveying system.
14. A closure device for a tissue defect according to claim 13, wherein:
before the tissue defect is closed, the auxiliary fracture structure is operated to drive the locking unit to rotate, the locking force F03 borne by the auxiliary fracture structure, the locking force F04 borne by the locking unit, the critical fracture force F3 borne by the auxiliary fracture structure, the critical fracture force F4 borne by the locking unit, the critical fracture force F11 borne by the connecting unit and the critical fracture force F8 borne by the reinforced connecting structure meet the following requirements: f03 < F3, F03= F04, F3 < F4 < F11, F3 < F4 < F8;
when the locking unit is locked gradually, the connecting unit is tensioned gradually, the F03 and the F04 are increased gradually, when the locking unit is locked completely, the F03 reaches the F3 when the auxiliary breaking structure is operated further, and the auxiliary breaking structure is broken and separated.
15. A tissue defect closure device as defined in claim 14, wherein:
the conveying system comprises a locking mechanism, wherein the locking mechanism comprises a locking power source, a locking transmission rod and a locking transmission structure fixedly connected to the far end of the locking transmission rod;
the conveying system comprises a releasing mechanism, and the releasing mechanism comprises a releasing power source and a releasing transmission medium; the releasing mechanism is the locking mechanism, and the releasing transmission medium is the locking transmission rod;
when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area;
when the locking power source acts, the locking piece and the connecting piece are 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 concentrated area to be self-locked.
16. A tissue defect closure device as defined in claim 15, wherein:
the connecting unit and the auxiliary fracture structure are made of materials with different properties; or the locking unit and the auxiliary breaking structure are made of materials with different properties; wherein the content of the first and second substances,
the connecting unit is made of a high polymer material or a degradable metal material; the locking unit and the auxiliary breaking structure are made of a metal material.
17. A tissue defect closure device as defined in claim 16, wherein:
the locking unit, and/or the reinforced connecting structure, and/or the connecting unit are self-locked in a winding manner in the concentrated area to form a cable structure or a twist-shaped structure, and the cable structure or the twist-shaped structure has at least one turn.
18. A closure device for a tissue defect, comprising:
the closure device comprises a closure unit, a release unit and a delivery system, wherein the closure unit comprises a connecting unit, a locking unit connected with the connecting unit, a fixing piece and a reinforced connecting structure, the locking unit is positioned in the proximal end region of the connecting unit, the release unit is positioned in the proximal end region of the locking unit, and the delivery system is positioned in the proximal end region of the release unit or the locking unit; the locking unit or the releasing unit is connected with the conveying system;
the connecting unit at least comprises one or more connecting pieces; the locking unit at least comprises one or more locking pieces, and the locking pieces are in a parallel structure or a twisted structure or a braided structure; the releasing unit comprises an auxiliary operation structure, wherein the fixing piece is positioned at the distal end area of the connecting piece and is connected with the connecting piece, part or all of the fixing piece is attached or anchored to the inner surface or the outer surface of the distal end of the target tissue, and the fixing piece comprises an outer shell structure and/or an inner support structure from outside to inside; wherein, the fixing piece is strip-shaped; one end or two ends of the fixing piece are provided with buffer structures, and each buffer structure comprises one or more of a flexible reducing structure, a flexible fine branch structure, a local thickening structure, an S-shaped structure, a wave-shaped structure, a spring structure, a circular ring and a ball head; when the fixing piece comprises the inner supporting structure, the inner supporting structure is positioned in a middle section area or a whole section area of the shell structure along the axial direction of the fixing piece; wherein the inner support structure is more rigid or has a higher bending modulus than the outer shell structure; the housing structure defining the relative positions of the distal end of the retaining member and the inner support structure; the number and the positions of the connecting pieces and the fixing pieces are in one-to-one correspondence;
wherein the reinforced connection structure is not connected to the delivery system; the reinforcing connecting structure is connected with a plurality of fixing pieces and is independently free from the proximal end area or the whole area of the locking piece and/or the connecting piece; or the reinforced connecting structure is connected with a plurality of connecting units and is independently free from the proximal end region or the whole region of the retaining member and/or the connecting member; or, the reinforced connecting structure is connected to part or all of the locking unit; the reinforced connecting structure is made of a flexible metal material or a high polymer material;
operating the releasing unit to drive the locking pieces to rotate and tension the connecting unit, wherein the locking pieces are close to each other and realize self-locking and locking, so that the tissue defect is closed;
the locking unit is connected with the releasing unit, and the auxiliary operation structure is operated to separate the releasing unit from the locking piece.
19. A tissue defect closure device as defined in claim 18, wherein:
the auxiliary operation structure comprises a fusible link structure, a low-temperature breakable link structure, a breakable link structure and a detachable link structure which are arranged at the proximal end area of the releasing unit.
20. A closure device for a tissue defect according to claim 19, wherein: when the reinforced connecting structure is connected to part or all of the locking unit, the reinforced connecting structure and the locking piece are in a parallel structure or a twisted structure or a braided structure and are connected with the far end region of the releasing unit, and then the near end region of the releasing unit is connected with the conveying system.
21. A closure device for a tissue defect according to claim 20, wherein:
before the tissue defect is closed, when the releasing unit is operated to drive the locking unit to rotate, the locking force F05 of the releasing unit, the locking force F06 of the locking unit, the critical fracture force F5 of the releasing unit, the critical fracture force F6 of the locking unit, the critical fracture force F12 of the connecting unit and the critical fracture force F9 of the reinforced connecting structure meet the following requirements: f05 < F5, F05= F06, F5 < F6 < F12, F5 < F6 < F9.
22. A tissue defect closure device as defined in claim 21, wherein:
the conveying system comprises a locking mechanism, and the locking mechanism comprises a locking power source, a locking transmission rod and a locking transmission structure fixedly connected to the far end of the locking transmission rod;
the conveying system comprises a releasing mechanism, wherein the releasing mechanism comprises a releasing power source and a releasing transmission medium;
the locking mechanism is different from the releasing mechanism, the locking power source is operated, the locking member is rotated to close the tissue defect, the releasing power source is operated, and the locking member is separated from the releasing unit;
when preassembling, the proximal end area of the releasing unit is connected with the locking transmission structure to form a concentrated area;
when the locking power source acts, the locking piece and the connecting piece are 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 concentrated area to be self-locked.
23. A closure device for a tissue defect according to claim 22, wherein:
the locking unit, and/or the reinforced connecting structure, and/or the connecting unit are self-twisted in the concentrated area to form a cable structure or a twist-shaped structure, and the cable structure or the twist-shaped structure is at least one circle.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111079433.7A CN113827284B (en) | 2021-09-15 | 2021-09-15 | Tissue defect's closure apparatus |
| PCT/CN2022/089058 WO2023040272A1 (en) | 2021-09-15 | 2022-04-25 | Tissue defect closure instrument |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111079433.7A CN113827284B (en) | 2021-09-15 | 2021-09-15 | Tissue defect's closure apparatus |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN113827284A CN113827284A (en) | 2021-12-24 |
| CN113827284B true CN113827284B (en) | 2023-04-14 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111079433.7A Active CN113827284B (en) | 2021-09-15 | 2021-09-15 | Tissue defect's closure apparatus |
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| Country | Link |
|---|---|
| CN (1) | CN113827284B (en) |
| WO (1) | WO2023040272A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113827284B (en) * | 2021-09-15 | 2023-04-14 | 宁波迪创医疗科技有限公司 | Tissue defect's closure apparatus |
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| CN103654883A (en) * | 2013-12-06 | 2014-03-26 | 先健科技(深圳)有限公司 | Plugging device with locking mechanism |
| WO2018236822A1 (en) * | 2017-06-19 | 2018-12-27 | Heartstitch, Inc. | Suturing devices and methods for suturing an opening in the apex of the heart |
| CN112423672A (en) * | 2018-07-18 | 2021-02-26 | 阿瑟雷克斯股份有限公司 | Knotless closed suture and tissue fixation method |
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| US6752813B2 (en) * | 1999-04-09 | 2004-06-22 | Evalve, Inc. | Methods and devices for capturing and fixing leaflets in valve repair |
| JP2007504885A (en) * | 2003-09-11 | 2007-03-08 | エヌエムティー メディカル， インコーポレイティッド | Devices, systems and methods for suturing tissue |
| JP2009500118A (en) * | 2005-07-07 | 2009-01-08 | コーディス・コーポレイション | Patent foramen ovale closure device with steerable delivery system |
| CN203576563U (en) * | 2013-12-06 | 2014-05-07 | 先健科技(深圳)有限公司 | Plugging device with locking mechanism |
| US20180280013A1 (en) * | 2015-01-23 | 2018-10-04 | Beacon Surgical Instruments, Llc | Surgical support device and methods of use |
| US10575842B2 (en) * | 2017-02-09 | 2020-03-03 | Arthrex, Inc. | Knotless self-locking anchor constructs and methods of tissue fixation |
| CN109247965B (en) * | 2018-10-10 | 2021-11-26 | 先健科技(深圳)有限公司 | Suturing device |
| CN110353821B (en) * | 2019-06-20 | 2023-08-01 | 上海汇禾医疗科技股份有限公司 | Clamping device and clamping assembly |
| CN113827284B (en) * | 2021-09-15 | 2023-04-14 | 宁波迪创医疗科技有限公司 | Tissue defect's closure apparatus |
| CN113827285A (en) * | 2021-09-15 | 2021-12-24 | 宁波迪创医疗科技有限公司 | Closure device for tissue defects |
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2021
- 2021-09-15 CN CN202111079433.7A patent/CN113827284B/en active Active
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- 2022-04-25 WO PCT/CN2022/089058 patent/WO2023040272A1/en unknown
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103654883A (en) * | 2013-12-06 | 2014-03-26 | 先健科技(深圳)有限公司 | Plugging device with locking mechanism |
| WO2018236822A1 (en) * | 2017-06-19 | 2018-12-27 | Heartstitch, Inc. | Suturing devices and methods for suturing an opening in the apex of the heart |
| CN112423672A (en) * | 2018-07-18 | 2021-02-26 | 阿瑟雷克斯股份有限公司 | Knotless closed suture and tissue fixation method |
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| Publication number | Publication date |
|---|---|
| WO2023040272A1 (en) | 2023-03-23 |
| CN113827284A (en) | 2021-12-24 |
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