WO2023160665A1 - 一种封堵器 - Google Patents

一种封堵器 Download PDF

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Publication number
WO2023160665A1
WO2023160665A1 PCT/CN2023/078248 CN2023078248W WO2023160665A1 WO 2023160665 A1 WO2023160665 A1 WO 2023160665A1 CN 2023078248 W CN2023078248 W CN 2023078248W WO 2023160665 A1 WO2023160665 A1 WO 2023160665A1
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WO
WIPO (PCT)
Prior art keywords
hole
locking
limiting
occluder
locking ring
Prior art date
Application number
PCT/CN2023/078248
Other languages
English (en)
French (fr)
Inventor
陈娟
胡金鹏
王云兵
王帆
刘灿
刘德中
秦永文
潘湘斌
Original Assignee
上海形状记忆合金材料有限公司
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Filing date
Publication date
Application filed by 上海形状记忆合金材料有限公司 filed Critical 上海形状记忆合金材料有限公司
Publication of WO2023160665A1 publication Critical patent/WO2023160665A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/00597—Implements comprising a membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00915—Material properties transparent or translucent for radioactive radiation
    • A61B2017/0092—Material properties transparent or translucent for radioactive radiation for X-rays

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to an occluder.
  • congenital heart diseases include ventricular septal defect, atrial septal defect, patent ductus arteriosus, patent foramen ovale, etc.
  • the only effective way to treat this type of congenital heart disease was surgical thoracotomy.
  • minimally invasive interventional therapy has gradually matured and replaced surgical thoracotomy.
  • occluders for occlusion treatment.
  • the mainstream occluders on the market are mostly made of nickel-titanium alloy materials, which utilize the superelastic properties of nickel-titanium alloy materials to achieve closure of the defect position Blockage treatment.
  • conventional metal occluders will be accompanied by a certain rate of complications during treatment.
  • the occluder mainly plays the role of a bridge in the human body, promoting the endothelialization of surrounding tissues on the surface of the occluder, so as to realize the closure of the defect.
  • the endothelialization is complete, the mission of the occluder has been completed, and if it stays in the body, it will cause a series of complications, including allergies and arrhythmia caused by the precipitation of nickel ions. Since the nickel-titanium alloy material is not degradable, the metal seal After implantation, the occlusion device will permanently exist in the heart, which will increase the probability of complications.
  • the purpose of the embodiments of the present invention is to overcome the defects described in the prior art, thereby providing an occluder that is not easy to fall off and has a good occluding effect. Its specific technical scheme is as follows:
  • An embodiment of the present invention provides an occluder made of degradable materials, including a mesh skeleton and a locking member;
  • the mesh skeleton includes an upper panel, a waist and a lower panel formed in sequence, the lower panel has a welded tail end of the mesh skeleton, and a limited through hole is opened on the welded tail end;
  • the locking part includes a tensioning part and a locking part, the tensioning part is radial, the diffuse end of the tensioning part is connected to the upper disk surface, and the contracting end of the tensioning part is connected to the locking part , the proximal end of the locking part is provided with a locking ring, the diameter of the locking ring is larger than the diameter of the distal end of the limiting through hole, and the locking ring can be set in/through the welding tail end through deformation limit through hole.
  • the limiting through hole includes several first through holes connected in series, the opening diameter of the distal end of the first through hole is smaller than the diameter of the locking ring, and the first through hole is close to The diameter of the opening at the end is larger than the diameter of the locking ring.
  • the longitudinal section of the first through hole is trapezoidal.
  • the limiting through hole further includes a second through hole communicating with the first through hole at the proximal end, and the opening diameter of the distal end of the second through hole is equal to that of the proximal end of the second through hole. Opening diameter.
  • the locking part further includes a drawing wire, the distal end of the drawing wire is fixed on the upper disk surface, and the proximal end of the drawing wire Winding forms the locking ring.
  • the opening diameter of the distal end of the limiting through hole is smaller than the opening diameter of the proximal end
  • the locking ring includes several locking ring units connected in series, each of the locking units can be deformed one by one from The opening at the distal end of the limiting through hole enters/passes through the limiting through hole.
  • the drawing wire is made of degradable material, and the drawing wire is wound with a developing wire.
  • the surface of the welding tail is provided with external threads, and the external threads are connected with an external pushing device.
  • the sidewall of the welding tail end further has a developing ring disposed around the limiting through hole.
  • the occluder further includes a flow-blocking film
  • the flow-blocking film is made of a degradable material, including a first flow-blocking film covering the inner wall of the upper disk, and a first flow-blocking film at the cross-section of the waist.
  • the tightening part includes multiple sets of degradable drawstrings, the proximal ends of each set of drawstrings are gathered and fixed on the locking part, and the distal ends of each set of drawstrings pass through in turn.
  • the third choke film, the second choke film and the first choke film are dispersed and fixed on the upper disk surface.
  • each set of drawstrings is composed of several degradable wires.
  • the waist of the mesh skeleton can be passed through the septal defect of body tissue; when the locking ring is limited in the limiting through hole at the welding tail end, the locking part Drive the tensioning part to move the upper disc surface closer to the lower disc surface, so that the upper disc surface and the lower disc face will generate a clamping force around the septal defect, so that the occluder can block the septal defect.
  • the locking ring can be deformed into the limiting through hole and locked in the limiting through hole.
  • the waist of the mesh framework can be pierced at the septal defect, and the upper and lower discs are respectively blocked on both sides of the septal defect, and the distal end of the tensioning part based on the locking piece is radiating.
  • the shape is fixed on the upper plate surface, and the proximal end gathers on the locking part of the locking part.
  • the locking ring of the locking part can be deformed. Therefore, when a pulling force is applied to the locking ring, the locking part will drive the tensioning part to move the upper plate towards the lower plate, so that The upper disk surface and the lower disk face produce a certain clamping force around the septal defect.
  • the diameter of the locking ring is greater than the distance of the limiting through hole. Therefore, when the pulling force disappears, the locking ring will be limited in the limiting through hole at the welding tail end, thereby ensuring the sealing effect of the present disclosure, and avoiding the defect of insufficient elasticity of the material during the sealing operation. The problem of falling off is easy to occur.
  • Figure 1 is a perspective view of an occluder provided by an embodiment of the present invention.
  • Fig. 2 is the front view of the occluder provided by one embodiment of the present invention.
  • Fig. 3 is a top view of the occluder provided by one embodiment of the present invention.
  • Fig. 4 is the cross-sectional view of mesh skeleton along AA line in Fig. 2;
  • Fig. 5 is a schematic structural diagram of a locking member provided by an embodiment of the present invention.
  • Fig. 6 is a cross-sectional view of the melting tail end along line A-A in Fig. 2;
  • Fig. 7 is a schematic diagram of the connection between the locking member and the welding tail in one embodiment of the present invention.
  • Fig. 8 is a cross-sectional view of the fusion tail along the line A-A shown in Fig. 2 in another embodiment of the present invention.
  • Fig. 9 is a cross-sectional view along line A-A shown in Fig. 2 after the occluder is implanted in another embodiment of the present invention.
  • Fig. 10 is a schematic structural diagram of a locking part in another embodiment of the present invention.
  • Fig. 11 is a cross-sectional view along line A-A shown in Fig. 2 after the occluder is implanted in another embodiment of the present invention.
  • orientation or positional relationship indicated by the terms “center”, “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inner”, “outer” etc. are based on the drawings
  • the orientations or positional relationships shown are only for the convenience of describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as an important aspect of the present invention. limits.
  • the terms “first”, “second”, and “third” are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.
  • the occluder made of alloy material will have the risk of complications if it remains in the patient's body during the operation or after the operation.
  • the occluder made of degradable material is used to solve the above problems, but the elasticity of the degradable material is relatively low.
  • the alloy material is weak, and it is often very easy to fall off during the closure operation, resulting in operation failure.
  • This application proposes an occluder made of degradable materials, including a mesh skeleton and locking parts;
  • the mesh frame includes the upper panel, the waist and the lower panel formed in sequence, and the lower panel has a welded tail end of the mesh skeleton, and a limited through hole is opened on the welded tail end;
  • the locking part includes a tensioning part and a locking part, the tensioning part is radial, the diffuse end of the tensioning part is connected to the upper plate, the contracting end of the tensioning part is connected to the locking part, the proximal end of the locking part is provided with a locking ring, and the locking
  • the diameter of the ring is larger than the diameter of the distal end of the limiting through hole, and the locking ring can be inserted into/passed through the limiting through hole at the welding tail end through deformation.
  • the waist of the mesh framework can be pierced at the septal defect, and the upper and lower discs are respectively blocked on both sides of the septal defect, and the distal end of the tensioning part based on the locking piece is radiating.
  • the shape is fixed on the upper plate surface, and the proximal end gathers on the locking part of the locking part.
  • the locking ring of the locking part can be deformed. Therefore, when a pulling force is applied to the locking ring, the locking part will drive the tensioning part to move the upper plate towards the lower plate, so that The upper disk surface and the lower disk face produce a certain clamping force around the septal defect.
  • the diameter of the locking ring is greater than the distance of the limiting through hole. Therefore, when the pulling force disappears, the locking ring will be limited in the limiting through hole at the welding tail end, thereby ensuring the sealing effect of the present disclosure, and avoiding the defect of insufficient elasticity of the material during the sealing operation. The problem of falling off is easy to occur.
  • the proximal end is the end close to the operator, and the distal end is the end far away from the operator.
  • the upper plate is the end far away from the operator, and the welding tail is near the operator's end.
  • the present application proposes an occluder, please refer to FIG.
  • the mesh skeleton 100 is made of degradable materials, for example, polylactic acid, polyglycolic acid , polydioxanone or polyhydroxybutyric acid, and the network skeleton 100 is usually formed by welding a tubular network structure with only one closing point, please refer to Figure 4, which includes the upper The plate surface 110, the waist portion 120 and the lower plate surface 130, the closing part is located on the lower plate surface 130, which is melted to form a welded tail end 140, and a limited through hole 141 is opened on the welded tail end 140; wherein, please refer to the accompanying drawings 1-3, the upper plate surface 110 The diameter of the upper disk 110 is 6-18mm larger than that of the waist 120, the diameter of the lower disk 130 is 4-12mm larger than that of the waist 120, and the diameter of the upper disk 110 is larger than the diameter of the lower disk 130.
  • the surface of the welding tail 140 is provided with an external thread to increase its surface roughness, increase the friction with the external pushing device, and further ensure the safety of transportation.
  • the choke film is made of degradable material, including the first choke film 210 covering the inner wall of the upper panel 130 , the second choke film 220 located on the cross section of the waist 120 and covering the lower panel 130 The third flow blocking film 230 on the inner wall.
  • the first flow blocking film 210, the second flow blocking film 220 and the third flow blocking film 230 are sewn together with the mesh skeleton 100 through degradable silk, the first flow blocking film 210, the second flow blocking film 220, the third flow blocking film
  • the material of the flow film 230 and the degradable silk can be amorphous polylactic acid, left-handed polylactic acid, right-handed polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid or polylactic acid-glycolic acid copolymer, In this embodiment, any one or both of polydioxanone, polycaprolactone, polyglycolic acid, polylactic acid-glycolic acid copolymer or amorphous polylactic acid, L-polylactic acid and D-polylactic acid are preferred.
  • the structure of the flow-blocking film is spunlace non-woven fabric, needle-punched non-woven fabric, spunbond non-woven fabric, heat-bonded non-woven fabric, wet-laid non-woven fabric or electrospun fiber film; flow-blocking film
  • the number of layers can be 2-6 layers.
  • the locking member 300 includes a tightening portion 310 and a locking portion 320, the tightening portion 310 is radial, and the tightening portion 310 It includes a plurality of sets of degradable drawstrings 311, the proximal ends of each set of drawstrings 311, that is, the constricted ends, are collected and fixed on the locking part 320, and the distal ends of each set of drawstrings 311, that is, the diffuse ends, pass through the third flow blocking film 230, The second choke film 220 and the first choke film 210 are dispersed and fixed on the upper disk surface 110 .
  • each group of drawstrings 311 is composed of several degradable wires, the proximal ends of the several degradable wires in the drawstrings 311 of each group are connected together, and the distal ends of the several degradable wires in the drawstrings 311 of each group are all connected together.
  • each set of drawstrings 311 is composed of two degradable wires.
  • the locking part 320 is composed of a drawing wire 321 and a locking ring 322, and the distal end of the drawing wire 321 passes through the third choke film 230, the second choke film 220 and the first choke film 210 in turn and is fixed on the top.
  • the proximal end of the drawing wire 321 is wound to form a locking ring 322 , and the drawing wire 321 and the locking ring 322 of the locking portion 320 are wound with a developing wire.
  • the diameter of the locking ring 321 is larger than the diameter of the distal end of the limiting through hole 141 , and the locking ring 321 can be inserted into/passed through the limiting through hole 141 of the welding tail 140 through deformation.
  • the waist 120 of the mesh skeleton 100 can be inserted at the septal defect 400, and the upper disk surface 110 and the lower disk surface 130 are respectively blocked on both sides of the septal defect 400.
  • the distal end of the tightening part 310 is radially fixed on the upper disc surface 110, and the proximal end gathers on the locking part 320 of the locking part 300.
  • the locking ring 322 of the locking part 320 can be deformed, so when a pulling force is applied to the locking ring 322, the locking part 320 will drive the tensioning part 310 to move the upper disk surface 110 closer to the lower disk surface 130, so that the upper disk surface 110 and the lower disk surface 130 will generate a certain clamping force around the spacer defect 400, when the locking ring 322 deforms and passes through the limiting through hole 141 After the opening at the distal end enters the limiting through hole 141, the diameter of the locking ring 322 is greater than the diameter of the distal end of the limiting through hole 141. Therefore, when the pulling force disappears, the locking ring 322 will be limited to the limit of the welding tail end 140.
  • the drawing wire 321 of the locking part 320 and the locking ring 322 are wound with a developing wire, and the welded tail end 140 is embedded in the developing ring 142. Therefore, during the operation image process, pulling the locking ring 322 will pass through the developing ring 142. Therefore, it is convenient It can clearly judge whether the blocking process is locked or not through visual operation, which greatly increases the efficiency of the operation.
  • the occluder is only suitable for a certain type of surgical environment, and cannot be well blocked in the case position in different types of surgical environments.
  • this The application proposes the following technical solutions.
  • the lock ring 322 is a spring coil wound by a degradable drawing wire 321, and simultaneously the drawing wire 321 and the locking ring 322 are also wound with developing filaments, and the locking ring 322 has a central circle, this structure The locking ring 322 has a space for elastic deformation.
  • the molding process of the welding tail end 140 is to form a whole with the mesh skeleton 100 after thermal melting of degradable wire; wherein the limiting through hole 141 includes several first through holes 1411 connected in series, the first The opening diameter of the distal end of the through hole 1411 is smaller than the diameter of the locking ring 322, and the opening diameter of the proximal end of the first through hole 1411 is greater than the diameter of the locking ring 322.
  • the longitudinal section of the first through hole 1411 can be trapezoidal, then the limit The through hole 141 is a through hole formed by connecting N trapezoidal holes.
  • Fig. 9 is a cross-sectional view along line A-A shown in Fig. 2 after the occluder is implanted into the body in this embodiment, where 400 is a tissue septal defect in the heart body.
  • 400 is a tissue septal defect in the heart body.
  • the locking ring 322 since the outer diameter of the locking ring 322 is larger than the diameter of the distal opening of the first through hole 1411 and smaller than the diameter of the proximal opening of the first through hole 1411, at the same time
  • the locking ring 322 can pass through the first through hole 1411, so that the upper disk surface 110 and the lower disk surface 120 generate a certain clamping force around the septal defect 400, when When the locking ring 322 is pulled into different first through holes 1411, the pitch of the drawing wire 321 will change, thereby driving the tensioning part 310 to reduce the distance between the upper disk surface 110 and the lower disk surface 120, so that the space defect 400.
  • the limiting through hole 141 also includes a second through hole 1412 communicating with the first through hole 1411 at the proximal end, and the opening at the distal end of the second through hole 1412 is The mouth diameter is equal to the opening diameter of the proximal end of the second through hole 1412 .
  • the second through hole 1412 is a cylindrical hole with a diameter equal to the diameter of the distal end of the first through hole 1411.
  • the diameter of the second through hole 1412 is greater than the maximum outer diameter of the locking ring 322, in the final In the locked state, it can also ensure that the locking ring 322 is limited in the welding tail end 140, which is more conducive to the endothelialization of the occluder in the later stage.
  • the opening diameter of the distal end of the limiting through hole 141 is smaller than the opening diameter of the proximal end, such as a trapezoidal hole, and the locking ring 322 includes several
  • the locking ring units 3221 are formed in series, and each locking unit 3221 can enter/pass through the limiting through hole 141 from the opening at the far end of the limiting through hole 141 through deformation one by one.
  • the limiting through hole 141 can include a first through hole 1411 and a second through hole 1412 connected in series, the first through hole 1411 is a trapezoidal hole, the second through hole 1412 is a cylindrical hole, and the diameter of the second through hole 1412 is larger than that of the locking pin. Therefore, the maximum outer diameter of the unit 3221 can also ensure that the locking unit 3221 is limited in the welding tail end 140 in the final locked state, which is more conducive to the endothelialization of the later occluder.
  • septal defect mainly refers to atrial septal defect or ventricular septal defect.
  • Atrial septal defect refers to an abnormal channel between the left and right atrium, and the normal anatomical structure is destroyed, so that blood can reach the other atrium from the ischemic site.
  • Ventricular septal defect means that there is an abnormal channel between the left ventricle and the right ventricle, and the original normal anatomical structure is destroyed. Due to the high pressure between the two ventricles, blood can flow from one side to the other.
  • the shunt to the right is the main one, and in the later stage of development, there may be right-to-left shunt, left-to-right shunt, and two-way shunt.
  • Body tissue is the tissue that makes up a living body.

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Abstract

本发明公开一种封堵器，由可降解材料制成，包括网状骨架和锁定件；所述网状骨架包括顺次成型的上盘面、腰部和下盘面，所述下盘面具有所述网状骨架的熔接尾端，所述熔接尾端上开设有限位通孔；所述锁定件包括拉紧部和锁定部，所述拉紧部呈辐射状，所述拉紧部的扩散端与所述上盘面连接，所述拉紧部的收缩端与所述锁定部连接，所述锁定部的近端设有锁定环，所述锁定环的直径大于所述限位通孔的远端的直径，所述锁定环可通过形变卡设于/穿出所述熔接尾端的限位通孔中。本发明提供的封堵器不易脱落，封堵效果好。

Description

一种封堵器 技术领域
本发明涉及介入型医疗器械技术领域，尤其涉及一种封堵器。
背景技术
常见的先天性心脏病包括室间隔缺损、房间隔缺损、动脉导管未闭、卵圆孔未闭等几种类型，以往治疗该类先天性心脏病唯一有效的方法是进行外科开胸手术，如今随着医疗器械和手术技术的发展，微创介入治疗逐渐发展成熟并替代了外科开胸手术，此疗法既避免了开胸手术痛苦大、创伤大、费用高、风险大等诸多弊端，也避免了单纯打针容易复发，容易造成肺栓塞(一旦发生肺栓塞，有生命危险)的弊端。
常规的微创介入手术主要采用心脏封堵器进行封堵治疗，目前市场上主流的封堵器多由镍钛合金材料制成，其利用镍钛合金材料的超弹性特性实现对缺损位置的封堵治疗。然而，常规的金属封堵器在进行治疗的时候会伴随一定比率的并发症发生。另外封堵器在人体中主要起到一个桥梁的作用，促进周围组织在封堵器表面的内皮化，从而实现缺损的封堵。但是内皮化完全后，封堵器的使命已完成，继续留在体内，会引起一系列并发症，包括镍离子析出引起的过敏、心律失常等，由于镍钛合金材料不可降解，因此，金属封堵器植入人体后将永久存在于心脏，这会增加并发症的发生概率。
基于上述问题，目前市面上出现了一些可降解封堵器，但是由于可降解材料的弹性远远小于镍钛合金材料的弹性，在封堵手术过程中往往极易脱落而造成手术失败。
发明内容
本发明实施例的目的在于克服现有技术中所述的缺陷，从而提供一种封堵器，该封堵器不易脱落，封堵效果好。其具体技术方案如下：
本发明实施例提供了一种封堵器，由可降解材料制成，包括网状骨架和锁定件；
所述网状骨架包括顺次成型的上盘面、腰部和下盘面，所述下盘面具有所述网状骨架的熔接尾端，所述熔接尾端上开设有限位通孔；
所述锁定件包括拉紧部和锁定部，所述拉紧部呈辐射状，所述拉紧部的扩散端与所述上盘面连接，所述拉紧部的收缩端与所述锁定部连接，所述锁定部的近端设有锁定环，所述锁定环的直径大于所述限位通孔的远端的直径，所述锁定环可通过形变卡设于/穿出所述熔接尾端的限位通孔中。
在一些实施例中，所述限位通孔包括若干个串联连通的第一通孔，所述第一通孔的远端的开口直径小于所述锁定环的直径，所述第一通孔近端的开口直径大于所述锁定环的直径，优选地，所述第一通孔的纵剖面呈梯形。
在一些实施例中，所述限位通孔还包括与近端的第一通孔连通的第二通孔，所述第二通孔远端的开口直径等于所述第二通孔近端的开口直径。
在一些实施例中，所述锁定部还包括拉丝，所述拉丝的远端固定于所述上盘面上，所述拉丝的近端 绕制形成所述锁定环。
在一些实施例中，所述限位通孔的远端的开口直径小于近端的开口直径，所述锁定环包括若干个串联而成的锁定环单元，各个所述锁定单元可逐个通过形变从所述限位通孔远端的开口进入/穿出所述限位通孔中。
在一些实施例中，所述拉丝由可降解材质制成，所述拉丝上绕制有显影丝。
在一些实施例中，所述熔接尾端的表面开设有外螺纹，所述外螺纹与外部推动装置连接。
在一些实施例中，所述熔接尾端的侧壁上还具有环绕所述限位通孔设置的显影环。
在一些实施例中，所述封堵器还包括阻流膜，所述阻流膜为可降解材质，包括覆盖于所述上盘面的内壁上的第一阻流膜、位于所述腰部横截面上的第二阻流膜以及覆盖于所述下盘面内壁上的第三阻流膜。
在一些实施例中，所述拉紧部包括多组可降解的拉带，各组所述拉带的近端汇集固定于所述锁定部上，各组所述拉带的远端依次穿过所述第三阻流膜、第二阻流膜和第一阻流膜而分散固定于所述上盘面上。
在一些实施例中，每组所述拉带由若干条可降解丝组成。
在一些实施例中，所述网状骨架的所述腰部能穿设于机体组织的间隔缺损处；当所述锁定环被限位于熔接尾端的所述限位通孔中时，所述锁定部带动所述拉紧部将所述上盘面向所述下盘面靠拢，使得所述上盘面和所述下盘面对所述间隔缺损周围产生夹持力以让所述封堵器封堵所述间隔缺损。
在一些实施方式中，所述锁定环可通过形变进入所述限位通孔中并卡设于所述限位通孔中。
本发明提供的技术方案带来的有益效果是：
采用这样的封堵器，就可以在网状骨架的腰部穿设于间隔缺损处，上盘面和下盘面分别封堵在间隔缺损的两侧后，基于锁定件的拉紧部的远端呈辐射状固定在上盘面上，近端汇集在锁定件的锁定部上，锁定部的锁定环能进行形变，因此当对锁定环施加拉力，锁定部会带动拉紧部将上盘面向下盘面靠拢，使得上盘面和下盘面对间隔缺损周围产生一定的夹持力，当锁定环发生形变通过限位通孔远端的开口进入限位通孔后，基于锁定环的直径大于限位通孔的远端的直径，因此，当拉力消失后，锁定环将被限位于熔接尾端的限位通孔中，从而保证本公开的封堵效果，避免在封堵手术过程中因自身材料弹性不足的缺陷而容易发生脱落的问题。
附图说明
为了更清楚地说明本发明实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明一个实施例所提供的封堵器的立体图；
图2为本发明一个实施例所提供的封堵器的主视图；
图3为本发明一个实施例所提供的封堵器的俯视图；
图4为图2中网状骨架沿A-A线的剖视图；
图5为本发明一个实施例所提供的锁定件的结构示意图；
图6为图2中熔融尾端沿A-A线的剖视图；
图7为本发明一个实施例中锁定件与熔接尾端的连接示意图；
图8为本发明又一实施例中熔融尾端沿图2所示的A-A线的剖视图；
图9为本发明又一实施例中封堵器植入体内后沿图2所示A-A线的剖视图；
图10为本发明再一实施例中锁定部的结构示意图；
图11为本发明再一实施例中封堵器植入体内后沿图2所示A-A线的剖视图。
附图标记说明：
网状骨架-100；上盘面-110；腰部-120；下盘面-130；熔接尾端140；限位通孔-141；第一通孔-
1411；第二通孔-1412；显影环-142；外螺纹-143；
第一阻流膜-210；第二阻流膜-220；第三阻流膜-230；
锁定件-300；拉紧部-310；拉带-311；锁定部-320；拉丝321；锁定环322；锁定单元-3221；
间隔缺损-400。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将对本发明实施例中的技术方案进行清楚、完整地描述。需要说明的是，后述的术语是考虑到在本发明中的功能而定义的，可根据使用人员、运用人员的意图或惯例而有所不同。因此，对这种术语的定义应基于本说明书整体的内容来定义。
例如，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
此外，下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
合金材料的封堵器在手术过程中或者术后留存于患者体内均会存在发生并发症的风险，相关技术中采用可降解材料制成封堵器解决所述问题，但可降解材料的弹性较合金材料弱，在封堵手术过程中往往极易脱落而造成手术失败。
基于对上述问题的分析以及发现，提出本申请。
本申请提出一种封堵器，由可降解材料制成，包括网状骨架和锁定件；
网状骨架包括顺次成型的上盘面、腰部和下盘面，下盘面具有网状骨架的熔接尾端，熔接尾端上开设有限位通孔；
锁定件包括拉紧部和锁定部，拉紧部呈辐射状，拉紧部的扩散端与上盘面连接，拉紧部的收缩端与锁定部连接，锁定部的近端设有锁定环，锁定环的直径大于限位通孔的远端的直径，锁定环可通过形变卡设于/穿出熔接尾端的限位通孔中。
采用这样的封堵器，就可以在网状骨架的腰部穿设于间隔缺损处，上盘面和下盘面分别封堵在间隔缺损的两侧后，基于锁定件的拉紧部的远端呈辐射状固定在上盘面上，近端汇集在锁定件的锁定部上，锁定部的锁定环能进行形变，因此当对锁定环施加拉力，锁定部会带动拉紧部将上盘面向下盘面靠拢，使得上盘面和下盘面对间隔缺损周围产生一定的夹持力，当锁定环发生形变通过限位通孔远端的开口进入限位通孔后，基于锁定环的直径大于限位通孔的远端的直径，因此，当拉力消失后，锁定环将被限位于熔接尾端的限位通孔中，从而保证本公开的封堵效果，避免在封堵手术过程中因自身材料弹性不足的缺陷而容易发生脱落的问题。
为了更清楚地理解本公开实施例提供的封堵器，下面将参照附图对本发明的具体实施例进行说明，在这一过程中，附图所示的线的厚度或结构要素的大小等可以为了说明的明确性和方便而以夸张的方式示出。
实施例1
请参阅1-图6，在本公开中所述近端为靠近操作者的一端，所述远端为远离操作者的一端，示例性地，上盘面为远离操作者的一端，熔接尾端为靠近操作者的一端。本申请提出一种封堵器，请参阅图2，包括网状骨架100、阻流膜和锁定件300；网状骨架100的材质为可降解材料，示例性地，如聚乳酸、聚乙醇酸、聚对二氧环己酮或聚羟基丁酸，网状骨架100通常由仅具有一处收口的管状网结构熔接成型，请参阅图4，其包括由远端到近端顺次成型的上盘面110、腰部120和下盘面130，收口处位于下盘面130，经熔融形成熔接尾端140，熔接尾端140上开设有限位通孔141；其中，请参阅附图1-3，上盘面110的直径比腰部120的直径大6-18mm，下盘面130的直径比腰部120的直径大4-12mm，上盘面110的直径大于下盘面130的直径。熔接尾端140的表面开设有外螺纹，以增加其表面粗糙度，增加与外部推动装置的摩擦力，进一步确保输送的安全性。在熔接尾端140的侧壁上还具有环绕限位通孔141设置的显影环142。
请继续参阅图4，阻流膜为可降解材质，包括覆盖于上盘面130的内壁上的第一阻流膜210、位于腰部120横截面上的第二阻流膜220以及覆盖于下盘面130内壁上的第三阻流膜230。第一阻流膜210、第二阻流膜220和第三阻流膜230通过可降解丝与网状骨架100缝在一起，第一阻流膜210、第二阻流膜220、第三阻流膜230和可降解丝的材质可以为无定形聚乳酸、左旋聚乳酸、右旋聚乳酸、聚对二氧环己酮、聚己内酯、聚乙醇酸或聚乳酸-羟基乙酸共聚物，在本实施例中优选聚对二氧环己酮、聚己内酯、聚乙醇酸、聚乳酸-羟基乙酸共聚物或无定形聚乳酸、左旋聚乳酸和右旋聚乳酸中任意一种或两种以上共混物；阻流膜的结构为水刺无纺布、针刺无纺布、纺粘无纺布、热合无纺布、湿法无纺布或静电纺丝纤维膜；阻流膜的层数可以为2-6层。
请参阅图4和图7，锁定件300包括拉紧部310和锁定部320，拉紧部310呈辐射状，拉紧部310 包括多组可降解的拉带311，各组拉带311的近端即收缩端汇集固定于锁定部320上，各组拉带311的远端即扩散端依次穿过第三阻流膜230、第二阻流膜220和第一阻流膜210而分散固定于上盘面110上。其中，每组拉带311由若干条可降解丝，每组的拉带311中的若干条可降解丝的近端均汇集连接，每组拉带311中的若干条可降解丝的远端均汇集连接，在本实施例中，每组拉带311由两条可降解丝组成。请参阅图4-5，锁定部320由拉丝321和锁定环322构成，拉丝321的远端依次穿过第三阻流膜230、第二阻流膜220和第一阻流膜210固定于上盘面110上，拉丝321的近端绕制形成锁定环322，锁定部320的拉丝321和锁定环322上绕制有显影丝。请参阅图4和6，锁定环321的直径大于限位通孔141的远端的直径，锁定环321可通过形变卡设于/穿出熔接尾端140的限位通孔141中。
采用这样的封堵器，就可以在网状骨架100的腰部120穿设于间隔缺损400处，上盘面110和下盘面130分别封堵在间隔缺损400的两侧后，基于锁定件300的拉紧部310的远端呈辐射状固定在上盘面110上，近端汇集在锁定件300的锁定部320上，锁定部320的锁定环322能进行形变，因此当对锁定环322施加拉力，锁定部320会带动拉紧部310将上盘面110向下盘面130靠拢，使得上盘面110和下盘面130对间隔缺损400周围产生一定的夹持力，当锁定环322发生形变通过限位通孔141远端的开口进入限位通孔141后，基于锁定环322的直径大于限位通孔141的远端的直径，因此，当拉力消失后，锁定环322将被限位于熔接尾端140的限位通孔141中，从而保证本公开的封堵效果，避免在封堵手术过程中因自身材料弹性不足的缺陷而容易发生脱落的问题。另外，锁定部320的拉丝321和锁定环322上绕制有显影丝，熔接尾端140嵌入了显影环142，因此，在手术影像过程中，拉动锁定环322会经过显影环142，因此，便可清晰的判断封堵过程是否锁紧可视化操作，极大的增加了手术的效率。
相关技术中，封堵器仅适用于某一类手术环境，并不能在不同类型的手术环境中均能很好的封堵在病例位置，为了进一步提高本公开的通用性和封堵效果，本申请提出以下技术方案。
实施例2
请参阅图5，在本实施例中，锁定环322为可降解的拉丝321绕制的弹簧圈，同事拉丝321和锁定环322上还绕制有显影丝，锁定环322具有中心圈，此结构使锁定环322具有弹性形变的空间。
请参阅图8，熔接尾端140的成型工艺为可降解丝材热熔成型后与网状骨架100形成一个整体；其中限位通孔141包括若干个串联连通的第一通孔1411，第一通孔1411的远端的开口直径小于锁定环322的直径，第一通孔1411近端的开口直径大于锁定环322的直径，例如，第一通孔1411的纵剖面可以为梯形，则限位通孔141为由N个梯形小孔连接而成的通孔。
图9为本实施例中封堵器植入体内后沿图2所示的A-A线处的剖视图，其中400为心脏机体组织间隔缺损。当封堵器从鞘管里释放出来后，通过拉动锁定环322，由于锁定环322的外径大于第一通孔1411远端开口的直径，小于第一通孔1411近端开口的直径，同时基于锁定环322上中心圈的结构，在一定作用拉力的情况下，锁定环322能通过第一通孔1411，使得上盘面110和下盘面120对间隔缺损400周围产生一定的夹持力，当锁定环322拉入到不同的第一通孔1411中时，拉丝321的节距会发生变化，从而带动拉紧部310使得上盘面110和下盘面120之间的距离缩小，使得对间隔缺损400周围的夹持力度增加，以此实现对不同厚度的间隔缺损400可采用不同的锁紧位置，使得封堵更加有效。
另外限位通孔141还包括与近端的第一通孔1411连通的第二通孔1412，第二通孔1412远端的开 口直径等于第二通孔1412近端的开口直径。通俗地可理解为第二通孔1412为直径等于第一通孔1411远端直径的柱形孔，如此设置，由于第二通孔1412的直径大于锁定环322的最大外径，因此，在最终的锁紧状态下，也能保证锁定环322限位于熔接尾端140内，这样更有助与后期的封堵器的内皮化。
实施例3
请参阅图10-11，在本实施例中，与实施例2不同的是，限位通孔141的远端的开口直径小于近端的开口直径，例如为梯形孔，锁定环322包括若干个串联而成的锁定环单元3221，各个锁定单元3221可逐个通过形变从限位通孔141远端的开口进入/穿出限位通孔141中。当然限位通孔141可以包括串联的第一通孔1411和第二通孔1412，第一通孔1411为梯形孔，第二通孔1412为柱形孔，第二通孔1412的直径大于锁定单元3221的最大外径，因此，在最终的锁紧状态下，也能保证锁定单元3221限位于熔接尾端140内，这样更有助与后期的封堵器的内皮化。
需要说明的是，间隔缺损主要是指房间隔缺损或心室隔缺损，房间隔缺损是指左右心房之间存在异常通道，正常的解剖结构破坏，导致血液可以从缺血部位到达另一侧心房。室间隔缺损是指左心室和右心室之间存在异常通道，原有的正常解剖结构破坏，由于两侧心室之间的压力较大，血液可以由一侧流向另一侧，早期主要以左侧向右侧分流为主，发展到后期可能会出现右向左分流，左向右分流和双向分流的状况下。机体组织为构成生物体的组织。
以上所述仅为本发明的较佳实施例，并不用以限制本发明的保护范围，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (14)

  1. 一种封堵器，其特征在于，由可降解材料制成，包括网状骨架和锁定件；
    所述网状骨架包括顺次成型的上盘面、腰部和下盘面，所述下盘面具有所述网状骨架的熔接尾端，所述熔接尾端上开设有限位通孔；
    所述锁定件包括拉紧部和锁定部，所述拉紧部呈辐射状，所述拉紧部的扩散端与所述上盘面连接，所述拉紧部的收缩端与所述锁定部连接，所述锁定部的近端设有锁定环，所述锁定环的直径大于所述限位通孔的远端的直径，所述锁定环可通过形变卡设于/穿出所述熔接尾端的所述限位通孔中。
  2. 根据权利要求1所述的封堵器，其特征在于，所述限位通孔包括若干个串联连通的第一通孔，所述第一通孔的远端的开口直径小于所述锁定环的直径，所述第一通孔近端的开口直径大于所述锁定环的直径。
  3. 根据前述任一权利要求所述的封堵器，其特征在于，所述第一通孔的纵剖面呈梯形。
  4. 根据前述任一权利要求所述的封堵器，其特征在于，所述限位通孔还包括与近端的第一通孔连通的第二通孔，所述第二通孔远端的开口直径等于所述第二通孔近端的开口直径。
  5. 根据前述任一权利要求所述的封堵器，其特征在于，所述锁定部还包括拉丝，所述拉丝的远端固定于所述上盘面上，所述拉丝的近端绕制形成所述锁定环。
  6. 根据前述任一权利要求所述的封堵器，其特征在于，所述限位通孔的远端的开口直径小于近端的开口直径，所述锁定环包括若干个串联而成的锁定环单元，各个所述锁定单元可逐个通过形变从所述限位通孔远端的开口进入和/或穿出所述限位通孔中。
  7. 根据前述任一权利要求所述的封堵器，其特征在于，所述拉丝由可降解材质制成，所述拉丝上绕制有显影丝。
  8. 根据前述任一权利要求所述的封堵器，其特征在于，所述熔接尾端的表面开设有外螺纹，所述封堵器通过所述外螺纹与外部推动装置连接。
  9. 根据前述任一权利要求所述的封堵器，其特征在于，所述熔接尾端的侧壁上还具有环绕所述限位通孔设置的显影环。
  10. 根据前述任一权利要求所述的封堵器，其特征在于，所述封堵器还包括阻流膜，所述阻流膜为可降解材质，包括覆盖于所述上盘面的内壁上的第一阻流膜、位于所述腰部横截面上的第二阻流膜以及覆盖于所述下盘面内壁上的第三阻流膜。
  11. 根据前述任一权利要求所述的封堵器，其特征在于，所述拉紧部包括多组可降解的拉带，各组所述拉带的近端汇集固定于所述锁定部上，各组所述拉带的远端依次穿过所述第三阻流膜、第二阻流膜和第一阻流膜而分散固定于所述上盘面上。
  12. 根据前述任一权利要求所述的封堵器，其特征在于，每组所述拉带由若干条可降解丝组成。
  13. 根据前述任一权利要求所述的封堵器，其特征在于，所述网状骨架的所述腰部能穿设于机体组织的间隔缺损处；当所述锁定环被限位于熔接尾端的所述限位通孔中时，所述锁定部带动所述拉紧部将所述上盘面向所述下盘面靠拢，使得所述上盘面和所述下盘面对所述间隔缺损周围产生夹持力以让所述封堵器封堵所述间隔缺损。
  14. 前述任一权利要求所述的封堵器，其特征在于，所述锁定环可通过形变进入所述限位通孔中并 卡设于所述限位通孔中。
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