WO2018184438A1 - 封堵器及封堵装置 - Google Patents

封堵器及封堵装置 Download PDF

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Publication number
WO2018184438A1
WO2018184438A1 PCT/CN2018/078276 CN2018078276W WO2018184438A1 WO 2018184438 A1 WO2018184438 A1 WO 2018184438A1 CN 2018078276 W CN2018078276 W CN 2018078276W WO 2018184438 A1 WO2018184438 A1 WO 2018184438A1
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WO
WIPO (PCT)
Prior art keywords
locking
locking member
occluder
locking hole
proximal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2018/078276
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English (en)
French (fr)
Inventor
陈贤淼
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to EP18781056.9A priority Critical patent/EP3607887A4/en
Priority to US16/493,985 priority patent/US11311281B2/en
Publication of WO2018184438A1 publication Critical patent/WO2018184438A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • 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
    • 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
    • A61B2017/00619—Locking means for locking the implement in expanded state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to an interventional medical device, in particular to an occluder and a occlusion device for interventional treatment of congenital heart disease.
  • Percutaneous interventional techniques are rapidly developing treatments for diseases in recent years, and the field of application of this technology is becoming more widespread.
  • catheter interventional therapy can be used to place a variety of materials, instruments and drugs into the heart, arteries and veins of the human body.
  • the device may be a cardiac defect occluder, a blood vessel plug, a vascular filter, or the like.
  • Transcatheter interventional occluder is a commonly used device in transcatheter interventional therapy. It can be used for minimally invasive treatment of congenital heart disease such as atrial septal defect, ventricular septal defect, patent ductus arteriosus and patent foramen ovale.
  • the occluder of the prior art generally comprises a occluding body having two occluding units for covering the tissue of the two side walls of the defect site.
  • memory metal or polymer materials are often used to prepare the plugging unit.
  • the memory metal may fail during use, and the polymer material has low elasticity or inelasticity, which will result in between the two blocking units.
  • the contraction force is insufficient, and the two sides of the defect site cannot be closely attached to affect the sealing effect. Therefore, the occluder needs an effective restraining structure to keep the distance between the two blocking units (ie, the waist height of the occluder) stable. Ensure the reliability of the plugging.
  • the technical problem to be solved by the present invention is to provide an occluder and a occlusion device having a locking function in view of the deficiencies of the prior art.
  • the meshing body includes a cavity having a cavity and a proximal plug, the proximal plug having a locking hole therethrough, the occluder further comprising a locking member located in the cavity a distal end of the locking member is in contact with a distal end of the blocking body, the locking member is an elastic member, and the locking member includes a connecting portion connected to the blocking body and is adjacent to the connecting portion a first bent portion connected to the end, a joint of the connecting portion and the first bent portion has a first bending angle, and a cross section of the first bent portion perpendicular to a length thereof a diameter of the circumscribed circle of the projection is smaller than a diameter of a minimum inscribed circle of the locking hole, and a projection width of the first bending portion on a plane perpendicular to a longitudinal central axis direction of the locking hole is larger than the locking hole The diameter of the largest inscribed circle.
  • a mesh-shaped blocking body and a proximal plug are provided, wherein the proximal plug has a locking hole penetrating the cavity, and the occluder Also included is a locking member located within the cavity, a distal end of the locking member abutting a distal end of the occluding body, the locking member being an elastic member, the locking member including the occluding body a connecting portion and a plurality of end-to-end bending portions, the proximal end of the plurality of end-to-end bending portions being connected to the proximal end of the connecting portion, and the connecting portion is closest to the connecting portion Having a first angle of bend between the folds, a diameter of a circumscribed circle of each of the bends in a cross section perpendicular to the length thereof is smaller than a diameter of a minimum inscribed circle of the lock hole, The projection width of the plurality of end-to-end bent portions on a plane perpendicular
  • a projection width of the bent portion closest to the connecting portion on a plane perpendicular to a longitudinal central axis direction of the locking hole is larger than a diameter of a maximum inscribed circle of the locking hole.
  • the bent portion closest to the connecting portion is a first bent portion from the first bending portion
  • the most recent bent portion is a second bent portion
  • the second bent portion and the first bent portion have a second bending angle
  • the first bending angle is equal to the The second bend angle
  • the angle of the first bending angle ranges from 120 degrees to 175 degrees.
  • the proximal end of the locking member is provided with a threaded hole that communicates with the outside.
  • the threaded hole is coaxial with the bent portion.
  • the locking member in the occluder, is a hollow tubular structure, and the threaded hole communicates with the inner cavity of the locking member.
  • the proximal end of the locking member is provided with rounded corners.
  • the proximal plug is provided with an external thread.
  • the distal end of the locking hole is provided with a transition zone, and the distal end of the transition zone is larger than the proximal aperture of the transition zone.
  • the material of the plugging body is made of a polymer material that is biocompatible with the human body.
  • a occlusion device comprising: the occlusion device according to claim 1, a hollow delivery mechanism at least distally open, a lock for connecting the delivery mechanism and the occluder And a traction member movably received in the conveying mechanism, the distal end of the traction member being detachably connected to the proximal end of the bending portion of the locking member after passing through the distal end of the conveying mechanism.
  • the locking device has a proximal end portion provided with a threaded hole communicating with the outside, and a distal end of the pulling member is provided to cooperate with the threaded hole of the locking member. External thread.
  • the lock device includes a hollow first connector and a second connector connected to the proximal end of the first connector, the first connector is configured There is an internal thread that cooperates with the external thread of the proximal plug of the occluder, and the second connector is sleeved on the outer wall of the transport mechanism.
  • the locking process can be completed by using the locking member and the proximal bolt having the locking hole, and the structure is simple, and the locking operation is simplified.
  • the locking member of the present invention has elasticity, and the locking member includes a connecting portion and the first bent portion, and the connecting portion and the first bent portion have a bending angle.
  • the invention only needs to control the projection width of the first bending portion on a plane perpendicular to the longitudinal central axis direction of the locking hole to be larger than the maximum inscribed circle of the locking hole.
  • a diameter, and a diameter of the circumcircle that controls the projection of the first bent portion in a cross section perpendicular to the longitudinal direction thereof is smaller than a diameter of the smallest inscribed circle of the locking hole, and the first bent portion is along the locking hole
  • the projection width on the plane perpendicular to the longitudinal central axis direction is mainly determined by the angle of the bending. Therefore, it is not necessary to control the dimensional accuracy between the locking member and the locking hole in the micrometer level, and only the angle of the bending angle needs to be controlled.
  • the locking member can be set relatively smaller, and a certain size can be reserved, which can effectively prevent the polymer material from swelling and causing the size thereof to change, thereby causing the sealing. You can not be locked. Therefore, the structure of the invention is simple, the size of the locking member is easy to control, the processing is convenient, the preparation process and the locking operation are simplified, and the locking reliability of the locking member is high, the failure is not easy, and the locking operation process is reversible, and the locking process and the recycling process are simple and easy. .
  • the locking member of the invention is generally bent and tubular, and the dimensions of the respective parts are matched to effectively reduce the size of the locking member, and prevent the shrinkage rebound of the occluder due to the excessive size of a certain portion of the locking member.
  • the traction member is detachably connected with the locking member of the occluder, and the traction member can conveniently control the connection or the disconnection, thereby improving the operability of the connection between the traction member and the occluder, and the connection can be disconnected and evacuated after the locking is completed, thereby reducing Residual in the body; at the same time, the traction member does not need to pass through the distal end of the occluder, which can avoid damage to the heart tissue, reduce the time of sealing operation and improve the operation efficiency.
  • the locking member is only fixed to the distal end of the blocking body, and the locking member is disposed in the same direction as the sheath tube, the structure and the fixing manner of the locking member do not affect the deformation of the occluder in the delivery sheath tube and the defect portion after being pushed into position.
  • the sealing, the size of the sheath only needs to match the size of the occluder, no need to increase the size of the sheath, which is conducive to surgical operation.
  • FIG. 1 is a schematic structural view of an occluder according to Embodiment 1 of the present invention.
  • FIG. 2 is a schematic view showing a locked state of an occluder according to Embodiment 1 of the present invention
  • Figure 3 is a partial structural view of the locking member of the occluder of Figure 2 when locked with the proximal end plug;
  • Figure 4 is a schematic view showing the structure of the locking hole of the occluder of Figure 1;
  • Figure 5 is a schematic structural view of an occluder according to Embodiment 2 of the present invention.
  • Figure 6 is a schematic structural view of the locking member of the occluder of Figure 5;
  • FIG. 7 is a schematic structural view of a occlusion device according to Embodiment 3 of the present invention.
  • Figure 8 is a schematic structural view of the lock sleeve of the occlusion device of Figure 7;
  • Figure 9 is a schematic view showing the occlusion device in the sheath tube according to Embodiment 3 of the present invention.
  • Figure 10 is a schematic view of the occlusion device of Figure 9 pushing the sheath
  • Figure 11 is a schematic view showing the release of the occluder portion of Figure 10;
  • Figure 12 is a schematic view of the occluder of Figure 11 released to the defect site but not locked;
  • Figure 13 is a schematic view of the occluder of Figure 12 in a locked state.
  • distal and near end are used as the orientation words, which are the conventional terms in the field of interventional medical devices, wherein “distal” means the end away from the operator during the operation, "Proximal” means the end that is close to the operator during the procedure.
  • the axial direction refers to a direction parallel to the center of the distal end of the medical device and the proximal end; the radial direction refers to a direction perpendicular to the axial direction.
  • the occluder 100 includes a meshing body 1 having a cavity 103 and a proximal plug 2 and a distal end 3 .
  • the proximal plug 2 is fixedly coupled to the proximal end of the blocking body 1 .
  • the distal head 3 is fixedly connected to the distal end of the blocking body 1.
  • the plugging body 1 comprises two first blocking units 101 and two blocking units 102 of a disk-like structure, and the two blocking units 101 and 102 are connected to form a "work" shape.
  • the occluder 100 also includes a locking member 14 located within the cavity 103.
  • the distal end of the locking member 14 is coupled to the distal end of the blocking body 1.
  • the proximal plug 2 has a locking aperture 15 that extends into the cavity 103.
  • the locking hole 15 is disposed coaxially with the proximal plug 2 .
  • the structure of the plugging body 1 is for example only and is not intended to limit the invention, and one of ordinary skill in the art can select any suitable plug body 1 structure under the teachings of the present invention.
  • the mesh structure is easy to be deformed, and the occluder 100 can effectively compress the income into the sheath during the transportation process, and is also convenient to form two disc-like structures for facilitating the sealing of the defect when the sheath is pushed to the defect site.
  • the locking member 14 includes a connecting portion 141 and a first bent portion 142 connected to the proximal end of the connecting portion 141.
  • the connecting portion 141 and the first bent portion 142 have a predetermined bending angle A.
  • the locking member 14 is an elastic member that can be elastically deformed by an external force, that is, under the action of an external force, the first bending angle A between the connecting portion 141 and the first bending portion 142 can be changed, and After the external force disappears, the first bending angle A between the connecting portion 141 and the first bending portion 142 is restored to the original angle.
  • the diameter of the circumscribed circle of the projection of the first bent portion 142 in a cross section perpendicular to the longitudinal direction thereof is smaller than the diameter of the minimum inscribed circle of the locking hole 15.
  • the locking member 14 is a columnar structure having a circular cross section.
  • the outer diameter d of the first bending portion 142 is the first bending portion 142.
  • the locking hole 15 is a cylindrical hole in the embodiment, and the maximum inscribed circle diameter of the locking hole 15 is equal to the minimum inscribed circle diameter, and the locking hole 15 is The inner diameter D is its largest inscribed circle diameter and its smallest inscribed circle diameter.
  • the proximal end of the first bent portion 142 can be inserted into the locking hole 15 and passed out from the proximal end of the locking hole 15.
  • a projection width of the first bent portion 142 on a plane perpendicular to a longitudinal central axis direction of the locking hole 15 is larger than a diameter of a maximum inscribed circle of the locking hole 15.
  • the projection width refers to the distance between the two points which are the farthest from each other on the projection of the first bent portion 142 on the plane perpendicular to the longitudinal central axis of the locking hole 15.
  • the projection width of the first bending portion 142 on a plane perpendicular to the longitudinal central axis direction of the locking hole 15 is D1, and after the first bending portion 142 is worn out, without being subjected to an external force, Locking is achieved between the locking member 14 and the locking aperture 15.
  • the locking hole 15 can also be a conical hole, a gourd-shaped hole, a quadrangular prism hole or the like, as long as the diameter of the smallest inscribed circle of the locking hole 15 is larger than the first bending portion 142 is vertical. a diameter of a circumscribed circle projected on a cross section in a longitudinal direction thereof, and a projection width of the first bent portion 142 on a plane perpendicular to a longitudinal central axis direction of the locking hole 15 is larger than the locking hole 15 The diameter of the largest inscribed circle can be.
  • the occluder 100 includes a natural state and a locked state, wherein, in the natural state, that is, in a state free from external force, as shown in FIG. 1, the first blocking unit 101 and the second of the occluder 100 The blocking unit 102 is far away, and the proximal end of the locking member 14 is not inserted into the locking hole 15.
  • the outer diameter d of the first bent portion 142 of the locking member 14 is smaller than the inner diameter D of the locking hole 15, and preferably, the overall width of the locking member 14 is kept uniform.
  • the locking member 14 drives the distal end of the blocking body 1.
  • the end moves toward the proximal plug 2, and since the outer diameter d of the first bent portion 142 is smaller than the inner diameter D of the locking hole 15, the proximal end of the first bent portion 142 can be inserted into the locking hole 15, with the locking member 14
  • the first bent portion 142 of the locking member 14 acts strongly with the inner wall of the locking hole 15, and under the squeezing action of the inner wall of the locking hole 15, the first bent portion 142 is bent, so that the first bending
  • the angle A becomes larger such that the projection D1 of the first bent portion 142 on a plane perpendicular to the longitudinal central axis of the locking hole 15 is smaller than or equal to the inner diameter D of the locking hole 15, and the first bent portion 142 can continue to be inserted and locked.
  • the first bending angle A is continuously reduced, when the yoke is locked
  • the width D1 of the first bent portion 142 on a plane perpendicular to the longitudinal central axis of the locking hole 15 is larger than the inner diameter D of the locking hole 15, the first bent portion 142
  • the side surface abuts against the proximal end surface of the locking hole 15, so that the locking member 14 cannot move to the distal end, and the locking of the locking member 14 is completed, so that the two blocking units 101 and 102 cannot rebound under their own elasticity, and continue to be maintained. In a state of being close to each other.
  • the external force of the pulling lock member may be a proximally-oriented traction force applied by the doctor to the locking member 14.
  • the first blocking unit 101 and the second blocking unit 102 of the blocking body 1 are at a constant distance (ie, the body is sealed).
  • the waist height is constant).
  • the respective components of the occluder 100 are of a preferred size. Specifically, since the occluder 100 is delivered to the body by intervention, the size of the proximal plug 2 of the occluder 100 cannot be excessively large, thereby limiting the inner diameter D of the locking hole 15, see FIG. 3, locking The inner diameter D of the hole 15 ranges from 0.5 to 3 mm, and the first bending angle A between the connecting portion 141 of the locking member 14 and the first bending portion 142 is 120 to 175 degrees, and the locking member 14 The length L of the first bent portion 142 ranges from 0.5 to 3 mm.
  • the outer diameter d of the connecting portion 141 and the first bent portion 142 is smaller than the inner diameter D of the locking hole 15, wherein the connecting portion 141 is equal to the outer diameter d of the first bent portion 142 and the ratio of the inner diameter D of the locking hole 15 It is 0.5-0.95. If the ratio of the outer diameter d of the first bent portion 142 to the inner diameter D of the locking hole 15 is too small, the locking may be unreliable. If the ratio of the outer diameter d of the first bent portion 142 to the inner diameter D of the locking hole 15 is too large, It may be difficult to cause the first bent portion 142 to enter the locking hole 15.
  • the width D1 of the projection of the first bent portion 142 on a plane perpendicular to the longitudinal central axis of the locking hole 15 is larger than the inner diameter D of the locking hole 15, such that when the first bent portion 142 passes through the locking hole 15, the locking member 14
  • the connecting portion 141 can be smoothly located in the locking hole 15, and the occluder 100 can also coordinately deform to adapt to the heart beat during the beating, that is, during the beating of the heart, since the width of the connecting portion 141 is smaller than the locking hole
  • the inner diameter D of 15, the connecting portion 141 can still move toward the proximal end of the occluder 100, so that the first occluding unit 100 and the second occluding unit 101 of the occluder 100 can still act under pressure as the heart beats.
  • the continuation is continued, so that the occluder 100 can coordinately deform as the heart beats.
  • the locking function of the occluder 100 is mainly achieved by a locking member 14 provided in the cavity 103 of the blocking body 1 and a locking hole 15 provided in the proximal plug 2.
  • the locking member 14 can be made of a metal material or a polymer material having biocompatibility with the human body.
  • the distal end of the locking member 14 is in contact with the distal end of the blocking body 1. Under the traction of an external force (e.g., the pulling force of the traction member), the locking member 14 can move the distal end of the blocking body 1 toward the proximal end.
  • FIG. 1 shows the natural state in which the occluder 100 is unlocked
  • FIG. 2 shows the state in which the occlusion device 100 locks the defect portion 18 after being locked.
  • the mesh structure of the plug body 1 can be made by a memory alloy material or a polymer material by braiding, pipe cutting, injection molding or the like.
  • the memory alloy material includes nickel-titanium alloy; the polymer material has good biocompatibility, and compared with the metal material, the polymer material can avoid the problem caused by the release of the metal element in the body, and the material with good biocompatibility can be Effectively reduce infection at the site of closure.
  • the plugging body 1 of the present invention can be woven by a degradable polymer filament, and the degradable polymer filament can be selected from polyethylene terephthalate (PET) and polylactic acid (PLA: Poly-L).
  • the distal end of the blocking body 1 is further provided with a distal end cap 3, and the locking member 14 is connected to the distal end cap 3; it can be understood that, in other embodiments, the blocking body 1 is blocked.
  • the distal end can also be used without a head structure.
  • the locking member 14 can be directly coupled to the distal end of the occluding body 1.
  • the braided wire is used to form the mesh body of the plug body 1
  • the distal end cap 3 and the proximal plug 2 can be respectively disposed at the distal end and the proximal end to receive and fix the ends of the braided wire forming the mesh structure.
  • the shape and structure of the distal end cap 3 and the proximal plug head 2 are not particularly limited.
  • the distal end cap 3 is a camber body
  • the proximal plug head 2 is a columnar structure.
  • polymer materials Compared with traditional memory alloys (such as nickel-titanium alloy), polymer materials have lower elastic modulus and smaller elastic range. Memory alloys may fail due to fatigue during long-term use and cannot effectively block defective parts. Both of the above may make the occluding body 1 not well maintain its predetermined shape after being shaped. At this time, it is necessary to improve the molding performance of the occluder 100 in the human body through the locking structure.
  • the locking structure 14 and the locking hole 15 are respectively designed according to the present invention.
  • the locking structure is applicable not only to the blocking body 1 of the polymer material, but also to the occluder 100 of other materials.
  • the dimensional accuracy of the locking member is very high, and usually requires an accuracy of about 1 micrometer. For metal materials, this precision is difficult to achieve, and the polymer is difficult to achieve. In terms of materials, this dimensional accuracy is more difficult to control.
  • the locking member and the proximal plug which are prepared from the polymer material are exposed to water during the cleaning process, and are exposed to blood during the operation, in which the polymer material swells due to water absorption or Due to the adsorption of biomolecules in the blood, the dimensional accuracy of the polymer components is affected, thereby affecting the locking function, that is, the interference fit is difficult to achieve due to subtle changes in size, which may eventually lead to surgical failure.
  • the locking process can be completed by using the locking member and the proximal bolt having the locking hole, and the structure is simple, and the locking operation is simplified.
  • the locking member of the present invention has elasticity, and the locking member includes a connecting portion and the first bent portion, and the connecting portion and the first bent portion have a bending angle.
  • the invention only needs to control the projection width of the first bending portion on a plane perpendicular to the longitudinal central axis direction of the locking hole to be larger than the maximum inscribed circle of the locking hole.
  • a diameter, and a diameter of the circumcircle that controls the projection of the first bent portion in a cross section perpendicular to the longitudinal direction thereof is smaller than a diameter of the smallest inscribed circle of the locking hole, and the first bent portion is along the locking hole
  • the projection width on the plane perpendicular to the longitudinal central axis direction is mainly determined by the angle of the bending. Therefore, it is not necessary to control the dimensional accuracy between the locking member and the locking hole in the micrometer level, and it is only necessary to control the angle of the bending angle.
  • the locking member can be set relatively smaller, and a certain size can be reserved, which can effectively prevent the polymer material from swelling and causing the size thereof to change, thereby causing the sealing.
  • the device cannot be locked. Therefore, the structure of the invention is simple, the size of the locking member is easy to control, the processing is convenient, the preparation process and the locking operation are simplified, and the locking reliability of the locking member is high, the failure is not easy, and the locking operation process is reversible, and the locking process and the recycling process are simple and easy. .
  • a threaded hole 145 may be disposed at a proximal end of the first bent portion 142 of the locking member 14. In the embodiment, the threaded hole 145 is disposed coaxially with the first bent portion 142, and the coaxially disposed threaded hole 145 may be easier. Connected to the push mechanism.
  • the locking member 14 can also adopt a hollow tubular design.
  • an internal thread is provided on the inner wall of the hollow tubular locking member 14 having a predetermined size, and is bent into a preset. The angle is thereby formed to form the connecting portion 141 and the first bent portion 142.
  • the machining process can be simplified, while the hollow tubular locking member 14 easily controls the coaxiality between the threaded hole and the first bent portion 142, making the locking member 14 easier to pull or push with the traction device. Device connection.
  • no thread can be disposed at the proximal end of the locking member 14, and the locking member 14 can also be detachably connected to the pulling device or the pushing device by means of a buckle.
  • connection between the locking member 14 and the traction device or the pushing device can be other connection manners, which are not enumerated here, as long as the detachable connection between the locking member 14 and the pusher or the pushing device can be ensured. Just fine.
  • the proximal end of the first bend 142 of the locking member 14 adds a fillet 1421.
  • the rounded corner 1421 refers to a circular arc transition between the proximal end surface of the first bent portion 142 and the sidewall of the first bent portion 142, and the outer diameter of the proximal end surface is smaller than the outer side wall of the first bent portion 142. path.
  • the locking hole 15 is provided near the distal end thereof with a hollow transition zone 16 which gradually increases in length from the proximal end to the distal end and communicates with the locking hole 15. Since the proximal end portion of the first bent portion 142 is provided with the rounded corner 1421, it is more easily inserted into the tapered transition portion 16 having a larger opening to enter the locking hole 15.
  • the entirety of the transition zone 16 can be similar to a conical or flared shape, with the proximal radial extent of the transition zone 16 being less than the distal radial extent, it being understood that in other embodiments, the transition zone 16 can also resemble a trapezoidal shape. Alternatively, in other embodiments, when the radial length of the locking member 14 and the locking hole 15 are large, the transition region may not be provided.
  • the proximal edge of the transition zone 16 is provided with a circular chamfer 161 that can be mated with the fillet 1421 on the locking member 14 when locked When the piece 14 is moved proximally under external force traction, the circular chamfer 161 can prevent the proximal end edge of the transition zone 16 from collapsing with the proximal end of the locking member 14, enabling the locking member 14 to be more easily inserted into the locking hole 15.
  • another embodiment of the present invention further provides an occluder 100a.
  • the occluder 100a is substantially the same as the occluder 100 provided by the first embodiment, except that in the embodiment, the occlusion device is blocked.
  • the locking piece 14a of the device 100a includes a connecting portion 141a, a first bent portion 142a, and a second bent portion 143a.
  • the proximal end of the connecting portion 141a is connected to the distal end of the first bent portion 142a, and the proximal end of the first bent portion 142a is connected to the distal end of the second bent portion 143a.
  • the first bending portion 142a and the connecting portion 141a have a first bending angle A1, and the first bending portion 142a and the second bending portion 143a have a second bending angle.
  • the first bending angle A1 is the same as the second bending angle A2, and the purpose is to ensure that the connecting portion 141a and the first portion are the same when the first bending angle A1 and the second bending angle A2 are the same size.
  • the two-folded portion 143a is maintained in a parallel state, so that the direction of the force of the locking member 14a can be kept constant during the pulling process by the external force, and the locking member 14a is more conveniently connected with the traction device, and the locking can be ensured.
  • the proximal end of the piece 14a is more easily inserted into the locking hole 15a.
  • the first bending angle A1 may also be different from the second bending angle A2, as long as the first bending portion 142a and the second bending portion 143a are integrally formed along the locking hole.
  • the projection width on the plane perpendicular to the longitudinal central axis direction of 15a may be larger than the inner diameter of the locking hole 15a.
  • the projection of the second bent portion 143a on a plane perpendicular to the longitudinal central axis direction of the locking hole 15a may partially or completely fall into the first folding In the projection of the curved portion 142a on a plane perpendicular to the longitudinal central axis direction of the locking hole 15a, when the first bending angle A1 is equal to the second bending angle A2, the second bent portion 143a is along the locking hole 15a
  • the projections on the vertical plane of the longitudinal central axis direction may all fall into the projection of the first bent portion 142a on a plane perpendicular to the longitudinal central axis direction of the locking hole 15a.
  • the locking member may also be provided with a plurality of bending portions, each of the bending portions is similar in shape to the first bending portion or the second bending portion, and the plurality of bending portions are connected end to end.
  • a proximal end of the plurality of end-to-end bending portions is connected to the distal end of the connecting portion, and the connecting portion has a first bending angle between the bent portion closest to the connecting portion, and each bent portion is perpendicular to the length thereof
  • the diameter of the projected circumscribed circle on the upper cross section is smaller than the diameter of the smallest inscribed circle of the locking hole, and the projection of the plurality of end-to-end connected bends on the plane perpendicular to the longitudinal central axis direction of the locking hole
  • the width is greater than the diameter of the largest inscribed circle of the locking aperture.
  • the projection width of the bent portion closest to the connecting portion on a plane perpendicular to the longitudinal central axis direction of the locking hole is larger than the diameter of the largest inscribed circle of the locking hole.
  • another embodiment of the present invention further provides a occlusion device 300b.
  • the occlusion device 300b of the present embodiment includes the occluder 100b, at least A hollow conveying mechanism 200b having an open end, a lock sleeve 6b for connecting the transport mechanism 200b and the occluder 100b, and a movable tractor 4b accommodated in the transport mechanism 200b.
  • the distal end of the traction member 4b extends through the distal end of the delivery mechanism 200b and is detachably connectable in the cavity with the proximal end of the locking member 14b; the traction member 4b can be pulled by an external force applied by a surgeon such as a doctor to the proximal end.
  • the locking member 14b causes the distal end of the occluder 100b to move toward the proximal end until the proximal end of the locking member 14b passes through the locking hole 15b and is pressed against the locking occluder 100b on the end face of the proximal plug 2b.
  • the locking sleeve 6b is used for connecting the conveying mechanism 200b and the proximal plug 2b of the occluder 100b.
  • the locking sleeve 6b includes a first connecting head 61b and a second connecting head 62b connected to each other, and the first connecting head
  • the proximal end of 61b is coupled to the distal end of second connector 62b.
  • the first connector 61b and the second connector 62b are both hollow and connected to each other.
  • the first connector 61b and the second connector 62b are both in a cylindrical shape, wherein the inner diameter of the first connector 61b is larger than the second connector.
  • the inner diameter of the head 62b is used for connecting the conveying mechanism 200b and the proximal plug 2b of the occluder 100b.
  • the locking sleeve 6b includes a first connecting head 61b and a second connecting head 62b connected to each other, and the first connecting head
  • An internal thread 611b for engaging the external thread of the proximal plug 2b of the occluder 100b is provided on the inner surface of the first coupling head 61b.
  • the second connector 62b is first sleeved on the distal end of the delivery mechanism 200b by laser welding, and the first connector 61b is sleeved on the proximal plug 2b of the occluder 100b, and the screwing mechanism is rotated. 200b, the lock sleeve 6b can be fastened to the proximal plug 2b.
  • the locking process is completed by the locking member 14b and the proximal plug 2b having the locking hole 15b.
  • the locking member 14b has a rod shape and the like, and has a bending angle, and the locking structure is simple, and no complicated process is required. The mechanical structure and mating relationship simplify the preparation process and locking operation. Further, by elastic deformation, the proximal end of the locking member 14b passes through the locking hole 15b and is exposed from the locking hole 15b, and then the top end portion of the locking hole 15b is aligned with the locking end portion, so that the locking reliability is high and the failure is not easy.
  • FIGS 9 through 13 illustrate the process by which the occluder 100b cooperates with the delivery mechanism 200b for delivery, release, and locking.
  • the occluder 100b and the delivery mechanism 200b are first joined together by a locking sleeve 6b that is threadedly coupled to the proximal plug 2b and that is received within the sheath 30b.
  • the distal end of the traction member 4b and the locking member 14b are screwed.
  • the traction member 4b is disposed along the axial direction of the sheath 30b, and does not constrain the free deformation of the occluder 100b.
  • the occluder 100b is pushed to the heart defect portion 18b, and the traction member 4b is pulled toward the proximal end, so that the two disc-shaped structures of the occluder 100b gradually come together to form a "work" shape, and the state shown in Fig. 7 is formed.
  • the specific process is as follows:
  • the locking member 14b Under the traction of the traction member 4b, the locking member 14b abuts against the locking hole 15b of the proximal plug 2b, due to the force between the inner wall of the proximal plug 2b and the second bent portion 143b of the locking member 14b, The proximal end of the locking member 14b is inserted into the locking hole 15b, and the second bent portion 143b of the locking member 14b and the first bent portion 142b strongly interact with the inner wall of the locking hole 15b, and the pressing action on the inner wall of the locking hole 15b
  • the first bending portion 142b and the second bending portion 143b are bent, so that the first bending angle A1 and the second bending angle A2 become larger, and the first bending portion 142b and the second bending portion 143b
  • the projection width on the plane perpendicular to the longitudinal central axis direction of the locking hole 15b is smaller than the inner diameter of the locking hole 15b, and the locking member 14b can continue to be
  • the occluder 100b further includes a unlocked state, and the traction member 4b can be axially operated before the connection of the unreleased traction member 4b and the locking member 14b is connected.
  • the traction member 4b is moved distally until the locking member 14b returns into the cavity of the occluder 100b through the locking hole 15b, and the occluder 100b is returned from the state of FIG. 13 to the state of FIG. 11, and the locking is released;
  • the delivery tube 5b can be further pulled to the proximal end, and the occluder 100b can be returned into the sheath tube 30b to realize the recovery occluder 100b.

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Abstract

一种封堵器(100,100a,100b)及封堵装置(300b)，包括网状带有空腔(103,103a)的封堵本体(1,1a)和近端栓头(2,2a,2b)，近端栓头(2,2a,2b)具有与空腔(103,103a)贯通的锁定孔(15,15a,15b)，封堵器(100,100a,100b)还包括锁定件(14,14a,14b)，锁定件(14,14a,14b)的远端与封堵本体(1,1a)的远端相接，锁定件(14,14a,14b)为弹性件，锁定件(14,14a,14b)包括与封堵本体(1,1a)连接的连接部(141,141a)以及第一弯折部(142,142a,142b)，具有第一弯折夹角(A,A1)，第一弯折部(142,142a,142b)在垂直于其长度方向上的横截面上的投影的外接圆的直径小于锁定孔(15,15a, 15b)的最小内切圆的直径，第一弯折部(142,142a,142b)在锁定孔(15,15a,15b)的纵向中心轴方向垂直的平面上的投影宽度大于锁定孔(15,15a,15b)的最大内切圆的直径。封堵器(100,100a,100b)和封堵装置(300b)结构简单，锁定件(14,14a,14b)尺寸易于控制，方便加工，简化了制备工艺和锁定操作，同时锁定件(14,14a,14b)的锁定可靠性高，不易失效，锁定操作过程可逆，锁定过程和回收过程均简单易行。

Description

封堵器及封堵装置 技术领域
本发明涉及一种介入医疗器械，尤其涉及一种介入治疗先天性心脏病的封堵器及封堵装置。
背景技术
经皮介入技术是近年来发展非常迅速的疾病治疗手段，并且该技术适用领域也越来越广泛。其中采用导管介入治疗方法可以放置各种各样的材料、器械和药物到人体的心脏、动静脉血管。其中器械可以为心脏缺损封堵器、血管塞、血管滤器等。
经导管介入封堵器是经导管介入治疗方法中常用的器械，可用于微创治疗房间隔缺损、室间隔缺损、动脉导管未闭和卵圆孔未闭等先天性心脏病。现有技术中的封堵器一般包括具有两个封堵单元的封堵本体，用来盖住缺损部位两侧壁的组织。然而，当前多采用记忆金属或高分子材料制备封堵单元，记忆金属可能会在使用中疲劳失效，高分子材料又有低弹性或无弹性的特点，这将导致两个封堵单元之间的收缩力不足，并不能贴紧缺损部位的两侧而影响封堵效果，因此封堵器需要有效的约束结构来保持两个封堵单元之间的距离(即封堵器的腰高)稳定，以确保封堵可靠性。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种具有锁 定功能的封堵器和封堵装置。
本发明解决其技术问题所采用的技术方案是：
包括网状带有空腔的封堵本体和近端栓头，所述近端栓头具有与所述空腔贯通的锁定孔，所述封堵器还包括位于所述空腔内的锁定件，所述锁定件的远端与所述封堵本体的远端相接，所述锁定件为弹性件，所述锁定件包括与所述封堵本体连接的连接部以及与所述连接部近端相连接的第一弯折部，所述连接部与所述第一弯折部的连接处具有第一弯折夹角，所述第一弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于所述锁定孔的最小内切圆的直径，所述第一弯折部在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
本发明一实施方式中，包括网状带有空腔的封堵本体和近端栓头，其特征在于，所述近端栓头具有与所述空腔贯通的锁定孔，所述封堵器还包括位于所述空腔内的锁定件，所述锁定件的远端与所述封堵本体的远端相接，所述锁定件为弹性件，所述锁定件包括与所述封堵本体连接的连接部以及多个首尾相连的弯折部，所述多个首尾相连的弯折部的近端与所述连接部近端相连，且所述连接部与距所述连接部最近的弯折部之间具有第一弯折夹角，每个所述弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于所述锁定孔的最小内切圆的直径，所述多个首尾相连的折弯部组成的整体在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
本发明一实施方式中，距所述连接部最近的所述弯折部在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
本发明一实施方式中，所述封堵器中，所述多个首尾相连的弯折部中，距所述连接部最近的弯折部为第一弯折部，距所述第一弯折部最近的弯折部为第二弯折部，所述第二弯折部与所述第一弯折部之间具有第二弯折夹角，且所述第一弯折夹角等于所述第二弯折夹角。
本发明一实施方式中，所述封堵器中，所述第一弯折夹角的角度范围为120度至175度。
本发明一实施方式中，所述封堵器中，所述锁定件近端端部设置有与外界相连通的螺纹孔。
本发明一实施方式中，所述封堵器中，所述螺纹孔与所述弯折部共轴。
本发明一实施方式中，所述封堵器中，所述锁定件为中空管状结构，所述螺纹孔与所述锁定件的内腔相连通。
本发明一实施方式中，所述封堵器中，所述锁定件的近端端部设有圆角。
本发明一实施方式中，所述近端栓头设置有外螺纹。
本发明一实施方式中，所述锁定孔远端端部设置有过渡区，所述过渡区的远端孔径大于所述过渡区的近端孔径。
本发明一实施方式中，所述封堵本体的材料采用与人体生物相容的高分子材料。
一种封堵装置，其特征在于，所述封堵装置包括如权利要求1所述封堵器、至少远端开口的中空输送机构、用于连接所述输送机构与所述封堵器的锁套和可移动地收容于所述输送机构内的牵引件，所述牵引件的远端贯穿所述输送机构的远端后与所述锁定件的弯折部近端可拆卸连接。
本发明一实施方式中，所述的封堵装置，所述锁定件近端端部设置有与外界相连通的螺纹孔，所述牵引件的远端设有与所述锁定件螺纹孔相配合的 外螺纹。
本发明一实施方式中，所述的封堵装置，所述锁套包括中空的第一连接头以及与所述第一连接头近端相连接的第二连接头，所述第一连接头设置有与所述封堵器的近端栓头的外螺纹相配合的内螺纹，所述第二连接头套设于所述输送机构外壁。
本发明的封堵器中，采用锁定件和具有锁定孔的近端栓头配合即可完成锁定过程，结构简单，简化了锁定操作。本发明锁定件具有弹性，且锁定件包括连接部以及第一弯折部两部分，并且连接部以及第一弯折部之间具有弯折夹角。本发明在实现锁定机构的扣紧解脱的过程中，只需要控制第一弯折部在沿所述锁定孔纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径，并且控制第一弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于锁定孔的最小内切圆的直径，而第一弯折部在沿所述锁定孔纵向中心轴方向垂直的平面上的投影宽度主要由弯折夹角来决定，因此本发明的锁定件以及锁定孔之间不需要将尺寸精度控制在微米级别，只需要控制弯折夹角的大小以及第一弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径即可，由于在加工时，连接部以及第一弯折部之间的弯折夹角易于控制，同时在设计时，可以将锁定件相对设置的更小一些，预留出一定的尺寸，能够有效防止高分子材料溶胀而导致其尺寸发生变化从从而导致封堵器无法锁定。因此本发明结构简单，锁定件尺寸易于控制，方便加工，简化了制备工艺和锁定操作，同时锁定件的锁定可靠性高，不易失效，并且锁定操作过程可逆，锁定过程和回收过程均简单易行。
本发明锁定件整体为弯折管状，各部分尺寸相适配能够有效减小锁定件尺寸，防止因锁定件某一部分尺寸过大而影响封堵器的收缩回弹。
采用牵引件与上述封堵器的锁定件可拆卸连接，牵引件能方便控制连接或解除连接，提高了牵引件与封堵器连接的易操作性，锁定完成后可解除连接并撤离体外，减少体内残留；同时牵引件不需要穿过封堵器的远端，可以避免对心脏组织的损害，同时减少了封堵手术时间，提高了手术效率。并且由于锁定件只与封堵本体远端固定，且锁定件设置方向与鞘管方向相同，锁定件的结构和固定方式不影响封堵器在输送鞘管中的变形以及推送到位后对缺损部位的封堵，鞘管尺寸只需与封堵器大小配合，无需额外增加鞘管尺寸，利于手术操作。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明实施例1提供的封堵器的结构示意图；
图2是本发明实施例1提供的封堵器锁定状态的示意图；
图3是图2中封堵器的锁定件与近端栓头锁定时的局部结构示意图；
图4是图1中封堵器的锁定孔的结构示意图；
图5是本发明实施例2封堵器的结构示意图；
图6是图5中的封堵器的锁定件的结构示意图；
图7是本发明实施例3提供的封堵装置的结构示意图；
图8是图7中的封堵装置的锁套的结构示意图；
图9是本发明实施例3中封堵装置位于鞘管中的示意图；
图10是图9中封堵器推出鞘管的示意图；
图11是图10中封堵器部分释放的示意图；
图12是图11中封堵器到达缺损部位释放但未锁定的示意图；
图13是图12中封堵器锁定状态下的示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
为了更加清楚地描述本发明的结构，采用“远端”、“近端”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。所述轴向，指平行于医疗器械远端中心和近端中心连线的方向；所述径向，指垂直于上述轴向的方向。
实施例1
请参阅图1，封堵器100包括网状带有空腔103的封堵本体1和近端栓头2以及远端封头3，近端栓头2固定连接于封堵本体1近端，远端封头3固定连接于封堵本体1远端。封堵本体1包括两个盘状结构的第一封堵单元101、第二封堵单元102，两个封堵单元101和102联通形成“工”字形。封堵器100还包括位于空腔103内的锁定件14。锁定件14的远端与封堵本体1远端相连接。近端栓头2具有与空腔103贯通的锁定孔15。优选的，锁定孔15与近端栓头2同轴设置。
可以理解的是，封堵本体1的结构仅用作举例，并不是对本发明的限制，本领域的普通技术人员可在本发明的启示下选择任意适合的封堵本体1结构。网状结构易于变形，输送过程中方便封堵器100有效压缩收入到鞘管中，并且还方便在推出鞘管到达缺损部位时，变形成利于封堵缺损的两个盘状结构。
锁定件14包括连接部141以及与连接部141近端相连接的第一弯折部142，连接部141与第一弯折部142之间具有预设的弯折夹角A。锁定件14 为弹性件，其可在外力作用下可发生弹性形变，即在外力的作用下，连接部141与第一弯折部142之间的第一弯折夹角A能够发生变化，并在外力消失后，连接部141与第一弯折部142之间的第一弯折夹角A恢复至原来的角度。
所述第一弯折部142在垂直于其长度方向上的横截面上的投影的外接圆的直径小于锁定孔15的最小内切圆的直径。优选的，请一并参阅图3，本实施例中，锁定件14为横截面为圆形的柱状结构，此时，第一弯折部142的外径d即为第一弯折部142在垂直于其长度方向上的横截面上的投影的外接圆的直径。可以理解的是，在其他实施例中，锁定件14可以为横截面为椭圆形、梯形或者其他形状的结构。
请参阅图2及图3，本实施例中，优选的，本实施例中锁定孔15为圆柱形孔，锁定孔15的最大内切圆直径与最小内切圆直径相等，且锁定孔15的内径D即为其最大内切圆直径，也是其最小内切圆直径。第一弯折部142的近端能够插入锁定孔15，并从锁定孔15的近端穿出。所述第一弯折部142在所述锁定孔15的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔15的最大内切圆的直径。这里投影宽度是指第一弯折部142在锁定孔15的纵向中心轴垂直的平面上的投影上相距最远的两点之间的距离。本实施例中，第一弯折部142在所述锁定孔15的纵向中心轴方向垂直的平面上的投影宽度为D1，第一弯折部142穿出后，在不受外力的情况下，锁定件14与锁定孔15之间实现锁定。
可以理解的是，其他实施例中，锁定孔15也可以为圆锥形孔、葫芦形孔、四棱柱形孔等，只要锁定孔15的最小内切圆的直径大于第一弯折部142在垂直于其长度方向上的横截面上的投影的外接圆的直径，且所述第一弯折部142在所述锁定孔15的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔 15的最大内切圆的直径即可。
进一步的，封堵器100包括自然状态以及锁定状态，其中，在自然状态下，即在不受外力的状态下，如图1所示，封堵器100的第一封堵单元101与第二封堵单元102相远离，锁定件14近端未插入至锁定孔15内。锁定件14的第一弯折部142的外径d小于锁定孔15的内径D，优选的，锁定件14的整体宽度保持一致。
请一并参阅图1至图3，当锁定件14在外力的作用下朝近端移动时，即从自然状态转变为图2所示的锁定状态时，锁定件14带动封堵本体1的远端朝近端栓头2运动，由于第一弯折部142的外径d小于锁定孔15的内径D，第一弯折部142的近端能够插入至锁定孔15中，随着锁定件14的插入，锁定件14的第一弯折部142会与锁定孔15的内壁有力的作用，在锁定孔15的内壁的挤压作用下，导致第一弯折部142弯曲，从而第一弯折夹角A变大，使得第一弯折部142在与锁定孔15的纵向中心轴垂直的平面上的投影的D1小于或者等于锁定孔15的内径D，第一弯折部142能够继续插入锁定孔15中，当第一弯折部142的远端从锁定孔15的远端露出时，锁定孔15内壁对第一弯折部142的力的作用逐渐消失，第一弯折部142逐渐恢复原来的形状，随着锁定件14朝近端继续移动，第一弯折夹角A不断减小，当拉拽锁定件14朝近端移动的外力消失后，由于第一弯折部142在与锁定孔15的纵向中心轴垂直的平面上的宽度D1大于锁定孔15的内径D，第一弯折部142的侧面与锁定孔15的近端端面相抵，使得锁定件14无法朝远端移动，完成了锁定件14的锁定，从而两个封堵单元101和102无法在自身弹性的作用下回弹，继续保持在相互靠近的状态。
上述拉动锁定件的外力可以是医生向锁定件14施加的朝近端的牵引力， 锁定状态下封堵本体1的第一封堵单元101与第二封堵单元102距离恒定(即封堵本体的腰高恒定)。
本实施例中，为了更好的完成上述操作，封堵器100的各个部件存在优选的尺寸。具体的，因为封堵器100是通过介入方式输送到体内的，因此封堵器100的近端栓头2的尺寸不能过大，从而限制了锁定孔15的内径D，请参阅图3，锁定孔15的内径D取值范围为0.5-3毫米，锁定件14的连接部141以及第一弯折部142之间的第一弯折夹角A的取值为120至175度，锁定件14的第一弯折部142的长度L取值范围为0.5～3毫米。连接部141及第一弯折部142的外径d小于锁定孔15内径D的取值，其中连接部141与第一弯折部142的外径d相等，且与锁定孔15内径D的比值为0.5-0.95。若第一弯折部142的外径d与锁定孔15内径D的比值过小，会导致锁定不可靠，若第一弯折部142的外径d与锁定孔15内径D的比值过大，会导致第一弯折部142进入锁定孔15较为困难。第一弯折部142在与锁定孔15的纵向中心轴垂直的平面上的投影的宽度D1大于锁定孔15的内径D，这样当第一弯折部142通过锁定孔15后，锁定件14的连接部141的能较顺畅地的位于锁定孔15中，同时心脏在跳动过程中封堵器100还可以协调变形以适应心脏搏动，即在心脏跳动过程中，由于连接部141的宽度小于锁定孔15的内径D，连接部141依然能够朝封堵器100的近端移动，从而随着心脏跳动，封堵器100的第一封堵单元100以及第二封堵单元101依然能够在压力的作用下继续靠近，从而封堵器100能够随着心脏的跳动而协调变形。
封堵器100的锁定功能主要由设于封堵本体1的空腔103内的锁定件14、以及近端栓头2上设置的锁定孔15配合实现。锁定件14可使用金属材料或具有与人体生物相容性的高分子材料制作。锁定件14的远端与封堵本体1的 远端相接，在外力(例如牵引件的拉力)的牵引下，锁定件14可带动封堵本体1远端朝近端运动。
图1示出了封堵器100未锁定的自然状态；图2示出了封堵器100锁定后封堵缺损部位18的状态。
封堵本体1的网状结构可采用记忆合金材料或高分子材料通过编织、管材切割、注塑成型等方式制成。记忆合金材料包括镍钛合金；高分子材料具有良好的生物相容性，且相比金属材料，高分子材料能避免金属元素在体内释放带来的问题，同时生物相容性好的材料，可有效减少封堵部位感染。本发明中的封堵本体1可采用可降解高分子丝编织而成，该可降解高分子丝可选择聚苯二甲酸乙二醇酯(PET：Polyethylene Terephthalate)、聚乳酸(PLA：Poly-L-lactide Acid)、聚乙醇酸(PGA：Poly-glycolide)、聚羟基脂肪酸脂(PHA：Poly-hydroxyalkanoate)、聚二氧环己酮(PDO：Poly-dioxanone)、聚己内酯(PCL：Poly-caprolactone)等类似的材料。
请再次参阅图1-2，封堵本体1的远端还设有远端封头3，锁定件14与远端封头3相连；可以理解的是，在其他实施例中，封堵本体1远端也可采用无封头结构。当采用远端无封头结构的封堵器100时，锁定件14可直接与封堵本体1的远端相连。在采用编织丝制成网格结构的封堵本体1时，远端封头3和近端栓头2可分别设置在远端和近端收容并固定形成网状结构的编织丝的端部。远端封头3和近端栓头2形状和结构不作特别限定，本实施例中，远端封头3为弧面体，近端栓头2为柱状结构。
高分子材料与传统的记忆合金(例如镍钛合金)相比，具有弹性模量较低、弹性范围较小的特点，而记忆合金在长期使用中可能因疲劳而失效，无法有效封堵缺损部位，上述两者均有可能使得封堵本体1定型后并不能很好 地保持其预定型形态，此时则需要通过锁定结构来改善封堵器100在人体内的成型性能。本发明相应设计了锁定结构，包括锁定件14以及锁定孔15，该锁定结构不但适用于高分子材料的封堵本体1，同样也适用于其他材质的封堵器100锁定。
现有技术中，在实现两个结构的扣紧释放时，对锁定件的尺寸精度要求非常高，通常需要要求1微米左右的精度，对于金属材料来说，这个精度比较难以达到，而高分子材料来说，这个尺寸精度更加难以控制。另外，高分子材料制备而成的锁定件和近端栓头，在清洗过程中会接触到水，在手术过程中会接触到血液，在这些过程中，由于高分子材料吸水溶胀的特性，或由于血液中生物分子的吸附，都会影响高分子部件的尺寸精度，从而影响锁定功能，即由于尺寸产生细微的变化导致过盈配合难以实现，最终可能会导致手术失败。本发明的封堵器中，采用锁定件和具有锁定孔的近端栓头配合即可完成锁定过程，结构简单，简化了锁定操作。本发明锁定件具有弹性，且锁定件包括连接部以及第一弯折部两部分，并且连接部以及第一弯折部之间具有弯折夹角。本发明在实现锁定机构的扣紧解脱的过程中，只需要控制第一弯折部在沿所述锁定孔纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径，并且控制第一弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于锁定孔的最小内切圆的直径，而第一弯折部在沿所述锁定孔纵向中心轴方向垂直的平面上的投影宽度主要由弯折夹角来决定，因此本发明的锁定件以及锁定孔之间不需要将尺寸精度控制在微米级别，只需要控制弯折夹角的大小以及第一弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径即可，由于在加工时，连接部以及第一弯折部之间的弯折夹角易于控制，同时在设计时，可以将锁定件相对设置的更 小一些，预留出一定的尺寸，能够有效防止高分子材料溶胀而导致其尺寸发生变化从从而导致封堵器无法锁定。因此本发明结构简单，锁定件尺寸易于控制，方便加工，简化了制备工艺和锁定操作，同时锁定件的锁定可靠性高，不易失效，并且锁定操作过程可逆，锁定过程和回收过程均简单易行。
请参阅图3，由于锁定件14要与推送器或推送装置可拆卸连接，则其中一种可拆卸连接方式可采用螺纹连接。可以在锁定件14的第一弯折部142的近端设有螺纹孔145，本实施例中，螺纹孔145与第一弯折部142同轴设置，同轴设置的螺纹孔145可以更加容易的与推送机构相连。
可以理解的是，在其他实施例中，锁定件14也可以采用中空管状设计，在生产时，在具有预定尺寸的中空管状的锁定件14的内壁设置内螺纹，并将其折弯成预设角度，从而形成连接部141以及第一弯折部142。当锁定件14为中空管状时，能够简化加工工艺，同时中空管状的锁定件14易于控制螺纹孔与第一弯折部142之间的共轴性，使锁定件14更加易于与牵引装置或者推送装置连接。
可以理解的是，在其他实施例中，在锁定件14近端也可以不设置螺纹，锁定件14也可以与牵引装置或推送装置通过卡扣的形式可拆卸连接。
还可以理解的是，锁定件14与牵引装置或推送装置之间的连接可以为其他连接方式，在此不一一列举，只要能够保证锁定件14与推送器或推送装置之间为可拆卸连接即可。
请继续参阅图3，为了使锁定件14更加易于插入至近端栓头2的锁定孔15中，锁定件14的第一弯折部142的近端端部增加圆角1421。圆角1421是指第一弯折部142的近端端面与第一弯折部142的侧壁之间圆弧过渡，且近端端面的外径小于第一弯折部142的侧壁的外径。相应的，请参阅图4，锁定 孔15靠近其远端的地方设置有中空的过渡区16，过渡区16从近端至远端径向长度逐渐增加，且与锁定孔15相连通。由于第一弯折部142近端端部设置有圆角1421，其更加容易插入至开口较大的锥形过渡区16，从而进入锁定孔15中。
过渡区16的整体可以类似于圆锥形或者喇叭形，过渡区16的近端径向长度小于远端径向长度，可以理解的是，在其他实施例中，过渡区16也可以类似于梯形，或者，在其他实施例中，当锁定件14与锁定孔15的径向长度差距较大时，也可以不设置过渡区。
还可以理解的是，在其他实施例中，过渡区16的近端边缘设置有圆弧形倒角161，设置圆弧形倒角161可以与锁定件14上的圆角1421相配合，当锁定件14在外力牵引下朝近端移动时，圆弧形倒角161能够避免过渡区16近端边缘与锁定件14的近端相顶，能够使锁定件14更加易于插入锁定孔15中。
实施例2
请参阅图5，本发明另一实施例还提供了一种封堵器100a，封堵器100a与第一实施提供的封堵器100大致相同，不同之处在于，本实施例中，封堵器100a的锁定件14a包括连接部141a、第一弯折部142a以及第二弯折部143a。其中，连接部141a近端与第一弯折部142a远端相连，第一弯折部142a近端与第二弯折部143a远端连接。
请一并参阅图6，第一弯折部142a与连接部141a之间具有第一弯折夹角A1，第一弯折部142a与第二弯折部143a之间具有第二弯折夹角A2。优选地，第一弯折夹角A1与第二弯折夹角A2大小相同，其目的在于，当第一折弯角A1与第二折弯角A2大小相同时，能够保证连接部141a与第二折弯部143a保持在平行状态，从而锁定件14a在被外力牵引拉拽的过程中，其力的作用 方向能够保持不变，更加方便锁定件14a与牵引装置相连接，同时也能够保证锁定件14a的近端更加容易的插入至锁定孔15a中。
可以理解的是，在其他实施例中，第一折弯角A1也可以与第二折弯角A2不同，只要保证第一折弯部142a以及第二折弯部143a组成的整体在沿锁定孔15a的纵向中心轴方向垂直的平面上的投影宽度大于锁定孔15a的内径即可。
当第一折弯角A1与第二折弯角A2不相等时，第二折弯部143a的在沿锁定孔15a的纵向中心轴方向垂直的平面上的投影可以部分或者全部落入第一折弯部142a在沿锁定孔15a的纵向中心轴方向垂直的平面上的投影中，当第一折弯角A1与第二折弯角A2相等时，第二折弯部143a的在沿锁定孔15a的纵向中心轴方向垂直的平面上的投影可以全部落入第一折弯部142a在沿锁定孔15a的纵向中心轴方向垂直的平面上的投影中。
可以理解的是，在其他实施例中，锁定件也可以设置多个弯折部，每个弯折部形状类似于第一弯折部或者第二弯折部，多个弯折部首尾相连，多个首尾相连的弯折部的近端与连接部远端相连，连接部与距连接部最近的弯折部之间具有第一弯折夹角，每个弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于所述锁定孔的最小内切圆的直径，多个首尾相连的折弯部组成的整体在锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。距离连接部最近的弯折部在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
实施例3
如图7所示，本发明又一实施例还提供了一种封堵装置300b，以实施例 2提供的封堵器为例，本实施例的封堵装置300b包括封堵器100b、至少远端开口的中空的输送机构200b、用于连接输送机构200b与封堵器100b的锁套6b以及可移动的收容于输送机构200b内的牵引件4b。牵引件4b的远端贯穿输送机构200b的远端并可在空腔中与锁定件14b的近端可拆卸连接；牵引件4b可在操作者如医生施加的朝近端的外力的作用下牵引锁定件14b带动封堵器100b的远端朝近端运动，直至锁定件14b近端穿过锁定孔15b后抵压至近端栓头2b的端面上锁定封堵器100b。
封堵器100b的结构在实施例2中有完整表述，在此不再赘述。
请一并参阅图8，锁套6b用于连接输送机构200b以及封堵器100b近端栓头2b，锁套6b包括相互连接的第一连接头61b以及第二连接头62b，第一连接头61b的近端连接于第二连接头62b的远端。第一连接头61b以及第二连接头62b均中空且相互联通，从整体上看，第一连接头61b以及第二连接头62b均呈筒状，其中第一连接头61b的内径大于第二连接头62b的内径。在第一连接头61b的内表面设置有用于与封堵器100b近端栓头2b外螺纹相配合的内螺纹611b。在连接时，首先通过激光焊接将第二连接头62b套设于输送机构200b的远端，将第一连接头61b套设在封堵器100b的近端栓头2b上，通过旋拧输送机构200b，即可将锁套6b与近端栓头2b紧固连接。
上述封堵器100b中，采用锁定件14b与具有锁定孔15b的近端栓头2b配合完成锁定过程，锁定件14b为杆状及类似结构，并且具有折弯角度，锁定结构简单，无需复杂的机械结构和配合关系，简化了制备工艺和锁定操作。并且，通过弹性形变，锁定件14b近端通过锁定孔15b并从锁定孔15b露出后，会与锁定孔15b的近端端部相顶，锁定可靠性高，不易失效。
图9到图13示出了封堵器100b与输送机构200b配合实施输送、释放以 及锁定的过程。首先通过锁套6b将封堵器100b和输送机构200b连接在一起，锁套6b与近端栓头2b螺纹连接，并收入鞘管30b内。牵引件4b的远端和锁定件14b通过螺纹连接，当封堵器100b收入鞘管30b内时，牵引件4b顺着鞘管30b的轴向方向设置，不约束封堵器100b的自由变形。
将封堵器100b推送至心脏缺损部位18b，向近端拉动牵引件4b，使封堵器100b的两个盘状结构渐渐靠拢，形成“工”字状，形成如图7所示的状态。具体过程如下：
在牵引件4b的牵引下，锁定件14b抵至近端栓头2b的锁定孔15b，由于近端栓头2b的内壁与锁定件14b第二弯折部143b之间存在力的作用，随着锁定件14b近端插入至锁定孔15b中，锁定件14b的第二弯折部143b以及第一弯折部142b会与锁定孔15b的内壁有力的作用，在锁定孔15b的内壁的挤压作用下，导致第一弯折部142b以及第二弯折部143b弯曲，从而第一弯折夹角A1以及第二弯折夹角A2变大，第一弯折部142b以及第二弯折部143b在沿锁定孔15b的纵向中心轴方向垂直的平面上的投影宽度小于锁定孔15b的内径，锁定件14b能够继续插入锁定孔15b中，当锁定件14b的远端从锁定孔15b的远端露出时，锁定孔15b内壁对第一弯折部142b以及第二弯折部143b的力的作用逐渐消失，第一弯折部142b以及第二弯折部143b逐渐恢复原来的形状，锁定件14b在沿锁定孔15b的纵向中心轴方向垂直的平面上的投影宽度大于锁定孔15b的内径，第一弯折部142b的侧面与锁定孔15b的近端端面相抵，使得锁定件14b无法朝远端移动，完成了封堵器100b的锁定。
旋转牵引件4b，解脱与锁定件14b的连接，解脱连接后向回撤牵引件4b，旋转输送管5b，解脱锁套6b与近端栓头2b的连接，最后后撤输送管5b，完成拆卸。
由于锁定件14b通过弹性形变穿过锁定孔15b，因此该锁定过程可逆，封堵器100b还包括锁定解除状态，在未解脱牵引件4b和锁定件14b的连接前，可以轴向操作牵引件4b，使牵引件4b向远端移动，直至锁定件14b通过锁定孔15b返回进入封堵器100b的空腔中，封堵器100b从图13状态退回到图11状态，锁定解除；回到图11状态后，可以进一步向近端拉动输送管5b，让封堵器100b回收入鞘管30b内，实现回收封堵器100b。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 一种封堵器，包括网状带有空腔的封堵本体和近端栓头，其特征在于，所述近端栓头具有与所述空腔贯通的锁定孔，所述封堵器还包括位于所述空腔内的锁定件，所述锁定件的远端与所述封堵本体的远端相接，所述锁定件为弹性件，所述锁定件包括与所述封堵本体连接的连接部以及与所述连接部近端相连接的第一弯折部，所述连接部与所述第一弯折部的连接处具有第一弯折夹角，所述第一弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于所述锁定孔的最小内切圆的直径，所述第一弯折部在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
  2. 一种封堵器，包括网状带有空腔的封堵本体和近端栓头，其特征在于，所述近端栓头具有与所述空腔贯通的锁定孔，所述封堵器还包括位于所述空腔内的锁定件，所述锁定件的远端与所述封堵本体的远端相接，所述锁定件为弹性件，所述锁定件包括与所述封堵本体连接的连接部以及多个首尾相连的弯折部，所述多个首尾相连的弯折部的远端与所述连接部近端相连，且所述连接部与距所述连接部最近的弯折部之间具有第一弯折夹角，每个所述弯折部在垂直于其长度方向上的横截面上的投影的外接圆的直径小于所述锁定孔的最小内切圆的直径，所述多个首尾相连的折弯部组成的整体在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
  3. 根据权利要求2所述的封堵器，其特征在于，距所述连接部最近的所述弯折部在所述锁定孔的纵向中心轴方向垂直的平面上的投影宽度大于所述锁定孔的最大内切圆的直径。
  4. 根据权利要求3所述的封堵器，其特征在于，所述多个首尾相连的弯折部中，距所述连接部最近的弯折部为第一弯折部，距所述第一弯折部最近的弯折部为第二弯折部，所述第二弯折部与所述第一弯折部之间具有第二弯折夹角，且所述第一弯折夹角等于所述第二弯折夹角。
  5. 根据权利要求1-4任一所述的封堵器，其特征在于，所述第一弯折夹角的角度范围为120度至175度。
  6. 根据权利要求1-4任一所述的封堵器，其特征在于，所述锁定件近端端部设置有与外界相连通的螺纹孔。
  7. 根据权利要求6所述的封堵器，其特征在于，所述螺纹孔与所述弯折部共轴。
  8. 根据权利要求6所述的封堵器，其特征在于，所述锁定件为中空管状结构，所述螺纹孔与所述锁定件的内腔相连通。
  9. 根据权利要求1至4任一所述的封堵器，其特征在于，所述锁定件的近端端部设有圆角。
  10. 根据权利要求1至4任一所述的封堵器，其特征在于，所述近端栓头设置有外螺纹。
  11. 根据权利要求1至4任一所述的封堵器，其特征在于，所述锁定孔远端端部设置有过渡区，所述过渡区的远端孔径大于所述过渡区的近端孔径。
  12. 根据权利要求1至4任一所述的封堵器，其特征在于，所述封堵本体的材料采用与人体生物相容的高分子材料。
  13. 一种封堵装置，其特征在于，所述封堵装置包括如权利要求1所述封堵器、至少远端开口的中空输送机构、用于连接所述输送机构与所述封堵器的锁套和可移动地收容于所述输送机构内的牵引件，所述牵引件的远端贯 穿所述输送机构的远端后与所述锁定件的弯折部近端可拆卸连接。
  14. 根据权利要求13所述的封堵装置，其特征在于，所述锁定件近端端部设置有与外界相连通的螺纹孔，所述牵引件的远端设有与所述锁定件螺纹孔相配合的外螺纹。
  15. 根据权利要求14所述的封堵装置，其特征在于，所述近端栓头设置有外螺纹；所述锁套包括中空的第一连接头以及与所述第一连接头近端相连接的第二连接头，所述第一连接头设置有与所述近端栓头的外螺纹相配合的内螺纹，所述第二连接头套设于所述输送机构外壁。
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