WO2023116837A1 - 封堵装置与封堵系统 - Google Patents

封堵装置与封堵系统 Download PDF

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Publication number
WO2023116837A1
WO2023116837A1 PCT/CN2022/141163 CN2022141163W WO2023116837A1 WO 2023116837 A1 WO2023116837 A1 WO 2023116837A1 CN 2022141163 W CN2022141163 W CN 2022141163W WO 2023116837 A1 WO2023116837 A1 WO 2023116837A1
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WO
WIPO (PCT)
Prior art keywords
occlusion
disk
supporting frame
blocking
segments
Prior art date
Application number
PCT/CN2022/141163
Other languages
English (en)
French (fr)
Inventor
程晓阳
赵江浪
Original Assignee
杭州德诺电生理医疗科技有限公司
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.)
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Application filed by 杭州德诺电生理医疗科技有限公司 filed Critical 杭州德诺电生理医疗科技有限公司
Publication of WO2023116837A1 publication Critical patent/WO2023116837A1/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
    • A61B17/0057—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
    • A61B17/0057—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
    • 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, 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
    • A61B2017/00632—Occluding a cavity, i.e. closing a blind opening

Definitions

  • the present application relates to the technical field of medical devices, in particular to an occlusion device and an occlusion system.
  • Foramen Ovale is a physiological channel in the embryonic stage of the heart interatrial septum. It usually closes within the first year after birth, and about 20% to 25% of adults have incomplete closure of the foramen ovale. Arrhythmia is one of the most common congenital heart abnormalities in adults.
  • Patent Oval Foramen PFO
  • PFO patent Oval Foramen
  • the main treatment methods for PFO are drug therapy and PFO closure (compared with drugs, PFO closure has obvious advantages).
  • the covering film is combined with the frame by suturing and fixing with other fixing parts, resulting in poor adhesion between the disk surface and the tissue to be occluded, resulting in a slow rate of endothelialization , the partial endothelialization of the occlusion device is obvious, part of the endothelialization is incomplete, and the problem of poor occlusion occurs.
  • the present application provides an occlusion device and a occlusion system to solve the problem that the endothelialization rate is too slow due to the large gap between the covering film and the supporting framework.
  • the embodiment of the present application provides an occlusion device, the occlusion device is used to occlude a gap in the tissue, and the occlusion device includes: a support frame, and the support frame is used to release in the gap At the position, the peripheral edge of the support frame is used to cover the peripheral tissue of the gap; the covering film covers at least one side of the support frame, and at least part of the cover film is seamlessly connected with the support frame.
  • the coating is directly formed on the support frame by electrospinning, dipping or spraying; or, the coating is formed by electrospinning, dipping, spraying, casting Forming or braiding, and the formed film is fixed on the supporting frame by hot pressing or bonding.
  • the supporting frame includes an outer side away from the notch and an inner side facing the notch, and the coating covers the inner side of the supporting frame; or, covers the outer side of the supporting frame ; Or, coated on the inside and outside of the supporting frame.
  • the material of the covering film includes non-degradable materials
  • the non-degradable materials include polyethylene terephthalate, polytetrafluoroethylene, thermoplastic polyurethane elastomer rubber, silicone rubber, polyurethane, polyester At least one of vinyl alcohol, hydrogel, expanded polytetrafluoroethylene, polyethylene, high-density polyethylene, and polyethylene terephthalate.
  • the thickness of the coating is 0.01-0.2 mm.
  • the material of the covering film includes degradable materials
  • the degradable materials include polylactic acid, polycaprolactone, polybutylene succinate, 1,3-propylene glycol, and poly(L- At least one of lactide-co- ⁇ -caprolactone) series copolymers.
  • the coating has a thickness of 0.001mm-0.1mm.
  • the supporting frame is configured as a network structure, and the network structure includes an edge segment and a plurality of intermediate segments connected to the edge segments, and the plurality of intermediate segments are located in the area surrounded by the edge segments.
  • the cover is seamlessly connected to the edge segments and optionally to the plurality of intermediate segments.
  • the material of the supporting frame includes at least one of degradable materials and non-degradable materials.
  • a part of the structure of the supporting frame is made of the degradable material, and the rest of the structure of the supporting frame is made of a non-degradable material.
  • the middle section includes a plurality of first sections and a plurality of second sections, the edge section and the plurality of first sections are made of a non-degradable material, and the plurality of second sections are made of Made of biodegradable material.
  • the edge segment is surrounded by the first segment and the second segment to form a plurality of first meshes; the edge segment is surrounded by the plurality of first segments to form a plurality of second meshes
  • the size of at least one of the second mesh holes is larger than the size of one of the first mesh holes.
  • each intersection of the middle segment and the edge segment forms a first connection point
  • each intersection of the first segment and the corresponding second segment forms a second connection point
  • the covering film is seamlessly connected with the supporting frame at the positions of the first connection point and the second connection point.
  • the covering film is seamlessly connected with the edge section and all of the middle section.
  • the support frame and the membrane constitute an occlusion disk
  • the occlusion disk includes a first occlusion disk and a second occlusion disk
  • the occlusion device further includes a The pulling member of the blocking disk and the second blocking disk, the first blocking disk and the second blocking disk are respectively used to block one side of the gap, and the pulling member is used for Adjusting the distance between the first blocking disk and the second blocking disk.
  • the first occlusion disk is located at the distal end of the second occlusion disk, a plurality of connecting rings are provided on the first occlusion disk, and the pulling member passes through the plurality of connecting rings.
  • a plurality of connection rings so as to realize the connection between the pulling member and the first occlusion disk;
  • the plurality of connection rings include a plurality of first connection rings located outside the geometric center of the first occlusion disk, the The covering film of the first blocking disk is provided with perforations, and the plurality of first connecting rings pass through the holes and are fixed on the supporting frame of the first blocking disk.
  • a filling body is disposed in the through hole, so that the first connecting ring is in sealing connection with the covering membrane of the first occlusion disk.
  • the filler is filled in the through hole by electrospinning, dipping or spraying.
  • the plurality of connection rings include a second connection ring located at the geometric center of the first occlusion disk, and the second connection ring is fixed on the support frame.
  • an embodiment of the present application provides a occlusion system, including a conveyor and the occlusion device as described above, and the conveyor is used to deliver the occlusion device to the opening.
  • the occlusion device and the occlusion system provided in the embodiments of the present application are based on covering at least one side of the support frame with a film, at least part of the film is seamlessly connected with the support frame, and the tissue moves from the edge of the occlusion device to its axis.
  • Directional climbing reduces the area of the surface that needs to be endothelialized in the occlusion device, and also improves the connection strength between the coating and the supporting frame, reducing the ratio of the coating and the supporting frame being separated from each other during the endothelialization process and Possibility, reduce or avoid the situation that the local endothelialization of the occlusion device is better, and the local endothelialization speed is slower, and it is not easy to form complications such as thrombus, inflammatory reaction and endothelial hyperplasia, which is conducive to improving the rate of endothelialization of the occlusion device .
  • Fig. 1 is a schematic structural diagram of a plugging system provided by an embodiment of the present application.
  • Fig. 2 is a schematic structural view of a first embodiment of an occlusion disc of the occlusion device of the occlusion system in Fig. 1 .
  • Fig. 3 is a schematic structural view of the supporting frame of the closure device of the closure system in Fig. 2 .
  • Fig. 4 is a schematic structural diagram of a second embodiment of the occlusion disk of the occlusion device of the occlusion system in Fig. 1 .
  • Fig. 5 is a structural schematic diagram of a first state of the supporting frame of the occlusion device of the occlusion system in Fig. 4 .
  • Fig. 6 is a structural schematic diagram of a second state of the supporting frame of the occlusion device of the occlusion system in Fig. 4 .
  • Fig. 7 is a schematic structural diagram of another embodiment of the closure device of the closure system in Fig. 1 .
  • FIG. 8 is a schematic diagram of the inner structure of the first occlusion disk of the occlusion device of the occlusion system in FIG. 7 .
  • the end of the device close to the operator is usually called the proximal end
  • the end of the device away from the operator is called the distal end.
  • the distal end refers to the end of the delivery device that can be freely inserted into the body of an animal or human body
  • the proximal end refers to the end of the delivery device that is used by a user or a machine. one end of the operation.
  • FIG. 1 is a schematic structural diagram of a blocking system 1000 provided in an embodiment of the present application.
  • the occlusion system 1000 includes a conveyor 200 and an occlusion device 100 .
  • the occluding device 100 is used to occlude gaps in tissues to be occluded.
  • the delivery device 200 is used to deliver and release the occlusion device 100 to the opening.
  • the gap in the tissue to be blocked is, for example, but not limited to a tissue defect site in the vasculature.
  • the gap includes but not limited to foramen ovale, ductus arteriosus, atrial septum, interventricular septum, left atrial appendage ostium, etc.
  • the occlusion device 100 may be, but not limited to, a left atrial appendage occlusion device, a PFO occlusion device, an atrial septal occlusion device, or an interventricular septal occlusion device.
  • the opening is taken as an example of the foramen ovale to illustrate the advantages of the closure system 1000 for treating the patent foramen ovale. It can be understood that the gap can also be other tissue defect sites mentioned above.
  • the transporter 200 includes a sheath 201 for receiving the occlusion device 100 and a control handle 202 fixed at the proximal end of the sheath 201 .
  • the control handle 202 is used to control the occlusion device 100 to protrude from the sheath tube 201 and release to the opening; or to control the occlusion device 100 to be retracted into the sheath tube 201 .
  • FIG. 1 is only an example of the closure system 1000, and does not constitute a limitation to the closure system 1000, and the closure system 1000 may include more or less than those shown in FIG. components, or a combination of certain components, or different components, for example, the occlusion system 1000 may also include positioners and sensors.
  • the occlusion device 100 is used to occlude gaps in tissue.
  • the occlusion device 100 includes a support frame 101 and a membrane 103 .
  • the supporting frame 101 is used to release at the gap, the peripheral edge of the supporting frame 101 is used to cover the peripheral tissue of the gap, and the axial position of the supporting frame 101 may be used to contact the peripheral tissue of the gap, or to be blocked in the gap, (that is, use in the channel enclosed by the surrounding tissues of the gap).
  • the occlusion device 100 provided in the embodiment of the present application is based on covering at least one side of the support frame 101 with the covering membrane 103, at least part of the covering film 103 is seamlessly connected with the support frame 101, and the tissue moves from the edge of the occlusion device 100 to the Climbing in the axial direction reduces the surface area of the occluding device 100 that needs to be endothelialized, and also improves the connection strength between the coating 103 and the supporting frame 101, reducing the endothelialization between the coating 103 and the supporting frame 101.
  • the ratio and possibility of mutual detachment during the process reduce or avoid the situation that the local endothelialization of the occlusion device 100 is better and the local endothelialization speed is slower, and it is not easy to form complications such as thrombus, inflammatory reaction, and endothelial hyperplasia, which is beneficial to The rate of endothelialization of the occlusion device 100 is increased.
  • the coating 103 is directly formed on the support frame 101 by electrospinning, dipping or spraying, so that the coating 103 can be tightly formed on the outer surface of the support frame 101, that is, the coating 103 Covering the surface of the supporting frame 101 to realize the seamless connection between the covering film 103 and the supporting frame 101 .
  • the coating 103 is formed by electrospinning, dipping, spraying, tape casting or weaving, and the formed coating is fixed on the support frame 101 by hot pressing or bonding. , so that the covering film 103 can be attached to the outer surface of the supporting frame 101 to reduce gaps at the connection between the supporting frame 101 and the covering film 103 .
  • the covering membrane 103 is formed on the support frame 101 by electrospinning to obtain a covering membrane 103 with a relatively large porosity, so that cells can better infiltrate into the inside of the covering membrane 103, which is beneficial to Cell crawling and endothelialization make the tissue and cells better combined.
  • the occlusion device 100 includes two occlusion disks, namely a first occlusion disk 11 and a second occlusion disk 13 .
  • the structure of the first blocking disk 11 is similar to that of the second blocking disk 13.
  • Both blocking disks include the above-mentioned supporting frame 101 and a covering film 103.
  • the covering film 103 covers at least one side of the corresponding supporting frame 101, and the covering film At least part of 103 is seamlessly connected with the corresponding supporting frame 101 .
  • one of the two occlusion disks includes the above-mentioned supporting frame 101 and a covering film 103, and the covering film 103 covers at least one side of the supporting frame 101, and at least part of the covering film 103 is compatible with the supporting frame 103.
  • the framework 101 is seamlessly connected; the other one of the two occlusion disks only includes the support framework 101, that is, the coating 103 is omitted, or the coating and the support framework 101 on the other occlusion disk are not seamless.
  • the connection method of connection such as using suture, additional fixing parts for fixing and other processes to connect to the support frame.
  • both the first blocking disk 11 and the second blocking disk 13 are in the shape of a single-layer disk, that is, in the axial direction, the support frame 101 forms a single-layer mesh structure.
  • the first occlusion disk 11 and the second occlusion disk 13 are used to attach to the peripheral tissues on both sides of the notch on both sides of the notch.
  • any one of the first blocking disk 11 and the second blocking disk 13 may adopt a double-layer mesh disk structure, that is, the support frame 101 forms a double-layer mesh structure in the axial direction.
  • the support frame 101 includes an outer side away from the notch and an inner side facing the notch.
  • the membrane 103 is wrapped on the inner side of the supporting frame 101; or, the membrane 103 is wrapped on the outer side of the supporting frame 101, so as to block blood flow.
  • the coating 103 is covered on the inside and outside of the support frame 101, so that the coating 103 and the support frame 101 are completely integrated, which is more conducive to the attachment of the entire disk surface of the occlusion device 100 to the tissue, and cells The endothelialization effect is better and the endothelialization speed is faster.
  • the material of the covering film 103 includes a degradable material.
  • the degradable materials include, but are not limited to polylactic acid (Polylactic acid, PLA), polycaprolactone (Polycaprolactone, PCL), polybutylene succinate (Polybutylene succinate, PBS), 1,3-propanediol (Propanediol, PDO) and poly(L-lactide-co- ⁇ -caprolactone) series copolymers.
  • the occlusion device 100 of the present application is beneficial to improve the biocompatibility of the occlusion device 100 by using the coating 103 made of degradable materials.
  • the coating 103 will gradually degrade after being used for a certain period of time, and eventually Change into water and carbon dioxide that are easily absorbed and metabolized by the human body, thereby helping to reduce irritation to the human body, thereby reducing the long-term complication rate of the long-term indwelling occlusion device 100 .
  • the thickness of the covering film 103 is 0.001mm-0.1mm, so as to ensure that the covering film 103 has a certain While improving the strength, ensure that the covering film 103 can be easily degraded in vivo.
  • the material of the covering film 103 includes non-degradable materials.
  • the non-degradable materials include, but are not limited to polyethylene terephthalate (Polyethylene terephthalate, PET), polytetrafluoroethylene (Poly tetra Fluoroethylene, PTFE), thermoplastic polyurethane elastomer rubber (Thermoplastic polyurethanes, TPU), silicone rubber, hydrogel, polyurethane (Polyurethane, PU), polyvinyl alcohol (Polyvinyl alcohol, PVA), expanded polytetrafluoroethylene (Expanded Poly tetrafluoroethylene, expanded PTFE), polyethylene (Polyethene, PE), high density polyethylene (High density polyethylene, HDPE), polyethylene terephthalate (Polyethylene glycol terephthalate, PET) at least one.
  • the thickness of the covering film 103 is approximately 0.01-0.2 mm. In this way, while ensuring that the mechanical properties of the coating 103 meet the standards, the thickness of the coating 103 should be as thin as possible. The thinner the coating 103 is, the lower the probability of some inflammations and chronic diseases in the body caused by the coating 103 .
  • FIG. 2 is a schematic structural diagram of a first embodiment of the occlusion disk 105 of the occlusion device 100 of the occlusion system 1000 in FIG. 1 .
  • the support frame 101 and the membrane 103 constitute an occlusion disk 105 .
  • the support frame 101 is configured as a mesh structure.
  • the support skeleton 101 can be woven by braiding wires with a shape memory effect to form a mesh structure; or, the support skeleton 101 can also cut at least one of a rod-like structure, a tubular structure and a plate-like structure with a shape memory effect to form a mesh shape structure.
  • the mesh structure includes edge segments 102 and a plurality of intermediate segments 104 connecting edge segments 102 . A plurality of intermediate segments 104 are located within the area enclosed by the edge segments 102 .
  • the supporting frame 101 may be made of degradable materials and/or non-degradable materials.
  • the cover film 103 is seamlessly joined to the edge segments 102 and optionally to a plurality of intermediate segments 104 .
  • the covering film 103 is seamlessly connected with the edge section 102 and the entire middle section 104, which not only enhances the reliability and stability of the connection between the supporting frame 101 and the covering film 103, but also helps to improve the biological stability of the occluding device 100.
  • Compatibility and endothelialization rate are not easy to form complications such as thrombosis, inflammatory reaction, and endothelial hyperplasia, and the occlusion effect is better.
  • the covering film 103 can be seamlessly connected with at least part of the edge section 102, for example, the covering film 103 can be seamlessly connected with the edge section 102 through some bonding points or hot pressing points; or, the covering film 103 can also be Directly connects seamlessly with the entirety of the edge segment 102 .
  • the covering film 103 may not be fixedly connected with the middle section 104; or, the covering film 103 may also be seamlessly connected with at least part of the middle section 104, for example, by means of bonding or heat pressing to achieve seamlessness. connection; alternatively, the covering film 103 and the middle section 104 can also be connected with a gap by means of sewing or the like.
  • the covering film 103 can be seamlessly connected with at least part of the middle section 104, for example, the covering film 103 can be seamlessly connected with the middle section 104 through some bonding points or hot pressing points, or directly connected with the middle section 104. All seamlessly connected.
  • the covering film 103 may not be fixedly connected with the edge section 102; or, the covering film 103 may also be seamlessly connected with at least part of the edge section 102, for example, by means of bonding or heat pressing to achieve seamlessness. connection; or, the covering film 103 and the edge segment 102 can also be connected with a gap by means of sewing or the like.
  • the radial dimension of the coating 103 is greater than the radial dimension of the supporting frame 101, that is, the peripheral edge of the coating 103 exceeds the edge segment 102 of the supporting frame 101, and the peripheral edge of the coating 103 is a free edge , not fixed on the support frame 101.
  • the peripheral edge of the coating 103 is flush with the peripheral edge of the support frame 101 , and the peripheral edge of the coating 103 is fixed to the peripheral edge of the support frame 101 .
  • FIG. 3 is a schematic structural diagram of the supporting frame 101 of the blocking disc 105 in FIG. 2 . As shown in Fig.
  • the entire structure of the support frame 101 is made of the same material.
  • the material of the supporting frame 101 includes a biocompatible metal material, thereby enhancing the overall strength of the supporting frame 101 .
  • all structures of the supporting frame 101 are made of metal materials.
  • the material of the supporting frame 101 includes a non-degradable metal material.
  • the non-degradable metal material includes but not limited to at least one of stainless steel, tungsten alloy, cobalt-based alloy and nickel-titanium alloy.
  • the material of the supporting frame 101 includes a degradable metal material.
  • the degradable metal material includes, but is not limited to, at least one of magnesium alloy, iron alloy or zinc alloy.
  • the material of the supporting frame 101 may also include or further include at least one of polymer materials, non-degradable non-metallic materials, degradable non-metallic materials or any combination thereof.
  • the support frame 101 is configured as a mesh structure.
  • the support skeleton 101 can be woven by braiding wires with a shape memory effect to form a mesh structure; or, the support skeleton 101 can also cut at least one of a rod-like structure, a tubular structure and a plate-like structure with a shape memory effect to form a mesh shape structure.
  • the mesh structure includes edge segments 102 and a plurality of intermediate segments 104 connecting edge segments 102 .
  • a plurality of intermediate segments 104 are located within the area enclosed by the edge segments 102 . Wherein, the edge segments 102 together form a closed area.
  • Each middle section 104 is configured in an arc shape. In some embodiments, the middle section may also exhibit a linear structure.
  • the support skeleton 101 has a convergence point 1011 .
  • the network structure is formed by a plurality of support rings 111 arranged in a cross radial pattern.
  • a plurality of support rings 111 are arranged in a circumferential direction from a converging point 1011 of the network structure.
  • the number of support rings 111 is six, and the six support rings 111 are arranged in a clockwise or counterclockwise direction along a circumferential direction and are cross-connected.
  • the number of support rings 111 can also be 5, 8 or other numbers, which can be set according to actual needs. Adjacency setting or spacing setting.
  • Each supporting ring 111 can be in the shape of but not limited to ellipse, semicircle, petal or irregular shape.
  • Each support ring 111 includes a circumferential segment 106 and two intermediate segments 104 correspondingly connected to opposite ends of the circumferential segment 106 .
  • Each middle segment 104 extends radially along the circumferential segment 106 and converges at the converging point 1011, thereby enhancing the reliability and stability of the connection between the supporting frame 101 and the covering membrane 103, thereby improving the sealing capacity of the blocking device 100 Effect.
  • Each circumferential segment 106 extends along the circumferential direction of the mesh structure, and all the circumferential segments 106 are connected end to end to form the edge segment 102 .
  • Plurality of intermediate segments 104 includes a first segment 1041 and a second segment 1042 .
  • the first ends of the first section 1041 and the second section 1042 are relatively far away from the converging point 1011 of the support frame 101, and are connected to the edge section 102, and the second ends of the first section 1041 and the second section 1042 are opposite to the first end. Close to the convergence point 1011 of the support frame 101 .
  • the material of the first section 1041 and the second section 1042 are the same, and both are made of metal materials.
  • connection between any two adjacent support rings 111 can be achieved by welding, penetration and/or Or fixedly connected together by twisting and knotting.
  • the middle section 104 and the circumferential section 106 of each supporting ring 111 may both include a plurality of metal braided wires, or may be cut from a whole metal tube, or may be mixed and matched.
  • the edge section 102 when the middle section 104 is directly cut and formed from a whole metal pipe, the edge section 102 includes a plurality of metal braided wires, and the middle section 104 is welded to the inner and/or outer circumference of the edge section 102 .
  • any two adjacent support rings 111 are cross-connected to each other.
  • each support ring 111 includes multiple metal braided wires
  • the multiple metal braided wires form gaps among each other.
  • the middle section 104 of one of the supporting rings 111 is inserted in the gap of the middle section 104 of the other supporting ring 111 adjacent to it; the circumferential section 106 of one of the supporting rings 111 is inserted in the other supporting ring adjacent to it 111 in the gap of the circumferential segment 106, and optionally welded at the intersection of the two, so as to improve the connection strength.
  • the edge section 102 includes a plurality of metal braided wires and is braided to form a whole, and the middle section 104 includes a plurality of metal braided wires.
  • the middle section 104 is inserted into the gap of the edge section 102 ; alternatively, the edge section 102 is inserted into the gap of the middle section 104 .
  • the edge section 102 includes a plurality of metal braided wires, and is braided by a plurality of metal braided wires to form a whole, and the middle section 104 is directly cut and formed from a metal pipe, and the middle section 104 is inserted into the gap of the edge section 102 middle.
  • the edge section 102 is directly cut and formed from a metal tube
  • the middle section 104 includes a plurality of metal braided wires
  • the edge section 102 is inserted into the gap of the middle section 104 .
  • FIG. 4 is a schematic structural diagram of a second embodiment of the occlusion disc 105 a of the occlusion device 100 a in FIG. 1 .
  • the support frame 101a and the membrane 103 constitute an occlusion disk 105a.
  • the main difference between the supporting frame 101a provided in this embodiment and the supporting frame 101 provided in the first embodiment is that in this embodiment, the material of the edge segment 102 is the same as that of the first segment 1041, and the material of the first segment 1041 The material of the second section 1042a may be different; in addition, the covering film 103 is seamlessly connected with the edge section 102 and the first section 1041 .
  • the plurality of intersection points 113 includes a plurality of first connection points 1131 and a plurality of second connection points 1132 .
  • a first connection point 1131 is formed at the intersection of the edge segment 102 and each intermediate segment 104
  • a second connection point is formed at the intersection of each first segment 1041 and the corresponding second segment 1042a 1132.
  • the multiple first connection points 1131 are relatively far away from the converging point 1011 of the supporting frame 101
  • the multiple second connecting points 1132 are relatively close to the converging point 1011 of the supporting frame 101 .
  • first connection points 1131 are located on the edge segment 102
  • second connection points 1132 are located between the first connection points 1131 and the convergence point 1011 .
  • the covering film 103 is seamlessly connected to the support frame 101 at positions corresponding to the first connection point 1131 and/or the second connection point 1132 .
  • FIG. 5 is a schematic structural diagram of a second embodiment in which the support frame 101 a of the occlusion device 100 in FIG. 4 is in the first state.
  • part of the structure of the supporting frame 101a is made of a first material
  • another part of its structure is made of a second material, wherein the first material is different from the second material.
  • the material of the supporting frame 101a includes biocompatible non-degradable materials and degradable materials, that is, part of the structure of the supporting frame 101a is made of non-degradable materials.
  • the non-degradable materials can be the above-mentioned Non-degradable metal materials.
  • degradable materials Another part of the structure of the supporting frame 101a is made of degradable materials.
  • a degradable material is added to the support frame 101a of the occlusion device 100, thereby reducing the release of metal ions, and the degradable frame will not remain in the body after degradation, reducing the incidence of complications.
  • the degradable materials include degradable metal materials and/or the aforementioned degradable non-metallic materials.
  • Degradable non-metallic materials include, but are not limited to, polylactic acid, polycaprolactone, polybutylene succinate, 1,3-propylene glycol, and poly(L-lactide-co- ⁇ -caprolactone) Series of copolymers, polygluconate, polyhydroxybutyrate tyrate), polyanhydride (polyanhydride), polyphosphate (polyphosphoester) in one or at least two copolymers or blends.
  • the material of the first segment 1041 is different from the material of the second segment 1042a.
  • the first section 1041 is made of non-degradable material
  • the second section 1042a is made of degradable material.
  • the first section 1041 is made of a non-degradable metal material
  • the second section 1042a is made of a degradable non-metallic material, so as to ensure the overall support strength and mechanical properties such as resilience of the supporting frame 101a, while reducing the support
  • the metal content of the skeleton 101a reduces the incidence of complications.
  • the number of the first segments 1041 may be less than the number of the second segments 1042a, thereby reducing the risk of inflammation caused by the support frame 101a, which is beneficial to reducing the stimulation of the support frame 101a to the tissue to be occluded.
  • a plurality of first segments 1041 are evenly spaced, so that the overall strength of the supporting frame 101a can be ensured even after the second segment 1042a is partially or completely degraded, and the deformation of the supporting frame 101a is avoided to reduce the plugging effect.
  • the plurality of first segments 1041 are symmetrically arranged from the geometric center of the supporting frame 101a, so as to improve the force uniformity of the supporting frame 101a and better occlude the tissue to be occluded.
  • a plurality of first sections 1041 are connected with the edge section 102 to form a whole, thereby improving the overall strength of the supporting frame 101a.
  • the number of the first segments 1041 may be greater than the number of the second segments 1042a, thereby improving the overall strength and mechanical properties of the supporting frame 101a such as resilience.
  • the number of first segments 1041 can also be equal to the number of second segments 1042a, and multiple first segments 1041 and multiple second segments 1042a Alternate arrangement of settings.
  • FIG. 6 is a schematic structural diagram of a second embodiment in which the support frame 101a of the occlusion device 100 in FIG. 4 is in the second state, wherein the first state refers to the support frame 101 The state before the degradation of the plurality of second segments 1042; the second state refers to the state after the degradation of the plurality of second segments 1042 of the support frame 101.
  • the edge segment 102 is surrounded by the first segment 1041 and the second segment 1042 to form a plurality of first meshes 1012; after the degradation of the plurality of second segments 1042, the edge segment 102 Surrounded by a plurality of first sections 1041, a plurality of second meshes 1013 are formed, at least one second mesh 1013 has a size larger than that of a first mesh 1012, so that after the endothelialization of the subsequent occluding device 100, it can The tissue to be treated (such as atrial septum) is punctured at the position of the second mesh hole 1013 .
  • tissue to be treated such as atrial septum
  • the shapes and sizes of the plurality of first mesh holes 1012 may be the same or different. In this embodiment, the shapes of the plurality of first meshes 1012 are partially the same, and the rest are different. Specifically, in the circumferential direction of the support frame 101, there are two first mesh holes 1012 with the same shape and size. In the radial direction of the supporting frame 101 , any two adjacent first mesh holes 1012 have different shapes and sizes. The plurality of second mesh holes 1013 have the same shape and size, and the area of each second mesh hole 1013 is greater than the area of any one of the first mesh holes 1012 .
  • FIG. 7 is a schematic structural diagram of another embodiment of the closure device 100 a of the closure system 1000 in FIG. 1 .
  • the structure of the blocking device 100a is similar to that of the blocking device 100a in the first embodiment. The difference is that the peripheral edge of the coating 103 is flush with the peripheral edge of the supporting frame 101 , and the peripheral edge of the coating 103 is fixed on the peripheral edge of the supporting frame 101 .
  • FIG. 8 is a schematic diagram of the inner structure of the first occlusion disc 11 in the occlusion device 100 a of the occlusion system 1000 in FIG. 7 .
  • every two adjacent support rings 111 are cross-connected, and two adjacent support rings 111 cross each other to form one or more intersection points.
  • the multiple intersections of the support ring 111 only include a plurality of first connection points 1131, that is, a first connection point 1131 is formed at the intersection of each intermediate segment 104 and the edge segment 102, and any adjacent two intermediate segments 104 are far away from each other.
  • each intermediate section 104 is formed with an end connection section 114 at an end away from the edge section 102 , and any two adjacent end connection sections 114 are arranged at intervals.
  • the blocking device 100 a includes a first blocking disk 11 and a second blocking disk 13 .
  • the occlusion device 100 a further includes a pulling member 15 connecting the first occlusion disk 11 and the second occlusion disk 13 .
  • Both the first occlusion disk 11 and the second occlusion disk 13 are used to occlude the gap, that is, the first occlusion disk 11 and the second occlusion disk 13 are respectively used to cover one side of the gap in the occlusion tissue.
  • the pulling member 15 is used to adjust the distance between the first blocking disk 11 and the second blocking disk 13 .
  • the first occlusion disk 11 is located on the far side of the second occlusion disk 13, and a plurality of connection rings 12 are arranged on the first occlusion disk 11, and the pulling member 15 passes through the plurality of connection rings 12, and the
  • the first connecting ring 12 includes a plurality of first connecting rings 121 located outside the geometric center of the first blocking disk 11, and the coating 103 of the first blocking disk 11 is provided with a perforation 1031, and the perforation 1031 is connected to the first connecting ring 121.
  • a plurality of first connection rings 121 are fixed on the support frame 101 of the first blocking disc 11 through the corresponding perforations 1031, preferably, the first connection rings 121 are inserted between the plurality of metal braided wires on the support frame 101 In the gap formed between (refer to the above-mentioned implementation mode, which will not be described in detail here).
  • the pulling member 15 passes through multiple connecting rings 12 to realize the connection between the pulling member 15 and the first occlusion disk 11 .
  • the first connecting ring 121 is annular and forms a threading hole 1211 , and the pulling member 15 passes through the threading hole 1211 of the first connecting ring 121 .
  • the pulling member 15 can slide in the first connecting ring 121, thereby assisting in adjusting the length of the pulling member 15 between the first blocking disk 11 and the second blocking disk 13, and then The distance between the first blocking disk 11 and the second blocking disk 13 is adjusted.
  • the plurality of first connecting rings 121 can be fixed on the first occlusion disk 11 by means of bonding, knotting and the like.
  • a filling body is provided in the perforation 1031, so that the first connecting ring 121 is in sealing connection with the covering film 103 of the first occlusion disk 11, thereby further reducing the area of the surface of the occlusion device 100a that needs to be endothelialized.
  • the process of climbing from the edge of the occlusion device 100a to the axial direction is beneficial to improve the biocompatibility and endothelialization rate of the occlusion device 100a, and it is not easy to form complications such as thrombus, inflammatory reaction and endothelial hyperplasia.
  • the filler can be filled in the through hole 1031 by, but not limited to, electrospinning, dipping or spraying. It can be understood that the material of the covering film 103 is applicable to the material of the filling body, and the material of the filling body can also be other biocompatible materials.
  • the two ends of the pulling member 15 pass through the second blocking disk 13 and form an adjustment line knot 150 on the side of the second blocking disk 13 away from the first blocking disk 11, the first blocking disk 11 and the second blocking disk 11
  • the distance between the discs 13 can be adjusted by adjusting the end of the puller 15, so as to meet the needs of different patients and different anatomical structures of tissues.
  • the disc shape of the first blocking disk 11 and the second blocking disk 13 can be set to circular, polygonal, elliptical, triangular or other irregular shapes, the radial dimension of the first blocking disk 11 is the same as that of the second blocking disk.
  • the radial dimensions of 13 may be the same or different, for example, the radial dimension of the first blocking disk 11 is smaller than the radial dimension of the second blocking disk 13 .
  • both the first blocking disk 11 and the second blocking disk 13 are approximately hexagonal in shape, and the radial dimension of the first blocking disk 11 is equal to the radial dimension of the second blocking disk 13 .
  • the structure of the second blocking disk 13 is similar to that of the first blocking disk 11 , the difference is that the second blocking disk 13 is not provided with multiple connecting rings. The structure of the first blocking disc 11 will be described in detail below.
  • each supporting ring 111 is formed by twisting and braiding multiple braided wires or arranged side by side, that is, all the supporting rings 111 are braided by multiple strands.
  • the wire is twisted and braided to form a disk structure, so that the first occlusion disk 11 and the second occlusion disk 13 have strong flexibility and mechanical strength, and can fully adhere to the surface of the tissue to be occluded.
  • the supporting framework 101 of the first occlusion disk 11 and the support framework 101 of the second occlusion disk 13 are respectively a single-layer braided mesh structure, a single-layer cut frame structure, a double-layer braided mesh structure or a double-layer cut frame structure. any kind.
  • the supporting framework 101 of the first occlusion disk 11 and the support framework 101 of the second occlusion disk 13 are both single-layer braided mesh structures.
  • part of the support ring 111 in the first occlusion disk 11 includes multiple strands of braided wire, and other support rings 111 in the first occlusion disk 11 include a strand of braided wire.
  • the support frame 101 can also be formed into a disc structure with a hollow structure by laser cutting plate/tube-shaped nickel-titanium alloy, so as to enhance the support of the support frame 101 .
  • the plurality of connection rings 12 further include a second connection ring 122
  • the occlusion device 100 a further includes a connection piece 14
  • the second connection ring 122 is connected to the support frame 101 through the connection piece 14 .
  • the connecting piece 14 is arranged at the geometric center of the first blocking disc 11 .
  • the connecting piece 14 is arranged at an eccentric position on the first occlusion disk 11 .
  • a plurality of support rings 111 supporting the frame 101 are arranged around the circumference of the connecting member 14 .
  • the support rings 111 on the first blocking disc 11 are evenly spaced.
  • the second connecting ring 122 is connected to the connecting member 14 by, for example, winding, knotting, bonding, braiding, additional fixing parts, etc.
  • the second connecting ring 122 is roughly located at the geometric center of the first occlusive disc 11 .
  • a plurality of support rings 111 are arranged at least one week around the connecting member 14 to form a single-layer or multi-layer network structure.
  • the connecting piece 14 and the support frame 101 can be integrally formed; or can be fixedly connected together by means of welding, bonding or the like.
  • the connecting piece 14 can be a steel sleeve with open ends, and the connecting piece 14 can also be a combination of multi-layer steel sleeves. Ends of the plurality of support rings 111 are connected to the connecting piece 14 and are fixedly connected to the connecting piece 14 by means of interference fit, welding or bonding, such as being fixed to the outer peripheral surface of the connecting piece 14 .
  • the material of the connector 14 includes, but is not limited to, stainless steel, nickel-titanium alloy or other biocompatible materials.
  • the second connecting ring 122 can be fixed on the connecting member 14 by bonding, knotting, etc., so as to prevent the second connecting ring 122 from being displaced.
  • the first connecting ring 121 is disposed around the second connecting ring 122 .
  • the number of the first connecting ring 121 and the second connecting ring 122 may include one or more.
  • the number of the first connecting ring 121 includes multiple, and the number of the second connecting ring 122 includes one.
  • a plurality of first connecting rings 121 are evenly arranged around the second connecting ring 122 for at least one circle, so as to improve the uniformity of force on the first blocking disc 11 during the pulling-up and releasing process of the pulling member 15 .
  • the plurality of first connection rings 121 are evenly spaced.
  • the second connecting ring 122 is annular and forms a threading hole, and the pulling member 15 is passed through the threading hole of the first connecting ring 121 and the threading hole of the second connecting ring 122 .
  • the second connecting ring 122 is arranged at the geometric center of the first occluding disk 11, and the pulling member 15 passes through the threading hole of the second connecting ring 122 and is tightened.
  • the connection between the second connecting ring 122 and the pulling member 15 The intersection is located on the geometric center of the first blocking disk 11, so that the first blocking disk 11 is subjected to a uniform pulling force.
  • the connecting ring 12 and the puller 15 may be non-absorbable biocompatible sutures, such as metal threads, cotton threads, polyester, polypropylene, and the like.
  • the connecting ring 12 and the puller 15 can also be made of absorbable biocompatible sutures, such as catgut, polyglycolide, multi-filament non-biodegradable sutures and the like.
  • the material of the connecting ring 12 includes, but is not limited to, at least one of polypropylene, polyethylene terephthalate, and polytetrafluoroethylene.
  • the material of the pulling member 15 includes, but is not limited to at least one of polytetrafluoroethylene, polyglycolide, polyglycolide, polylactic acid, collagen, nylon suture, and polyester suture.
  • the pulling member 15 is a suture made of polytetrafluoroethylene. Due to the high mechanical strength of the polytetrafluoroethylene material, the toughness of the pulling member 15 is improved.
  • the material of the connecting ring 12 is polypropylene with good tensile strength and hardness.
  • the connecting ring 12 uses a double-strand suture, so that the occlusion device 100a has better connection strength. In other embodiments, the connecting ring 12 can also use more strands of suture, or one suture.
  • the first occlusion disk 11 is delivered to the left atrium by the conveyor 200 and deployed in the left atrium
  • the second occlusion disk 13 is delivered by the conveyor 200. Delivered to and deployed in the right atrium.
  • the puller 15 connected between the first occlusion disk 11 and the second occlusion disk 13 is flexible and its length can be adjusted.
  • the puller 15 is passed through the foramen ovale between the primary diaphragm and the secondary diaphragm Pull the free end of the puller 15 toward the proximal end, the puller 15 is tightened, and the puller 15 is located on the geometric center of the first occlusion disc 11, and the puller 15 is gradually shortened, that is, the first The distance between the occlusion disk 11 and the second occlusion disk 13 is gradually reduced, the primary diaphragm and the secondary diaphragm are close to each other and are clamped by the first occlusion disk 11 and the second occlusion disk 13, the second A blocking disk 11 covers the primary diaphragm and secondary diaphragm around the foramen ovale, and the second blocking disk 13 covers the primary diaphragm and the secondary diaphragm surrounding the foramen ovale, that is, the foramen ovale is on the left and right Openings on both sides of the atrium are covered by the first occlusion disk 11 and the second o
  • the first occlusion disc 11 and the second occlusion disc 13 all include a support frame 101 and a film 103 seamlessly connected to at least the support frame 101, the film 103 on both sides of the foramen ovale can prevent blood from flowing into the egg.
  • the round hole prevents the flow of blood from the left atrium into the right atrium for immediate closure.
  • the blocking device in the embodiment of the present application has a structure of double blocking disks, and the two blocking disks are separated.
  • the blocking device may also be columnar, that is, the supporting frame is in the shape of a plunger, and the supporting frame encloses an inner cavity.
  • the occluding device can also be an integrated double occluding disk structure, and an integrally formed waist is arranged between the double occluding disks, or it can be in other regular or irregular shapes, and the specific structure of the occluding device is not limited. .
  • the covering film can be arranged at a preset position on the support frame as required.
  • the preset position may be the outer surface of the supporting frame for contacting the tissue surrounding the gap, or the inner cavity surrounded by the supporting frame.
  • the porosity of the coating can be increased, so as to facilitate the infiltration of tissue cells into the coating, and facilitate the endothelialization of the supporting framework and the coating.
  • the occlusion device and the occlusion system provided in the embodiments of the present application are based on seamlessly connecting at least part of the covering film with the support frame, thereby reducing the area of the surface of the occlusion device that needs to be endothelialized.
  • the occlusion tissue crawls from the edge of the occlusion device to the axial direction, which is beneficial to increase the rate of endothelialization of the occlusion device.

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Abstract

一种封堵装置（100、100a）和封堵系统（1000）。封堵装置（100、100a）包括支撑骨架（101、101a）和覆膜（103）。支撑骨架（101、101a）用于释放于组织中的缺口处，支撑骨架（101、101a）的周向边缘用于覆盖缺口周缘组织。覆膜（103）覆盖于支撑骨架（101、101a）的至少一侧，覆膜（103）中的至少部分与支撑骨架（101、101a）无缝连接，从而减小了封堵装置（100、100a）需要内皮化的表面的面积，提高了覆膜（103）与支撑骨架（101、101a）之间的连接强度，降低了覆膜（103）与支撑骨架（101、101a）在内皮化过程中相互脱离的可能性，避免了封堵装置（100、100a）局部内皮化较好，局部内皮化速度较慢的情况发生，不容易形成血栓、炎症反应及内皮增生等并发症，有利于提高封堵装置（100、100a）内皮化的速率。

Description

封堵装置与封堵系统
本申请要求于2021年12月24日提交中国专利局、申请号为202111604804.9、申请名称为“封堵装置与封堵系统”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，尤其涉及一种封堵装置与封堵系统。
 背景技术
卵圆孔（Foramen Ovale）是心脏房间隔胚胎时期的一个生理性通道，一般在出生后第1年内闭合，而成年人中约有20%～25%卵圆孔不完全闭合，卵圆孔未闭是目前成人中最为常见的先天性心脏异常之一。
近几年来的研究发现，卵圆孔未闭 (Patent Oval Foramen，PFO)和不明原因缺血性脑卒中、偏头痛等有较为密切的关系。研究认为PFO可以作为来自静脉循环“反常栓子”，引发卒中。已有大量临床数据证实10％～40％的PFO与不明原因脑卒中的发生密切相关。中国每年至少有15～50万脑卒中患者是PFO引起。一系列研究表明，不明原因脑卒中患者，年龄低于55岁的PFO发生率约为47～56％。
目前对于PFO治疗方式，主要是药物治疗和PFO封堵（PFO封堵相比于药物，有着明显优势）。
然而，现有技术中的卵圆孔未闭封堵装置，将覆膜通过缝合、其他固定件固定的方式结合在骨架上，造成盘面与待封堵组织贴附不良，导致内皮化速率过慢，封堵装置局部内皮化明显，部分内皮化不全，封堵性不佳的问题出现。
 技术问题
有鉴于此，本申请提供一种封堵装置与封堵系统，以解决覆膜与支撑骨架的缝隙大而导致内皮化速率过慢的问题。
 技术解决方案
第一方面，本申请实施例提供一种封堵装置，所述封堵装置用于封堵组织中的缺口，所述封堵装置包括：支撑骨架，所述支撑骨架用于释放于所述缺口处，所述支撑骨架的周向边缘用于覆盖所述缺口周缘组织；覆膜，覆盖于所述支撑骨架的至少一侧，所述覆膜中的至少部分与所述支撑骨架无缝连接。
在一些实施例中，所述覆膜通过静电纺丝方式、浸渍方式或喷涂方式直接形成于所述支撑骨架上；或者，所述覆膜通过静电纺丝方式、浸渍方式、喷涂方式、流延成型方式或编织方式成型，成型后的覆膜通过热压方式或粘接方式固定于所述支撑骨架上。
在一些实施例中，所述支撑骨架包括背离所述缺口的外侧及朝向所述缺口的内侧，所述覆膜包覆于所述支撑骨架的内侧；或者，包覆于所述支撑骨架的外侧；或者，包覆于所述支撑骨架的内侧和外侧。
在一些实施例中，所述覆膜的材料包括不可降解材料，所述不可降解材料包括聚对苯二甲酸乙二醇酯、聚四氟乙烯、热塑性聚氨酯弹性体橡胶、硅橡胶、聚氨酯、聚乙烯醇、水凝胶、膨体聚四氟乙烯、聚乙烯、高密度聚乙烯、聚对苯二甲酸乙二醇酯中的至少一种。
在一些实施例中，所述覆膜的厚度为0.01-0.2mm。
在一些实施例中，所述覆膜的材料包括可降解材料，所述可降解材料包括聚乳酸、聚己内酯、聚丁二酸丁二醇酯、1,3-丙二醇和聚(L-丙交酯-co-ε-己内酯)系列共聚物中的至少一种。
在一些实施例中，所述覆膜的厚度为0.001mm-0.1mm。
在一些实施例中，所述支撑骨架构造为网状结构，所述网状结构包括边缘段和连接所述边缘段的多个中间段，所述多个中间段位于所述边缘段围成的区域内，所述覆膜与所述边缘段及可选择地与所述多个中间段无缝连接。
在一些实施例中，所述支撑骨架的材料包括可降解材料和不可降解材料中的至少一种。
在一些实施例中，所述支撑骨架的一部分结构由所述可降解材料制成，所述支撑骨架的其余部分结构由不可降解材料制成。
在一些实施例中，所述中间段包括多个第一段和多个第二段，所述边缘段和所述多个第一段由不可降解材料制成，所述多个第二段由可降解材料制成。
在一些实施例中，所述边缘段与所述第一段和所述第二段合围形成多个第一网孔；所述边缘段与所述多个第一段合围形成多个第二网孔，至少一所述第二网孔的尺寸大于一所述第一网孔的尺寸。
在一些实施例中，每一个所述中间段与所述边缘段的交叉处形成有第一连接点，每一个所述第一段与对应的第二段的交叉处形成有第二连接点，所述覆膜与所述支撑骨架在所述第一连接点和所述第二连接点的位置处无缝连接。
在一些实施例中，所述覆膜与所述边缘段及全部所述中间段无缝连接。
在一些实施例中，所述支撑骨架与所述覆膜构成封堵盘，所述封堵盘包括第一封堵盘和第二封堵盘，所述封堵装置还包括连接所述第一封堵盘和所述第二封堵盘的牵拉件，所述第一封堵盘和所述第二封堵盘分别用于封堵所述缺口的一侧，所述牵拉件用于调节所述第一封堵盘和所述第二封堵盘之间的距离。
在一些实施例中，所述第一封堵盘位于所述第二封堵盘的远端，所述第一封堵盘上设置有多个连接环，所述牵拉件穿过所述多个连接环，以实现所述牵拉件与所述第一封堵盘连接；所述多个连接环包括位于所述第一封堵盘的几何中心外的多个第一连接环，所述第一封堵盘的覆膜上开设有穿孔，所述多个第一连接环穿过所述穿孔而固定于所述第一封堵盘的支撑骨架上。
在一些实施例中，所述穿孔内设置有填充体，以使得所述第一连接环与所述第一封堵盘的覆膜密封连接。
在一些实施例中，所述填充体通过静电纺丝方式、浸渍方式或喷涂方式填充于所述穿孔内。
在一些实施例中，所述多个连接环包括位于所述第一封堵盘的几何中心的第二连接环，所述第二连接环固定于支撑骨架上。
第二方面，本申请实施例提供一种封堵系统，包括输送器以及如上所述的封堵装置，所述输送器用于将所述封堵装置输送至所述缺口。
 有益效果
本申请实施例提供的封堵装置及封堵系统，基于将覆膜覆盖于支撑骨架的至少一侧，覆膜中的至少部分与支撑骨架无缝连接，组织从封堵装置的边缘向其轴线方向爬附，减小了封堵装置需要内皮化的表面的面积，另外还提高了覆膜与支撑骨架之间的连接强度，降低了覆膜与支撑骨架在内皮化过程中相互脱离的比例以及可能性，减少或避免了封堵装置局部内皮化较好，局部内皮化速度较慢的情况发生，不容易形成血栓、炎症反应以及内皮增生等并发症，有利于提高封堵装置内皮化的速率。
 附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术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申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1是本申请实施例提供的封堵系统的结构示意图。
图2是图1中的封堵系统的封堵装置的封堵盘的第一实施方式的结构示意图。
图3是图2中的封堵系统的封堵装置的支撑骨架的结构示意图。
图4是图1中的封堵系统的封堵装置的封堵盘的第二实施方式的结构示意图。
图5是图4中的封堵系统的封堵装置的支撑骨架的第一状态的结构示意图。
图6是图4中的封堵系统的封堵装置的支撑骨架的第二状态的结构示意图。
图7是图1中的封堵系统的封堵装置的另一实施方式的结构示意图。
图8是图7中的封堵系统的封堵装置的第一封堵盘的内侧结构示意图。
1000、封堵系统；100，100a、封堵装置；101，101a、支撑骨架；1011、中心汇聚点；1012、第一网孔；1013、第二网孔；102、边缘段；104、中间段；1041、第一段；1042，1042a、第二段；103、覆膜；1031、穿孔；105，105a、封堵盘；111、支撑环；113、交叉点；1131、第一连接点；1132、第二连接点；114、端部连接段；11、第一封堵盘；13、第二封堵盘；12、连接环；121、第一连接环；1211、穿线孔；122、第二连接环；14、连接件；15、牵拉件；150、调节线结；200、输送器；201、鞘管；202、控制手柄。
 本发明的实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例，都属于本申请保护的范围。
首先需要说明的是，在介入医疗领域，沿着器械的输送路径，通常将器械靠近操作者的一端称作近端，将器械远离操作者的一端称作远端。具体地，针对用于将可植入装置输送并释放于患者体内的输送器而言，远端是指输送器可自由插入到动物或人体体内的一端，近端是指输送器供用户或机器操作的一端。
可以理解的是，本申请的说明书和权利要求书及上述附图中的术语仅是为了描述特定实施例，并非要限制本申请。本申请的说明书和权利要求书及上述附图中的术语“第一”、“第二”等是用于区别不同对象，而非用于描述特定顺序。除非上下文另有明确表述，否则单数形式“一”和“所述”也旨在包括复数形式。术语“包括”以及它们任何变形，意图在于覆盖不排他的包含。此外，本申请可以以多种不同的形式来实现，并不限于本实施例所描述的实施例。提供以下具体实施例的目的是便于对本申请公开内容更清楚透彻的理解，其中上、下、左、右等指示方位的字词仅是针对所示结构在对应附图中位置而言。
说明书后续描述为实施本申请的较佳实施例，然而上述描述乃以说明本申请的一般原则为目的，并非用以限定本申请的范围。本申请的保护范围当视所附权利要求所界定者为准。
请参阅图1，图1所示为本申请实施例提供的封堵系统1000的结构示意图。封堵系统1000包括输送器200及封堵装置100。封堵装置100用于封堵待封堵组织中的缺口。输送器200用于将封堵装置100输送并释放于该缺口。所述待封堵组织中的缺口例如是，但不局限于脉管系统中的组织缺损部位。所述缺口包括但不限于卵圆孔、动脉导管、房间隔、室间隔、左心耳口部等。例如，封堵装置100可以是，但不局限于左心耳封堵装置、PFO封堵装置、房间隔封堵装置或室间隔封堵装置等。需要说明的是，本申请中以所述缺口为卵圆孔为例，说明封堵系统1000用于治疗卵圆孔未闭的优势。可以理解的是，所述缺口还可以是上述提到的其它组织缺损部位。
具体地，在本实施例中，输送器200包括用于收容封堵装置100的鞘管201及固定于鞘管201近端的控制手柄202。控制手柄202用于控制封堵装置100从鞘管201内伸出，并且释放至所述缺口处；或者，用于控制封堵装置100回收至鞘管201内。
本领技术人员应当理解的是，所述图1仅是封堵系统1000的示例，并不构成对封堵系统1000的限定，且封堵系统1000可以包括比图1所示更多或更少的部件，或者组合某些部件，或者不同的部件，例如封堵系统1000还可以包括定位器及传感器等。
封堵装置100用于封堵组织中的缺口。封堵装置100包括支撑骨架101和覆膜103。支撑骨架101用于释放于缺口处，支撑骨架101的周向边缘用于覆盖缺口周缘组织，支撑骨架101的轴线位置可能用于接触缺口周缘组织，或者用于封堵在缺口中，（即用于封堵在缺口周缘组织围成的通道中）。本申请实施例提供的封堵装置100，基于将覆膜103覆盖于支撑骨架101的至少一侧，覆膜103中的至少部分与支撑骨架101无缝连接，组织从封堵装置100的边缘向其轴线方向爬附，减小了封堵装置100需要内皮化的表面的面积，另外还提高了覆膜103与支撑骨架101之间的连接强度，降低了覆膜103与支撑骨架101在内皮化过程中相互脱离的比例以及可能性，减少或避免了封堵装置100局部内皮化较好，局部内皮化速度较慢的情况发生，不容易形成血栓、炎症反应以及内皮增生等并发症，有利于提高封堵装置100内皮化的速率。
在一些实施例中，覆膜103通过静电纺丝方式、浸渍方式或喷涂方式直接形成于支撑骨架101上，从而覆膜103能够紧紧地形成于支撑骨架101的外表面上，即覆膜103包覆于支撑骨架101的表面，以实现覆膜103与支撑骨架101之间的无缝连接。在另一些实施例中，覆膜103通过静电纺丝方式、浸渍方式、喷涂方式、流延成型方式或编织方式成型，成型后的覆膜通过热压方式或粘接方式固定于支撑骨架101上，从而覆膜103能够贴接于支撑骨架101的外表面，以减少在支撑骨架101与覆膜103之间的连接处产生缝隙。
优选地，在本实施例中，覆膜103通过静电纺丝方式形成于支撑骨架101上，以获得孔隙率较大的覆膜103，从而使细胞更好的浸润到覆膜103的内部，利于细胞的爬覆以及内皮化，使组织与细胞更好的结合。
本实施方式中，封堵装置100包括两个封堵盘，分别为第一封堵盘11与第二封堵盘13。第一封堵盘11与第二封堵盘13的结构相似，两个封堵盘中均包括上述支撑骨架101以及覆膜103，覆膜103覆盖于对应支撑骨架101的至少一侧，覆膜103中的至少部分与对应支撑骨架101无缝连接。在变更实施方式中，两个封堵盘中的一个封堵盘包括上述的支撑骨架101以及覆膜103，覆膜103覆盖于支撑骨架101的至少一侧，覆膜103中的至少部分与支撑骨架101无缝连接；两个封堵盘中的另一个封堵盘仅包括支撑骨架101，即省略覆膜103，或者另一封堵盘上设置的覆膜与支撑骨架101并未采用无缝连接的连接方式，比如采用缝合、额外设置固定件进行固定等工艺连接于支撑骨架。
本实施方式中，第一封堵盘11与第二封堵盘13均为单层盘面形状，即在轴向上，支撑骨架101形成单层的网面结构。第一封堵盘11与第二封堵盘13用于在缺口的两侧贴附在缺口两侧的周缘组织上。在变更实施方式中，第一封堵盘11与第二封堵盘13中的任意一个可以采用双层网盘的结构，即支撑骨架101在轴向上形成双层的网面结构。
支撑骨架101包括背离缺口的外侧及朝向缺口的内侧。在一些实施例中，覆膜103包覆于支撑骨架101的内侧；或者，覆膜103包覆于支撑骨架101的外侧，以实现封堵血流。在其它一些实施例中，覆膜103包覆于支撑骨架101的内侧和外侧，从而实现覆膜103与支撑骨架101完全一体化，更有利于封堵装置100的整个盘面与组织贴附，细胞内皮化效果更佳，且内皮化速度较快。
可选地，在本实施例中，覆膜103的材料包括可降解材料。所述可降解材料包括，但不局限于聚乳酸（Polylactic acid，PLA）、聚己内酯(Polycaprolactone，PCL)、聚丁二酸丁二醇酯（Poly butylene succinate，PBS）、1,3-丙二醇（Propanediol，PDO）和聚(L-丙交酯-co-ε-己内酯)系列共聚物中的至少一种。如此，本申请的封堵装置100通过采用由可降解材料制成的覆膜103，有利于提高封堵装置100的生物相容性，覆膜103在使用到一定时间后会逐渐降解，并最终变成容易被人体吸收和代谢的水和二氧化碳，从而有利于减小对人体的刺激，进而能够降低封堵装置100长期留置的远期并发症率。可选地，为了兼顾覆膜103的强度及覆膜103的降解度，当覆膜103由可降解材料制成时，覆膜103的厚度为0.001mm-0.1mm，从而确保覆膜103具有一定强度的同时，确保覆膜103能够在体内容易降解。
在一些实施例中，覆膜103的材料包括不可降解材料。所述不可降解材料包括，但不局限于聚对苯二甲酸乙二醇酯（Polyethylene terephthalate，PET）、聚四氟乙烯（Poly tetra fluoroethylene，PTFE）、热塑性聚氨酯弹性体橡胶(Thermoplastic polyurethanes，TPU)、硅橡胶、水凝胶、聚氨酯（Polyurethane，PU）、聚乙烯醇（Polyvinyl alcohol，PVA）、膨体聚四氟乙烯（Expanded Poly tetra fluoroethylene，expanded PTFE）、聚乙烯（Polyethene，PE）、高密度聚乙烯（High density polyethylene，HDPE）、聚对苯二甲酸乙二醇酯（Polyethylene glycol terephthalate，PET）中的至少一种。当覆膜103由不可降解材料制成时，覆膜103的厚度大致为0.01-0.2mm。如此，在确保覆膜103的力学性能达标的情况下，覆膜103的厚度尽量薄一些，覆膜103的厚度越薄，覆膜103所造成体内的一些炎症、慢性病的概率越低。
请一并参阅图1和图2，图2所示是图1中的封堵系统1000的封堵装置100的封堵盘105的第一实施方式的结构示意图。如图2所示，支撑骨架101和覆膜103构成封堵盘105。
支撑骨架101构造为网状结构。支撑骨架101可以由具有形状记忆效应的编织丝编织而形成网状结构；或者，支撑骨架101还可以切割具有形状记忆效应的杆状结构、管状结构及板状结构中的至少一者而形成网状结构。网状结构包括边缘段102和连接边缘段102的多个中间段104。多个中间段104位于边缘段102围成的区域内。在本实施例中，支撑骨架101可以由可降解材料和/或不可降解材料制成。
覆膜103与边缘段102及可选择地与多个中间段104无缝连接。在一些实施例中，覆膜103与边缘段102及全部中间段104无缝连接，不仅增强了支撑骨架101与覆膜103连接的可靠性和稳定性，且有利于提高封堵装置100的生物相容性与内皮化的速率，不容易形成血栓、炎症反应以及内皮增生等并发症，且封堵效果更佳。
在一些实施方式中，覆膜103可以与边缘段102中的至少部分无缝连接，比如覆膜103通过一些粘接点或热压点与边缘段102无缝连接；或者，覆膜103还可以直接与边缘段102的全部无缝连接。在这种实施方式中，覆膜103可以与中间段104不固定连接；或者，覆膜103还可以与中间段104中的至少部分无缝连接，例如，粘接或热压等方式实现无缝连接；或者，覆膜103还可以与中间段104通过缝合等方式实现有缝隙连接。
在一些实施方式中，覆膜103可以与中间段104中的至少部分无缝连接，比如覆膜103通过一些粘接点或热压点与中间段104无缝连接，或者直接与中间段104的全部无缝连接。在这种实施方式中，覆膜103可以与边缘段102不固定连接；或者，覆膜103还可以与边缘段102中的至少部分无缝连接，例如，粘接或热压等方式实现无缝连接；或者，覆膜103还可以与边缘段102通过缝合等方式实现有缝隙连接。
如图1所示，覆膜103的径向尺寸大于支撑骨架101的径向尺寸，即，覆膜103的周向边缘超出支撑骨架101的边缘段102，覆膜103的周向边缘为自由边缘，并未固定在支撑骨架101。在一些实施方式中，比如图2所示，覆膜103的周向边缘与支撑骨架101的周向边缘平齐，覆膜103的周向边缘固定在支撑骨架101的周向边缘。请一并参阅图2和图3，图3所示为图2中的封堵盘105的支撑骨架101的结构示意图。如图3所示，支撑骨架101的全部结构由同一材料制成。具体地，支撑骨架101的材料包括具有生物相容性的金属材料，从而增强了支撑骨架101的整体强度。在本实施例中，支撑骨架101的全部结构均由金属材料制成。在一些实施例中，支撑骨架101的材料包括不可降解金属材料。不可降解金属材料包括但不局限于不锈钢、钨合金、钴基合金和镍钛合金中的至少一种。在其它一些实施例中，支撑骨架101的材料包括可降解金属材料。可降解金属材料包括，但不局限于镁合金、铁合金或锌合金中的至少一种。在一些实施例中，支撑骨架101的材料还可以包括或进一步包括高分子聚合物材料、不可降解的非金属材料、可降解的非金属材料中的至少一者或它们之间的任意组合。
支撑骨架101构造为网状结构。支撑骨架101可以由具有形状记忆效应的编织丝编织而形成网状结构；或者，支撑骨架101还可以切割具有形状记忆效应的杆状结构、管状结构及板状结构中的至少一者而形成网状结构。网状结构包括边缘段102和连接边缘段102的多个中间段104。多个中间段104位于边缘段102围成的区域内。其中，边缘段102共同围合形成一封闭区域。每一个中间段104构造成弧形结构。在一些实施方式中，中间段还可以呈现为直线型结构。
具体地，支撑骨架101具有汇聚点1011。网状结构由多个支撑环111呈交叉放射状排列形成。多个支撑环111自网状结构的汇聚点1011沿周向排布。在本实施例中，支撑环111的数量为六个，六个支撑环111按顺时针方向或逆时针方向沿周向排列且交叉连接。其他实施例中，支撑环111的数量还可以为5个、8个或其他数量，具体可以依据实际需要而设置，例如多个支撑环111按顺时针方向或逆时针方向沿周向排列且彼此邻接设置或间隔设置。每一支撑环111可以呈但不局限于椭圆、半圆形、花瓣形或不规则形状等。每一个支撑环111包括一个周向段106和与周向段106的相对两端分别对应连接的两个中间段104。每一个中间段104沿周向段106的径向延伸，且在汇聚点1011汇集，从而增强了支撑骨架101与覆膜103连接的可靠性和稳定性，进而提升了封堵装置100的封堵效果。每一个周向段106沿网状结构的周向延伸，且所有周向段106首尾相连而形成边缘段102。
多个中间段104包括第一段1041和第二段1042。第一段1041与第二段1042的第一端均相对远离支撑骨架101的汇聚点1011，且与边缘段102相连接，第一段1041与第二段1042的第二端均相对第一端靠近支撑骨架101的汇聚点1011。在本实施例中，第一段1041的材料和第二段1042的材料相同，且均由金属材料制成。
在一些实施例中，任意相邻两个支撑环111之间的连接，即边缘段102与中间段104之间及任意相邻两个中间段104之间的连接，可以通过焊接、穿插和/或缠绕打结等方式固定连接在一起。每一个支撑环111的中间段104和周向段106可以是均包括多根金属编织丝，也可以是即均由整根金属管切割而成，还可以是两者混合搭配。具体地，在一些实施方式中，中间段104由整根金属管直接切割成型得到时，边缘段102包括多根金属编织丝，中间段104与边缘段102的内周和/或外周焊接连接。
在其它一些实施方式中，任意相邻两个支撑环111相互交叉连接。具体地，每一个支撑环111包括多根金属编织丝时，多根金属编织丝彼此之间形成缝隙。其中一个支撑环111的中间段104穿插于与其相邻的其中另一个支撑环111的中间段104的缝隙中；其中一个支撑环111的周向段106穿插于与其相邻的其中另一个支撑环111的周向段106的缝隙中，并且可选择地在两者的交叉处焊接，以提高连接强度。
在一些实施例中，边缘段102包括多根金属编织丝，且由多根金属编织丝编织形成一个整体，中间段104包括多根金属编织丝。在这种实施例中，中间段104穿插于边缘段102的缝隙中；或者，边缘段102穿插于中间段104的缝隙中。在另一些实施例中，边缘段102包括多根金属编织丝，且由多根金属编织丝编织形成一个整体，中间段104由金属管直接切割成型得到，中间段104穿插于边缘段102的缝隙中。在其它一些实施例中，边缘段102由金属管直接切割成型得到，中间段104包括多根金属编织丝，边缘段102穿插于中间段104的缝隙中。
请参阅图4，图4所示是图1中的封堵装置100a的封堵盘105a的第二实施方式的结构示意图。如图4所示，支撑骨架101a和覆膜103构成封堵盘105a。在本实施例中提供的支撑骨架101a与第一实施方式提供的支撑骨架101的主要区别在于，本实施方式中，边缘段102的材料与第一段1041的材料相同，第一段1041的材料可以与第二段1042a的材料不同；另外覆膜103与边缘段102及第一段1041无缝连接。
每相邻的两个支撑环111交叉连接，且相邻的两个支撑环111彼此交叉而形成一个或多个交叉点113。多个交叉点113包括多个第一连接点1131和多个第二连接点1132。在本实施例中，边缘段102与每一个中间段104的交叉处形成有一个第一连接点1131，每一个第一段1041与对应的第二段1042a的交叉处形成有一个第二连接点1132。多个第一连接点1131相对远离支撑骨架101的汇聚点1011，多个第二连接点1132相对靠近支撑骨架101的汇聚点1011。具体地，多个第一连接点1131位于边缘段102上，多个第二连接点1132位于第一连接点1131和汇聚点1011之间。可选地，覆膜103与支撑骨架101在对应第一连接点1131和/或第二连接点1132的位置处无缝连接。
请一并参阅图4和图5，图5所示为图4中的封堵装置100的支撑骨架101a处于第一状态的第二实施方式的结构示意图。如图5所示，支撑骨架101a的部分结构由第一材料制成，另一部分结构由第二材料制成，其中，第一材料不同于第二材料。具体地，支撑骨架101a的材料同时包括具有生物相容性的不可降解材料和可降解材料，即支撑骨架101a的部分结构由不可降解材料制成，在本实施例中，不可降解材料可以为上述不可降解金属材料。支撑骨架101a的另一部分结构由可降解材料制成。本申请中封堵装置100的支撑骨架101a中加入可降解材料，从而减少了金属离子的释放，可降解骨架降解后不会留在体内，降低了并发症的发生率。所述可降解材料包括可降解金属材料和/或上述可降解非金属材料。可降解非金属材料包括，但不局限于聚乳酸、聚己内酯、聚丁二酸丁二醇酯、1,3-丙二醇和聚(L-丙交酯-co-ε-己内酯)系列共聚物、聚葡萄糖酸(polyglyconate)、聚羟丁酸(polyhydroxybu tyrate)、聚酸酐(polyanhydride)、聚磷酸酯(polyphosphoester)中的一种或至少两种的共聚或共混物。
如图5所示，第一段1041的材料不同于第二段1042a的材料。在本实施例中，第一段1041由不可降解材料制成，第二段1042a由可降解材料制成。优选地，第一段1041由不可降解的金属材料制成，第二段1042a由可降解的非金属材料制成，从而确保支撑骨架101a的整体支撑强度以及回弹性等机械性能，同时减少了支撑骨架101a的金属含量，降低了并发症的发生率。
在本实施例中，第一段1041的数量可以少于第二段1042a的数量，从而降低了支撑骨架101a引起的炎症反应的风险，有利于减小支撑骨架101a对待封堵组织的刺激。具体地，多个第一段1041均匀间隔设置，如此在第二段1042a部分或全部降解后仍能够确保支撑骨架101a的整体强度，避免支撑骨架101a发生变形而出现降低封堵效果的现象。可选地，多个第一段1041自支撑骨架101a的几何中心呈中心对称设置，从而提高支撑骨架101a的受力均匀性且更好封堵待封堵组织。多个第一段1041与边缘段102连接而形成一个整体，从而提升了支撑骨架101a的整体强度。在一些实施例中，第一段1041的数量还可以多于第二段1042a的数量，从而提升了支撑骨架101a的整体强度以及回弹性等机械性能。在另一些实施例中，为了兼顾支撑骨架101a的强度及生物相容性，第一段1041的数量还可以等于第二段1042a的数量，且多个第一段1041和多个第二段1042a交替排布设置。
请一并参阅图5和图6，图6所示为图4中的封堵装置100的支撑骨架101a处于第二状态的第二实施方式的结构示意图，其中，第一状态是指支撑骨架101的多个第二段1042降解之前的状态；第二状态是指支撑骨架101的多个第二段1042降解之后的状态。可以理解地，在多个第二段1042降解之前，边缘段102与第一段1041与第二段1042合围形成多个第一网孔1012；在多个第二段1042降解之后，边缘段102与多个第一段1041合围形成多个第二网孔1013，至少一个第二网孔1013的尺寸大于一第一网孔1012的尺寸，从而便于后续封堵装置100内皮化之后，能够在第二网孔1013的位置处进行待治疗组织（例如房间隔）穿刺。可选地，第二段1042a和覆膜103的材料均为可降解材料的情况下，更便于穿刺操作。多个第一网孔1012的形状和大小可以相同也可以不同。本实施方式中，多个第一网孔1012的形状部分相同，其余部分不相同。具体地，在支撑骨架101的周向上，具有两个形状和大小相同的第一网孔1012。在支撑骨架101的径向上，任意相邻的两个第一网孔1012的形状和尺寸均不同。多个第二网孔1013形状与大小均相同，每个第二网孔1013的面积均大于任意一个第一网孔1012的面积。
请参阅图7，图7所示是图1中的封堵系统1000的封堵装置100a的另一实施方式的结构示意图。在本实施例中，封堵装置100a的结构与第一实施例的封堵装置100a的结构相似。不同之处在于，覆膜103的周向边缘与支撑骨架101的周向边缘平齐，覆膜103的周向边缘固定在支撑骨架101的周向边缘。
请一并参阅图1和图7至图8，图8是图7中的封堵系统1000的封堵装置100a中的第一封堵盘11的内侧结构示意图。在本实施例中，每相邻的两个支撑环111交叉连接，且相邻的两个支撑环111彼此交叉而形成一个或多个交叉点。支撑环111的多个交叉点仅包括多个第一连接点1131，即每一个中间段104与边缘段102的交叉处形成有第一连接点1131，任意相邻的两个中间段104在远离边缘段102的一端相互结合并形成有端部连接段114，从而确保支撑骨架101的整体支撑强度以及回弹性等机械性能。可选地，覆膜103与支撑骨架101在对应第一连接点1131和/或多个端部连接段114的位置处无缝连接。如图1所示，在一些实施例中，每一个中间段104在远离边缘段102的一端形成有端部连接段114，且任意相邻的两个端部连接段114间隔设置。
在本实施例中，封堵装置100a包括第一封堵盘11、第二封堵盘13。封堵装置100a还包括连接第一封堵盘11和第二封堵盘13的牵拉件15。第一封堵盘11和第二封堵盘13均用于封堵缺口，即第一封堵盘11和第二封堵盘13分别用于覆盖封堵组织中的缺口的一侧。牵拉件15用于调节第一封堵盘11和第二封堵盘13之间的距离。
具体地，第一封堵盘11位于第二封堵盘13的远侧，第一封堵盘11上设置有多个连接环12，牵拉件15穿过所述多个连接环12，多个连接环12包括位于第一封堵盘11的几何中心外的多个第一连接环121，第一封堵盘11的覆膜103上开设有穿孔1031，穿孔1031与第一连接环121一一对应，多个第一连接环121穿过对应穿孔1031而固定于第一封堵盘11的支撑骨架101上，优选地，第一连接环121穿插于支撑骨架101上多根金属编织丝之间形成的缝隙中（参考上述实施方式，在此不做赘述）。牵拉件15穿过多个连接环12，以实现牵拉件15与第一封堵盘11连接。
第一连接环121呈环状并形成穿线孔1211，牵拉件15穿过第一连接环121的穿线孔1211。当拉紧牵拉件15时，牵拉件15能够在第一连接环121中滑动，从而协助调节第一封堵盘11与第二封堵盘13之间的牵拉件15的长度，进而调节第一封堵盘11和第二封堵盘13之间的距离。多个第一连接环121可以通过粘接、打结等方式固定于第一封堵盘11上。
可选地，穿孔1031内设置有填充体，以使得第一连接环121与第一封堵盘11的覆膜103密封连接，从而进一步减小封堵装置100a需要内皮化的表面的面积，组织从封堵装置100a的边缘向轴线方向爬附的过程中，有利于提高封堵装置100a的生物相容性与内皮化的速率，不容易形成血栓、炎症反应以及内皮增生等并发症。填充体可以，但不局限于通过静电纺丝方式、浸渍方式或喷涂方式填充于穿孔1031内。可以理解地，覆膜103的材料适用于填充体的材料，填充体的材料还可以为其它具有生物相容性的材料。
牵拉件15的两端穿过第二封堵盘13并在第二封堵盘13背离第一封堵盘11的一侧形成调节线结150，第一封堵盘11与第二封堵盘13之间的间距能够通过调节牵拉件15的端部来调节，以适应不同患者及不同组织解剖结构的需求。第一封堵盘11与第二封堵盘13的盘面形状可以设置为圆形、多边形、椭圆形、三角形或者其他不规则形状，第一封堵盘11的径向尺寸与第二封堵盘13的径向尺寸可以相同，也可以不同，比如，第一封堵盘11的径向尺寸小于第二封堵盘13的径向尺寸。本实施例中，第一封堵盘11及第二封堵盘13均呈大致六边形盘状，第一封堵盘11的径向尺寸等于第二封堵盘13的径向尺寸。第二封堵盘13的结构与第一封堵盘11的结构相似，不同之处在于，第二封堵盘13上未设置多个连接环。下面以第一封堵盘11的结构进行详细介绍。
在本实施例中，第二封堵盘13与第一封堵盘11中，每一支撑环111均由多股编织丝缠绕编织或并排设置而成，即所有支撑环111均由多股编织丝缠绕编织而形成盘状结构，使得第一封堵盘11及第二封堵盘13具有较强的柔韧性以及机械强度，能充分与待封堵组织的表面贴合。第一封堵盘11的支撑骨架101与第二封堵盘13的支撑骨架101分别为单层编织网状结构、单层切割框架结构、双层编织网状结构或者双层切割框架结构中的任意一种。本实施例中，第一封堵盘11的支撑骨架101与第二封堵盘13的支撑骨架101均为单层编织网状结构。
可以理解的是，在一些实施方式中，第一封堵盘11中的部分支撑环111是包括多股编织丝的，第一封堵盘11中的其它支撑环111包括一股编织丝。在一些实施例中，支撑骨架101还可以通过激光切割板/管状的镍钛合金而形成具有镂空结构的盘状结构，从而增强支撑骨架101的支撑性。
第一封堵盘11中，多个连接环12还包括第二连接环122，封堵装置100a还包括连接件14，第二连接环122通过连接件14连接于支撑骨架101上。连接件14设置在第一封堵盘11的几何中心。在其它实施方式中，连接件14设置在第一封堵盘11上偏心的位置。具体地，支撑骨架101的多个支撑环111围绕连接件14的周向设置。优选地，第一封堵盘11上的支撑环111均匀间隔排布。第二连接环122连接于连接件14上，可以采用比如通过缠绕、打结、粘接、编织、额外固定件等方式，第二连接环122大致位于第一封堵盘11的几何中心。可选地，多个支撑环111围绕连接件14周向布置至少一周，以形成单层或多层网状结构。
连接件14与支撑骨架101可以一体成型；或者可以通过焊接、粘接等方式固定连接在一起。连接件14可以两端开口的钢套，连接件14也可以是多层钢套的组合。多个支撑环111的端部连接于连接件14，且通过过盈配合、焊接或粘接的方式固定连接于连接件14，比如固定于连接件14的外周面。连接件14的材质包括，但不局限于不锈钢、镍钛合金或其他生物相容性材料。
第二连接环122可以通过粘接、打结等方式固定于连接件14上，以防止第二连接环122发生移位。第一连接环121围绕第二连接环122的周围设置。第一连接环121及第二连接环122的数量可以均包括一个或多个。在本实施例中，第一连接环121的数量包括多个，第二连接环122的数量包括一个。优选地，多个第一连接环121围绕第二连接环122均匀布置至少一圈，以提高牵拉件15收线放线过程中第一封堵盘11受力的均匀性。在一些实施方式中，多个第一连接环121是均匀间隔分布的。第二连接环122呈环形并形成穿线孔，牵拉件15穿设于第一连接环121的穿线孔及第二连接环122的穿线孔中。
优选地，第二连接环122设置于第一封堵盘11的几何中心，牵拉件15穿过第二连接环122的穿线孔后并拉紧，第二连接环122与牵拉件15的相交处位于第一封堵盘11的几何中心上，从而使第一封堵盘11受到均匀的拉力，第一封堵盘11定位后调节牵拉件15的长度时，第一封堵盘11不容易发生偏斜。
连接环12与牵拉件15可选为非吸收生物相容性缝合线，例如金属线、棉线、聚酯、聚丙烯等。连接环12与牵拉件15也可选用可吸收生物相容性缝合线，例如羊肠线、聚乙交酯、多丝非生物可降解缝合线等。
在本实施例中，连接环12的材料包括，但不局限于聚丙烯、聚对苯二甲酸乙二醇酯、聚四氟乙烯中的至少一种。牵拉件15的材料包括，但不局限于聚四氟乙烯、聚乙交酯、聚乙丙交酯、聚乳酸、胶原蛋白、尼龙缝合线、聚酯缝合线中的至少一种。优选地，牵拉件15为聚四氟乙烯制成的缝合线。由于聚四氟乙烯材料的机械强度高，因此提升了牵拉件15的韧性。优选地，连接环12的材料选用有较好的抗拉强度和硬度的聚丙烯。连接环12采用的是双股缝合线，使封堵装置100a有更好的连接强度。在其它实施方式中，连接环12还可以采用更多股股缝合线，或者一股缝合线。
请一并参阅图1至图8，在使用的过程中，第一封堵盘11被输送器200输送至从左心房并在所述左心房中展开，第二封堵盘13被输送器200输送至右心房并在右心房中展开。连接于第一封堵盘11与第二封堵盘13之间的牵拉件15具有柔性且长度可以调节，牵拉件15穿设在原发膈与继发膈之间的卵圆孔中；向近端拉动牵拉件15的自由端，牵拉件15被拉紧，且牵拉件15位于第一封堵盘11的几何中心上，并使牵拉件15逐渐缩短，即第一封堵盘11与第二封堵盘13之间的间距逐渐缩小，所述原发膈与所述继发膈相互靠近并被第一封堵盘11和第二封堵盘13夹持，第一封堵盘11在卵圆孔的周围覆盖原发膈与继发膈，并且第二封堵盘13在卵圆孔的周围覆盖原发膈与继发膈，即所述卵圆孔在左右心房中的两侧开口分别被第一封堵盘11与第二封堵盘13覆盖。由于第一封堵盘11及第二封堵盘13均包括支撑骨架101以及无缝连接于至少支撑骨架101上的覆膜103，卵圆孔两侧的覆膜103能阻止血液流入所述卵圆孔，从而避免了血流从左心房流入右心房，以实现即时封堵。在封堵装置100、100植入后，原发膈与继发膈向第一封堵盘11及第二封堵盘13的接触位置爬附，以完成内皮化后使卵圆孔闭合，形成完整的房间隔。
本申请实施方式中的封堵装置为双封堵盘结构，两个封堵盘是分体的。在变更实施方式中，封堵装置还可以是呈柱状，即支撑骨架呈柱塞状，支撑骨架围成一内腔。封堵装置还可以呈一体式的双封堵盘结构，该双封堵盘之间还设置有一体成型的腰部，或者是呈其他规则或不规则形状，对封堵装置的具体结构不进行限定。
可以理解的是，覆膜可以根据需要设置于支撑骨架上的预设位置。该预设位置，可以是支撑骨架上用于接触缺口周缘组织的外侧面，也可以是支撑骨架围成的内腔。
可以理解的是，在一些实施方式中，可以增大覆膜的孔隙率，从而便于组织细胞浸润至覆膜中，便于支撑骨架与覆膜的内皮化。
本申请实施例提供的封堵装置及封堵系统，基于将所述覆膜中的至少部分与所述支撑骨架无缝连接，从而减小了封堵装置需要内皮化的表面的面积，待封堵组织从封堵装置的边缘向轴线方向爬附，有利于提高封堵装置内皮化的速率。
以上对本申请实施例进行了详细介绍，本文中应用了具体个例对本申请的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本申请的方法及其核心思想；同时，对于本领域的一般技术人员，依据本申请的思想，在具体实施方式及应用范围上均会有改变之处，综上上述，本说明书内容不应理解为对本申请的限制。

Claims (20)

  1. 一种封堵装置，其特征在于，所述封堵装置用于封堵组织中的缺口，所述封堵装置包括：
    支撑骨架，所述支撑骨架用于释放于所述缺口处，所述支撑骨架的周向边缘用于覆盖所述缺口周缘组织；
    覆膜，覆盖于所述支撑骨架的至少一侧，所述覆膜中的至少部分与所述支撑骨架无缝连接。
  2. 如权利要求1所述的封堵装置，其特征在于，所述覆膜通过静电纺丝方式、浸渍方式或喷涂方式直接形成于所述支撑骨架上；或者，
    所述覆膜通过静电纺丝方式、浸渍方式、喷涂方式、流延成型方式或编织方式成型，成型后的所述覆膜通过热压方式或粘接方式固定于所述支撑骨架上。
  3. 如权利要求1所述的封堵装置，其特征在于，所述支撑骨架包括背离所述缺口的外侧及朝向所述缺口的内侧，所述覆膜包覆于所述支撑骨架的内侧；或者，包覆于所述支撑骨架的外侧；或者，包覆于所述支撑骨架的内侧和外侧。
  4. 如权利要求1所述的封堵装置，其特征在于，所述覆膜的材料包括不可降解材料，所述不可降解材料包括聚对苯二甲酸乙二醇酯、聚四氟乙烯、热塑性聚氨酯弹性体橡胶、硅橡胶、水凝胶、聚氨酯、聚乙烯醇、膨体聚四氟乙烯、聚乙烯、高密度聚乙烯、聚对苯二甲酸乙二醇酯中的至少一种。
  5. 如权利要求4所述的封堵装置，其特征在于，所述覆膜的厚度为0.01-0.2mm。
  6. 如权利要求1所述的封堵装置，其特征在于，所述覆膜的材料包括可降解材料，所述可降解材料包括聚乳酸、聚己内酯、聚丁二酸丁二醇酯、1,3-丙二醇和聚(L-丙交酯-co-ε-己内酯)系列共聚物中的至少一种。
  7. 如权利要求6所述的封堵装置，其特征在于，所述覆膜的厚度为0.001mm-0.1mm。
  8. 如权利要求1所述的封堵装置，其特征在于，所述支撑骨架的材料包括可降解材料和不可降解材料中的至少一种。
  9. 如权利要求8所述的封堵装置，其特征在于，所述支撑骨架的一部分结构由所述可降解材料制成，所述支撑骨架的其余部分结构由不可降解材料制成。
  10. 如权利要求8所述的封堵装置，其特征在于，所述支撑骨架构造为网状结构，所述网状结构包括边缘段和连接所述边缘段的多个中间段，所述多个中间段位于所述边缘段围成的区域内，所述覆膜与所述边缘段及可选择地与所述多个中间段无缝连接。
  11. 如权利要求10所述的封堵装置，其特征在于，所述多个中间段包括多个第一段和多个第二段，所述边缘段和所述多个第一段由不可降解材料制成，所述多个第二段由可降解材料制成。
  12. 如权利要求11所述的封堵装置，其特征在于，所述边缘段与所述第一段和所述第二段合围形成多个第一网孔；所述边缘段与所述多个第一段合围形成多个第二网孔，至少一所述第二网孔的尺寸大于一所述第一网孔的尺寸。
  13. 如权利要求10所述的封堵装置，其特征在于，每一个所述中间段与所述边缘段的交叉处形成有第一连接点，每一个所述第一段与对应的所述第二段的交叉处形成有第二连接点，所述覆膜与所述支撑骨架在所述第一连接点和所述第二连接点的位置处无缝连接。
  14. 如权利要求10所述的封堵装置，其特征在于，所述覆膜与所述边缘段及全部所述中间段无缝连接。
  15. 如权利要求1-14任意一项所述的封堵装置，其特征在于，所述封堵装置包括第一封堵盘和第二封堵盘，所述支撑骨架与所述覆膜构成所述第一封堵盘与所述第二封堵盘，所述封堵装置还包括连接所述第一封堵盘和所述第二封堵盘的牵拉件，所述第一封堵盘和所述第二封堵盘分别用于封堵所述缺口的一侧，所述牵拉件用于调节所述第一封堵盘和所述第二封堵盘之间的距离。
  16. 如权利要求15所述的封堵装置，其特征在于，所述第一封堵盘位于所述第二封堵盘的远端，所述第一封堵盘上设置有多个连接环，所述牵拉件穿过所述多个连接环，以实现所述牵拉件与所述第一封堵盘连接；所述多个连接环包括位于所述第一封堵盘的几何中心外的多个第一连接环，所述第一封堵盘的所述覆膜上开设有穿孔，所述多个第一连接环穿过所述穿孔而固定于所述第一封堵盘的所述支撑骨架上。
  17. 如权利要求16所述的封堵装置，其特征在于，所述穿孔内设置有填充体，以使得所述第一连接环与所述第一封堵盘的所述覆膜密封连接。
  18. 如权利要求17所述的封堵装置，其特征在于，所述填充体通过静电纺丝方式、浸渍方式或喷涂方式填充于所述穿孔内。
  19. 如权利要求16所述的封堵装置，其特征在于，所述多个连接环包括第二连接环，所述第一封堵盘的所述支撑骨架还包括连接件，所述第二连接环连接于所述连接件。
  20. 一种封堵系统，其特征在于，包括输送器以及如权利要求1-19任意一项所述的封堵装置，所述输送器用于将所述封堵装置输送至所述缺口。
PCT/CN2022/141163 2021-12-24 2022-12-22 封堵装置与封堵系统 WO2023116837A1 (zh)

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