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WO2025139956A1 - Covered stent and delivery system - Google Patents

Covered stent and delivery system Download PDF

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Publication number
WO2025139956A1
WO2025139956A1 PCT/CN2024/140284 CN2024140284W WO2025139956A1 WO 2025139956 A1 WO2025139956 A1 WO 2025139956A1 CN 2024140284 W CN2024140284 W CN 2024140284W WO 2025139956 A1 WO2025139956 A1 WO 2025139956A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
channel
embedded
segment
wave
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.)
Pending
Application number
PCT/CN2024/140284
Other languages
French (fr)
Chinese (zh)
Inventor
徐旸
唐江峰
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
Publication of WO2025139956A1 publication Critical patent/WO2025139956A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/072Encapsulated stents, e.g. wire or whole stent embedded in lining
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91508Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a difference in amplitude along the band
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91516Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a change in frequency along the band
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91566Adjacent bands being connected to each other connected trough to trough
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/91583Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a stent graft and a delivery system.
  • the iliac arteries include the common iliac arteries, the external iliac arteries and the internal iliac arteries.
  • an iliac artery bifurcation stent and an internal iliac covered stent can be implanted through intravascular therapy to reconstruct the arterial blood vessels.
  • the iliac artery bifurcation stent in the prior art usually has two branch channels, which are used to reconstruct the internal iliac artery and the external iliac artery respectively.
  • the waveform design of the internal iliac artery channel will provide a certain support strength.
  • the first wave ring includes a plurality of first wave rods, and support members are provided between adjacent first wave rods, and the plurality of support members are configured to make the compressible distance between the first wave rods at the second channel portion smaller than the compressible distance between the first wave rods at the first channel portion.
  • a gap is provided between the support member and the adjacent first wave rod, and the gap at the second channel portion is smaller than the gap at the first channel portion.
  • the support member is an elastic support member, both sides of which are respectively connected to two adjacent first wave rods, and the elastic modulus of the elastic support member at the second channel portion is greater than the elastic modulus of the elastic support member at the first channel portion.
  • the support strength of the tumor cavity segment at the proximal or distal end is greater than the support strength at the middle position.
  • FIG2 is a schematic diagram of the main support structure in Embodiment 1 of the present invention.
  • FIG4 is a schematic diagram of the wave angle distribution structure of the first wave ring in Embodiment 1 of the present invention.
  • FIG7 is a schematic diagram of the structure of the support members of different lengths of the first wave coil in the second embodiment of the present invention.
  • FIG8 is a schematic diagram of the structure of the support members of different heights of the first wave coil in the second embodiment of the present invention.
  • FIG10 is a schematic diagram of the structure of a stent graft in other embodiments of the second embodiment of the present invention.
  • FIG11 is a schematic diagram of the structure of the main support in Embodiment 3 of the present invention.
  • FIG12 is a schematic diagram of a structure in which a first wave coil is provided with a fracture in Embodiment 3 of the present invention.
  • FIG13 is a schematic diagram of the overall structure of the stent graft in Embodiment 4 of the present invention.
  • FIG14 is a schematic diagram of a structure of different wire diameters of a first embedded stent and a second embedded stent in Embodiment 4 of the present invention.
  • FIG16 is a schematic diagram of a structure of different grid densities of a first embedded bracket and a second embedded bracket in Embodiment 5 of the present invention.
  • FIG. 17 is a schematic diagram showing that the first channel and the second channel of the tumor cavity segment in Embodiment 6 of the present invention have different axial lengths.
  • FIG18 is a schematic diagram of the flat structure of the exposed section of the second embedded bracket in Embodiment 6 of the present invention.
  • FIG20 is a schematic diagram of a structure in which a variable diameter proximal wave ring is provided at the proximal end of the tumor cavity segment in Embodiment 6 of the present invention.
  • FIG21 is a schematic diagram of another stent graft structure in Embodiment 6 of the present invention.
  • FIG22 is a schematic diagram of the structure of a stent graft in Embodiment 7 of the present invention.
  • FIG24 is a schematic diagram of different axial lengths of the first embedded bracket and the second embedded bracket in Embodiment 7 of the present invention.
  • FIG. 31 is a schematic diagram of the structure of the hook and the hanging rod in Embodiment 9 and Embodiment 10 of the present invention.
  • the proximal segment 101 of the stent graft 100 can be anchored to the innominate artery, the distal segment 103 is anchored to the right common carotid artery, the second channel 1022 connects the right common carotid artery and the innominate artery, and the first channel 1021 connects the right clavicular artery and the innominate artery by inserting a stent.
  • the proximal segment 101 and the distal segment 103 of the stent graft 100 provided by itself may not be directly anchored on the blood vessel, but may be indirectly fixed by anchoring to other stents.
  • the above is only an example of the more common application positions of the stent graft 100 provided by the present application in the human body, and does not limit the application of the stent graft 100 provided by the present application.
  • the stent graft 100 provided by the present application may also be applicable to other bifurcated blood vessel locations in the human body.
  • the total support strength of the first channel 1021 and the embedded stent 20 of the tumor cavity section 102 of the coated stent 100 of the present application is set to be less than the support strength of the second channel 1022; in this way, the part with small support strength will be deformed first and the deformation amount will be large when subjected to the squeezing force, while the part with large support strength will be deformed slowly and the deformation will be large.
  • the second channel 1022 has a greater supporting strength to ensure that it deforms less when subjected to the same extrusion force as the first channel 1021, thereby maintaining the shape of the second channel 1022.
  • the first channel 1021 due to its smaller supporting strength, deforms first and with a greater amount, so that the deformation of the tumor cavity segment 102 falls more on the first channel 1021, maintaining the shape of the second channel 1022; and the first channel 1021, due to the provision of the embedded stent 20, the part of the embedded stent 20 that is not connected to the tumor cavity segment 102 in the cavity is basically not deformed, and can still maintain a good channel shape.
  • the embedded stent 20 has a mesh body 201 and a second covering 202, wherein the mesh body 201 adopts a mesh woven stent structure, and the mesh support structure can provide better tension, thereby providing better shape retention, and the mesh body 201 can provide more contact sites when the iliac stent is implanted, so that there is greater friction between the iliac stent and the embedded stent 20, which can effectively enhance the adhesion and the anti-slip performance of the stent; please refer to FIG.
  • the supporting strength of the first coating 104 is set to be greater than the supporting strength of the second coating 202.
  • the first coating 104 adopts PET film and the second coating 202 adopts ePTFE film.
  • the PET film has the characteristics of high tensile strength, while the ePTFE film has weak tensile strength, smooth surface, and is not easy to form thrombus. It has good long-term patency and small pores for small blood vessels. Combining the PET film and the ePTFE film can not only ensure the overall strength of the stent coating, but also make the coated stent 100 have a better effect of isolating blood flow, ensuring the long-term patency of the branch and good blocking effect.
  • the supporting strength of the first coating 104 is greater than the supporting strength of the second coating 202, which can make the supporting strength of the coating part of the second channel 1022 part greater than the supporting strength of the embedded stent 20 of the first channel 1021 part, so that the embedded stent 20 is easier to deform than the second channel 1022 part, and thus easily deforms with the deformation of the first channel 1021 part.
  • the coated stent 100 when the coated stent 100 is folded and compressed, since the wave peak positions are not constrained by suturing, other suturing points can be slightly displaced to adapt to the folding of the coating and the deformation of the stent wave rings, so that the coated stent can be better folded; further, the unsutured wave peaks can reduce the suturing ratio of the coating, so the coating can have better flexibility to adapt to blood vessels with more complex curvatures.
  • the tumor cavity segment 102 includes a plurality of first wave circles 1023 spaced apart in the axial direction, and the first wave circles 1023 are also Z-shaped annular wave circles.
  • the plurality of first wave circles 1023 are set to have the same wave number, and the wave crests and/or wave troughs of adjacent first wave circles 1023 are set relative to each other.
  • the same wave number is set and the wave crests and/or wave troughs are set relative to each other, that is, the space between adjacent first wave circles 1023 is approximately
  • the parallel arrangement allows for uniform spacing between adjacent first wave coils 1023, which are connected only by a covering membrane, and thus have better flexibility, which helps the tumor cavity segment 102 to better conform to the curvature of the blood vessel; preferably, the wave number of the first wave coil 1023 can be made equal to the wave number of the proximal support wave coil 1011, and the wave crests and/or wave troughs are arranged relatively to each other, so that the connection between the tumor cavity segment 102 and the proximal segment 101 and between the tumor cavity segment 102 and the proximal segment 101 also maintains good flexibility.
  • the wave height of all waveforms of the first wave ring 1023 can be gradually increased from the second channel 1022 portion to the first channel 1021 portion, and the wave angle can be gradually reduced, so as to form a structure with gradually decreasing support strength.
  • the gradual reduction of support strength can avoid the tumor cavity segment 102 from suddenly forming a large support strength difference at the junction of the second channel 1022 portion and the first channel 1021 portion, thereby causing unpredictable and unexpected deformation of the tumor cavity segment 102 at this position.
  • the embedded stent 20 is woven with metal braided wires of smaller wire diameter.
  • the wire diameter d of the embedded stent 20 is smaller than half of the wire diameter D of the first wave coil 1023 of the second channel 1022, that is, d is smaller than half D, and the wire diameter M of the first wave coil 1023 of the first channel 1021 is also smaller than that of the first wave coil 1023 of the second channel 1022.
  • the wire diameters of the embedded bracket 20 and the first wave coil 1023 of the first channel 1021 part of the present application are not limited to the above settings.
  • the technicians can adjust the wire diameters of the embedded bracket 20 and the wire diameters of the first wave coil 1023 of the first channel 1021 part according to the actual bracket requirements to ensure that the sum of their supporting strengths is smaller than that of the second channel 1022 part.
  • the support strength of the tumor cavity segment 102 at the proximal and/or distal ends may also be greater than the support strength at the middle position; in one embodiment, the support strength of the first wave ring 1023 at the proximal and distal ends of the tumor cavity segment 102 is greater than the support strength of the first wave ring 1023 at the middle position.
  • This setting is because when a blood vessel usually forms a tumor cavity, the intersection of the tumor cavity and the normal blood vessel is usually a location where the compression is more severe.
  • the first wave ring 1023 at the proximal and distal ends of the tumor cavity segment 102 is set to have a higher support strength, which can better resist the compression from the intersection of the blood vessel and the tumor cavity; further By setting the middle position to a lower support strength, the tumor cavity segment 102 can have a certain degree of flexibility and better adapt to the shape of the blood vessel; in other embodiments, only the support strength of the first wave coil 1023 located at the proximal position of the tumor cavity segment 102 can be set greater than the support strength of the first wave coil 1023 at the middle position, so as to at least ensure the support strength of the stent at the blood inflow position; in order to achieve the above-mentioned change in support strength, the wire diameter or wave angle of the proximal first wave coil 1023 of the tumor cavity segment 102 can be made greater than the wire diameter or wave angle of the first wave coil 1023 at the middle position.
  • the support strength is specifically manifested as the deformation of the overall tubular inner cavity (the first channel 1021 portion and the second channel 1022 portion) of the coated stent 100 after the tumor cavity segment 102 is compressed, that is, under the same force conditions, the same force (the force needs to make the first channel 1021 portion and the second channel 1022 portion both deform) is used to press the outer side walls of the first channel 1021 portion and the second channel 1022 portion, and the radial cross-sectional areas of the first channel 1021 portion and the second channel 1022 portion after pressing are measured and calculated.
  • the bracket with a larger total cross-sectional area measured after compression has a greater support strength
  • the bracket with a smaller total cross-sectional area has a smaller support strength.
  • the support member 10233 can be a straight-line structure with two side ends, and in order to avoid the two side ends of the straight-line structure support member 10233 piercing the membrane and scratching the blood vessel, the two ends can be bent to form a ring or the two ends can be formed into an anti-damage head end, etc., which is not shown in the figure; it can be understood that multiple straight-line structure support members 10233 can be support members 10233 with the same length, which are respectively arranged at different axial positions between adjacent first wave bars 10232, for example, in the second channel 1022 part, the support members 10233 with the same length are arranged near the wave angle position to provide a smaller gap 10234; it can also be understood that multiple straight-line structure support members 10233 can be support members 10233 with different lengths, which are respectively arranged at the same axial position between adjacent first wave bars 10232, for example, the length of the support member 10233 in the second channel 1022 part is greater than the length of the support member 10233
  • the elastic deformation degree of 235 is small, that is, when the elastic modulus is large, the deformation degree of the two adjacent first wave rods 10232 that can be close to each other is small, and the support strength that can be provided is large; in this way, by setting the elastic modulus of the elastic support member 10235 of the second channel 1022 portion to be greater than the elastic modulus of the elastic support member 10235 of the first channel 1021 portion; the elastic support member 10235 with a large elastic modulus provides a greater supporting force in the second channel 1022 portion, and conversely, the elastic support member 10235 with a small elastic modulus provides a smaller supporting force in the first channel 1021 portion.
  • the elastic support member 10235 can be a spring structure, both sides of the spring structure are respectively connected to the first wave rods 10232 on both sides, and the elastic modulus of the spring structure of the second channel 1022 portion is set to be greater than the elastic modulus of the spring structure of the first channel 1021 portion.
  • the elastic support member 10235 can be an elastic connecting member with a spring member in the middle and connecting structures on both sides, wherein the deformation distance of the first wave rods 10232 on both sides can be limited by setting the total length of the middle spring member; for example, the length of the spring member of the elastic connecting member in the second channel 1022 is set to be smaller than the length of the spring member of the elastic connecting member in the first channel 1021; the deformation degree that can be provided by the shorter spring member is smaller than the deformation degree that can be provided by the longer spring member, so that, under the same force, the shorter spring member reaches the deformation limit first compared with the longer spring member, thereby providing a stable supporting force.
  • the axial length of the tumor cavity segment 102 located in the first channel 1021 and the embedded stent 20 can be made smaller than the axial length of the second channel 1022 so that the support position when compressed in the radial direction is reduced and the area that can withstand the pressure is small; thus, the support strength of the tumor cavity segment 102 located in the first channel 1021 can be made smaller than the support strength of the second channel 1022;
  • the distal port and the opening 1024 of the embedded stent 20 may be both configured as oblique openings, and the oblique openings are oriented in a direction away from the second channel 1022; and the oblique openings may also enable the internal iliac stent to have a larger selection entrance when the embedded stent 20 is implanted, thereby reducing the difficulty of selection; wherein the proximal port of the embedded stent 20 is also configured as an oblique opening to increase the receiving area for blood flow.
  • the support member 10233 is at least partially provided with a developing structure (not shown in the figure).
  • a developing structure the shape of the support member 10233 can be set to a shape and structure with a marking identification function according to needs, such as a letter-shaped support member 10233 or a number-shaped support member 10233.
  • the support member 10233 can also be entirely a developing structure.
  • the preferred developing structure can be tantalum wire or gold wire.
  • the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first embodiment, except that the first wave coil 1023 is provided with a break 10231 at least in a portion of the first channel 1021. It can be understood that the first wave coil 1023 is provided with a break 10231 to form a C-shaped wave coil 1026, and the first wave coil 1023 does not provide supporting force at the position of the break 10231.
  • the break 10231 is located in the first channel 1021, so that the tumor cavity segment 102 is only covered by the membrane at the position of the first channel 1021, without the support of the first wave coil 1023, and the supporting force of the first channel 1021 is provided by the embedded support 20, and the supporting strength of the embedded support 20 is lower than the supporting strength of the first wave coil 1023, so that the supporting strength of the tumor cavity segment 102 in the first channel 1021 is less than the supporting strength in the second channel 1022.
  • the fracture 10231 only covers the position where the embedded stent 20 is connected to the membrane of the tumor cavity segment 102, and the broken ends of the C-shaped wave ring 1026 are connected to the two sides of the connection position between the embedded stent 20 and the membrane of the tumor cavity segment 102, that is, the first channel 1021 of the tumor cavity segment 102 is only connected to the embedded stent 20, and there is no support force provided by the first wave ring 1023.
  • the two ends of the C-shaped wave coil 1026 located at the fracture 10231 are wrapped around to form a circular ring structure 10261 or an anti-damage end.
  • the circular ring structure 10261 can store the ends of the metal wires of the braided C-shaped wave coil 1026, thereby preventing the sharp ends from piercing the membrane and scratching the blood vessels.
  • the structures of the main stent 10 and the embedded stent 20 are substantially the same as those in the first embodiment, except that the embedded stent 20 in the tumor cavity segment 102 includes a first embedded stent 21 and a second embedded stent 22 arranged in a radial direction, wherein the first embedded stent 21 is communicated with the distal segment 103; an opening 1024 is provided at the distal end of the tumor cavity segment 102, and a distal port of the second embedded stent 22 is communicated with the opening 1024; wherein the tumor cavity segment 102 includes a first channel 1021 and a second channel 1022, wherein the second channel 1022 accommodates the first embedded stent 21, and the first channel 1021 accommodates the second embedded stent 22;
  • the second channel 1022 and the first channel 1021 are separated by the embedded first embedded bracket 21 and the second embedded bracket 22 to form a blood flow cavity.
  • the first embedded bracket 21 and the second embedded bracket 22 can respectively provide support to maintain the channel shape to avoid occlusion due to pressure; the first embedded bracket 21 is arranged in the second channel 1022, so that when extrusion occurs, the first embedded bracket 21 of the second channel 1022 has a supporting force that resists the second embedded bracket 22 of the first channel 1021, so that the coated stent 100 of the present application can be implanted in the first iliac stent.
  • the first channel 1021 can also avoid the occlusion of the second channel 1022 caused by excessive squeezing of the second channel 1022 by the first channel 1021, thereby better maintaining the overall shape and smoothness of the dual channels; wherein, the blood inlet at the proximal section 101 and the blood outlet at the distal end of the tumor cavity section 102 are both occupied by the proximal port and the distal port of the first embedded stent 21 and the second embedded stent 22, so that when the blood flows from the proximal section 101 into the tumor cavity section 102, it is diverted by the first embedded stent 21 and the second embedded stent 22.
  • the present application sets the support strength of the portion of the tumor cavity segment 102 of the coated stent 100 that is in the second channel 1022 as a whole to be greater than the support strength of the portion that is in the first channel 1021; that is, it can be achieved by setting the support strength of the first embedded stent 21 to be greater than the support strength of the second embedded stent 22, on the premise that the support strength of the tumor cavity segment 102 is uniform; or on the premise that the support strength of the first embedded stent 21 is equal to the support strength of the second embedded stent 22, the support strength of the second channel 1022 of the tumor cavity segment 102 is greater than the support strength of the first channel 1021; or the support strength of the first embedded stent 21 is set to be greater than the support strength of the second embedded stent 22 and the support strength of the
  • the first embedded stent 21 and the second embedded stent 22 both have a mesh body 201 and a second surface coating 202, and the tumor cavity section 102 of the main stent 10 includes a plurality of first wave rings 1023 spaced apart along the axial direction, and the mesh body 201 can provide better ductility, and the second surface coating 202 of the first embedded stent 21 and the second embedded stent 22 can be opened more smoothly to prevent local positions from being squeezed and collapsed, and at the same time, more support sites can be provided to conflict with the iliac internal stent during implantation to increase friction; by adjusting the first embedded stent 21 and the second internal The wire diameter of the embedded stent 22, and the wire diameter of the first wave coil 1023 located in the second channel 1022 and the wire diameter of the first wave coil 1023 located in the first channel 1021 can be adjusted to make the first channel 1021 part and the second channel 1022 part of the stent graft 100 located in the
  • a larger stent wire diameter can provide higher support performance. Therefore, by making the wire diameter of the first embedded stent 21 larger than the wire diameter of the second embedded stent 22, and/or the wire diameter of the first wave coil 1023 located in the second channel 1022 larger than the wire diameter of the first wave coil 1023 located in the first channel 1021;
  • the wire diameter of the first embedded stent 21 is larger than the wire diameter of the second embedded stent 22, and the wire diameter of the first wave coil 1023 located in the second channel 1022 is larger than the wire diameter of the first wave coil 1023 located in the first channel 1021; the wire diameter of the first wave coil 1023 in the first channel 1021 is small, and when the tumor cavity section 102 is subjected to the extrusion force, the first wave coil 1023 in the first channel 1021 is deformed first before the first wave coil 1023 in the second channel 1022, thereby preferentially affecting the deformation of the second embedded stent 22 located in the first channel 1021, and because the wire diameter of the second embedded stent 22 is It is smaller than the first embedded stent 21, so that the deformation of the second embedded stent 22 is better than that of the first embedded stent 21, and the supporting strength on the single-layer stent is distributed to the inner and outer two-layer stents for sharing, so that the supporting strength on a
  • the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first and fourth embodiments, except that, in the present embodiment, by making the mesh density of the first embedded support 21 greater than the mesh density of the second embedded support 22, the support strength of the tumor cavity section 102 of the coated support 100 as a whole in the second channel 1022 is set to be greater than the support strength of the part in the first channel 1021.
  • the first embedded support 21 and the second embedded support 22 include a mesh body 201, and the mesh body 201 has a plurality of mesh structures.
  • a higher mesh density means an increase in the number of braided wires required, and a smaller area of a single mesh means a greater pressure that can be withstood, and a larger mesh density can provide a greater support strength.
  • the first embedded bracket 21 and the second embedded bracket 22 have a woven diamond grid structure
  • the first embedded bracket 21 has a first diamond grid
  • the second embedded bracket 22 has a second diamond grid
  • the first diamond grid and the second diamond grid both have an upper vertex and a lower vertex in the axial direction, and a left vertex and a right vertex in the radial direction
  • the spacing between the upper vertex and the lower vertex of the first diamond grid is D1
  • the spacing between the left vertex and the right vertex is L1.
  • the spacing between the upper vertex and the lower vertex of the second diamond grid is D2, and the spacing between the left vertex and the right vertex is L2; preferably, D1 and L1 can be made smaller than D2 and L2, so that the area occupied by a single first diamond grid is smaller than the area occupied by a single second diamond grid, so that, under the same bracket deployment area, the first embedded bracket 21 has a higher grid density, providing a stronger support strength than the second embedded bracket 22.
  • the L1 of the first diamond grid can be at least smaller than the L2 of the second diamond grid, so that the density of the first diamond grid is changed only in the circumferential direction of the first embedded bracket 21. In this way, the density of the first diamond grid can be increased at least in the radial direction, thereby achieving the effect of enhancing the support strength in the radial direction.
  • the wave angle of the first wave loop 1023 of the tumor cavity segment 102 located in the second channel 1022 is greater than the wave angle of the first wave loop 1023 located in the first channel 1021; in another embodiment, the wave height of all waveforms of the first wave loop 1023 can be gradually increased from the second channel 1022 portion to the first channel 1021 portion, and the wave angle can be gradually reduced, forming a structure with gradually decreasing support strength; in this way, the gradual reduction of support strength can avoid the tumor cavity segment 102 from suddenly forming a large support strength difference at the junction of the second channel 1022 portion and the first channel 1021 portion, thereby causing unpredictable and unexpected deformation of the tumor cavity segment 102 at this position.
  • the problem of poor flexibility of the bracket at some positions which may be caused by setting changes in support strength only on the first embedded bracket 21 and the second embedded bracket 22 or setting strength changes on the first wave coil 1023 of the tumor cavity segment 102 can be avoided.
  • the support strength of the tumor cavity section 102 of the coated stent 100 as a whole that is located in the second channel 1022 can be set to be greater than the support strength of the part that is located in the first channel 1021.
  • the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first embodiment and the fourth to fifth embodiments, except that the support strength of the tumor cavity segment 102 in the first channel 1021 and the second channel 1022 is changed by providing different axial lengths (H1 and H2 in FIG. 17 ) to the first channel 1021 and the second channel 1022 of the tumor cavity segment 102; specifically, the axial length H2 of the second channel 1022 is greater than the axial length H1 of the first channel 1021, and the tumor cavity segment 102 has an axial length H2 in the second channel 1022.
  • a channel 1021 has an axial length H1, and the length of H2 is greater than the length of H1, so that when the second channel 1022 of the tumor cavity section 102 is under pressure, the length and contact area that can withstand pressure are greater than the compressed length and contact area of the first channel 1021, so that the pressure is better dispersed, providing better support performance and improving support strength; please refer to Figures 18 and 19, wherein the distal end of the second embedded stent 22 includes an exposed segment 221, the exposed segment 221 passes through the opening 1024, and the exposed segment 221 passes through the first channel 1021, so that the first channel 1021 of the coated stent 100 also has There is a distribution of different support strengths.
  • the distal end of the exposed section 221 is a flat end or an oblique end; when it is set to a flat end, the exposed section 221 can have more attachment support positions with the intervened internal iliac stent, thereby effectively improving the long-term stability of the internal iliac stent after intervention; and when it is set to an oblique end, the opening direction of the oblique end is in the direction away from the second channel 1022, so that the internal iliac stent can be enlarged without enlarging the diameter of the second embedded stent 22.
  • the selection entrance of the stent makes the selection of the internal iliac stent faster and more convenient; and the enlarged selection entrance can also improve the accuracy of the selection of the internal iliac stent; in some embodiments, the exposed section 221 is fitted with the adjacent second channel 1022, and the exposed section 221 can be a free end and can be separated from the second channel 1022.
  • the support of the position where the second channel 1022 contacts the exposed section 221 is effectively weakened, so that when the selection port of the internal iliac stent of the exposed section 221 is compressed and the position where the second channel 1022 abuts can undergo a certain amount of deformation, thereby buffering the squeezing force and preventing the selection port from being further squeezed.
  • a proximal wave ring 1025 is provided at the proximal position of the tumor cavity segment 102.
  • the proximal wave ring 1025 at the proximal end of the tumor cavity segment 102 is set so that the proximal diameter is smaller than the distal diameter, so that the proximal wave ring 1025 has an inclined angle, forming a stent structure that is narrow near and wide far away.
  • the distal port of the first embedded stent 21 is an oblique port or a flat port
  • the distal port of the second embedded stent 22 is also an oblique port or a flat port
  • the distal blood outflow port of the tumor cavity covering segment 102 is flush with the distal ports of the first embedded stent 21 and the second embedded stent 22, and is fixed by bonding or suturing
  • the distal port of the second embedded stent 22 is provided with a second distal oblique port 223
  • the distal port of the first embedded stent 21 is provided with a first distal oblique port 213 or a flat port
  • Figure 26 when the distal ports of the first embedded stent 21 and the second embedded stent 22 are set as oblique ports, the first distal oblique port 213 and the second distal oblique port 223 are respectively aligned with the first proximal oblique port 211

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Abstract

Provided in the present invention are a covered stent and a delivery system. The covered stent comprises a main stent having a tubular main body and an embedded stent. The main stent comprises a proximal section, an aneurysm sac section and a distal section in the axial direction. The aneurysm sac section comprises a first channel and a second channel which are arranged in the radial direction, the second channel communicating with the distal section, and the first channel being provided with an opening at the distal end and being internally provided with the embedded stent. The provision of the embedded stent provides a channel for implantation of an internal iliac artery stent, so as to enable the internal iliac artery stent to have better anchoring performance, wherein the total scaffolding strength of the first channel and the embedded stent is smaller than that of the second channel, and since the second channel has the higher scaffolding strength, the first channel deforms before the second channel when the covered stent is subjected to compression, so as to enable the second channel to keep a better channel form, thereby preventing compression-induced occlusion and ensuring blood to smoothly pass through the second channel.

Description

覆膜支架及输送系统Stent graft and delivery system 技术领域Technical Field

本发明涉及医疗器械技术领域,尤其涉及一种覆膜支架及输送系统。The present invention relates to the technical field of medical devices, and in particular to a stent graft and a delivery system.

背景技术Background Art

髂动脉包括髂总动脉、髂外动脉和髂内动脉;现有技术在治疗髂动脉瘤疾病中,可通过腔内治疗术植入一枚髂动脉分叉支架和一枚髂内覆膜支架以重建动脉血管,现有技术的髂动脉分叉支架通常带有两个分支通道,分别用以重建髂内动脉和髂外动脉,为了确保髂内动脉通道不受血管压闭造成通道堵塞,髂内动脉通道的波形设计会提供一定的支撑强度,实际上,髂外动脉通道的血流通畅性远比髂内动脉通道的血流通畅性更为重要,因此,一般髂外动脉则通过设计较大的管腔来保证血流的通畅性,但髂外动脉通道管腔过大则会对病人的血管解剖要求较高,不利于扩展器械的适用范围。The iliac arteries include the common iliac arteries, the external iliac arteries and the internal iliac arteries. In the prior art, in the treatment of iliac artery aneurysm diseases, an iliac artery bifurcation stent and an internal iliac covered stent can be implanted through intravascular therapy to reconstruct the arterial blood vessels. The iliac artery bifurcation stent in the prior art usually has two branch channels, which are used to reconstruct the internal iliac artery and the external iliac artery respectively. In order to ensure that the internal iliac artery channel is not blocked by vascular compression, the waveform design of the internal iliac artery channel will provide a certain support strength. In fact, the blood flow patency of the external iliac artery channel is far more important than that of the internal iliac artery channel. Therefore, the external iliac artery is generally designed with a larger lumen to ensure the patency of blood flow. However, if the lumen of the external iliac artery channel is too large, it will place higher requirements on the patient's vascular anatomy, which is not conducive to expanding the scope of application of the device.

发明内容Summary of the invention

基于此,有必要提供一种新的覆膜支架,能够提供髂内支架植入通道的同时,在支架受压时可以使髂外通路具有更好的支撑强度以保持髂外通路的整体形态。Based on this, it is necessary to provide a new covered stent that can provide an internal iliac stent implantation channel and, when the stent is compressed, can give the external iliac passage better support strength to maintain the overall shape of the external iliac passage.

一种覆膜支架,包括具有管状主体的主体支架和内嵌支架,所述主体支架沿轴向包括近端段、瘤腔段和远端段;所述近端段通过所述瘤腔段与所述远端段相连通;所述瘤腔段包括沿径向设置的第一通道和第二通道,所述第二通道与所述远端段连通,所述第一通道的远端设有与外界相连通的开口;所述内嵌支架设于所述第一通道内,所述内嵌支架至少部分与所述第一通道的侧壁连接,且所述内嵌支架的远端与所述开口连通;所述第一通道与所述内嵌支架的总支撑强度小于所述第二通道的支撑强度。A coated stent comprises a main stent with a tubular body and an embedded stent, the main stent comprising a proximal segment, a tumor cavity segment and a distal segment along the axial direction; the proximal segment is connected with the distal segment through the tumor cavity segment; the tumor cavity segment comprises a first channel and a second channel arranged along the radial direction, the second channel is connected with the distal segment, and the distal end of the first channel is provided with an opening connected to the outside; the embedded stent is arranged in the first channel, the embedded stent is at least partially connected to the side wall of the first channel, and the distal end of the embedded stent is connected with the opening; the total support strength of the first channel and the embedded stent is less than the support strength of the second channel.

在一个实施例中,所述瘤腔段包括沿轴向间隔设置的多个第一波圈,多个所述第一波圈的波数相同,且相邻的所述第一波圈的波峰和/或波谷相对设置。In one embodiment, the tumor cavity segment includes a plurality of first wave circles spaced apart along the axial direction, the plurality of first wave circles have the same wave number, and the wave crests and/or wave troughs of adjacent first wave circles are arranged opposite to each other.

在一个实施例中,所述第一波圈至少位于所述第一通道的部分设有断口。In one embodiment, at least a portion of the first wave coil located in the first channel is provided with a break.

在一个实施例中,所述第一波圈位于所述第二通道部分的波角大于同一所述第一波圈位于所述第一通道部分的波角,或者所述第一波圈位于所述第二通道部分的丝径大于同一所述第一波圈位于所述第一通道部分的丝径。In one embodiment, the wave angle of the first wave coil located in the second channel portion is greater than the wave angle of the same first wave coil located in the first channel portion, or the wire diameter of the first wave coil located in the second channel portion is greater than the wire diameter of the same first wave coil located in the first channel portion.

在一个实施例中,所述第一波圈包括多个第一波杆,相邻的所述第一波杆之间设有支撑件,多个所述支撑件被配置为:使处于所述第二通道部分处的所述第一波杆之间的可压缩距离小于处于所述第一通道部分处的所述第一波杆之间的可压缩距离。In one embodiment, the first wave ring includes a plurality of first wave rods, and support members are provided between adjacent first wave rods, and the plurality of support members are configured to make the compressible distance between the first wave rods at the second channel portion smaller than the compressible distance between the first wave rods at the first channel portion.

在一个实施例中,所述支撑件与相邻的所述第一波杆之间具有间隙,所述第二通道部分处的所述间隙小于所述第一通道部分处的所述间隙。In one embodiment, a gap is provided between the support member and the adjacent first wave rod, and the gap at the second channel portion is smaller than the gap at the first channel portion.

在一个实施例中,所述支撑件为弹性支撑件,所述弹性支撑件的两侧分别与相邻的两个所述第一波杆连接,所述第二通道部分处的所述弹性支撑件的弹性模量大于所述第一通道部分处的所述弹性支撑件的弹性模量。In one embodiment, the support member is an elastic support member, both sides of which are respectively connected to two adjacent first wave rods, and the elastic modulus of the elastic support member at the second channel portion is greater than the elastic modulus of the elastic support member at the first channel portion.

在一个实施例中,所述近端段包括多个沿轴向间隔设置的近端支撑波圈,所述远端段包括多个沿轴向间隔设置的远端支撑波圈,所述内嵌支架包括网状主体。In one embodiment, the proximal segment includes a plurality of proximal support waves spaced apart in the axial direction, the distal segment includes a plurality of distal support waves spaced apart in the axial direction, and the embedded stent includes a mesh body.

在一个实施例中,所述主体支架表面覆盖有第一覆膜,所述内嵌支架表面覆盖有第二覆膜,所述第一覆膜的支撑强度大于所述第二覆膜的支撑强度。In one embodiment, the surface of the main support is covered with a first coating, and the surface of the embedded support is covered with a second coating, and the support strength of the first coating is greater than the support strength of the second coating.

在一个实施例中,所述瘤腔段位于近端和远端的支撑强度大于中间位置的支撑强度。In one embodiment, the support strength of the tumor cavity segment at the proximal and distal ends is greater than the support strength at the middle position.

在一个实施例中,所述瘤腔段位于近端或远端的支撑强度大于中间位置的支撑强度。In one embodiment, the support strength of the tumor cavity segment at the proximal or distal end is greater than the support strength at the middle position.

本发明的有益效果在于:与现有技术相比,本发明提供一种覆膜支架,包括具有管状主体的主体支架和内嵌支架,主体支架沿轴向包括近端段、瘤腔段和远端段;瘤腔段包括沿径向设置的第一通道和第二通道,第二通道与远端段连通,第一通道的远端设有开口且内设内嵌支架,通过设置内嵌支架以提供髂内支架的植入通道,使髂内支架具有更好的锚定性;其中,第一通道与内嵌支架的总支撑强度小于第二通道的支撑强度,第二通道具有更高的支撑强度以在覆膜支架受压时,第一通道部分优先于第二通道部分发生变形,使得第二通道部分能够保持更好的通道形态,避免受压闭塞,确保血液在第二通道部分顺畅通过。The beneficial effects of the present invention are as follows: compared with the prior art, the present invention provides a coated stent, comprising a main stent with a tubular body and an embedded stent, the main stent including a proximal section, a tumor cavity section and a distal section along the axial direction; the tumor cavity section includes a first channel and a second channel arranged along the radial direction, the second channel is connected to the distal section, the distal end of the first channel is provided with an opening and an embedded stent is arranged therein, and the embedded stent is provided to provide an implantation channel for the internal iliac stent, so that the internal iliac stent has better anchoring property; wherein, the total support strength of the first channel and the embedded stent is less than the support strength of the second channel, and the second channel has a higher support strength so that when the coated stent is under pressure, the first channel portion deforms prior to the second channel portion, so that the second channel portion can maintain a better channel morphology, avoid occlusion due to pressure, and ensure that blood passes smoothly through the second channel portion.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

图1为本发明实施例一中覆膜支架整体结构示意图;FIG1 is a schematic diagram of the overall structure of a stent graft in Embodiment 1 of the present invention;

图2为本发明实施例一中主体支架结构示意图;FIG2 is a schematic diagram of the main support structure in Embodiment 1 of the present invention;

图3为本发明实施例一中内嵌支架结构示意图;FIG3 is a schematic diagram of the structure of the embedded bracket in the first embodiment of the present invention;

图4为本发明实施例一中第一波圈波角分布结构示意图;FIG4 is a schematic diagram of the wave angle distribution structure of the first wave ring in Embodiment 1 of the present invention;

图5为本发明实施例一中第一波圈波角渐缩结构示意图;FIG5 is a schematic diagram of a first wave coil with a tapered wave angle in Embodiment 1 of the present invention;

图6为本发明实施例一中第一波圈丝径分布结构示意图;FIG6 is a schematic diagram of the first wave coil wire diameter distribution structure in Example 1 of the present invention;

图7为本发明实施例二中第一波圈不同长度支撑件结构示意图;FIG7 is a schematic diagram of the structure of the support members of different lengths of the first wave coil in the second embodiment of the present invention;

图8为本发明实施例二中第一波圈不同高度支撑件结构示意图;FIG8 is a schematic diagram of the structure of the support members of different heights of the first wave coil in the second embodiment of the present invention;

图9为本发明实施例二中支撑件为弹性支撑件时的结构示意图;FIG9 is a schematic structural diagram of a second embodiment of the present invention when the supporting member is an elastic supporting member;

图10为本发明实施例二中其他实施例中覆膜支架的结构示意图;FIG10 is a schematic diagram of the structure of a stent graft in other embodiments of the second embodiment of the present invention;

图11为本发明实施例三中主体支架结构示意图;FIG11 is a schematic diagram of the structure of the main support in Embodiment 3 of the present invention;

图12为本发明实施例三中第一波圈设有断口结构示意图;FIG12 is a schematic diagram of a structure in which a first wave coil is provided with a fracture in Embodiment 3 of the present invention;

图13为本发明实施例四中覆膜支架整体结构示意图;FIG13 is a schematic diagram of the overall structure of the stent graft in Embodiment 4 of the present invention;

图14为本发明实施例四中第一内嵌支架和第二内嵌支架不同丝径结构示意图;FIG14 is a schematic diagram of a structure of different wire diameters of a first embedded stent and a second embedded stent in Embodiment 4 of the present invention;

图15为本发明图14中A位置局部放大示意图;FIG15 is a partial enlarged schematic diagram of position A in FIG14 of the present invention;

图16为本发明实施例五中第一内嵌支架和第二内嵌支架不同网格密度结构示意图;FIG16 is a schematic diagram of a structure of different grid densities of a first embedded bracket and a second embedded bracket in Embodiment 5 of the present invention;

图17为本发明实施例六中瘤腔段的第一通道和第二通道设有不同的轴向长度示意图。FIG. 17 is a schematic diagram showing that the first channel and the second channel of the tumor cavity segment in Embodiment 6 of the present invention have different axial lengths.

图18为本发明实施例六中第二内嵌支架露出段平口结构示意图;FIG18 is a schematic diagram of the flat structure of the exposed section of the second embedded bracket in Embodiment 6 of the present invention;

图19为本发明实施例六中第二内嵌支架露出段斜口结构示意图;FIG19 is a schematic diagram of the oblique structure of the exposed section of the second embedded bracket in Embodiment 6 of the present invention;

图20为本发明实施例六中瘤腔段的近端位置设有变径近端波圈结构示意图;FIG20 is a schematic diagram of a structure in which a variable diameter proximal wave ring is provided at the proximal end of the tumor cavity segment in Embodiment 6 of the present invention;

图21为本发明实施例六中其他覆膜支架结构示意图;FIG21 is a schematic diagram of another stent graft structure in Embodiment 6 of the present invention;

图22为本发明实施例七中覆膜支架结构示意图;FIG22 is a schematic diagram of the structure of a stent graft in Embodiment 7 of the present invention;

图23为本发明实施例七中主体支架结构示意图;FIG23 is a schematic diagram of the main support structure in Embodiment 7 of the present invention;

图24为本发明实施例七中第一内嵌支架和第二内嵌支架不同轴向长度示意图;FIG24 is a schematic diagram of different axial lengths of the first embedded bracket and the second embedded bracket in Embodiment 7 of the present invention;

图25为本发明实施例七中三角形波圈支架结构示意图;FIG25 is a schematic diagram of the structure of a triangular wave coil support in Embodiment 7 of the present invention;

图26为本发明实施例七中第一内嵌支架和第二内嵌支架两端设显影件结构示意图;26 is a schematic diagram of a structure in which developing members are arranged at both ends of the first embedded bracket and the second embedded bracket in Embodiment 7 of the present invention;

图27为本发明实施例七中过渡支架采用波圈支架结构示意图;FIG27 is a schematic diagram of the structure of a transition bracket using a corrugated bracket in Embodiment 7 of the present invention;

图28为本发明实施例七中过渡支架采用网状编织支架结构示意图;FIG. 28 is a schematic diagram of a transition bracket using a mesh braided bracket structure in Embodiment 7 of the present invention;

图29为本发明实施例八中异形波圈结构示意图;FIG29 is a schematic diagram of the structure of a special-shaped corrugated ring in Embodiment 8 of the present invention;

图30为本发明实施例八中异形波圈远端高波渐低结构示意图;FIG30 is a schematic diagram of a structure in which the high wave at the far end of the special-shaped wave coil gradually decreases in Embodiment 8 of the present invention;

图31为本发明实施例九和实施例十中钩挂件与挂杆结构示意图;31 is a schematic diagram of the structure of the hook and the hanging rod in Embodiment 9 and Embodiment 10 of the present invention;

图32为本发明实施例十中支架输送系统结构示意图;FIG32 is a schematic diagram of the structure of a stent delivery system in Embodiment 10 of the present invention;

图33为本发明实施例十中覆膜支架设于输送器内的结构示意图。FIG33 is a schematic diagram of the structure of the coated stent disposed in the conveyor in the tenth embodiment of the present invention.

具体实施方式DETAILED DESCRIPTION

为了能够更好地理解本申请的构思,以下结合附图对本申请的实施方式做具体说明,以下具体实施例仅是本申请的部分实施例,并非对本申请的限制。In order to better understand the concept of the present application, the implementation methods of the present application are specifically described below in conjunction with the accompanying drawings. The following specific embodiments are only partial embodiments of the present application and are not limitations of the present application.

为了便于描述,可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系,这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如,如果在图中的装置翻转,那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此,示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段,但是,这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出,否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此,以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

为了更加清楚地描述本申请的结构,此处限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言,“远端”表示血管远离心脏的一端,“近端”血管靠近心脏的一端;“轴向”表示其长度方向,“径向”表示垂直于“轴向”的方向;“上端”和“下端”为相对远离的两端,当定义一端为“上端”时,则相远离的另一端为“下端”。In order to more clearly describe the structure of this application, the terms "proximal end" and "distal end" are defined here as commonly used terms in the field of interventional medicine. Specifically, "distal end" refers to the end of the blood vessel away from the heart, and "proximal end" refers to the end of the blood vessel close to the heart; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial"; "upper end" and "lower end" are two ends that are relatively far away. When one end is defined as the "upper end", the other end that is far away is the "lower end".

实施例一:Embodiment 1:

请参阅图1-图2,本发明提供一种覆膜支架100,覆膜支架100通常由金属骨架和覆膜材料组成,金属骨架可以采用Z形波或者编织网状设计,覆膜材料具有一定的血流隔绝能力,并通过加压加热、缝合等方式与金属骨架进行结合以形成完整的覆膜支架100;覆膜支架100的近端一般置于髂总动脉或与腹主动脉支架连接,管腔直径一般与髂总动脉直径相匹配。在本实施例中,参阅图1和图3,覆膜支架100具有管状主体的主体支架10和内嵌支架20,主体支架10直接置于血管内与血管管壁接触,内嵌支架20设于主体支架10的内腔内用于血流的分流,主体支架10的表面覆盖有第一覆膜104,内嵌支架20的表面覆盖有第二覆膜202;其中,主体支架10沿轴向包括近端段101、瘤腔段102和远端段103;近端段101连接于瘤腔段102的近端侧,远端段103连接于瘤腔段102的远端侧,近端段101通过瘤腔段102与远端段103相连通;瘤腔段102在覆膜支架100安装于病变血管内时,一般置于血管的瘤腔位置,瘤腔段102由沿着径向方向设置的第二通道1022和第一通道1021共同组成,通常设置瘤腔段102的径向宽度大于远端段103的直径和近端段101的直径,使得瘤腔段102内的第一通道1021和第二通道1022均具有足够的流通空间以避免在植入后受到瘤腔的挤压发生完全闭塞;将第二通道1022和第一通道1021隔绝形成相对独立的两个血流通道,分别为髂外通道和髂内通道,使用时,第一通道1021用于通入髂内支架,第二通道1022用于连接延伸的远端段103建立与髂外动脉血管的流通;在本实施例中,通过将内嵌支架20设于第一通道1021内,使得第一通道1021和第二通道1022相对独立隔绝,并且,第一通道1021的远端开设有用于与外界连通的开口1024,并且内嵌支架20的远端与开口1024连通,内嵌支架20的设置能够使得形成的第一通道1021的形态与待植入的髂内支架的形态相适配,从而确保支架在植入时和植入后都具有更好的适配性;内嵌支架20设于第一通道1021时,至少部分与瘤腔段102的第一通道1021部分的侧壁连接,优选的,内嵌支架20与瘤腔段102的连接为多点粘接或者缝合的面接触连接,如此设置,能够确保内嵌支架20至少与瘤腔段102连接的部分始终保持与主体支架10的瘤腔段102贴合,在瘤腔段102受到挤压时,贴合部分能够随着瘤腔段102的变形同时发生变形,从而有效避免在瘤腔段102发生变形时,内嵌支架20不发生变形而仅是在瘤腔段102内腔发生位移,影响第二通道1022的宽度和通过性。Please refer to Figures 1 and 2. The present invention provides a coated stent 100. The coated stent 100 is generally composed of a metal skeleton and a coating material. The metal skeleton can adopt a Z-shaped wave or a woven mesh design. The coating material has a certain blood flow isolation ability and is combined with the metal skeleton by pressurization, heating, suturing, etc. to form a complete coated stent 100; the proximal end of the coated stent 100 is generally placed in the common iliac artery or connected to the abdominal aorta stent, and the lumen diameter generally matches the diameter of the common iliac artery. In this embodiment, referring to Figures 1 and 3, the coated stent 100 has a main stent 10 with a tubular body and an embedded stent 20. The main stent 10 is directly placed in the blood vessel and contacts the blood vessel wall. The embedded stent 20 is arranged in the inner cavity of the main stent 10 for blood flow diversion. The surface of the main stent 10 is covered with a first coating 104, and the surface of the embedded stent 20 is covered with a second coating 202; wherein the main stent 10 includes a proximal segment 101, a tumor cavity segment 102 and a distal segment 103 along the axial direction; the proximal segment 101 is connected to the proximal side of the tumor cavity segment 102, the distal segment 103 is connected to the distal side of the tumor cavity segment 102, and the proximal segment 101 is connected to the distal segment 103 through the tumor cavity segment 102. The tumor cavity segment 102 is connected; when the stent graft 100 is installed in the diseased blood vessel, it is generally placed at the tumor cavity position of the blood vessel. The tumor cavity segment 102 is composed of a second channel 1022 and a first channel 1021 arranged along the radial direction. The radial width of the tumor cavity segment 102 is usually set to be larger than the diameter of the distal segment 103 and the diameter of the proximal segment 101, so that the first channel 1021 and the second channel 1022 in the tumor cavity segment 102 have sufficient flow space to avoid being squeezed by the tumor cavity after implantation and completely blocked; the second channel 1022 and the first channel 1021 are isolated to form two relatively independent blood flow channels, namely the external iliac channel and the internal iliac channel. When in use, the first channel 1021 is used to pass the internal iliac stent, and the second channel 1022 is used to connect the extended distal segment 103 to establish communication with the external iliac artery. In this embodiment, by arranging the embedded stent 20 in the first channel 1021, the first channel 1021 and the second channel 1022 are relatively independent and isolated, and the distal end of the first channel 1021 is provided with an opening 1024 for communicating with the outside world, and the distal end of the embedded stent 20 is communicated with the opening 1024. The arrangement of the embedded stent 20 can make the shape of the formed first channel 1021 compatible with the shape of the internal iliac stent to be implanted, thereby ensuring that the stent has better adaptability both during and after implantation. The embedded stent 20 When arranged in the first channel 1021, at least a portion of it is connected to the side wall of the first channel 1021 portion of the tumor cavity segment 102. Preferably, the connection between the embedded bracket 20 and the tumor cavity segment 102 is a surface contact connection by multi-point bonding or suturing. Such an arrangement can ensure that at least the portion of the embedded bracket 20 connected to the tumor cavity segment 102 always remains in contact with the tumor cavity segment 102 of the main bracket 10. When the tumor cavity segment 102 is squeezed, the contacting portion can deform simultaneously with the deformation of the tumor cavity segment 102, thereby effectively avoiding that when the tumor cavity segment 102 is deformed, the embedded bracket 20 does not deform but only moves in the inner cavity of the tumor cavity segment 102, thereby affecting the width and passability of the second channel 1022.

在其他的实施例中,本申请所提供的覆膜支架100不仅应用于重建髂总动脉、髂内动脉和髂外动脉,还可应用于重建腹主动脉和主动脉血管弓部的有锁骨下动脉,当应用于重建腹主动脉时,当动脉瘤或夹层等血管疾病的病变部位位于腹主动脉区域时,该覆膜支架100的近端段101可锚定于肾动脉下缘,远端段103锚定于髂总动脉内,第二通道1022连接腹主动脉和髂总动脉,第一通道1021通过置入一枚支架连接腹主动脉和髂总动脉的血流。当应用于重建右锁骨下动脉时,动脉瘤或夹层等血管疾病的病变部位位于右锁骨下和右颈总动脉区域,该覆膜支架100的近端段101可锚定于无名动脉,远端段103锚定于右颈总动脉,第二通道1022连接右颈总动脉和无名动脉,第一通道1021通过置入一枚支架连接右锁骨动脉和无名动脉。又或者本身所提供的覆膜支架100的近端段101和远端段103也可以不直接锚定于血管上,而是通过锚定于其它支架间接进行固定。以上,仅为举例的本申请所提供的覆膜支架100在人体内较为常见的应用位置,并不对本申请所提供的覆膜支架100的应用加以限制,在血管类型和病变位置合适的情况下,本申请所提供的覆膜支架100也可适用于人体内的其他分叉血管位置。In other embodiments, the covered stent 100 provided in the present application is not only used to reconstruct the common iliac artery, the internal iliac artery and the external iliac artery, but can also be used to reconstruct the abdominal aorta and the subclavian artery in the aortic arch. When used to reconstruct the abdominal aorta, when the lesion site of vascular diseases such as aneurysm or dissection is located in the abdominal aorta area, the proximal segment 101 of the covered stent 100 can be anchored at the lower edge of the renal artery, and the distal segment 103 is anchored in the common iliac artery. The second channel 1022 connects the abdominal aorta and the common iliac artery, and the first channel 1021 connects the blood flow of the abdominal aorta and the common iliac artery by inserting a stent. When applied to the reconstruction of the right subclavian artery, the lesions of vascular diseases such as aneurysms or dissections are located in the right subclavian and right common carotid artery regions. The proximal segment 101 of the stent graft 100 can be anchored to the innominate artery, the distal segment 103 is anchored to the right common carotid artery, the second channel 1022 connects the right common carotid artery and the innominate artery, and the first channel 1021 connects the right clavicular artery and the innominate artery by inserting a stent. Alternatively, the proximal segment 101 and the distal segment 103 of the stent graft 100 provided by itself may not be directly anchored on the blood vessel, but may be indirectly fixed by anchoring to other stents. The above is only an example of the more common application positions of the stent graft 100 provided by the present application in the human body, and does not limit the application of the stent graft 100 provided by the present application. When the blood vessel type and the lesion location are suitable, the stent graft 100 provided by the present application may also be applicable to other bifurcated blood vessel locations in the human body.

在本实施例中,请参阅图1和图2,为了确保覆膜支架100的瘤腔段102在受到挤压时,第一通道1021通过内嵌支架20获得一定的支撑性的同时,确保第二通道1022能够保持较好的形态,避免受到过度挤压发生闭塞,本申请覆膜支架100的瘤腔段102的第一通道1021与内嵌支架20的总支撑强度设置为小于第二通道1022的支撑强度;如此,支撑强度小的部分在受到挤压力时,优先产生变形且变形量大,而支撑强度大的部分则缓慢产生变形,且变形量有限;从而,第二通道1022具有更大支撑强度能够确保其在受到与第一通道1021相同挤压力的情况下,变形量更小,从而能够维持第二通道1022的形态,而第一通道1021由于支撑强度较小,优先发生变形且变形量更大,使得瘤腔段102的变形更多的落在第一通道1021部分,维持了第二通道1022的形态;而第一通道1021由于内嵌支架20的设置,内嵌支架20在腔内不与瘤腔段102连接的部分基本不发生变形,依旧能够保持较好的通道形态。In this embodiment, please refer to Figures 1 and 2. In order to ensure that when the tumor cavity section 102 of the coated stent 100 is squeezed, the first channel 1021 obtains a certain degree of support through the embedded stent 20, while ensuring that the second channel 1022 can maintain a good shape to avoid occlusion due to excessive squeezing, the total support strength of the first channel 1021 and the embedded stent 20 of the tumor cavity section 102 of the coated stent 100 of the present application is set to be less than the support strength of the second channel 1022; in this way, the part with small support strength will be deformed first and the deformation amount will be large when subjected to the squeezing force, while the part with large support strength will be deformed slowly and the deformation will be large. The amount is limited; thus, the second channel 1022 has a greater supporting strength to ensure that it deforms less when subjected to the same extrusion force as the first channel 1021, thereby maintaining the shape of the second channel 1022. The first channel 1021, due to its smaller supporting strength, deforms first and with a greater amount, so that the deformation of the tumor cavity segment 102 falls more on the first channel 1021, maintaining the shape of the second channel 1022; and the first channel 1021, due to the provision of the embedded stent 20, the part of the embedded stent 20 that is not connected to the tumor cavity segment 102 in the cavity is basically not deformed, and can still maintain a good channel shape.

在本实施例中,请参阅图3,内嵌支架20具有网状主体201和第二覆膜202,其中网状主体201采用网状编织的支架结构,网状支撑结构能够提供较好的张力,从而提供较好的形态保持,并且,网状主体201在髂内支架植入时,能够提供更多的接触位点,从而使得髂内支架与内嵌支架20之间具有更大的摩擦力,能够有效的增强贴附力和支架防滑脱性能;请参阅图2,近端段101沿轴向设有多个近端支撑波圈1011,远端段103沿轴向设有多个远端支撑波圈1031,近端支撑波圈1011和远端支撑波圈1031均采用Z形环状波圈以提供支撑力,Z形环状波圈能够在提供支撑力的同时,波圈之间留有覆膜间隙,使得支架能够在覆膜间隙位置发生变形,具有好的柔顺性,其中,近端支撑波圈1011的直径大于远端支撑波圈1031的直径,以适应不同的血管直径。在其他的实施例中,网状主体也可以通过切割管状金属,譬如镍钛管、不锈钢管等形成切割网状主体。In this embodiment, please refer to FIG. 3 , the embedded stent 20 has a mesh body 201 and a second covering 202, wherein the mesh body 201 adopts a mesh woven stent structure, and the mesh support structure can provide better tension, thereby providing better shape retention, and the mesh body 201 can provide more contact sites when the iliac stent is implanted, so that there is greater friction between the iliac stent and the embedded stent 20, which can effectively enhance the adhesion and the anti-slip performance of the stent; please refer to FIG. 2 , the proximal section 101 is along the A plurality of proximal support rings 1011 are axially provided, and a plurality of distal support rings 1031 are axially provided at the distal section 103. Both the proximal support rings 1011 and the distal support rings 1031 adopt Z-shaped annular rings to provide support force. The Z-shaped annular rings can provide support force while leaving a film gap between the rings, so that the stent can be deformed at the film gap position and has good flexibility. The diameter of the proximal support ring 1011 is larger than the diameter of the distal support ring 1031 to adapt to different blood vessel diameters. In other embodiments, the mesh body can also be formed by cutting tubular metals, such as nickel-titanium tubes, stainless steel tubes, etc.

其中,设置第一覆膜104的支撑强度大于第二覆膜202的支撑强度,在本实施例中,第一覆膜104采用PET膜,第二覆膜202采用ePTFE膜,PET膜具有拉伸强度高的特点,而ePTFE膜的拉伸强度强度较弱,表面光滑,不易形成血栓,对于尺寸小的血管远期通畅性好,孔隙小;将PET膜和ePTFE膜结合起来使用,既保证了支架覆膜整体的强度,也使覆膜支架100具有更好的隔绝血流的效果,确保分支远期的通畅性,封堵效果好;而第一覆膜104的支撑强度大于第二覆膜202的支撑强度可以使得第二通道1022部分覆膜部分的支撑强度大于第一通道1021部分的内嵌支架20的支撑强度,从而使得内嵌支架20相较于第二通道1022部分易于变形,从而容易随着第一通道1021部分的变形而变形。Among them, the supporting strength of the first coating 104 is set to be greater than the supporting strength of the second coating 202. In this embodiment, the first coating 104 adopts PET film and the second coating 202 adopts ePTFE film. The PET film has the characteristics of high tensile strength, while the ePTFE film has weak tensile strength, smooth surface, and is not easy to form thrombus. It has good long-term patency and small pores for small blood vessels. Combining the PET film and the ePTFE film can not only ensure the overall strength of the stent coating, but also make the coated stent 100 have a better effect of isolating blood flow, ensuring the long-term patency of the branch and good blocking effect. The supporting strength of the first coating 104 is greater than the supporting strength of the second coating 202, which can make the supporting strength of the coating part of the second channel 1022 part greater than the supporting strength of the embedded stent 20 of the first channel 1021 part, so that the embedded stent 20 is easier to deform than the second channel 1022 part, and thus easily deforms with the deformation of the first channel 1021 part.

在本实施例中,为了使覆膜支架100在安装至输送器时更容易的被压缩并且具有更小的压缩折叠体积,近端支撑波圈1011、远端支撑波圈1031和第一波圈1023可通过缝合的方式缝合于第一覆膜表面,具体的,缝合时,近端支撑波圈1011、远端支撑波圈1031和第一波圈1023的至少朝向近端方向的波峰不与第一覆膜缝合,如此,在覆膜支架100进行折叠压缩时,由于波峰位置不受到缝合束缚,其他的缝合点能够发生细微的位移以适应覆膜的折叠以及支架波圈的变形,从而使覆膜支架更好的被折叠;进一步的,不缝合的波峰能够减小覆膜的缝合比例,所以覆膜可具有更好的柔顺性以适应具有更复杂弯曲程度的血管。In the present embodiment, in order to make the coated stent 100 more easily compressed and have a smaller compressed folding volume when installed on the conveyor, the proximal supporting wave ring 1011, the distal supporting wave ring 1031 and the first wave ring 1023 can be sutured to the surface of the first coating by suturing. Specifically, during suturing, the wave peaks of the proximal supporting wave ring 1011, the distal supporting wave ring 1031 and the first wave ring 1023, at least in the proximal direction, are not sutured with the first coating. In this way, when the coated stent 100 is folded and compressed, since the wave peak positions are not constrained by suturing, other suturing points can be slightly displaced to adapt to the folding of the coating and the deformation of the stent wave rings, so that the coated stent can be better folded; further, the unsutured wave peaks can reduce the suturing ratio of the coating, so the coating can have better flexibility to adapt to blood vessels with more complex curvatures.

在本实施例中,请参阅图2,瘤腔段102包括沿轴向间隔设置的多个第一波圈1023,第一波圈1023同样为Z形环状波圈,而为了使瘤腔段102保持较好的柔顺性,设置多个第一波圈1023的波数相同,且相邻的第一波圈1023的波峰和/或波谷相对设置;此处,设置为相同的波数且波峰和/或波谷相对,也就是相邻的第一波圈1023之间近乎于平行设置,使得相邻的第一波圈1023之间具有均匀的间隔距离,仅通过覆膜连接,故柔顺性较好,有益于瘤腔段102更好的顺应血管的弯曲形态;优选的,可使第一波圈1023的波数与近端支撑波圈1011的波数也相等,且波峰和/或波谷相对设置,从而使得瘤腔段102与近端段101以及瘤腔段102与近端段101的连接处同样保持较好的柔顺性。In this embodiment, referring to FIG. 2 , the tumor cavity segment 102 includes a plurality of first wave circles 1023 spaced apart in the axial direction, and the first wave circles 1023 are also Z-shaped annular wave circles. In order to maintain good flexibility of the tumor cavity segment 102, the plurality of first wave circles 1023 are set to have the same wave number, and the wave crests and/or wave troughs of adjacent first wave circles 1023 are set relative to each other. Here, the same wave number is set and the wave crests and/or wave troughs are set relative to each other, that is, the space between adjacent first wave circles 1023 is approximately The parallel arrangement allows for uniform spacing between adjacent first wave coils 1023, which are connected only by a covering membrane, and thus have better flexibility, which helps the tumor cavity segment 102 to better conform to the curvature of the blood vessel; preferably, the wave number of the first wave coil 1023 can be made equal to the wave number of the proximal support wave coil 1011, and the wave crests and/or wave troughs are arranged relatively to each other, so that the connection between the tumor cavity segment 102 and the proximal segment 101 and between the tumor cavity segment 102 and the proximal segment 101 also maintains good flexibility.

在本实施例中,请参阅图4和图5,为了使得第一通道1021与内嵌支架20的总支撑强度小于第二通道1022的支撑强度,瘤腔段102的同一第一波圈1023位于第二通道1022部分的波角(图中角a)大于同一第一波圈1023位于第一通道1021部分的波角(图中角b);这是由于具有较大的波角的波形在波圈发生形变时,发生变形所需要的力大于具有较小波角的波形,故支撑强度也同样大于具有较小波角的波形;在一些实施例中,为了使波角具有区别的情况下,相邻的第一波圈1023波数相同且的波峰和/或波谷相对设置,可使位于第二通道1022部分的波形的波高小于第一通道1021部分的波形的波高,且第二通道1022部分的波形的波角(图中角d)大于第一通道1021部分的波形的波角(图中角c)。在另一个实施例中,可以使第一波圈1023的所有波形的波高,自第二通道1022部分向第一通道1021部分逐渐增大,且波角逐渐减小,形成支撑强度渐缩的结构;如此,支撑强度的渐缩可避免瘤腔段102在第二通道1022部分和第一通道1021部分交界的位置突然形成较大的支撑强度差,从而导致瘤腔段102在该位置发生不可预知和不期望的变形。In the present embodiment, please refer to FIG. 4 and FIG. 5 . In order to make the total support strength of the first channel 1021 and the embedded stent 20 smaller than the support strength of the second channel 1022, the wave angle of the same first wave circle 1023 of the tumor cavity segment 102 located in the second channel 1022 (angle a in the figure) is greater than the wave angle of the same first wave circle 1023 located in the first channel 1021 (angle b in the figure); this is because when the wave circle of the waveform with a larger wave angle is deformed, the force required for deformation is greater than that of the waveform with a smaller wave angle, so the support strength is also greater than that of the waveform with a smaller wave angle; in some embodiments, in order to make the wave angles different, adjacent first wave circles 1023 have the same wave number and the crests and/or troughs are arranged relatively, so that the wave height of the waveform located in the second channel 1022 can be smaller than the wave height of the waveform in the first channel 1021, and the wave angle of the waveform in the second channel 1022 (angle d in the figure) is greater than the wave angle of the waveform in the first channel 1021 (angle c in the figure). In another embodiment, the wave height of all waveforms of the first wave ring 1023 can be gradually increased from the second channel 1022 portion to the first channel 1021 portion, and the wave angle can be gradually reduced, so as to form a structure with gradually decreasing support strength. In this way, the gradual reduction of support strength can avoid the tumor cavity segment 102 from suddenly forming a large support strength difference at the junction of the second channel 1022 portion and the first channel 1021 portion, thereby causing unpredictable and unexpected deformation of the tumor cavity segment 102 at this position.

在另一些实施例中,请参阅图6,为了使得第一通道1021与内嵌支架20的总支撑强度小于第二通道1022的支撑强度,可使第一波圈1023位于第二通道1022部分的丝径R1大于第一波圈1023位于第一通道1021部分的丝径R2,较大的丝径在发生变形时,需要抵抗材料本身的刚度所要付出的力更大,故在相同受力的情况下,具有较大丝径的波圈发生的变形量相比具有较小丝径的波圈发生的变形量更少,故具有更强的支撑强度;一些实施例中,可以将小丝径的编织丝和丝径的编织丝通过连接件或者扣合件的方式连接在一起,连接后分别置于瘤腔段102的第一通道1021部分和第二通道1022部分;也可以将第一波圈1023一体切割成型后,通过化学腐蚀、物理打磨等方式在第一通道1021部分减小其丝径,或者使第一波圈1023的丝径自第二通道1022部分到第一通道1021部分方向具有逐渐减小的渐缩结构。In other embodiments, please refer to FIG. 6 , in order to make the total support strength of the first channel 1021 and the embedded bracket 20 smaller than the support strength of the second channel 1022, the wire diameter R1 of the first wave coil 1023 located in the second channel 1022 can be larger than the wire diameter R2 of the first wave coil 1023 located in the first channel 1021. When a larger wire diameter is deformed, a greater force is required to resist the stiffness of the material itself. Therefore, under the same force, the deformation amount of the wave coil with a larger wire diameter is less than that of the wave coil with a smaller wire diameter. It has stronger supporting strength. In some embodiments, the braided wire with a small wire diameter and the braided wire with a large wire diameter can be connected together by means of connectors or fasteners, and after connection, they are respectively placed in the first channel 1021 part and the second channel 1022 part of the tumor cavity segment 102. The first wave ring 1023 can also be cut and formed as one piece, and its wire diameter can be reduced in the first channel 1021 part by means of chemical corrosion, physical polishing, etc., or the wire diameter of the first wave ring 1023 can have a gradually decreasing tapered structure from the second channel 1022 part to the first channel 1021 part.

为了使内嵌支架20和瘤腔段102的第一通道1021部分的支撑强度小于第二通道1022部分,内嵌支架20采用较小丝径的金属编织丝编织而成,在本实施例中,内嵌支架20的丝径d小于第二通道1022部分的第一波圈1023丝径D的二分之一,也就是说d小于二分之一D,且第一通道1021部分的第一波圈1023的丝径M也小于第二通道1022部分的第一波圈1023丝径D的二分之一,如此可以确保内嵌支架20与第一通道1021部分的支撑强度之和始终小于第二通道1022部分;但是本申请内嵌支架20和第一通道1021部分的第一波圈1023的丝径并不是仅能如上述设置,技术人员可根据实际支架需求调整内嵌支架20的丝径和第一通道1021部分的第一波圈1023的丝径,确保其支撑强度之和小于第二通道1022部分即可。In order to make the support strength of the embedded stent 20 and the first channel 1021 of the tumor cavity segment 102 smaller than that of the second channel 1022, the embedded stent 20 is woven with metal braided wires of smaller wire diameter. In this embodiment, the wire diameter d of the embedded stent 20 is smaller than half of the wire diameter D of the first wave coil 1023 of the second channel 1022, that is, d is smaller than half D, and the wire diameter M of the first wave coil 1023 of the first channel 1021 is also smaller than that of the first wave coil 1023 of the second channel 1022. 23 is half of the wire diameter D, so as to ensure that the sum of the supporting strengths of the embedded bracket 20 and the first channel 1021 part is always smaller than that of the second channel 1022 part; however, the wire diameters of the embedded bracket 20 and the first wave coil 1023 of the first channel 1021 part of the present application are not limited to the above settings. The technicians can adjust the wire diameters of the embedded bracket 20 and the wire diameters of the first wave coil 1023 of the first channel 1021 part according to the actual bracket requirements to ensure that the sum of their supporting strengths is smaller than that of the second channel 1022 part.

其中,瘤腔段102位于近端和/或远端的支撑强度也可以大于中间位置的支撑强度;在一个实施例中,将瘤腔段102位于近端和远端的第一波圈1023的支撑强度大于中间位置的第一波圈1023的支撑强度,如此设置,是由于通常血管形成瘤腔时,在瘤腔与正常血管的交接处通常为挤压较为严重的位置,将瘤腔段102近端和远端的第一波圈1023设置具有较高支撑强度,能够较好的抵抗来自血管和瘤腔交接位置的挤压;进一步的将中间位置设为较低的支撑强度,能够使得瘤腔段102具备一定的柔顺性,较好的适应血管的形态;在其他实施例中,可仅设置位于瘤腔段102近端位置的第一波圈1023的支撑强度大于中间位置的第一波圈1023的支撑强度,如此可至少确保支架位于血液流入位置的支架的支撑强度;为了实现上述支撑强度的变化,可使瘤腔段102的近端第一波圈1023的丝径或者波角大于中间位置的第一波圈1023的丝径或者波角实现。The support strength of the tumor cavity segment 102 at the proximal and/or distal ends may also be greater than the support strength at the middle position; in one embodiment, the support strength of the first wave ring 1023 at the proximal and distal ends of the tumor cavity segment 102 is greater than the support strength of the first wave ring 1023 at the middle position. This setting is because when a blood vessel usually forms a tumor cavity, the intersection of the tumor cavity and the normal blood vessel is usually a location where the compression is more severe. The first wave ring 1023 at the proximal and distal ends of the tumor cavity segment 102 is set to have a higher support strength, which can better resist the compression from the intersection of the blood vessel and the tumor cavity; further By setting the middle position to a lower support strength, the tumor cavity segment 102 can have a certain degree of flexibility and better adapt to the shape of the blood vessel; in other embodiments, only the support strength of the first wave coil 1023 located at the proximal position of the tumor cavity segment 102 can be set greater than the support strength of the first wave coil 1023 at the middle position, so as to at least ensure the support strength of the stent at the blood inflow position; in order to achieve the above-mentioned change in support strength, the wire diameter or wave angle of the proximal first wave coil 1023 of the tumor cavity segment 102 can be made greater than the wire diameter or wave angle of the first wave coil 1023 at the middle position.

在本实施例中,支撑强度具体表现为覆膜支架100整体在瘤腔段102受压之后的整体管状内腔(第一通道1021部分和第二通道1022部分)的变形量,即在相同的受力条件下,采用相同的力(该力需要让第一通道1021部分和第二通道1022部分均能产生形变)对第一通道1021部分和第二通道1022部分的外侧壁进行压覆,测量和计算压覆后第一通道1021部分和第二通道1022部分的径向横截面积即可,此处,压覆后测量得到的总横截面积大的支架则具有更大的支撑强度,总横截面积更小的支架则具有更小的支撑强度;在一些实施例中,可通过平板测力计分别将独立分隔后的第一通道1021部分和第二通道1022部分进行压缩,压缩相同的变形量时,测量其所需要的力,测得的力大的则支撑强度更大,测得的力小的则支撑强度更小,在本实施例中,第二通道1022部分测得的力总是大于第一通道1021部分测得的力。In this embodiment, the support strength is specifically manifested as the deformation of the overall tubular inner cavity (the first channel 1021 portion and the second channel 1022 portion) of the coated stent 100 after the tumor cavity segment 102 is compressed, that is, under the same force conditions, the same force (the force needs to make the first channel 1021 portion and the second channel 1022 portion both deform) is used to press the outer side walls of the first channel 1021 portion and the second channel 1022 portion, and the radial cross-sectional areas of the first channel 1021 portion and the second channel 1022 portion after pressing are measured and calculated. Here, the bracket with a larger total cross-sectional area measured after compression has a greater support strength, and the bracket with a smaller total cross-sectional area has a smaller support strength. In some embodiments, the first channel 1021 part and the second channel 1022 part that are independently separated can be compressed respectively by a flat-plate dynamometer, and the force required for compression with the same deformation amount is measured. The larger the measured force, the greater the support strength, and the smaller the measured force, the smaller the support strength. In this embodiment, the force measured in the second channel 1022 part is always greater than the force measured in the first channel 1021 part.

实施例二:Embodiment 2:

在本实施例中,请参阅图7-图9,主体支架10和内嵌支架20的结构与实施例一中大体相同,不同之处在于,第一波圈1023包括多个第一波杆10232,多个第一波杆10232之间呈角度的首尾相接,形成Z形或者M形环状波圈,其中,相邻的第一波杆10232之间设有支撑件10233,支撑件10233通过缝合或者粘接的方式连接于相邻两个第一波杆10232之间的第一覆膜104上,用于在相邻的两个第一波杆10232受到挤压力变形时,两个第一波杆10232绕其波角做相互靠近的压缩运动,运动至支撑件10233位置时,支撑件10233的两侧分别与两个第一波杆10232相互抵持,阻止两个第一波杆10232继续移动压缩,限制波形的变形程度从而提供支撑力,为了使得第一波圈1023在第二通道1022部分的支撑强度大于在第一通道1021部分的支撑强度,多个支撑件10233被配置为:使第二通道1022部分的第一波杆10232之间的可压缩距离小于第一通道1021部分的第一波杆10232之间的可压缩距离;这是由于相邻的两个第一波杆10232之间的可压缩距离小了,则使得波形可变形的程度降低,则第一波圈1023在该波形位置的支撑性能更好。In the present embodiment, referring to FIGS. 7-9 , the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first embodiment, except that the first wave ring 1023 includes a plurality of first wave rods 10232, and the plurality of first wave rods 10232 are connected end to end at an angle to form a Z-shaped or M-shaped annular wave ring, wherein a support member 10233 is provided between adjacent first wave rods 10232, and the support member 10233 is connected to the first coating 104 between two adjacent first wave rods 10232 by sewing or bonding, and is used for when two adjacent first wave rods 10232 are deformed by extrusion force, the two first wave rods 10232 make a compression movement around their wave angle to approach each other, and when the two adjacent first wave rods 10232 move to the position of the support member 10233, the support member The two sides of 10233 respectively resist against the two first wave rods 10232 to prevent the two first wave rods 10232 from continuing to move and compress, thereby limiting the deformation degree of the waveform and providing supporting force. In order to make the supporting strength of the first wave ring 1023 in the second channel 1022 part greater than the supporting strength in the first channel 1021 part, the multiple support members 10233 are configured as follows: the compressible distance between the first wave rods 10232 in the second channel 1022 part is smaller than the compressible distance between the first wave rods 10232 in the first channel 1021 part; this is because the compressible distance between two adjacent first wave rods 10232 is smaller, which reduces the degree of deformation of the waveform, and the first wave ring 1023 has better supporting performance at this waveform position.

请参阅图7和图8,在一个实施例中,为了达到上述效果,可以设置支撑件10233与相邻的第一波杆10232之间具有间隙10234,设置间隙10234的目的在于使得第一波杆10232与支撑件10233之间具有可活动变形的空间,该空间越大,则间隙10234越大,波形能够发生变形的程度越大,则支撑强度越低;反之,间隙10234越小,波形能够发生变形的程度越小,则支撑强度越高,故通过将第二通道1022部分支撑件10233与相邻第一波杆10232之间的间隙10234设置小于第一通道1021部分支撑件10233与相邻第一波杆10232之间的间隙10234,能够使第一波圈1023在第二通道1022部分获得的支撑强度大于在第一通道1021部分获得的支撑强度;如此设置,当第一波圈1023受到挤压力时,第一波杆10232之间发生相对靠近的变形,当位于第二通道1022部分的第一波杆10232与支撑件10233相互抵持时,位于第一通道1021部分的第一波杆10232依旧能继续发生变形,使得瘤腔段102在第一通道1021部分的变形量大于在第二通道1022部分的变形量。Please refer to FIG. 7 and FIG. 8. In one embodiment, in order to achieve the above-mentioned effect, a gap 10234 may be provided between the support member 10233 and the adjacent first wave rod 10232. The purpose of providing the gap 10234 is to allow a movable and deformable space to exist between the first wave rod 10232 and the support member 10233. The larger the space, the larger the gap 10234, the greater the degree to which the waveform can be deformed, and the lower the support strength. On the contrary, the smaller the gap 10234, the smaller the degree to which the waveform can be deformed, and the higher the support strength. Therefore, by setting the gap 10234 between the support member 10233 of the second channel 1022 and the adjacent first wave rod 10232 to be smaller than the first channel 10232, the support member 10233 may be provided with a gap 10234. The gap 10234 between the 21-part support member 10233 and the adjacent first wave rod 10232 can enable the support strength obtained by the first wave ring 1023 in the second channel 1022 part to be greater than the support strength obtained in the first channel 1021 part; with such a configuration, when the first wave ring 1023 is subjected to an extrusion force, the first wave rods 10232 are deformed to be relatively close to each other, and when the first wave rod 10232 located in the second channel 1022 part and the support member 10233 are pressed against each other, the first wave rod 10232 located in the first channel 1021 part can continue to deform, so that the deformation amount of the tumor cavity segment 102 in the first channel 1021 part is greater than the deformation amount in the second channel 1022 part.

其中,请参阅图7和图8,支撑件10233可以是具有两侧端部的一字型结构,而为了避免一字型结构支撑件10233的两侧端部刺破覆膜划伤血管,可将两端弯曲形成圆环或者将两端形成防损伤头端等,图中未示出;可以理解的是,多个一字型结构的支撑件10233可以是具有相同长度的支撑件10233,分别设于相邻第一波杆10232之间的不同轴向位置,譬如在第二通道1022部分,具有相同长度的支撑件10233设于靠近波角位置,以提供较小的间隙10234;还可以理解的是,多个一字型结构的支撑件10233可以是具有不同长度的支撑件10233,分别设于相邻第一波杆10232之间的相同轴向位置,譬如在第二通道1022部分支撑件10233的长度大于在第一通道1021部分的支撑件10233的长度,以提供较小的间隙10234。Wherein, please refer to Figures 7 and 8, the support member 10233 can be a straight-line structure with two side ends, and in order to avoid the two side ends of the straight-line structure support member 10233 piercing the membrane and scratching the blood vessel, the two ends can be bent to form a ring or the two ends can be formed into an anti-damage head end, etc., which is not shown in the figure; it can be understood that multiple straight-line structure support members 10233 can be support members 10233 with the same length, which are respectively arranged at different axial positions between adjacent first wave bars 10232, for example, in the second channel 1022 part, the support members 10233 with the same length are arranged near the wave angle position to provide a smaller gap 10234; it can also be understood that multiple straight-line structure support members 10233 can be support members 10233 with different lengths, which are respectively arranged at the same axial position between adjacent first wave bars 10232, for example, the length of the support member 10233 in the second channel 1022 part is greater than the length of the support member 10233 in the first channel 1021 part to provide a smaller gap 10234.

在另外一个实施例中,请参阅图9,支撑件10233为弹性支撑件10235,其中弹性支撑件10235的两侧分别与相邻的第一波杆10232连接,如此设置,相邻的两个第一波杆10232之间相互靠近的变形程度通过弹性支撑件10235的弹性变形程度决定,当弹性支撑件10235的弹性变形程度大,也就是弹性模量小的时候,则邻的两个第一波杆10232之间可相互靠近的变形程度大,可提供的支撑强度低;而当弹性支撑件10235的弹性变形程度小,也就是弹性模量大的时候,则邻的两个第一波杆10232之间可相互靠近的变形程度小,可提供的支撑强度大;如此,通过将第二通道1022部分的弹性支撑件10235的弹性模量设置为大于第一通道1021部分的弹性支撑件10235的弹性模量;弹性模量大的弹性支撑件10235在第二通道1022部分提供更大的支撑力,反之弹性模量小的弹性支撑件10235在第一通道1021部分提供更小的支撑力。In another embodiment, please refer to FIG. 9 , the support member 10233 is an elastic support member 10235, wherein both sides of the elastic support member 10235 are respectively connected to adjacent first wave rods 10232. In this way, the degree of deformation of two adjacent first wave rods 10232 approaching each other is determined by the degree of elastic deformation of the elastic support member 10235. When the degree of elastic deformation of the elastic support member 10235 is large, that is, the elastic modulus is small, the degree of deformation of the two adjacent first wave rods 10232 approaching each other is large, and the support strength that can be provided is low; and when the elastic support member 10235 is large, the degree of deformation of the two adjacent first wave rods 10232 approaching each other is large, and the support strength that can be provided is low. When the elastic deformation degree of 235 is small, that is, when the elastic modulus is large, the deformation degree of the two adjacent first wave rods 10232 that can be close to each other is small, and the support strength that can be provided is large; in this way, by setting the elastic modulus of the elastic support member 10235 of the second channel 1022 portion to be greater than the elastic modulus of the elastic support member 10235 of the first channel 1021 portion; the elastic support member 10235 with a large elastic modulus provides a greater supporting force in the second channel 1022 portion, and conversely, the elastic support member 10235 with a small elastic modulus provides a smaller supporting force in the first channel 1021 portion.

一些实施例中,弹性支撑件10235可以为弹簧结构,弹簧结构的两侧分别与两侧的第一波杆10232连接,第二通道1022部分的弹簧结构的弹性模量设置为大于第一通道1021部分的弹簧结构的弹性模量。In some embodiments, the elastic support member 10235 can be a spring structure, both sides of the spring structure are respectively connected to the first wave rods 10232 on both sides, and the elastic modulus of the spring structure of the second channel 1022 portion is set to be greater than the elastic modulus of the spring structure of the first channel 1021 portion.

在其他的一些实施例中,请参阅图9,弹性支撑件10235可以为中间具有弹簧件,两侧设有连接结构的弹性连接件,其中,可以通过设置中间弹簧件的总长度从而限制两侧第一波杆10232的变形距离;譬如将第二通道1022部分的弹性连接件的弹簧件长度设置为小于第一通道1021部分的弹性连接件的弹簧件的长度;较短的弹簧件可提供的变形程度小于较长的弹簧件可提供的变形程度,如此,在相同受力的情况下,较短的弹簧件相比较长的弹簧件优先达到变形极限,提供稳定的支撑力。In some other embodiments, please refer to Figure 9, the elastic support member 10235 can be an elastic connecting member with a spring member in the middle and connecting structures on both sides, wherein the deformation distance of the first wave rods 10232 on both sides can be limited by setting the total length of the middle spring member; for example, the length of the spring member of the elastic connecting member in the second channel 1022 is set to be smaller than the length of the spring member of the elastic connecting member in the first channel 1021; the deformation degree that can be provided by the shorter spring member is smaller than the deformation degree that can be provided by the longer spring member, so that, under the same force, the shorter spring member reaches the deformation limit first compared with the longer spring member, thereby providing a stable supporting force.

在其他实施例中,请参阅图10,可通过使瘤腔段102位于第一通道1021部分以及内嵌支架20的轴向长度小于第二通道1022部分的轴向长度使得其在径向上受压时的支撑位置减小,可承受压力的面积小;如此,可使得瘤腔段102位于第一通道1021的支撑强度小于第二通道1022的支撑强度;In other embodiments, referring to FIG. 10 , the axial length of the tumor cavity segment 102 located in the first channel 1021 and the embedded stent 20 can be made smaller than the axial length of the second channel 1022 so that the support position when compressed in the radial direction is reduced and the area that can withstand the pressure is small; thus, the support strength of the tumor cavity segment 102 located in the first channel 1021 can be made smaller than the support strength of the second channel 1022;

在一些实施例中,请参阅图10,可以将内嵌支架20的远端口和开口1024均设置为斜口,且斜口方向朝向远离第二通道1022的方向实现;并且,斜口的设置还能够使得髂内支架在植入内嵌支架20时的选入口更大,降低选入难度;其中内嵌支架20的近端口也设置为斜口以增加血液通入的接收面积。In some embodiments, referring to FIG. 10 , the distal port and the opening 1024 of the embedded stent 20 may be both configured as oblique openings, and the oblique openings are oriented in a direction away from the second channel 1022; and the oblique openings may also enable the internal iliac stent to have a larger selection entrance when the embedded stent 20 is implanted, thereby reducing the difficulty of selection; wherein the proximal port of the embedded stent 20 is also configured as an oblique opening to increase the receiving area for blood flow.

在其中一个实施例中,支撑件10233至少部分设有显影结构(图中未示出),当支撑件10233设有显影结构时,支撑件10233的形状可以根据需求设置为带有标记识别作用的形状和结构,譬如字母形状支撑件10233或者数字形状支撑件10233,支撑件10233也可以全部为显影结构,优选的显影结构可以是钽丝或者金丝。In one embodiment, the support member 10233 is at least partially provided with a developing structure (not shown in the figure). When the support member 10233 is provided with a developing structure, the shape of the support member 10233 can be set to a shape and structure with a marking identification function according to needs, such as a letter-shaped support member 10233 or a number-shaped support member 10233. The support member 10233 can also be entirely a developing structure. The preferred developing structure can be tantalum wire or gold wire.

实施例三Embodiment 3

在本实施例中,请参阅图11和图12,主体支架10和内嵌支架20的结构与实施例一中大体相同,不同之处在于,第一波圈1023至少在第一通道1021的部分设有断口10231,可以理解的,第一波圈1023设有断口10231形成C形波圈1026,在断口10231的位置第一波圈1023不提供支撑力,将断口10231位置设于第一通道1021,使得瘤腔段102在第一通道1021位置仅通过覆膜覆盖,无第一波圈1023支撑,第一通道1021的支撑力由内嵌支架20提供,而内嵌支架20的支撑强度低于第一波圈1023的支撑强度,使得瘤腔段102在第一通道1021的支撑强度小于在第二通道1022的支撑强度。In the present embodiment, referring to FIG. 11 and FIG. 12 , the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first embodiment, except that the first wave coil 1023 is provided with a break 10231 at least in a portion of the first channel 1021. It can be understood that the first wave coil 1023 is provided with a break 10231 to form a C-shaped wave coil 1026, and the first wave coil 1023 does not provide supporting force at the position of the break 10231. The break 10231 is located in the first channel 1021, so that the tumor cavity segment 102 is only covered by the membrane at the position of the first channel 1021, without the support of the first wave coil 1023, and the supporting force of the first channel 1021 is provided by the embedded support 20, and the supporting strength of the embedded support 20 is lower than the supporting strength of the first wave coil 1023, so that the supporting strength of the tumor cavity segment 102 in the first channel 1021 is less than the supporting strength in the second channel 1022.

在其中一个实施例中,断口10231仅覆盖内嵌支架20与瘤腔段102覆膜连接的位置,C形波圈1026的断开两端与内嵌支架20与瘤腔段102覆膜的连接位置的两侧相接,即瘤腔段102的第一通道1021部分仅与内嵌支架20连接的位置没有第一波圈1023提供支撑力,如此设置,瘤腔段102在受到挤压力时,第一通道1021部分与内嵌支架20连接的部分由于支撑强度较小,优先产生变形,从而能够有效的避免挤压对第二通道1022的形态产生过大的影响。In one of the embodiments, the fracture 10231 only covers the position where the embedded stent 20 is connected to the membrane of the tumor cavity segment 102, and the broken ends of the C-shaped wave ring 1026 are connected to the two sides of the connection position between the embedded stent 20 and the membrane of the tumor cavity segment 102, that is, the first channel 1021 of the tumor cavity segment 102 is only connected to the embedded stent 20, and there is no support force provided by the first wave ring 1023. With this arrangement, when the tumor cavity segment 102 is subjected to extrusion pressure, the part where the first channel 1021 is connected to the embedded stent 20 is deformed first due to its smaller support strength, thereby effectively avoiding the extrusion from having too much influence on the shape of the second channel 1022.

请进一步参阅图20,C形波圈1026位于断口10231的两个端部回绕形成圆环结构10261或者防损伤端头,圆环结构10261能够将编织C形波圈1026的金属丝的端部进行收纳,进而避免尖锐的端部刺破覆膜划伤血管。Please further refer to Figure 20. The two ends of the C-shaped wave coil 1026 located at the fracture 10231 are wrapped around to form a circular ring structure 10261 or an anti-damage end. The circular ring structure 10261 can store the ends of the metal wires of the braided C-shaped wave coil 1026, thereby preventing the sharp ends from piercing the membrane and scratching the blood vessels.

实施例四Embodiment 4

在本实施例中,请参阅图13,主体支架10和内嵌支架20的结构与实施例一中大体相同,不同之处在于,瘤腔段102内的内嵌支架20包括沿径向设置的第一内嵌支架21和第二内嵌支架22,其中第一内嵌支架21与远端段103连通;瘤腔段102的远端设有开口1024,第二内嵌支架22的远端口与开口1024连通;其中,瘤腔段102包括第一通道1021和第二通道1022,第二通道1022收容所述第一内嵌支架21,第一通道1021收容所述第二内嵌支架22;In this embodiment, please refer to FIG. 13 , the structures of the main stent 10 and the embedded stent 20 are substantially the same as those in the first embodiment, except that the embedded stent 20 in the tumor cavity segment 102 includes a first embedded stent 21 and a second embedded stent 22 arranged in a radial direction, wherein the first embedded stent 21 is communicated with the distal segment 103; an opening 1024 is provided at the distal end of the tumor cavity segment 102, and a distal port of the second embedded stent 22 is communicated with the opening 1024; wherein the tumor cavity segment 102 includes a first channel 1021 and a second channel 1022, wherein the second channel 1022 accommodates the first embedded stent 21, and the first channel 1021 accommodates the second embedded stent 22;

第二通道1022和第一通道1021通过内嵌第一内嵌支架21和第二内嵌支架22进行分隔形成血液流腔,第一内嵌支架21和第二内嵌支架22能够分别提供支撑性以维持通道形态避免受压闭塞;在第二通道1022设置第一内嵌支架21,能够在发生挤压时,第二通道1022的第一内嵌支架21具有与第一通道1021的第二内嵌支架22相互抵抗的支撑力,从而使得本申请的覆膜支架100,在能够为髂内支架植入第一通道1021时提供形态较好的通路的同时,又能够避免第一通道1021对第二通道1022的过度挤压导致的第二通道1022的闭塞,从而能够较好的维持双通道的整体形态和顺畅性;其中,瘤腔段102位于近端段101的血液流入口和位于远端的血液流出口均被第一内嵌支架21和第二内嵌支架22的近端口和远端口占据,使得血流从近端段101流入瘤腔段102时,均被第一内嵌支架21和第二内嵌支架22分流。The second channel 1022 and the first channel 1021 are separated by the embedded first embedded bracket 21 and the second embedded bracket 22 to form a blood flow cavity. The first embedded bracket 21 and the second embedded bracket 22 can respectively provide support to maintain the channel shape to avoid occlusion due to pressure; the first embedded bracket 21 is arranged in the second channel 1022, so that when extrusion occurs, the first embedded bracket 21 of the second channel 1022 has a supporting force that resists the second embedded bracket 22 of the first channel 1021, so that the coated stent 100 of the present application can be implanted in the first iliac stent. While providing a better-shaped passage, the first channel 1021 can also avoid the occlusion of the second channel 1022 caused by excessive squeezing of the second channel 1022 by the first channel 1021, thereby better maintaining the overall shape and smoothness of the dual channels; wherein, the blood inlet at the proximal section 101 and the blood outlet at the distal end of the tumor cavity section 102 are both occupied by the proximal port and the distal port of the first embedded stent 21 and the second embedded stent 22, so that when the blood flows from the proximal section 101 into the tumor cavity section 102, it is diverted by the first embedded stent 21 and the second embedded stent 22.

在本实施例中,请参阅图14-图16,为了在瘤腔段102发生挤压时或者支架展开时,确保第二通道1022的展开形态,保证其血流的通畅度,本申请将覆膜支架100的瘤腔段102整体处于第二通道1022的部分的支撑强度设置为大于处于第一通道1021的部分的支撑强度;也就是说,可以在瘤腔段102的支撑强度均匀的前提下,通过设置第一内嵌支架21的支撑强度大于第二内嵌支架22的支撑强度实现;或者在第一内嵌支架21的支撑强度等于第二内嵌支架22的支撑强度的前提下,使得瘤腔段102的第二通道1022的支撑强度大于第一通道1021的支撑强度实现;或者设置第一内嵌支架21的支撑强度大于第二内嵌支架22的支撑强度且瘤腔段102的第二通道1022的支撑强度大于第一通道1021的支撑强度。In the present embodiment, please refer to Figures 14 to 16. In order to ensure the expanded shape of the second channel 1022 and the patency of its blood flow when the tumor cavity segment 102 is squeezed or the stent is deployed, the present application sets the support strength of the portion of the tumor cavity segment 102 of the coated stent 100 that is in the second channel 1022 as a whole to be greater than the support strength of the portion that is in the first channel 1021; that is, it can be achieved by setting the support strength of the first embedded stent 21 to be greater than the support strength of the second embedded stent 22, on the premise that the support strength of the tumor cavity segment 102 is uniform; or on the premise that the support strength of the first embedded stent 21 is equal to the support strength of the second embedded stent 22, the support strength of the second channel 1022 of the tumor cavity segment 102 is greater than the support strength of the first channel 1021; or the support strength of the first embedded stent 21 is set to be greater than the support strength of the second embedded stent 22 and the support strength of the second channel 1022 of the tumor cavity segment 102 is greater than the support strength of the first channel 1021.

在本实施例中,请参阅图14和图15,第一内嵌支架21和第二内嵌支架22均具有网状主体201和表面第二覆膜202,而主体支架10的瘤腔段102则包括沿轴向间隔设置的多个第一波圈1023,网状主体201能够提供更好的延展性,将第一内嵌支架21和第二内嵌支架22的表面第二覆膜202更为平整的张开,防止局部位置被挤压发生塌陷,同时能够提供较多的支撑位点以与髂内支架植入时相抵触,增加摩擦力;通过调整第一内嵌支架21和第二内嵌支架22的丝径,以及调整第一波圈1023位于第二通道1022的丝径和所述第一波圈1023位于第一通道1021的丝径,可以使覆膜支架100位于瘤腔段102的第一通道1021部分和第二通道1022部分具有支撑强度差,可以理解,更大的支架丝径可以提供更高的支撑性能,故通过使第一内嵌支架21的丝径大于第二内嵌支架22的丝径,和/或第一波圈1023位于第二通道1022的丝径大于第一波圈1023位于第一通道1021的丝径;In this embodiment, referring to FIG. 14 and FIG. 15 , the first embedded stent 21 and the second embedded stent 22 both have a mesh body 201 and a second surface coating 202, and the tumor cavity section 102 of the main stent 10 includes a plurality of first wave rings 1023 spaced apart along the axial direction, and the mesh body 201 can provide better ductility, and the second surface coating 202 of the first embedded stent 21 and the second embedded stent 22 can be opened more smoothly to prevent local positions from being squeezed and collapsed, and at the same time, more support sites can be provided to conflict with the iliac internal stent during implantation to increase friction; by adjusting the first embedded stent 21 and the second internal The wire diameter of the embedded stent 22, and the wire diameter of the first wave coil 1023 located in the second channel 1022 and the wire diameter of the first wave coil 1023 located in the first channel 1021 can be adjusted to make the first channel 1021 part and the second channel 1022 part of the stent graft 100 located in the tumor cavity section 102 have a difference in support strength. It can be understood that a larger stent wire diameter can provide higher support performance. Therefore, by making the wire diameter of the first embedded stent 21 larger than the wire diameter of the second embedded stent 22, and/or the wire diameter of the first wave coil 1023 located in the second channel 1022 larger than the wire diameter of the first wave coil 1023 located in the first channel 1021;

请参阅图14,使第一内嵌支架21的丝径大于第二内嵌支架22的丝径,和第一波圈1023位于第二通道1022的丝径大于第一波圈1023位于第一通道1021的丝径;第一通道1021第一波圈1023的丝径小,在瘤腔段102受到挤压力时,第一通道1021的第一波圈1023优先于第二通道1022的第一波圈1023发生变形,从而优先影响位于第一通道1021内的第二内嵌支架22的变形,而由于第二内嵌支架22的丝径小于第一内嵌支架21,使得发生在第二内嵌支架22的变形优于第一内嵌支架21,将在单层支架上的支撑强度分散至内外两层支架上进行分摊,能够使得单个支架上的支撑强度不至于太大,并且,同时减小瘤腔段102第一通道1021的第一波圈1023以及第二髂内支架的丝径,能够避免在单个支架上丝径落差太大,两个支架的丝径都不至于减少的太细,从而避免过小的丝径设置导致支架难以维持支撑效果以及丝径太大导致柔顺性差的问题。Please refer to FIG. 14 , in which the wire diameter of the first embedded stent 21 is larger than the wire diameter of the second embedded stent 22, and the wire diameter of the first wave coil 1023 located in the second channel 1022 is larger than the wire diameter of the first wave coil 1023 located in the first channel 1021; the wire diameter of the first wave coil 1023 in the first channel 1021 is small, and when the tumor cavity section 102 is subjected to the extrusion force, the first wave coil 1023 in the first channel 1021 is deformed first before the first wave coil 1023 in the second channel 1022, thereby preferentially affecting the deformation of the second embedded stent 22 located in the first channel 1021, and because the wire diameter of the second embedded stent 22 is It is smaller than the first embedded stent 21, so that the deformation of the second embedded stent 22 is better than that of the first embedded stent 21, and the supporting strength on the single-layer stent is distributed to the inner and outer two-layer stents for sharing, so that the supporting strength on a single stent is not too large, and at the same time, the wire diameter of the first wave ring 1023 of the first channel 1021 of the tumor cavity section 102 and the second iliac internal stent are reduced, which can avoid a large difference in wire diameter on a single stent, and the wire diameters of the two stents are not reduced too thin, thereby avoiding the problem that the stent is difficult to maintain the supporting effect due to the setting of too small wire diameter and the poor flexibility due to too large wire diameter.

实施五Implementation Five

在本实施例中,请参阅图16,主体支架10和内嵌支架20的结构与实施例一和实施例四中大体相同,不同之处在于,在本实施例中,通过使第一内嵌支架21的网格密度大于第二内嵌支架22的网格密度,使得覆膜支架100的瘤腔段102整体处于第二通道1022的部分的支撑强度设置为大于处于第一通道1021的部分的支撑强度,,具体的,第一内嵌支架21和第二内嵌支架22包括网状主体201,网状主体201具有多个网格结构,网格密度越高,意味着所需要的编织丝数量增加,并且单个网格的面积越小,能够承受的压力越大,较大的网格密度能够提供的支撑强度越大。In the present embodiment, referring to FIG. 16 , the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first and fourth embodiments, except that, in the present embodiment, by making the mesh density of the first embedded support 21 greater than the mesh density of the second embedded support 22, the support strength of the tumor cavity section 102 of the coated support 100 as a whole in the second channel 1022 is set to be greater than the support strength of the part in the first channel 1021. Specifically, the first embedded support 21 and the second embedded support 22 include a mesh body 201, and the mesh body 201 has a plurality of mesh structures. A higher mesh density means an increase in the number of braided wires required, and a smaller area of a single mesh means a greater pressure that can be withstood, and a larger mesh density can provide a greater support strength.

在本实施例中,请继续参阅图16,第一内嵌支架21和第二内嵌支架22具有编织成型的菱形网格结构,第一内嵌支架21具有第一菱形网格,第二内嵌支架22具有第二菱形网格,第一菱形网格和第二菱形网格在轴向上均具有上顶点和下顶点,在径向上具有左顶点和右顶点,第一菱形网格的上顶点和下顶点之间的间距为D1,左顶点和右顶点之间的间距为L1。第二菱形网格的上顶点和下顶点之间的间距为D2,左顶点和右顶点之间的间距为L2;优选的,可以使D1和L1均小于D2和L2,使得单个第一菱形网格所占的面积小于单个第二菱形网格所占面积,从而,在相同的支架展开面积下,第一内嵌支架21具有更高的网格密度,提供强于第二内嵌支架22的支撑强度。In this embodiment, please continue to refer to FIG. 16 , the first embedded bracket 21 and the second embedded bracket 22 have a woven diamond grid structure, the first embedded bracket 21 has a first diamond grid, the second embedded bracket 22 has a second diamond grid, the first diamond grid and the second diamond grid both have an upper vertex and a lower vertex in the axial direction, and a left vertex and a right vertex in the radial direction, the spacing between the upper vertex and the lower vertex of the first diamond grid is D1, and the spacing between the left vertex and the right vertex is L1. The spacing between the upper vertex and the lower vertex of the second diamond grid is D2, and the spacing between the left vertex and the right vertex is L2; preferably, D1 and L1 can be made smaller than D2 and L2, so that the area occupied by a single first diamond grid is smaller than the area occupied by a single second diamond grid, so that, under the same bracket deployment area, the first embedded bracket 21 has a higher grid density, providing a stronger support strength than the second embedded bracket 22.

在另一个实施例中,请继续参阅图16,可以至少使第一菱形网格的L1小于第二菱形网格的L2,从而仅在第一内嵌支架21的周向方向上改变第一菱形网格的密度,如此,能够至少在径向方向上增大第一菱形网格的密度,从而达到径向方向上的支撑强度增强的效果。In another embodiment, please continue to refer to Figure 16, the L1 of the first diamond grid can be at least smaller than the L2 of the second diamond grid, so that the density of the first diamond grid is changed only in the circumferential direction of the first embedded bracket 21. In this way, the density of the first diamond grid can be increased at least in the radial direction, thereby achieving the effect of enhancing the support strength in the radial direction.

在其中实施例中,瘤腔段102的第一波圈1023位于第二通道1022部分的波角大于第一波圈1023位于第一通道1021部分的波角;在另一个实施例中,可以使第一波圈1023的所有波形的波高,自第二通道1022部分向第一通道1021部分逐渐增大,且波角逐渐减小,形成支撑强度渐缩的结构;如此,支撑强度的渐缩可避免瘤腔段102在第二通道1022部分和第一通道1021部分交界的位置突然形成较大的支撑强度差,从而导致瘤腔段102在该位置发生不可预知和不期望的变形。通过同时使第一内嵌支架21的网格密度大于第二内嵌支架22的网格密度并且第一波圈1023位于第二通道1022的波角大于第一波圈1023位于第一通道1021的波角,同时在瘤腔段102的第一波圈1023和第一内嵌支架21及第二内嵌支架22上设置支撑强度的变化,能够避免仅在第一内嵌支架21及第二内嵌支架22上设置支撑强度的变化或瘤腔段102的第一波圈1023上设置强度变化所可能导致的部分位置上的支架柔顺性差的问题。In one embodiment, the wave angle of the first wave loop 1023 of the tumor cavity segment 102 located in the second channel 1022 is greater than the wave angle of the first wave loop 1023 located in the first channel 1021; in another embodiment, the wave height of all waveforms of the first wave loop 1023 can be gradually increased from the second channel 1022 portion to the first channel 1021 portion, and the wave angle can be gradually reduced, forming a structure with gradually decreasing support strength; in this way, the gradual reduction of support strength can avoid the tumor cavity segment 102 from suddenly forming a large support strength difference at the junction of the second channel 1022 portion and the first channel 1021 portion, thereby causing unpredictable and unexpected deformation of the tumor cavity segment 102 at this position. By making the grid density of the first embedded bracket 21 greater than the grid density of the second embedded bracket 22 and the wave angle of the first wave coil 1023 in the second channel 1022 greater than the wave angle of the first wave coil 1023 in the first channel 1021, and setting changes in support strength on the first wave coil 1023 of the tumor cavity segment 102 and the first embedded bracket 21 and the second embedded bracket 22, the problem of poor flexibility of the bracket at some positions which may be caused by setting changes in support strength only on the first embedded bracket 21 and the second embedded bracket 22 or setting strength changes on the first wave coil 1023 of the tumor cavity segment 102 can be avoided.

可以理解的是,通过使第一内嵌支架21的网格密度大于第二内嵌支架22的网格密度,和/或第一波圈1023位于第二通道1022的波角大于第一波圈1023位于第一通道1021的波角,均可使得覆膜支架100的瘤腔段102整体处于第二通道1022的部分的支撑强度设置为大于处于第一通道1021的部分的支撑强度。It can be understood that by making the grid density of the first embedded bracket 21 greater than the grid density of the second embedded bracket 22, and/or the wave angle of the first wave circle 1023 located in the second channel 1022 greater than the wave angle of the first wave circle 1023 located in the first channel 1021, the support strength of the tumor cavity section 102 of the coated stent 100 as a whole that is located in the second channel 1022 can be set to be greater than the support strength of the part that is located in the first channel 1021.

实施例六Embodiment 6

在本实施例中,请参阅图17-图19,主体支架10和内嵌支架20的结构与实施例一和实施例四~实施例五中大体相同,不同之处在于,通过将瘤腔段102的第一通道1021和第二通道1022设有不同的轴向长度(图17中H1和H2)从而改变瘤腔段102位于第一通道1021和第二通道1022的支撑强度;具体的,第二通道1022的轴向长度H2大于第一通道1021的轴向长度H1,瘤腔段102在第二通道1022具有轴向长度H2,在第一通道1021具有轴向长度H1,H2的长度大于H1的长度使得瘤腔段102的第二通道1022在受压时,可承受压力的长度和接触面积大于第一通道1021的受压长度和接触面积从而,从而使得压力更好的被分散,提供更好的支撑性能,提升支撑强度;请进一步参阅图18和图19,其中,第二内嵌支架22的远端包括露出段221,露出段221从开口1024穿出,露出段221穿出第一通道1021,使得覆膜支架100的第一通道1021同样具有不同支撑强度的分布,在髂内支架的介入端仅有第二内嵌支架22单层支架作为支撑,使得在该位置具有较好的柔顺性,从而便于髂内支架的选入;进一步的,露出段221的远端口为平口或者斜口;当设置为平口时,露出段221能够与介入的髂内支架具有更多的贴附支撑位置,从而能够有效的提高髂内支架介入之后的长期稳定性;而当设置为斜口时,斜口的开口方向朝远离第二通道1022的方向,如此能够在不扩大第二内嵌支架22的直径的情况下扩大髂内支架的选入口,从而使得髂内支架的选入更加快捷和方便;且扩大的选入口也能够提升髂内支架选入的准确性;在一些实施例中,露出段221与相邻的第二通道1022贴合,露出段221可为自由端,可相对第二通道1022分离,如此设置能够使髂内支架植入后,向髂内血管延伸时在该位置不会受到过大的压力从而发生压折闭塞等问题;露出段221也可通过缝合或者粘接的方式与第二通道1022的侧壁固定连接,避免摆动,能够使得髂内支架更好的选入。In the present embodiment, referring to FIGS. 17 to 19 , the structures of the main support 10 and the embedded support 20 are substantially the same as those in the first embodiment and the fourth to fifth embodiments, except that the support strength of the tumor cavity segment 102 in the first channel 1021 and the second channel 1022 is changed by providing different axial lengths (H1 and H2 in FIG. 17 ) to the first channel 1021 and the second channel 1022 of the tumor cavity segment 102; specifically, the axial length H2 of the second channel 1022 is greater than the axial length H1 of the first channel 1021, and the tumor cavity segment 102 has an axial length H2 in the second channel 1022. A channel 1021 has an axial length H1, and the length of H2 is greater than the length of H1, so that when the second channel 1022 of the tumor cavity section 102 is under pressure, the length and contact area that can withstand pressure are greater than the compressed length and contact area of the first channel 1021, so that the pressure is better dispersed, providing better support performance and improving support strength; please refer to Figures 18 and 19, wherein the distal end of the second embedded stent 22 includes an exposed segment 221, the exposed segment 221 passes through the opening 1024, and the exposed segment 221 passes through the first channel 1021, so that the first channel 1021 of the coated stent 100 also has There is a distribution of different support strengths. At the intervention end of the internal iliac stent, only the second embedded stent 22 single-layer stent is used as support, so that it has good flexibility at this position, thereby facilitating the selection of the internal iliac stent; further, the distal end of the exposed section 221 is a flat end or an oblique end; when it is set to a flat end, the exposed section 221 can have more attachment support positions with the intervened internal iliac stent, thereby effectively improving the long-term stability of the internal iliac stent after intervention; and when it is set to an oblique end, the opening direction of the oblique end is in the direction away from the second channel 1022, so that the internal iliac stent can be enlarged without enlarging the diameter of the second embedded stent 22. The selection entrance of the stent makes the selection of the internal iliac stent faster and more convenient; and the enlarged selection entrance can also improve the accuracy of the selection of the internal iliac stent; in some embodiments, the exposed section 221 is fitted with the adjacent second channel 1022, and the exposed section 221 can be a free end and can be separated from the second channel 1022. Such a setting can ensure that after the internal iliac stent is implanted, it will not be subjected to excessive pressure at this position when extending to the internal iliac blood vessel, thereby causing problems such as compression and occlusion; the exposed section 221 can also be fixedly connected to the side wall of the second channel 1022 by suturing or bonding to avoid swinging, so that the internal iliac stent can be better selected.

其中,请参阅图18-图19,由于第二内嵌支架22穿出瘤腔段102的开口1024,在开口1024位置仅有单层支架,相比其他位置支撑性减弱较大,为了确保本申请覆膜支架100的瘤腔段102在受到挤压时在第一通道1021位置相比在第二通道1022位置更易变形的同时,避免露出段221的选入口压迫闭塞,将第二通道1022靠近露出段221部分的支架支撑性减弱,可将第二通道1022的至少与露出段221位于相同轴向位置上的第一波圈1023设有断口10231,形成C形波圈1026,并且断口10231朝向露出段221,如此设置,第二通道1022与露出段221接触的位置支撑性被有效的减弱,使得露出段221的髂内支架选入口在受到压迫时在于第二通道1022抵持的位置能够发生一定量的形变从而缓冲挤压力,从而避免选入口被进一步的挤压。18-19, since the second embedded stent 22 passes through the opening 1024 of the tumor cavity segment 102, there is only a single-layer stent at the opening 1024, and the support is greatly weakened compared with other positions. In order to ensure that the tumor cavity segment 102 of the coated stent 100 of the present application is easier to deform at the first channel 1021 position than at the second channel 1022 position when being squeezed, and to avoid compression and occlusion of the selected entrance of the exposed segment 221, the support of the stent at the second channel 1022 close to the exposed segment 221 is weakened, and the second channel 1022 can be At least the first wave ring 1023 of the channel 1022 located at the same axial position as the exposed section 221 is provided with a break 10231 to form a C-shaped wave ring 1026, and the break 10231 is directed toward the exposed section 221. With this arrangement, the support of the position where the second channel 1022 contacts the exposed section 221 is effectively weakened, so that when the selection port of the internal iliac stent of the exposed section 221 is compressed and the position where the second channel 1022 abuts can undergo a certain amount of deformation, thereby buffering the squeezing force and preventing the selection port from being further squeezed.

与实施例三中相同,C形波圈1026位于断口10231的两个端部回绕形成圆环结构,圆环结构能够将编织C形波圈1026的金属丝的端部进行收纳,进而避免尖锐的端部刺破覆膜划伤血管。Similar to the third embodiment, the two ends of the C-shaped wave coil 1026 at the break 10231 are wrapped around to form a circular ring structure, which can store the ends of the metal wires of the braided C-shaped wave coil 1026, thereby preventing the sharp ends from piercing the coating and scratching the blood vessels.

在本实施例中,请参阅图20,为了覆膜支架100能够更好的适应病变血管的形态,在瘤腔段102的近端位置设有近端波圈1025,将瘤腔段102近端的近端波圈1025设置为近端的直径小于远端的直径,使得近端波圈1025具有倾斜角度,形成近窄远宽的支架结构,如此,覆膜支架100的瘤腔段102在与近端段101相接的位置形成一个由宽到窄的渐变过渡结构,以适应正常血管到病变血管的直径的变化,增强在近端段101与血管的锚定性,以提升覆膜支架100植入后的稳定性;在本实施例中,为了瘤腔段102的第一通道1021和第二通道1022都能过具有较好的通过性,将瘤腔段102的径向尺寸做的比近端段101和远端段103大,并且第一内嵌支架21的设置和第二内嵌支架22的设置能够确保第一通道1021和髂外通达的血液通过性,其中瘤腔血管相较于近端血管同样具有一个尺寸由大到小的变化,从而设置近端波圈能够顺应该结构的同时,能够增强本申请覆膜支架100的表面贴附性,避免支架在血管内摆动,同时能够避免支架在血管内滑脱移位。In this embodiment, please refer to FIG. 20 . In order for the coated stent 100 to better adapt to the morphology of the diseased blood vessel, a proximal wave ring 1025 is provided at the proximal position of the tumor cavity segment 102. The proximal wave ring 1025 at the proximal end of the tumor cavity segment 102 is set so that the proximal diameter is smaller than the distal diameter, so that the proximal wave ring 1025 has an inclined angle, forming a stent structure that is narrow near and wide far away. In this way, the tumor cavity segment 102 of the coated stent 100 forms a gradual transition structure from wide to narrow at the position where it connects with the proximal segment 101, so as to adapt to the change in diameter from normal blood vessels to diseased blood vessels, enhance the anchoring of the proximal segment 101 and the blood vessel, and improve the stability of the coated stent 100 after implantation. In the present embodiment, in order to ensure that the first channel 1021 and the second channel 1022 of the tumor cavity segment 102 have better permeability, the radial dimension of the tumor cavity segment 102 is made larger than that of the proximal segment 101 and the distal segment 103, and the setting of the first embedded stent 21 and the second embedded stent 22 can ensure the blood permeability of the first channel 1021 and the external iliac region, wherein the tumor cavity blood vessel also has a size change from large to small compared with the proximal blood vessel, so that the setting of the proximal wave ring can conform to the structure while enhancing the surface adhesion of the coated stent 100 of the present application, avoiding the swing of the stent in the blood vessel, and avoiding the stent from slipping and shifting in the blood vessel.

在其他实施例中,请参阅图21,第一内嵌支架21和第二内嵌支架22的近端口和远端口可分别设为平口或者斜口,例如将第二内嵌支架22的近端口和远端口均设为平行的斜口,将第一内嵌支架21的近端口设为斜口,如此可进一步的通过使第二内嵌支架22形成不稳定的平行四边形结构从而在径向上具有错开的支撑点,受压时容易发生形变以减小支撑强度,而第一内嵌支架21和第二内嵌支架22近端口的斜口设置则能够形成更大的血液流入口以顺畅接受来自近端段的血液。In other embodiments, please refer to Figure 21, the proximal port and the distal port of the first embedded stent 21 and the second embedded stent 22 can be set to flat or oblique ports respectively. For example, the proximal port and the distal port of the second embedded stent 22 are both set to parallel oblique ports, and the proximal port of the first embedded stent 21 is set to an oblique port. In this way, the second embedded stent 22 can be further formed into an unstable parallelogram structure so that it has staggered support points in the radial direction, which is easy to deform when under pressure to reduce the support strength. The oblique setting of the proximal ports of the first embedded stent 21 and the second embedded stent 22 can form a larger blood inlet to smoothly receive blood from the proximal segment.

在本实施例中,主体支架10表面覆盖有第一覆膜104,第一内嵌支架21和第二内嵌支架22表面覆盖有第二覆膜202,第一覆膜104的支撑强度大于第二覆膜202的支撑强度;其中,第一覆膜104采用PET膜,第二覆膜202采用ePTFE膜,此处,第一覆膜104和第二覆膜202的支撑强度的变化主要提现在材料本身的特性上,第一覆膜104所采用的PET膜的拉伸强度通常在50-200MPa之间,具有较好的耐冲击性能,而第二覆膜202所采用的ePTFE膜的拉伸强度通常在23-30MPa之间,耐冲击性能较差;因此,采用具有不同拉伸强度的第一覆膜104和第二覆膜202可使得在主体支架10和第一内嵌支架21和第二内嵌支架22在覆膜层面变具有支撑强度的区别,更好的配合支架本身进行不同支撑强度的设置;第一内嵌支架21和第二内嵌支架22采用ePTFE膜目的在于,提高血液通过性的同时,尽可能减小覆膜对支撑强度的影响。In this embodiment, the surface of the main support 10 is covered with a first coating 104, and the surfaces of the first embedded support 21 and the second embedded support 22 are covered with a second coating 202. The supporting strength of the first coating 104 is greater than the supporting strength of the second coating 202. Among them, the first coating 104 adopts a PET film, and the second coating 202 adopts an ePTFE film. Here, the change in the supporting strength of the first coating 104 and the second coating 202 is mainly reflected in the characteristics of the material itself. The tensile strength of the PET film adopted by the first coating 104 is generally between 50-200MPa, and has good impact resistance. performance, while the tensile strength of the ePTFE membrane used in the second coating 202 is usually between 23-30MPa, and the impact resistance is poor; therefore, the use of the first coating 104 and the second coating 202 with different tensile strengths can make the main support 10 and the first embedded support 21 and the second embedded support 22 have different support strengths at the coating level, so as to better cooperate with the support itself to set different support strengths; the first embedded support 21 and the second embedded support 22 use ePTFE membrane for the purpose of improving blood permeability while minimizing the influence of the coating on the support strength.

在另一个实施例中,为了使本申请所提供的覆膜支架100更好的适应病变的髂动脉血管,将覆膜支架100的远端段103和近端段101的支撑强度设置为大于瘤腔段102和第一内嵌支架21以及第二内嵌支架22的总支撑强度;如此设置是因为,瘤腔段102本身具有支撑强度,设置了第一内嵌支架21以及第二内嵌支架22则在覆膜支架100的该位置的支撑强度是以瘤腔段102和第一内嵌支架21以及第二内嵌支架22的总支撑强度来衡量的,将覆膜支架100的远端段103和近端段101的支撑强度设置为大于瘤腔段102和第一内嵌支架21以及第二内嵌支架22的总支撑强度,可使得覆膜支架100在血管靠近髂动脉病变位置的近端血管和远端血管均具有较好的支撑性,提升与血管之间的锚定力,将本申请的覆膜支架100牢固的锚定在释放位置;而瘤腔段102位置支撑强度的减弱目的在于使其具有更好的柔顺性从而提升顺应性,更好的与瘤腔段102血管的形态贴合,避免贴附不佳。在其他的一些实施例中,将覆膜支架100的远端段103或者近端段101的支撑强度设置为大于瘤腔段102和第一内嵌支架21以及第二内嵌支架22的总支撑强度;在近端段101或者远端段103任意一端设置较大的支撑强度以满足在瘤腔段102具备较好的柔顺性的情况下,至少在一端具备较好的支撑锚定性能以确保覆膜支架100在体内血管锚定时的稳定性。In another embodiment, in order to make the coated stent 100 provided by the present application better adapt to the diseased iliac artery blood vessel, the support strength of the distal segment 103 and the proximal segment 101 of the coated stent 100 is set to be greater than the total support strength of the tumor cavity segment 102 and the first embedded stent 21 and the second embedded stent 22; this is set because the tumor cavity segment 102 itself has support strength, and the support strength of the first embedded stent 21 and the second embedded stent 22 at this position of the coated stent 100 is measured by the total support strength of the tumor cavity segment 102 and the first embedded stent 21 and the second embedded stent 22. The support strength of the distal segment 103 and the proximal segment 101 of the coated stent 100 is set to be greater than the total support strength of the tumor cavity segment 102 and the first embedded stent 21 and the second embedded stent 22, so that the coated stent 100 can have better support for both the proximal and distal blood vessels close to the iliac artery lesion position, thereby improving the anchoring force between the blood vessels and the coated stent 100 of the present application, and firmly anchoring the coated stent 100 in the release position; and the purpose of weakening the support strength at the tumor cavity segment 102 is to make it have better flexibility and thus improve compliance, so as to better fit the shape of the blood vessel in the tumor cavity segment 102 and avoid poor adhesion. In some other embodiments, the support strength of the distal segment 103 or the proximal segment 101 of the coated stent 100 is set to be greater than the total support strength of the tumor cavity segment 102 and the first embedded stent 21 and the second embedded stent 22; a larger support strength is set at either the proximal segment 101 or the distal segment 103 to ensure that the tumor cavity segment 102 has good flexibility, while at least one end has good support and anchoring performance to ensure the stability of the coated stent 100 when anchored in the blood vessels in the body.

在一些实施例中,能够通过同时减小第一内嵌支架21和第二内嵌支架22以及瘤腔段102的支撑强度实现,譬如将第一内嵌支架21和第二内嵌支架22的整体支撑强度小于近端段101或远端段103的支撑强度的二分之一,将瘤腔段102的支撑强度小于端段或远端段103的支撑强度的二分之一。In some embodiments, this can be achieved by simultaneously reducing the support strength of the first embedded stent 21 and the second embedded stent 22 and the tumor cavity segment 102, for example, making the overall support strength of the first embedded stent 21 and the second embedded stent 22 less than half of the support strength of the proximal segment 101 or the distal segment 103, and making the support strength of the tumor cavity segment 102 less than half of the support strength of the proximal segment or the distal segment 103.

实施例七Embodiment 7

在本实施例中,请参阅图22和图23,主体支架10和内嵌支架的结构与实施例一和实施例四~实施例六中大体相同,不同之处在于,主体支架10位于近端段101和远端段103设有支撑波圈,而瘤腔覆膜段102不设有第一波圈1023,仅覆盖有覆膜,瘤腔覆膜段102的内腔设有第一内嵌支架21和第二内嵌支架22,通过第一内嵌支架21和第二内嵌支架22提供支撑性能;其中,主体支架10的近端段101、瘤腔覆膜段102和远端段103可通过第一覆膜104相连,近端段101和远端段103表面设有支撑波圈,瘤腔覆膜段102仅设有覆膜;也可以近端段101和瘤腔覆膜段102通过单片覆膜相连,远端段103通过粘接或者缝合的方式连接于瘤腔覆膜段102第二通道1022的远端;请参阅图24,第一内嵌支架21和第二内嵌支架22包括网状主体201,设置网状主体201的目的在于强调更好的形态支撑性;相较于支撑波圈,网状主体201能够具有更好的覆膜张力,从而即使在提供较小的编织丝丝径的情况下,同样能够提供较好的覆膜张力从而保持血液通路的形态;瘤腔覆膜段102仅覆盖覆膜,能够在第一内嵌支架21和第二内嵌支架22设置较小的丝径的情况下,使得覆膜支架100在瘤腔覆膜段102整体的支撑强度小于近端段101和远端段103,从而使瘤腔覆膜段102整体在能够维持第一通道1021和第二通道1022的形态和通过性的同时,具备更好的柔顺性。In the present embodiment, please refer to Figures 22 and 23. The structures of the main stent 10 and the embedded stent are substantially the same as those in the first embodiment and the fourth to sixth embodiments, except that the main stent 10 is provided with support waves at the proximal section 101 and the distal section 103, while the tumor cavity coating section 102 is not provided with the first wave circle 1023, but is only covered with a coating, and the inner cavity of the tumor cavity coating section 102 is provided with a first embedded stent 21 and a second embedded stent 22, and support performance is provided by the first embedded stent 21 and the second embedded stent 22; wherein, the proximal section 101, the tumor cavity coating section 102 and the distal section 103 of the main stent 10 can be connected by the first coating 104, the surfaces of the proximal section 101 and the distal section 103 are provided with support waves, and the tumor cavity coating section 102 is only provided with a coating; the proximal section 101 and the tumor cavity coating section 102 can also be connected by a single piece of coating, and the distal section 103 is connected by bonding or suturing. 24, the first embedded stent 21 and the second embedded stent 22 include a mesh body 201, and the purpose of setting the mesh body 201 is to emphasize better morphological support; compared with the supporting wave ring, the mesh body 201 can have better coating tension, so that even when a smaller braided wire diameter is provided, it can also provide better coating tension to maintain the shape of the blood passage; the tumor cavity coating segment 102 is only covered with a coating, and when a smaller wire diameter is set for the first embedded stent 21 and the second embedded stent 22, the overall support strength of the coated stent 100 in the tumor cavity coating segment 102 is less than the proximal segment 101 and the distal segment 103, so that the tumor cavity coating segment 102 as a whole can maintain the shape and permeability of the first channel 1021 and the second channel 1022 while having better flexibility.

在本实施例中,请参阅图23-图26,第一内嵌支架21和第二内嵌支架22至少在其远端的远端口位置和其近端的近端口位置与瘤腔覆膜段102的第一覆膜104通过粘接或者缝合的方式进行连接,其中,瘤腔覆膜段102位于近端的血液流入口和位于远端的血液流出口均被第一内嵌支架21和第二内嵌支架22的近端口和远端口占据,使得血流从近端段101流入瘤腔覆膜段102时,均被第一内嵌支架21和第二内嵌支架22分流,从而避免在瘤腔覆膜段102发生内漏;第一内嵌支架21和第二内嵌支架22的近端口和远端口可设置为平口或者斜口;In this embodiment, please refer to Figures 23 to 26, the first embedded stent 21 and the second embedded stent 22 are connected to the first covering film 104 of the tumor cavity covering segment 102 by bonding or suturing at least at the distal end of the distal port position and the proximal end of the proximal port position, wherein the blood inlet at the proximal end and the blood outlet at the distal end of the tumor cavity covering segment 102 are occupied by the proximal port and the distal port of the first embedded stent 21 and the second embedded stent 22, so that when the blood flows from the proximal segment 101 into the tumor cavity covering segment 102, it is shunted by the first embedded stent 21 and the second embedded stent 22, thereby avoiding internal leakage in the tumor cavity covering segment 102; the proximal port and the distal port of the first embedded stent 21 and the second embedded stent 22 can be set to be flat or oblique;

请参阅图24,为了提高血流的通过性,且瘤腔覆膜段102具有更好的柔顺性,将第一内嵌支架21和第二内嵌支架22的近端口设置为斜口,其中位于第一内嵌支架21的近端设有第一近端斜口211,位于第二内嵌支架22的近端设有第二近端斜口222,第一近端斜口211与第二近端斜口222相对设置,两个斜口在轴向的切面上形成一个V形截面;如此设置,第一内嵌支架21和第二内嵌支架22的双斜口设置能够在瘤腔覆膜段102的血液流入口位置增大血液流入口的承接面积,使得血液的流入更加通畅;并且,斜口设置使得第一内嵌支架21和第二内嵌支架22在径向的两侧上的支撑点减少,从而一定程度上能够降低在径向上的支撑强度,使得覆膜支架100位于瘤腔覆膜段102的支撑强度小于近端段101和远端段103的支撑强度;并且,通常支架在弯曲时,大弯侧为延展的部分,而小弯侧为压缩的部分,将第一近端斜口211与第二近端斜口222设置为相对设置的双斜口设计,使得覆膜支架100在弯曲时,大弯侧都在第一近端斜口211或者第二近端斜口222的斜口延伸长度较长的一侧,小弯侧位于斜口延伸长度较短的一侧,故在弯曲时,第一近端斜口211和第二近端斜口222的斜口结构正好顺应支架弯曲的结构,斜口延伸长度较长的一侧在大弯侧,斜口延伸长度较短的一侧在小弯侧,使得覆膜支架100至少在瘤腔覆膜段的部分具有更好的柔顺性,在覆膜支架100弯曲时,可有效的防止在瘤腔覆膜段102内发生内嵌支架的弯折。Please refer to Figure 24. In order to improve the permeability of blood flow and make the tumor cavity coating section 102 have better flexibility, the proximal ports of the first embedded stent 21 and the second embedded stent 22 are set to be beveled, wherein a first proximal beveled port 211 is provided at the proximal end of the first embedded stent 21, and a second proximal beveled port 222 is provided at the proximal end of the second embedded stent 22. The first proximal beveled port 211 and the second proximal beveled port 222 are arranged opposite to each other, and the two bevels form a V-shaped cross-section on the axial section; in this way, the double beveled port setting of the first embedded stent 21 and the second embedded stent 22 can increase the receiving area of the blood flow inlet at the blood flow inlet position of the tumor cavity coating section 102, so that the blood inflow is smoother; and the beveled port setting reduces the support points of the first embedded stent 21 and the second embedded stent 22 on both sides of the radial direction, thereby reducing the support strength in the radial direction to a certain extent, so that the coated stent 100 is located at the tumor cavity coating. The supporting strength of the membrane segment 102 is smaller than that of the proximal segment 101 and the distal segment 103; and, usually, when the stent is bent, the larger curved side is the extended part, and the smaller curved side is the compressed part. The first proximal bevel 211 and the second proximal bevel 222 are set as a double bevel design set opposite to each other, so that when the coated stent 100 is bent, the larger curved side is on the side of the first proximal bevel 211 or the second proximal bevel 222 with a longer extending length of the bevel, and the smaller curved side is on the side with a shorter extending length of the bevel. Therefore, when bending, the bevel structure of the first proximal bevel 211 and the second proximal bevel 222 just conforms to the bending structure of the stent, the side with a longer extending length of the bevel is on the larger curved side, and the side with a shorter extending length of the bevel is on the smaller curved side, so that the coated stent 100 has better flexibility at least in the part of the tumor cavity coated segment. When the coated stent 100 is bent, the bending of the embedded stent in the tumor cavity coated segment 102 can be effectively prevented.

在其他的实施例中,第一近端斜口211和第二近端斜口222的设置,可使第一内嵌支架21和第二内嵌支架22在的长轴侧壁和短轴侧壁形成错位,从而在将本申请的覆膜支架100压缩放入输送鞘管内时,错位结构的长轴侧壁和短轴侧壁可使第一内嵌支架21和第二内嵌支架21折叠后的体积更小,更易送入输送鞘管内。In other embodiments, the setting of the first proximal bevel 211 and the second proximal bevel 222 can cause the long-axis side walls and short-axis side walls of the first embedded stent 21 and the second embedded stent 22 to be offset, so that when the coated stent 100 of the present application is compressed and placed into a delivery sheath, the long-axis side walls and short-axis side walls of the offset structure can make the first embedded stent 21 and the second embedded stent 21 smaller in size after folding, and easier to deliver into the delivery sheath.

在本实施例中,请参阅图24和图26,第一内嵌支架21的远端口为斜口或者平口,第二内嵌支架22的远端口也为斜口或者平口,且瘤腔覆膜段102的远端血液流出口与第一内嵌支架21和第二内嵌支架22的远端口平齐贴合,通过粘接或者缝合的方式固定;其中,第二内嵌支架22的远端口设有第二远端斜口223,第一内嵌支架21的远端口设有第一远端斜口213或者平口;请参阅图26,当第一内嵌支架21和第二内嵌支架22的远端口设为斜口时,第一远端斜口213和第二远端斜口223分别与第一近端斜口211和第二近端斜口222平行;非矩形的平行四边形和矩形相比,其相对的相侧边的支撑力小于矩形相对的两侧边的支撑力;如此,平行设置的斜口,能够使得第一内嵌支架21和第二内嵌支架22径向两侧的支撑位置形成错开的结构,从而,在受到径向的挤压力时,部分的径向压力会被平行四边形的特殊结构转化为轴向的力,从而有效的分散径向压力达到减小径向支撑力的效果,使得第一内嵌支架21和第二内嵌支架22在提供管道形态保持力的同时,具有较好的柔顺性从而使覆膜支架100的瘤腔覆膜段102部分具有更好的柔顺性。In the present embodiment, please refer to Figures 24 and 26, the distal port of the first embedded stent 21 is an oblique port or a flat port, the distal port of the second embedded stent 22 is also an oblique port or a flat port, and the distal blood outflow port of the tumor cavity covering segment 102 is flush with the distal ports of the first embedded stent 21 and the second embedded stent 22, and is fixed by bonding or suturing; wherein, the distal port of the second embedded stent 22 is provided with a second distal oblique port 223, and the distal port of the first embedded stent 21 is provided with a first distal oblique port 213 or a flat port; please refer to Figure 26, when the distal ports of the first embedded stent 21 and the second embedded stent 22 are set as oblique ports, the first distal oblique port 213 and the second distal oblique port 223 are respectively aligned with the first proximal oblique port 211 And it is parallel to the second proximal bevel 222; compared with the rectangle, the supporting force of the opposite sides of the non-rectangular parallelogram is smaller than the supporting force of the opposite two sides of the rectangle; in this way, the parallel bevels can make the supporting positions on the radial sides of the first embedded stent 21 and the second embedded stent 22 form a staggered structure, so that when subjected to radial extrusion pressure, part of the radial pressure will be converted into axial force by the special structure of the parallelogram, thereby effectively dispersing the radial pressure to achieve the effect of reducing the radial supporting force, so that the first embedded stent 21 and the second embedded stent 22 have better flexibility while providing the pipeline shape retention force, so that the tumor cavity coated section 102 of the coated stent 100 has better flexibility.

在一个其他的实施例中,请参阅图24,第二内嵌支架22的远端口为第二远端斜口223,第一内嵌支架21的远端口为第一远端平口212,如此设置,能够使得第一内嵌支架21远离第二内嵌支架22的一侧的轴向长度H3大于第二内嵌支架22远离第一内嵌支架21的一侧的轴向长度H4,从而使得第一内嵌支架21具有更多以的支架支撑位置以分散来自血管的挤压力,从而具有相比第二内嵌支架22更好的支撑强度;In another embodiment, referring to FIG. 24 , the distal end of the second embedded stent 22 is a second distal oblique end 223, and the distal end of the first embedded stent 21 is a first distal flat end 212. Such a configuration enables the axial length H3 of the first embedded stent 21 away from the second embedded stent 22 to be greater than the axial length H4 of the second embedded stent 22 away from the first embedded stent 21, so that the first embedded stent 21 has more stent support positions to disperse the squeezing force from the blood vessel, thereby having better support strength than the second embedded stent 22.

请参阅图25,当第一内嵌支架21的远端口设置为斜口时,远端段103与瘤腔连接位置的支撑波圈为适配第一远端斜口213的倾斜结构,设置为三角形波圈1032,其中三角形波圈1032的一侧波高大于另一侧波高且呈渐低结构,或者在低波高一侧形成断口。Please refer to Figure 25. When the distal end of the first embedded stent 21 is set as an oblique end, the supporting wave ring at the connection position between the distal segment 103 and the tumor cavity is an inclined structure adapted to the first distal oblique end 213, and is set as a triangular wave ring 1032, wherein the wave height on one side of the triangular wave ring 1032 is greater than the wave height on the other side and presents a gradually lowering structure, or a break is formed on the side with low wave height.

在本实施例中,请参阅图25,其中覆膜支架100还包括连接于近端段和瘤腔覆膜段102之间的过渡段1027,当第一内嵌支架21和第二内嵌支架22的近端口设置为双斜口时,过渡段1027位于瘤腔覆膜段102的近端与第一近端斜口211和第二近端斜口222之间的位置,其中过渡段1027设有过渡支架10271,过渡支架10271能够将双斜口之间形成的过渡段1027的覆膜进行支撑,从而避免瘤腔覆膜段102的该位置缺少支撑结构导致塌陷或者释放不佳。In the present embodiment, please refer to FIG. 25 , wherein the coated stent 100 further includes a transition section 1027 connected between the proximal section and the tumor cavity coated section 102, and when the proximal ports of the first embedded stent 21 and the second embedded stent 22 are set as double bevels, the transition section 1027 is located between the proximal end of the tumor cavity coated section 102 and the first proximal bevel 211 and the second proximal bevel 222, wherein the transition section 1027 is provided with a transition bracket 10271, and the transition bracket 10271 can support the coating of the transition section 1027 formed between the double bevels, thereby avoiding collapse or poor release due to lack of support structure at this position of the tumor cavity coated section 102.

在本实施例中,请参阅图27-图28,过渡支架10271单独设置于过渡段1027上,并且过渡支架10271的形状与过渡段1027形状相适配,此处,由于近端段101靠近瘤腔覆膜段102的支撑波圈的远端为波高均匀的平口,而第一近端斜口211和第二近端斜口222之间形成V形口,为了过渡支架10271在近端和远端分别与瘤腔覆膜段102的近端和第一近端斜口211和第二近端斜口222平齐,过渡支架10271的近端包括平口,而远端则包括凸出的V形凸起。In this embodiment, please refer to Figures 27-28, the transition bracket 10271 is separately arranged on the transition section 1027, and the shape of the transition bracket 10271 is adapted to the shape of the transition section 1027. Here, since the distal end of the supporting wave ring of the proximal section 101 close to the tumor cavity coating section 102 is a flat mouth with uniform wave height, and a V-shaped mouth is formed between the first proximal bevel 211 and the second proximal bevel 222, in order to make the transition bracket 10271 flush with the proximal end of the tumor cavity coating section 102 and the first proximal bevel 211 and the second proximal bevel 222 at the proximal and distal ends respectively, the proximal end of the transition bracket 10271 includes a flat mouth, and the distal end includes a protruding V-shaped protrusion.

在一些实施例中,过渡支架10271可以是环形支架,也可以是单独的片状支架;当过渡支架10271设置为环形支架时,V形凸起至少设置两个且对称设于环形支架的两侧,用于与第一近端斜口211和第二近端斜口222形成的V形对开口相适配,环形支架能够提供更好的整体支撑性能,不仅在过渡段1027区域提供支撑还能在近端段101和瘤腔覆膜段102的交接部分提供支撑,使覆膜支架100在近端段101和瘤腔覆膜段102的过渡位置连接更为稳定;当过渡支架10271设置为单独的片状支架时,片状支架至少设置有两片,其对称设置于第一近端斜口211和第二近端斜口222形成的V形对开口两侧,且单片片状支架的近端侧为平边,远端侧为中间凸起两侧渐低的V形边;单片片状支架直接分别在两侧的过渡段1027提供支撑力,能够确保过渡段1027被支撑的同时使得近端段101和瘤腔覆膜段102之间具有更好的柔顺性。In some embodiments, the transition stent 10271 can be an annular stent or a separate sheet stent; when the transition stent 10271 is set as an annular stent, at least two V-shaped protrusions are set and symmetrically arranged on both sides of the annular stent, which are used to adapt to the V-shaped openings formed by the first proximal oblique opening 211 and the second proximal oblique opening 222. The annular stent can provide better overall support performance, not only providing support in the transition section 1027 area, but also providing support at the junction of the proximal section 101 and the tumor cavity coating section 102, so that the coated stent 100 can be more easily inserted into the proximal section 101 and the tumor cavity. The transition position connection of the cavity coating section 102 is more stable; when the transition bracket 10271 is set as a separate sheet bracket, the sheet bracket is provided with at least two pieces, which are symmetrically arranged on both sides of the V-shaped opening formed by the first proximal bevel 211 and the second proximal bevel 222, and the proximal side of the single-piece sheet bracket is a flat edge, and the distal side is a V-shaped edge with gradually lowering sides of the middle bulge; the single-piece sheet bracket directly provides support force on the transition sections 1027 on both sides, which can ensure that the transition section 1027 is supported while ensuring better flexibility between the proximal section 101 and the tumor cavity coating section 102.

其中,在一个实施例中,请参阅图27和图28,过渡支架10271为具有Z形或者W形编织结构的波圈支架,采用波圈支架的形式与近端段101的近端支撑波圈1011结构相近,使得在该位置与近端段101具有更好的衔接,从而提升覆膜支架100整体的柔顺性;在另一个实施例中,过渡支架10271为具有网状编织结构的网状编织支架,采用网状编织支架的结构与第一内嵌支架21和第二内嵌支架22的结构相近,从而使瘤腔覆膜段102的整体性更高,并且网状编织支架的支撑张力更强,使内壁更加平整,可进一步确保在该位置血流的通畅性。Among them, in one embodiment, please refer to Figures 27 and 28, the transition stent 10271 is a wave coil stent with a Z-shaped or W-shaped weaving structure, and the form of the wave coil stent is similar to the structure of the proximal support wave coil 1011 of the proximal segment 101, so that it has a better connection with the proximal segment 101 at this position, thereby improving the overall flexibility of the coated stent 100; in another embodiment, the transition stent 10271 is a mesh woven stent with a mesh woven structure, and the structure of the mesh woven stent is similar to the structure of the first embedded stent 21 and the second embedded stent 22, so that the integrity of the tumor cavity coated segment 102 is higher, and the supporting tension of the mesh woven stent is stronger, making the inner wall smoother, which can further ensure the patency of blood flow at this position.

实施例八Embodiment 8

在本实施例中,请参阅图29和图30,主体支架10和内嵌支架20的结构与实施例七中大体相同,不同之处在于,过渡支架10271不单独设置,通过在近端段101的远端设置一个异形波圈1012,异形波圈1012的部分延伸至瘤腔覆膜段102内在过渡段1027形成支撑结构以形成过渡支架10271,具体的异形波圈1012的近端具有均匀的等高近端波102711,远端包括多个具有不等高的远端高波102712,远端高波102712朝远端凸起,顶点与第一内嵌支架21和第二内嵌支架22的第一近端斜口211和第二近端斜口222平齐,以支撑过渡段1027;异形波圈1012的远端高波102712至少设有两个,且两个远端高波102712沿异形波圈1012的直径对称设置于远端两侧,两个远端高波102712的顶点靠近V形对开口的底部;请进一步参阅图29,异形波圈1012的远端高波102712还可以设置多个,在异形波圈1012的远端相对两侧分别形成中间波高最高,朝两边波高渐低的山峰状结构,以适配过渡段1027形状;将近端段101远端的支撑波圈设置为异形波圈1012,能够避免过渡段1027缺少支撑结构导致局部塌陷或者释放不佳影响血液通畅的同时,异形波圈1012在近端段101和瘤腔覆膜段102之间延伸的结构能够使得覆膜支架100在近端段101和瘤腔覆膜段102之间的连接力更足,支架整体性更高,从而避免在瘤腔覆膜段102和近端段101之间的过渡位置发生弯折的情况。In this embodiment, please refer to Figures 29 and 30. The structures of the main support 10 and the embedded support 20 are substantially the same as those in the seventh embodiment, except that the transition support 10271 is not provided separately, and a special-shaped wave ring 1012 is provided at the distal end of the proximal section 101, and a portion of the special-shaped wave ring 1012 extends into the transition section 1027 in the tumor cavity covering section 102 to form a support structure to form the transition support 10271. The proximal end has a uniform proximal wave 102711 of equal height, and the distal end includes a plurality of distal high waves 102712 of unequal height, the distal high wave 102712 protrudes toward the distal end, and the apex is flush with the first proximal oblique opening 211 and the second proximal oblique opening 222 of the first embedded bracket 21 and the second embedded bracket 22 to support the transition section 1027; the distal high wave 102712 of the special-shaped wave ring 1012 is provided with at least two, and the two distal high waves 102712 are arranged along the special-shaped wave The diameter of the circle 1012 is symmetrically arranged on both sides of the distal end, and the apexes of the two distal high waves 102712 are close to the bottom of the V-shaped opening; please refer to Figure 29, the distal high waves 102712 of the special-shaped wave circle 1012 can also be set in multiple, and a peak-like structure with the highest wave height in the middle and gradually decreasing wave height on both sides is formed on the opposite sides of the distal end of the special-shaped wave circle 1012 to adapt to the shape of the transition section 1027; the supporting wave circle at the distal end of the proximal section 101 is set as a special-shaped wave The circle 1012 can prevent the transition section 1027 from lacking a supporting structure, causing local collapse or poor release that affects blood flow. At the same time, the structure of the special-shaped wave circle 1012 extending between the proximal section 101 and the tumor cavity coating section 102 can make the connection force between the proximal section 101 and the tumor cavity coating section 102 of the coated stent 100 stronger and the integrity of the stent higher, thereby avoiding bending at the transition position between the tumor cavity coating section 102 and the proximal section 101.

实施例九Embodiment 9

在本实施例中,主体支架10和内嵌支架20的结构与实施例七-实施例八中大体相同,不同之处在于,主体支架10的远端段103与瘤腔覆膜段102通过粘接或者缝合的方式拼接后固定,主体支架10的表面设有第一覆膜104,内嵌支架20的表面设有第二覆膜202,且第一覆膜104为PET膜,第二覆膜202为ePTFE膜,远端段103与瘤腔覆膜段102为拼接式设置,可以使得远端段103的表面覆膜也采用ePTFE膜,以进一步确保髂外血管血流的通畅性。In this embodiment, the structures of the main stent 10 and the embedded stent 20 are substantially the same as those in Embodiments 7 to 8, except that the distal segment 103 of the main stent 10 and the tumor cavity coating segment 102 are spliced and fixed by bonding or suturing, the surface of the main stent 10 is provided with a first coating 104, the surface of the embedded stent 20 is provided with a second coating 202, and the first coating 104 is a PET film, and the second coating 202 is an ePTFE film. The distal segment 103 and the tumor cavity coating segment 102 are spliced, so that the surface coating of the distal segment 103 can also adopt an ePTFE film to further ensure the patency of blood flow in the external iliac vessels.

其中,在一个实施例中,第一内嵌支架21和远端段103一体式成型,远端段103直接延伸至瘤腔覆膜段102内与瘤腔覆膜段102缝合,位于瘤腔覆膜段102内第二通道1022部分形成第一内嵌支架21,位于瘤腔覆膜段102外的部分形成远端段103;如此,第一内嵌支架21和远端段103一体式成型的支架主体可采用波圈支架或者网状编织支架,而表面覆膜则采用ePTFE膜,此处,一体式成型意指第一内嵌支架21和远端段103成型于同一张ePTFE覆膜上,形成的整体支架不具有粘接结构或者缝合结构;将第一内嵌支架21和远端段103一体式成型能够使得血流进入第二通道1022流向髂外血管时,通道内没有拼接结构产生的阻挡物或者凸起部分影响其内壁的顺滑度,能够有效的进一步提升血流通过时的通畅性。In one embodiment, the first embedded stent 21 and the distal segment 103 are integrally formed, the distal segment 103 directly extends into the tumor cavity coating segment 102 and is sutured with the tumor cavity coating segment 102, the second channel 1022 portion located in the tumor cavity coating segment 102 forms the first embedded stent 21, and the portion located outside the tumor cavity coating segment 102 forms the distal segment 103; in this way, the stent body formed integrally with the first embedded stent 21 and the distal segment 103 can adopt a wave coil stent or a mesh braided stent, and the surface coating The membrane is made of ePTFE membrane. Here, one-piece molding means that the first embedded stent 21 and the distal segment 103 are molded on the same ePTFE covering film, and the formed overall stent does not have an adhesive structure or a suture structure; the one-piece molding of the first embedded stent 21 and the distal segment 103 can ensure that when the blood flows into the second channel 1022 and flows to the external iliac vessels, there are no obstacles or protrusions caused by the splicing structure in the channel to affect the smoothness of its inner wall, which can effectively further improve the patency of the blood flow.

在本实施例中,请参阅图26,第一内嵌支架21及第二内嵌支架22的近端端口和/或远端端口设有显影件203;在第一内嵌支架21及第二内嵌支架22的近端端口和远端端口均设有显影件203,显影件203的设置能够帮助操作者通过显影设备快速的定位瘤腔覆膜段102的位置以及第一通道1021和第二通道1022的相对位置以及压缩后的形态变化,还能够帮助操作者快速定位髂内支架的选入口位置,以实现髂内支架快速且精准的植入。In this embodiment, please refer to Figure 26, the proximal port and/or distal port of the first embedded bracket 21 and the second embedded bracket 22 are provided with a developing component 203; the proximal port and distal port of the first embedded bracket 21 and the second embedded bracket 22 are both provided with a developing component 203. The setting of the developing component 203 can help the operator to quickly locate the position of the tumor cavity coating segment 102 and the relative position of the first channel 1021 and the second channel 1022 as well as the morphological changes after compression through the developing equipment, and can also help the operator to quickly locate the selected entrance position of the internal iliac stent to achieve rapid and accurate implantation of the internal iliac stent.

在本实施例中,请参阅图31,为了实现本身所提供的覆膜支架100能够在血管内完成初次释放之后,位置不准确时依旧能够进行释放位置的微调,在主体支架10的近端段101上设置有多个钩挂件1013,钩挂件1013设有多个,且沿着近端段101的轴向方向排列设置,并且在同一轴向位置上钩挂件1013至少设有两个,如此,同一轴向位置上的两个钩挂件1013能够牵拉至相同位置后,钩挂在挂杆30上,不同轴向位置上的钩挂件1013均钩挂在挂杆30上之后则能够将覆膜支架100至少近端段101的部分实现至少部分径缩束缚,从而在初次从输送器的导管释放出来之后支架处于半束缚状态,并未完全释放,此时若释放位置不准确则能够进行释放位置的微调后,再将挂杆30抽出实现支架的完全释放;其中,钩挂件1013可以是高分子材质的环状钩挂物,如PET材质的环状线材;可以通过缝合或者粘接的方式固定于近端段101的近端支撑波圈1011上或者覆膜上。In this embodiment, please refer to FIG. 31 , in order to achieve that after the provided covered stent 100 is initially released in the blood vessel, the release position can still be finely adjusted when the position is inaccurate, a plurality of hooks 1013 are provided on the proximal section 101 of the main stent 10, and the hooks 1013 are provided in plurality and arranged along the axial direction of the proximal section 101, and at least two hooks 1013 are provided at the same axial position, so that the two hooks 1013 at the same axial position can be pulled to the same position and then hooked on the hanging rod 30, and the hooks 1013 at different axial positions can be pulled to the same position and then hooked on the hanging rod 30. After 013 are hooked on the hanging rod 30, at least the proximal section 101 of the coated stent 100 can be at least partially diametrically contracted, so that the stent is in a semi-constrained state after being first released from the catheter of the conveyor and is not fully released. At this time, if the release position is inaccurate, the release position can be fine-tuned and then the hanging rod 30 can be pulled out to fully release the stent; wherein, the hook 1013 can be an annular hook made of a polymer material, such as an annular wire made of PET material; it can be fixed to the proximal supporting wave ring 1011 of the proximal section 101 or the coating by suturing or bonding.

实施例十Embodiment 10

在本实施例中,请参阅图32-图33,提供一种支架输送系统1000,该支架输送系统1000包括如实施例一~实施例九所提供的覆膜支架100,并且还包括输送器200,输送器200用于将本申请的覆膜支架100输送至指定的血管位置并释放,其中输送器200通常包括输送鞘管2001和输送手柄2002,输送手柄2002用于控制输送鞘管2001的进退以将支架从输送鞘管2001中释放,请参阅图31,其中输送鞘管2001包括挂杆30,挂杆30用于将覆膜支架100近端段101上的钩挂件1013进行钩挂,钩挂后使得覆膜支架100的至少近端段101呈半束缚状态。In the present embodiment, please refer to Figures 32-33, a stent delivery system 1000 is provided, and the stent delivery system 1000 includes the coated stent 100 provided in Examples 1 to 9, and also includes a conveyor 200, the conveyor 200 is used to deliver the coated stent 100 of the present application to a designated blood vessel position and release it, wherein the conveyor 200 generally includes a delivery sheath 2001 and a delivery handle 2002, the delivery handle 2002 is used to control the advance and retreat of the delivery sheath 2001 to release the stent from the delivery sheath 2001, please refer to Figure 31, wherein the delivery sheath 2001 includes a hanging rod 30, the hanging rod 30 is used to hook the hooking member 1013 on the proximal segment 101 of the coated stent 100, so that after hooking, at least the proximal segment 101 of the coated stent 100 is in a semi-constrained state.

在本实施例中,覆膜支架100至少瘤腔覆膜段102的第一通道1021内设有预置导丝40,预制导丝在本申请覆膜支架100生产完成后便预先放置在覆膜支架100内,这样当支架释放后,无需再重新送入导丝;通过在瘤腔覆膜段102的第一通道1021内设预置导丝40,能够减少导丝通入和选入的操作,直接通过预置导丝40的引导可快速的将髂内支架引导至第一通道1021的第一内嵌支架21内进行释放,提升释放的精准度,同时能够降低手术时间。In the present embodiment, a pre-installed guide wire 40 is provided in at least the first channel 1021 of the tumor cavity coated section 102 of the coated stent 100. The pre-installed guide wire is pre-placed in the coated stent 100 of the present application after the production is completed. In this way, there is no need to re-introduce the guide wire after the stent is released. By providing a pre-installed guide wire 40 in the first channel 1021 of the tumor cavity coated section 102, the operation of introducing and selecting the guide wire can be reduced. The internal iliac stent can be quickly guided into the first embedded stent 21 of the first channel 1021 for release directly through the guidance of the pre-installed guide wire 40, thereby improving the accuracy of the release and reducing the operation time.

上述具体实施例仅为本发明的部分实施例,并非对本发明的限制,本说明书不能对本发明构思的所有实施例做穷举,且上述不同实施例的部分特征可以相互替换或组合,本领域技术人员也可以根据实际需求做简单替换,本发明的构思以要求的保护范围为准。The above-mentioned specific embodiments are only some embodiments of the present invention and are not limitations of the present invention. This specification cannot be an exhaustive list of all embodiments of the present invention. Some features of the above-mentioned different embodiments may be replaced or combined with each other. Those skilled in the art may also make simple replacements according to actual needs. The concept of the present invention shall be subject to the required protection scope.

Claims (34)

一种覆膜支架,其特征在于,包括具有管状主体的主体支架和内嵌支架,所述主体支架沿轴向包括近端段、瘤腔段和远端段;所述近端段通过所述瘤腔段与所述远端段相连通;所述瘤腔段包括沿径向设置的第一通道和第二通道,所述第二通道与所述远端段连通,所述第一通道的远端设有与外界相连通的开口;所述内嵌支架设于所述第一通道内,所述内嵌支架至少部分与所述第一通道的侧壁连接,且所述内嵌支架的远端与所述开口连通;所述第一通道与所述内嵌支架的总支撑强度小于所述第二通道的支撑强度。A coated stent, characterized in that it includes a main stent with a tubular body and an embedded stent, the main stent includes a proximal segment, a tumor cavity segment and a distal segment along the axial direction; the proximal segment is connected with the distal segment through the tumor cavity segment; the tumor cavity segment includes a first channel and a second channel arranged along the radial direction, the second channel is connected with the distal segment, and the distal end of the first channel is provided with an opening connected to the outside world; the embedded stent is arranged in the first channel, the embedded stent is at least partially connected to the side wall of the first channel, and the distal end of the embedded stent is connected with the opening; the total support strength of the first channel and the embedded stent is less than the support strength of the second channel. 根据权利要求1所述的覆膜支架,其特征在于,所述瘤腔段包括沿轴向间隔设置的多个第一波圈,多个所述第一波圈的波数相同,且相邻的所述第一波圈的波峰和/或波谷相对设置。The coated stent according to claim 1 is characterized in that the tumor cavity segment includes a plurality of first wave circles arranged at intervals along the axial direction, the plurality of first wave circles have the same wave number, and the crests and/or troughs of adjacent first wave circles are arranged relatively. 根据权利要求2所述的覆膜支架,其特征在于,所述第一波圈至少位于所述第一通道的部分设有断口。The coated stent according to claim 2 is characterized in that the first wave ring is provided with a break at least in the portion located in the first channel. 根据权利要求2所述的覆膜支架,其特征在于,所述第一波圈位于所述第二通道部分的波角大于同一所述第一波圈位于所述第一通道部分的波角,或者所述第一波圈位于所述第二通道部分的丝径大于同一所述第一波圈位于所述第一通道部分的丝径。The coated stent according to claim 2 is characterized in that the wave angle of the first wave coil located in the second channel part is greater than the wave angle of the same first wave coil located in the first channel part, or the wire diameter of the first wave coil located in the second channel part is greater than the wire diameter of the same first wave coil located in the first channel part. 根据权利要求2所述的覆膜支架,其特征在于,所述第一波圈包括多个第一波杆,相邻的所述第一波杆之间设有支撑件,多个所述支撑件被配置为:使处于所述第二通道部分处的所述第一波杆之间的可压缩距离小于处于所述第一通道部分处的所述第一波杆之间的可压缩距离。The coated support according to claim 2 is characterized in that the first wave ring includes a plurality of first wave bars, and support members are provided between adjacent first wave bars, and the plurality of support members are configured to make the compressible distance between the first wave bars at the second channel portion smaller than the compressible distance between the first wave bars at the first channel portion. 根据权利要求5所述的覆膜支架,其特征在于,所述支撑件与相邻的所述第一波杆之间具有间隙,所述第二通道部分处的所述间隙小于所述第一通道部分处的所述间隙。The coated stent according to claim 5 is characterized in that there is a gap between the support member and the adjacent first wave rod, and the gap at the second channel part is smaller than the gap at the first channel part. 根据权利要求5所述的覆膜支架,其特征在于,所述支撑件为弹性支撑件,所述弹性支撑件的两侧分别与相邻的两个所述第一波杆连接,所述第二通道部分处的所述弹性支撑件的弹性模量大于所述第一通道部分处的所述弹性支撑件的弹性模量。The coated support according to claim 5 is characterized in that the support member is an elastic support member, both sides of the elastic support member are respectively connected to two adjacent first wave rods, and the elastic modulus of the elastic support member at the second channel portion is greater than the elastic modulus of the elastic support member at the first channel portion. 根据权利要求1所述的覆膜支架,其特征在于,所述近端段包括多个沿轴向间隔设置的近端支撑波圈,所述远端段包括多个沿轴向间隔设置的远端支撑波圈,所述内嵌支架包括网状主体。The coated stent according to claim 1 is characterized in that the proximal segment includes a plurality of proximal support rings spaced apart along the axial direction, the distal segment includes a plurality of distal support rings spaced apart along the axial direction, and the embedded stent includes a mesh body. 根据权利要求1所述的覆膜支架,其特征在于,所述主体支架表面覆盖有第一覆膜,所述内嵌支架表面覆盖有第二覆膜,所述第一覆膜的支撑强度大于所述第二覆膜的支撑强度。The coated stent according to claim 1 is characterized in that the surface of the main stent is covered with a first coating, the surface of the embedded stent is covered with a second coating, and the support strength of the first coating is greater than the support strength of the second coating. 根据权利要求1-9任意一项所述的覆膜支架,其特征在于,所述瘤腔段位于近端和远端的支撑强度大于中间位置的支撑强度。The coated stent according to any one of claims 1-9 is characterized in that the support strength of the tumor cavity segment at the proximal and distal ends is greater than the support strength at the middle position. 根据权利要求1-9任意一项所述的覆膜支架,其特征在于,所述瘤腔段位于近端或远端的支撑强度大于中间位置的支撑强度。The coated stent according to any one of claims 1-9 is characterized in that the support strength of the tumor cavity segment at the proximal or distal end is greater than the support strength at the middle position. 根据权利要求1所述的覆膜支架,其特征在于,所述内嵌支架包括第一内嵌支架和第二内嵌支架,所述第二通道设有第一内嵌支架,所述第一通道设有第二内嵌支架,所述第一内嵌支架与所述远端段连通;所述瘤腔段的远端设有与外界连通的开口,所述第二内嵌支架的远端口与所述开口连通;所述第一内嵌支架和所述第二通道的支撑强度,大于所述第二内嵌支架和所述第一通道的支撑强度。The coated stent according to claim 1 is characterized in that the embedded stent includes a first embedded stent and a second embedded stent, the second channel is provided with a first embedded stent, the first channel is provided with a second embedded stent, and the first embedded stent is connected to the distal segment; the distal end of the tumor cavity segment is provided with an opening connected to the outside, and the distal port of the second embedded stent is connected to the opening; the supporting strength of the first embedded stent and the second channel is greater than the supporting strength of the second embedded stent and the first channel. 根据权利要求12所述的覆膜支架,其特征在于,所述第二通道收容所述第一内嵌支架,所述第一通道收容所述第二内嵌支架,所述第一内嵌支架的支撑强度大于所述第二内嵌支架的支撑强度和/或所述第二通道的支撑强度大于所述第一通道的支撑强度。The coated stent according to claim 12 is characterized in that the second channel accommodates the first embedded stent, the first channel accommodates the second embedded stent, the support strength of the first embedded stent is greater than the support strength of the second embedded stent and/or the support strength of the second channel is greater than the support strength of the first channel. 根据权利要求13所述的覆膜支架,其特征在于,所述第一内嵌支架和所述第二内嵌支架包括网状主体,所述瘤腔段包括多个沿轴向间隔设置的第一波圈。The coated stent according to claim 13 is characterized in that the first embedded stent and the second embedded stent include a mesh body, and the tumor cavity segment includes a plurality of first wave rings arranged at intervals along the axial direction. 根据权利要求14所述的覆膜支架,其特征在于,所述第一内嵌支架的丝径大于所述第二内嵌支架的丝径,和/或所述第一波圈位于所述第二通道处的丝径大于所述第一波圈位于所述第一通道处的丝径。The coated stent according to claim 14 is characterized in that the wire diameter of the first embedded stent is larger than the wire diameter of the second embedded stent, and/or the wire diameter of the first wave coil located at the second channel is larger than the wire diameter of the first wave coil located at the first channel. 根据权利要求14所述的覆膜支架,其特征在于,所述第一内嵌支架的网格密度大于所述第二内嵌支架的网格密度,和/或所述第一波圈位于所述第二通道处的波角大于所述第一波圈位于所述第一通道处的波角。The coated stent according to claim 14 is characterized in that the grid density of the first embedded stent is greater than the grid density of the second embedded stent, and/or the wave angle of the first wave ring at the second channel is greater than the wave angle of the first wave ring at the first channel. 根据权利要求14所述的覆膜支架,其特征在于,所述第二通道的轴向长度大于所述第一通道的轴向长度,所述第二内嵌支架的远端包括露出段,所述露出段从所述开口穿出。The coated stent according to claim 14 is characterized in that the axial length of the second channel is greater than the axial length of the first channel, and the distal end of the second embedded stent includes an exposed segment, and the exposed segment passes through the opening. 根据权利要求17所述的覆膜支架,其特征在于,所述第二通道至少与所述露出段位于相同轴向位置上的所述第一波圈设有断口,所述断口朝向所述露出段。The coated stent according to claim 17 is characterized in that the first wave ring, wherein the second channel is located at least at the same axial position as the exposed section, is provided with a break, and the break faces the exposed section. 根据权利要求12所述的覆膜支架,其特征在于,所述瘤腔段的近端设有过渡波圈,所述过渡波圈的近端直径小于其远端直径。The coated stent according to claim 12 is characterized in that a transition wave ring is provided at the proximal end of the tumor cavity segment, and the proximal diameter of the transition wave ring is smaller than the distal diameter thereof. 根据权利要求12所述的覆膜支架,其特征在于,所述主体支架表面覆盖有第一覆膜,所述第一内嵌支架和所述第二内嵌支架表面覆盖有第二覆膜,所述第一覆膜的支撑强度大于所述第二覆膜的支撑强度。The coated stent according to claim 12 is characterized in that the surface of the main stent is covered with a first coating, the surfaces of the first embedded stent and the second embedded stent are covered with a second coating, and the support strength of the first coating is greater than the support strength of the second coating. 根据权利要求12-20任意一项所述的覆膜支架,其特征在于,所述远端段和所述近端段的支撑强度大于所述瘤腔段与所述第一内嵌支架以及所述第二内嵌支架的总支撑强度。The coated stent according to any one of claims 12-20 is characterized in that the support strength of the distal segment and the proximal segment is greater than the total support strength of the tumor cavity segment, the first embedded stent, and the second embedded stent. 根据权利要求12-20任意一项所述的覆膜支架,其特征在于,所述远端段或所述近端段的支撑强度大于所述瘤腔段与所述第一内嵌支架以及所述第二内嵌支架的总支撑强度。The coated stent according to any one of claims 12-20 is characterized in that the support strength of the distal segment or the proximal segment is greater than the total support strength of the tumor cavity segment, the first embedded stent, and the second embedded stent. 根据权利要求1所述的覆膜支架,其特征在于,所述瘤腔段包括瘤腔覆膜段,所述近端段通过所述瘤腔覆膜段与所述远端段相连通;所述近端段和所述远端段设有支撑波圈;所述内嵌支架在所述瘤腔覆膜段内设有沿径向设置的第一内嵌支架和第二内嵌支架,所述第一内嵌支架将所述近端段与所述远端段连通;所述瘤腔覆膜段的远端设有与外界相连通的开口,所述第二内嵌支架的远端口与所述开口连通;所述第一内嵌支架的支撑强度大于所述第二内嵌支架的支撑强度。The coated stent according to claim 1 is characterized in that the tumor cavity segment includes a tumor cavity coated segment, and the proximal segment is connected with the distal segment through the tumor cavity coated segment; the proximal segment and the distal segment are provided with supporting wave rings; the embedded stent is provided with a first embedded stent and a second embedded stent arranged radially in the tumor cavity coated segment, and the first embedded stent connects the proximal segment with the distal segment; the distal end of the tumor cavity coated segment is provided with an opening connected to the outside world, and the distal port of the second embedded stent is connected to the opening; the support strength of the first embedded stent is greater than the support strength of the second embedded stent. 根据权利要求23所述的覆膜支架,其特征在于,所述第一内嵌支架和所述第二内嵌支架包括网状主体,所述第一内嵌支架的网状主体的丝径大于所述第二内嵌支架的丝径,和/或第一内嵌支架的网格密度大于所述第二内嵌支架的网格密度。The coated stent according to claim 23 is characterized in that the first embedded stent and the second embedded stent comprise a mesh body, the wire diameter of the mesh body of the first embedded stent is greater than the wire diameter of the second embedded stent, and/or the mesh density of the first embedded stent is greater than the mesh density of the second embedded stent. 根据权利要求24所述的覆膜支架,其特征在于,所述第一内嵌支架至少与所述瘤腔覆膜段连接部分的轴向长度大于或者等于所述第二内嵌支架与所述瘤腔覆膜段连接部分的轴向长度。The coated stent according to claim 24 is characterized in that the axial length of at least the connection portion between the first embedded stent and the tumor cavity coated segment is greater than or equal to the axial length of the connection portion between the second embedded stent and the tumor cavity coated segment. 根据权利要求25所述的覆膜支架,其特征在于,所述第一内嵌支架的近端设有第一近端斜口,所述第二内嵌支架的近端设有第二近端斜口,所述第一近端斜口与所述第二近端斜口相对设置。The coated stent according to claim 25 is characterized in that the proximal end of the first embedded stent is provided with a first proximal bevel, the proximal end of the second embedded stent is provided with a second proximal bevel, and the first proximal bevel and the second proximal bevel are arranged opposite to each other. 根据权利要求26所述的覆膜支架,其特征在于,所述第一内嵌支架的远端设有第一远端斜口且与所述第一近端斜口平行,所述第二内嵌支架的远端设有平口;或所述第二内嵌支架的远端设有第二远端斜口且与所述第二近端斜口平行。The coated stent according to claim 26 is characterized in that the distal end of the first embedded stent is provided with a first distal bevel and is parallel to the first proximal bevel, and the distal end of the second embedded stent is provided with a flat end; or the distal end of the second embedded stent is provided with a second distal bevel and is parallel to the second proximal bevel. 根据权利要求26所述的覆膜支架,其特征在于,所述覆膜支架还包括连接于所述近端段和所述瘤腔覆膜段之间的过渡段,所述过渡段设有过渡支架。The coated stent according to claim 26 is characterized in that the coated stent also includes a transition section connected between the proximal section and the tumor cavity coated section, and the transition section is provided with a transition stent. 根据权利要求28所述的覆膜支架,其特征在于,所述过渡支架的近端与所述瘤腔覆膜段的近端平齐,所述过渡支架的远端两侧分别与所述第一近端斜口和所述第二近端斜口平齐。The coated stent according to claim 28 is characterized in that the proximal end of the transition stent is flush with the proximal end of the tumor cavity coated section, and the two sides of the distal end of the transition stent are flush with the first proximal bevel and the second proximal bevel respectively. 根据权利要求28所述的覆膜支架,其特征在于,所述近端段的远端包括异形波圈,所述异形波圈的远端包括多个远端高波,所述远端高波延伸至所述过渡段形成所述过渡支架。The coated stent according to claim 28 is characterized in that the distal end of the proximal segment includes a special-shaped wave ring, the distal end of the special-shaped wave ring includes a plurality of distal high waves, and the distal high waves extend to the transition segment to form the transition stent. 根据权利要求23所述的覆膜支架,其特征在于,所述第一内嵌支架和所述远端段一体式成型。The coated stent according to claim 23 is characterized in that the first embedded stent and the distal segment are formed in one piece. 根据权利要求23所述的覆膜支架,其特征在于,所述第一内嵌支架及所述第二内嵌支架的近端端口和/或远端端口设有显影件。The coated stent according to claim 23 is characterized in that the proximal port and/or the distal port of the first embedded stent and the second embedded stent are provided with a developing component. 根据权利要求1-32任意一项所述的覆膜支架,其特征在于,所述近端段设有多个钩挂件,所述钩挂件沿所述近端段的轴向排列,且相同轴向位置上至少设有两个所述钩挂件。The coated stent according to any one of claims 1-32 is characterized in that the proximal segment is provided with a plurality of hooks, the hooks are arranged along the axial direction of the proximal segment, and at least two of the hooks are provided at the same axial position. 一种支架输送系统,其特征在于,包括权利要求1-33任意一项所述的覆膜支架及输送器,所述输送器包括挂杆,所述钩挂件与所述挂杆连接,连接后所述覆膜支架至少部分呈压缩状态。A stent delivery system, characterized in that it comprises the coated stent and conveyor according to any one of claims 1-33, wherein the conveyor comprises a hanging rod, the hook is connected to the hanging rod, and after the connection, the coated stent is at least partially in a compressed state.
PCT/CN2024/140284 2023-12-27 2024-12-18 Covered stent and delivery system Pending WO2025139956A1 (en)

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