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WO2021098578A1 - 双层管腔支架 - Google Patents

双层管腔支架 Download PDF

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Publication number
WO2021098578A1
WO2021098578A1 PCT/CN2020/128323 CN2020128323W WO2021098578A1 WO 2021098578 A1 WO2021098578 A1 WO 2021098578A1 CN 2020128323 W CN2020128323 W CN 2020128323W WO 2021098578 A1 WO2021098578 A1 WO 2021098578A1
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WO
WIPO (PCT)
Prior art keywords
stent
opening structure
layer
edge
double
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/128323
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English (en)
French (fr)
Inventor
肖本好
方毅
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.)
Shenzhen Lifetech Endovascular Medical Co Ltd
Original Assignee
Shenzhen Lifetech Endovascular Medical 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 Shenzhen Lifetech Endovascular Medical Co Ltd filed Critical Shenzhen Lifetech Endovascular Medical Co Ltd
Priority to US17/773,696 priority Critical patent/US20220387166A1/en
Priority to EP20890002.7A priority patent/EP4062869A4/en
Publication of WO2021098578A1 publication Critical patent/WO2021098578A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A61F2/91—Stents 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
    • A61F2/915—Stents 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A61F2/91—Stents 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
    • A61F2/915—Stents 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to the field of medical devices, in particular to a double-layered lumen stent.
  • stents In the field of interventional medicine, the use of stents to treat or relieve human luminal stenosis or other diseases is widely used in clinical practice.
  • Stents can be divided into vascular stents (aortic stents, peripheral vascular stents, etc.) and non-vascular stents (tracheal stents, esophageal stents, etc.) according to their different uses and use environments.
  • This technology for treating lesions with a stent generally uses a compressible stent. When using a compressible stent, it is first compressed into a delivery system outside the human body, and then digital imaging (such as CT, ultrasound or DSA) is used.
  • digital imaging such as CT, ultrasound or DSA
  • the delivery system expands the compressible stent through balloon expansion or expands the compressible stent through self-expansion, compressible stent Relying on its own radial force and the contraction force of the human body's lumen to be anchored at a specific location, so as to restore the function of the tissue or organ at the diseased location, and achieve the purpose of treating or alleviating the pain.
  • the stent graft is the first choice for the treatment of aortic dissection or aortic aneurysm. Medical staff can release the aortic stent graft to achieve the purpose of minimally invasive treatment, and the aortic stent graft can be treated The advantages of good effect and less surgical complications.
  • the aortic stent graft is often used to treat aortic vessels with branched vessels. In order to treat the aortic vessels without affecting the blood supply of the branch vessels, the aortic stent graft is usually used between the aortic stent graft and the aorta.
  • chimney stents are released between the walls of the blood vessels, and the “chimney stents” form the blood flow channels of the branch vessels, so as to ensure that the aortic stent graft can cover the aortic dissection breach or isolate the aortic aneurysm
  • the cavity does not cover the branch blood vessels.
  • the “chimney stent” has gradually developed from a single-layer structure to a multi-layer structure.
  • a double-layer luminal stent includes a main body luminal stent and an outer skirt stent sheathed on the outer wall of the main luminal stent.
  • the outer skirt stent includes a supporting structure and a covering layer arranged on the supporting structure.
  • One end of the layer skirt stent is connected to the outer wall of the main body lumen stent, and the other end of the outer layer skirt stent is an opening structure formed by a supporting structure, and the covering layer forms an oblique cut shape at the edge of the opening structure.
  • the coating layer of the outer skirt stent forms an oblique cut shape at the edge of the opening structure.
  • the edge of the opening structure adopts an asymmetric oblique cut-shaped covering layer
  • the covering layer at the edge of the opening structure is on the cross-sectional area of the inlet of the delivery sheath.
  • the area is small, which is conducive to the smooth assembly of the double-lumen stent into the delivery sheath.
  • the above-mentioned double-lumen stent can be used as a "chimney stent" at the branch blood vessels of the aortic vessel.
  • the outer skirt stent with a flat opening structure is covered with the corresponding aortic stent.
  • the edges of the membrane are flush, and the double-layer luminal stent of the present invention can increase the anchoring length between the membrane layer at the edge of the opening structure and the vascular wall by forming an oblique cut-shaped covering layer at the edge of the opening structure.
  • Fig. 1 is a schematic structural diagram of a double-lumen stent according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of the opening structure on the outer skirt bracket of the first embodiment of the present invention
  • FIG. 3 is a schematic structural diagram of a double-lumen stent anchored into a blood vessel according to an embodiment of the present invention
  • FIG. 4 is a schematic structural view of the opening structure on the outer skirt bracket of the second embodiment of the present invention.
  • FIG. 5 is a schematic structural view of the opening structure on the outer skirt bracket of the third embodiment of the present invention.
  • Fig. 6 is a schematic structural diagram of a double-layered lumen stent corresponding to the opening structure shown in Fig. 5;
  • FIG. 7 is a schematic structural view of the opening structure on the outer skirt bracket of the fourth embodiment of the present invention.
  • Fig. 8 is a schematic structural view of the opening structure on the outer skirt bracket of the fifth embodiment of the present invention.
  • the orientation can be defined according to the blood flow direction.
  • the blood flow is defined from the proximal end to the distal end.
  • the specific implementation of the double-lumen stent 100 is as follows:
  • the embodiment of the present invention provides a double-lumen stent 100.
  • the double-lumen stent 100 is composed of a main lumen stent 10 and an outer skirt stent 20.
  • the main lumen stent 10 includes an inlet end and an outlet end, and the inlet end and the outlet end are located in the same axial direction.
  • the outer skirt stent 20 is sleeved on the outer wall of the main body lumen stent 10, when the double-layer lumen stent 100 is implanted in the vessel lumen After being internalized, the lumen of the main body lumen stent 10 can be used as a blood flow channel.
  • the main body lumen stent 10 at least includes a support body 11 and a membrane covering structure 12, which is attached to the inner wall and outer wall of the support body 11 to form the inner wall and outer surface of the main body lumen stent 10.
  • the outer skirt support 20 includes a supporting structure 21 and a film layer 22 disposed on the supporting structure 21.
  • the outer skirt support 20 includes a connecting structure 23 and an opening structure 24, wherein the connecting structure 23 is substantially a cone-shaped barrel structure distributed in the axial direction, and one end of the connecting structure 23 is provided with
  • the connection boundary connected to the main body lumen stent 10, the connection method of the connection boundary on the connection structure 23 and the main body lumen stent 10 can be suture, winding or welding, etc.
  • the connection boundary is used to prevent the main body lumen stent 10 from being connected to the outside.
  • the opening structure 24 is roughly a straight barrel-shaped structure distributed in the axial direction, and one end of the opening structure 24 is connected to the other end of the connecting structure 23, and the other end of the opening structure 24
  • An opening of the outer skirt stent 20 is formed, wherein the opening structure 24 is in a contracted state when assembled into the delivery sheath, and the opening structure 24 is in an open state when released in a blood vessel.
  • the opening structure 24 may also be a cone-shaped barrel structure, that is, the opening structure 24 may also be a structure formed by the connecting structure 23 extending away from the connecting boundary.
  • the support structure 21 may be a corrugated metal rod or a strip metal sheet made of various biocompatible materials, including known materials implanted in medical devices or a combination of various biocompatible materials, such as 316L Stainless steel, cobalt, chromium, nickel, titanium, magnesium, iron and other alloys, as well as nickel-titanium-tantalum alloys, etc., or other biocompatible metal materials.
  • various biocompatible materials such as 316L Stainless steel, cobalt, chromium, nickel, titanium, magnesium, iron and other alloys, as well as nickel-titanium-tantalum alloys, etc., or other biocompatible metal materials.
  • the support structure 21 can be wound by wire or formed by cutting.
  • the internal connection of the support structure 21 can be realized by stitching, winding, weaving, cutting or film coating, etc.
  • the coating layer 22 can be It is an ePTFE film or a PET film, and the coating layer 22 can cover the inner wall and the outer wall of the support structure 21 by stitching or hot
  • the coating layer 22 is formed with an oblique cut shape at the edge of the opening structure 24, and the axial length of the coating layer 22 on one side of the opening structure 24 is S , The axial length of the other side is L.
  • the corrugated metal rod at the edge of the opening structure 24 has multiple wave structures distributed in the circumferential direction, and the multiple axial dimensions of the multiple wave structures increase in the circumferential direction.
  • the multiple wave structures form an oblique cut shape at the edge of the opening structure 24, and the coating layer 22 covers the multiple wave structures to form an oblique cut shape.
  • the port of the coating layer 22 is flush with the port of the support structure 21.
  • the wave structure includes two adjacent poles and a structure connecting the two adjacent poles.
  • one side of the opening structure 24 is composed of the first wave rod 211 and the second wave rod 212 to form a short wave crest.
  • the height of the short wave peak is S
  • the other side of the opening structure 24 is formed by a third wave rod.
  • 213 and the fourth wave rod 214 constitute a high wave crest, the height of the high wave crest is L
  • the coating layer 22 is wrapped on the first wave rod 211, the second wave rod 212, the third wave rod 213, and the fourth wave rod 214, and From the short wave crest to the high wave crest, an oblique cut shape is formed.
  • the wave height S is equal to 1/2 to 2/3 of the wave height L, so as to facilitate the expansion of the outer skirt support 20 in a self-expanding manner.
  • the wave height of the short wave crest is designed to be approximately the same size as the normal wave height, for example, short
  • the wave height S of the wave crest is equal to the normal wave height of 1/2-2/3.
  • the purpose is to make the side of the short wave crest of the outer skirt stent 20 also function to seal the gap between the outer skirt stent 20 and the vessel wall
  • the effect is that even if the positions of the short wave crest and the high wave crest of the outer skirt bracket 20 are reversed during the release process, the outer skirt bracket 20 will not leak internally at the low wave crest due to the wave height, so the design can be The risk of internal leakage of the outer skirt bracket 20 due to improper operation is reduced.
  • Fig. 3 is a schematic diagram of the structure of the double-lumen stent 100 anchored into the blood vessel according to an embodiment of the present invention.
  • the aortic vessel A has a branch vessel B, and the aortic stent 200 establishes the aortic vessel A in the aortic vessel A.
  • the double-lumen stent 100 serves as a "chimney stent" to connect the aortic stent 200 and the branch blood vessel B, wherein the main body luminal stent 10 and the aortic stent 200 in the double-lumen stent 100 squeeze to establish branches The blood flow channel of blood vessel B.
  • the cover layer 22 of the outer skirt stent 20 forms an oblique cut shape at the edge of the opening structure 24, which is opposite to that along the opening.
  • the structure 24 has a circumferentially flush coating layer 22, and the oblique cut-shaped coating layer 22 can reduce the restraint of the opening structure 24 on the outer skirt support 20, and reduce the coating layer at the opening structure 24 on the outer skirt support 20 22 and the main lumen stent 10, thereby reducing the release resistance of the opening structure 24 on the outer skirt stent 20 during the release of the double-lumen stent 100, and avoiding the double-lumen stent 100 during the release process.
  • the adhesion of the covering layer 22 to the main body luminal stent 10 causes the opening structure 24 to be unable to be completely released.
  • the edge of the opening structure 24 adopts an asymmetric oblique cut-shaped covering layer 22, the covering layer 22 at the edge of the opening structure 24 is transporting
  • the area on the cross-sectional area of the inlet of the sheath is small, which facilitates the assembly of the double-lumen stent 100 into the delivery sheath.
  • the openings at both ends of the main lumen stent 10 can also adopt an incision-like structure, which facilitates the smooth assembly of the double-layer lumen stent 100 into the delivery sheath.
  • the above-mentioned double-lumen stent 100 can be used as a "chimney stent" at the branch vessel B on the aortic vessel A.
  • a general "chimney stent” is used, the outer skirt stent with the opening structure 24 flush 20 is flush with the covering edge of the corresponding aortic stent 200, and the present invention forms an oblique cut-shaped covering layer 22 at the edge of the opening structure 24.
  • the short wave peak side of the covering layer 22 is aligned with the edge of the aortic stent 200.
  • the edge of the membrane is flush, and the high peak side of the membrane layer 22 exceeds the edge of the membrane of the aortic stent 200, thereby increasing the anchoring length between the opening structure 24 and the vessel wall, and preventing the outer skirt stent 20 from being damaged due to
  • the anchoring area is insufficient and displaced, and the outer skirt stent 20 adopts the oblique incision-shaped covering layer 22 to facilitate blood flow through the oblique incision.
  • the transition area formed by the oblique cut-shaped opening structure 24 on the outer skirt stent 20 and the aortic stent 200 can seal the gap between the two, thereby reducing the risk of type I endoleak.
  • FIG. 4 is a structural diagram of the opening structure 24 on the outer skirt support 20 in the second embodiment of the present invention.
  • the difference from the opening structure 24 in the first embodiment is that the edge of the opening structure 24 in the first embodiment
  • the supporting structure 21 is in the shape of an oblique cut
  • the supporting structure 21 at the edge of the opening structure 24 in the second embodiment is a flush structure
  • the coating layer 22 is formed by decreasing the axial dimension on the opening structure 24 in the circumferential direction Oblique cut shape.
  • the corrugated metal rod at the edge of the opening structure 24 in the second embodiment has a plurality of corrugated structures distributed in the circumferential direction, and the plurality of corrugated structures have the same axial size, and the coating layer 22 covers more than one corrugated metal rod.
  • the coating layer 22 on the multiple corrugated structures decrease in the circumferential direction.
  • the coating layer 22 extends from the trough of the corrugated structure on one side to the peak of the corrugated structure on the other side. Therefore, the coating layer 22 at the edge of the opening structure 24 can form an oblique cut shape according to a linear change.
  • the double-lumen stent 100 using the asymmetric membrane layer 22 in the second embodiment can enable the outer skirt stent 20 to achieve the purpose of self-expansion and deployment when released.
  • the double-lumen stent 100 When the double-lumen stent 100 is used as a "chimney stent", the double-lumen stent 100 needs to be positioned first, and the main body luminal stent 10 in the double-lumen stent 100 extends into other stents by means of visual marking positioning.
  • the “chimney mouth” of the “chimney mouth” the blood flow channel of the branch blood vessels is established.
  • the opening structure 24 on the outer skirt stent 20 is squeezed to the inner wall of the “chimney mouth” by the way of visual marking, and the outer skirt stent 20.
  • the short side of the oblique cut-shaped covering layer 22 is aligned with the edge coverings of other stents.
  • the end position of the oblique cut-shaped covering layer 22 on the outer skirt stent 20 is beyond the edge coverings of other stents. This plays a role in blocking the gap and reducing Type I internal leakage.
  • the double-layer luminal stent 100 is released in the blood vessel, it is anchored by the main body luminal stent 10 and the outer skirt stent 20.
  • the difference from the first embodiment is that the outer skirt of the second embodiment The anchoring area of the stent 20 increases the length of the L-S, which can reduce the risk of the double-lumen stent 100 being displaced in the blood vessel, and also help to reduce type I endoleak.
  • the double Compared with a stent with a flat cover layer and a length of L, the layered luminal stent 100 can also reduce the difficulty of sheathing.
  • the part of the outer skirt stent 20 beyond the upper edge of the other stents is a bare metal rod, which can reduce the phenomenon that the outer skirt stent 20 shields other branch blood vessels.
  • FIG. 5 is a schematic diagram of the structure of the opening structure 24 on the outer skirt stent 20 according to the third embodiment of the present invention.
  • FIG. 6 is a schematic diagram of the structure of the double-lumen stent 100 corresponding to the opening structure 24 shown in FIG. 5, the opening structure 24
  • the corrugated metal rods at the edge of the have multiple wave structures distributed in the circumferential direction, and the coating layer 22 is not provided in the gap between each two adjacent wave crests of the multiple wave structures.
  • the coating layer 22 adopts a petal-like coating shape to cover two adjacent wave crests on the corrugated metal rod, and the coating layer 22 is not provided between the two adjacent wave crests, so that the coating layer 22 is in the open structure
  • a petal structure is formed at the edge of 24, and the covering film layer 22 can be made of ePTFE film or PET film, and covered on the inner wall and outer wall of the opening structure 24 by stitching or hot melting.
  • the opening structure 24 By forming a petal-shaped coating layer 22 on the edge area of the opening structure 24, when the opening structure 24 is assembled into the delivery sheath, since part of the area of the edge of the opening structure 24 is not covered by the coating layer 22, it is beneficial to the opening structure 24. Assembled into the delivery sheath, when the outer skirt stent 20 is released in the blood vessel, the area not covered by the membrane layer 22 is more conducive to self-expansion and deployment, so that the entire opening structure 24 can be smoothly deployed when released. At the same time, when the double-layer luminal stent 100 is reconstructing the blood vessel channel, it is advantageous for blood flow to pass through the area of the opening structure 24 that is not covered by the covering layer 22.
  • the edge of the opening structure 24 is designed with an odd number of wave crests, which is more conducive to the self-expanding expansion of the opening structure 24.
  • the number of wave crests at the edge of the opening structure 24 is equal to 2n+5, and n is a natural number.
  • the number of wave structures at the position is an odd number, after the double-layer luminal stent 100 is assembled, the number of wave crests at the edge of the opening structure 24 is an even number. There is a risk of sticking causing the opening structure 24 to fail to expand.
  • FIG. 7 is a schematic structural view of the opening structure 24 on the outer skirt support 20 according to the fourth embodiment of the present invention.
  • the corrugated metal rod at the edge of the opening structure 24 has multiple wave structures distributed in the circumferential direction, and multiple wave structures At least part of the upper portion near the edge of the opening structure 24 is not provided with the coating layer 22.
  • the wave crest at the edge of the opening structure 24 is composed of two wave rods, and only a part of the two wave rods in the axial direction is covered with the coating layer 22, that is, only half of the wave peak composed of the two wave rods is covered.
  • the film layer 22 is covered, thereby forming a semi-naked wave structure at the edge area of the opening structure 24.
  • the opening structure 24 When the opening structure 24 is assembled into the delivery sheath, since a part of the opening structure 24 does not have the film layer 22, the opening structure 24 It is easier to assemble into the delivery sheath. When the opening structure 24 is released, the area on the opening structure 24 that is not bound by the covering layer 22 is easier to expand and expand, thereby driving the entire opening structure 24 to expand smoothly.
  • the exposed length of the wave structure at the opening structure 24 is equal to 1/3 to 2/3 of the wave height, so as to facilitate the sheathing and self-expansion of the opening structure 24.
  • FIG. 8 is a schematic structural view of the opening structure 24 on the outer skirt support 20 according to the fifth embodiment of the present invention.
  • the coating layer 22 includes a first oblique strip-shaped coating film 221 disposed at the edge of the opening structure 24, and a plurality of first oblique strip-shaped coating films 221 are distributed at the edge of the opening structure 24 along a circumferential distance.
  • the layer 22 further includes a second oblique strip-shaped coating film 222 disposed at the edge of the opening structure 24, a plurality of second oblique strip-shaped coating films 222 are distributed at the edge of the opening structure 24 along a circumferential distance, and a plurality of The second oblique strip-shaped coating film 222 and the plurality of first oblique strip-shaped coating films 221 cross each other.
  • the inner wall of the wave crest area composed of the first wave rod 211 and the second wave rod 212 at the edge area of the opening structure 24 is covered by a complete coating layer, and the wave crest formed by the first wave rod 211 and the second wave rod 212
  • the outer surface of the area is covered with an oblique strip-shaped film, the starting end of the first oblique strip-shaped film 221 covers the outer surface of the first wave rod 211, and the start end of the second oblique strip-shaped film 222 covers the outer surface of the first wave rod 211.
  • the inclined strip-shaped covering film is not limited to being provided on the inner wall and outer surface of the opening structure 24, and can also be provided on the outer surface of other parts of the outer skirt bracket 20.
  • the width of the first oblique strip-shaped coating film 221 is W1
  • the width of the second oblique strip-shaped coating film 222 is W2
  • L1 is the first
  • the lengths of the wave rod 211 and the second wave rod 212 facilitate the sheathing and self-expansion of the wave rod at the opening structure 24.
  • the use of an oblique strip covering film can make the outer surface of the opening structure 24 more flexible. Better.

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Abstract

一种双层管腔支架（100），包括主体管腔支架（10）和套设于主体管腔支架（10）的外壁的外层裙边支架（20），外层裙边支架（20）包括支撑结构（21）及设置于支撑结构（21）的覆膜层（22），外层裙边支架（20）的一端连接于主体管腔支架（10）的外壁，外层裙边支架（20）的另一端为由支撑结构（21）构成的开口结构（24），覆膜层（22）在开口结构（24）的边缘处形成斜切口形状。该双层管腔支架（100），当医务人员通过输送装置将双层管腔支架（100）释放在血管等人体组织处时，可以降低覆膜层（22）对外层裙边支架（20）上开口结构（24）的束缚，以及降低外层裙边支架（20）上开口结构（24）处的覆膜层（22）与主体管腔支架（10）之间的粘附力，以此降低双层管腔支架（100）在释放过程中外层裙边支架（20）的释放阻力。

Description

双层管腔支架 技术领域
本发明涉及医疗器械领域，特别是涉及一种双层管腔支架。
背景技术
本部分提供的仅仅是与本公开相关的背景信息，其并不必然是现有技术。
在介入医学领域，使用支架治疗或缓解人体管腔狭窄或其他病变的技术被广泛地应用于临床。根据支架的用途不同以及使用环境不同，可以将支架分为血管类支架(主动脉支架、外周血管支架等)和非血管类支架(气管支架、食道支架等)。这种通过支架治疗病变的技术一般都是采用一种可压缩支架，在使用可压缩支架时，首先在人体外将其压缩到一种输送系统中，然后通过数字影像(如CT、超声或DSA)手段将可压缩支架输送到指定位置，最后通过预定方式将可压缩支架释放在病变位置，输送系统通过球囊扩张的方式展开可压缩支架或者可压缩支架通过自膨胀的方式展开，可压缩支架依靠自身的径向力和人体内管腔的收缩力锚定在特定位置，以此恢复病变位置处组织或器官的功能，达到治疗或缓解病痛的目的。
覆膜支架作为一种可压缩支架，是治疗主动脉夹层或主动脉瘤的首选支架，医务人员可以通过释放主动脉覆膜支架的方法达到微创治疗的目的，且主动脉覆膜支架具有治疗效果好、手术并发症少的优点。目前，主动脉覆膜支架常用于治疗具有分支血管的主动脉血管，为了使主动脉覆膜支架在治疗主动脉血管的同时不影响分支血管的血液供应，通常在主动脉覆膜支架与主动脉血管的管壁之间释放一个或多个“烟囱支架”，通过“烟囱支架”形成分支血管的血流通道，这样就能保证主动脉覆膜支架在覆盖主动脉夹层破口或者隔绝主动脉瘤腔的同时又不遮盖分支血管。随着覆膜支架技术的发展，“烟囱支架”也逐渐从单层结构向多层结构发展，目前对于多层的“烟囱支架”的技术还存在缺点：针对完全覆膜的多层“烟囱支架”，在多层“烟囱支架”装配完成后，多层“烟囱支架”中的内外层支架之间会存在黏附问题或者出现屈曲变形现象，从而导致多层“烟囱支架”释放后外层支架不能自然弹开，造成多层“烟囱支架”对 主动脉覆膜支架与主动脉血管的管壁之间缝隙的封堵效果不佳。
发明内容
基于此，有必要提供一种双层管腔支架。
一种双层管腔支架，包括主体管腔支架和套设于主体管腔支架的外壁的外层裙边支架，外层裙边支架包括支撑结构构成及设置于支撑结构的覆膜层，外层裙边支架的一端连接于主体管腔支架的外壁，外层裙边支架的另一端为由支撑结构构成的开口结构，覆膜层在开口结构的边缘处形成斜切口形状。
上述双层管腔支架，当医务人员通过输送装置将双层管腔支架释放在血管等人体组织处时，由于外层裙边支架的覆膜层在开口结构的边缘处形成斜切口形状，因此，可以降低覆膜层对外层裙边支架的开口结构的束缚，以及降低外层裙边支架的开口结构处的覆膜层与主体管腔支架之间的粘附力，从而降低双层管腔支架在释放过程中外层裙边支架上开口结构的释放阻力，避免在释放双层管腔支架的过程中覆膜层粘接主体管腔支架导致外层裙边支架的开口结构不能够完全释放。
上述双层管腔支架在装配至输送鞘管内时，由于开口结构的边缘采用不对称的斜切口形状的覆膜层，所以开口结构边缘处的覆膜层在输送鞘管的进口横截面积上的区域较小，有利于双层管腔支架顺利地装配至输送鞘管内。
上述双层管腔支架能够作为主动脉血管上分支血管处的“烟囱支架”使用，一般的“烟囱支架”在使用时，开口结构平齐的外层裙边支架与对应的主动脉支架的覆膜边缘齐平，而本发明的双层管腔支架通过在开口结构的边缘处形成斜切口形状的覆膜层，可以增加开口结构边缘处的覆膜层与血管管壁之间的锚定长度，可以防止外层裙边支架由于锚定区域不足而移位，且外层裙边支架采用斜切口形状的覆膜层有利于血流从斜切口的侧边流通。
附图说明
通过阅读下文优选实施方式的详细描述，各种其他的优点和益处对于本领域普通技术人员将变得清楚明了。附图仅用于示出优选实施方式的目的，而并不认为是对本发明的限制。而且在整个附图中，用相同的参考符号表示相同的 部件。在附图中：
图1为本发明一个实施例的双层管腔支架的结构示意图；
图2为本发明第一实施例的外层裙边支架上开口结构的结构示意图；
图3为本发明一个实施例的双层管腔支架锚定至血管内的结构示意图；
图4为本发明第二实施例的外层裙边支架上开口结构的结构示意图；
图5为本发明第三实施例的外层裙边支架上开口结构的结构示意图；
图6为与图5所示开口结构对应的双层管腔支架的结构示意图；
图7为本发明第四实施例的外层裙边支架上开口结构的结构示意图；
图8为本发明第五实施例的外层裙边支架上开口结构的结构示意图。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳的实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
需要说明的是，当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“外”、“内”、“端”、“周向”、“轴向”、“上”、“侧”、“近”、“远”以及类似的表述只是为了说明的目的。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
为了使本领域的技术人员更好地理解本申请中的技术方案，下面结合不同类型的支架端部结构的实施例，对技术方案进行清晰、完整地描述，更进一步地，此实施例仅仅是本申请中的一部分实施例，而不是全部的实施例。另外，在阐述血管中，可以按照血流方向定义方位，本发明中定义血流从近端流向远端。双层管腔支架100的具体实施方式如下：
如图1所示，本发明的实施例提供了一种双层管腔支架100，双层管腔支 架100由主体管腔支架10和外层裙边支架20两个部分构成，主体管腔支架10包括进口端和出口端，且进口端和出口端位于同一轴线方向上，外层裙边支架20套设于主体管腔支架10的外壁，当双层管腔支架100植入至血管管腔内后，主体管腔支架10的内腔可以作为血流通道，例如，血液可以通过主体管腔支架10的进口端流入主体管腔支架10内，然后从主体管腔支架10的出口端流出。具体地，主体管腔支架10至少包括支撑体11和覆膜结构12，该覆膜结构12附着在支撑体11的内壁和外壁，组成主体管腔支架10的内壁和外表面。
外层裙边支架20包括支撑结构21及设置于支撑结构21的覆膜层22。在图示的实施例中，外层裙边支架20包括连接结构23和开口结构24，其中，连接结构23大致为沿轴向方向分布的锥型桶状结构，且连接结构23的一端设置有与主体管腔支架10连接的连接边界，连接结构23上的连接边界与主体管腔支架10的连接方式可以是缝合、缠绕或焊接等连接方式，连接边界用于避免主体管腔支架10与外层裙边支架20之间的血液出现外漏，开口结构24大致为沿轴向方向分布的直桶状结构，且开口结构24的一端与连接结构23的另一端相连，开口结构24的另一端形成外层裙边支架20的开口，其中，开口结构24在装配至输送鞘管内时处于收缩状态，开口结构24在血管内时释放时处于张开状态。需要说明的是，在其他实施例中，开口结构24也可以为锥型桶状结构，即，开口结构24也可以为连接结构23向远离连接边界延伸形成的结构。
支撑结构21可以为由各种生物相容性的材料制成的波纹状金属杆或条形金属片，包括植入医疗器械中的已知材料或各种生物相容性材料的组合，例如316L不锈钢、钴、铬、镍、钛、镁、铁等合金，以及镍钛钽合金等，或者其它生物相容性的金属材料。以波纹状金属杆为例，支撑结构21可以通过金属丝绕制或者通过切割形成，支撑结构21的内部连接方式可以采用缝合、缠绕、编织、切割或覆膜等方式实现，覆膜层22可以是ePTFE膜或PET膜，覆膜层22可以通过缝合或热熔等方式覆盖支撑结构21的内壁和外壁。
如图1和图2所示，根据本发明的第一实施例，覆膜层22在开口结构24的边缘处形成斜切口形状，覆膜层22在开口结构24的一侧轴向长度是S，另外一侧轴向长度是L，具体地，开口结构24的边缘处的波纹状金属杆具有沿周向分布的多个波形结构，且多个波形结构的多个轴向尺寸沿周向递增，多个波 形结构在开口结构24的边缘处形成斜切口形状，覆膜层22覆盖在多个波形结构上形成斜切口形状。在本实施例中，覆膜层22的端口与支撑结构21的端口齐平。在本申请中，波形结构包括两个相邻波杆及连接该两个相邻波杆的结构。
具体地，如图2所示，开口结构24的一侧由第一波杆211与第二波杆212构成矮波峰，矮波峰的高度为S，开口结构24的另一侧由第三波杆213与第四波杆214构成高波峰，高波峰的高度为L，覆膜层22包裹在第一波杆211、第二波杆212、第三波杆213和第四波杆214上，并从矮波峰向高波峰递进形成斜切口形状。进一步地，波高S等于波高L的1/2至2/3，以便利于外层裙边支架20能够通过自膨胀的方式展开，矮波峰的波高设计为与正常波高的尺寸大致相同，例如，矮波峰的波高S等于1/2‐2/3的正常波高，目的是让外层裙边支架20的矮波峰一侧同样能够起到封堵外层裙边支架20与血管管壁之间缝隙的效果，即使外层裙边支架20在释放过程中矮波峰和高波峰的位置释放反了，也不会因为波高的原因造成外层裙边支架20在矮波峰处出现内漏现象，这样设计可以降低因为操作不当造成外层裙边支架20内漏的风险。
如图3为本发明一个实施例的双层管腔支架100锚定至血管内的结构示意图，主动脉血管A上具有分支血管B，主动脉支架200在主动脉血管A内建立主动脉血管A的血流通道，双层管腔支架100作为“烟囱支架”连通主动脉支架200与分支血管B，其中，双层管腔支架100中的主体管腔支架10与主动脉支架200挤压建立分支血管B的血流通道。
当医务人员通过输送装置将双层管腔支架100释放在血管等人体组织处时，由于外层裙边支架20的覆膜层22在开口结构24的边缘处形成斜切口形状，相对于沿开口结构24周向齐平的覆膜层22，斜切口形状的覆膜层22可以降低对外层裙边支架20上开口结构24的束缚，以及降低外层裙边支架20上开口结构24处的覆膜层22与主体管腔支架10之间的粘附力，从而降低双层管腔支架100在释放过程中外层裙边支架20上开口结构24的释放阻力，避免双层管腔支架100在释放过程中覆膜层22粘附主体管腔支架10导致开口结构24不能够完全释放。
进一步地，上述双层管腔支架100在装配至输送鞘管内时，由于开口结构24的边缘采用不对称的斜切口形状的覆膜层22，所以开口结构24边缘处的覆 膜层22在输送鞘管的进口横截面积上的区域较小，有利于双层管腔支架100装配至输送鞘管内。主体管腔支架10的两端开口亦可采用切口状结构，利于双层管腔支架100顺利地装配至输送鞘管内。
再进一步地，上述双层管腔支架100能够作为主动脉血管A上分支血管B处的“烟囱支架”使用，一般的“烟囱支架”在使用时，开口结构24平齐的外层裙边支架20与对应的主动脉支架200的覆膜边缘齐平，而本发明通过在开口结构24的边缘处形成斜切口形状的覆膜层22，覆膜层22的矮波峰侧与主动脉支架200的覆膜边缘齐平，覆膜层22的高波峰侧超出主动脉支架200的覆膜边缘，以此增加开口结构24与血管管壁之间的锚定长度，可以防止外层裙边支架20由于锚定区域不足而移位，且外层裙边支架20采用斜切口形状的覆膜层22有利于血流从斜切口流通。同时，外层裙边支架20上斜切口形状的开口结构24与主动脉支架200挤压形成的过渡区域可以对两者之间的间隙进行封堵，以此降低I型内漏的风险。
图4为本发明第二实施例的外层裙边支架20上开口结构24的结构示意图，与第一实施例中开口结构24的不同之处在于，第一实施例中开口结构24的边缘处的支撑结构21为斜切口形状，而第二实施例中的开口结构24的边缘处的支撑结构21为齐平结构，覆膜层22通过在开口结构24上的轴向尺寸沿周向递减形成斜切口形状。具体地，第二实施例中开口结构24的边缘处的波纹状金属杆具有沿周向分布的多个波形结构，且多个波形结构的多个轴向尺寸相同，覆膜层22覆盖于多个波形结构上，且覆膜层22在多个波形结构上的多个轴向尺寸沿周向递减，具体地，覆膜层22从一侧波形结构的波谷延伸至另一侧波形结构的波峰，从而使开口结构24边缘处的覆膜层22能够按照线性变化形成斜切口形状。采用实施例二中不对称覆膜层22的双层管腔支架100可以使外层裙边支架20在释放时能够达到自膨胀展开的目的。
当双层管腔支架100作为“烟囱支架”使用时，首先需要对双层管腔支架100进行定位，双层管腔支架100中的主体管腔支架10通过显影标识定位的方式伸入其他支架的“烟囱口”内，以此建立分支血管的血流通道，外层裙边支架20上的开口结构24通过显影标识定位的方式挤压至“烟囱口”的内壁，且外层裙边支架20上斜切口形状的覆膜层22的短边侧与其他支架的边缘覆膜对 齐，外层裙边支架20上斜切口形状的覆膜层22的终止位置超出其他支架的边缘覆膜，以此起到封堵间隙的作用，减少I型内漏。
进一步地，当双层管腔支架100释放在血管内后，通过主体管腔支架10和外层裙边支架20进行锚定，与实施例一的不同之处在于，实施例二中外层裙边支架20的锚定区域增加了L‐S的长度，这样可以降低双层管腔支架100在血管内移位的风险，而且还有助于降低I型内漏，同时，实施例二中的双层管腔支架100与覆膜层齐平且长度为L的支架相比，还会降低装鞘难度。另外，外层裙边支架20上超出其它支架上边缘覆膜的部分为裸金属杆，这样可以减少外层裙边支架20遮蔽其它分支血管的现象。
图5为本发明第三实施例的外层裙边支架20上开口结构24的结构示意图，图6为与图5所示开口结构24对应的双层管腔支架100的结构示意图，开口结构24的边缘处的波纹状金属杆具有沿周向分布的多个波形结构，多个波形结构中每相邻的两个波峰之间的空隙未设置覆膜层22。具体地，覆膜层22采用花瓣状覆膜形状覆盖波纹状金属杆上相邻的两个波峰，且相邻两个波峰之间未设置覆膜层22，从而使覆膜层22在开口结构24的边缘处形成一个花瓣结构，覆膜层22通过可以采用ePTFE膜或PET膜制成，并通过缝合或热熔等方式覆盖在开口结构24的内壁和外壁。
通过在开口结构24的边缘区域形成一个花瓣状的覆膜层22，当开口结构24装配至输送鞘管内时，由于开口结构24边缘的部分区域未被覆膜层22覆盖，有利于开口结构24装配至输送鞘管内，在血管内释放外层裙边支架20时，具有无覆膜层22覆盖的区域更利于自膨胀展开，从而使整个开口结构24在释放时能够顺利地展开。同时，当双层管腔支架100在重建血管通道时，利于血流从开口结构24处无覆膜层22覆盖的区域通过。进一步地，开口结构24的边缘处设计有奇数个波峰，更有利于开口结构24的自膨胀展开，例如，开口结构24边缘处的波峰数量等于2n+5，n为自然数，当开口结构24边缘处的波形结构数量为奇数时，双层管腔支架100装配后不会因为开口结构24边缘处的波峰数量是偶数而发生多个波峰两两之间粘接在一起，降低由于覆膜层22发生粘附导致开口结构24无法展开的风险。
图7为本发明第四实施例的外层裙边支架20上开口结构24的结构示意图， 开口结构24的边缘处的波纹状金属杆具有沿周向分布的多个波形结构，多个波形结构上靠近开口结构24的边缘处的至少部分未设置覆膜层22。具体地，开口结构24边缘处的波峰由两个波杆构成，两个波杆上沿轴向方向只有一部分覆盖有覆膜层22，即，由两个波杆组成的波峰只有一半区域被覆膜层22覆盖，由此在开口结构24的边缘区域形成一个半裸的波形结构，当开口结构24装配至输送鞘管内时，由于开口结构24的部分区域没有覆膜层22，因此，开口结构24更容易装配至输送鞘管内，当开口结构24释放时，开口结构24上没有覆膜层22束缚的区域更容易自膨胀展开，从而带动整个开口结构24顺利地展开。具体地，开口结构24处波形结构的裸露长度等于波高的1/3至2/3，以利于开口结构24的装鞘以及自膨胀展开。
图8为本发明第五实施例的外层裙边支架20上开口结构24的结构示意图，
覆膜层22包括设置于开口结构24的边缘处的第一倾斜状条形覆膜221，多个第一倾斜状条形覆膜221沿周向间距分布于开口结构24的边缘处，覆膜层22还包括设置于开口结构24的边缘处的第二倾斜状条形覆膜222，多个第二倾斜状条形覆膜222沿周向间距分布于开口结构24的边缘处，且多个第二倾斜状条形覆膜222与多个第一倾斜状条形覆膜221相互交叉。具体地，开口结构24的边缘区域处由第一波杆211和第二波杆212组成的波峰区域的内壁采取完整的覆膜层覆盖，第一波杆211和第二波杆212组成的波峰区域的外表面采用倾斜状条形覆膜覆盖，第一倾斜状条形覆膜221的起始端覆盖在第一波杆211的外表面，第二倾斜状条形覆膜222的起始端覆盖在第二波杆212的外表面，然后第一倾斜状条形覆膜221和第二倾斜状条形覆膜222均沿周向延伸，直至开口结构24的边缘在周向上被倾斜状条形覆膜覆盖。其中，第一波杆211和第二波杆212组成的波峰区域的内壁采取完整的覆膜层主要是为了隔绝病变区域，外表面采用倾斜状条形覆膜主要是为了降低对第一波杆211和第二波杆212的束缚。另外，倾斜状条形覆膜不限于设置于开口结构24的内壁和外表面，还可以设置于外层裙边支架20上其他部位的外表面。具体地，第一倾斜状条形覆膜221的宽度为W1，第二倾斜状条形覆膜222的宽度为W2，W1＝W2＝(1/2‐2/3)L1，L1为第一波杆211和第二波杆212的长度，以此利于开口结构24处波杆的装鞘及自膨胀展开，另外，采取倾斜状条形覆膜的方式可以使开口结构24 外表面的柔顺性更佳。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种双层管腔支架，包括主体管腔支架和套设于所述主体管腔支架的外壁的外层裙边支架，所述外层裙边支架包括支撑结构及设置于所述支撑结构的覆膜层，其特征在于，所述外层裙边支架的一端连接于所述主体管腔支架的外壁，所述外层裙边支架结构的另一端为由所述支撑结构构成的开口结构，所述覆膜层在所述开口结构的边缘处形成斜切口形状。
  2. 根据权利要求1所述的双层管腔支架，其特征在于，所述支撑结构包括沿周向分布的波纹状金属杆，且多个所述波纹状金属杆沿轴向分布构成桶状结构。
  3. 根据权利要求2所述的双层管腔支架，其特征在于，所述开口结构的边缘处的所述波纹状金属杆具有沿周向分布的多个波形结构，且所述多个波形结构的多个轴向尺寸沿周向递增，所述多个波形结构在所述开口结构的边缘处形成斜切口形状。
  4. 根据权利要求2所述的双层管腔支架，其特征在于，所述开口结构的边缘处的所述波纹状金属杆具有沿周向分布的多个波形结构，且所述多个波形结构的多个轴向尺寸相同，所述覆膜层覆盖于所述多个波形结构上，且所述覆膜层在所述多个波形结构上的多个轴向尺寸沿周向递减。
  5. 根据权利要求2所述的双层管腔支架，其特征在于，所述开口结构的边缘处的所述波纹状金属杆具有沿周向分布的多个波形结构，所述多个波形结构中每相邻的两个波形之间的空隙未设置所述覆膜层。
  6. 根据权利要求5所述的双层管腔支架，其特征在于，所述波纹状金属杆的波峰数量为2n+5，n为自然数。
  7. 根据权利要求2所述的双层管腔支架，其特征在于，所述开口结构的边缘处的所述波纹状金属杆具有沿周向分布的多个波形结构，所述多个波形结构上靠近所述开口结构的边缘处的至少部分未设置所述覆膜层。
  8. 根据权利要求2所述的双层管腔支架，其特征在于，所述覆膜层包括设置于所述开口结构的边缘处的第一倾斜状条形覆膜，多个所述第一倾斜状条形覆膜沿周向间距分布于所述开口结构的边缘处。
  9. 根据权利要求8所述的双层管腔支架，其特征在于，所述覆膜层包括设置于所述开口结构的边缘处的第二倾斜状条形覆膜，多个所述第二倾斜状条形覆膜沿周向间距分布于所述开口结构的边缘处，且多个所述第二倾斜状条形覆膜与多个所述第一倾斜状条形覆膜相互交叉。
  10. 根据权利要求9所述的双层管腔支架，其特征在于，所述开口结构的边缘处的所述波纹状金属杆具有沿周向分布的多个波形结构，每个波形结构的两侧分别设置有所述第一倾斜状条形覆膜和所述第二倾斜状条形覆膜。
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CN112823766B (zh) 2022-12-20

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