WO2022116727A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2022116727A1
WO2022116727A1 PCT/CN2021/125251 CN2021125251W WO2022116727A1 WO 2022116727 A1 WO2022116727 A1 WO 2022116727A1 CN 2021125251 W CN2021125251 W CN 2021125251W WO 2022116727 A1 WO2022116727 A1 WO 2022116727A1
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WO
WIPO (PCT)
Prior art keywords
wave
stent
wave ring
ring
groove
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/CN2021/125251
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English (en)
French (fr)
Inventor
肖本好
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to US18/038,948 priority Critical patent/US20230414339A1/en
Priority to EP21899761.7A priority patent/EP4257094A4/en
Publication of WO2022116727A1 publication Critical patent/WO2022116727A1/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
    • 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
    • A61F2/852—Two or more distinct overlapping stents
    • 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
    • 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
    • A61F2/89—Stents 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
    • 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
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • 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
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially

Definitions

  • the invention relates to the field of interventional medical devices, in particular to a covered stent.
  • Aneurysm and arterial dissection are common clinical vascular diseases. Without medical intervention, the aneurysm has the risk of rupture and poses a great threat to the life of the patient.
  • the stent graft may block the opening of the branch blood vessel after implantation, thereby blocking the blood flow of the branch blood vessel.
  • One of the methods to solve this problem in the prior art is to provide a groove structure on the stent-graft. After implantation, the groove structure corresponds to the branch blood vessel, and a window is opened on the groove structure to allow blood flow to pass through and ensure the branch blood vessel. blood supply.
  • the existing stent-graft with the groove structure is implanted into the blood vessel, the artery at the branch site will squeeze the groove structure, resulting in the reduction of the volume of the groove structure, and the coating at the groove structure (ie the concave structure).
  • the bottom surface of the groove fits the opening of the branch blood vessel, which causes the blood flow of the branch blood vessel to be blocked, so that the function of the groove structure cannot be achieved. Or, due to the squeezing effect, the distance between the window on the groove structure and the opening of the branch blood vessel is too close, which is not conducive to the subsequent operation of reconstructing the blood supply of the branch blood vessel, such as the operation of introducing the guide wire into the window when the delivery track is established, and the subsequent branch stent. The operation of the conveyor introduction window opening, etc.
  • a stent-graft comprising a first stent, a second stent and a membrane, the membrane is coated on the first stent to form a lumen structure with a groove in the middle, and the second stent is at least partially accommodated in In the groove, the longitudinal central axis of the first bracket and the longitudinal central axis of the second bracket are parallel or substantially parallel.
  • the first support includes a plurality of first wave circles and at least one second wave circle, the plurality of first wave circles are located at two ends of the first support, the second wave circle The ring is located in the middle of the first bracket, and the second wave ring is radially opposite to the groove.
  • the second wave ring is a closed-loop structure with peaks and troughs or an open-loop structure with peaks and troughs.
  • the second wave ring when the second wave ring is a closed-loop structure with wave crests and wave troughs, the second wave ring includes a first non-closed wave ring and a first closed portion, and the first non-closed wave
  • the ring is an open-loop wave ring with wave crests and wave troughs, the open-loop wave ring has two free ends, the first closed portion includes a straight rod, and the two ends of the straight rod are respectively directly connected to the two free ends. or indirectly connected;
  • the second wave ring is an open-loop structure with peaks and troughs
  • the second wave ring is an open-loop wave ring with peaks and troughs
  • the open-loop wave ring has two free ends, and the two The free end is a passivation structure.
  • the second stent includes at least one third wave ring
  • the third wave ring is a closed-loop structure with peaks and troughs or an open-loop structure with peaks and troughs.
  • the plurality of the third wave circles are arranged at intervals along the axial direction or are arranged in a non-spaced arrangement along the axial direction.
  • the third wave ring when the third wave ring is a closed-loop structure with wave crests and wave troughs, the third wave ring includes a second non-closed wave ring and a second closed portion, and the second non-closed wave
  • the ring is an open-loop wave ring with wave crests and wave troughs.
  • the open-loop wave ring has two free ends. connected directly or indirectly;
  • the third wave ring is an open-loop structure with peaks and troughs
  • the third wave ring is an open-loop wave ring with peaks and troughs
  • the open-loop wave ring has two free ends, and the two The free end is a passivation structure.
  • the groove includes a bottom surface and a side surface surrounding the bottom surface, the third wave ring is at least partially accommodated in the groove, and the third wave ring and the bottom surface are not fixed connect.
  • the second stent is an integrated stent formed by weaving braided silk or an integrated stent formed by cutting.
  • a first window is opened on one side of the second bracket.
  • the groove includes a bottom surface and a side surface surrounding the bottom surface, a first window is opened on a side of the second bracket close to the bottom surface, and a second window is also opened on the second bracket A window, the first window and the second window are diametrically opposed.
  • the groove includes a bottom surface and a side surface surrounding the bottom surface, and at least one of the bottom surface and the side surface is provided with a through hole.
  • the radial support strength of the first support is P1
  • the radial support strength of the second support is P2
  • the P1 and P2 satisfy: 1/2 ⁇ (P2/P1) ⁇ 1; or, the P1 and P2 satisfy: 1 ⁇ (P2/P1) ⁇ 2.
  • the second stent of the above-mentioned stent-graft is at least partially accommodated in the groove.
  • the bottom of the groove tends to approach the branch blood vessel due to the radial extrusion effect of the second stent. Blocking or restricting, so as to avoid or slow down the bottom surface of the groove from fitting into the opening of the branch vessel.
  • FIG. 1 is a schematic structural diagram of a stent graft according to an embodiment
  • FIG. 2 is an isometric test diagram of the stent-graft shown in FIG. 1;
  • FIG. 3 is a side view of a second wave ring of an embodiment
  • FIG. 4 is a front view of a second wave ring of another embodiment
  • Fig. 5 is the side view of the second wave circle shown in Fig. 4;
  • Fig. 6 is the top view of the second wave circle shown in Fig. 4;
  • FIG. 7 is a front view of a second wave ring of another embodiment
  • Fig. 8 is the side view of the second wave circle shown in Fig. 7;
  • Fig. 9 is the top view of the second wave circle shown in Fig. 7;
  • FIG. 10 is a front view of the third wave ring of an embodiment
  • Figure 11 is a top view of the third wave ring shown in Figure 10;
  • Figure 12 is a side view of the third wave ring shown in Figure 10;
  • FIG. 13 is a front view of a third wave ring of another embodiment
  • Figure 14 is a side view of a stent graft according to an embodiment
  • FIG. 15 is a schematic structural diagram of a second bracket according to an embodiment
  • 16 is a schematic structural diagram of a second bracket according to another embodiment
  • FIG. 17 is a schematic structural diagram of a stent graft according to another embodiment.
  • 19 is a bottom view of the third wave ring of an embodiment
  • 20 is an isometric view of a stent graft of another embodiment
  • 21 is an isometric view of a stent graft of another embodiment
  • FIG. 22 is an isometric view of a stent graft of another embodiment
  • Fig. 23 is a schematic diagram of the state of the stent-graft shown in Fig. 1 being implanted in a blood vessel;
  • FIG. 24 is a schematic diagram showing a state in which a branch stent is implanted in the state shown in FIG. 23 .
  • proximal is defined as the end close to the heart
  • distal is defined as the end away from the heart
  • Axial refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device
  • radial refers to the direction perpendicular to the above-mentioned axial direction.
  • a stent graft 100 includes a first stent 110 , a second stent 120 and a film 130 , wherein the film 130 covers the first stent 110 to form openings at both ends and a recess in the middle.
  • the lumen structure of the groove 140 is shown in FIG. 2 .
  • the lumen structure has a lumen in communication with the two open ends for the passage of blood flow.
  • the groove 140 has a bottom surface 140a and sides surrounding the bottom surface 140a.
  • the side surfaces are a side surface 140b, a side surface 140c, a side surface 140d, and a side surface 140e, respectively.
  • the side surface 140b and the side surface 140e are opposite to each other in the axial direction, and the side surface 140c and the side surface 140d are opposite to each other in the radial direction.
  • the bottom surface 140a is a plane or a curved surface, and the curved surface can be a concave surface that is concave relative to the opening of the groove 140, a convex surface that protrudes upward relative to the opening of the groove 140, or has both a concave portion and a convex portion. surface.
  • the second bracket 120 is at least partially received in the groove 140, and the longitudinal center axis I-I of the first bracket 110 and the longitudinal center axis II-II of the second bracket 120 are parallel or substantially parallel. Wherein, when being substantially parallel, it means that the angle between the longitudinal center axis I-I and the longitudinal center axis II-II is greater than 0° but less than 10°.
  • the first stent 110 and the second stent 120 are made of materials with good biocompatibility and good elasticity, such as nickel-titanium alloy, stainless steel, and the like.
  • the cover film 130 is made of a film material with good biocompatibility, such as PET, PTFE, and the like.
  • the combination or fixation method of the covering film 130 and the first stent 110 is not limited, for example, a high temperature pressing method or a suture fixing method may be used.
  • the coating film 130 may have a single-layer structure or a multi-layer structure.
  • the second bracket 120 is completely accommodated in the groove 140 , and the outer surface of the second bracket 120 away from the bottom surface 140 a of the groove 140 is flush with the outer surface of the first bracket 110 , as shown in FIG. 1 .
  • the cut plane of the second stent 120 and the first stent 110 in the opening direction of the groove 140 is coplanar (the cut plane is parallel to the longitudinal center axis I-I and the longitudinal center axis II-II), and the entire stent graft 100 has a uniform outer surface. path.
  • the outer surface of the bottom surface 140 a of the second bracket 120 away from the groove 140 is lower than the open end of the groove 140 , that is, the outer diameter of the second bracket 120 is smaller than the depth of the groove 140 .
  • the difference between the outer diameter of the second bracket 120 and the depth of the groove 140 (or the distance between the tangent plane of the second bracket 120 parallel to the longitudinal center axis II-II and the end face of the open end of the groove 140 ) It should not exceed 25% of the outer diameter of the second stent 120, so as to avoid the need to use the groove 140 with an excessively deep depth so that the groove 140 blocks the main blood vessel and affects the blood flow of the main blood vessel.
  • the second bracket 120 is partially received in the groove 140 , that is, a part of the second bracket 120 protrudes out of the groove 140 .
  • the distance between the height of the protruding portion and the end face of the open end of the groove 140 does not exceed 10% of the outer diameter of the second stent 120 to avoid affecting the anchoring of the first stent 110 of the stent graft 100 to the main blood vessel.
  • the second stent 120 is prevented from excessively pressing the blood vessel wall and causing damage to the blood vessel wall.
  • the first bracket 110 has axially opposed first and second ends 110A and 110B.
  • the first bracket 110 includes a plurality of first wave rings 112 and at least one second wave ring 114 .
  • the plurality of first wave rings 112 are located at the first end 110A and the second end 110B of the first bracket 110 .
  • At least one second wave ring 114 is located between the first wave rings 112 at both ends, and is radially opposite to the groove 140 . That is, the second wave ring 114 is located in the middle of the first bracket 110 .
  • the first wave ring 112 is a Z-shaped wave ring structure.
  • the Z-shaped wave ring structure is a closed-loop structure with wave crests and wave troughs formed by connecting a plurality of first wave rods (not marked in the figure) end to end.
  • At least one first wave ring 112 is located at the first end 110A, and at least one first wave ring 112 is located at the second end 110B.
  • the first wave circles 112 at both ends are arranged at intervals along the axial direction (the extension direction of the longitudinal center axis I-I).
  • the two or more first wave coils 112 at each end are connected by an axial connector (not shown in the figure) or the multiple first wave coils 112 without any connection member are connected together by the film 130 .
  • the number of the first wave circles 112 located at the first end 110A and the number of the first wave circles 112 located at the second end 110B may be equal or different.
  • the waveforms, wave heights, wave numbers, etc. may be the same or different.
  • the number of the first wave circles 112 located on both sides of the second wave circle 114 may be equal or unequal.
  • the radial dimension of the second wave ring 114 (the distance from the two largest points in the radial direction, the same below. For example, the diameter) is smaller than the radial size (for example, the diameter) of the first wave ring 112, so that when the coating film 130 covers After the first stent 110 is formed, a lumen structure with openings at both ends and a groove 140 in the middle is formed.
  • the second wave ring 114 is a closed-loop structure with wave crests and wave troughs formed by connecting a plurality of second wave rods (not shown) end to end, as shown in FIG. 3 , but the diameter of the second wave ring 114 is smaller than the diameter of the first wave circle 112 .
  • the second wave ring 114 is opposite to the bottom surface 140a of the groove 140, and radially supports the region where the coating film 130 is located on the bottom surface 140a.
  • the second wave ring 114 is fixedly connected to the area of the coating 130 located on the bottom surface 140a.
  • the second wave ring 114 is fixedly connected to at least one of the portions of the coating 130 located on the side surface 140b, the side surface 140c, the side surface 140d and the side surface 140e, but is not connected to the portion of the coating film 130 located on the bottom surface 140a.
  • the connection method includes, but is not limited to, directly fixing and connecting the two by gluing, suturing, and the like.
  • a connector is used to indirectly connect the second wave ring 114 and the coating 130 .
  • the second wave ring 114 is a closed-loop structure, including a first non-closed wave ring 1142 and a first closed portion 1144 .
  • the first non-closed wave coil 1142 is a non-closed structure with wave crests and wave troughs connected end to end by a plurality of wave rods (not shown) and the ends are not connected.
  • the first non-closed wave ring 1142 is a 1/2-3/4 circumference structure.
  • the first non-closed wave circle 1142 is 5/9 ⁇ 8/9 of a circumference.
  • a non-closed wave circle 1142 is 1/4 ⁇ 5/9 of the circumference.
  • Both ends of the first closed portion 1144 are respectively connected with the two free ends of the first non-closed wave coil 1142 to form a closed-loop structure.
  • the first closing portion 1144 is a rod structure, including a straight rod 1144A.
  • the straight rod 1144A is opposite to the bottom surface 140a.
  • the straight rod 1144A of the second wave ring 114 of this structure has a flat area, which can be better matched with the bottom surface 140a of the groove 140, so as to better radially support the area of the coating film 130 located on the bottom surface 140a, which is beneficial to maintain the concave
  • the bottom surface 140a of the groove 140 is flat or substantially flat, which is beneficial to maintain the shape of the groove 140 and avoid the deformation of the groove 140 and cause the area of the covering film 130 located in the groove 140 to fit the opening of the branch blood vessel, thereby avoiding the branch blood vessel. obstruction of blood flow occurs.
  • the second wave ring 114 is fixedly connected to the area of the film 130 located on the bottom surface 140a through the straight rod 1144A. It can also be fixedly connected to the inner surface of the film 130 through other parts, and the straight rod 1144A is not fixedly connected to the area of the film 130 located on the bottom surface 140a, that is, the groove 140 only overlaps the straight rod 1144A of the second wave ring 114. , not fixed by glue, suture, etc.
  • the first closing portion 1144 further includes two arc-shaped rods 1144B respectively connected with two ends of the straight rod 1144A, and one end of the two arc-shaped rods 1144B away from the straight rod 1144A is respectively connected with the first non-closed wave.
  • the two free ends of the ring 1142 are connected.
  • the arc-shaped rod 1144B is arranged to form a transition to avoid stress concentration, thereby avoiding the risk of fracture of the connection portion between the first closed portion 1144 and the first non-closed wave ring 1142 .
  • the first closed portion 1144 is omitted, that is, the second wave ring 114 only includes the first non-closed wave ring 1142 , so that the second wave ring 114 is an open-loop structure, as shown in FIG. 7 .
  • the two free ends of the second wave ring 114 are passivated structures to avoid puncturing the film 130 .
  • two free ends of the second wave ring 114 are respectively curled toward the inner cavity direction or the outer cavity direction to form two passivation structures 1143 .
  • the passivation structure may be in other manners, for example, may be a spherical structure fixed to the free end of the second wave ring 114 by welding or other fixing manners.
  • the second bracket 120 includes at least one third wave ring 122 .
  • the number of the third wave circles 122 is plural, and the plurality of third wave circles 122 are disposed in the groove 140 at intervals along the longitudinal center axis II-II.
  • the plurality of third wave rings 122 are disposed in the groove 140 without spacing along the longitudinal center axis II-II.
  • the third wave ring 122 is a closed-loop structure.
  • the third wave ring 122 includes a second non-closed wave ring 1222 and a second closed portion 1224 .
  • the second non-closed wave coil 1222 is a closed-loop structure with a plurality of wave rods 1222 a connected end to end and the ends are not connected, so that the second non-closed wave coil 1222 has two free ends.
  • the second non-closed wave ring 1222 is a 1/2-3/4 circumference structure.
  • the second closing part 1224 includes a linear connecting rod 1224A and two arc-shaped transition rods 1224B respectively connected with two ends of the linear connecting rod 1224A. Two ends of the two arc-shaped transition rods 1224B are respectively connected with the two free ends of the second non-closed wave ring 1222 , thereby forming a closed-loop third wave ring 122 .
  • the third wave ring 122 is accommodated in the groove 140 , and the second closing portion 1224 of the third wave ring 122 is disposed on the bottom surface 140 a of the groove 140 . More specifically, the linear connecting rod 1224A of the second closing portion 1224 is disposed on the bottom surface 140a of the groove 140, and the arc of the second non-closed wave ring 1222 matches the arc of the first wave ring 112 of the first bracket 110, so that
  • the outline of the stent graft 10 is a hollow cylindrical structure or a substantially hollow cylindrical structure.
  • the third wave ring 122 includes a second non-closed wave ring 1222 and a second closed portion 1224, which can not only match the shape of the groove 140, but also match the radian of the first wave ring 112, so as to be a groove 140 provides better radial support, and enables the outer contour of the stent graft 100 to smoothly transition, so that the contour of the stent graft 100 is a hollow cylindrical structure or a substantially hollow cylindrical structure to facilitate delivery and release.
  • the third wave ring 122 is fixed on the side surface 140 d through the wave rod 1222 a , so that the third wave ring 122 is fixed in the groove 140 .
  • the third wave ring 122 is in the position when it is located in the groove 140
  • the wave rod 1222a of the third wave ring 122 is fixedly connected to the edge line of the side surface 140d
  • the third wave ring Another wave bar 1222a of 112 is fixedly connected to the edge line of the side surface 140c.
  • the structure of the third wave ring 122 omits the linear connecting rod 1224A, that is, the third wave ring 122 includes a second non-closed wave coil 1222 and two non-closed wave coils 1222 respectively.
  • the two arc-shaped transition rods 1224B are connected with the free ends, so that the third wave ring 122 has an opening and is a non-closed loop structure.
  • the third wave ring 122 is fixed in the groove 140 by the wave rod 1222a of the third wave ring 122 being fixedly connected with the edge lines of the side surface 140d and the side surface 140c.
  • the third wave ring 122 is fixed in the groove 140 by connecting the wave rod 1222a of the third wave ring 122 to the side surface 140d and the side surface 140c, but the connection part is not necessarily located on the edge line of the side surface 140d and the side surface 140c.
  • the omission of the linear connecting rod 1224A helps to reduce the amount of metal used. Moreover, when subjected to a radial force towards the bottom surface 140a of the groove 140, the second non-closed wave ring 1222 of the third wave ring 122 can squeeze the bottom surface 140a of the groove 140, preventing the bottom surface 140a of the groove 140d from fitting The openings of branch vessels.
  • each arc-shaped transition rod 1224B is a passivation structure to avoid damage to the coating 130 .
  • the form of the passivation structure is not limited, for example, the passivation structure may be the same as the passivation structure of the second wave ring 114 . It will not be repeated here.
  • the third wave ring 122 is a closed-loop structure with wave crests and wave troughs formed by connecting a plurality of wave rods end to end, that is, the third wave ring 112 is a cylindrical wave ring.
  • the contact area between the cylindrical third wave ring 122 and the bottom surface 140a of the groove 140 is small, which is beneficial to the subsequent window opening operation.
  • the cylindrical third wave ring 122 is fixedly connected to the side surface 140c and the side surface 140d of the groove 140 through the radially opposite wave rods, and the bottom of the third wave ring 122 is not in contact with the bottom surface 140a of the groove 140 . connected.
  • the plurality of third wave rings 122 are arranged at intervals along the axial direction (the extending direction of the longitudinal center axis II-II). Adjacent third wave rings 122 may be connected by axial connectors (not shown), or may not be connected. Providing the axial connecting piece can stabilize the release position of the third wave ring 122 .
  • the axial connector may be a rigid connector or a flexible connector.
  • the form of the rigid connector is not limited, and it can be a straight rod, a special-shaped rod, etc. made of metal materials.
  • an axial connecting member 124 is used to connect the connected third wave coils 122 .
  • the axial connector 124 is a straight rod-shaped rigid connector.
  • the number of axial connectors 124 is not more than two.
  • the number of the axial connecting pieces 124 is one, that is, only one axial connecting piece 124 is used to connect two adjacent third wave rings 122 .
  • the axial connector 124 is a flexible connector. There is no limit to the position and number of flexible connectors. In the embodiment, the number of the flexible connecting pieces is three, and the three flexible connecting pieces are located on the side of the second bracket 120 away from the bottom surface 140 a of the groove 140 .
  • the second bracket 120 is an integral metal frame.
  • the second stent 120 is a lumen mesh structure formed by braiding a metal wire, or a lumen mesh structure formed by cutting a metal tube.
  • the second bracket 120 includes a plurality of third wave circles 122 (not shown in FIG. 17 ) that are not spaced apart, and the wave crests and wave troughs of two adjacent third wave circles 122 are axially opposite and connected, so that each third wave circle 122 is axially opposite and connected.
  • the crests and troughs of the wave circle 122 are no longer free ends.
  • the second stent 120 with this structure has an integrated structure, which can avoid the phenomenon that the free end of the wave crest and/or the trough of a single wave coil is easily pushed into the branch blood vessel, thereby avoiding the damage to the branch blood vessel caused by a single wave coil. Improve the safety of use.
  • the bottom of the second bracket 120 is connected to the bottom surface 140 a of the groove 140 .
  • the side surface of the second bracket 120 is connected to the side surface 140c and the side surface 140d of the groove 140 .
  • the second stent 120 is connected to the membrane 130 or the first wave ring 112 through an axial connecting rod 150 .
  • One end of the axial connecting rod 150 is connected to the first end of the second bracket 120 , and the other end extends axially out of the groove 140 and is connected to the covering film 130 or the first wave ring 112 .
  • each axial connecting rod 150 there are at least two axial connecting rods 150 .
  • the two axial connecting rods 150 are located at opposite ends of the second bracket 120 in the axial direction, and both axial connecting rods 150 are located at the open end of the groove 140 .
  • One end of each axial connecting rod 150 is connected to the second bracket 120 , and the other end extends axially from the open end of the groove 140 to the outside of the groove 140 a , and is connected to the covering film 130 or the first wave ring 112 .
  • the bottom of the second bracket 120 (the position close to the bottom surface 140a of the groove 140 ) is not fixedly connected to the bottom surface 140a of the groove 140 to facilitate adjustment of the relative position of the bottom of the second bracket 120 and the bottom surface 140a of the groove 140 , thereby It is convenient for the operation of subsequent fenestration and implantation of branch stents.
  • the form of the axial connecting rod 150 is not limited.
  • it can be a straight rod, a special-shaped rod, and the like.
  • the shape of the cross section of the second bracket 120 is not limited.
  • it may be the structure shown in FIG. 10 including the second non-closed wave coil 1222, the linear connecting rod 1224A and the arc-shaped transition rod 1224B, or the structure shown in FIG. 13 including the second non-closed wave coil 1222 and the arc-shaped transition rod 1224B.
  • the cylindrical structure shown in FIG. 14 may also be used. The details are not repeated here.
  • a first window 124 is opened at the bottom of the second bracket 120 (a position close to the bottom surface 140 a of the groove 140 ).
  • the first window 124 is located in the middle area of the second bracket 120 . Since the window 124 is not blocked or interfered by the metal frame, the subsequent operations of opening the window and implanting the branch stent are easier.
  • a second window 126 is further opened at a portion of the second bracket 120 diametrically opposite to the first window 124 , and the first window 124 is opposite to the second window 126 , that is, the second bracket
  • the central region of 120 is a metal-free framework.
  • the second window 124 and the metal frame at the edge of the second window 126 are supported, so that after the stent graft 100 is implanted in the blood vessel, the metal frame presses the bottom surface 140a of the groove 140 to avoid the bottom surface 140a of the groove 140 It is displaced in the direction close to the opening of the branch blood vessel to fit the opening of the branch.
  • the subsequent operations of opening the window and implanting the branch stent are more convenient.
  • the amount of metal used is smaller, and the radial size of the compressed stent graft 100 is smaller, so that a smaller gauge delivery sheath can be used for delivery, less damage to the patient, or more patients. .
  • the position of the first window 124 is opened at the bottom of the second bracket 120 , or on the side opposite to the bottom of the second bracket 120 (ie the second bracket 120 ) to open the first window 124.
  • the groove 140 is provided with a through hole penetrating the side surface of the groove 140 for blood flow to pass through.
  • at least one of the bottom surface 140a, the side surface 140b, the side surface 140c, the side surface 140d and the side surface 140e of the groove 140 is provided with a through hole.
  • the groove 140 is provided with a first through hole 142 penetrating the side surface 140b. Blood flow can flow from the main blood vessel to each branch blood vessel through the first through hole 142. When the lesions do not accumulate to the root of the branch arteries, subsequent implantation of branch stents is unnecessary, which is more economical for the patient.
  • the first through hole 142 and the first window 124 can be used as a channel for the branch bracket, and the branch bracket enters the second bracket 120 from the first through hole 142, and passes from the first through hole 142 to the second bracket 120.
  • a window 124 extends out of the second bracket 120 .
  • the groove 140 is provided with a second through hole 144 penetrating the side surface 140e, which can also realize that blood flow can flow from the main blood vessel to each branch blood vessel through the second through hole 144. When it accumulates to the root of the branch artery, there is no need to implant the branch stent in the future.
  • first through holes 142 and the second through holes 144 may exist at the same time, or one of the first through holes 142 and the second through holes 144 may exist alternatively.
  • the groove 140 is provided with a third through hole 146 penetrating the bottom surface 140a, so that blood flow can flow from the main blood vessel to each branch blood vessel through the third through hole 146.
  • the third through hole 146 is provided, in the subsequent implantation of the branch stent, there is no need to perform an in-situ window opening operation on the bottom surface 140a, but the branch stent is directly fed through the third through hole 146 .
  • the third through hole 146 when the third through hole 146 is provided, at least one of the first through hole 142 and the second through hole 144 may be omitted or both may be retained.
  • first through holes 142 the second through holes 144 and the third through holes 146 are not limited, as long as the blood flow can pass through without adversely affecting the overall structure of the groove 140 That's it.
  • the first through hole 142 , the second through hole 144 and the third through hole 146 are all circular holes, and the number of the first through hole 142 and the second through hole 144 is one, and the third The number of through holes 146 is three.
  • the diseased vessel 1 is a vessel in the aortic arch, and an arterial dissection 2 occurs on the side of the arch that is opposite to the branch vessel.
  • the groove 140 corresponds to the branch blood vessel.
  • the three branch blood vessels 101 are radially opposite to the groove 140 .
  • the part where the groove 140 is located is also bent, resulting in the bottom surface 140a of the groove 140 ( FIG. 23 ).
  • (not shown) has a tendency to bulge toward the direction close to the branch blood vessel 101, but due to the radial support performance of the second stent 120 itself, it can provide a reverse support force to the bottom surface 140a of the groove 140 to limit the groove 140.
  • the bottom surface 140 tends to bulge toward the branch blood vessel 101 , so that the bottom 140 a of the groove 140 can be far away from the opening of the branch blood vessel 101 , thereby preventing the covering 130 from blocking the opening of the branch blood vessel 101 .
  • a window is opened through the bottom surface 140a (not shown in FIG.
  • the branch stent 200 is sent into the branch blood vessel 101 from the opening and released.
  • the branch stent 200 establishes a blood flow channel between the branch blood vessel 101 and the diseased blood vessel 1 .
  • the shape of the groove 140 can be better maintained, so that the bottom surface 140a of the groove 140 and the opening of the branch blood vessel 200 keep a sufficient distance to facilitate in-situ fenestration and branch implantation Bracket 200.
  • the position of the third wave ring 122 can be adjusted according to needs. The operation is more convenient, and the position accuracy is improved and the operation time is shortened. At the same time, after the branch stent 200 is released, the third wave ring 122 is fixed around the branch stent 200 to form a stable support, maintain the stability of the position of the branch stent 200, and keep the branch blood vessel continuously unobstructed.
  • second wave ring 114 of different embodiments and the third wave ring 122 of different embodiments are respectively introduced above, and the second wave ring 114 of different embodiments and the third wave ring 122 of different embodiments can be arbitrarily combination.
  • the second wave ring 114 shown in FIG. 7 can be combined with the third wave ring 122 shown in FIG. 10 , and the linear connecting rod 1224A of the third wave ring is relatively matched with the bottom surface 140a of the groove 140 , which can better The bottom surface 140a of the groove 140 is squeezed to prevent the bottom surface 140a from fitting into the opening of the branch blood vessel.
  • the second wave ring 114 has an open structure, which is beneficial to reduce the amount of metal and reduce the radial dimension of the stent graft 100 after compression.
  • the second wave ring 114 shown in FIG. 4 can be combined with the third wave ring 122 shown in FIG. 10 , so that the straight rod 1144A of the second wave ring 114 is opposite to the straight connecting rod 1224A of the third wave ring 122 , co-operate.
  • the second wave ring 114 shown in FIG. 7 can be combined with the third wave ring 122 shown in FIG. 13 , and the third wave ring 122 exerts a radial support force on the groove 140 through the second non-closed wave ring 1222 . In this combination, a smaller amount of metal is used.
  • the second wave ring 114 shown in FIG. 7 can be combined with the third wave ring 122 shown in FIG. 14 , and the third wave ring 122 exerts a radial support force on the groove 140 through the second non-closed wave ring 1222 .
  • the second wave ring 114 shown in FIG. 7 can be combined with the second bracket 120 shown in FIG. 17 to provide radial support force to the groove 140 through the second bracket 120, and the second bracket 120 of this structure
  • the third wave ring 122 whose end is free can avoid the risk of damaging the inner wall of the branch blood vessel.
  • the second wave ring 114 shown in FIG. 7 may be combined with the third wave ring 122 shown in FIG. 18 or FIG. 19 .
  • the second wave ring 114 shown in Embodiment 4 can be combined with the third wave ring 122 shown in FIG. 13 , and the bottom surface 140 a of the groove 140 is squeezed by the straight rod 1144A of the second wave ring 114 , while reducing the metal The amount used is to reduce the radial dimension of the compressed stent graft 100 .
  • the radial support strength P1 of the first support 110 and the radial support strength P2 of the second support 120 are different from each other. Wait.
  • P1 and P2 satisfy: 1/2 ⁇ (P2/P1) ⁇ 1, that is, the radial support strength P2 of the second support 120 is smaller than the radial support strength P1 of the first support 110, but P2 should be sufficient is larger than 0.5 times of P1, so that when the first stent 110 and the second stent 120 are subjected to the same radial compression force, the reduction in the radial dimension of the second stent 120 after being radially compressed will not be too large, To facilitate the operation of opening the window.
  • P1 and P2 satisfy: 1 ⁇ (P2/P1) ⁇ 2, that is, the radial support strength P2 of the second support 120 is greater than or equal to the radial support strength P1 of the first support 110, and P2 is smaller than P1 2 times, so that when the first support 110 and the second support 120 are subjected to the same radial compression force, the reduction in the radial dimension of the first support 110 after being radially compressed will not be too large to keep the flow through The blood flow of the first stent 110 is smooth.
  • the radial support strength is equal to the ratio of the radial support force to the axial length.
  • P2 F2/L2.
  • P1 F1/L1.
  • the flat plate compression method may be used to test the radial support force F1 of the first bracket 110 and the radial support force F2 of the second bracket 120 .
  • a radial compression method is used to test the radial support force F1 of the first bracket 110 and the radial support force F2 of the second bracket 120 . That is, when the sizes of F1 and F2 are to be compared, F1 and F2 are tested under the same conditions using the same test method.
  • the radial compression method is used to test the radial support force F1 received by the first stent 110 when it is compressed by 50% and the radial support force F2 received by the second stent 120 when it is compressed by 50%.
  • the radial support force F1 of the first bracket 110 is related to parameters such as the rod diameter, wave number, and angle at the trough or peak of the second wave ring 114
  • the radial support force F2 of the second bracket 120 is related to the third wave ring 122 . It is related to parameters such as the rod diameter, wave number, angle at the trough or peak of the wave, etc., and those skilled in the art can adjust it as needed.
  • the stent graft 100 further includes an anchoring stent 160 .
  • the anchoring stent 160 is located at the first end 110A of the first stent 110 and is connected to the first wave ring 112 or to the covering Membrane 130 is attached.
  • the anchoring stent 160 is a bare stent, not including any membranes.
  • Anchoring stent 160 includes at least one anchoring wave ring 162 . When the number of the anchor wave circles 162 is plural, the plurality of anchor wave circles 162 are arranged at intervals along the longitudinal center axis I-I.
  • the anchoring stent 160 is located at the proximal end of the stent-graft 100 when the stent-graft 100 is implanted in the blood vessel.
  • the anchoring stent 160 is provided to further improve the anchoring performance of the end of the stent-graft 100 .
  • first wave ring 110 there is one first wave ring 110 at the first end 110A, and when the groove 140 is only radially opposite to two branch blood vessels 101 (two branch blood vessels 101 near the second end 110B)
  • first wave ring 110 cooperates with the anchoring stent 160, the proximal end of the stent-graft 100 is anchored, and since the anchoring stent 160 is a bare stent, it will not completely block the opening of the third branch blood vessel 101 , the operation of opening the window and implanting the branch stent 200 is unnecessary.
  • the wave rod length of the anchoring wave ring 162 is smaller than the wave rod length of the first wave ring 162, and the wave number of the anchor wave ring 162 is greater than the wave number of the first wave ring 162, so that the anchor of the anchor bracket 160 is anchored. Better performance.

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Abstract

一种覆膜支架(100)，包括第一支架(110)、第二支架(120)和覆膜(130)，覆膜(130)包覆于第一支架(110)上形成中部具有凹槽(140)的管腔结构，第二支架(120)至少部分收容于凹槽(140)中，且第一支架(110)的纵向中心轴线(I-I)和第二支架(120)的纵向中心轴线(II-II)平行或大致平行。覆膜支架(110)能够避免或减缓凹槽(140)的底面(140a)贴合分支血管(101)的开口。

Description

覆膜支架 技术领域
本发明涉及介入式医疗器械领域，特别是涉及一种覆膜支架。
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。
动脉瘤和动脉夹层是临床上常见的血管疾病，如果不加医学干预，动脉瘤具有破裂的风险，对患者的生命造成极大的威胁。
随着现在医学技术的不断发展，利用微创手术将覆膜支架植入体内，治疗动脉瘤及动脉夹层的治疗手术被使用，因其创伤小，恢复快，得到了广泛应用。此治疗方式是将覆膜支架压缩入输送装置中，沿着事先植入的导丝轨道引导进入人体，到达病变位置后，将覆膜支架释放出来隔绝病变，重建血流通道，动脉瘤和动脉夹层在丧失血流供应后，瘤腔内残存血液逐渐血栓并肌化成血管组织，扩张状态的瘤壁因受压而收缩，逐渐恢复接近原始状态，从而达到治疗动脉瘤和动脉夹层的目的。
当动脉瘤或动脉夹层的发生部位靠近分支血管时，植入覆膜支架后可能遮挡分支血管的开口，从而导致分支血管的血流受阻。现有技术解决该问题的方法之一是在覆膜支架上设有凹槽结构，植入后，凹槽结构对应分支血管，凹槽结构上开设有窗口，以允许血流通过，保证分支血管的血流供应。然而，现有的设有凹槽结构的覆膜支架植入血管中后，分支部位的动脉会挤压凹槽结构，导致凹槽结构的体积变小，凹槽结构处的覆膜(即凹槽的底面)贴合分支血管的开口，导致分支血管的血流受阻，从而起不到凹槽结构的应发挥的作用。或者，由于挤压作用，导致凹槽结构上的窗口与分支血管开口的距离太近，不利于后续重建分支血管血运的操作，比如建立输送轨道时，导丝导入窗口的操作，后续分支支架输送器导入开窗的操作等。
发明内容
基于此，有必要提供一种能够避免或减缓凹槽的底面贴合分支血管的开口的覆膜支架。
一种覆膜支架，包括第一支架、第二支架和覆膜，所述覆膜包覆于所述第一支架上形成中部具有凹槽的管腔结构，所述第二支架至少部分收容于所述凹槽中，且所述第一支架的纵向中心轴线和所述第二支架的纵向中心轴线平行或大致平行。
在其中一个实施例中，所述第一支架包括多个第一波圈和至少一个第二波圈，所述多个第一波圈位于所述第一支架的两端，所述第二波圈位于所述第一支架的中部，且所述第二波圈与所述凹槽径向相对。
在其中一个实施例中，所述第二波圈为具有波峰和波谷的闭环结构或具有波峰和波谷的开环结构。
在其中一个实施例中，当所述第二波圈为具有波峰和波谷的闭环结构时， 所述第二波圈包括第一非闭合波圈和第一闭合部，所述第一非闭合波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述第一闭合部包括直杆，所述直杆的两端分别与所述两个自由端直接或间接相连；
当所述第二波圈为具有波峰和波谷的开环结构时，所述第二波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述两个自由端为钝化结构。
在其中一个实施例中，所述第二支架包括至少一个第三波圈，所述第三波圈为具有波峰和波谷的闭环结构或具有波峰和波谷的开环结构。
在其中一个实施例中，所述第三波圈为多个，多个所述第三波圈沿轴向间隔排列或沿轴向非间隔排列。
在其中一个实施例中，当所述第三波圈为具有波峰和波谷的闭环结构时，所述第三波圈包括第二非闭合波圈和第二闭合部，所述第二非闭合波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述第二闭合部包括直线连接杆，所述直线连接杆的两端分别与所述两个自由端直接或间接相连；
当所述第三波圈为具有波峰和波谷的开环结构时，所述第三波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述两个自由端为钝化结构。
在其中一个实施例中，所述凹槽包括底面和围绕所述底面的侧面，所述第三波圈至少部分收容于所述凹槽中，且所述第三波圈与所述底面不固定连接。
在其中一个实施例中，所述第二支架为由编织丝编织形成的一体式支架或为由切割形成的一体式支架。
在其中一个实施例中，所述第二支架的一侧开设有第一窗口。
在其中一个实施例中，所述凹槽包括底面和围绕所述底面的侧面，所述第二支架的靠近所述底面的一侧开设有第一窗口，所述第二支架还开设有第二窗口，所述第一窗口和所述第二窗口在径向上相对。
在其中一个实施例中，所述凹槽包括底面和围绕所述底面的侧面，所述底面和侧面中的至少一个开设有通孔。
在其中一个实施例中，所述第一支架的径向支撑强度为P1，所述第二支架的径向支撑强度为P2，所述P1和P2满足：1/2<(P2/P1)<1；或者，所述P1和P2满足：1≤(P2/P1)≤2。
上述覆膜支架的第二支架至少部分收容于凹槽中，当覆膜支架顺应血管的弯曲而弯曲时，由于第二支架的径向挤压作用，凹槽的底面向分支血管靠近的趋势被阻挡或限制，从而能够避免或减缓凹槽的底面贴合分支血管的开口。
附图说明
图1为一实施例的覆膜支架的结构示意图；
图2为图1所示的覆膜支架的等轴测试图；
图3为一实施例的第二波圈的侧视图；
图4为另一实施例的第二波圈的正视图；
图5为图4所示的第二波圈的侧视图；
图6为图4所示的第二波圈的俯视图；
图7为另一实施例的第二波圈的正视图；
图8为图7所示的第二波圈的侧视图；
图9为图7所示的第二波圈的俯视图；
图10为一实施例的第三波圈的正视图；
图11为图10所示的第三波圈的俯视图；
图12为图10所示的第三波圈侧视图；
图13为另一实施例的第三波圈的正视图；
图14为一实施例的覆膜支架的侧视图；
图15为一实施例的第二支架的结构示意图；
图16为另一实施例的第二支架的结构示意图；
图17为另一实施例的覆膜支架的结构示意图；
图18为一实施例的第三波圈的仰视图；
图19为一实施例的第三波圈的仰视图；
图20为另一实施例的覆膜支架的等轴测试图；
图21为另一实施例的覆膜支架的等轴测试图；
图22为另一实施例的覆膜支架的等轴测试图；
图23为图1所示的覆膜支架植入血管中的状态示意图；
图24为在图23所示的状态植入分支支架的状态示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
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。
在本文中，定义“近端”为靠近心脏的一端，定义“远端”为远离心脏的一端。“轴向”指平行于医疗器械远端中心和近端中心连线的方向，“径向”指垂直于上述轴向的方向。
请参阅图1，一实施例的覆膜支架100，包括第一支架110、第二支架120和覆膜130，其中，覆膜130包覆于第一支架110上形成两端开口且中间具有凹槽140的管腔结构，如图2所示。管腔结构具有与两个开口端连通的内腔，以供血流通过。凹槽140具有底面140a和围绕底面140a的侧面。在一实施例中，侧面分别为侧面140b、侧面140c、侧面140d和侧面140e。其中，侧面140b和侧面140e在轴向上相对，侧面140c和侧面140d在径向上相对。在不受力的状态下，底面140a为平面或曲面，曲面可以为相对凹槽140的开口下凹的凹面、相对凹槽140的开口向上凸起的凸面或同时具有凹陷部和凸起部的曲面。第二 支架120至少部分收容于凹槽140中，且第一支架110的纵向中心轴线I-I和第二支架120的纵向中心轴线II-II平行或大致平行。其中，大致平行时是指纵向中心轴线I-I和纵向中心轴线II-II的角度大于0°但小于10°。
其中，第一支架110和第二支架120采用具有良好生物相容性和良好弹性的材料制成，例如，镍钛合金、不锈钢等。覆膜130采用良好生物相容性的薄膜材料制成，例如，PET、PTFE等。覆膜130和第一支架110的结合或固定方式不限，例如，可以采用高温加压方式，也可以采用缝合固定方式。覆膜130的可以为单层结构，也可以多层结构。
在一实施例中，第二支架120完全收容于凹槽140中，并且，第二支架120的远离凹槽140的底面140a的外表面与第一支架110的外表面平齐，如图1所示，即第二支架120和第一支架110在凹槽140的开口方向的切面共面(该切面与纵向中心轴线I-I和纵向中心轴线II-II平行)，整个覆膜支架100具有均一的外径。或者，第二支架120的远离凹槽140的底面140a的外表面低于凹槽140开口端，即第二支架120的外径小于凹槽140的深度。在一实施例中，第二支架120的外径与凹槽140的深度的差值(或第二支架120的与纵向中心轴线II-II平行的切面与凹槽140的开口端的端面的距离)不超过第二支架120的外径的25％，以避免需要使用深度过大的凹槽140而使凹槽140对主体血管形成遮挡而影响主体血管的血流。在另一实施例中，第二支架120部分收容于凹槽140中，即第二支架120有部分凸出于凹槽140外。凸出部分的高度与凹槽140的开口端的端面的距离不超过第二支架120的外径10％，以避免影响覆膜支架100的第一支架110与主体血管的锚定。或者，避免第二支架120过度挤压血管壁而造成血管壁损伤。
第一支架110具有轴向相对的第一端110A和第二端110B。第一支架110包括多个第一波圈112和至少一个第二波圈114。多个第一波圈112位于第一支架110的第一端110A和第二端110B。至少一个第二波圈114位于两端的第一波圈112之间，且与凹槽140在径向上相对。即，第二波圈114位于第一支架110的中部。
在一实施例中，第一波圈112为Z型波圈结构。Z型波圈结构为由多个第一波杆(图未标)首尾相连形成的具有波峰和波谷的闭环结构。位于第一端110A的第一波圈112至少为一个，位于第二端110B的第一波圈112至少为一个。在一实施例中，位于第一端110A的第一波圈112为两个或多个，位于第二端110B的第一波圈112为两个或多个。当两端的第一波圈112的数量大于或等于2时，每一端的大于或等于2个第一波圈112沿轴向(纵向中心轴线I-I的延伸方向)间隔排列。并且，每一端的大于或等于2个第一波圈112之间通过轴向连接件(图未示)连接或多个第一波圈112之间无任何连接件，通过覆膜130连在一起。在其他实施例中，位于第一端110A的第一波圈112的数量和位于第二端110B的第一波圈112的数量可以相等，也可以不等。
需要说明的是，位于第二波圈114两侧的多个第一波圈112之间，波形、波高、波数等可以相同，也可以不同。位于第二波圈114的两侧的第一波圈112的数量可以相等，也可以不等。
第二波圈114的径向尺寸(径向方向距离最大的两点的距离，下同。例如直径)小于第一波圈112的径向尺寸(例如，直径)，使得当覆膜130包覆于第一支架110上后形成两端开口且中间具有凹槽140的管腔结构。
在一实施例中，第二波圈114为由多个第二波杆(图未标)首尾相连形成的具有波峰和波谷的闭环结构，如图3所示，但第二波圈114的直径小于第一波圈112的直径。第二波圈114与凹槽140的底面140a相对，并径向支撑覆膜130位于底面140a的区域。第二波圈114与覆膜130的位于底面140a的区域固定连接。或者，第二波圈114与覆膜130的位于侧面140b、侧面140c、侧面140d和侧面140e的部位中的至少一个固定连接，但不与覆膜130的位于底面140a的部位连接。连接的方式包括但不限于采用胶粘、缝合等方式将两者直接固定连接。或者，采用连接件间接连接第二波圈114和覆膜130。
在一实施例中，如图4所示，第二波圈114为闭环结构，包括第一非闭合波圈1142和第一闭合部1144。请一并参阅图5和图6，第一非闭合波圈1142为由多个波杆(图未标)首尾相连且端部不相连的具有波峰和波谷的非闭合结构。在一实施例中，当凹槽140的底面140a为平面时，第一非闭合波圈1142为1/2～3/4个圆周结构。当凹槽140的底面140a为凹面时，第一非闭合波圈1142为5/9～8/9个圆周。当凹槽140的底面140a为凹面时，一非闭合波圈1142为1/4～5/9个圆周。第一闭合部1144的两端分别与第一非闭合波圈1142的两个自由端相连从而形成闭环结构。第一闭合部1144为杆件结构，包括直杆1144A。直杆1144A与底面140a相对。这种结构的第二波圈114的直杆1144A具有平面区域，能够与凹槽140的底面140a较好地匹配，以较好地径向支撑覆膜130位于底面140a的区域，有利于维持凹槽140的底面140a为平面或大致为平面，从而有利于维持凹槽140的形状，避免凹槽140变形而导致覆膜130的位于凹槽140的区域贴合分支血管的开口，从而避免分支血管的血流受阻的现象发生。
第二波圈114通过直杆1144A与覆膜130位于底面140a的区域固定连接。也可以通过其他部位与覆膜130的内表面固定连接，而直杆1144A不与覆膜130位于底面140a的区域固定连接，即凹槽140仅仅搭接在第二波圈114的直杆1144A上，并未使用胶粘、缝合等方式固定。
在一实施例中，第一闭合部1144还包括分别与直杆1144A的两端相连的两个弧形杆1144B，两个弧形杆1144B的远离直杆1144A的一端分别与第一非闭合波圈1142的两个自由端相连。设置弧形杆1144B，以形成过渡，避免应力集中，从而避免第一闭合部1144与第一非闭合波圈1142的连接部位断裂的风险。
在一实施例中，省略第一闭合部1144，即第二波圈114仅包括第一非闭合波圈1142，使得第二波圈114为非闭环结构，如图7所示。第二波圈114的两个自由端为钝化结构，以避免刺破覆膜130。在一实施例中，如图8和图9所示，第二波圈114的两个自由端分别向腔内方向或腔外方向卷曲而形成两个钝化结构1143。在另一实施例中，钝化结构可以为其他方式，例如可以为通过焊接或其他固定方式固定于第二波圈114的自由端的球状结构。
请回到图1，在一实施例中，第二支架120包括至少一个第三波圈122。在一实施例中，第三波圈122的数量为多个，多个第三波圈122沿纵向中心轴线 II-II间隔地设置于凹槽140中。在另一实施例中，多个第三波圈122沿纵向中心轴线II-II非间隔地设置于凹槽140中。
请参阅图10，在一实施例中，第三波圈122为闭环结构。第三波圈122包括第二非闭合波圈1222和第二闭合部1224。请一并参阅图11，第二非闭合波圈1222为由多个波杆1222a首尾相连且端部不相连的非闭环结构，使得第二非闭合波圈1222具有两个自由端。在一实施例中，当凹槽140的底面140a为平面时，第二非闭合波圈1222为1/2～3/4个圆周结构。当凹槽140的底面140a为凹面时，第一非闭合波圈1142为5/9～8/9个圆周。当凹槽140的底面140a为凹面时，一非闭合波圈1142为1/4～5/9个圆周。第二闭合部1224包括直线连接杆1224A和分别与直线连接杆1224A的两端相连的两个弧形过渡杆1224B。两个弧形过渡杆1224B的两端分别与第二非闭合波圈1222的两个自由端相连，从而形成闭环的第三波圈122。
第三波圈122收容于凹槽140中，且第三波圈122的第二闭合部1224设置于凹槽140的底面140a上。更具体地，第二闭合部1224的直线连接杆1224A设置于凹槽140的底面140a上，第二非闭合波圈1222的弧度与第一支架110的第一波圈112的弧度相匹配，使得覆膜支架10的轮廓为中空的圆柱结构或大致为中空的圆柱结构。
因此，第三波圈122包括第二非闭合波圈1222和第二闭合部1224，不仅能与凹槽140的形状相匹配，也可以和第一波圈112的弧度相匹配，从而为凹槽140提供较好的径向支撑，且使覆膜支架100的外部轮廓能够平滑过渡，以使覆膜支架100的轮廓为中空的圆柱结构或大致为中空的圆柱结构，以方便输送和释放。
在一实施例中，第三波圈122通过波杆1222a固定于侧面140d上，实现第三波圈122固定于凹槽140中。在一实施例中，如图12所示，第三波圈122处于位于凹槽140中时的位置状态，第三波圈122的波杆1222a与侧面140d的边缘线固定相连，第三波圈112的另一波杆1222a与侧面140c的边缘线固定相连。
在一实施例中，请参阅图13，第三波圈122的结构省略直线连接杆1224A，即第三波圈122包括第二非闭合波圈1222及分别与第二非闭合波圈1222的两个自由端相连的两个弧形过渡杆1224B，使得第三波圈122具有开口，为非闭环结构。通过第三波圈122的波杆1222a与侧面140d及侧面140c的边缘线固定相连使第三波圈122固定于凹槽140中。或者，通过第三波圈122的波杆1222a与侧面140d和侧面140c相连使第三波圈122固定于凹槽140中，但连接部位不一定位于侧面140d和侧面140c的边缘线上。
省略直线连接杆1224A有利于减少金属用量。并且，当受到朝向凹槽140的底面140a的径向力作用时，第三波圈122的第二非闭合波圈1222可以挤压凹槽140的底面140a，防止凹槽140d的底面140a贴合分支血管的开口部位。
每个弧形过渡杆1224B的自由端为钝化结构，以避免损伤覆膜130。钝化结构的形式不限，例如，钝化结构可以与第二波圈114的钝化结构相同。此处不再赘述。
在另一实施例中，请参阅图14，第三波圈122为由多个波杆首尾相连形成 的具有波峰和波谷的闭环结构，即第三波圈112为圆筒状波圈。圆筒状的第三波圈122与凹槽140的底面140a的接触面积较小，有利于后续开窗操作。
在一实施方式中，圆筒状的第三波圈122通过径向上相对的波杆与凹槽140的侧面140c和侧面140d固定连接，第三波圈122的底部与凹槽140的底面140a不相连。
需要说明的是，当第三波圈122的数量为多个时，多个第三波圈122沿轴向(纵向中心轴线II-II的延伸方向)间隔排列。相邻的第三波圈122之间可以通过轴向连接件(图未示)相连，可以不相连。设置轴向连接件可以稳定第三波圈122释放的位置。
当相邻的第三波圈122之间通过轴向连接件相连时，轴向连接件可以刚性连接件，也可以为柔性连接件。
刚性连接件的形式不限，可以为金属材料制成的直杆、异形杆等。请参阅图15，在一实施例中，采用轴向连接件124连接相连的第三波圈122。轴向连接件124为直杆状的刚性连接件。并且，当覆膜支架100弯曲时，形成大弯侧和小弯侧，轴向连接件124位于大弯侧，以免影响覆膜支架100弯曲。在一实施例中，轴向连接件124的数量不超过2个。在一实施例中，轴向连接件124的数量为1个，即仅使用一个轴向连接件124连接相邻的两个第三波圈122。
请参阅图16，在一实施例中，轴向连接件124为柔性连接件。柔性连接件的位置不限，数量也不限。在实施例中，柔性连接件的数量为3个，并且，三个柔性连接件位于第二支架120的远离凹槽140的底面140a的一侧。
在另一实施例中，请参阅图17，第二支架120为一个整体的金属骨架。例如，第二支架120为由金属丝编织形成的管腔网状结构，或为切割金属管形成的管腔网状结构。或者，第二支架120包括多个非间隔排列的第三波圈122(图17未示)，相邻的两个第三波圈122的波峰和波谷轴向相对且相连，使得每个第三波圈122的波峰和波谷不再是具有自由端的状态。这种结构的第二支架120为一体式结构，能够避免因单个波圈的波峰和/或波谷的自由端而容易顶入分支血管内的现象，从而避免了单个波圈对分支血管造成损伤，提高了使用的安全性。
在一实施例中，第二支架120的底部与凹槽140的底面140a相连。在另一实施例中，第二支架120的侧面与凹槽140的侧面140c及侧面140d相连。
在另一实施例中，如图17所示，第二支架120通过轴向连接杆150与覆膜130或第一波圈112相连。轴向连接杆150的一端与第二支架120的第一端，另一端轴向延伸至凹槽140外，并与覆膜130或第一波圈112相连。
轴向连接杆150至少为两个。当轴向连接杆150为两个时，两个轴向连接杆150位于第二支架120的轴向相对的两端，且两个轴向连接杆150均位于凹槽140的开口端。每个轴向连接杆150的一端与第二支架120相连，另一端从凹槽140的开口端轴向延伸至凹槽140a外，并与覆膜130或第一波圈112相连。
并且，第二支架120的底部(靠近凹槽140的底面140a的部位)与凹槽140的底面140a不固定连接，以方便调整第二支架120的底部与凹槽140的底面140a相对位置，从而方便在后续开窗和植入分支支架的操作。
轴向连接杆150的形式不限。例如，可以为直杆、异形杆等。
可以理解，在第二支架120为整体的金属骨架的实施例中，第二支架120的横截面的形状不限。例如，可以为图10所示的包括第二非闭合波圈1222、直线连接杆1224A和弧形过渡杆1224B的结构，也可以为图13所示的包括第二非闭合波圈1222和弧形过渡杆1224B，但省略直线连接杆1224A的结构。还可以为图14所示的圆筒状结构。此处不再详细赘述。
请参阅图18，在另一实施例中，第二支架120的底部开设(靠近凹槽140的底面140a的部位)开设有第一窗口124。第一窗口124位于第二支架120的中部区域。由于窗口124部分没有金属骨架的阻挡或干扰，使得后续的开窗和植入分支支架的操作更为容易。并且，有利于减少金属的使用量，同时由于减小压缩后的第二支架120的径向尺寸，从而减少压缩后的覆膜支架100的径向尺寸，以便可以使用较小规格的输送鞘管进行输送，对患者的损伤较小，或者适用于更多的患者。
请参阅图19，在另一实施例中，第二支架120的与第一窗口124径向相对的部位还开设有第二窗口126，第一窗口124和第二窗口126相对，即第二支架120的中部区域为无金属骨架。如此，通过第二窗口124和第二窗口126边缘的金属骨架进行支撑，使得当覆膜支架100植入血管中后，金属骨架挤压凹槽140的底面140a，以避免凹槽140的底面140a朝向靠近分支血管开口的方向位移而贴合分支开口部位。并且，在保障支撑作用的同时，更方便后续的开窗和植入分支支架的操作。并且，金属的使用量更小，压缩后的覆膜支架100的径向尺寸更小，以便可以使用更小规格的输送鞘管进行输送，对患者的损伤更小，或者适用于更多的患者。
在另外的实施例中，当省略第二窗口126时，第一窗口124的位置开设在第二支架120的底部，也可以在第二支架120的与底部相对的一侧(即第二支架120的顶部)开设第一窗口124。
在一实施例中，凹槽140上开设有贯通凹槽140的侧面的通孔，以供血流通过。在一实施例中，凹槽140的底面140a、侧面140b、侧面140c、侧面140d和侧面140e中的至少一个开设有通孔。具体的，请参阅图20，在一实施例中，凹槽140上开设有贯通侧面140b的第一通孔142。血流可以从主体血管经第一通孔142流向各分支血管，当病变没有累计到分支动脉根部时，后续无需再植入分支支架，对于患者来说更经济。
当第一窗口124开设于第二支架120的顶部时，第一通孔142和第一窗口124可以作为分支支架的通道，分支支架从第一通孔142进入第二支架120中，并从第一窗口124伸出第二支架120。
请参阅图21，在一实施例中，凹槽140上开设有贯通侧面140e的第二通孔144，亦可以实现血流可以从主体血管经第二通孔144流向各分支血管，当病变没有累计到分支动脉根部时，后续无需再植入分支支架。
需要说明的是，第一通孔142和第二通孔144可以同时存在，也可以是第一通孔142和第二通孔144中的一个择一存在。
请参阅图22，在一实施例中，凹槽140上开设有贯通底面140a的第三通孔 146，亦可以实现血流可以从主体血管经第三通孔146流向各分支血管，当病变没有累计到分支动脉根部时，后续无需再植入分支支架。或者，当设有第三通孔146时，在后续的植入分支支架时，无需再在底面140a上进行原位开窗操作，而是直接通过第三通孔146送入分支支架。
需要说明的是，当开设有第三通孔146时，第一通孔142和第二通孔144中的至少一个可以省略，也可以都保留。
还需要说明的是，第一通孔142、第二通孔144和第三通孔146的形状和数量不限，只要满足血流能够通过，且不会对凹槽140的整体结构产生不良影响即可。
在一实施例中，第一通孔142、第二通孔144和第三通孔146均为圆形孔，并且，第一通孔142和第二通孔144的数量均为一个，第三通孔146的数量为3个。
以下以图1所示的实施例说明覆膜支架100的使用方法。如图23所示，病变血管1为主动脉弓部血管，弓部的与分支血管相对的一侧发生动脉夹层2。当将覆膜支架100植入病变血管1中后，凹槽140对应分支血管部位。具体地，三个分支血管101均与凹槽140在径向上相对。当覆膜支架100植入病变血管1中后，覆膜支架100顺应病变血管1自身的弯曲而弯曲，弯曲过程中，凹槽140所在部位一并弯曲，导致凹槽140的底面140a(图23未示)具有向靠近分支血管101的方向凸出的趋势，但由于第二支架120自身的径向支撑性能，能够给凹槽140的底面140a提供反向的支撑力，以限制凹槽140的底面140向靠近分支血管101的方向凸出的趋势，从而使得凹槽140的底部140a能够远离分支血管101的开口，从而避免覆膜130遮挡分支血管101的开口。请一并参阅图24，接着，采用原位开窗技术，开设贯穿凹槽140的底面140a(图23未示)的窗口，将分支支架200从该开窗中送入分支血管101中并释放分支支架200，建立分支血管101与病变血管1的血流通道。
由于第二支架120的径向支撑作用，能够较好地保持凹槽140的形状，使得凹槽140的底面140a与分支血管200的开口保持足够的距离，以方便原位开窗及植入分支支架200。
并且，由于第二支架120的底部与凹槽140的底面140a不是固定连接的，使得在原位开窗及植入分支支架200的过程中，可以根据需要，调整第三波圈122的位置，使得操作更为方便，有利于提高位置准确性及缩短手术时间。同时，当分支支架200释放完成后，第三波圈122固定在分支支架200周围，形成稳定支撑，维持分支支架200位置的稳定，以保持分支血管持续畅通。
需要说明的是，上文分别介绍了不同实施例的第二波圈114和不同实施例的第三波圈122，不同实施例的第二波圈114和不同实施例第三波圈122可以任意组合。
例如，图7所示的第二波圈114可以与图10所示的第三波圈122组合，通过第三波圈的直线连接杆1224A与凹槽140的底面140a较为匹配，可以较好地挤压凹槽140的底面140a，防止底面140a贴合分支血管的开口。并且，第二波圈114为开口结构，有利于减少金属用量和降低压缩后覆膜支架100的径向尺 寸。
又如，图4所示的第二波圈114可以与图10所示的第三波圈122组合，使得第二波圈114的直杆1144A与第三波圈122的直线连接杆1224A相对，相互配合。
又如，图7所示的第二波圈114可以与图13所示的第三波圈122组合，第三波圈122通过第二非闭合波圈1222对凹槽140施加径向支撑力。这种组合，使用的金属量较小。
又如，图7所示的第二波圈114可以与图14所示的第三波圈122组合，第三波圈122通过第二非闭合波圈1222对凹槽140施加径向支撑力。
又如，图7所示的第二波圈114可以与图17所示的第二支架120组合，通过第二支架120对凹槽140提供径向支撑力，并且这种结构的第二支架120能够避免端部为自由端的第三波圈122能够避免损伤分支血管内壁的风险。
又如，图7所示的第二波圈114可以与图18或图19所示的第三波圈122组合。
又如，实施例4所示的第二波圈114可以与图13所示的第三波圈122组合，通过第二波圈114的直杆1144A挤压凹槽140的底面140a，同时减少金属的使用量即减少压缩后的覆膜支架100的径向尺寸。
其他的组合方式不再一一赘述。
无论不同的结构的第二波圈114和不同结构的第三波圈122如何组合，在一实施例中，第一支架110的径向支撑强度P1和第二支架120的径向支撑强度P2不等。
在一实施例中，P1和P2满足：1/2<(P2/P1)<1，即第二支架120的径向支撑强度P2小于第一支架110的径向支撑强度P1，但P2应足够大，大于P1的0.5倍，使得当第一支架110和第二支架120受到大小相等的径向压缩力时，第二支架120被径向压缩后的径向尺寸的减少量不至于过大，以方便进行开窗的操作。
在一实施例中，P1和P2满足：1≤(P2/P1)≤2，即第二支架120的径向支撑强度P2大于或等于第一支架110的径向支撑强度P1，且P2小于P1的2倍，使得当第一支架110和第二支架120受到大小相等的径向压缩力时，第一支架110被径向压缩后的径向尺寸的减少量不至于过大，以保持流经第一支架110的血流畅通。
需要说明的是，径向支撑强度等于径向支撑力与轴向长度的比值。例如，当第二支架120所受到的径向支撑力为F2，第二支架120的轴向长度为L2，则P2＝F2/L2。当第一支架110所受到的径向支撑力为F1，第一支架110的轴向长度为L1，则P1＝F1/L1。其中，L1为第一支架110的与第二支架120径向相对部分的轴向长度，L1＝L2。
还需要说明的是，可以采用平板压缩法测试第一支架110的径向支撑力F1和第二支架120的径向支撑力F2。或者，采用径向压缩法测试第一支架110的径向支撑力F1和第二支架120的径向支撑力F2。即，当要比较F1和F2的大小时，采用相同的测试方法、在相同的条件下测试F1和F2。例如，分别采用径 向压缩法测试第一支架110被压缩50％时受到的径向支撑力F1的大小及第二支架120被压缩50％时受到的径向支撑力F2的大小。当采用平板压缩法时，将两个平板分别压缩支架的两侧，两个平板平行，且两个平板以纵向中心轴线的对称轴对称设置。并且，两个平板分别为支架的的两个切平面。
第一支架110的径向支撑力F1与第二波圈114的杆径、波数、波谷或波峰处的夹角等参数有关，第二支架120的径向支撑力F2与第三波圈122的的杆径、波数、波谷或波峰处的夹角等参数有关，本领域技术人员可以根据需要调整。
请再次回到图1，在一实施例中，覆膜支架100还包括锚定支架160，锚定支架160位于第一支架110的第一端110A，并与第一波圈112相连或与覆膜130相连。锚定支架160为裸支架，不包括任何覆膜。锚定支架160包括至少一个锚定波圈162。当锚定波圈162的数量为多个时，多个锚定波圈162沿纵向中心轴线I-I间隔排列。
当将覆膜支架100植入血管中时，锚定支架160位于覆膜支架100的近端。设置锚定支架160以进一步提高覆膜支架100端部的锚定性能。
在一实施例中，位于第一端110A的第一波圈110为一个，并且，当凹槽140仅与两个分支血管101(靠近第二端110B的两个分支血管101)在径向上相对时，通过一个第一波圈110和锚定支架160配合，实现覆膜支架100近端的锚定，并且，由于锚定支架160为裸支架，不会完全遮挡第三个分支血管101的开口，无需再进行开窗和植入分支支架200的操作。
在一实施例中，锚定波圈162的波杆长度小于第一波圈162的波杆长度，并且锚定波圈162的波数大于第一波圈162的波数，使得锚定支架160的锚定性能较好。
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 (13)

  1. 一种覆膜支架，其特征在于，包括第一支架、第二支架和覆膜，所述覆膜包覆于所述第一支架上形成中部具有凹槽的管腔结构，所述第二支架至少部分收容于所述凹槽中，且所述第一支架的纵向中心轴线和所述第二支架的纵向中心轴线平行或大致平行。
  2. 根据权利要求1所述覆膜支架，其特征在于，所述第一支架包括多个第一波圈和至少一个第二波圈，所述多个第一波圈位于所述第一支架的两端，所述第二波圈位于所述第一支架的中部，且所述第二波圈与所述凹槽径向相对。
  3. 根据权利要求2所述覆膜支架，其特征在于，所述第二波圈为具有波峰和波谷的闭环结构或具有波峰和波谷的开环结构。
  4. 根据权利要求3所述覆膜支架，其特征在于，当所述第二波圈为具有波峰和波谷的闭环结构时，所述第二波圈包括第一非闭合波圈和第一闭合部，所述第一非闭合波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述第一闭合部包括直杆，所述直杆的两端分别与所述两个自由端直接或间接相连；
    当所述第二波圈为具有波峰和波谷的开环结构时，所述第二波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述两个自由端为钝化结构。
  5. 根据权利要求1所述覆膜支架，其特征在于，所述第二支架包括至少一个第三波圈，所述第三波圈为具有波峰和波谷的闭环结构或具有波峰和波谷的开环结构。
  6. 根据权利要求5所述覆膜支架，其特征在于，所述第三波圈为多个，多个所述第三波圈沿轴向间隔排列或沿轴向非间隔排列。
  7. 根据权利要求5或6所述覆膜支架，其特征在于，当所述第三波圈为具有波峰和波谷的闭环结构时，所述第三波圈包括第二非闭合波圈和第二闭合部，所述第二非闭合波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述第二闭合部包括直线连接杆，所述直线连接杆的两端分别与所述两个自由端直接或间接相连；
    当所述第三波圈为具有波峰和波谷的开环结构时，所述第三波圈为具有波峰和波谷的开环波圈，所述开环波圈具有两个自由端，所述两个自由端为钝化结构。
  8. 根据权利要求5或6所述覆膜支架，其特征在于，所述凹槽包括底面和围绕所述底面的侧面，所述第三波圈至少部分收容于所述凹槽中，且所述第三波圈与所述底面不固定连接。
  9. 根据权利要求1所述覆膜支架，其特征在于，所述第二支架为由编织丝编织形成的一体式支架或为由切割形成的一体式支架。
  10. 根据权利要求9所述覆膜支架，其特征在于，所述第二支架的一侧开设有第一窗口。
  11. 根据权利要求9所述覆膜支架，其特征在于，所述凹槽包括底面和围绕所述底面的侧面，所述第二支架的靠近所述底面的一侧开设有第一窗口，所述第二支架还开设有第二窗口，所述第一窗口和所述第二窗口在径向上相对。
  12. 根据权利要求1所述覆膜支架，其特征在于，所述凹槽包括底面和围绕所述底面的侧面，所述底面和侧面中的至少一个开设有通孔。
  13. 根据权利要求1所述覆膜支架，其特征在于，所述第一支架的径向支撑强度为P1，所述第二支架的径向支撑强度为P2，所述P1和P2满足：1/2<(P2/P1)<1；或者，所述P1和P2满足：1≤(P2/P1)≤2。
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116370144A (zh) * 2023-05-19 2023-07-04 杭州唯强医疗科技有限公司 血管支架及系统
CN119257808A (zh) * 2023-07-06 2025-01-07 先健科技(深圳)有限公司 血管支架

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023124901A1 (zh) * 2021-12-31 2023-07-06 先健科技(深圳)有限公司 管腔支架
CN115177400B (zh) * 2022-06-28 2025-06-06 杭州创心医学科技有限公司 一种覆膜支架
CN118267207B (zh) * 2022-12-29 2025-12-02 先健科技(深圳)有限公司 管腔支架
CN118267203B (zh) * 2022-12-29 2025-07-08 先健科技(深圳)有限公司 管腔支架
WO2025119133A1 (zh) * 2023-12-04 2025-06-12 先健科技(深圳)有限公司 凹槽支架及其制作方法
CN120227189B (zh) * 2023-12-28 2026-03-13 先健科技(深圳)有限公司 覆膜支架

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103720529A (zh) * 2013-12-30 2014-04-16 先健科技(深圳)有限公司 主动脉弓术中支架及该支架的制造方法
US20160067067A1 (en) * 2014-09-10 2016-03-10 The Cleveland Clinic Foundation Frame structures, stent grafts incorporating the same, and methods for extended aortic repair
CN106923931A (zh) * 2015-12-31 2017-07-07 先健科技(深圳)有限公司 覆膜支架
CN109938895A (zh) * 2017-12-20 2019-06-28 杭州唯强医疗科技有限公司 开窗型覆膜支架
WO2020066874A1 (ja) * 2018-09-27 2020-04-02 川澄化学工業株式会社 ステントグラフト

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5109194B2 (ja) * 2006-11-07 2012-12-26 ウィリアム・エイ・クック・オーストラリア・プロプライエタリー・リミテッド ステントグラフト
WO2009042796A2 (en) * 2007-09-26 2009-04-02 Trivascular2, Inc. Alignment stent apparatus and method
AU2010254599B1 (en) * 2010-12-15 2011-02-17 Cook Incorporated Hybrid Type A dissection device
US9668892B2 (en) * 2013-03-11 2017-06-06 Endospan Ltd. Multi-component stent-graft system for aortic dissections
EP3003230B1 (en) * 2013-06-05 2018-07-25 Aortic Innovations Surena, LLC Variable depression stents (vds) and billowing graft assemblies
US20170296326A1 (en) * 2014-09-22 2017-10-19 National University Of Singapore Stent graft device
CN106923943B (zh) * 2015-12-31 2019-12-10 先健科技(深圳)有限公司 覆膜支架
JP6986522B2 (ja) * 2016-05-25 2021-12-22 ボルトン メディカル インコーポレイテッド ステントグラフト
CN108261275A (zh) * 2016-12-31 2018-07-10 先健科技(深圳)有限公司 可吸收支架
CN111035470B (zh) * 2018-10-12 2022-05-10 先健科技(深圳)有限公司 覆膜支架组件及管腔支架

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103720529A (zh) * 2013-12-30 2014-04-16 先健科技(深圳)有限公司 主动脉弓术中支架及该支架的制造方法
US20160067067A1 (en) * 2014-09-10 2016-03-10 The Cleveland Clinic Foundation Frame structures, stent grafts incorporating the same, and methods for extended aortic repair
CN106923931A (zh) * 2015-12-31 2017-07-07 先健科技(深圳)有限公司 覆膜支架
CN109938895A (zh) * 2017-12-20 2019-06-28 杭州唯强医疗科技有限公司 开窗型覆膜支架
WO2020066874A1 (ja) * 2018-09-27 2020-04-02 川澄化学工業株式会社 ステントグラフト

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4257094A4 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116370144A (zh) * 2023-05-19 2023-07-04 杭州唯强医疗科技有限公司 血管支架及系统
CN119257808A (zh) * 2023-07-06 2025-01-07 先健科技(深圳)有限公司 血管支架

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CN120605130A (zh) 2025-09-09
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