WO2020252702A1 - 分段式覆膜支架及其制备方法 - Google Patents

分段式覆膜支架及其制备方法 Download PDF

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Publication number
WO2020252702A1
WO2020252702A1 PCT/CN2019/091935 CN2019091935W WO2020252702A1 WO 2020252702 A1 WO2020252702 A1 WO 2020252702A1 CN 2019091935 W CN2019091935 W CN 2019091935W WO 2020252702 A1 WO2020252702 A1 WO 2020252702A1
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WIPO (PCT)
Prior art keywords
wave
spiral
support frame
stent graft
ring structure
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/CN2019/091935
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English (en)
French (fr)
Inventor
王永胜
李安伟
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.)
Hangzhou Endonom Medtech Co Ltd
Original Assignee
Hangzhou Weiqiang Medical Technology Co Ltd
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Filing date
Publication date
Application filed by Hangzhou Weiqiang Medical Technology Co Ltd filed Critical Hangzhou Weiqiang Medical Technology Co Ltd
Priority to EP19933395.6A priority Critical patent/EP3988062A4/en
Priority to US17/620,250 priority patent/US20220362003A1/en
Priority to PCT/CN2019/091935 priority patent/WO2020252702A1/zh
Publication of WO2020252702A1 publication Critical patent/WO2020252702A1/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
    • A61F2/88—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 formed as helical or spiral coils
    • 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
    • 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
    • A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • 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
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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 invention relates to the field of medical equipment, in particular to a segmented stent graft and a preparation method thereof.
  • the middle layer of the arterial wall of normal human blood vessels is rich in elastic fibers, which can transmit blood with each heartbeat. If the middle layer of the arterial wall is damaged and the elastic fibers are broken and replaced by fibrous scar tissue, the arterial wall will lose its elasticity and cannot withstand the impact of blood flow, causing the vascular wall to bulge or tear the intima, forming an aortic aneurysm or dissection.
  • Aortic dissection is a dangerous aortic disease with rapid progression and high mortality. The incidence rate is about 0.3%.
  • the untreated early mortality rate increases by 1% per hour, and more than 50% of patients die within 1 week. .
  • a minimally invasive method is used to place the stent graft to the lesion location to isolate the lesion, effectively protect the aortic aneurysm wall from the compression of the system arterial pressure, and prevent aortic aneurysm and dissection rupture.
  • the technique is called endovascular repair .
  • the fenestration technique is to open the fenestration hole in the branch vessel opening corresponding to the fenestration stent to preserve the blood supply of the branch.
  • the chimney technique is similar to the periscope technique in that a small stent graft that connects a branch vessel to the aorta is placed side by side outside the stent graft. At present, most of this technique is used to preserve a branch vessel, but the branch stent graft is vulnerable The aortic stent is compressed and blocked, and because the stent graft is placed side by side, it is easy to produce type I endoleak. Therefore, there is a clinical need to develop a stent graft that is more suitable for branch vessels.
  • the present invention provides a segmented stent graft suitable for branch vessels.
  • the specific technical solutions are as follows.
  • a segmented stent graft includes a film and a support frame fixed on the film, the support frame includes a ring structure and a spiral structure;
  • the ring structure refers to a ring structure composed of a plurality of first wave units connected end to end; the spiral structure refers to a tubular structure formed by a plurality of second wave units connected end to end and arranged in a continuous spiral.
  • the overall extension direction of the spiral structure is parallel to the support frame.
  • the cyclic structure includes a first cyclic structure and a second cyclic structure
  • the support frame includes a proximal ring support frame, a middle spiral support frame and a distal ring support frame in sequence from the proximal end to the distal end.
  • the proximal ring support frame includes a plurality of first ring structures parallel to each other.
  • the middle spiral support frame is a spiral structure, and the distal end ring support frame includes a plurality of second ring structures parallel to each other.
  • each of the first wave units is composed of a first wave crest, a first wave rod and a first wave trough, and the first wave rod connects the first wave crest and the first wave trough; the first wave rods adjacent in the circumferential direction A first wave crest is formed close to the proximal end, and the first wave rods adjacent in the circumferential direction form a first wave trough close to the distal end; each second wave unit is composed of a second wave crest and a second wave rod.
  • the second wave rod connects the second wave crest and the second wave trough; the circumferentially adjacent second wave rods meet near the proximal end to form a second wave crest, and the circumferentially adjacent second wave The rods meet near the distal end to form a second trough.
  • the first wave peaks and the first wave valleys of the two axially adjacent first wave units are located on the same axis.
  • the first ring structure includes a first start wave rod, a first end wave rod, and a plurality of first wave units connected between the first start wave rod and the first end wave rod,
  • the first starting pole is the first first pole in a circle of the first ring structure
  • the first end pole is the last first pole in a circle of the first ring structure
  • the wave rod; the first starting wave rod and the first end wave rod are connected by winding, welding or steel sleeve fixing.
  • the first end-point pole of the first ring structure includes a first end-point extension section, the first end-point extension section extends to the starting point of an adjacent first ring-shaped structure, and the first end point extends
  • the segments constitute the first initial wave rods of the adjacent first ring structures to connect the two adjacent first ring structures.
  • the second ring structure includes a second start wave rod, a second end wave rod, and a plurality of first waveforms connected between the second start wave rod and the second end wave rod Unit, the second starting pole is the first first pole in a circle of the second ring structure, and the second end pole is the last pole in a circle of the second ring structure A first wave rod; the second start wave rod and the second end wave rod are connected by winding, welding or fixing with a steel sleeve.
  • the second end-point pole of the second ring structure includes a second end-point extension section, the second end-point extension section extends to the start position of an adjacent second ring structure, and the second end point extends
  • the segments constitute the second starting poles of the adjacent second ring structures to connect the two adjacent second ring structures.
  • the central spiral support frame includes a spiral start wave rod, a spiral end wave rod, and a spiral part connected between the spiral start wave rod and the spiral end wave rod. It is the first second wave rod of the middle spiral support frame, and the spiral terminal wave rod is the last second wave rod that the middle spiral support frame extends along the spiral direction.
  • the proximal end and/or the distal end of the middle spiral support frame are connected to the ring structure by winding, welding or fixing with a steel sleeve.
  • the spiral initial wave rod includes a spiral initial extension section, and the spiral initial extension section is connected to one of the first wave rods in the first ring structure to support the proximal end annularly
  • the frame is connected with the central spiral support frame.
  • the "the spiral initial extension section is connected to one of the first wave rods in the first ring structure" includes the spiral initial extension section and all the closest to the middle spiral support frame.
  • One of the first wave rods of the first ring structure is connected.
  • the spiral terminal pole includes a spiral terminal extension, and the spiral terminal extension is connected to one of the first poles in the second ring structure to connect the middle spiral support frame with the The remote annular support frame is connected.
  • the "the spiral terminal extension section is connected to one of the first wave rods in the second ring structure" includes the spiral terminal extension section and the second spiral support frame closest to the middle part.
  • One of the two ring structures is connected with the first wave rod.
  • the second wave crests of the two axially adjacent second wave units are located on the same axis.
  • the central spiral support frame extends from the proximal end to the distal end, the central spiral support frame includes a spiral portion, the spiral portion is composed of spiral units, and the spiral angle of each spiral unit is 1-75° .
  • the supporting framework is knitted by continuous filaments.
  • the continuous filament is a single metal wire or a composite wire composed of multiple metal wires.
  • the strength of the proximal annular support frame is greater than the strength of the central spiral support frame.
  • the wire diameter of the metal wire used in the proximal annular support frame is larger than the wire diameter of the metal wire used in the central spiral support frame and the distal annular support frame.
  • the rigidity of the wire material used in the proximal annular support frame is greater than the rigidity of the wire material used in the central spiral support frame.
  • the support frame is a straight pipe structure with equal diameter or a tapered pipe structure with non-equal diameter.
  • the distal annular support frame includes a transitional second annular structure, and the second annular structure is disposed on a side of the transition second annular structure away from the proximal annular support frame; the transition The second annular structure is horn-shaped, and the diameter of the transitional second annular structure gradually increases from the proximal end to the distal direction.
  • the covering film includes an inner layer covering film and an outer layer covering film
  • the support frame is arranged between the inner layer covering film and the outer layer covering film
  • the inner layer covering film is located on the supporting frame
  • the outer coating film is located outside the support frame.
  • the segmented stent graft further includes at least one imaging point.
  • the present invention also provides a method for preparing a segmented stent graft.
  • the method for preparing the segmented stent graft includes:
  • Sleeve a support frame on the inner layer of the film, the support frame and the layer of film tightly connected;
  • the outer covering film is wrapped around the support frame.
  • the annular structure in the segmented stent graft provided by the present invention has a better radial support force and reduces the compression force, and the spiral structure has better flexibility and can adapt to various bending shapes. , Deformation of the arcuate branch vessels; the combination of the ring structure and the spiral structure can adapt to the different requirements of the flexibility of the stent graft for different branch vessels.
  • Figure 1 is a schematic structural diagram of a segmented stent graft provided by the present invention.
  • Fig. 2 is a schematic structural diagram of a first wave unit in a segmented stent graft provided by the present invention.
  • Fig. 3 is a schematic structural diagram of a second wave unit in a segmented stent graft provided by the present invention.
  • Fig. 4 is a schematic structural diagram of a supporting skeleton in a segmented stent graft provided by the present invention.
  • Figure 5 is a structural schematic diagram of a segmented stent graft provided by the present invention in which the ring structure is connected by a steel sleeve.
  • Fig. 6 is a schematic structural diagram of the interconnection between the supporting frameworks in a segmented stent graft provided by the present invention.
  • Fig. 7 is a structural schematic diagram of a segmented stent graft provided by the present invention in which the spiral initial extension section and the first wave rod are connected and fixed by a steel sleeve.
  • FIG. 8 is a schematic structural diagram of the connection between the spiral initial extension section and the first initial probing rod in the segmented stent graft provided by the present invention.
  • Fig. 9 is a structural schematic diagram of a segmented stent graft provided by the present invention in which the diameter of the proximal ring support frame is larger than the diameter of the distal ring support frame.
  • Fig. 10 is a structural schematic diagram of a segmented stent graft provided by the present invention in which the support frame is an equal-diameter straight tube.
  • Figure 11 is a schematic diagram of a segmented stent graft provided by the present invention when used in conjunction with an aortic stent.
  • Fig. 12 is a schematic diagram of another segmented stent graft provided by the present invention when used in conjunction with an aortic stent.
  • Fig. 13 is a schematic structural diagram of a segmented stent graft provided by the present invention including an inner layer membrane and an outer layer membrane.
  • Figure 14 is a flow chart of a method for preparing a segmented stent graft provided by the present invention.
  • Figure 15 is a schematic diagram of preparing a segmented stent graft provided by the present invention.
  • the present invention provides a segmented stent graft 100.
  • the segmented stent graft 100 includes a film 120 and a support frame 110 fixed to the film 120.
  • the support frame 110 includes a ring shape.
  • the ring structure 1200 refers to a ring structure composed of a plurality of first wave units 1100 (see FIG. 2) connected end to end. There is a gap between the adjacent ring structures 1200.
  • the spiral structure 1300 refers to a tubular structure formed by a plurality of second wave units 1400 (see FIG. 3) connected end to end and continuously arranged spirally, and the overall extension direction of the spiral structure 1300 is parallel to the support frame 110 .
  • the ring structure 1200 has better radial support force and can reduce the compression of other stents.
  • the spiral structure 1300 has better flexibility and can adapt to the deformation of various curved and arcuate branch blood vessels.
  • the structure 1300 can be combined to meet the different requirements of the flexibility of the stent graft from different branch vessels.
  • the ring structure 1200 includes a first ring structure 1210 and a second ring structure 1220.
  • the support frame 110 includes a proximal ring support frame 111, a central spiral support frame 112, and a distal ring support frame 113 in turn from the proximal end A to the distal end B, wherein the proximal ring support frame 111 includes a plurality of first rings parallel to each other
  • the middle spiral support frame 112 is a spiral structure 1300
  • the distal end ring support frame 113 includes a plurality of second ring structures 1220 parallel to each other.
  • the middle spiral support frame 112 adopts the helical structure 1300, which has very good flexibility and can adapt to the deformation of various curved and arcuate branch blood vessels, while the proximal ring support frame 111 and the distal ring support frame 113 adopts a ring structure 1200, so that the entire support frame 110 has a good radial support force at both ends, and achieves the effect of stabilizing the support frame 110.
  • each of the first wave units 1100 is composed of a first wave peak 1112, a first wave rod 1111, and a first wave valley 1113 ,
  • the first wave rod 1111 connects the first wave peak 1112 and the first wave valley 1113.
  • the circumferentially adjacent first wave rods 1111 meet at the proximal end A to form a first wave crest 1112, and the circumferentially adjacent first wave rods 1111 meet at the distal end B to form a first wave trough 1113.
  • the heights of the first wave crests 1112 adjacent in the circumferential direction may be the same or not, and may be arranged at intervals of high and low.
  • the heights of the first wave troughs 1113 adjacent in the circumferential direction may be the same or different, and may be arranged at intervals of high and low.
  • the configuration of the first waveform unit 1100 includes one or more of U-shaped waves, V-shaped waves, and S-shaped waves. It can be understood that the first wave unit 1100 in the first ring structure 1210 and the second ring structure 1220 may be the same, or may be adjusted in size.
  • the length of the first wave rod 1111 in the first wave-shaped unit 1100 is 3-10 mm, and the included angle formed by the extension lines of two adjacent first wave rods 1111 is 30-150 degrees , The height of the first wave unit is 3-10mm.
  • the first wave peaks 1112 and the first wave valleys 1113 of the two axially adjacent first wave units 1100 are located on the same axis.
  • the crest 1112a and the trough 1113 in Fig. 2 are located on the same axis L1.
  • the direction of the axis L1 is parallel to the support frame.
  • the first wave crest 1112a and the first wave trough 1113 as shown in Figure 2 are located on the same axis L1, that is, the wave crests and wave troughs between two adjacent ring structures in the axial direction are opposite (the shortest distance), that is, the first wave crest 1112a and the first wave trough
  • the distance between 1113 is the smallest, so that a near-diamond-shaped unit structure 1114 can be formed between the axially adjacent first wave units 1100 to strengthen the proximal annular support 111 and the distal annular support formed by the first wave units 1100 113 radial support force.
  • each of the second wave units 1400 is composed of a second wave crest 1412, a second wave rod 1411, and a second wave trough 1413.
  • the second wave rod 1411 connects the second wave peak 1412 and the Two wave valley 1413.
  • Circumferentially adjacent second wave rods 1411 meet near the proximal end A to form a second wave peak 1412
  • circumferentially adjacent second wave rods 1411 meet near the distal end B to form a second wave trough 1413. It is understandable that the heights of the second wave crests 1412 adjacent in the circumferential direction may be the same or not, and may be arranged at intervals of high and low.
  • the heights of the second troughs 1413 adjacent in the circumferential direction may be the same or not, and may be arranged at intervals of high and low. It can be understood that the configuration of the second waveform unit 1400 includes one or more of U-shaped waves, V-shaped waves, and S-shaped waves.
  • the length of the second wave rod 1411 in the second wave unit 1400 is 3-10 mm, and the angle formed by the extension lines of two adjacent second wave rods 1411 is 30-150 degrees , The height of the second wave unit is 3-10mm.
  • the second wave crests 1412 of the two axially adjacent second wave units 1400 are located on the same axis.
  • the second wave crest 1412 and the axially adjacent second wave crest 1412a as shown in FIG. 3 are located on the same axis L2. It can be understood that the direction of the axis L2 is parallel to the support frame. That is to say, the second wave crests 1412 of the two axially adjacent second wave units 1400 in the central spiral support frame 112 correspond.
  • the second wave crest 1412 in FIG. 3 corresponds to the axially adjacent second wave crest 1412a, so that there is more space for moving towards each other between the second wave crest 1412 and the axially adjacent second wave crest 1412a to ensure the spiral structure.
  • the flexibility of the 1300 structure is possible to ensure the spiral structure.
  • the first ring structure 1210 includes a first start pole 1211, a first end pole 1212, and connected to the first start pole 1211 and the first end A plurality of first wave units between the poles 1212.
  • the first starting wave rod 1211 is the first first wave rod in a circle of the first ring structure 1210
  • the first end wave rod 1212 is the last first wave rod in a circle of the first ring structure 1210.
  • the first start wave rod 1211 and the first end wave rod 1212 are connected by winding, welding or steel sleeve fixing.
  • the connection is shown in a manner that the first end pole 1212 is wound on the first start pole 1211. Please refer to FIG. 5.
  • the first end wave rod 1212 and the first start wave rod 1211 are connected and fixed by a steel sleeve 150.
  • the first end-point wave rod 1212 of the first ring structure 1210 includes a first end-point extension 1213, and the first end-point extension 1213 extends to the adjacent first ring structure 1210a
  • the first end extension 1213 constitutes the first initial wave rod 1211a of the adjacent first ring structure 1210a to connect the first ring structure 1210 and the adjacent first ring structure 1210a. In order to make the connection between the first ring structures 1210 stronger and more stable.
  • the second ring structure 1220 includes a second start pole 1221, a second end pole 1222, and connected to the second start pole 1221 and the second A plurality of first wave units between the two end points 1222.
  • the second starting wave rod 1221 is the first first wave rod in a circle of the second ring structure 1220
  • the second end wave rod 1222 is the last first wave rod in a circle of the second ring structure 1220.
  • the second start wave rod 1221 and the second end wave rod 1222 are connected by winding, welding or steel sleeve fixing. In FIG. 4, the connection is shown in the manner that the second end pole 1222 is wound on the second start pole 1221.
  • FIG. 5 the second end wave rod 1222 and the second start wave rod 1221 are connected and fixed by a steel sleeve 150.
  • the second end-point wave rod 1222 of the second ring structure 1220 includes a second end-point extension section 1223, and the second end-point extension section 1223 extends to the adjacent second ring structure 1220a
  • the second end extension 1223 constitutes the second starting wave rod 1221a of the adjacent second ring structure 1220a to connect the second ring structure 1220 and the adjacent second ring structure 1220a. In order to make the connection between the second ring structures 1220 stronger and more stable.
  • the central spiral support frame 112 includes a spiral start pole 1121, a spiral end pole 1122, and is connected to the spiral start pole 1121 and the spiral end pole 1122 Between the spiral part 1124, the spiral start wave rod 1121 is the first second wave rod of the central spiral support frame 112, and the spiral end wave rod 1122 is the last second wave rod that the central spiral support frame 112 extends along the spiral direction. .
  • the spiral start wave rod 1121 is arranged adjacent to the proximal annular support 111 compared to the spiral end wave rod 1122.
  • the spiral portion 1124 is connected by a plurality of spiral units 1125 and spirally extends from the proximal end A to the distal end B.
  • the overall spiral direction of the central spiral support frame 112 refers to the direction in which the proximal end A points to the distal end B.
  • proximal end and/or the distal end of the middle spiral support frame 112 are connected to the ring structure 1200 by winding, welding or fixing with a steel sleeve.
  • the spiral initial wave rod 1121 includes a spiral initial extension section 1123, the spiral initial extension section 1123 and the first ring structure 1210a in the proximal ring support 111
  • a first wave rod 1111a is connected to connect the proximal annular support frame 111 and the central spiral support frame 112.
  • the spiral initial extension section 1123 is connected to one of the first wave rods 1111a of the first ring structure 1210a by winding, welding or fixing with a steel sleeve.
  • the spiral initial extension 1123 is wound on the first wave rod 1111a.
  • FIG. 7 the spiral initial extension section 1123 and the first wave rod 1111 a are connected and fixed by a steel sleeve 150.
  • the spiral initial extension 1123 is connected to one of the first wave rods 1111a of the first annular structure 1210a in the proximal annular support 111
  • the spiral initial extension 1123 is connected to the first starting wave rod 1211a of the first ring structure 1210a in the proximal ring support frame 111.
  • a steel sleeve 150 is used for connection.
  • the spiral initial extension 1123 is connected to one of the first wave rods 1111a of the first annular structure 1210a in the proximal annular support 111
  • the initial extension section 1123 is connected to one of the first wave rods 1111a of the first ring structure 1210a closest to the central spiral support frame 112.
  • the first ring structure 1210a closest to the central spiral support 112 is shown as the first ring structure 1210a in FIG. 6.
  • the spiral initial extension section 1123 can be connected to the first wave rod in the first ring structure 1210 at any position in the proximal ring support frame 111. That is, the spiral starting wave rod 1121 of the middle spiral support frame 112 can be extended into the proximal annular support frame 111 to further improve the stability of the overall structure of the stent.
  • the spiral end pole 1122 includes a spiral end extension 1126, and the spiral end extension 1126 is connected to one of the first poles 1111b of the second ring structure 1220b to connect the middle spiral support frame 112 with the distal ring support frame 113 .
  • the spiral end extension section 1126 is connected to one of the first wave rods 1111b in the second ring structure 1220b by winding, welding or fixing with a steel sleeve. In FIG. 6, the spiral wave rod 1111 b is wound on the spiral end extension 1126.
  • the “helical terminal extension 1126 is connected to one of the first wave rods 1111b in the second ring structure 1220b” includes the spiral terminal extension 1126 and the second terminal wave in the second ring structure 1220.
  • the rod 1222b is connected.
  • the "helical terminal extension 1126 is connected to one of the first wave rods 1111b in the second ring structure 1220b" includes the helical terminal extension 1126 and the second closest to the central spiral support 112 One of the first wave rods 1111b in the ring structure 1220b is connected.
  • the second ring structure 1220b closest to the central spiral support frame 112 is shown as the second ring structure 1220b in FIG. 6.
  • spiral terminal extension 1126 can also be connected to the first wave rod in the second ring structure 1220 at any position in the distal ring support frame 113. That is, the spiral terminal wave rod 1122 of the central spiral support frame 112 can be extended into the distal annular support frame 113, which further improves the stability of the overall structure of the stent.
  • the proximal and distal ends of the central spiral support frame 112 are respectively connected to the ring structure, and the support frames 110 are integrally connected together to restrain each other, and the support frames 110 have stronger radial and axial stability.
  • the distal annular support frame 113 includes a transitional second annular structure 1220b, and the second annular structure 1220 is disposed on the transition second annular structure 1220b away from the proximal annular support frame 111 One side.
  • the transitional second annular structure 1220b is horn-shaped, and the diameter of the transitional second annular structure 1220b from the proximal end A to the distal end B gradually increases. After the distal annular support frame 113 enters the branch vessel, a larger diameter can increase its adherence and reduce the occurrence of endoleaks.
  • the transitional second annular structure 1220b can better connect the central spiral support frame 112 with the second annular structure 1220 in the distal annular support frame 113, and further improve the overall stability of the segmented stent graft 100.
  • the smallest diameter of the transitional second annular structure 1220b near the proximal end A is equal to the diameter of the central spiral support 112, and the largest diameter of the transitional second annular structure 1220b near the distal end B is the same as that of the second annular structure 1220.
  • the diameters are equal.
  • the second ring structure 1220 in the central spiral support frame 112 and the distal end ring support frame 113 are better connected.
  • the axial length of the proximal annular support frame 111 is 5-50 mm.
  • the middle spiral support frame 112 extends from the proximal end A to the distal end B, the middle spiral support frame 112 includes a spiral portion 1124, the spiral portion 1124 is composed of spiral units 1125, and the spiral angle of each spiral unit 1125 is 1-75°. Preferably, the spiral angle of the spiral unit 1125 is 5-45°. Within the above-mentioned spiral angle range, the middle spiral support frame 112 has very good flexibility and can be bent arbitrarily to adapt to different curved or arched blood vessels.
  • the diameter of the proximal annular support 111 may be larger than the diameter of the distal annular support 113. Used for blood vessels with a larger diameter at the proximal end A and a smaller diameter at the distal end B.
  • the diameter of the proximal annular support 111 may be equal to the diameter of the distal annular support 113.
  • the entire supporting frame 111 is a straight tubular stent extending with equal diameter.
  • the support frame 110 is woven from continuous filaments.
  • the continuous filament may be a single-stranded filament or a multi-strand composite filament.
  • the material of the filament may be selected from metal materials or polymer materials, and the metal material may be selected from stainless steel, cobalt alloy, tantalum, Nitinol, or other biocompatible metals; preferably made of memory alloy, the multi-strand composite wire can be formed by twisting or weaving multi-strand wires, and the materials of the multi-strand wires can be the same or different.
  • the continuous filament is a single metal wire or a composite wire composed of multiple metal wires, such as stainless steel, cobalt alloy, tantalum, nickel-titanium alloy, or other biocompatible metals; preferably It is made of memory alloy, more preferably Nitinol. It is woven with continuous metal wires, which can improve the stability of the support frame 110.
  • the proximal support frame 111 will be squeezed by the aortic vessel stent 200, requiring a relatively large radial support force;
  • Figure 12 the specific structure of the ring stent and the spiral stent is not clearly shown in this figure
  • several branch stents need to be used at the same time in some multi-branch blood vessels.
  • the proximal end of the branch stent will also Squeezed by the adjacent branch bracket.
  • the strength of the proximal annular support frame 111 is greater than the strength of the central spiral support frame 112; to achieve this effect, the rigidity of the wire material used in the proximal annular support frame 111 is greater than that of the central spiral support frame 112
  • the rigidity of the wire material used, or the wire diameter of the wire used in the proximal annular support frame 111 is larger than the wire diameter of the wire used in the central spiral support frame 112.
  • the wire diameter of the metal wire used in the proximal annular support frame 111 is 0.3 mm.
  • the wire diameter of the metal wire used in the middle spiral support frame 112 is smaller than the wire diameter of the distal annular support frame 112. In order to ensure that the middle spiral support frame 112 has good flexibility.
  • the wire diameter of the metal wire used in the middle spiral support frame 112 is 0.25 mm.
  • the covering film 120 further includes an inner covering film 121 and an outer covering film 122, and the support frame 110 is disposed between the inner covering film 121 and the outer covering film 122, and The inner covering film 121 is located inside the support frame 110, and the outer covering film 122 is located outside the support frame 110.
  • the materials of the inner layer film 121 and the outer layer film 122 can be independently selected from polymer materials with excellent biocompatibility, such as expanded polytetrafluoroethylene, PET, polyester, polyurethane, silicone, ultra-high molecular weight Polyethylene or other suitable materials, preferably the inner coating 121 and the outer coating 122 are both made of expanded polytetrafluoroethylene material. Expanded polytetrafluoroethylene can effectively block fluid penetration and strengthen the radial support force of the segmented stent graft 100.
  • the inner layer covering film 121 and the outer layer covering film 122 are respectively an integral structure.
  • both the inner layer covering film 121 and the outer layer covering film 122 are an integral structure. In order to make the segmented stent graft 100 stronger. It can be understood that the inner layer coating 121 and the outer layer coating 122 can be formed into an integrated structure by heat sealing.
  • the segmented stent graft 100 further includes at least one developing point 130.
  • the developing point 130 can be arranged in a circular or figure-of-eight shape, and is fixed near the support frame 110 by sewing or welding.
  • the material of the developing point can be selected from gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.
  • there are two developing points 130 and the two developing points 130 are symmetrically distributed on the support frame 110. Further, the two developing points 130 are respectively located on the first wave peak of the proximal annular support frame 111 and on the first wave valley of the distal annular support frame 112. This ensures that the whole segmented stent graft 100 can be effectively monitored.
  • the present invention also provides a method for preparing a segmented stent graft.
  • the method for preparing a segmented stent graft 100 includes step S100, step S200, and step S300. The detailed steps are described below.
  • step S100 the inner coating film 121 is wound on the coating mold rod 123.
  • step S200 the support frame 110 is sleeved on the inner coating film 121, and the support frame 110 and the inner coating film 121 are closely connected.
  • the supporting framework 110 adopts the supporting framework in any of the above-mentioned embodiments.
  • step S300 the outer covering film 122 is wrapped around the support frame 110.

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Abstract

一种分段式覆膜支架（100），包括覆膜（120）和固定于覆膜（120）上的支撑骨架（110），支撑骨架（110）包括环状结构（1200）和螺旋结构（1300）；环状结构（1200）是指由多个第一波形单元（1100）首尾相接组成的环形结构；螺旋结构（1300）是指由多个第二波形单元（1400）首尾相接且连续螺旋排布形成的管状结构，螺旋结构（1300）的整体延伸方向与支撑骨架（110）平行。还提供一种分段式覆膜支架（100）的制备方法。该分段式覆膜支架（100）中的环状结构（1200）具有较好的径向支撑力而降低受压迫力，螺旋结构（1300）具有较好的柔顺性，能够适应各种弯形、弓形分支血管的变形，将环状结构（1200）和螺旋结构（1300）组合起来，可以适应不同分支血管对覆膜支架柔顺性的不同需求。

Description

分段式覆膜支架及其制备方法 技术领域
本发明涉及医疗器械领域，具体涉及一种分段式覆膜支架及其制备方法。
背景技术
正常的人体血管动脉壁中层富有弹力纤维，可随每次心搏进行舒缩而传送血液。如果动脉壁中层受损，弹力纤维断裂，代之以纤维疤痕组织，动脉壁即会失去弹性，不能耐受血流冲击，引起血管壁膨出或者内膜撕裂，形成主动脉瘤或者夹层。主动脉夹层是一种病情危险、进展迅速、死亡率高的主动脉疾病，发病率约为0.3％，未经处理的早期死亡率每小时递增1％，50％以上的患者于1周内死亡。
随着医学技术的发展，对于凶险的主动脉疾病越来越多的采用开放手术、杂交手术或者微创手术等外科的方法进行积极的治疗。通过微创的方法将覆膜支架放置到病变位置从而达到隔绝病变，有效保护主动脉瘤壁免受系统动脉压的压迫，进而防止主动脉瘤、夹层破裂的技术称为主动脉腔内修复术。
因为创伤小、治疗效果确切，主动脉腔内修复术已经成为B型主动脉夹层和肾下腹主动脉瘤的重要治疗选择。然而，对于毗邻或者波及必须要保留主要分支血管的病变，如累及升主动脉和主动脉弓的A型夹层或者累及肾动脉及以上重要分支的腹主动脉瘤，目前常规的方法还是通过开放手术用人工血管替换病变动脉，开放手术中要在一定时间和一定程度上完全的阻断主动脉血流，需要外科、麻醉和体外循环与手术室的密切配合，当下只有少数几家医院才有能力进行主动脉手术，加之主动脉手术较长时间的体外循环、心肌阻断以及机体温度波动，使主动脉外科手术的术后死亡率和其它系统并发症的发生率明显高于其他心脏手术，尤其是累及主动脉弓的手术。一方面是A型夹层病人在夹层病例中占到了80％，另一方面是开放手术难度大，术后并发症高，难以大规模开展，近些年不断有新的技术提出和应用用于扩展微创腔内修复术的适用范围，比如带分支的覆膜支架、开窗技术、烟囱技术、潜望镜技术、通过杂交手术进行转流用于保留重要分支血管的血供。
一体成型带有分支的支架将分支部分引导到分支血管内释放有很大的困难，使用微创技术目前成功得到临床应用的只有单分支支架，主动脉弓部分有三个重要分支，分支的间距位置个体差异很大，多分支支架目前在开放手术中有报道进行临床使用，但是将带有三个分支的支架同时引导到相应分支血管中即便是在开放手术中也是非常困难的。开窗技术是在覆膜支架对应的分支血管开口处的覆膜开窗洞，保留分支的血供，开窗支架安置时只需尽量将窗洞对准分支 血管，操作相对简单，可以应用于多分支的保留，但是容易产生I型内漏。烟囱技术和潜望镜技术类似，都是在覆膜支架外并排放置一个连通分支血管到主动脉的小的覆膜支架，这种技术目前大部分用于保留一个分支血管，但是分支覆膜支架易受到主动脉支架的压迫而阻闭，另外由于覆膜支架是并排放置，也很容易产生I型内漏。因此，临床上需要开发更加适合分支血管的覆膜支架。
发明内容
有鉴于此，本发明提供一种适合分支血管的分段式覆膜支架，具体技术方案如下。
一种分段式覆膜支架，所述分段式覆膜支架包括覆膜和固定于覆膜上的支撑骨架，所述支撑骨架包括环状结构和螺旋结构；
所述环状结构是指由多个第一波形单元首尾相接组成的环形结构；所述螺旋结构是指由多个第二波形单元首尾相接且连续螺旋排布形成的管状结构，所述螺旋结构的整体延伸方向与所述支撑骨架平行。
优选的，所述环状结构包括第一环状结构和第二环状结构；
所述支撑骨架由近端至远端依次包括近端环形支撑架、中部螺旋支撑架和远端环形支撑架，所述近端环形支撑架包括多个互相平行的第一环状结构，所述中部螺旋支撑架为螺旋结构，所述远端环形支撑架包括多个互相平行的第二环状结构。
优选的，每个所述第一波形单元由第一波峰、第一波杆和第一波谷组成，所述第一波杆连接第一波峰和第一波谷；周向相邻的所述第一波杆在靠近近端处相接形成第一波峰，周向相邻的所述第一波杆在靠近远端处相接形成第一波谷；每个所述第二波形单元由第二波峰、第二波杆和第二波谷组成，所述第二波杆连接第二波峰和第二波谷；周向相邻的所述第二波杆在靠近近端处相接形成第二波峰，周向相邻的所述第二波杆在靠近远端处相接形成第二波谷。
优选的，轴向相邻的两圈所述第一波形单元的第一波峰与第一波谷位于同一轴线上。
优选的，所述第一环状结构包括第一起始波杆、第一终点波杆以及连接于所述第一起始波杆与所述第一终点波杆之间的多个第一波形单元，所述第一起始波杆为所述第一环状结构一圈中的第一个第一波杆，所述第一终点波杆为所述第一环状结构一圈中的最后一个第一波杆；所述第一起始波杆和所述第一终点波杆通过缠绕、焊接或者钢套固定的方式连接。
优选的，所述第一环状结构的第一终点波杆包括第一终点延伸段，所述第一终点延伸段延伸到相邻的第一环状结构的起点位置，所述第一终点延伸段构成相邻的所述第一环状结构的第一起始波杆，以将相邻的两个所述第一环状结构连接。
优选的，所述第二环状结构包括第二起始波杆、第二终点波杆以及连接于所述第二起始波 杆与所述第二终点波杆之间的多个第一波形单元，所述第二起始波杆为所述第二环状结构一圈中的第一个第一波杆，所述第二终点波杆为所述第二环状结构一圈中的最后一个第一波杆；所述第二起始波杆和所述第二终点波杆通过缠绕、焊接或者钢套固定的方式连接。
优选的，所述第二环状结构的第二终点波杆包括第二终点延伸段，所述第二终点延伸段延伸到相邻的第二环状结构的起点位置，所述第二终点延伸段构成相邻的所述第二环状结构的第二起始波杆，以将相邻的两个所述第二环状结构连接。
优选的，所述中部螺旋支撑架包括螺旋起始波杆、螺旋终点波杆以及连接于所述螺旋起始波杆与所述螺旋终点波杆之间的螺旋部，所述螺旋起始波杆为所述中部螺旋支撑架的第一个第二波杆，所述螺旋终点波杆为所述中部螺旋支撑架沿螺旋方向延伸的最后一个第二波杆。
优选的，所述中部螺旋支撑架的近端和/或远端与环状结构通过缠绕、焊接或者钢套固定的方式连接。
优选的，所述螺旋起始波杆包括螺旋起始延伸段，所述螺旋起始延伸段与所述第一环状结构中的其中一个第一波杆连接，以将所述近端环形支撑架与所述中部螺旋支撑架连接。
优选的，所述“所述螺旋起始延伸段与所述第一环状结构中的其中一个第一波杆连接”包括所述螺旋起始延伸段与最靠近所述中部螺旋支撑架的所述第一环状结构的其中一个第一波杆连接。
优选的，所述螺旋终点波杆包括螺旋终点延伸段，所述螺旋终点延伸段与所述第二环状结构中的其中一个第一波杆连接，以将所述中部螺旋支撑架与所述远端环形支撑架连接。
优选的，所述“所述螺旋终点延伸段与所述第二环状结构中的其中一个第一波杆连接”包括所述螺旋终点延伸段与最靠近所述中部螺旋支撑架的所述第二环状结构中的其中一个第一波杆连接。
优选的，轴向相邻的两个所述第二波形单元的第二波峰位于同一轴线上。
优选的，所述中部螺旋支撑架由近端向远端延伸，所述中部螺旋支撑架包括螺旋部，所述螺旋部由螺旋单元组成，每一所述螺旋单元的螺旋角度为1-75°。
优选的，所述支撑骨架由连续的丝状物编织而成。
优选的，所述连续的丝状物为单根金属丝或者多根金属丝组成的复合丝。
优选的，所述近端环形支撑架的强度大于中部螺旋支撑架的强度。
优选的，所述近端环形支撑架所用金属丝的丝径大于所述中部螺旋支撑架及所述远端环形支撑架所用金属丝的丝径。
优选的，所述近端环形支撑架所用金属丝材料的刚性大于中部螺旋支撑架所用金属丝材料的刚性。
优选的，所述支撑骨架为等径直管结构或者非等径锥管结构。
优选的，所述远端环形支撑架包括过渡第二环状结构，所述第二环状结构设置在所述过渡第二环状结构远离所述近端环形支撑架的一侧；所述过渡第二环状结构成喇叭状，且所述过渡第二环状结构由近端指向远端方向的直径逐渐变大。
优选的，所述覆膜包括内层覆膜和外层覆膜，所述支撑骨架设于所述内层覆膜和外层覆膜之间，且所述内层覆膜位于所述支撑骨架内侧，所述外层覆膜位于所述支撑骨架外侧。
优选的，所述分段式覆膜支架还包括至少一个显影点。
本发明还提供一种分段式覆膜支架的制备方法，所述分段式覆膜支架的制备方法包括：
将内层覆膜缠绕在覆膜模棒上；
将支撑骨架套在内层覆膜上，所述支撑骨架与所述层覆膜紧密相接；
将外层覆膜裹住所述支撑骨架。
本发明的有益效果：本发明提供的分段式覆膜支架中的环状结构具有较好的径向支撑力而降低受压迫力，螺旋结构具有较好的柔顺性，能够适应各种弯形、弓形分支血管的变形；将环状结构和螺旋结构组合起来，可以适应不同分支血管对覆膜支架柔顺性的不同需求。
附图说明
图1为本发明提供的一种分段式覆膜支架的结构示意图。
图2为本发明提供的一种分段式覆膜支架中的第一波形单元的结构示意图。
图3为本发明提供的一种分段式覆膜支架中的第二波形单元的结构示意图。
图4为本发明提供的一种分段式覆膜支架中的支撑骨架的结构示意图。
图5为本发明提供的一种分段式覆膜支架中的环状结构采用钢套连接的结构示意图。
图6为本发明提供的一种分段式覆膜支架中的支撑骨架之间相互连接的结构示意图。
图7为本发明提供的一种分段式覆膜支架中的螺旋起始延伸段与第一波杆通过钢套连接固定的结构示意图。
图8为本发明提供的一种分段式覆膜支架中螺旋起始延伸段与第一起始波杆连接的结构示意图。
图9为本发明提供的一种分段式覆膜支架中近端环形支撑架的直径大于远端环形支撑架的直径的结构示意图。
图10为本发明提供的一种分段式覆膜支架中支撑骨架为等径直管的结构示意图。
图11为本发明提供的一种分段式覆膜支架与主动脉血管支架配合使用时的示意图。
图12为本发明提供的另一种分段式覆膜支架与主动脉血管支架配合使用时的示意图。
图13为本发明提供的一种包括内层覆膜和外层覆膜的分段式覆膜支架的结构示意图。
图14为本发明提供的一种分段式覆膜支架的制备方法流程图。
图15为本发明提供的制备分段式覆膜支架的示意图。
具体实施方式
以下所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本发明的保护范围。
请参阅图1，本发明提供一种分段式覆膜支架100，所述分段式覆膜支架100包括覆膜120以及固定于覆膜120的支撑骨架110，所述支撑骨架110包括环状结构1200以及螺旋结构1300。所述环状结构1200是指由多个第一波形单元1100(参阅图2)首尾相接组成的环形结构。相邻的所述环状结构1200之间具有间隙。所述螺旋结构1300是指由多个第二波形单元1400(参阅图3)首尾相接且连续螺旋排布形成的管状结构，且所述螺旋结构1300的整体延伸方向与所述支撑骨架110平行。环状结构1200具有较好的径向支撑力而能够减少其他支架的压迫，螺旋结构1300具有较好的柔顺性，能够适应各种弯形、弓形分支血管的变形，将环状结构1200和螺旋结构1300组合起来，可以适应不同分支血管对覆膜支架柔顺性的不同需求。
在进一步的实施例中，环状结构1200包括第一环状结构1210和第二环状结构1220。支撑骨架110由近端A至远端B依次包括近端环形支撑架111、中部螺旋支撑架112和远端环形支撑架113，其中近端环形支撑架111包括多个互相平行的第一环状结构1210，中部螺旋支撑架112为螺旋结构1300，远端环形支撑架113包括多个互相平行的第二环状结构1220。该实施例中，中部螺旋支撑架112采用是的螺旋结构1300，具有非常好的柔顺性，能够适应各种弯形、弓形分支血管的变形，而近端环形支撑架111和远端环形支撑架113采用环状结构1200，使整个支撑骨架110在两端具有较好的径向支撑力，达到稳定支撑骨架110的效果。
请参阅图2，在进一步的实施例中，在近端或者远端的环状结构中，每个所述第一波形单元1100由第一波峰1112、第一波杆1111和第一波谷1113组成，第一波杆1111连接第一波峰1112和第一波谷1113。周向相邻的第一波杆1111在靠近近端A处相接形成第一波峰1112，周向相邻的第一波杆1111在靠近远端B处相接形成第一波谷1113。可以理解的是，周向相邻的第一波峰1112的高度可以一致，也可以不一致，可以高低间隔设置。同样的，周向相邻的第一波谷1113的高度可以一致，也可以不一致，可以高低间隔设置。可以理解的是，第一波形单元1100构成包括U形波、V形波、S形波中的一种或多种。可以理解的是，第一环状结构1210和第二环状结构1220中的第一波形单元1100可以相同，也可以在尺寸上做适应性调整。
在进一步的实施例中，所述第一波形单元1100中的第一波杆1111的长度为3-10mm，相邻两个第一波杆1111的延伸线所形成的夹角为30-150度，第一波形单元的高度为3-10mm。在进一步的实施例中，在近端或者远端的环状结构中，轴向相邻的两圈所述第一波形单元1100的第一波峰1112与第一波谷1113位于同一轴线上。如图2中的波峰1112a和波谷1113，位于同一轴线L1上。其中轴线L1的方向与支撑骨架平行。如图2中的第一波峰1112a和第一波谷1113位于同一轴线L1上,即轴向相邻两圈环状结构之间波峰与波谷相对(距离最短)，即第一波峰1112a和第一波谷1113之间的距离最小，可使轴向相邻的第一波形单元1100之间形成近菱形单元结构1114,以增强由第一波形单元1100形成的近端环形支撑架111和远端环形支撑架113的径向支撑力。
请参阅图3，在中部螺旋结构中，每个所述第二波形单元1400由第二波峰1412、第二波杆1411和第二波谷1413组成，第二波杆1411连接第二波峰1412和第二波谷1413。周向相邻的第二波杆1411在靠近近端A处相接形成第二波峰1412，周向相邻的第二波杆1411在靠近远端B处相接形成第二波谷1413。可以理解的是，周向相邻的第二波峰1412的高度可以一致，也可以不一致，可以高低间隔设置。同样的，周向相邻的第二波谷1413的高度可以一致，也可以不一致，可以高低间隔设置。可以理解的是，第二波形单元1400构成包括U形波、V形波、S形波中的一种或多种。
在进一步的实施例中，所述第二波形单元1400中的第二波杆1411的长度为3-10mm，相邻两个第二波杆1411的延伸线所形成的夹角为30-150度，第二波形单元的高度为3-10mm。
在进一步的实施例中，在中部螺旋结构中，轴向相邻的两个所述第二波形单元1400的第二波峰1412位于同一轴线上。如图3中的第二波峰1412和轴向相邻的第二波峰1412a位于同一轴线L2上。可以理解的是，轴线L2的方向与支撑骨架平行。也就是说中部螺旋支撑架112中轴向相邻的两个第二波形单元1400的第二波峰1412对应。如图3中的第二波峰1412和轴向相邻的第二波峰1412a对应,使得第二波峰1412与轴向相邻的第二波峰1412a之间具有更多相向运动的空间，以保证螺旋结构1300结构的柔顺性。
请参阅图4，在进一步的实施例中，第一环状结构1210包括第一起始波杆1211、第一终点波杆1212，以及连接于所述第一起始波杆1211与所述第一终点波杆1212之间的多个第一波形单元。第一起始波杆1211为第一环状结构1210一圈中的第一个第一波杆，第一终点波杆1212为第一环状结构1210一圈中的最后一个第一波杆。第一起始波杆1211和第一终点波杆1212通过缠绕、焊接或者钢套固定的方式连接。图4中为采用第一终点波杆1212缠绕在第一起始波杆1211上的方式连接。请参阅图5，在图5中，第一终点波杆1212与第一起始波杆1211通过钢套150连接固定。
请参阅图6，在进一步的实施例中，第一环状结构1210的第一终点波杆1212包括第一终 点延伸段1213，第一终点延伸段1213延伸到相邻的第一环状结构1210a的起点位置，第一终点延伸段1213构成相邻的第一环状结构1210a的第一起始波杆1211a，以将第一环状结构1210和相邻的第一环状结构1210a连接。以使第一环状结构1210之间的连接更牢固稳定。
请参阅图4，在进一步的实施例中，第二环状结构1220包括第二起始波杆1221、第二终点波杆1222，以及连接于所述第二起始波杆1221与所述第二终点波杆1222之间的多个第一波形单元。第二起始波杆1221为第二环状结构1220一圈中的第一个第一波杆，第二终点波杆1222为第二环状结构1220一圈中的最后一个第一波杆。第二起始波杆1221和第二终点波杆1222通过缠绕、焊接或者钢套固定的方式连接。图4中为采用第二终点波杆1222缠绕在第二起始波杆1221上的方式连接。在图5中，第二终点波杆1222与第二起始波杆1221通过钢套150连接固定。
请参阅图6，在进一步的实施例中，第二环状结构1220的第二终点波杆1222包括第二终点延伸段1223，第二终点延伸段1223延伸到相邻的第二环状结构1220a的起点位置，第二终点延伸段1223构成相邻的第二环状结构1220a的第二起始波杆1221a，以将第二环状结构1220和相邻的第二环状结构1220a连接。以使第二环状结构1220之间的连接更牢固稳定。
请参阅图4，在进一步的实施例中，中部螺旋支撑架112包括螺旋起始波杆1121、螺旋终点波杆1122，以及连接于所述螺旋起始波杆1121与所述螺旋终点波杆1122之间的螺旋部1124，螺旋起始波杆1121为中部螺旋支撑架112的第一个第二波杆，螺旋终点波杆1122为中部螺旋支撑架112沿螺旋方向延伸的最后一个第二波杆。其中螺旋起始波杆1121相较于螺旋终点波杆1122临近所述近端环形支撑架111设置。所述螺旋部1124由多个螺旋单元1125连接且由近端A向远端B螺旋延伸。其中中部螺旋支撑架112整体的螺旋方向是指都近端A指向远端B的方向。
在进一步的实施例中，所述中部螺旋支撑架112的近端和/或远端与环状结构1200通过缠绕、焊接或者钢套固定的方式连接。
请参阅图6，在进一步的实施例中，其中螺旋起始波杆1121包括螺旋起始延伸段1123，螺旋起始延伸段1123与近端环形支撑架111中的第一环状结构1210a的其中一个第一波杆1111a连接，以将近端环形支撑架111与中部螺旋支撑架112连接。其中螺旋起始延伸段1123与第一环状结构1210a的其中一个第一波杆1111a通过缠绕、焊接或者钢套固定的方式连接。在图6中，螺旋起始延伸段1123缠绕在第一波杆1111a上。请参阅图7，在图7中，螺旋起始延伸段1123与第一波杆1111a通过钢套150连接固定。
可以理解的是，请参阅图8，所述“螺旋起始延伸段1123与近端环形支撑架111中的第一环状结构1210a的其中一个第一波杆1111a连接”包括螺旋起始延伸段1123与近端环形支 撑架111中的第一环状结构1210a的第一起始波杆1211a连接。在图8中采用钢套150连接。
请再次参阅图6，在进一步的实施例中，所述“螺旋起始延伸段1123与近端环形支撑架111中的第一环状结构1210a的其中一个第一波杆1111a连接”包括螺旋起始延伸段1123与最靠近中部螺旋支撑架112的第一环状结构1210a的其中一个第一波杆1111a连接。其中最靠近中部螺旋支撑架112的第一环状结构1210a如图6中的第一环状结构1210a所示。
可以理解的是，包括螺旋起始延伸段1123可以与近端环形支撑架111中的任意位置的第一环状结构1210中的第一波杆连接。即可以将中部螺旋支撑架112的螺旋起始波杆1121延伸到近端环形支撑架111中，进一步提高支架整体结构的稳定性。
螺旋终点波杆1122包括螺旋终点延伸段1126，螺旋终点延伸段1126与第二环状结构1220b中的其中一个第一波杆1111b连接，以将中部螺旋支撑架112与远端环形支撑架113连接。其中螺旋终点延伸段1126与第二环状结构1220b中的其中一个第一波杆1111b通过缠绕、焊接或者钢套固定的方式连接。在图6中，螺旋波杆1111b缠绕在螺旋终点延伸段1126上。
可以理解的是，所述“螺旋终点延伸段1126与第二环状结构1220b中的其中一个第一波杆1111b连接”包括螺旋终点延伸段1126与第二环状结构1220中的第二终点波杆1222b连接。
在进一步的实施例中，所述“螺旋终点延伸段1126与第二环状结构1220b中的其中一个第一波杆1111b连接”包括螺旋终点延伸段1126与最靠近中部螺旋支撑架112的第二环状结构1220b中的其中一个第一波杆1111b连接。其中最靠近中部螺旋支撑架112的第二环状结构1220b如图6中的第二环状结构1220b所示。
可以理解的是，螺旋终点延伸段1126还可以与远端环形支撑架113中的任意位置的第二环状结构1220中的第一波杆连接。即可以将中部螺旋支撑架112的螺旋终点波杆1122延伸到远端环形支撑架113中，进一步提高支架整体结构的稳定性。
所述中部螺旋支撑架112的近端和远端分别连接在环状结构上，支撑骨架110整体连接在一起，相互约束，支撑骨架110径向和轴向稳定性更强。
请参阅图4，在进一步的实施例中，远端环形支撑架113包括过渡第二环状结构1220b，第二环状结构1220设置在过渡第二环状结构1220b远离近端环形支撑架111的一侧。过渡第二环状结构1220b成喇叭状，且过渡第二环状结构1220b由近端A指向远端B方向的直径逐渐变大。当远端环形支撑架113进入分支血管后，较大的直径能够增加其贴壁性，减少内漏的发生。过渡第二环状结构1220b可以较好的衔接中部螺旋支撑架112与远端环形支撑架113中的第二环状结构1220,进一步提高分段式覆膜支架100的整体稳固性。
可以理解的是，过渡第二环状结构1220b靠近近端A处最小直径与中部螺旋支撑架112的直径相等，过渡第二环状结构1220b靠近远端B处最大直径与第二环状结构1220的直径相等。以更 好的衔接中部螺旋支撑架112与远端环形支撑架113中的第二环状结构1220。
在进一步的实施例中，近端环形支撑架111的轴向长度为5-50mm。
在进一步的实施例中，中部螺旋支撑架112由近端A向远端B延伸，中部螺旋支撑架112包括螺旋部1124，螺旋部1124由螺旋单元1125组成，每一螺旋单元1125的螺旋角度为1-75°。优选的，螺旋单元1125的螺旋角度为5-45°。在上述螺旋角度范围内，使得中部螺旋支撑架112具有非常好的柔顺性，可任意弯曲，以适应不同的弯形或者弓形的血管。
请参阅图9，可以理解的是，在其他实施例中，近端环形支撑架111的直径可以大于远端环形支撑架113的直径。用于在近端A处直径较大而远端B处直径较小的血管。
请参阅图10，可以理解的是，在其他实施例中，近端环形支撑架111的直径可以等于远端环形支撑架113的直径。整个支撑骨架111为等径延伸的直型管状支架。
在进一步的实施例中，支撑骨架110由连续的丝状物编织而成。所述连续的丝状物可以是单股丝，或者多股复合丝，所述丝状物的材料可选自金属材料或者高分子材料，所述金属材料可选自不锈钢、钴合金、钽、镍钛合金，或其它生物相容的金属；优选记忆合金制成，所述多股复合丝可通过多股丝捻绕或者编织而成，所述多股丝的材料可以相同或者不同。
在进一步的实施例中，所述连续的丝状物为单根金属丝或者多根金属丝组成的复合丝，例如不锈钢，钴合金、钽、镍钛合金，或其它生物相容的金属；优选记忆合金制成，更优选的是镍钛合金。采用连续金属丝编织而成，可以提高支撑骨架110的稳定性。
请参阅图11，所述分段式覆膜支架100与主动脉血管支架200配合使用时，近端支撑架111会受到主动脉血管支架200的挤压，需要较大的径向支撑力；另一方面，如图12所示(此图中未明确画出环状支架和螺旋支架的具体结构)，在一些多分支血管处需要同时使用几个分支支架，此时，分支支架近端还会受到相邻的分支支架的挤压。因此，在进一步的实施例中，近端环形支撑架111的强度大于中部螺旋支撑架112的强度；为了达到这种效果，近端环形支撑架111所用金属丝材料的刚性大于中部螺旋支撑架112所用金属丝材料的刚性，或者近端环形支撑架111所用金属丝的丝径大于中部螺旋支撑架112所用金属丝的丝径。以保证近端环形支撑架111具有良好的径向支撑力，能够与血管中的其他分支支架牢固衔接。优选的，近端环形支撑架111所用金属丝的丝径为0.3mm。
在进一步的实施例中，中部螺旋支撑架112所用金属丝的丝径小于远端环形支撑架112的丝径。以保证中部螺旋支撑架112具有良好的柔顺性。优选的，中部螺旋支撑架112所用金属丝的丝径为0.25mm。
请再次参阅图13，在进一步的实施例中，覆膜120还包括内层覆膜121和外层覆膜122，支撑骨架110设于内层覆膜121和外层覆膜122之间，且内层覆膜121位于支撑骨架110内侧， 外层覆膜122位于支撑骨架110外侧。其中内层覆膜121和外层覆膜122的材料可相互独立的选自具有优良生物相容性的高分子材料，例如膨化聚四氟乙烯、PET、涤纶、聚氨酯、硅酮、超高分子量聚乙烯或其他合适材料，优选内层覆膜121和外层覆膜122均为膨体聚四氟乙烯材料所制。膨体聚四氟乙烯能很好地对流体渗透进行阻挡且加强分段式覆膜支架100的径向支撑力。
在进一步的实施例中，内层覆膜121和外层覆膜122分别为一体式结构。
在进一步的实施例中，内层覆膜121和外层覆膜122两者为一体式结构。以使分段式覆膜支架100更牢固。可以理解的是，内层覆膜121和外层覆膜122可采用热合方式使两者形成一体式结构。
在进一步的实施例中，分段式覆膜支架100还包括至少一个显影点130，所述显影点130可设置成圆环形或者8字形，通过缝合或者焊接等方式固定在支撑骨架110的近端和远端，所述显影点的材料可选自金、铂、铂-钨、钯、铂-铱、铑、钽，或这些金属的合金或复合物。优选的，显影点130为两个，这两个显影点130对称分布在支撑骨架110上。进一步的，连个显影点130分别位于近端环形支撑架111的第一波峰上和远端环形支撑架112的第一波谷上。以保证分段式覆膜支架100整体能够被有效监测得到。
请参阅图14和图15，本发明还提供一种分段式覆膜支架的制备方法，分段式覆膜支架100的制备方法包括步骤S100、步骤S200和步骤S300。详细步骤介绍如下。
步骤S100，将内层覆膜121缠绕在覆膜模棒123上。
步骤S200，将支撑骨架110套在内层覆膜121上，支撑骨架110与内层覆膜121紧密相接。其中支撑骨架110采用上述任一实施例中的支撑骨架。
步骤S300，将外层覆膜122裹住支撑骨架110。
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本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 (26)

  1. 一种分段式覆膜支架，其特征在于，所述分段式覆膜支架包括覆膜和固定于覆膜上的支撑骨架，所述支撑骨架包括环状结构和螺旋结构；
    所述环状结构是指由多个第一波形单元首尾相接组成的环形结构；所述螺旋结构是指由多个第二波形单元首尾相接且连续螺旋排布形成的管状结构，所述螺旋结构的整体延伸方向与所述支撑骨架平行。
  2. 如权利要求1所述的分段式覆膜支架，其特征在于，所述环状结构包括第一环状结构和第二环状结构；
    所述支撑骨架由近端至远端依次包括近端环形支撑架、中部螺旋支撑架和远端环形支撑架，所述近端环形支撑架包括多个互相平行的第一环状结构，所述中部螺旋支撑架为螺旋结构，所述远端环形支撑架包括多个互相平行的第二环状结构。
  3. 如权利要求2所述的分段式覆膜支架，其特征在于，每个所述第一波形单元由第一波峰、第一波杆和第一波谷组成，所述第一波杆连接第一波峰和第一波谷；周向相邻的所述第一波杆在靠近近端处相接形成第一波峰，周向相邻的所述第一波杆在靠近远端处相接形成第一波谷；每个所述第二波形单元由第二波峰、第二波杆和第二波谷组成，所述第二波杆连接第二波峰和第二波谷；周向相邻的所述第二波杆在靠近近端处相接形成第二波峰，周向相邻的所述第二波杆在靠近远端处相接形成第二波谷。
  4. 如权利要求3所述的分段式覆膜支架，其特征在于，轴向相邻的两圈所述第一波形单元的第一波峰与第一波谷位于同一轴线上。
  5. 如权利要求3所述的分段式覆膜支架，其特征在于，所述第一环状结构包括第一起始波杆、第一终点波杆以及连接于所述第一起始波杆与所述第一终点波杆之间的多个第一波形单元，所述第一起始波杆为所述第一环状结构一圈中的第一个第一波杆，所述第一终点波杆为所述第一环状结构一圈中的最后一个第一波杆；所述第一起始波杆和所述第一终点波杆通过缠绕、焊接或者钢套固定的方式连接。
  6. 如权利要求5所述的分段式覆膜支架，其特征在于，所述第一环状结构的第一终点波杆包括第一终点延伸段，所述第一终点延伸段延伸到相邻的第一环状结构的起点位置，所述第一终点延伸段构成相邻的所述第一环状结构的第一起始波杆，以将相邻的两个所述第一环状结构连接。
  7. 如权利要求5所述的分段式覆膜支架，其特征在于，所述第二环状结构包括第二起始波杆、第二终点波杆以及连接于所述第二起始波杆与所述第二终点波杆之间的多个第一波形单元，所述第二起始波杆为所述第二环状结构一圈中的第一个第一波杆，所述第二终点波杆为所述第二环状结构一圈中的最后一个第一波杆；所述第二起始波杆和所述第二终点波杆通过缠绕、 焊接或者钢套固定的方式连接。
  8. 如权利要求7所述的分段式覆膜支架，其特征在于，所述第二环状结构的第二终点波杆包括第二终点延伸段，所述第二终点延伸段延伸到相邻的第二环状结构的起点位置，所述第二终点延伸段构成相邻的所述第二环状结构的第二起始波杆，以将相邻的两个所述第二环状结构连接。
  9. 如权利要求7所述的分段式覆膜支架，其特征在于，所述中部螺旋支撑架包括螺旋起始波杆、螺旋终点波杆以及连接于所述螺旋起始波杆与所述螺旋终点波杆之间的螺旋部，所述螺旋起始波杆为所述中部螺旋支撑架的第一个第二波杆，所述螺旋终点波杆为所述中部螺旋支撑架沿螺旋方向延伸的最后一个第二波杆。
  10. 如权利要求9所述的分段式覆膜支架，其特征在于，所述中部螺旋支撑架的近端和/或远端与环状结构通过缠绕、焊接或者钢套固定的方式连接。
  11. 如权利要求10所述的分段式覆膜支架，其特征在于，所述螺旋起始波杆包括螺旋起始延伸段，所述螺旋起始延伸段与所述第一环状结构中的其中一个第一波杆连接，以将所述近端环形支撑架与所述中部螺旋支撑架连接。
  12. 如权利要求11所述的分段式覆膜支架，其特征在于，所述“所述螺旋起始延伸段与所述第一环状结构中的其中一个第一波杆连接”包括所述螺旋起始延伸段与最靠近所述中部螺旋支撑架的所述第一环状结构的其中一个第一波杆连接。
  13. 如权利要求10所述的分段式覆膜支架，其特征在于，所述螺旋终点波杆包括螺旋终点延伸段，所述螺旋终点延伸段与所述第二环状结构中的其中一个第一波杆连接，以将所述中部螺旋支撑架与所述远端环形支撑架连接。
  14. 如权利要求13所述的分段式覆膜支架，其特征在于，所述“所述螺旋终点延伸段与所述第二环状结构中的其中一个第一波杆连接”包括所述螺旋终点延伸段与最靠近所述中部螺旋支撑架的所述第二环状结构中的其中一个第一波杆连接。
  15. 如权利要求3所述的分段式覆膜支架，其特征在于，轴向相邻的两个所述第二波形单元的第二波峰位于同一轴线上。
  16. 如权利要求2所述的分段式覆膜支架，其特征在于，所述中部螺旋支撑架由近端向远端延伸，所述中部螺旋支撑架包括螺旋部，所述螺旋部由螺旋单元组成，每一所述螺旋单元的螺旋角度为1-75°。
  17. 如权利要求2所述的分段式覆膜支架，其特征在于，所述支撑骨架由连续的丝状物编织而成。
  18. 如权利要求17所述的分段式覆膜支架，其特征在于，所述连续的丝状物为单根金属丝 或者多根金属丝组成的复合丝。
  19. 如权利要求18所述的分段式覆膜支架，其特征在于，所述近端环形支撑架的强度大于中部螺旋支撑架的强度。
  20. 如权利要求19所述的分段式覆膜支架，其特征在于，所述近端环形支撑架所用金属丝的丝径大于所述中部螺旋支撑架及所述远端环形支撑架所用金属丝的丝径。
  21. 如权利要求19所述的分段式覆膜支架，其特征在于，所述近端环形支撑架所用金属丝材料的刚性大于中部螺旋支撑架所用金属丝材料的刚性。
  22. 如权利要求1所述的分段式覆膜支架，其特征在于，所述支撑骨架为等径直管结构或者非等径锥管状结构。
  23. 如权利要求2所述的分段式覆膜支架，其特征在于，所述远端环形支撑架包括过渡第二环状结构，所述第二环状结构设置在所述过渡第二环状结构远离所述近端环形支撑架的一侧；所述过渡第二环状结构成喇叭状，且所述过渡第二环状结构由近端指向远端方向的直径逐渐变大。
  24. 如权利要求1所述的分段式覆膜支架，其特征在于，所述覆膜包括内层覆膜和外层覆膜，所述支撑骨架设于所述内层覆膜和外层覆膜之间，且所述内层覆膜位于所述支撑骨架内侧，所述外层覆膜位于所述支撑骨架外侧。
  25. 如权利要求2所述的分段式覆膜支架，其特征在于，所述分段式覆膜支架还包括至少一个显影点。
  26. 一种分段式覆膜支架的制备方法，其特征在于，所述分段式覆膜支架的制备方法包括：
    将内层覆膜缠绕在覆膜模棒上；
    将支撑骨架套在内层覆膜上，所述支撑骨架与所述层覆膜紧密相接；
    将外层覆膜裹住所述支撑骨架。
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