WO2021110001A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2021110001A1
WO2021110001A1 PCT/CN2020/133175 CN2020133175W WO2021110001A1 WO 2021110001 A1 WO2021110001 A1 WO 2021110001A1 CN 2020133175 W CN2020133175 W CN 2020133175W WO 2021110001 A1 WO2021110001 A1 WO 2021110001A1
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WO
WIPO (PCT)
Prior art keywords
wave
opening
stent graft
proximal
stent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/133175
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English (en)
French (fr)
Inventor
肖本好
唐江峰
刘彩萍
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Lifetech Endovascular Medical Co Ltd
Original Assignee
Shenzhen Lifetech Endovascular Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shenzhen Lifetech Endovascular Medical Co Ltd filed Critical Shenzhen Lifetech Endovascular Medical Co Ltd
Priority to US17/774,977 priority Critical patent/US12167957B2/en
Priority to EP20896721.6A priority patent/EP4070764B1/en
Publication of WO2021110001A1 publication Critical patent/WO2021110001A1/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
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length

Definitions

  • the invention belongs to the field of medical equipment, and specifically relates to a covered stent.
  • Aortic stent graft is generally used for minimally invasive surgery in the aortic cavity. It mainly treats aortic diseases such as aortic aneurysm and aortic dissection.
  • the aortic stent graft can isolate the location of the aortic disease from the blood flow to achieve The purpose of healing.
  • the existing aortic stent graft is mainly composed of nickel-titanium metal stent and PTFE membrane.
  • the PTFE membrane is divided into inner and outer layers, and the metal stent is wrapped between the outer membrane and the inner membrane.
  • the inner and outer coatings are closely integrated through the coating heat treatment process at high temperature.
  • This type of stent graft because the metal stent is completely wrapped in the PTFE membrane, all that is in direct contact with the blood vessel wall is the outer PTFE membrane.
  • the characteristic of PTFE membrane is that the surface is very smooth, the inner surface of the stent graft is smooth, and it is not easy to form thrombus when the blood flow passes.
  • the outer surface of the stent graft is smooth, which is easy to cause due to the small friction factor when it is attached to the inner surface of the blood vessel wall. Stent displacement occurred. Once the stent is displaced, the operation may fail.
  • the stent graft 200 As shown in FIG. 1, in order to reduce the risk of displacement of the stent graft 200, it is currently common practice to use a narrow strip of film 230 when the stent is covered with the outer film 20 to expose a part of the wave crests or troughs of the metal stent 10, thereby Increase the anti-displacement performance of the stent.
  • the stent graft 200 also has the following problems during use:
  • Figure 2 shows the state of a normal stent graft (the outer layer of the stent graft is not a narrow strip of the stent graft) 300 when it is bent.
  • 1 is the larger curve side of the stent (the side with the larger bending radius).
  • 2 is the small bending side of the stent (the side with the smaller turning radius).
  • the wave trough of the metal wave ring 311 is embedded in the inner side of the wave crest of the metal wave ring 311 below (the side close to the axis of the stent graft is the inside, and the side away from the axis of the stent graft is One side is the outer side).
  • the stacked form of the film and the metal wave ring 311 in the stent cavity is that the trough of the upper metal wave ring 311 covers the wave crest of the lower metal wave ring 311. Therefore, the stent The stacked state of the covering film and the metal corrugation ring 311 at the cavity is in the direction of the blood flow.
  • FIG. 3 shows the state of the stent graft 200 with the outer cover film 20 using a narrow strip of the film 230 when the stent graft 200 is bent.
  • the exposed wave troughs of the metal corrugation ring will warp.
  • the exposed wave trough of the metal wave ring is blocked by the lower narrow strip film 230 when it is tilted.
  • the wave trough of the metal wave ring on the small bend side 2 of the stent is covered
  • the stacked form of the membrane and metal corrugated ring in the lumen of the stent is against the direction of blood flow, which easily leads to the formation of thrombus and also affects the patency of blood flow.
  • the purpose of the present invention is to at least solve the problem that the existing stent graft is easy to cause thrombus at the bend when the outer layer of the stent is covered with a narrow strip of film.
  • the embodiment of the present invention proposes a stent graft, which has a proximal large curve side and a proximal small curve side.
  • the stent graft includes a main body stent, an inner layer covering the inner side of the main body stent, and An outer layer covering the outer side of the main body stent.
  • the main body stent includes a plurality of wave rings arranged at intervals along the axial direction.
  • the wave rings are formed with alternately arranged wave crests and wave troughs.
  • the covering film is provided with a first opening, and the first opening exposes at least one wave trough located at or near the proximal large curvature side.
  • the first opening extends from the proximal minor curvature side to the proximal greater curvature side, and the height of the first opening is from the proximal minor curvature side to the proximal greater curvature side.
  • the proximal greater curvature side gradually increases, and the first opening exposes a plurality of wave troughs located at or near the proximal greater curvature side at the proximal less curvature side All the troughs are covered by the outer coating.
  • the first opening is a rectangular opening provided on the proximal large bend side and extending in the circumferential direction, and the rectangular opening exposes a plurality of wave troughs located on the same wave ring outer.
  • the length of the first opening in the circumferential direction is 1/3 to 2/3 of the length of the outer coating film in the circumferential direction.
  • the first openings are multiple and are distributed on the proximal greater curvature side and positions close to the proximal greater curvature, and each of the first openings is such that one The rectangular opening where the trough is exposed.
  • the first openings are multiple and are distributed on the proximal greater curvature side and positions close to the proximal greater curvature, and each of the first openings is such that one The wave trough extends to the gap outside the outer coating film.
  • a second opening is further provided on the outer covering film, the second opening is close to the distal end of the main body stent, and the second opening is extended in the circumferential direction and has a head and tail. Connected annular openings, and the second opening exposes all wave crests located on the same wave ring.
  • the stent graft further includes a plurality of reinforcement wires arranged at intervals along the axial direction, each of the reinforcement wires is wound around the main body stent in a circumferential direction, and the reinforcement wires avoid The first opening and the second opening are arranged.
  • the height of the exposed part of the wave ring does not exceed 1/3 of the height of the wave ring.
  • an arc-shaped transition section is provided on the screw rod connecting the wave crest and the wave trough.
  • a first opening is provided on the outer layer of the membrane, and the first opening exposes at least one wave trough located at or near the proximal greater curvature side.
  • the wave trough is easy to hang on the blood vessel wall, which can prevent the stent graft from shifting.
  • the wave crests and troughs located on the proximal side of the stent graft are kept covered by the outer membrane, and the proximal side of the small curvature
  • the trough of the wave ring is embedded in the inner side of the crest of the adjacent lower wave ring.
  • the stack of the stent cavity coating and wave ring is that the trough of the upper wave ring covers the lower wave ring.
  • the wave crest as a result, the overlay state of the stent lumen and the wave ring are stacked in the direction of blood flow, thereby reducing the risk of thrombosis.
  • the outer layer of the stent covered with a narrow strip of film, the exposed part of the metal stent lacks the outer layer of the film but only the inner layer of the film, which will cause the overall thickness of the film to be uneven, and there are places where the film thickness is thinner. Risk of rupture.
  • the stent graft of the present invention only reveals relatively few troughs through the first opening. It is understandable that the exposed area of the main stent is less, and the thickness of the stent graft is The uneven area is also relatively reduced, so that the risk of film rupture is reduced.
  • Fig. 1 is a schematic diagram of an existing stent graft in which a narrow strip of film is used as the outer layer of the film;
  • Figure 2 is a schematic diagram of an existing common stent graft
  • Fig. 3 is a schematic diagram of the stent graft shown in Fig. 1 when it is bent;
  • Figure 4 is a schematic diagram of a stent graft in one of the embodiments of the present invention.
  • Fig. 5 is a schematic diagram of the stent graft shown in Fig. 4 when it is bent;
  • Fig. 6 is a schematic diagram of the stent graft in one of the embodiments of the present invention when a reinforcement wire is provided;
  • FIG. 7 is a schematic diagram of the stent graft in one of the embodiments of the present invention when an arc-shaped transition section is provided on the screw rod of the wave ring;
  • Fig. 8 is an enlarged schematic diagram of part A in Fig. 7;
  • Fig. 9 is a schematic diagram of a protruding part provided on the screw rod of the wave ring in the stent graft according to another embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the stent graft of the second embodiment of the present invention.
  • FIG. 11 is a schematic diagram of the stent graft of the third embodiment of the present invention.
  • Fig. 12 is a schematic diagram of the stent graft according to the fourth embodiment of the present invention.
  • first, second, third, etc. may be used in the text to describe multiple elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be These terms are restricted. These terms may only be used to distinguish one element, component, region, layer or section from another region, layer or section. Unless clearly indicated by the context, terms such as “first”, “second” and other numerical terms do not imply an order or order when used in the text. Therefore, the first element, component, region, layer or section discussed below may be referred to as a second element, component, region, layer or section without departing from the teachings of the example embodiments.
  • spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature as shown in the figure. These relative terms are, for example, “inner”, “outer”, and “inner”. “, “outside”, “below”, “below”, “above”, “above”, etc.
  • This spatial relationship term is intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then elements described as “below other elements or features” or “below other elements or features” will then be oriented as “above the other elements or features" or “over the other elements or features". Above features”.
  • the example term “below” can include an orientation of above and below.
  • the device can be otherwise oriented (rotated by 90 degrees or in other directions) and the spatial relative relationship descriptors used in the text are explained accordingly.
  • the orientation can be defined according to the direction of blood flow, and the blood flow can be defined from the proximal end to the distal end.
  • the end where blood flows in is defined as the "proximal end", and the end where blood flows out.
  • distal generally refers to the length of the stent when it is delivered.
  • one of the embodiments of the present invention proposes a stent graft 100, which has a proximal greater curvature side 110 and a proximal less curvature side 120, where the greater curvature side refers to the stent graft 100
  • the side with the larger bend radius, and the side with the smaller bend refers to the side with the smaller bend radius.
  • the stent graft 100 includes a main body stent 10, an inner layer of membrane (not shown in the figure) provided on the inner side of the main body stent 10, and an outer layer of membrane 20 provided on the outer side of the main body stent 10, and the main body stent 10 It includes a plurality of wave rings 11 arranged at intervals along the axial direction.
  • the wave ring 11 is formed with alternating peaks 111 and wave troughs 112.
  • a first opening 21 is provided on the outer covering film 20, and the first opening 21 is located near At least one wave trough 112 at or near the proximal large curvature side 110 is exposed.
  • the inflection point close to the proximal direction of the stent graft 100 is defined as the crest, and the inflection point close to the distal direction of the stent graft 100 is defined as trough.
  • the stent graft 100 has a shape when it is implanted in the curved part of the thoracic arch as shown in FIG. 5, the stent graft 100 is provided with a first opening 21 on the outer membrane 20, and the first opening 21 makes At least one wave trough 112 located at the proximal greater curvature side 110 or close to the proximal greater curvature side 110 is exposed, and the exposed trough 112 is easy to hang on the blood vessel wall, thereby preventing the displacement of the stent graft 100 , The crests and troughs at the proximal side 120 of the stent graft 100 remain covered by the outer coating 20, and the trough 122 of the wave circle 11 at the proximal side 120 is embedded in the adjacent lower wave.
  • the inner side of the wave crest 111 of the ring 11, from the perspective of the stent lumen, the stent lumen film and the wave ring are stacked in such a way that the wave trough 111 of the upper wave ring 11 covers the wave crest of the lower wave ring 11.
  • the stacked state of the film and the corrugated ring 11 follows the direction of blood flow, thereby reducing the risk of thrombus formation.
  • the outer layer of the film adopts a narrow strip of film covered stent.
  • the exposed part of the metal stent lacks the outer layer of film and only has the inner layer of film, which will cause the overall film thickness to be uneven. Risk of rupture.
  • the stent graft 100 of the embodiment of the present invention only exposes relatively few troughs 112 through the first opening 21. It can be understood that the main body stent 10 has less exposed area, and the stent graft 100 The area of uneven thickness of the film on 100 is also relatively reduced, thereby reducing the risk of film rupture.
  • the first opening 21 extends from the proximal minor curvature side 120 to the proximal greater curvature side 110, the height of the first opening 21 gradually increases from the proximal minor curvature side 120 to the proximal greater curvature side 110, and the first opening 21.
  • a plurality of wave troughs 112 located at or near the proximal major bend side 110 are exposed, and the wave troughs 112 at the proximal minor bend side 120 are all covered by the outer coating 20.
  • the first opening 21 extends from the proximal minor curvature side 120 to the proximal greater curvature side 110, and the height of the first opening 21 gradually increases from the proximal minor curvature side 120 to the proximal greater curvature side 110 Therefore, the first opening 21 can be formed by cutting the outer film 20 covering the main body stent 10 along an oblique line, so that the wave trough 112 at and near the proximal large bend side 110 is exposed.
  • this method of forming the first opening 21 can make the film at the proximal minor curvature side 120 thicker, and the membrane at the proximal major curvature side 110 is relatively thinner, so that the stent graft 100 is easier to pass from the proximal end.
  • the large curve side 110 is bent to the proximal small curve side 120, and the stent graft 100 is more flexible.
  • the number of the first openings 21 may be one or multiple. When the number of the first openings 21 is multiple, the multiple first openings 21 are arranged at intervals along the axial direction of the stent graft 100. It can be understood that the larger the number of the first openings 21, the more the wave circles 11 at the proximal end that can be exposed, and the better the anchoring effect of the proximal end of the stent graft 100 in the blood vessel.
  • a second opening 22 is also provided on the outer covering film 20, the second opening 22 is close to the distal end of the main body stent 10, the second opening 22 is an annular opening that extends in the circumferential direction and is connected end to end. All wave crests 111 located on the same wave circle 11 are exposed.
  • the distal end of the stent graft 100 is generally located in the straight section of the aortic blood vessel and will not be bent too much. Therefore, the second opening 22 may adopt a manner in which the entire wave crest 111 of the wave ring 11 is exposed. In this embodiment, the second opening 22 is used to expose the wave crest 111 of the wave circle 11 near the distal end of the stent graft 100.
  • the exposed wave crest 111 is easy to hang on the blood vessel wall, thereby enhancing the distal end of the stent graft 100.
  • the anchoring force between the end and the blood vessel can prevent the distal end of the stent graft 100 from contracting proximally.
  • the number of the second openings 22 may be one or multiple. When the number of the second openings 22 is multiple, the multiple second openings 22 are arranged at intervals along the axial direction of the stent graft 100. It can be understood that the greater the number of the second openings 22, the more the wave circles 11 at the distal end that can be exposed, and the better the anchoring effect of the distal end of the stent graft 100 in the blood vessel.
  • the height a of the exposed part of the wave ring 11 does not exceed 1/3 of the wave ring height c, that is, a ⁇ 1/3c, where the wave ring height c refers to the wave ring 11 in the axial direction of the stent graft 100
  • the size, height a refers to the size of the exposed part of the wave ring 11 in the axial direction of the stent graft 100. It can be understood that the greater the height c of the exposed part of the wave ring 11, the smaller the contact area between the unexposed part and the outer coating film 20, which will cause the metal wire constituting the wave ring 11 to be more easily relative to the outer coating film. 20 is shifted. Therefore, limiting the height a of the exposed part of the wave ring 11 to a range of 1/3c can reduce the risk of the metal wire being displaced relative to the outer coating 20.
  • the stent graft 100 further includes a plurality of reinforcement wires 30 arranged at intervals along the axial direction.
  • Each reinforcement wire 30 is wound around the main body stent 10 in the circumferential direction.
  • the arrangement of the reinforcement wires 30 can be effective.
  • the ground strengthens the bonding force between the wave ring 11 and the outer coating 20, especially for the wave ring 11 with exposed parts, it is more beneficial to prevent the wave ring 11 from shifting relative to the outer coating 20.
  • the reinforcing wire 30 avoids the arrangement of the first opening 21 and the second opening 22. Specifically, at a position close to the first opening 21, the reinforcement line 30 can be kept at a distance of 2 mm to 3 mm from the edge of the first opening 21 to ensure that the reinforcement line 30 will not be exposed to the outer coating 20 through the first opening 21. outer. Similarly, at a position close to the second opening 22, the reinforcement line 30 can be kept at a distance of 2 mm to 3 mm from the edge of the second opening 22 to ensure that the reinforcement line 30 will not be exposed to the outer coating 20 through the second opening 22 outer.
  • the reinforcing wire 30 may be a PTFE wire, that is, a wire made of PTFE material.
  • the screw rod on which the wave crest and the wave trough are connected is provided with a protrusion 113.
  • the protrusion 113 is an arc-shaped transition section.
  • the other parts are all linear transitions.
  • the force of the wave ring 11 against the relative displacement of the metal wire and the film is relatively small, which is likely to cause the problem of displacement.
  • the wave ring 11 with exposed parts it can be set as an arc segment transition with a smaller curvature during heat setting, thereby increasing the contact area between the metal wire and the coating.
  • this structure is After the film is wrapped, the force of the metal wire on the inner and outer layer of the film is not along the straight line of the wire, but along the direction of the tangent to the arc segment of the metal wire, which can greatly improve the resistance of the wave ring 11 metal
  • the force of the displacement of the silk and the covering film reduces the risk of displacement between the wave ring 11 and the covering film.
  • the arc-shaped transition section in this embodiment is not limited to being formed by weaving, but can also be formed by cutting.
  • At least one protrusion 113 is provided on the screw rod between the wave crest 111 and the wave trough 112.
  • the protruding portion 113 is used to increase the contact area between the metal wire and the covering film, to improve the bonding force between the metal wire and the covering film, and to reduce the risk of displacement of the wave ring 11 and the covering stent.
  • the shape of the protrusion 113 is not limited, as long as the contact area between the metal wire and the coating film can be increased.
  • the protrusion 113 is not limited to being a ring shape, and may also be an arc shape, a sphere, or the like. In this embodiment, the specific shape of the protrusion 113 is formed by cutting.
  • the second embodiment of the present invention proposes a stent graft 100, which has substantially the same structure as the first embodiment, except that the shape of the first opening 21 is different.
  • the second opening 21 is a rectangular opening arranged on the proximal large bend side 110 and extending in the circumferential direction.
  • the rectangular opening exposes a plurality of wave troughs 112 located on the same wave ring 11.
  • the wave trough 112 at the proximal greater bend side 110 can also be exposed, while the wave crests and troughs at the proximal minor bend side 120 are kept covered by the outer coating 20, thereby reducing the risk of thrombus formation.
  • the stent graft 100 in this embodiment can also reduce the uneven thickness of the film to a certain extent, thereby reducing the risk of film rupture.
  • the length of the first opening 21 in the circumferential direction is 1/3 to 2/3 of the length of the outer layer membrane 20 in the circumferential direction, so that the anchoring force between the proximal end of the stent graft 100 and the blood vessel can be obtained.
  • the obvious enhancement may not significantly reduce the force of resisting displacement between the wave ring 11 and the outer coating 20.
  • the third embodiment of the present invention proposes a stent graft 100, which has substantially the same structure as the second embodiment, except that the shape of the first opening 21 is different.
  • each first opening 21 is a rectangular opening that exposes a wave trough 112 to the outside.
  • the method of arranging the first opening 21 in this embodiment can further reduce the area of the portion covered by the outer film 20 on the main stent 10, thereby further reducing the size of the film on the stent graft 100.
  • the area with uneven thickness further reduces the risk of film rupture.
  • the fourth embodiment of the present invention proposes a stent graft 100, which has substantially the same structure as the third embodiment, except that the form of the first opening 21 is further improved.
  • first openings 21 there are a plurality of first openings 21, and they are distributed on the proximal greater curvature side 110 and positions close to the proximal greater curvature side 110, and each first opening 21 is such that a trough 112 extends to the outer coating 20.
  • the first opening 21 in this embodiment is a gap, and the trough 112 extends out of the outer coating 20 through the gap. In this way, the integrity of the outer coating 20 can be ensured, so that the coating The stent 100 does not form uneven film thickness, thereby minimizing the risk of film rupture.

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Abstract

本发明属于医疗器械领域，具体涉及一种覆膜支架。其具有近端大弯侧和近端小弯侧，覆膜支架包括主体支架、设置在主体支架的内侧的内层覆膜以及设置在主体支架的外侧的外层覆膜，主体支架包括多个沿轴向间隔排布的波圈，波圈上形成有交替排布的波峰和波谷，在外层覆膜上设置有第一开口，第一开口使位于近端大弯侧处或靠近近端大弯侧处的至少一个波谷显露在外。根据本发明实施例的覆膜支架，显露在外的波谷易于挂在血管壁上，从而能够起到防止覆膜支架移位的作用，位于覆膜支架的近端小弯侧处的波峰和波谷则保持由外层覆膜覆盖，由此，支架内腔的覆膜和波圈堆叠状态是顺着血流方向的，由此可以降低形成血栓的风险。

Description

覆膜支架 技术领域
本发明属于医疗器械领域，具体涉及一种覆膜支架。
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。
主动脉覆膜支架一般用于主动脉腔内介入微创手术，主要治疗主动脉瘤、主动脉夹层等主动脉病变，主动脉覆膜支架可将主动脉病变位置与血流隔离开来从而达到治愈的目的。现有主动脉覆膜支架主要由镍钛金属支架和PTFE覆膜组成。PTFE覆膜分内外两层，金属支架包裹在外层覆膜和内层覆膜之间。内、外层覆膜通过高温下覆膜热处理工艺紧密融合在一起。这种类型的覆膜支架，由于金属支架完全包裹在PTFE膜中，因此与血管壁直接接触的全部都是外层PTFE膜。PTFE膜的特性是表面非常光滑，覆膜支架内表面光滑，血流经过时不易形成血栓，但是覆膜支架外表面光滑，则会因与血管壁内表面贴合时摩擦因子较小而导致容易发生支架移位。支架一旦移位，就可能导致手术失败。
如图1所示，为了降低覆膜支架200移位的风险，目前较常见的做法是，支架覆外层覆膜20时采用窄条覆膜230，使金属支架10露出一部分波峰或者波谷，从而增加支架的抗移位性能。然而，这种覆膜支架200在使用时也有下述问题：
图2显示的是普通的覆膜支架(外层覆膜非采用窄条覆膜的覆膜支架)300在弯曲时的状态，图中1为支架大弯侧(弯转半径较大的一侧)，2为支架小弯侧(弯转半径较小的一侧)，在覆膜支架300发生弯曲时，金属支架310上金属波圈311的波谷相对于支架的侧壁会翘起，翘起的方向与覆膜支架300弯曲的方向相反。从支架外部来看，在支架小弯侧2，金属波圈311的波谷嵌入到下方金属波圈311的波峰的内侧(靠近覆膜支架的轴线的一侧为内侧，背离覆膜支架的轴线的一侧的为外侧)，从支架内腔来看，支架内腔处覆膜和金属波圈311的堆叠形态是上方金属波圈311的波谷覆盖下方金属波圈311的波峰，由此，支架内腔处覆膜和金属波圈311的堆叠状态是顺着血流方向的。
图3显示的是外层覆膜20采用窄条覆膜230的覆膜支架200在弯曲时的状态，在覆膜支架200发生弯曲时，金属波圈裸露在外的波谷会发生翘起。在支架小弯侧2，金属波圈裸露在外的波谷在翘起时受到下层的窄条覆膜230的阻挡作用，故而，从支架外部来看，支架小弯侧2的金属波圈的波谷覆盖在下方金属波圈的波峰，这种情况下，支架内腔处覆膜和金属波圈的堆叠形态是逆血流方向的，容易导致形成血栓，同时还会影响血液流动的通畅性。
发明内容
针对以上问题，本发明的目的是至少解决现有的覆膜支架在采用外层覆膜为窄条覆膜的方案时，在弯曲处容易引起血栓的问题。该目的是通过以下技术方案实现的：
本发明实施例提出了一种覆膜支架，其具有近端大弯侧和近端小弯侧，所述覆膜支架包括主体支架、设置在所述主体支架的内侧的内层覆膜以及设置在所述主体支架的外侧的外层覆膜，所述主体支架包括多个沿轴向间隔排布的波圈，所述波圈上形成有交替排布的波峰和波谷，在所述外层覆膜上设置有第一开口，所述第一开口使位于所述近端大弯侧处或靠近所述近端大弯侧处的至少一个波谷显露在外。
在本发明的一些实施例中，所述第一开口由所述近端小弯侧延伸至所述近端大弯侧，所述第一开口的高度由所述近端小弯侧至所述近端大弯侧逐渐增大，所述第一开口使位于所述近端大弯侧处或靠近所述近端大弯侧处的多个波谷显露在外，位于所述近端小弯侧处的波谷全部由所述外层覆膜覆盖。
在本发明的一些实施例中，所述第一开口为设置在所述近端大弯侧且沿周向延伸的矩形开口，所述矩形开口使位于同一所述波圈上的多个波谷显露在外。
在本发明的一些实施例中，所述第一开口在所述周向上的长度为所述外层覆膜在周向上长度的1/3至2/3。
在本发明的一些实施例中，所述第一开口为多个且分布于所述近端大弯侧及靠近所述近端大弯侧的位置，每一所述第一开口为使一个所述波谷 显露在外的矩形开口。
在本发明的一些实施例中，所述第一开口为多个且分布于所述近端大弯侧及靠近所述近端大弯侧的位置，每一所述第一开口为使一个所述波谷伸出至所述外层覆膜之外的缝隙。
在本发明的一些实施例中，在所述外层覆膜上还设置有第二开口，所述第二开口靠近所述主体支架的远端，所述第二开口为沿周向延伸且首尾相连的环状开口，所述第二开口使位于同一所述波圈上的全部波峰显露在外。
在本发明的一些实施例中，所述覆膜支架还包括多个沿轴向间隔布置的加固线，每一所述加固线均沿周向缠绕于所述主体支架上，所述加固线避让所述第一开口和第二开口设置。
在本发明的一些实施例中，所述波圈的显露部分的高度不超过所述波圈高度的1/3。
在本发明的一些实施例中，对于有显露在外的至少部分的波圈，其上连接波峰和波谷的丝杆上设有弧形过渡段。
本发明的优点在于：
根据本发明实施例的覆膜支架，其在外层覆膜上设置第一开口，第一开口使位于近端大弯侧处或靠近近端大弯侧处的至少一个波谷显露在外，显露在外的波谷易于挂在血管壁上，从而能够起到防止覆膜支架移位的作用，位于覆膜支架的近端小弯侧处的波峰和波谷则保持由外层覆膜覆盖，近端小弯侧处的波圈的波谷嵌入到与其相邻的下方波圈的波峰的内侧，从支架内腔来看，支架内腔覆膜和波圈的堆叠形态是上方波圈的波谷覆盖下方波圈的波峰，由此，支架内腔的覆膜和波圈堆叠状态是顺着血流方向的，由此可以降低形成血栓的风险。另外，外层覆膜采用窄条覆膜的覆膜支架，金属支架裸露部分由于缺少外层覆膜而仅有内层覆膜，会造成整体覆膜厚度不均匀，膜厚度较薄的位置有发生破裂的风险。与该覆膜支架相比，本发明实施例的覆膜支架，只通过第一开口使相对较少的波谷显露，可以理解的是，主体支架裸露的面积较少，覆膜支架上覆膜厚度不均匀的面积也相对减小，从而使得膜发生破 裂的风险降低。
附图说明
附图仅用于示出优选实施方式的目的，而并不认为是对本发明的限制。而且在整个附图中，用相同的参考符号表示相同的部件。在附图中：
图1为现有的外层覆膜采用窄条覆膜的覆膜支架的示意图；
图2为现有的普通的覆膜支架的示意图；
图3为图1所示的覆膜支架在弯曲时的示意图；
图4为本发明实施例之一的覆膜支架的示意图；
图5为图4所示的覆膜支架在弯曲时的示意图；
图6为本发明实施例之一的覆膜支架在设置有加固线时的示意图；
图7为本发明实施例之一的覆膜支架在波圈的丝杆上设有弧形过渡段时的示意图；
图8为图7中A部分的放大示意图；
图9为本发明另一实施例的覆膜支架中波圈的丝杆上设有突出部的示意图；
图10为本发明实施例之二的覆膜支架的示意图；
图11为本发明实施例之三的覆膜支架的示意图；
图12为本发明实施例之四的覆膜支架的示意图。
具体实施方式
下面将参照附图更详细地描述本公开的示例性实施方式。虽然附图中显示了本公开的示例性实施方式，然而应当理解，可以以各种形式实现本公开而不应被这里阐述的实施方式所限制。相反，提供这些实施方式是为了能够更透彻地理解本公开，并且能够将本公开的范围完整的传达给本领域的技术人员。
应理解的是，文中使用的术语仅出于描述特定示例实施方式的目的，而无意于进行限制。除非上下文另外明确地指出，否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的，并且因此指明所陈述的特征、步骤、操作、元 件和/或部件的存在，但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行，除非明确指出执行顺序。还应当理解，可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出，否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此，以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
为了便于描述，可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系，这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如，如果在图中的装置翻转，那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此，示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
另外，在阐述植入物时，可以按照血流方向定义方位，定义血流从近端流向远端，例如对于支架，本发明中定义血液流入的一端为“近端”，血流流出的一端为“远端”；“轴向”一般是指支架在被输送时的长度方向。
如图4、图5所示，本发明实施例之一提出了一种覆膜支架100，其具有近端大弯侧110和近端小弯侧120，其中，大弯侧是指覆膜支架100植入血管后发生弯曲时，弯曲半径较大的一侧，小弯侧则是指弯曲半径较小的一侧。具体而言，覆膜支架100包括主体支架10、设置在主体支架10的内侧的内层覆膜(图中未示出)以及设置在主体支架10的外侧的外层覆膜20，主体支架10包括多个沿轴向间隔排布的波圈11，波圈11上 形成有交替排布的波峰111和波谷112，在外层覆膜20上设置有第一开口21，第一开口21使位于近端大弯侧110处或靠近近端大弯侧110处的至少一个波谷112显露在外。
需要说明的是，在本发明中，波圈11上所形成的各拐点部位中，靠近覆膜支架100的近端方向的拐点定义为波峰，靠近覆膜支架100的远端方向的拐点定义为波谷。
根据本发明实施例的覆膜支架100，其植入胸动脉弓部弯曲部位时的形态如图5所示，覆膜支架100在外层覆膜20上设置第一开口21，第一开口21使位于近端大弯侧110处或靠近近端大弯侧110处的至少一个波谷112显露在外，显露在外的波谷112易于挂在血管壁上，从而能够起到防止覆膜支架100移位的作用，位于覆膜支架100的近端小弯侧120处的波峰和波谷则保持由外层覆膜20覆盖，近端小弯侧120处的波圈11的波谷122嵌入到与其相邻的下方波圈11的波峰111的内侧，从支架内腔来看，支架内腔覆膜和波圈的堆叠形态是上方波圈11的波谷111覆盖下方波圈11的波峰，由此，支架内腔的覆膜和波圈11堆叠状态是顺着血流方向的，由此可以降低形成血栓的风险。
另外，外层覆膜采用窄条覆膜的覆膜支架，金属支架裸露部分由于缺少外层覆膜而仅有内层覆膜，会造成整体覆膜厚度不均匀，膜厚度较薄的位置有发生破裂的风险。与该覆膜支架相比，本发明实施例的覆膜支架100，只通过第一开口21使相对较少的波谷112显露，可以理解的是，主体支架10裸露的面积较少，覆膜支架100上覆膜厚度不均匀的面积也相对减小，从而使得膜发生破裂的风险降低。
进一步地，第一开口21由近端小弯侧120延伸至近端大弯侧110，第一开口21的高度由近端小弯侧120至近端大弯侧110逐渐增大，第一开口21使位于近端大弯侧110处或靠近近端大弯侧110处的多个波谷112显露在外，位于近端小弯侧120处的波谷112全部由外层覆膜20覆盖。
在本实施例中，第一开口21由近端小弯侧120延伸至近端大弯侧110，并且第一开口21的高度由近端小弯侧120至近端大弯侧110逐渐增大，故而，第一开口21可以是将覆于主体支架10上的外层覆膜20沿斜线进 行裁剪而形成，使近端大弯侧110处及其附近的波谷112显露。另外，这种形成第一开口21的方式，可以使近端小弯侧120处的膜厚一些，近端大弯侧110处的膜相对薄一些，从而使覆膜支架100更容易由近端大弯侧110弯向近端小弯侧120，覆膜支架100的柔顺性更好。
进一步地，第一开口21的数量可以是一个，也可以是多个，当第一开口21的数量是多个时，多个第一开口21沿覆膜支架100的轴向间隔排布。可以理解的是，第一开口21的数量越多，能够显露的近端处的波圈11相对越多，覆膜支架100的近端在血管中的锚定效果越好。
进一步地，在外层覆膜20上还设置有第二开口22，第二开口22靠近主体支架10的远端，第二开口22为沿周向延伸且首尾相连的环状开口，第二开口22使位于同一波圈11上的全部波峰111显露在外。覆膜支架100的远端一般位于主动脉血管的直段位置，不会有太大的弯曲，因此，第二开口22可以采用使整个波圈11的波峰111均显露的方式。在本实施例中，第二开口22用于显露覆膜支架100的靠近远端处的波圈11的波峰111，显露在外的波峰111容易挂在血管壁上，从而增强覆膜支架100的远端与血管的锚定力，进而可以防止覆膜支架100的远端向近端收缩。
进一步地，第二开口22的数量可以是一个，也可以是多个，当第二开口22的数量是多个时，多个第二开口22沿覆膜支架100的轴向间隔排布。可以理解的是，第二开口22的数量越多，能够显露的远端处的波圈11相对越多，覆膜支架100的远端在血管中的锚定效果越好
进一步地，波圈11的显露部分的高度a不超过波圈高度c的1/3，即a≤1/3c，其中，波圈高度c指波圈11在覆膜支架100的轴向上的尺寸，高度a指波圈11的显露部分在覆膜支架100的轴向上的尺寸。可以理解的是，波圈11的显露部分的高度c越大，则未显露部分与外层覆膜20的接触面积越小，则会导致构成波圈11的金属丝容易相对于外层覆膜20发生移位。故而，将波圈11的显露部分的高度a限制在1/3c的范围内，可以降低金属丝相对于外层覆膜20发生移位的风险。
进一步地，如图6所示，覆膜支架100还包括多个沿轴向间隔布置的加固线30，每一加固线30均沿周向缠绕于主体支架10上，加固线30的 设置可以有效地加强波圈11与外层覆膜20的结合力，尤其对于有显露在外的部分的波圈11来说，更有利于防止波圈11相对于外层覆膜20发生移位。
进一步地，加固线30避让第一开口21和第二开口22设置。具体地，在靠近第一开口21的位置，加固线30可以与第一开口21的边缘保持2mm至3mm的距离，以保证加固线30不会通过第一开口21显露至外层覆膜20之外。同样地，在靠近第二开口22的位置，加固线30可以与第二开口22的边缘保持2mm至3mm的距离，以保证加固线30不会通过第二开口22显露至外层覆膜20之外。
进一步地，加固线30可以是PTFE线，即由PTFE材料制成的线。
进一步地，如图7、图8所示，对于有显露在外的至少部分的波圈11(包括近端处的有波谷112显露的波圈11，以及远端处的有波峰111显露的波圈11)，其上连接波峰和波谷的丝杆设有突出部113。在本实施例中，突出部113为弧形过渡段。对于波圈11来说，除去波峰111和波谷112处外，其它部分均是直线过渡，覆膜热处理后，由于波圈11上有显露部分，金属丝与膜相结合后，力是沿着直线段金属丝的方向，因此，波圈11抵抗金属丝和膜发生相对位移的力较小，容易导致移位的问题发生。在本实施例中，对于有显露部分的波圈11，其在热定型时可以定成曲率较小的弧线段过渡，由此可以增加金属丝和覆膜的接触面积，另外这种结构被覆膜包裹后，金属丝对内、外层覆膜的作用力不是沿着丝的直线方，而是沿着金属丝圆弧段切线的方向，可在很大程度上提高抵抗波圈11金属丝和覆膜发生移位的力，降低波圈11和覆膜之间移位的风险。可以理解地，本实施例中的弧形过渡段不限于通过编织的方式形成，也可以通过切割的方式形成。
进一步地，如图9所示，对于有显露在外的至少部分的波圈11(包括近端处的有波谷112显露的波圈11，以及远端处的有波峰111显露的波圈11)，波峰111和波谷112之间的丝杆上至少设有一个突出部113。突出部113用于增加金属丝与覆膜的接触面积，提高金属丝和覆膜的结合力，降低波圈11和覆膜支架移位的风险。突出部113的形状不作限定，以能 增加金属丝与覆膜的接触面积为准。具体地，突出部113不限于为环状，也可以为弧形、球体等。在本实施例中，突出部113具体的形状通过切割的方式来形成。
如图10所示，本发明实施例之二提出了一种覆膜支架100，其与实施例之一的结构大体相同，不同之处在于第一开口21的形状有所不同。
具体地，第二开口21为设置在近端大弯侧110且沿周向延伸的矩形开口，矩形开口使位于同一波圈11上的多个波谷112显露在外。由此，也可以使近端大弯侧110处的波谷112显露，而近端小弯侧120处的波峰和波谷保持由外层覆膜20覆盖，由此降低形成血栓的风险。另外，本实施例中的覆膜支架100也可以获得在一定程度上减小覆膜厚度不均匀的面积，从而降低膜破裂的风险。
进一步地，第一开口21在周向上的长度为外层覆膜20在周向上长度的1/3至2/3，由此既可以使覆膜支架100的近端与血管的锚定力获得明显的增强，也可以不明显降低波圈11与外层覆膜20之间的抵抗移位的力。
如图11所示，本发明实施例之三提出了一种覆膜支架100，其与实施例之二的结构大体相同，不同之处在于第一开口21的形状有所不同。
具体地，第一开口21为多个，并且分布于近端大弯侧110及靠近近端大弯侧110的位置，每一第一开口21为使一个波谷112显露在外的矩形开口。与实施例之二相比，本实施例中的设置第一开口21的方式可以进一步减小主体支架10上的无外层覆膜20覆盖部分的面积，从而进一步小覆膜支架100上覆膜厚度不均匀的面积，进而进一步降低膜破裂的风险。
如图12所示，本发明实施例之四提出了一种覆膜支架100，其与实施例之三的结构大体相同，不同之处在于进一步改进了第一开口21的形式。
具体地，第一开口21为多个，并且分布于近端大弯侧110及靠近近端大弯侧110的位置，每一第一开口21为使一个波谷112伸出至外层覆膜20之外的缝隙。相比于实施例之三，本实施例中的第一开口21为缝隙，波谷112通过缝隙伸出外层覆膜20，这种方式，可以保证外层覆膜20的 完整性，从而使覆膜支架100不会形成覆膜厚度不均匀的现象，进而将膜破裂的风险降至最低。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以所述权利要求的保护范围为准。

Claims (10)

  1. 一种覆膜支架，其具有近端大弯侧和近端小弯侧，其特征在于，所述覆膜支架包括主体支架、设置在所述主体支架的内侧的内层覆膜以及设置在所述主体支架的外侧的外层覆膜，所述主体支架包括多个沿轴向间隔排布的波圈，所述波圈上形成有交替排布的波峰和波谷，在所述外层覆膜上设置有第一开口，所述第一开口使位于所述近端大弯侧处或靠近所述近端大弯侧处的至少一个所述波谷显露在外。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述第一开口由所述近端小弯侧延伸至所述近端大弯侧，所述第一开口的高度由所述近端小弯侧至所述近端大弯侧逐渐增大，所述第一开口使位于所述近端大弯侧处或靠近所述近端大弯侧处的多个所述波谷显露在外，位于所述近端小弯侧处的所述波谷全部由所述外层覆膜覆盖。
  3. 根据权利要求1所述的覆膜支架，其特征在于，所述第一开口为设置在所述近端大弯侧且沿周向延伸的矩形开口，所述矩形开口使位于同一所述波圈上的多个所述波谷显露在外。
  4. 根据权利要求3所述的覆膜支架，其特征在于，所述第一开口在所述周向上的长度为所述外层覆膜在周向上长度的1/3至2/3。
  5. 根据权利要求1所述的覆膜支架，其特征在于，所述第一开口为多个且分布于所述近端大弯侧及靠近所述近端大弯侧的位置，每一所述第一开口为使一个所述波谷显露在外的矩形开口。
  6. 根据权利要求1所述的覆膜支架，其特征在于，所述第一开口为多个且分布于所述近端大弯侧及靠近所述近端大弯侧的位置，每一所述第一开口为使一个所述波谷伸出至所述外层覆膜之外的缝隙。
  7. 根据权利要求1所述的覆膜支架，其特征在于，在所述外层覆膜上 还设置有第二开口，所述第二开口靠近所述主体支架的远端，所述第二开口为沿周向延伸且首尾相连的环状开口，所述第二开口使位于同一所述波圈上的全部所述波峰显露在外。
  8. 根据权利要求7所述的覆膜支架，其特征在于，所述覆膜支架还包括多个沿轴向间隔布置的加固线，每一所述加固线均沿周向缠绕于所述主体支架上，所述加固线避让所述第一开口和第二开口设置。
  9. 根据权利要求1至8中任一项所述的覆膜支架，其特征在于，所述波圈的显露部分的高度不超过所述波圈高度的1/3。
  10. 根据权利要求1至8中任一项所述的覆膜支架，其特征在于，对于有显露在外的至少部分的所述波圈，其上连接所述波峰和所述波谷的丝杆上设有突出部。
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