WO2019128701A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2019128701A1
WO2019128701A1 PCT/CN2018/120319 CN2018120319W WO2019128701A1 WO 2019128701 A1 WO2019128701 A1 WO 2019128701A1 CN 2018120319 W CN2018120319 W CN 2018120319W WO 2019128701 A1 WO2019128701 A1 WO 2019128701A1
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WO
WIPO (PCT)
Prior art keywords
stent graft
waveform
region
wave
curved side
Prior art date
Application number
PCT/CN2018/120319
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English (en)
French (fr)
Inventor
刘彩萍
肖本好
Original Assignee
先健科技(深圳)有限公司
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Filing date
Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to EP18897536.1A priority Critical patent/EP3733126A4/en
Priority to US16/956,070 priority patent/US11576768B2/en
Publication of WO2019128701A1 publication Critical patent/WO2019128701A1/zh

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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
    • A61F2/82—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
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • 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 sheet material 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91508—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a difference in amplitude along the band
    • 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 sheet material 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91516—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a change in frequency along the band
    • 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 sheet material 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude

Definitions

  • the present invention relates to the field of medical device technology, and in particular, to a stent graft.
  • aortic stent graft endovascular grafting has been widely used in aortic aneurysms and arterial dissections of the thoracic and abdominal aorta. Its curative effect is small, the trauma is small, the recovery is quick, and the complications are few. The treatment. However, for special lesions such as the aortic arch, the celiac trunk, the bilateral renal artery, or the superior mesenteric artery, the use of a stent graft affects the blood supply to the arterial branch vessel.
  • the in-situ fenestration of the stent graft is often performed by laser or mechanical means during the operation, so that the stent graft produces the desired hole, and then the branch stent is transported to the hole to be docked with the stent graft.
  • the treatment protocol overcomes the dependence on the anatomy of the branching blood vessels of the human body.
  • the stent graft often has problems in that the window size is difficult to meet the requirements, or the window edge support is poor.
  • the technical problem to be solved by the present invention is to provide a stent graft suitable for in-situ fenestration for the above-mentioned drawbacks in the prior art.
  • a stent graft comprising a multi-turn corrugated ring, the stent graft comprising an A region in a circumferential direction, and a B region connected to the A region, the corrugated ring comprising the A region a first waveform segment, and a second waveform segment located in the B region, wherein the waveform of the first waveform segment has an angle ranging from 70° to 120°, and the wave height and phase of the first waveform segment
  • the ratio of the pitch of the adjacent first waveform segment ranges from 1/4 to 3; the angle of the waveform of the second waveform segment is 30° to 60°, and the wave height of the second waveform segment is adjacent to
  • the ratio of the pitch of the second waveform segment is 1/4 to 3/2, and the ratio of the wave height of the first waveform segment to the wave height of the second waveform segment is greater than or equal to 1/3 and less than 1 .
  • the A region includes a large curved side region and a small curved side region distributed in a circumferential direction, and the large curved side region has an angle of 80° to 100°.
  • the angle of the small curved side area is 75° to 95°.
  • the ratio of the wave height of the first waveform segment in the large curved side region to the wave height of the first waveform segment in the small curved side region is 0.7 to 1 .
  • the ratio of the wave pitch of the adjacent first waveform segments in the large curved side region to the wave pitch in the small curved side region is 0.7 to 1.
  • the large curved side region and the small curved side region are symmetrically disposed in a circumferential direction, and the B region is located between the large curved side region and the small curved side region. .
  • the ratio of the area covered by the large curved side region on the outer surface of the stent graft to the area covered by the small curved side region on the outer surface of the stent graft It is 0.7 to 1.3.
  • the angle of the B region in the circumferential direction is 15 to 90.
  • the peak of the first waveform segment and the corresponding peak of the adjacent first waveform segment are parallel to the busbar of the stent graft, 1/3 ⁇ L1/L2 ⁇ 1, 4 mm ⁇ L1 ⁇ 12 mm.
  • the wave height of the first waveform segment is 3 mm to 15 mm, and the wave height of the second waveform segment is 8 mm to 18 mm.
  • an in-situ fenestration stent graft embodying the present invention has the following beneficial effects:
  • the present application adjusts the A region by simultaneously setting A and B regions of different waveform angles in the circumferential direction of the stent graft.
  • the ratio of the wave height to the wave height of the B region enables the A region to meet the requirements for window opening, while the B region can satisfy the axial support force and prevent the stent from being shortened into the tumor cavity.
  • the position of the window can be satisfactorily satisfied at each position of the A region, and the adaptability of the stent is improved.
  • the local waveform distribution in the A region and the B region is dense, affecting the bending performance of the bracket at the position, or the local waveform distribution in the A region and the B region is sparse, resulting in poor support of the bracket at the position and easy deformation.
  • FIG. 1 is a schematic view of a straight tubular stent graft provided by one of the preferred embodiments of the present invention
  • Figure 2 is a radial development view of the stent graft of Figure 1;
  • Figure 3a is a schematic view showing the waveform of the stent graft of Figure 1 at an angle of 60°;
  • Figure 3b is a schematic view showing the angle of the waveform of the stent graft shown in Figure 1 at 90°;
  • Figure 3c is a schematic view showing the angle of the waveform of the stent graft shown in Figure 1 at 130 °;
  • 4a is a schematic view showing the phase of the adjacent first waveform segments being opposite when the adjacent first wave segments of the stent graft of FIG. 1 are not overlapped in the axial direction;
  • 4b is a schematic view showing the phase of adjacent first waveform segments being the same when the adjacent first wave segments of the stent graft of FIG. 1 are not overlapped in the axial direction;
  • 4c is a schematic view of the adjacent first waveform segment of the stent graft of FIG. 1 having a phase difference when adjacent first waveform segments have no overlap in the axial direction;
  • Figure 5 is a schematic view showing the adjacent first wave segments of the stent graft of Figure 1 overlapping in the axial direction;
  • Figure 6 is a schematic view showing the distribution of the keel region of the stent graft of Figure 1 on a stent graft;
  • FIG. 7 is a schematic structural view of a curved stent graft provided by one of the preferred embodiments of the present invention.
  • Figure 8 is an enlarged view of a portion G of the stent graft shown in Figure 7;
  • Figure 9 is a schematic view showing the structure of the first curved section of the stent graft of Figure 7 after being straightened along the first contour line;
  • Figure 10 is a schematic view showing the structure of the corrugated ring of the stent graft shown in Figure 7 after being axially arranged and coated in the axial direction at the first contour line;
  • Figure 11 is a schematic view showing the structure of the ring-shaped annular rings of the stent graft shown in Figure 1 when they abut each other;
  • Figure 12 is a schematic view of a stent graft provided by the second preferred embodiment of the present invention.
  • Figure 13 is a schematic view showing the structure of a stent graft according to a third embodiment of the present invention.
  • Figure 14 is a schematic view showing the structure of the stent graft shown in Figure 13 after being bent in the direction indicated by the first arrow;
  • Fig. 15 is a structural schematic view showing the stent graft of Fig. 13 bent in a direction indicated by a second arrow.
  • distal and near end are used as the orientation words, which are the common terms in the field of interventional medical devices, wherein “distal” means one end away from the operator during the operation, “near end” means One end of the operator during the procedure.
  • Axial refers to the direction parallel to the center of the distal end of the medical device and the proximal center;
  • radial refers to the direction perpendicular to the axial direction, the distance from the axis, refers to the distance along the radial direction of the axis.
  • a preferred embodiment of the present invention provides a stent graft which is substantially open at both ends and has a hollow tubular structure.
  • the stent graft comprises a multi-turn corrugated ring 101 and is fixed at a plurality.
  • a film 200 of a plurality of turns of the corrugated ring 101 is connected to the ring-shaped corrugated ring 101.
  • the film 200 is substantially a closed cavity structure with open ends, and is made of a polymer material having good biocompatibility, such as e-PTFE, PET material, and the like.
  • the film 200 is fixed on the multi-turn corrugated ring 101 and encloses a lumen having a longitudinal axis. When the stent is implanted into a blood vessel, the lumen acts as a passage through which blood flows.
  • the corrugated ring 101 is made of a material having good biocompatibility such as nickel titanium, stainless steel or the like.
  • the multi-turn corrugated loops 101 are arranged in order from the proximal end to the distal end, preferably in parallel spaced arrangements. It can be understood that the embodiment does not limit the specific arrangement of the multi-turn corrugated ring 101, and the multi-turn corrugated ring 101 can also be connected in a grid-like structure.
  • Each turn of the corrugated ring 101 is a closed cylindrical structure comprising a plurality of proximal vertices 102, a plurality of distal vertices 103, and a support 104 connecting the adjacent proximal vertices 102 and distal vertices 103, near
  • the end vertices 102 and the distal vertices 103 correspond to peaks or troughs of the waveform, respectively.
  • the multi-turn corrugated ring 101 has the same or similar waveform shape.
  • the corrugated ring 101 may be a Z-shaped wave, an M-shaped wave, a V-shaped wave, a sinusoidal wave structure, or the like, which may be radially compressed to be very Small diameter structure, etc.
  • the stent graft can be prepared by weaving a wire into a desired waveform, and the wire can be a nickel-titanium alloy wire having a wire diameter of, for example, 0.35 mm; after heat setting, the steel sleeve is used to sleeve both ends of the wire. The part is fixed by mechanical pressing to fasten the wire and the steel sleeve to form a metal ring. After the formation of the corrugated ring 101 is completed, the surface of the multi-turn corrugated ring 101 which is sequentially arranged is coated.
  • the inner surface and the outer surface of the multi-turn corrugated ring 101 may be entirely covered with an e-PTFE film, and the multi-turn corrugated ring 101 may be located between the two layers of the coating film 200, and the inner and outer layers are pressed by high temperature and pressure.
  • the e-PTFE film is bonded together to fix the multi-turn wave-changing ring 101 between the two layers of film.
  • the multi-turn corrugated ring 101 may also be stitched to the PET film.
  • corrugated ring 101 is integrally cut by a metal pipe, it is not necessary to be fixedly connected by a steel sleeve.
  • the two ends of the wire may be secured by welding to form a corrugated annulus.
  • the stent graft includes an A region in the circumferential direction and a B region connected to the A region, and the region enclosed by the broken line in the figure is the B region.
  • the waveform ring 101 includes a first waveform segment located in the A region and a second waveform segment located in the B region, and the waveform angle ⁇ of the first waveform segment is 70° to 120°, and the first waveform segment is segmented.
  • the ratio of the wave height L1 to the spacing L2 of the adjacent first waveform segments is 1/4 to 3; the waveform angle ⁇ of the second waveform segment is 30° to 60°, and the wave height L3 of the second waveform segment is adjacent to The ratio of the pitch L4 of the second waveform segment is 1/4 to 3/2, and the ratio of the wave height L1 of the first waveform segment to the wave height L3 of the second waveform segment is greater than or equal to 1/3 and less than 1.
  • the angle ⁇ of the waveform refers to the angle between the supports 104 connected to the same proximal vertex 102 or the distal vertex 103.
  • the puncture member When in-situ fenestration of the stent graft, the puncture member is used to puncture a small hole in the membrane, and then the balloon is used to dilate the orifice to expand to a desired size.
  • the wave loops 101 of Figures 3a, 3b and 3c have the same wave heights with angles of 60°, 90° and 130°, respectively.
  • a balloon having a diameter D1 (D1, preferably 3 mm to 18 mm) is respectively expanded into a circle of the same size at a corresponding position of each ring-shaped ring-shaped object 101. The corresponding position here refers to the center of the balloon respectively.
  • the distance between the apex of the proximal end of the corrugated ring 101 in Figures 3a, 3b and 3c is equal and the line is along the axial direction of the stent graft.
  • the hatched line in the figure is the shape of the window from which the balloon is expanded. It can be seen from the figure that when the angle between the waveforms is 90° and 130°, the window satisfying the size requirement can be expanded, and the waveform ring with the waveform angle of 60° can be expanded.
  • the object 101 limits the size of the fenestration such that the fenestration edge follows the corrugated annulus 101.
  • D2 the diameter
  • the corrugated ring 101 and the diameter are The larger the angle ⁇ corresponding to the intersecting segment of the circle of D2, the stronger the effect of the corrugated ring 101 on providing support to the edge of the window.
  • the corrugated ring 101 cannot provide sufficient support for the window opening edge.
  • the waveform ring 101 does not limit the size of the window opening, which is advantageous for window opening, but if the waveform angle is too large, it may result in
  • the edge of the window is away from the corrugated ring 101, and the corrugated ring 101 cannot provide sufficient support for the edge of the window. If the edge of the window does not have the support of the corrugated ring 101, the window will further under the action of the radial force of the branch bracket. The expansion eventually leads to the separation of the branch support from the support.
  • the angle of the waveform of the corrugated ring 101 is too large, and the number of waveforms distributed along the circumferential direction of the stent graft is too small, which is not conducive to maintaining the lumen morphology of the stent graft.
  • the waveform of the waveform ring 101 in a certain area is small, although the edge of the window can be provided with sufficient support, the angle of the waveform is too small, which limits the size of the window, making the window size difficult to meet.
  • the size of the branch vessel since the corrugated ring 101 has a certain rigidity, it is not easily deformed by an external force.
  • the corrugated ring 101 When the fenestration member abuts against the corrugated ring 101, the corrugated ring 101 is easily broken or the corrugated ring 101 is relatively opposed.
  • the over-displacement of the film 200 affects the radial support effect of the stent graft.
  • the A region and the B region of different waveform angles in the circumferential direction of the stent graft by setting the A region and the B region of different waveform angles in the circumferential direction of the stent graft, and adjusting the ratio of the wave height of the A region to the wave height of the B region, the A region can meet the requirement of window opening, and the B region can Meet the axial support force and avoid the stent shrinking into the tumor cavity.
  • the ratio of the wave height to the wave spacing in the A region and the ratio of the wave height to the wave spacing in the B region the position of the window can be satisfactorily satisfied at each position of the A region, and the adaptability of the stent is improved.
  • the local waveform distribution in the A region and the B region is dense, affecting the bending performance of the bracket at the position, or the local waveform distribution in the A region and the B region is sparse, resulting in poor support of the bracket at the position and easy deformation.
  • the first waveform segment includes a plurality of first proximal vertices 102a, a plurality of first distal vertices 103a, and a first support connecting adjacent first proximal vertices 102a and first distal vertices 103a.
  • the second waveform segment includes at least one second proximal vertex 102b, at least one second distal vertex 103b, and a second support 104b that connects adjacent second proximal vertex 102b and second distal vertex 103b.
  • the wave height L1 of the first waveform segment refers to the axial distance between the first proximal vertex 102a and the first distal vertex 103a, and the distance L2 of the adjacent first waveform segment is the first waveform segment.
  • the first proximal vertex 102a above is axially spaced from the first proximal vertex 102a on the adjacent first waveform segment.
  • the wave height L3 of the second waveform segment refers to the axial distance between the second proximal vertex 102b and the second distal vertex 103b, and the interval L4 of the adjacent second waveform segment is the second waveform segment.
  • first distal apex 103a and the second distal apex 103b are located in the same plane that is perpendicular to the longitudinal central axis of the stent.
  • L1 and L3 satisfy 3 mm ⁇ L1 ⁇ 15 mm, and 8 mm ⁇ L3 ⁇ 18 mm.
  • the plurality of first waveform segments of the A region are axially spaced apart.
  • the phases of the adjacent first waveform segments are different, the area available for windowing between adjacent first waveform segments is also different.
  • 4a, 4b and 4c are sequentially arranged in the case where the adjacent first waveform segments have no overlap in the axial direction, and the adjacent first waveform segments are equal in the case where the waveform structure and the wave spacing of the adjacent first waveform segments are equal.
  • the opposite phase means that the peaks of adjacent first waveform segments are opposite to the valleys, and the same phase means that the peaks of adjacent first waveform segments are opposite to the peaks, and the phase difference refers to The peaks of adjacent first waveform segments are staggered from the peaks and troughs.
  • the areas available for windowing between adjacent first waveform segments is the largest, and when the phases of adjacent first waveform segments are the same, The window opening area is the smallest.
  • the windowing region distribution is relatively uniform.
  • the phase height of the first waveform segment and the ratio of the wave height to the wave spacing can be adjusted to adapt to different phase conditions.
  • the adjacent first waveform segments do not overlap in the axial direction
  • the corresponding peak here means that the connection distance between the peak of the first waveform segment and the peak is the shortest compared to the other peaks on the adjacent first waveform segment; the corresponding valley refers to The other troughs on the adjacent first waveform segments have the shortest connection distance between the peaks of the first waveform segment and the trough.
  • the A region includes two sub-regions, respectively a large curved side region 100a and a small curved side region 100b distributed in the circumferential direction.
  • the angle of the waveform of the large curved side region 100a is 80° to 100°, preferably 90°, and the angle of the small curved side region 100b is 75° to 95°, preferably 80°.
  • the ratio of the wave height of the first waveform segment in the large curved side region 100a to the wave height of the first waveform segment in the small curved side region 100b is 0.7 to 1, and the wave pitch of the adjacent first waveform segment in the large curved side region 100a.
  • the ratio of the wave spacing to the small curved side region 100b is 0.7 to 1, and the area covered by the large curved side region 100a on the outer surface of the stent graft and the small curved side region 100b covered on the outer surface of the stent graft
  • the ratio of the areas is 0.7 to 1.3.
  • the area covered by the large curved side region 100a on the outer surface of the stent graft is equal to the area covered by the small curved side region 100b on the outer surface of the stent graft, and the first waveform segment is large.
  • the wave heights of the curved side regions 100a are all equal, and the wave pitch of the adjacent first waveform segments in the large curved side regions 100a are equal.
  • the wave heights of the first waveform segments in the small curved side regions 100b are also equal, and the wave pitches of the adjacent first waveform segments in the small curved side regions 100b are also equal.
  • the large curved side region 100a is disposed opposite to the small curved side region 100b in the circumferential direction, and the B region is connected between the large curved side region 100a and the small curved side region 100b.
  • the A area can also be divided into three or more sub-areas distributed along the circumferential direction as needed, and each sub-area can be arranged at intervals, or arranged continuously, and the waveform of the waveform segment of each sub-area The number of waveforms, waveform height and waveform angle can be set as needed.
  • the shortening ratio of the B region in the axial direction is smaller than the axial shortening ratio of the A region, and the shrinkage ratio of the stent graft in the axial direction of the B region is 10% to 40%.
  • the shortening ratio of the stent graft in the axial direction of the B region is (rs) / r ⁇ 100%.
  • (r-s) is the maximum value that the stent graft can be shortened.
  • the film stent is sleeved outside the inner tube for shortening, which can effectively avoid the phenomenon of folding when the stent is shortened, that is, the (r-s) of the present application is the maximum value that the stent graft can be shortened when it is not folded.
  • the stent graft When the stent graft is in the shape of a truncated cone, that is, the diameters of the two ends are not the same, the length in the axial direction is r in the natural state, the diameter of the large end is d1, and the diameter of the small end is d3, and the stent is covered and covered.
  • the membrane stent is on the inner tube of the cone or the inner tube of the frustum, and the vertical distance between the stent and the inner tube of the cone or the inner tube of the frustum is 0.05d1.
  • the position of the small end of the fixed stent is unchanged, and the pressure F along the axial direction is applied at the large end, 1N ⁇ F ⁇ 2N, the total length of the stent graft can no longer be shortened, and the stent graft is shortened along the axial direction.
  • the rate is (rs) / r ⁇ 100%.
  • (r-s) is the maximum value that the stent graft can be shortened.
  • the film stent is sleeved outside the inner tube for shortening, which can effectively avoid the phenomenon of folding when the stent is shortened, that is, the (r-s) of the present application is the maximum value that the stent graft can be shortened when it is not folded.
  • the stent graft When the stent graft itself is formed into a curved shape, as shown in FIG. 7, the stent graft includes a first curved section 400a and a second curved section 400b, and the first curved section 400a has a first contour line on a large curved side thereof 401a and a second contour line 402a on its small curved side, the second curved section 400b has a third contour line 401b on its large curved side and a fourth contour line 402b on its small curved side region.
  • the shortening rate of the curved section of the stent graft has two calculation modes, one calculation method is as follows: Referring to FIG.
  • the first curved section 400a is taken as an example, and the axial direction perpendicular to the stent graft is used.
  • the plane 109 divides the first curved section 400a, and cuts a plurality of notches 403 on the film 200 adjacent to the second contour line 402a.
  • the size of the notch 403 ensures that the stent graft is straightened along the first contour line 401a (or, A plurality of notches 403 are cut on the film 200 near the second contour line 402a.
  • the size of the notch 403 is just enough to ensure that the stent graft is straightened along the first contour line 401a.
  • the first curved section 400a is straightened as shown in FIG.
  • the axial pressure F, 1N ⁇ F ⁇ 2N is applied to the stent graft, the total length of the B region is s when the stent graft can no longer be shortened, and the stent graft is short along the axial direction in the B region.
  • the shrinkage is (rs) / r ⁇ 100%.
  • Another calculation method is as follows: taking the first curved section 400a as an example, the corrugated ring 101 is again axially arranged according to the wave spacing at the first contour line 401a, and the waveform ring 101 is re-aligned.
  • the film is applied (the film material and the process selection are kept in agreement with the original frame), as shown in Fig. 10, and then calculated according to the above calculation method of the shrinkage ratio.
  • the region forms a rigid axial support structure, so that the stent graft cannot continue to bend.
  • a ring of the corrugated ring 101 of the stent graft moves together with the membrane 200 fixed on the corrugated ring 101 in the direction of pressure, and is fixed to the corrugated ring.
  • the film 200 on 101 drives the film 200 distributed around the corrugated ring 101 to move together, and then the other ring-shaped ring 101 which is distributed near the film 200 around the corrugated ring 101 is approached.
  • One side of the corrugated ring 101 moves until the corrugated ring 101 cannot continue to move, and a rigid axial support structure is formed on the stent graft so that the stent does not continue to be shortened.
  • the shrinkage ratio of the stent graft in the axial direction of the B region is less than 10%, the shortening ratio of the B region is too small, and the B region can easily reach the maximum value that can be shortened regardless of the direction in which the stent is bent, so that B The area can no longer be shortened, limiting the stent from continuing to bend.
  • the stent graft has an axial shortening ratio of more than 40% in the B region, the axial support effect of the stent is poor, and the distal end of the stent may enter the tumor cavity when it is shortened to the proximal end, endangering the life of the patient.
  • the shrinkage of the stent graft in the B region is 10% to 40%, not only can the stent be bent in all directions, the stent can be adapted to the curved blood vessel, and the stent can be provided with sufficient axial support to achieve axial protection.
  • the stent graft can be bent in different directions to achieve continuous bending, thereby better adapting to the blood vessel morphology.
  • the stent graft has a shortening ratio in the axial direction of the B region of 20% to 30%.
  • the circumferential angle of the B region on the outer surface of the stent graft is ⁇ °, 15° ⁇ ⁇ ° ⁇ 90°.
  • ⁇ ° ⁇ 15° the circumferential angle covered by the B region on the outer surface of the stent graft is small, which may result in poor axial support of the entire stent graft, and the stent graft may easily oscillate under the impact of blood flow. And retraction, eventually leading to the retraction of the stent into the tumor cavity, endangering the patient's life; when ⁇ °>90°, the circumferential angle of the B region covering the outer surface of the stent graft is large, which is not conducive to the stent bending.
  • the B region is divided into two keel regions in the circumferential direction, which are a first keel region 300a and a second keel region 300b, respectively, and the two keel regions are respectively located between the large curved side region 100a and the small curved side region 100b.
  • the first keel region 300a and the second keel region 300b cover the outer surface of the stent graft at a circumferential angle of 15° to 45°, preferably 20° to 30°, and the first keel region 300a and the second keel region 300b are covered.
  • the circumferential angles may be the same or different.
  • the B region can also be divided into three or more keel regions as needed, and each keel region can be arranged at intervals, or continuously arranged, and the waveform of the waveform segmentation of each keel region, the number of waveforms, The waveform height and waveform angle can be set as needed.
  • the second waveform segment includes a second proximal vertex 102b, and the line between the second proximal vertex 102b of the adjacent second waveform segment is parallel to the axis of the stent graft.
  • one end of the multi-turn corrugated ring 101 is provided with at least one loop of the proximal corrugated ring 101a.
  • the waveform of the near-end waveform ring 101a is 30° to 60°, and the waveform of the proximal waveform ring 101a and the waveform ring 101 are the same, and both are V-shaped waves, Z-shaped waves or M-shaped waves. And the number of waveforms in the circumferential direction of the near-end corrugated ring 101a is larger than the number of waveforms of the corrugated ring 101 in the circumferential direction.
  • the other end of the multi-turn corrugated ring 101 can also be provided with at least one loop of the distal waveform ring (not shown), and the waveform of the distal waveform ring has an angle of 50° to 70°. °, the waveform of the distal waveform ring and the waveform ring 101 are also the same, both of which are V-shaped waves, Z-shaped waves or M-shaped waves, etc., and the number of waveforms of the distal waveform ring object in the circumferential direction is also larger than the waveform. The number of waveforms of the ring 101 in the circumferential direction.
  • the proximal waveform ring and the distal wave ring are made of materials with good biocompatibility, such as nickel titanium, stainless steel and the like. Both the proximal waveform ring and the distal waveform ring are closed cylindrical structures.
  • the proximal waveform annulus and the distal waveform annulus may be Z-shaped waves, M-shaped waves, V-shaped waves, sinusoidal wave structures, or other structures that are radially compressible to a small diameter. It can be understood that not only the number of turns of the proximal waveform ring and the distal waveform ring can be set as needed, but also the waveforms and waveforms of the proximal waveform ring and the distal waveform ring of each ring. And the waveform height can be set as needed.
  • the stent graft further comprises an anchoring bare stent 105 located at one or both ends of the stent graft and connected to the proximal corrugated annulus or the distal corrugated annulus.
  • Figure 12 illustrates a stent graft provided in accordance with a second preferred embodiment of the present invention, which differs from one of the embodiments in that between the second proximal vertex 102b of the adjacent second wave segment The line is inclined relative to the axis of the stent graft.
  • Figure 13 shows a stent graft provided in accordance with a third embodiment of the present invention, which differs from one of the embodiments in that it is attached to the side of the second proximal apex 102b adjacent to the large curved side region 100a.
  • the second support body 104b is distributed parallel to the axial direction of the stent graft, and is connected to the other side of the second proximal vertex 102b, and the second support body 104b adjacent to the small curved side region 100b is opposite to the axial direction of the stent graft. Tilt setting.
  • the second support bodies 104b adjacent to the large curved side region 100a of the adjacent second wave segment abut each other to form an axial support.
  • the angle between the second support bodies 104b adjacent to the large curved side region 100a of the adjacent second waveform segments is ⁇ °.
  • the angle between the second support bodies 104b adjacent to the small curved side regions 100b of the adjacent second waveform segments is ⁇ °. As can be seen from the figure, ⁇ ° ⁇ ⁇ °.
  • the second support body 104b distributed along the axial direction parallel to the stent-graft abuts against each other to form an axial support, the angle between the second support bodies 104b adjacent to the second wave segment is the smallest, and the axis of the stent The support force is the biggest. Therefore, the second support body 104b distributed in the axial direction parallel to the stent graft is disposed on the side close to the large curved side region 100a. When the stent is bent toward the small curved side, the second support body 104b can provide sufficient support for the stent.
  • the axial support force has the best axial support for the bracket.

Abstract

一种覆膜支架，包括多圈波形环状物（101），覆膜支架沿圆周方向包括A区域，及与A区域相连的B区域，波形环状物（101）包括位于A区域的第一波形分段，及位于B区域的第二波形分段，第一波形分段的波形夹角为70°～120°，第一波形分段的波高与相邻第一波形分段的间距的比值为1/4～3；第二波形分段的波形夹角为30°～60°，第二波形分段的波高与相邻第二波形分段的间距的比值为1/4～3/2，第一波形分段的波高与第二波形分段的波高的比值大于等于1/3，且小于1。A区域不仅有利于开窗，还可以使得波形环状物（101）靠近开窗边缘，给开窗边缘提供足够的支撑。

Description

覆膜支架 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种覆膜支架。
背景技术
近十余年来，主动脉覆膜支架腔内隔绝术已经广泛应用于胸、腹主动脉的动脉瘤和动脉夹层等病变，其疗效确切、创伤小、恢复快、并发症少，已成为一线的治疗方法。但是对于主动脉弓部、腹腔动脉干、双侧肾动脉或者肠系膜上动脉等特殊病变部位，使用覆膜支架会影响动脉分支血管的血液供应。针对这种情况，常通过激光或机械方式在手术过程中对覆膜支架进行原位开窗，使覆膜支架产生预期的孔洞，再将分支支架输送至该孔洞处与覆膜支架对接，这种治疗方案克服了对人体分支血管解剖结构的依赖性。
现有技术中的覆膜支架在进行原位开窗时，常常存在着窗口尺寸的大小较难满足要求，或者窗口边缘支撑性较差等问题。
发明内容
本发明要解决的技术问题在于，针对现有技术中的上述缺陷，提供一种适合原位开窗的覆膜支架。
本发明解决其技术问题所采用的技术方案是：
提供一种覆膜支架，包括多圈波形环状物，所述覆膜支架沿圆周方向包括A区域，及与所述A区域相连的B区域，所述波形环状物包括位于所述A区域的第一波形分段，及位于所述B区域的第二波形分段，所述第一波形分段的波形夹角范围为70°～120°，所述第一波形分段的波高与相邻所述第一波形分段的间距的比值范围为1/4～3；所述第二波形分段的波形夹角为30°～60°，所述第二波形分段的波高与相邻所述第二波形分段的间距的比值为1/4～3/2，所述第一波形分段的波高与所述第二波形分段的波高的比值大 于等于1/3，且小于1。
在本发明所述的覆膜支架中，所述A区域包括沿圆周方向分布的大弯侧区和小弯侧区，所述大弯侧区的波形夹角为80°～100°，所述小弯侧区的波形夹角为75°～95°。
在本发明所述的覆膜支架中，所述第一波形分段在所述大弯侧区的波高与所述第一波形分段在所述小弯侧区的波高的比值为0.7～1。
在本发明所述的覆膜支架中，相邻所述第一波形分段在所述大弯侧区的波间距与在所述小弯侧区的波间距的比值为0.7～1。
在本发明所述的覆膜支架中，所述大弯侧区与所述小弯侧区沿圆周方向对称设置，所述B区域位于所述大弯侧区与所述小弯侧区之间。
在本发明所述的覆膜支架中，所述大弯侧区在覆膜支架的外表面上覆盖的面积与所述小弯侧区在所述覆膜支架的外表面上覆盖的面积的比值为0.7～1.3。
在本发明所述的覆膜支架中，所述B区域沿圆周方向上的夹角为15°～90°。
在本发明所述的覆膜支架中，当所述第一波形分段的波峰与相邻的所述第一波形分段上对应的波峰的连线平行于所述覆膜支架的母线时，1/3≤L1/L2≤1，4mm≤L1≤12mm。
在本发明所述的覆膜支架中，当所述第一波形分段的波峰与相邻的所述第一波形分段上对应的波谷的连线平行于所述覆膜支架的母线时，1/4≤L1/L2≤3/4，4mm≤L1≤14mm。
在本发明所述的覆膜支架中，所述所述第一波形分段的波高为3mm～15mm，所述第二波形分段的波高为8mm～18mm。
综上所述，实施本发明的一种原位开窗覆膜支架，具有以下有益效果：本申请通过在覆膜支架的周向上设置不同波形夹角的A区域和B区域，同时调整A区域的波高与B区域的波高的比值，使得A区域能够满足开窗的要求，同时B区域能够满足轴向支撑力，避免支架短缩至瘤腔内。此外，通过调整A区域的波高与波间距的比值及B区域的波高与波间距的比值，可以使 A区域的各个位置处都能较好的满足开窗的要求，提高支架的适应性，同时避免A区域和B区域内局部波形分布较密，影响支架在该位置的弯曲性能，或者使得A区域和B区域内局部波形分布较稀疏，导致支架在该位置的支撑效果差，容易发生变形。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明较佳实施例之一提供的一种直管形覆膜支架的示意图；
图2是图1所示覆膜支架的径向展开图；
图3a是图1所示覆膜支架的波形夹角为60°的示意图；
图3b是图1所示覆膜支架的波形夹角为90°的示意图；
图3c是图1所示覆膜支架的波形夹角为130°的示意图；
图4a是图1所示覆膜支架的相邻第一波形分段沿轴向无重叠时，相邻第一波形分段相位相反的示意图；
图4b是图1所示覆膜支架的相邻第一波形分段沿轴向无重叠时，相邻第一波形分段相位相同时的示意图；
图4c是图1所示覆膜支架的相邻第一波形分段沿轴向无重叠时，相邻第一波形分段具有相位差时的示意图；
图5是图1所示覆膜支架的相邻第一波形分段沿轴向有重叠时的示意图；
图6是图1所示覆膜支架的龙骨区在覆膜支架上分布的示意图；
图7是本发明较佳实施例之一提供的一种弯曲覆膜支架的结构示意图；
图8是图7所示覆膜支架的G部放大图；
图9是图7所示覆膜支架的第一弯曲段沿第一轮廓线拉直后的结构示意图；
图10是图7所示覆膜支架的波形环状物按其在第一轮廓线处的波间距重新沿轴向排布并覆膜后的结构示意图；
图11是图1所示覆膜支架的各圈波形环状物相互抵着时的结构示意图；
图12是本发明较佳实施例之二提供的一种覆膜支架的示意图；
图13是本发明较佳实施例之三提供的一种覆膜支架的结构示意图；
图14为图13所示覆膜支架沿第一箭头所示的方向弯曲后的结构示意图；
图15为图13所示覆膜支架沿第二箭头所示的方向弯曲后的结构示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
需要说明的是，采用“远端”、“近端”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。轴向，指平行于医疗器械远端中心和近端中心连线的方向；径向，指垂直于上述轴向的方向，离轴线的距离，指沿上述径向抵达轴线的距离。
如图1所示，本发明较佳实施例之一提供了一种覆膜支架，其大致为两端开口，中空的管状结构，覆膜支架包括多圈波形环状物101，以及固定在多圈波形环状物101上以连接多圈波形环状物101的覆膜200。
覆膜200大致为中间封闭，两端开口的管腔结构，其采用具有良好生物相容性的高分子材料制成，如e-PTFE、PET材料等。覆膜200固定在多圈波形环状物101上，并围合成具有纵轴的管腔，当支架植入血管后，该管腔作为血流流过的通道。
波形环状物101采用具有良好生物相容性的材料制成，如镍钛、不锈钢等材料。多圈波形环状物101从近端到远端依次排布，优选为平行间隔排布。可以理解的是，本实施例并不限定多圈波形环状物101的具体排布方式，多圈波形环状物101还可以连接成网格状结构。每一圈波形环状物101为闭合圆柱状结构，其包括多个近端顶点102、多个远端顶点103、以及连接相邻的近端顶点102与远端顶点103的支撑体104，近端顶点102和远端顶点103分别对应为波形的波峰或波谷。多圈波形环状物101间具有相同或相似的 波形形状，例如，波形环状物101可以是Z形波、M形波、V形波、正弦型波结构、或其它可径向压缩为很小直径的结构等。
覆膜支架可以通过以下方式制备：将金属丝编织成所需波形，该金属丝可采用镍钛合金丝，丝径例如为0.35mm；经热定型后，采用钢套套接金属丝的两个端部，并通过机械压紧的方式固定，使金属丝和钢套连接紧固，从而形成金属环。波形环状物101制作完成后，在依次排布的多圈波形环状物101的表面覆膜。例如，可以在多圈波形环状物101的内表面和外表面整体覆e-PTFE膜，多圈波形环状物101位于两层覆膜200之间，通过高温加压的方式，将内外层的e-PTFE覆膜粘接在一起，从而将多圈波形换环状物101固定在两层覆膜之间。可以理解的是，在其它实施例中，也可以将多圈波形环状物101缝合固定在PET膜上。
当然，当波形环状物101通过金属管整体切割形成时，不需要通过钢套固定连接。或者，还可采用焊接的方式固定金属丝的两个端点来形成波形环状物。
参见图1，覆膜支架沿圆周方向包括A区域，及与A区域相连的B区域，图中虚线所围区域即为B区域。波形环状物101包括位于A区域的第一波形分段，及位于B区域的第二波形分段，第一波形分段的波形夹角α为70°～120°，第一波形分段的波高L1与相邻第一波形分段的间距L2的比值为1/4～3；第二波形分段的波形夹角α为30°～60°，第二波形分段的波高L3与相邻第二波形分段的间距L4的比值为1/4～3/2，第一波形分段的波高L1与第二波形分段的波高L3的比值大于等于1/3，且小于1。所说的波形夹角α指的是连接在同一近端顶点102或远端顶点103两侧的支撑体104间的夹角。
对覆膜支架进行原位开窗时，先用穿刺部件在覆膜上刺一个小孔，然后采用球囊扩张小孔，扩张至所需的尺寸。参见图3a、图3b和图3c，图3a、3b和3c中波形环状物101的波高相同，波形夹角分别为60°、90°和130°。用直径为D1(D1优选为3mm～18mm)的球囊分别在各圈波形环状物101的对应位置处扩一个相同尺寸的圆，此处所说的对应位置指的是球囊的圆心分别与图3a、3b和3c中波形环状物101的近端顶点之间连线的距离相 等，且该连线沿覆膜支架的轴线方向。图中阴影线为球囊扩出的窗的形状，由图示可知，当波形夹角为90°和130°时，可以扩出满足尺寸要求的窗，而波形夹角为60°的波形环状物101会限制开窗的尺寸，使开窗边缘沿着波形环状物101。图示中，直径为D2(D2＝110％D1)的圆所覆盖的波形环状物101的区域为波形环状物101给开窗边缘提供支撑的区域，即波形环状物101与直径为D2的圆的相交段对应的角度δ越大，波形环状物101给开窗边缘提供支撑的效果越强。由图示可知，当波形夹角越大时，波形环状物101与直径为D2的圆的相交段对应的角度δ越小，波形环状物101无法给开窗边缘提供足够的支撑。
由上述可知，当某一区域的波形环状物101的波形夹角较大时，波形环状物101不会限制开窗的尺寸，有利于开窗，但是若波形夹角过大，会导致开窗边缘远离波形环状物101，波形环状物101无法给开窗边缘提供足够的支撑，若开窗边缘没有波形环状物101的支撑，窗口在分支支架径向力的作用下会进一步扩大，最终导致分支支架与该支架分离。并且波形环状物101的波形夹角过大，还会导致该区域沿覆膜支架的圆周方向分布的波形个数过少，不利于维持覆膜支架的管腔形态。而当某一区域的波形环状物101的波形夹角较小时，虽然可以给开窗边缘提供足够的支撑，但是波形夹角太小，会限制开窗的尺寸，使得开窗尺寸较难满足分支血管的尺寸。并且，由于波形环状物101具有一定的刚性，在外力作用下不易变形，当开窗部件抵接至波形环状物101后，容易造成波形环状物101断裂或使波形环状物101相对覆膜200发生过度移位，影响覆膜支架的径向支撑效果。
本申请通过在覆膜支架的周向上设置不同波形夹角的A区域和B区域，同时调整A区域的波高与B区域的波高的比值，使得A区域能够满足开窗的要求，同时B区域能够满足轴向支撑力，避免支架短缩至瘤腔内。此外，通过调整A区域的波高与波间距的比值及B区域的波高与波间距的比值，可以使A区域的各个位置处都能较好的满足开窗的要求，提高支架的适应性，同时避免A区域和B区域内局部波形分布较密，影响支架在该位置的弯曲性能，或者使得A区域和B区域内局部波形分布较稀疏，导致支架在该位置的 支撑效果差，容易发生变形。
参见图2，第一波形分段包括多个第一近端顶点102a、多个第一远端顶点103a，及连接相邻第一近端顶点102a与第一远端顶点103a的第一支撑体104a。第二波形分段包括至少一个第二近端顶点102b、至少一个第二远端顶点103b，及连接相邻第二近端顶点102b与第二远端顶点103b的第二支撑体104b。其中，第一波形分段的波高L1指的是第一近端顶点102a与第一远端顶点103a之间沿轴向的距离，相邻第一波形分段的间距L2为第一波形分段上的第一近端顶点102a与相邻的第一波形分段上的第一近端顶点102a沿轴向的距离。第二波形分段的波高L3指的是第二近端顶点102b与第二远端顶点103b之间沿轴向的距离，相邻第二波形分段的间距L4为第二波形分段上第二近端顶点102b与相邻的第二波形分段上的第二近端顶点102b沿轴向的距离。在图示的实施例中，第一远端顶点103a与第二远端顶点103b位于垂直于支架的纵向中心轴的同一平面内。
当波形环状物101的波高太小时，不仅不利于波形加工，还会导致覆膜支架的径向支撑效果差，而当波形环状物101的波高太大时，会使支架的抗变形能力差，支架容易发生打折。故L1、L3满足3mm≤L1≤15mm，8mm≤L3≤18mm。优选的，6mm≤L1≤12mm，12mm≤L3≤14mm。
A区域的多个第一波形分段沿轴向间隔排列，当相邻第一波形分段的相位不同时，相邻第一波形分段之间可供开窗的面积也不相同。图4a、图4b和图4c依次为当相邻第一波形分段沿轴向无重叠时，在相邻第一波形分段的波形结构和波间距相等的情况下，相邻第一波形分段在相位相反、相位相同和具有相位差时的示意图。所说的相位相反指的是相邻第一波形分段的波峰与波谷相对，所说的相位相同指的是相邻第一波形分段的波峰与波峰相对，所说的相位差指的是相邻第一波形分段的波峰与波峰及波谷相互错开。由图示可知，当相邻第一波形分段的相位相反时，相邻第一波形分段之间可供开窗的面积最大，当相邻第一波形分段的相位相同时，可供开窗的面积最小。但是，当相邻第一波形分段的相位相同时，开窗区域分布比较均匀。
为了满足支架的开窗需求，可以通过调整第一波形分段的波高以及波高 与波间距的比值，来适应不同的相位情况。在相邻第一波形分段沿轴向无重叠的情况下，当第一波形分段的波峰与相邻的第一波形分段上对应的波峰的连线平行于覆膜支架的母线时，1/3≤L1/L2≤1，4mm≤L1≤12mm；当相邻第一波形分段的波峰与相邻的第一波形分段上对应的波谷的连线平行于覆膜支架的母线时，1/4≤L1/L2≤3/4，4mm≤L1≤14mm；当第一波形分段的波峰与相邻的第一波形分段上对应的波峰的连线与覆膜支架的母线相倾斜，且与相邻的第一波形分段上对应的波谷的连线也与覆膜支架的母线相倾斜时，1/4≤L1/L2≤1，4mm≤L1≤14mm。结合图5所示，在相邻第一波形分段沿轴向有重叠的情况下，1＜L1/L2≤3，5mm≤L1≤15mm。此处对应的波峰指的是，相比于相邻的第一波形分段上的其它波峰，第一波形分段的波峰与该波峰的连接距离最短；对应的波谷指的是，相比于相邻的第一波形分段上的其它波谷，第一波形分段的波峰与该波谷的连接距离最短。
结合图1和图6所示，A区域包括两个子区域，分别为沿圆周方向分布的大弯侧区100a和小弯侧区100b。其中，大弯侧区100a的波形夹角为80°～100°，优选为90°，小弯侧区100b的波形夹角为75°～95°，优选为80°。第一波形分段在大弯侧区100a的波高与第一波形分段在小弯侧区100b的波高的比值为0.7～1，相邻第一波形分段在大弯侧区100a的波间距与在小弯侧区100b的波间距的比值为0.7～1，且大弯侧区100a在覆膜支架的外表面上覆盖的面积与小弯侧区100b在覆膜支架的外表面上覆盖的面积的比值为0.7～1.3。在图示的实施例中，大弯侧区100a在覆膜支架的外表面上覆盖的面积与小弯侧区100b在覆膜支架的外表面上覆盖的面积相等，第一波形分段在大弯侧区100a的波高均相等，相邻第一波形分段在大弯侧区100a的波间距均相等。同样，第一波形分段在小弯侧区100b的波高也均相等，相邻第一波形分段在小弯侧区100b的波间距也均相等。
在图示的实施例中，大弯侧区100a与小弯侧区100b沿圆周方向相对设置，B区域连接在大弯侧区100a与小弯侧区100b之间。可以理解的是，A区域还可以根据需要划分为三个或更多沿圆周方向分布的子区域，各个子区域可以间隔排布，或者连续排布，并且每一子区域的波形分段的波形、波形个 数、波形高度与波形角度均可根据需要设置。
进一步的，B区域沿轴向的短缩率小于A区域沿轴向的短缩率，且覆膜支架在B区域沿轴向的短缩率为10％～40％。
覆膜支架沿轴向的短缩率的计算方式为：覆膜支架为直管形，其在自然状态下沿轴向的长度为r，直径为d1，将该覆膜支架套在直径为d2(d2比d1小，优选d2＝90％*d1)的内管上，对覆膜支架施加沿轴向的压力F，1N≤F≤2N，覆膜支架无法再短缩时B区域的总长度为s，覆膜支架在B区域沿轴向的短缩率为(r-s)/r×100％。其中，(r-s)即为覆膜支架可以短缩的最大值。将覆膜支架套在该内管外进行短缩，可以有效避免支架短缩时发生打折的现象，即本申请的(r-s)是覆膜支架在不打折时，可以短缩的最大值。
当覆膜支架为锥台形，即两端直径不一样大，其在自然状态下沿轴向的长度为r，大端直径为d1，小端直径为d3，将该覆膜支架套在和覆膜支架同锥度的圆椎内管上或锥台内管上，该覆膜支架与圆锥内管或锥台内管之间的垂直距离为0.05d1。固定覆膜支架小端位置不变，在大端施加沿轴向的压力F，1N≤F≤2N，覆膜支架无法再短缩时的总长度为s，覆膜支架沿轴向的短缩率为(r-s)/r×100％。其中，(r-s)即为覆膜支架可以短缩的最大值。将覆膜支架套在该内管外进行短缩，可以有效避免支架短缩时发生打折的现象，即本申请的(r-s)是覆膜支架在不打折时，可以短缩的最大值。
当覆膜支架本身被制作成弯曲形状时，如图7所示，覆膜支架包括第一弯曲段400a和第二弯曲段400b，第一弯曲段400a具有位于其大弯侧的第一轮廓线401a和位于其小弯侧的第二轮廓线402a，第二弯曲段400b具有位于其大弯侧的第三轮廓线401b和位于其小弯侧区的第四轮廓线402b。此时，该覆膜支架的弯曲段的短缩率具有两种计算方式，一种计算方式为：一并参见图8，以第一弯曲段400a为例，用垂直于覆膜支架轴向的平面109将第一弯曲段400a分割出来，在靠近第二轮廓线402a的覆膜200上剪若干个缺口403，该缺口403的大小能保证覆膜支架沿第一轮廓线401a拉直(或者，在靠近第二轮廓线402a的覆膜200上剪若干个缺口403，该缺口403的大小刚好能保证覆膜支架沿第一轮廓线401a拉直)，第一弯曲段400a拉直后如图9所示， 拉直后的第一弯曲段400a的长度为r，直径为d1，将拉直后的第一弯曲段400a套在直径为d2(d2比d1小，优选d2＝90％*d1)的内管上，对覆膜支架施加沿轴向的压力F，1N≤F≤2N，覆膜支架无法再短缩时B区域的总长度为s，覆膜支架在B区域沿轴向的短缩率为(r-s)/r×100％。另一种计算方式为：同样以第一弯曲段400a为例，将波形环状物101按其在第一轮廓线401a处的波间距重新沿轴向排布，并重新对波形环状物101进行覆膜(覆膜材料与工艺选择保持和原支架一致)，如图10所示，然后按照上述短缩率的计算方法进行计算。
覆膜支架弯曲时，当B区域或A区域中的任意一个区域达到可以短缩的最大值时，该区域会形成一个刚性的轴向支撑结构，使覆膜支架无法继续弯曲。参见图11，当覆膜支架弯曲时，覆膜支架的一圈波形环状物101与固定在该波形环状物101上的覆膜200一起沿压力的方向移动，固定在该波形环状物101上的覆膜200带动分布在该波形环状物101周边的覆膜200一起移动，随即分布在该波形环状物101周边的覆膜200拉动附近的另一圈波形环状物101朝靠近该波形环状物101的一侧移动，直至波形环状物101无法继续移动时，会在覆膜支架上形成一个刚性的轴向支撑结构，使支架不再继续短缩。
当覆膜支架在B区域沿轴向的短缩率小于10％时，使得B区域的短缩率太小，无论支架朝哪个方向弯曲，B区域很容易达到可以短缩的最大值，使B区域无法再短缩，从而限制支架继续弯曲。当覆膜支架在B区域沿轴向的短缩率大于40％时，将导致支架的轴向支撑效果差，支架的远端向近端短缩时可能进入瘤腔，危及患者生命。当覆膜支架在B区域的短缩率为10％～40％时，不仅可以使支架朝各个方向弯曲，使支架适应弯曲的血管，还能为支架提供足够的轴向支撑，达到轴向防短缩的作用，从而维持覆膜支架的管腔形态。参见图7，覆膜支架可以分别朝不同的方向弯曲，实现连续弯曲，从而更好的适应血管形态。优选的，覆膜支架在B区域沿轴向的短缩率为20％～30％。
参见图6，B区域在覆膜支架的外表面上覆盖的圆周角度为ε°，15°≤ ε°≤90°。当ε°＜15°时，B区域在覆膜支架的外表面上覆盖的圆周角度较小，会导致整个覆膜支架的轴向支撑效果差，覆膜支架在血流冲击下会容易发生摆动和回缩，最终导致支架缩回到瘤腔内，危及患者生命；当ε°＞90°时，B区域在覆膜支架的外表面上覆盖的圆周角度较大，不利于支架弯曲。当15°≤ε°≤90°时，既能给覆膜支架提供足够的轴向支撑，还能保证覆膜支架用于更加弯曲的血管时，也不发生打折，保持管腔通畅，使覆膜支架适应血管形态的范围更广。
本实施例中，B区域沿圆周方向划分为两个龙骨区，分别为第一龙骨区300a和第二龙骨区300b，两个龙骨区分别位于大弯侧区100a与小弯侧区100b之间。第一龙骨区300a和第二龙骨区300b在覆膜支架的外表面上覆盖的圆周角度为15°～45°，优选为20°～30°，第一龙骨区300a和第二龙骨区300b覆盖的圆周角度可以相同，也可以不同。可以理解的是，B区域还可以根据需要划分为三个或更多龙骨区，各个龙骨区可以间隔排布，或者连续排布，并且每一龙骨区的波形分段的波形、波形个数、波形高度与波形角度均可根据需要设置。
在图示的实施例中，第二波形分段包括一个第二近端顶点102b，相邻第二波形分段的第二近端顶点102b之间的连线平行于覆膜支架的轴线。
进一步的，参见图1和图2，所述多圈波形环状物101的一端设置有至少一圈近端波形环状物101a。
其中，近端波形环状物101a的波形夹角为30°～60°，近端波形环状物101a与波形环状物101的波形相同，都为V形波、Z形波或M形波等，且近端波形环状物101a沿圆周方向的波形个数大于波形环状物101沿圆周方向的波形个数。由于位于覆膜支架端部的近端波形环状物101a沿圆周方向的波形个数较多，使得覆膜支架端部的径向支撑力更大，可以有效提高覆膜支架端部的贴壁效果。
可以理解的是，所述多圈波形环状物101的另一端还可以设置至少一圈远端波形环状物(未示出)，远端波形环状物的波形夹角为50°～70°，远端波形环状物与波形环状物101的波形也相同，都为V形波、Z形波或M形波 等，远端波形环状物沿圆周方向的波形个数也大于波形环状物101沿圆周方向的波形个数。其中，近端波形环状物及远端波形环状物均采用具有良好生物相容性的材料制成，如镍钛、不锈钢等材料。近端波形环状物与远端波形环状物均为闭合圆柱状结构。近端波形环状物及远端波形环状物可以是Z形波、M形波、V形波、正弦型波结构、或其它可径向压缩为很小直径的结构等。可以理解的是，不仅近端波形环状物及远端波形环状物的圈数可根据需要设置，同时各圈近端波形环状物及远端波形环状物中的波形、波形个数及波形高度均可根据需要设置。
进一步的，覆膜支架还包括锚定裸支架105，该锚定裸支架105位于覆膜支架的一端或两端，与近端波形环状物或远端波形环状物相连接。
图12示出了本发明较佳实施例之二提供的一种覆膜支架，其与实施例之一的不同之处在于，相邻第二波形分段的第二近端顶点102b之间的连线相对覆膜支架的轴线倾斜设置。
图13示出了本发明较佳实施例之三提供的一种覆膜支架，其与实施例之一的不同之处在于，连接在第二近端顶点102b一侧、靠近大弯侧区100a的第二支撑体104b沿平行于覆膜支架的轴向分布，连接在该第二近端顶点102b另一侧、靠近小弯侧区100b的第二支撑体104b相对于覆膜支架的轴线方向倾斜设置。
当图13的覆膜支架沿第一箭头500所示的方向弯曲时，参见图14，相邻第二波形分段的靠近大弯侧区100a的第二支撑体104b相互抵接形成轴向支撑，相邻第二波形分段的靠近大弯侧区100a的第二支撑体104b间的夹角为η°。当图13的覆膜支架沿第二箭头600所示的方向弯曲时，参见图15，相邻第二波形分段的靠近小弯侧区100b的第二支撑体104b相互抵接形成轴向支撑，相邻第二波形分段的靠近小弯侧区100b的第二支撑体104b间的夹角为θ°。由图示可知，η°＜θ°。当相邻第二波形分段的第二支撑体104b相互抵接形成轴向支撑时，若相邻第二波形分段的第二支撑体104b之间的夹角越大，分解到支架轴向上的力越小，对支架的轴向支撑效果越差。故图14中沿平行于覆膜支架的轴向分布的第二支撑体104b相互抵接时形成的轴向支 撑效果优于图15中相对于覆膜支架的轴线方向倾斜设置的第二支撑体104b相互抵接时形成的轴向支撑效果。同时，当相邻第二波形分段的第二支撑体104b之间的夹角越大时，容易造成龙骨区的覆膜过度变形，导致覆膜支架表面不平，容易导致血栓的形成。
由于当沿平行于覆膜支架的轴向分布的第二支撑体104b相互抵接形成轴向支撑时，相邻第二波形分段的第二支撑体104b之间的夹角最小，支架的轴向支撑力最大。故将沿平行于覆膜支架的轴向分布的第二支撑体104b设置在靠近大弯侧区100a的一侧，当支架朝向小弯侧弯曲时，该第二支撑体104b可以为支架提供足够的轴向支撑力，对支架的轴向支撑效果最好。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种覆膜支架，包括多圈波形环状物，其特征在于，所述覆膜支架沿圆周方向包括A区域，及与所述A区域相连的B区域，所述波形环状物包括位于所述A区域的第一波形分段，及位于所述B区域的第二波形分段，所述第一波形分段的波形夹角范围为70°～120°，所述第一波形分段的波高与相邻所述第一波形分段的间距的比值范围为1/4～3；所述第二波形分段的波形夹角为30°～60°，所述第二波形分段的波高与相邻所述第二波形分段的间距的比值为1/4～3/2，所述第一波形分段的波高与所述第二波形分段的波高的比值大于等于1/3，且小于1。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述A区域包括沿圆周方向分布的大弯侧区和小弯侧区，所述大弯侧区的波形夹角为80°～100°，所述小弯侧区的波形夹角为75°～95°。
  3. 根据权利要求2所述的覆膜支架，其特征在于，所述第一波形分段在所述大弯侧区的波高与所述第一波形分段在所述小弯侧区的波高的比值为0.7～1。
  4. 根据权利要求2所述的覆膜支架，其特征在于，相邻所述第一波形分段在所述大弯侧区的波间距与在所述小弯侧区的波间距的比值为0.7～1。
  5. 根据权利要求2所述的覆膜支架，其特征在于，所述大弯侧区在覆膜支架的外表面上覆盖的面积与所述小弯侧区在所述覆膜支架的外表面上覆盖的面积的比值为0.7～1.3。
  6. 根据权利要求2所述的覆膜支架，其特征在于，所述大弯侧区与所述小弯侧区沿圆周方向对称设置，所述B区域位于所述大弯侧区与所述小弯侧区之间。
  7. 根据权利要求1所述的覆膜支架，其特征在于，所述B区域沿圆周方向上的夹角为15°～90°。
  8. 根据权利要求1所述的覆膜支架，其特征在于，当所述第一波形分段的波峰与相邻的所述第一波形分段上对应的波峰的连线平行于所述覆膜支架 的母线时，1/3≤L1/L2≤1，4mm≤L1≤12mm。
  9. 根据权利要求8所述的覆膜支架，当所述第一波形分段的波峰与相邻的所述第一波形分段上对应的波谷的连线平行于所述覆膜支架的母线时，1/4≤L1/L2≤3/4，4mm≤L1≤14mm。
  10. 根据权利要求1所述的覆膜支架，其特征在于，所述第一波形分段的波高为3mm～15mm，所述第二波形分段的波高为8mm～18mm。
PCT/CN2018/120319 2017-12-27 2018-12-11 覆膜支架 WO2019128701A1 (zh)

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