WO2019042202A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2019042202A1
WO2019042202A1 PCT/CN2018/101759 CN2018101759W WO2019042202A1 WO 2019042202 A1 WO2019042202 A1 WO 2019042202A1 CN 2018101759 W CN2018101759 W CN 2018101759W WO 2019042202 A1 WO2019042202 A1 WO 2019042202A1
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WO
WIPO (PCT)
Prior art keywords
diaphragm
stent graft
stent
membrane
rod
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Application number
PCT/CN2018/101759
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English (en)
French (fr)
Inventor
肖本好
王逸斐
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
Publication of WO2019042202A1 publication Critical patent/WO2019042202A1/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
    • A61F2/02—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

Definitions

  • the invention relates to the field of interventional medical device technology, in particular to a stent graft.
  • a stent graft can be used to perform an endovascular exclusion to isolate a lesion in a human lumen.
  • a stent graft can be used to isolate an arterial dissection or an aneurysm in a blood vessel.
  • Such methods have the advantages of small surgical trauma, low intraoperative blood transfusion, rapid postoperative recovery, and short hospital stay, and thus have gradually replaced traditional open surgery.
  • the stent graft generally comprises a metal stent and a permeation-proof coating material, and the coating material encapsulates the metal stent, and when released at the lesion position, the coating material functions to isolate blood flow.
  • the ePTFE material has a high elongation and is easily deformed. At the same time, the ePTFE material has a certain viscosity. When the temperature reaches 327 degrees, the ePTFE material will melt, and after cooling, the films will adhere to each other, and the bonding strength is obviously improved. Using this characteristic, the commonly used stent grafts generally use the structure of ePTFE inner membrane, metal stent, and ePTFE outer membrane.
  • the metal stent After high temperature treatment, the metal stent is wrapped and fixed by the bonding force between the inner and outer membranes. Since the metal stent is fixed after the film is fixed, the deformability of the stent is often limited. For the stent graft that needs to achieve greater flexibility, a partial coating is generally used to reduce the binding of the coating material to the metal stent.
  • the commonly used partial stent graft is a strip-like membrane, that is, the inner membrane covers the inner wall of the lumen of the entire metal stent, and is responsible for isolating blood flow in the body.
  • the outer film is partially covered in the strip form on the outer wall of the metal bracket to achieve the fixation of the metal bracket, wherein the area not covered by the outer membrane can provide a space for the metal bracket to be displaced relative to achieve the flexibility of the stent graft.
  • FIG. 1 is a schematic structural view of a stent graft 11 in the prior art.
  • the stent graft 11 includes a metal stent and a coating covering the metal stent.
  • the metal bracket includes a plurality of axially arranged coils 12, and the coating includes an inner membrane 14 and a plurality of outer membranes 16 attached to the inner membrane 14.
  • the inner membrane 14 covers the inner wall of the metal stent, and the outer membrane 16 has a strip structure.
  • Each of the outer membranes 16 covers a coil 12 from the circumferential direction of the metal stent, and exposes the crests and troughs of the coil 12, so that the coil 12 can be relatively displaced in the axial direction to improve the deformability of the stent graft.
  • the peaks/valleys of the coils 12 that are close to each other easily interfere with the outer membrane 16, which easily causes the outer membrane 16 to deform, tear, or even fall off, affecting the coating.
  • the safety performance of the membrane stent 11 is used, and the coverage area of the outer membrane 16 is reduced.
  • the possibility of interference between the peaks and troughs and the outer membrane during deformation can be reduced to some extent, the flexibility of the stent graft 12 is improved, but This may result in a small bonding strength between the outer membrane 16 and the inner membrane 14, resulting in an easy loosening or even falling off of the outer membrane.
  • a stent graft comprising a bare stent and a coating attached to the bare stent, the coating comprising a first membrane and a second membrane bonded to the first membrane, the first membrane a sheet covering a surface of the bare holder, the second diaphragm covering the surface of the bare holder away from the first diaphragm, the bare bracket including a plurality of axially distributed coils, the coil includes a plurality of peaks, a plurality of troughs, and a plurality of rods connecting the peaks and the troughs, the second diaphragm covering at least one of the rods, exposing the peaks and the troughs, and the The angle between the direction in which the second diaphragm extends at the position of the covered body and the axial direction of the stent graft is no more than 75°.
  • the angle between the extending direction of the rod and the extending direction of the second diaphragm covering the rod body is 90 ⁇ 20°.
  • At least three of the rods of each of the coils are covered with the second diaphragm.
  • the rods of the coil are covered with the second diaphragm.
  • the second diaphragm is a plurality of strips, and at least one of the second diaphragms covers at least two of the coils.
  • At least one of the second diaphragms covers all of the coils of the bare stent.
  • the second diaphragm is a plurality of strips, and at least one of the second diaphragms covers at least two of the rods of the coil.
  • the second diaphragm is folded back to cover the rod adjacent thereto after covering the rod of the coil.
  • the widths of the portions of the second diaphragm are equal and the second diaphragm is located in the middle of the shaft.
  • the length of the portion of the rod covered with the second diaphragm in the direction in which the rod extends is not less than 1/5 of the length of the rod in the direction in which the rod extends.
  • the second diaphragm encloses a plurality of parallelogram grids.
  • the number of the rods of each of the coils is equal.
  • a plurality of the coils form a mesh structure in an axial direction, and the peaks of two adjacent coils are disposed opposite to the troughs and are interlocked with each other to form an interlocking structure.
  • the second diaphragm on the rod of the coil that is hung by the peak position extends in a direction substantially parallel to the other An extending direction of the rod body adjacent to the same side of the rod body and on the same side of the rod.
  • the above-mentioned stent graft is exposed to the peaks and/or valleys of the coils under the same conditions, that is, when the bare stents are the same and the widths of the second membranes are the same, compared with the strip-shaped stent grafts coated along the circumferential direction.
  • the axial length of the region is large, so that the movable distance between the coils is large, so that the flexibility of the stent graft can be improved under the condition of ensuring stability.
  • each of the second diaphragms can extend to cover all the coils, and each of the second diaphragms can have a larger length, which can improve the bonding strength between each of the second diaphragms and the first diaphragm, and improve the stability of the stent. Sex, it can also reduce the number of second diaphragms, reduce the difficulty of coating, and improve production efficiency.
  • the second diaphragms in different directions can also be connected to each other, which can further improve the bonding strength between the second diaphragm and the coil, and improve the stability of the stent.
  • FIG. 1 is a schematic structural view of a stent graft in the prior art
  • FIG. 2 is a partial structural schematic view of the stent graft shown in FIG. 1 during deformation
  • FIG. 3 is a schematic structural view of a stent graft according to a first embodiment of the present invention.
  • FIG. 4 is a schematic structural view of a bare stent of the stent graft shown in FIG. 3;
  • Figure 5 is a partial structural schematic view of the stent graft shown in Figure 3 after deployment;
  • Figure 6 is a partial structural view showing the second diaphragm of Figure 3 mated with the rod body;
  • FIG. 7 is a schematic structural view of a second diaphragm of a stent graft and a bare stent according to an embodiment of the present invention.
  • Figure 8 is a schematic structural view of a stent graft according to a second embodiment of the present invention.
  • Figure 9 is a schematic structural view of a stent graft according to a third embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a bare stent of the stent graft shown in FIG. 9;
  • Figure 11 is a schematic structural view of a stent graft according to a fourth embodiment of the present invention.
  • Figure 12 is a schematic view showing the structure of the chimney bracket and the aortic stent graft
  • Figure 13 is a schematic view showing the structure of the fenestration bracket and the aortic stent graft.
  • the "film-covered stent” refers to a structure in which the surface of the bare stent is covered with a film
  • the bare stent refers to a structure including a plurality of corrugated rings and no film between the corrugated rings.
  • the stent graft 10 includes a bare stent 100 and a film 200 connected to the bare stent 100 .
  • the film 200 includes a first film 210 and a second film 220 that is bonded to the first film 210.
  • the first diaphragm 210 covers the surface of the bare stent 100 to block blood flow and prevent blood flow from flowing from the inside to the outside of the stent graft 10.
  • the second diaphragm 220 covers the surface of the bare stent 100 away from the first diaphragm 210 to fix the bare stent 100 between the first diaphragm 210 and the second diaphragm 220.
  • the first diaphragm 210 is located on the inner surface of the bare stent 100, and the second diaphragm 220 is located on the outer surface of the bare stent 100.
  • the first diaphragm 210 may also be located on the outer surface of the bare bracket 100, and the second diaphragm 220 is located on the inner surface of the bare bracket 100.
  • the first diaphragm 210 and the second diaphragm 220 are both made of ePTFE (expanded polytetrafluoroethylene), and the bare bracket 100 is composed of a coil of nickel-titanium wire.
  • ePTFE expanded polytetrafluoroethylene
  • the bare stent 100 includes a plurality of axially distributed coils 110.
  • the coil 110 includes a plurality of peaks 111, a plurality of valleys 113, and a plurality of rods connecting the adjacent peaks 111 and the valleys 113.
  • the second diaphragm 220 covers at least one of the rods 112, and exposes the peaks 111 and the troughs 113.
  • the angle between the extending direction of the second diaphragm 220 at the position of the covered rod 112 and the axial direction of the stent graft 10 is not more than 75°.
  • the angle between the extending direction of the second diaphragm 220 at the position of the covered rod 112 and the axial direction of the stent graft 10 is not more than 65°.
  • the stent graft 10 has a peak 111 and/or a trough of the coil 110 under the same conditions, that is, when the bare stent is the same and the width of the second diaphragm is the same as that of the strip-shaped stent graft coated in the circumferential direction.
  • the axial length of the exposed area at 113 is large, so that the movable distance between the coils 110 is large, so that the flexibility of the stent graft 10 can be improved under the condition of ensuring stability.
  • the angle between the extending direction of the second diaphragm 220 at the position of the covered rod 112 and the axial direction of the stent graft is 30° to 60° to further increase the exposed area at the peak 111 and/or the valley 113
  • the axial length further enhances the compliance of the stent graft 10.
  • the angle between the extending direction of the rod 112 and the extending direction of the second diaphragm 220 covering the rod 112 is 90 ⁇ 20°, that is, the second diaphragm 220 extends along the rod 112.
  • the direction covers the rod 112 in a direction of 90 ⁇ 20°.
  • a plurality of extending directions may appear on one second diaphragm 220, and the extending direction of the second diaphragm 220 refers to an extending direction of a portion of the second diaphragm 220 covering the rod 112.
  • the second diaphragm 220 can change the extending direction in a region not covered by the rod 112 so as to be at an appropriate angle with the extending direction of the rod 112. . Further, the angle between the extending direction of the rod 112 and the extending direction of the second diaphragm 220 covering the rod 112 is 90 ⁇ 10°, which helps the second diaphragm 220 to do without changing the extending direction. It is possible to cover more of the wave ring 110 to reduce the difficulty of the film and improve the production efficiency.
  • the extending direction of the second diaphragm 220 is parallel to the extending direction of the adjacent rod 112 covering the rod 112 of the second diaphragm 220. That is, the angle between the second diaphragm 220 and the rod 112 covered with the second diaphragm 220 is equal to the angle with the rod 112 adjacent to the rod 112 at the peak position.
  • the angles of the two rods 112 at the positions of the corresponding peaks 111 and/or the valleys 113 of the respective coils 110 are equal, which may contribute to the second diaphragm 220 being as far as possible without changing the extension. Cover more circles. Specifically, the number of the rods 112 in each of the coils 110 is equal, which may contribute to the improvement of the uniformity of the stent graft 10. More specifically, the lengths of the rods 112 in each of the coils 110 are equal. The angle between adjacent rods 112 in each of the coils 110 is not equal.
  • the number of the plurality of the coils 110 may not be exactly equal, the lengths of the rods 112 may not be equal, and the angle between the two rods 112 may not be completely equal.
  • the angle between the rods 112 may not be equal, and the lengths of the rods 112 may not be completely equal.
  • the plurality of coils 110 form a mesh structure in the axial direction, and the peaks 111 of the adjacent two coils 110 are disposed opposite to the valleys 113, and are interlocked with each other to form an interlocking structure.
  • the second diaphragm 220 on one of the rods 112 of the coil 110 that is buckled by the peak position extends substantially parallel to the other coil 110 and the rod 112.
  • the extending direction of the connected and identical sides of the rod, that is, from the top to the bottom, of the four interconnected rods 112, the second diaphragm 220 on the rod 112 of the lower coil 110 is extending substantially parallel.
  • the extending direction of the rod 112 on the same side as the rod 112 covered with the second diaphragm 220 can further increase the axial length of the exposed portion at the position of the peak 111 and/or the valley 113, thereby improving the coating.
  • the widths of the portions of the second diaphragm 220 are equal, and the second diaphragm 220 is located in the middle of the rod 112.
  • the length W of the portion of the rod 112 covered with the second diaphragm 220 in the extending direction of the rod 112 is not less than 1/5 of the total length L of the rod 112 in the extending direction of the rod 112, so that the coil 110 can be made 110.
  • the exposed areas at the peaks 111 and troughs 113 are larger, such that the relative displacement of the peaks 111 or troughs 113 is greater, the compliance of the stent graft 10 is better, and the second diaphragm 220 and the first diaphragm 210 are The contact area is large, so that the stability of the stent graft 10 is good.
  • the length W of all the portions of the rod body 112 covered with the second diaphragm 220 in the extending direction of the rod body 112 are equal to improve the uniformity of the stent graft 10.
  • the length W of the portion of the different rod body 112 covered with the second diaphragm 220 in the direction in which the rod body 112 extends may not be completely equal.
  • rod 112 can be linear. It will also be appreciated that the shaft 112 may also be non-linear, for example, a portion or all of the shaft 112 may be serrated.
  • the widths of the portions of the second diaphragm 220 may not be completely equal, for example, the edges of the second diaphragm 220 are saw-toothed.
  • At least three rods 112 of each of the coils 110 are covered with a second diaphragm 220 to improve the bonding strength of the bare stent 100 and the coating 200, and to prevent the bare stent 100 from falling off the coating 200.
  • all the rods 112 of the coil 110 are covered with the second diaphragm 220.
  • the second diaphragm 220 may cover only a portion of the rod 112 on the coil 110 under the premise of ensuring stability.
  • the second diaphragm 220 is a plurality of strips, and at least one second diaphragm 220 covers at least two coils 110 to increase the contact area of the second diaphragm 220 with the first diaphragm 210, and increase the second.
  • the bonding strength of the diaphragm 220 and the first diaphragm 210 can also reduce the number of the second diaphragm 220 and improve production efficiency.
  • At least one second diaphragm 220 covers all the coils 110 of the bare stent 100, that is, the second diaphragm 220 extends from the rod 112 of the first coil 110 to the rod 112 of the last coil 110, The second diaphragm covers the rod 112 of all the coils 110 passing through, so that the area covered by the second diaphragm 220 is longer, the bonding strength of the second diaphragm 220 of the first diaphragm 210 can be increased, and the second diaphragm can be lowered.
  • 220 has the probability of loosening, and can also reduce the number of the second diaphragm 220 under the same conditions, reduce the difficulty of the coating process, and improve the production efficiency.
  • each of the second diaphragms 220 may cover only one rod 112 of one of the coils 110. It can also be understood that, when the angle between the second diaphragm 220 and the rod 112 is satisfied, and the second diaphragm 220 does not cover the peaks 111 and the troughs 113, the second diaphragm 220 can span as much as possible.
  • the coil 110 is used to increase the bonding strength of the second diaphragm 220.
  • the second diaphragm 220 when the second diaphragm 220 extends from the axial direction of the shaft 112 of the coil 110 at an angle to the axial direction of the stent graft 10, in this direction, if the second diaphragm 220 needs to cover another wave When the crests 111 or troughs 113 of the circle 110, the second diaphragm 220 may end when the coil 110 is not reached. It can also be understood that the second diaphragm 220 can change the extending direction on the stent graft 10 along with the arrangement of the bare stent 100 to accommodate the rods 112 in different extending directions, so that one second diaphragm 220 can cover as much as possible. All the waves 110.
  • the number of the second diaphragms 220 is plural, and the number of the second diaphragms 220 is equal to the number of the rods 112 on the coil 110.
  • the second diaphragm 210 extends from the position of one of the rods 112 of the first coil 110 to the rod 112 of the second coil 110 in a direction that is at an appropriate angle to the axial direction. Then, it extends to the third wave ring 110 until the rod body 112 extends to the last wave ring 110. At this time, the film of the second diaphragm 220 is completed, and then the second second film 220 is completed in the same manner. The film is so lowered that all of the rods 112 are covered with the second film 220.
  • the number of the second diaphragms 220 may also be less than the number of the rods 112 on the coil 110.
  • the at least one second diaphragm 220 covers at least two rods 112 of one of the coils 110, that is, the at least one second diaphragm 220 has two different extending directions.
  • the second diaphragm 220 is folded back to cover the rod 112 adjacent thereto after covering the rod 112 of the wave ring 110 at the end, that is, the second diaphragm 220 covers the end from one direction to the end.
  • the second diaphragm 220 After the rod 112 of the coil 110 is bent around the rod 112, one end of the second diaphragm 220 passes through the inner surface of the rod 112 and passes out from the rod 112 adjacent to the rod 112, and then starts. Covering of the rod 112 in the other direction.
  • the second diaphragm 220 can realize all the rods 112 covering all the coils 110 without failing in a folded manner, that is, all the rods 112 on the bare bracket 100 can be realized by one second diaphragm 220. Coverage to further simplify the laminating process and increase production efficiency.
  • the second diaphragm 220 can also be covered by folding back only at a partial position.
  • the second diaphragm 220 is only folded at the position of the end coil 110 at the end, so that the second diaphragm 220 Covering all of the rods 112 can be achieved by only being equal to half the number of rods on the coil 110.
  • each of the rods 112 of the coil 110 is covered with a second diaphragm 220, and each of the second diaphragms 220 covers all of the coils 110.
  • the second diaphragm 220 is formed to form a plurality of parallelogram grids, and the second diaphragms 220 are connected to each other, the joint strength is large, and the probability of the film 200 being loosened is reduced, and even the second diaphragm 220 is In some places, loosening occurs unexpectedly. Since the second diaphragms 220 are connected to each other, it is difficult to cause the entire second diaphragm 220 to fall off, further increasing the stability of the stent graft 10.
  • the second diaphragm 220 is surrounded by a plurality of diamond-shaped meshes, each having the same area to improve the uniformity of the coating 200.
  • the coating of the second diaphragm 220 in one direction is started from a rod 112 of the first coil 110 of the bare stent 100, wherein the second diaphragm 220 is diagonally crossed to the phase in a substantially vertical direction.
  • the rod 112 corresponding to the adjacent wave ring 110 reaches the last wave ring 110 of the bare frame 10, and after completing the coating of the first second film 220, the waveform from the first wave ring 110 adjacent to the rod 112
  • the rod 112 starts the coating of the second second diaphragm 220, and the direction of the second second diaphragm 220 is parallel to the direction of the first second diaphragm 220, so that all the second diaphragms 220 are completed in one direction.
  • the end of the stent graft 10 can also be provided with an extension section 130.
  • the extension section 130 is two, and the two extension sections 130 are respectively located at two ends of the stent graft 10.
  • the extension section 130 includes an extended bare bracket (obscured, not shown) and an extended film disposed on the extended bare bracket.
  • the extended film includes a third diaphragm (obscured, not shown) and attached to the third diaphragm.
  • the fourth diaphragm 131 is blocked (not shown), the third diaphragm is disposed on the surface of the extended bare bracket adjacent to the first diaphragm 210, and the fourth diaphragm 131 is disposed on the extended bare bracket away from the third diaphragm. surface.
  • the extended bare stent may be identical in structure to the bare stent 100 of the stent graft 10.
  • the third diaphragm and the first diaphragm may be an integrally formed structure, that is, the first diaphragm and the third diaphragm are integrated, that is, one film covers the stent graft 10 and the extension 20 at the same time.
  • the fourth diaphragm 131 may be cylindrical, and the fourth diaphragm 131 completely covers the extended bare bracket, that is, the extended bare bracket is completely covered by the third diaphragm and the fourth diaphragm 131.
  • the stent graft 10 has a peak 111 of the coil 110 and/or under the same conditions, that is, when the bare stent is the same and the width of the second membrane is the same as that of the strip-shaped stent graft coated along the circumferential direction.
  • the axial length of the exposed area at the valley 113 is large, so that the movable distance between the coils 110 is large, so that the flexibility of the stent graft 10 can be improved under the condition of ensuring stability.
  • each of the second diaphragms 220 can extend over all of the coils 110, and each of the second diaphragms 220 can have a larger length, which can improve the bonding strength of each of the second diaphragms 220 and the first diaphragm 210, and improve
  • the stability of the stent graft 10 can also reduce the number of the second membranes 220, reduce the difficulty of coating, and improve production efficiency.
  • the second diaphragms 220 in different directions can also be connected to each other, and the bonding strength between the second diaphragm 220 and the coil 110 can be further improved, and the stability of the stent graft 10 can be improved.
  • the shape of the second diaphragm 220a of the stent graft 10a of the second embodiment of the present invention is W-shaped. Specifically, after completing the covering of the first rod 112a of one of the coils 110a, the second diaphragm 220a is bent to change the direction to adapt to the coverage of the coil 110a and its adjacent rod 112a, according to the same method. To cover all of the rods 112a on the coil 110a. In the present embodiment, one of the coils 110a is covered by a second diaphragm 220a, and both ends of the second diaphragm 220a are connected end to end.
  • one of the coils 110a may also be covered by a plurality of second diaphragms 220a, and one second diaphragm 220a covers only a portion of the rods 112a of the coils 110a.
  • the above-mentioned stent graft 10a has a peak 111a and/or a valley 113a of the coil 110a under the same conditions, that is, when the bare stent is the same and the width of the second membrane is the same as that of the strip-shaped stent graft in the circumferential direction.
  • the axial length of the bare region is large, so that the movable distance between the coils 110a is large, so that the flexibility of the stent graft 10a can be improved under the condition of ensuring stability.
  • the stent graft 10b is formed by cutting a nickel-titanium tube.
  • the bare bracket 100b includes a plurality of axially spaced coils 110b, and a portion of the position between the coils 110b is connected by a connecting rod 120.
  • the structure of the second diaphragm 220b can be referred to the second diaphragm 220 of the embodiment 1.
  • the structure of the bare stent in the present invention is not limited thereto.
  • the bare stent can also be replaced with other structures under the condition that the bare stent meets the requirements of the stent graft.
  • the stent graft 10c of the fourth embodiment of the present invention comprises a straight pipe section 101 and a taper section 102 connected to the straight pipe section 101.
  • the diameters of the two ends of the taper section 102 are different.
  • the end of the taper section 102 connected to the straight pipe section 101 is the same as the diameter of the corresponding straight pipe section 101, and the film further includes a fifth diaphragm 230 that is attached to the first diaphragm 210c.
  • the fifth diaphragm 230 covers the straight pipe section 101 and The boundary line of the tapered section 102.
  • the taper segment 102 there are two straight pipe segments 101, which are respectively located at two ends of the taper segment 102.
  • the diameters of the two straight pipe segments 101 are different, and the fifth diaphragm 230 is two, and the two fifth diaphragms 230 are respectively
  • the boundary between the straight pipe section 101 and the tapered section 102 is covered and extends along the circumferential direction of the stent graft 10c.
  • the fifth diaphragm 230 covers the peaks and troughs at the junction to prevent the peaks and troughs at the position from being stabbed in the direction of the rod, thereby causing irritation to the blood vessel wall.
  • the width of the fifth diaphragm 230 covers at least one wave circle of the boundary position, and covers at most three wave circles closest to the boundary line, which can ensure the appearance of the boundary line and ensure the stent graft 10c. Flexibility. More preferably, the fifth diaphragm 230 covers the two coils at the interface.
  • the fifth diaphragm 230 overlies the second diaphragm 220c.
  • the second diaphragm 220c may also be overlaid on the third diaphragm 230.
  • the stent graft of the above embodiment can be applied to a position where the flexibility of the stent is required to be high, for example, the position where the aortic lumen is connected to the branch vessel.
  • the stent grafts 10, 10a, 10b, 10c can be implanted into the arterial lumen along with the aortic stent graft 40 as part of the chimney stent 20.
  • the middle portion of the inner layer bracket of the chimney bracket 20 adopts the film stent of the above embodiment, so that the middle portion of the chimney bracket 20 has high flexibility, thereby ensuring that the chimney bracket 20 can better adapt to the aorta to the branch.
  • the stent grafts 10, 10a, 10b, 10c can also be implanted into the window of the aortic stent graft 40 as part of the fenestration stent 30.
  • the middle portion of the inner layer bracket of the windowing bracket 30 adopts the film covering bracket of the above embodiment, so that the middle portion of the window opening bracket 30 has high flexibility, thereby ensuring that the window opening bracket 30 can better conform to the complexity.
  • the vascular anatomy does not occur at a discount or stenosis.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Diaphragms And Bellows (AREA)

Abstract

一种覆膜支架，包括裸支架及与所述裸支架连接的覆膜，所述覆膜包括第一膜片及与所述第一膜片贴合的第二膜片，所述裸支架包括多个沿轴向分布的波圈，所述波圈包括多个波峰、多个波谷及连接相邻所述波峰及所述波谷的多个杆体，所述第二膜片覆盖至少一所述杆体，并裸露出所述波峰及所述波谷，且所述第二膜片在被覆盖的所述杆体位置处的延伸方向与所述覆膜支架的轴向方向之间的夹角不大于75°。

Description

覆膜支架 技术领域
本发明涉及介入医疗器械技术领域，尤其涉及一种覆膜支架。
背景技术
目前可采用覆膜支架实施腔内隔绝术来隔离人体管腔内的病变区域，例如，可采用覆膜支架在血管中隔绝动脉夹层或动脉瘤。此类方法具有手术创伤小、术中输血量少、术后恢复快及住院时间短等优点，因此已逐步取代传统的开腔手术。
覆膜支架一般包括金属支架及防渗透的覆膜材料，覆膜材料将金属支架进行包裹，当在病变位置释放后，覆膜材料起到隔绝血流的作用。ePTFE材质的覆膜延伸率高易变形，同时ePTFE材质间具备一定粘性，当温度达到327度时ePTFE材质会融化，冷却后薄膜之间将会相互粘合，结合强度明显提升。利用该特性，目前比较常用的覆膜支架一般使用ePTFE内膜、金属支架、ePTFE外膜的结构，经过高温处理后通过内外膜间的结合力将金属支架包裹固定。由于金属支架被覆膜固定后往往会限制覆膜支架的变形能力，对于需要达到较大柔顺性的覆膜支架，其一般采用部分覆膜的方式来降低覆膜材料对金属支架的束缚。
目前，比较常用部分覆膜支架为条状覆膜的方式，即，内膜覆盖整个金属支架的管腔内壁，负责体内隔绝血流。外膜以条状形式在金属支架外壁部分覆盖，以实现金属支架的固定，其中未被外膜覆盖的区域，可以为金属支架提供相对位移的空间，以实现覆膜支架的柔顺性。
请参阅图1，其为现有技术中覆膜支架11的结构示意图。覆膜支架11包括金属支架及覆盖在金属支架上的覆膜。金属支架包括多个轴向排列的波圈12，覆膜包括内膜14及与内膜14贴合的多条外膜16，内膜14覆盖金属支架的内壁， 外膜16为条状结构，每一条外膜16从金属支架的圆周方向覆盖一个波圈12，且裸露波圈12的波峰及波谷，这样，波圈12能够在轴向上发生相对位移，以提高覆膜支架的变形能力。
请参阅图2，当覆膜支架11发生变形时，例如弯曲时，相互靠近的波圈12的波峰/波谷容易与外膜16发生干涉，容易导致外膜16变形、撕裂甚至脱落，影响覆膜支架11使用的安全性能，而减小外膜16的覆盖区域，虽然能够在一定程度上减少变形过程中波峰/波谷与外膜发生干涉的可能性，提高覆膜支架12的柔顺性，但这样可能会导致外膜16与内膜14的结合强度较小，导致外膜易松动甚至脱落。
发明内容
基于此，有必要提供一种覆膜支架，其柔顺性较好，稳定性较高。
一种覆膜支架，包括裸支架及与所述裸支架连接的覆膜，所述覆膜包括第一膜片及与所述第一膜片贴合的第二膜片，所述第一膜片覆盖所述裸支架的表面，所述第二膜片覆盖所述裸支架远离所述第一膜片的表面，所述裸支架包括多个沿轴向分布的波圈，所述波圈包括多个波峰、多个波谷及连接相邻所述波峰及所述波谷的多个杆体，所述第二膜片覆盖至少一所述杆体，并裸露出所述波峰及所述波谷，且所述第二膜片在被覆盖的所述杆体位置处的延伸方向与所述覆膜支架的轴向方向之间的夹角不大于75°。
在其中一个实施例中，所述杆体延伸方向与覆盖在所述杆体上的所述第二膜片的延伸方向的夹角为90±20°。
在其中一个实施例中，每一所述波圈的至少三个所述杆体上覆盖有所述第二膜片。
在其中一个实施例中，所述波圈的所述杆体均覆盖有所述第二膜片。
在其中一个实施例中，所述第二膜片为多条，至少一条所述第二膜片至少覆盖两个所述波圈。
在其中一个实施例中，至少一条所述第二膜片覆盖所述裸支架的所有所述波圈。
在其中一个实施例中，所述第二膜片为多条，至少一条所述第二膜片覆盖一所述波圈的至少两个所述杆体。
在其中一个实施例中，所述第二膜片在覆盖所述波圈的所述杆体后，折返以覆盖与其相邻的所述杆体。
在其中一个实施例中，所述第二膜片各部分的宽度均相等，且所述第二膜片位于所述杆体的中部。
在其中一个实施例中，所述杆体覆盖有所述第二膜片的部分沿杆体延伸方向的长度不小于所述杆体沿所述杆体延伸方向的长度的1/5。
在其中一个实施例中，所述第二膜片围设形成多个平行四边形网格。
在其中一个实施例中，各所述波圈的所述杆体的数量相等。
在其中一个实施例中，多个所述波圈在轴向方向上形成网状结构，且相邻两个波圈的所述波峰与所述波谷相对设置，并相互挂扣形成互锁结构。
在其中一个实施例中，两个相互挂扣的所述波圈中，通过所述波峰位置挂扣的所述波圈的所述杆体上的第二膜片的延伸方向大致平行于另一所述波圈中与该所述杆体相邻且同侧的所述杆体的延伸方向。
上述覆膜支架，与沿着圆周方向覆膜的条状覆膜支架相比，在同等条件下，即裸支架相同、第二膜片的宽度相同时，波圈的波峰和/或波谷处裸露区域的轴向长度较大，使得波圈间可移动的距离较大，从而可以在保证稳定性的条件下，提高覆膜支架的柔顺性。而且，每一条第二膜片可以延伸覆盖全部波圈，每一条第二膜片的长度可以较大，可以提高每条第二膜片与第一膜片的结合强度，提高覆膜支架的稳定性，同时还可以减少第二膜片的数量，降低覆膜难度，提高生产效率。此外，不同方向的第二膜片之间还可以相互连接，可以进一步提高第二膜片与波圈的结合强度，提高覆膜支架的稳定性。
附图说明
图1为现有技术中覆膜支架的结构示意图；
图2为图1所示的覆膜支架在变形过程中的局部结构示意图；
图3为本发明第一实施例的覆膜支架的结构示意图；
图4为图3所示的覆膜支架的裸支架的结构示意图；
图5为图3所示的覆膜支架展开后的局部结构示意图；
图6为图3中第二膜片与杆体配合的局部结构示意图；
图7为本发明一实施方式的覆膜支架的第二膜片与裸支架配合的结构示意图；
图8为本发明第二实施例的覆膜支架的结构示意图；
图9为本发明第三实施例的覆膜支架的结构示意图；
图10为图9所示的覆膜支架的裸支架的结构示意图；
图11为本发明第四实施例的覆膜支架的结构示意图；
图12为烟囱支架与主动脉覆膜支架相互配合的结构示意图；
图13为开窗支架与主动脉覆膜支架相互配合的结构示意图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
本申请中“覆膜支架”是指裸支架表面覆盖有薄膜后的结构，裸支架是指包括多个波形环状物且各波形环状物之间没有薄膜的结构。
以下将结合具体实施例进一步详细说明本发明的技术方案。
实施例1
请参阅图3，覆膜支架10包括裸支架100及与裸支架100连接的覆膜200。覆膜200包括第一膜片210及与第一膜片210贴合的第二膜片220。第一膜片210覆盖裸支架100的表面，以阻隔血流，防止血流从覆膜支架10的内侧流向外侧。第二膜片220覆盖裸支架100远离第一膜片210的表面，以将裸支架100固定在第一膜片210与第二膜片220之间。在本实施例中，第一膜片210位于裸支架100的内表面，第二膜片220位于裸支架100的外表面。当然，在其他实施例中，第一膜片210也可以位于裸支架100的外表面，第二膜片220位于裸支架100的内表面。
具体到本实施例中，第一膜片210和第二膜片220均采用ePTFE(膨体聚四氟乙烯)覆膜，裸支架100采用镍钛丝编织而成的波圈组成。
请一并参阅图4，裸支架100包括多个沿轴向分布的波圈110，波圈110包括多个波峰111、多个波谷113及连接相邻波峰111及波谷113之间的多个杆体112，第二膜片220覆盖至少一杆体112，并裸露出波峰111及波谷113。请一并参阅图5，第二膜片220在被覆盖的杆体112位置处的延伸方向与覆膜支架10的轴向方向之间的夹角不大于75°。优选地，第二膜片220在被覆盖的杆体112位置处的延伸方向与覆膜支架10的轴向方向的夹角不大于65°。上述覆膜支架10，与沿圆周方向覆膜的条状覆膜支架相比，在同等条件下，即裸支架相同、第二膜片的宽度相同时，波圈110的波峰111和/或波谷113处裸露区域的轴向长度较大，使得波圈110间可移动的距离较大，从而可以在保证稳定性的条件下，提高覆膜支架10的柔顺性。
优选地，第二膜片220在被覆盖的杆体112位置处的延伸方向与覆膜支架的轴向方向的夹角为30°～60°，以进一步增加波峰111和/或波谷113处裸露区域的轴向长度，进一步提高覆膜支架10的柔顺性。
请一并参阅图5，杆体112的延伸方向与覆盖在杆体112上的第二膜片220的延伸方向的夹角为90±20°，也就是说，第二膜片220沿着杆体112延伸方向呈90±20°的方向覆盖杆体112。需要说明的是，一条第二膜片220上可能出现多个延伸方向，第二膜片220的延伸方向是指第二膜片220覆盖在杆体112上的部分的延伸方向。当第二膜片220覆盖有两个不同延伸方向的杆体112时，第二膜片220可以在未与杆体112覆盖的区域改变延伸方向，以使与该杆体112的延伸方向呈合适的夹角。更进一步地，杆体112的延伸方向与覆盖在杆体112上的第二膜片220的延伸方向的夹角为90±10°，有助于第二膜片220在不改变延伸方向的条件下尽可能覆盖较多的波圈110，以降低覆膜的难度，提高生产效率。优选的，第二膜片220的延伸方向与覆盖有第二膜片220的杆体112的相邻的杆体112的延伸方向平行。即，第二膜片220与覆盖有第二膜片220的杆体112之间的夹角等于与该杆体112在波峰位置处与其相邻的杆体112的夹角。
请继续参阅图4，各波圈110在对应的波峰111和/或波谷113位置处的两个 杆体112的夹角相等，可以有助于第二膜片220在不改变延伸的条件下尽可能覆盖较多的波圈。具体地，各波圈110中的杆体112的数量相等，可以有助于提高覆膜支架10的一致性。更具体地，各波圈110中杆体112的长度均相等。各波圈110中相邻杆体112之间的夹角不相等。可以理解的是，在其他实施例中，多个波圈110的杆体数量也可以不完全相等，杆体112的长度也可以不相等，两个杆体112之间的夹角也可以不完全相等。例如，当裸支架100为锥台状时，杆体112之间的夹角可以不相等，杆体112的长度也可以不完全相等。
具体到本实施例中，多个波圈110在轴向方向上形成网状结构，且相邻两个波圈110的波峰111与波谷113相对设置，并相互挂扣形成互锁结构。优选的，两个相互挂扣的波圈110中，通过波峰位置挂扣的波圈110的其中一杆体112上的第二膜片220的延伸方向大致平行于另一波圈110与该杆体112相连且同侧的杆体的延伸方向，也就是说，从上往下看，四根相互连接的杆体112中，位于下方的波圈110的杆体112上的第二膜片220的延伸方向大致平行于上方波圈中与覆盖有第二膜片220的杆体112同侧的杆体112的延伸方向，这样可以进一步加大波峰111和/或波谷113位置处裸露区域的轴向长度，提高覆膜支架10的柔顺性。需要说明的是，本申请中的大致平行是指两个方向之间的夹角可以在180°±10°的范围内变化。
请继续参阅5，第二膜片220各部分的宽度均相等，且第二膜片220位于杆体112的中部。请一并参阅图6，杆体112覆盖有第二膜片220的部分沿杆体112延伸方向的长度W不小于杆体112沿杆体112延伸方向上的总长度L的1/5，可以使得波圈110的波峰111及波谷113处的裸露区域较大，这样波峰111或波谷113处发生相对位移的长度较大，覆膜支架10的柔顺性较好，而且第二膜片220与第一膜片210的接触面积较大，使得覆膜支架10的稳定性较好。在本实施例中，所有杆体112覆盖有第二膜片220的部分沿杆体112延伸方向的长度W均相等，以提高覆膜支架10的一致性。当然，在其他实施例中，不同杆体112覆盖有第二膜片220的部分沿杆体112延伸方向的长度W也可以不完全相等。
可以理解的是，杆体112可以为直线型。还可以理解的是，杆体112还可以为非直线型，例如，杆体112的一部分或全部呈锯齿状。
需要说明的是，在某些实施例中，第二膜片220各部分的宽度也可以不完全相等，例如，第二膜片220的边缘呈锯齿状。
请继续参阅图5，每一波圈110的至少三个杆体112上覆盖有第二膜片220，以提高裸支架100与覆膜200的结合强度，避免裸支架100从覆膜200上脱落。具体到本实施例中，波圈110的所有杆体112上均覆盖有第二膜片220。当然，在其他实施例中，在保证稳定性的前提下，第二膜片220也可以只覆盖波圈110上的部分杆体112。
请继续参阅图5，第二膜片220为多条，至少一条第二膜片220至少覆盖两个波圈110，以增加第二膜片220与第一膜片210的接触面积，增加第二膜片220与第一膜片210的结合强度，还可以减少第二膜片220的数量，提高生产效率。更进一步地，至少一条第二膜片220覆盖裸支架100的所有波圈110，即，第二膜片220从第一个波圈110的杆体112开始延伸至最后一个波圈110的杆体112，第二膜片覆盖途经的所有波圈110的杆体112，这样，第二膜片220覆盖的区域较长，可以增加第一膜片210的第二膜片220的结合强度，降低第二膜片220出现松脱的概率，而且还可以减小相同条件下第二膜片220的数量，降低覆膜工艺难度，提高生产效率。
可以理解的是，当波圈110的杆体112之间排列不规律时，每一条第二膜片220也可以只覆盖一个波圈110的一个杆体112。还可以理解的是，在满足第二膜片220与杆体112之间夹角的要求下，且第二膜片220不覆盖波峰111及波谷113时，第二膜片220可以尽可能跨越更多的波圈110，以提高第二膜片220的结合强度。具体地，当第二膜片220从一个波圈110的杆体112与覆膜支架10的轴向方向呈一定夹角延伸时，在此方向上，若第二膜片220需要覆盖到另一波圈110的波峰111或波谷113时，第二膜片220可以在没有达到该波圈110时即结束。还可以理解的是，第二膜片220在覆膜支架10上可以随着裸支架100的排列而改变延伸方向以适应不同延伸方向的杆体112，以使得一条第二膜片220可以尽可能覆盖所有的波圈110。
更进一步地，裸支架100的所有波圈110的所有杆体112上均覆盖有第二膜片220，以进一步提高覆膜支架10的稳定性。具体地，第二膜片220为多条， 第二膜片220的数量等于波圈110上杆体112的数量。覆膜时，从第一个波圈110的其中一个杆体112的位置，将第二膜片210沿着与轴向方向呈合适夹角的方向延伸至第二个波圈110的杆体112上，随后延伸至第三个波圈110，直至延伸至最后一个波圈110的杆体112，此时完成一条第二膜片220的覆膜，然后再按照同样的方法完成第二条第二膜片220的覆膜，如此下去，以使所有的杆体112上均覆盖有第二膜片220。
需要说明的是，第二膜片220的数量还可以少于波圈110上的杆体112的数量。具体地，至少一条第二膜片220覆盖一波圈110的至少两个杆体112，即，至少一条第二膜片220具有两个不同的延伸方向。例如，请参阅图7，第二膜片220在覆盖端部的波圈110的杆体112后，折返以覆盖与其相邻的杆体112，即，第二膜片220从一个方向覆盖至端部的波圈110的杆体112后，绕着该杆体112折弯，以使第二膜片220的一端从该杆体112的内表面穿过并从与该杆体112相邻的杆体112穿出，再开始另一个方向上的杆体112的覆盖。在本实施例中，第二膜片220可以以折返的方式实现不间断覆盖所有波圈110的所有杆体112，即，通过一条第二膜片220即可实现裸支架100上的所有杆体112的覆盖，以进一步简化覆膜过程，提高生产效率。当然，第二膜片220也可以只在部分位置通过折返的方式覆膜，例如，第二膜片220只在末端的波圈110的位置通过折返的方式覆膜，这样，第二膜片220可以只等于波圈110上杆体数量的一半也可以实现所有杆体112的覆盖。
请参阅图5，波圈110的每一杆体112上覆盖有一个第二膜片220，且每一第二膜片220覆盖所有的波圈110。优选地，第二膜片220围设形成多个平行四边形网格，第二膜片220之间相互连接，结合强度较大，减少覆膜200发生松脱的概率，而且即使第二膜片220在某些地方意外发生松脱，由于第二膜片220之间相互连接，这样较难发生整条第二膜片220的脱落，进一步增加覆膜支架10的稳定性。更优选地，第二膜片220围设形成多个菱形网格，每一菱形网格的面积均相等，以提高覆膜200的一致性。具体在本实施例中，从裸支架100的第一个波圈110的一杆体112开始一个方向的第二膜片220的覆膜，其中第二膜片220以大致垂直的方向斜跨至相邻波圈110对应的杆体112，直至裸支架 10的最后一个波圈110，完成第一条第二膜片220的覆膜后，从第一个波圈110与该杆体112相邻的波形的杆体112开始第二条第二膜片220的覆膜，第二条第二膜片220的方向与第一条第二膜片220的方向平行，如此直至完成一个方向上所有第二膜片220的覆盖，然后在第一个波圈110的另一杆体112上以与其呈大致垂直的方向覆盖所经过的杆体112，以同样的方法完成与该方向平行的所有第二膜片220的覆膜。
在本实施例中，覆膜支架10的端部还可以设置有延长段130，延长段130为两个，两个延长段130分别位于覆膜支架10的两端。延长段130包括延长裸支架(被遮挡，图未示)及设置于延长裸支架上的延长覆膜，延长覆膜包括第三膜片(被遮挡，图未示)及与第三膜片贴合的第四膜片131(被遮挡，图未示)，第三膜片设置于延长裸支架靠近第一膜片210的表面，第四膜片131设置于延长裸支架远离第三膜片的表面。具体地，延长裸支架可与覆膜支架10的裸支架100的结构相同。第三膜片与第一膜片可为一体成型结构，即，第一膜片与第三膜片为一个整体，也就是说，一张膜同时覆盖覆膜支架10及延长段20。第四膜片131可为筒状，第四膜片131完全覆盖延长裸支架，即延长裸支架完全被第三膜片与第四膜片131包裹住。
上述覆膜支架10，与沿着圆周方向覆膜的条状覆膜支架相比，在同等条件下，即裸支架相同、第二膜片的宽度相同时，波圈110的波峰111和/或波谷113处裸露区域的轴向长度较大，使得波圈110间可移动的距离较大，从而可以在保证稳定性的条件下，提高覆膜支架10的柔顺性。而且，每一条第二膜片220可以延伸覆盖全部波圈110，每一条第二膜片220的长度可以较大，可以提高每条第二膜片220与第一膜片210的结合强度，提高覆膜支架10的稳定性，同时还可以减少第二膜片220的数量，降低覆膜难度，提高生产效率。此外，不同方向的第二膜片220之间还可以相互连接，可以进一步提高第二膜片220与波圈110的结合强度，提高覆膜支架10的稳定性。
实施例2
请参阅图8，与实施例1不同的是，本发明第二实施例的覆膜支架10a的第二膜片220a的形状呈W型。具体地，第二膜片220a在完成一个波圈110a的第 一个杆体112a的覆盖后，弯折以改变方向，使其适应该波圈110a与其相邻的杆体112a的覆盖，按照相同的方法，以覆盖该波圈110a上的所有杆体112a。在本实施例中，一个波圈110a由一条第二膜片220a覆盖，第二膜片220a的两端首尾连接。
当然，在其他实施例中，一个波圈110a还可以由多条第二膜片220a，一条第二膜片220a仅覆盖波圈110a的部分杆体112a。
上述覆膜支架10a，与沿圆周方向的条状覆膜支架相比，在同等条件下，即裸支架相同、第二膜片的宽度相同时，波圈110a的波峰111a和/或波谷113a处裸露区域的轴向长度较大，使得波圈110a间可移动的距离较大，从而可以在保证稳定性的条件下，提高覆膜支架10a的柔顺性。
实施例3
请参阅图9，与实施例1不同的是，本发明第三实施例中的覆膜支架10b，裸支架100b采用镍钛管经切割而形成。具体地，请一并参阅图10，裸支架100b包括多个沿轴向间隔排列的波圈110b，波圈110b之间的部分位置通过连接杆120连接。第二膜片220b的结构可参照实施例1的第二膜片220。
需要说明的是，本发明中的裸支架的结构不局限于此。在裸支架满足覆膜支架的要求的条件下，裸支架还可以用其他结构代替。
实施例4
请参阅图11，与实施例1不同的是，本发明第四实施例中的覆膜支架10c，包括直管段101及与直管段101连接的锥度段102，锥度段102两端部的直径不同，锥度段102与直管段101连接的一端与对应的直管段101的直径相同，覆膜还包括与第一膜片210c贴合的第五膜片230，第五膜片230覆盖直管段101与锥度段102的交界线。
在图示的实施例中，直管段101为两个，分别位于锥度段102的两端，两个直管段101的直径不同，第五膜片230为两个，两个第五膜片230分别覆盖直管段101与锥度段102的交界线，且沿覆膜支架10c的周向延伸。具体的，第五膜片230覆盖位于交界处的波峰及波谷，避免该位置的波峰及波谷沿杆体的方向刺出，而对血管壁造成刺激。优选的，第五膜片230的宽度覆盖交界线 位置的至少一个波圈，最多覆盖最接近交界线的三个波圈，既可以保证交界线处的外观形态，同时也可以保证覆膜支架10c的柔顺性。更优选的，第五膜片230覆盖交界处的两个波圈。
在图示的实施例中，第五膜片230覆盖在第二膜片220c上。当然，在其他实施例中，第二膜片220c也可以覆盖在第三膜片230上。
上述实施例中的覆膜支架可运用到对支架柔顺性要求较高的位置，例如，主动脉腔与分支血管连接的位置。请参阅图12，覆膜支架10、10a、10b、10c可作为烟囱支架20的一部分与主动脉覆膜支架40一并植入动脉腔内。具体的，烟囱支架20的内层支架的中部采用上述实施例的覆膜支架，这样使得烟囱支架20的中部具有较高的柔顺性，从而可以保证烟囱支架20能够较好地适应主动脉到分支血管的过渡。请参阅图13，覆膜支架10、10a、10b、10c还可作为开窗支架30的一部分植入到主动脉覆膜支架40的窗口内。具体的，开窗支架30的内层支架的中部采用上述实施例的覆膜支架，这样使得开窗支架30的中部具有较高的柔顺性，从而可以保证开窗支架30能够较好地顺应复杂的血管解剖形态，不发生打折或狭窄。
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 (15)

  1. 一种覆膜支架，包括裸支架及与所述裸支架连接的覆膜，其特征在于，所述覆膜包括第一膜片及与所述第一膜片贴合的第二膜片，所述第一膜片覆盖所述裸支架的表面，所述第二膜片覆盖所述裸支架远离所述第一膜片的表面，所述裸支架包括多个沿轴向分布的波圈，所述波圈包括多个波峰、多个波谷及连接相邻所述波峰及所述波谷的多个杆体，所述第二膜片覆盖至少一所述杆体，并裸露出所述波峰及所述波谷，且所述第二膜片在被覆盖的所述杆体位置处的延伸方向与所述覆膜支架的轴向方向之间的夹角不大于75°。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述杆体延伸方向与覆盖在所述杆体上的所述第二膜片的延伸方向的夹角为90±20°。
  3. 根据权利要求1所述的覆膜支架，其特征在于，每一所述波圈的至少三个所述杆体上覆盖有所述第二膜片。
  4. 根据权利要求3所述的覆膜支架，其特征在于，所述波圈的所述杆体均覆盖有所述第二膜片。
  5. 根据权利要求1所述的覆膜支架，其特征在于，所述第二膜片为多条，至少一条所述第二膜片至少覆盖两个所述波圈。
  6. 根据权利要求5所述的覆膜支架，其特征在于，至少一条所述第二膜片覆盖所述裸支架的所有所述波圈。
  7. 根据权利要求1所述的覆膜支架，其特征在于，所述第二膜片为多条，至少一条所述第二膜片覆盖一所述波圈的至少两个所述杆体。
  8. 根据权利要求7所述的覆膜支架，其特征在于，所述第二膜片在覆盖所述波圈的所述杆体后，折返以覆盖与其相邻的所述杆体。
  9. 根据权利要求1所述的覆膜支架，其特征在于，所述第二膜片各部分的宽度均相等，且所述第二膜片位于所述杆体的中部。
  10. 根据权利要求9所述的覆膜支架，其特征在于，所述杆体覆盖有所述第二膜片的部分沿杆体延伸方向的长度不小于所述杆体沿所述杆体延伸方向的长度的1/5。
  11. 根据权利要求1所述的覆膜支架，其特征在于，所述第二膜片围设形 成多个平行四边形网格。
  12. 根据权利要求1～11任一所述的覆膜支架，其特征在于，各所述波圈的所述杆体的数量相等。
  13. 根据权利要求12所述的覆膜支架，其特征在于，多个所述波圈在轴向方向上形成网状结构，且相邻两个所述波圈的所述波峰与所述波谷相对设置，并相互挂扣形成互锁结构。
  14. 根据权利要求13所述的覆膜支架，其特征在于，两个相互挂扣的所述波圈中，通过所述波峰位置挂扣的所述波圈的所述杆体上的第二膜片的延伸方向大致平行于另一所述波圈中与该所述杆体相邻且同侧的所述杆体的延伸方向。
  15. 根据权利要求1所述的覆膜支架，其特征在于，所述覆膜支架包括直管段及与所述直管段连接的锥度段，所述锥度段两端的直径不同，所述锥度段与所述直管段连接的一端与对应的所述直管段的直径相同，所述覆膜还包括与所述第一膜片贴合的第五膜片，所述第五膜片覆盖在所述直管段与所述锥度段的交界线。
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