WO2018010546A1 - 分支型覆膜支架 - Google Patents

分支型覆膜支架 Download PDF

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Publication number
WO2018010546A1
WO2018010546A1 PCT/CN2017/090588 CN2017090588W WO2018010546A1 WO 2018010546 A1 WO2018010546 A1 WO 2018010546A1 CN 2017090588 W CN2017090588 W CN 2017090588W WO 2018010546 A1 WO2018010546 A1 WO 2018010546A1
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WIPO (PCT)
Prior art keywords
projection
guiding
film
section
segment
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Ceased
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PCT/CN2017/090588
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English (en)
French (fr)
Inventor
刘彩萍
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Publication of WO2018010546A1 publication Critical patent/WO2018010546A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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

Definitions

  • the invention relates to the field of interventional medical device technology, in particular to a branch type stent graft.
  • a stent graft has been used to treat an aneurysm. Specifically, the compressed stent graft is loaded into the delivery system and transported along the guide wire to the lesion site for release, forming a new blood flow channel. After the aneurysm loses blood flow, the expanded tumor wall shrinks under negative pressure and returns to the original form, thereby achieving the purpose of treating the aneurysm.
  • FIG. 1 is a schematic diagram of a common iliac artery aneurysm involving the internal iliac artery.
  • the radial artery includes the right common iliac artery 11, the right internal iliac artery 12, the right external iliac artery 13, the left common iliac artery 14, and the left iliac artery.
  • the internal artery 15 and the left external iliac artery 16 are schematic diagrams of a common iliac artery aneurysm involving the internal iliac artery.
  • the radial artery includes the right common iliac artery 11, the right internal iliac artery 12, the right external iliac artery 13, the left common iliac artery 14, and the left iliac artery.
  • the internal artery 15 and the left external iliac artery 16 are examples of a common iliac artery 16 .
  • the aneurysm 17 occurs at the right common iliac artery 11 and involves the right internal iliac artery 12, which includes the aneurysm initiation site 18 and the aneurysm end site 19, wherein the aneurysm initiation site 18 is located in the right common iliac artery 11.
  • the end portion of the aneurysm 19 is located in the right internal iliac artery 12, and is partially located in the right external iliac artery 13, and the space between the initial site 18 of the aneurysm and the end portion 19 of the aneurysm constitutes a tumor cavity.
  • the prior art uses a branch-type stent graft to treat an aneurysm at a branch vessel site.
  • the branch-type stent graft 2 includes a body 21, a main branch 22, and a side branch 23.
  • the main body 21 and the lateral branch 23 are released in the right common iliac artery 11, the main body 21 covers the aneurysm initiation site 18, and the proximal end of the main body 21 is anchored on the normal vascular wall of the right common iliac artery 11; the main branch 22 The distal end is released in the right external iliac artery 13; the proximal end of the lateral branch 23 connected to the main body 21 is located below the initial site 18 of the aneurysm, and the distal end of the lateral branch 23 is located above the end of the aneurysm 19, that is, the lateral branch 23 accommodates Within the tumor cavity, and the inner diameter of the side branch 23 is constant from the proximal end to the distal end. Since the side branch 23 is located within the tumor cavity, the proximal opening of the side branch 23 can be normally opened, and the distal end of the side branch 23 can be changed by a certain angle depending on the position of the branch vessel.
  • a peripheral stent-graft 24 is released through the side branch 23 into the right internal iliac artery 12, and is connected to the side branch 23. This ensures the patency of the right internal iliac artery 12 and complete isolation of the aneurysm 17.
  • the outer diameter of the side branches 23 is designed to be small, so that the side branches 23 can be smoothly deployed in the tumor cavity, and thus can be branched on the side. 23 is connected to the peripheral stent graft 24 to complete the arterial reconstruction.
  • the outer diameter of the side branch 23 is small, the inner diameter of the proximal end of the side branch 23 is directly caused to be small, which makes it difficult to establish the orbit in the side branch 23 of the guide wire, and may even cause a surgical failure.
  • aneurysms are located in a relatively distorted blood vessel, so that the branched stent-graft placed at the twisted portion is also twisted, which tends to cause the proximal opening of the side branch to be compressed or even closed. This also makes it impossible for the guide wire to smoothly pass through the proximal opening of the side branch to establish a guidewire track, and may even lead to surgical failure.
  • the present invention provides a branch type stent graft comprising a main body, a main branch, a side branch and a transition section, wherein the main branch and the side branch are connected to the main body through the transition section, and the side branch includes a guiding segment directly connected to the transition segment, and a connecting segment connected to the guiding segment, the guiding segment comprising a guiding segment coating, the covering stent comprising an intersection of the guiding segment and the connecting segment a connecting surface surrounded by the line, and a projection surface passing through an intersection of the central axis of the connecting portion and the connecting surface and perpendicular to a central axis of the connecting portion, the proximal end of the guiding segment film being on the projection surface
  • the projected area is larger than the projected area of the distal end of the guiding segment film on the projection surface.
  • the projection of the distal end of the guiding segment coating on the projection surface is within a projection of the proximal end of the guiding segment coating on the projection surface.
  • the projection of the distal end of the guiding segment coating on the projection surface is inscribed on the projection of the proximal end of the guiding segment coating on the projection surface.
  • the guiding section further comprises a guiding section bare bracket, the transition section comprising a transition section film and a transition section bare bracket, at least one corrugated ring in the transition section bare bracket and the At least one corrugated annulus in the lead segment bare stent is combined into a closed loop that is simultaneously attached to the transition segment coating and the guiding segment coating.
  • the projection of the intersection of the proximal end of the guide section and the transition section in a plane perpendicular to the body axis is within a projection of the body on a plane perpendicular to its axis.
  • the projection of the main branch on a plane perpendicular to the body axis circumscribes the intersection of the proximal end of the guiding segment and the transition segment in a plane perpendicular to the body axis Projection on.
  • the projection of the main branch in a plane perpendicular to the body axis coincides with the projection of the body on a plane perpendicular to its axis.
  • the projection of the intersection of the proximal end of the guiding section and the transition section on a plane perpendicular to the body axis falls on the projection of the body on a plane perpendicular to its axis On the boundary line.
  • the main branch includes a main branch film and a main branch bare stent provided on the main branch film, and the proximal end of the guiding segment film is adjacent to the main branch film The ends are connected.
  • a portion of the side edges of the guide segment film are joined to a portion of the side edges of the main branch film.
  • the branch type stent graft of the present invention wherein the side branch includes the guiding section and the connecting section, and a projected area of the proximal end of the guiding section film on the projection surface is larger than the guiding section
  • the projected area of the distal end of the membrane on the projection surface thus, when the branching stent graft is implanted into the blood vessel, the guidewire is threaded from the body through the transition section into the lateral branch
  • the guide wire easily enters the guiding segment from the transition section and continues into the connecting section until the guide wire passes out of the side branch and into the right internal iliac artery, ensuring the guidewire track Smooth establishment.
  • Figure 1 is a schematic representation of a common iliac artery aneurysm involving the internal iliac artery.
  • Fig. 2 is a view showing the effect of the prior art branch-type stent graft implanted in the common iliac artery aneurysm shown in Fig. 1.
  • Fig. 3 is a view showing the effect of implanting the branch-type stent graft shown in Fig. 2 with the peripheral stent graft in the common iliac artery aneurysm shown in Fig. 1.
  • Fig. 4 is a schematic view showing a branch type stent graft according to a first embodiment of the present invention.
  • Fig. 5 is a schematic view showing a film of the branch type stent graft shown in Fig. 4.
  • Fig. 6 is a schematic view showing a main body coating film, a main branch coating film, and a transition portion coating film of the coating film of the branch type stent graft shown in Fig. 5.
  • Figure 7 is a plan view of Figure 6.
  • FIG. 8(a) to 8(b) are schematic views of the guide segment coating and the connecting segment coating of the coating shown in Fig. 5; wherein Fig. 8(a) is a front view and Fig. 8(b) is a plan view.
  • Fig. 9 is a view showing the effect of implanting the branch-type stent graft of Fig. 4 into the common iliac artery aneurysm shown in Fig. 1.
  • Fig. 10 is a view showing the effect of further joining the outer peripheral stent graft on the basis of Fig. 9.
  • Figure 11 is a schematic illustration of a distorted radial artery with a common aneurysm involving the internal iliac artery.
  • Fig. 12 is a view showing the effect of implanting the branch-type stent graft of Fig. 4 into the common iliac artery aneurysm shown in Fig. 11.
  • Fig. 13 is a view showing the effect of further joining the outer peripheral stent graft on the basis of Fig. 12.
  • FIGS. 14(a) to 14(b) are schematic views showing a deformation of the film of the guiding section and the film of the connecting section shown in Figs. 8(a) to 8(b); wherein Fig. 14(a) is a front view, Fig. 14 (b) is a plan view.
  • Fig. 15 is a view showing another structure of the film of the branch type stent graft shown in Fig. 4.
  • FIG. 16(a) to 16(c) are schematic diagrams showing the main body coating, the main branching film, and the transitional section coating of the coating film of the branch type stent graft shown in Fig. 15; wherein, Fig. 16(a) is mainly FIG. 16(b) is a left side view, and FIG. 16(c) is a top view.
  • Figure 17 (a) - Figure 17 (b) is a schematic view of the guiding section coating and the connecting section coating of the coating of the branch type stent graft shown in Figure 15; wherein Figure 17 (a) is a front view, Figure 17 ( b) is a top view.
  • Fig. 18 is a schematic view showing a coating film of a branch type stent graft according to a second embodiment of the present invention.
  • FIG. 19(a) to 19(c) are schematic views of the main body coating, the main branching film, and the transitional section coating of the coating film of the branch type stent graft shown in Fig. 18; wherein, Fig. 19(a) is mainly 19(b) is a left side view, and FIG. 19(c) is a top view.
  • Figure 20 (a) - Figure 20 (b) is a schematic view of the guiding section coating and the connecting section coating of the coating of the branch type stent graft shown in Figure 18; wherein Figure 20 (a) is a front view, Figure 20 ( b) is a top view.
  • blood flow is defined from the proximal end of the stent graft to the distal end of the 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 along the longitudinal direction and no film between the corrugated rings.
  • the branch-type stent graft 100 includes a main body 101 , a main branch 102 , a side branch 103 , and a transition section 104 .
  • the main branch 102 and the side branch 103 are connected to the main body 101 through the transition section 104 .
  • the main body 101 includes a main body film 1011 and a main body bare bracket 1012 disposed on the main body film 1011;
  • the main branch 102 includes a main branch film 1021 and a main branch bare bracket 1022 provided on the main branch film 1021;
  • the transition portion 104 includes The transition section film 1041 and the transition section bare bracket 1042 provided on the transition section film 1041.
  • the side branch 103 includes a guiding section 1031 and a connecting section 1032.
  • the proximal end of the guiding section 1031 is connected to the transition section 104, and the distal end of the guiding section 1031 is connected to the proximal end of the connecting section 1032, that is, the connecting section 1032 passes through the guiding section 1031.
  • the connecting section 1031 includes a guiding section coating 1033 and at least one guiding section bare bracket 1034 disposed on the guiding section coating 1033.
  • the connecting section 1032 includes a connecting section coating 1035 and a connecting section covering film 1035. At least one of the upper connecting segments is a bare bracket 1036.
  • each of the main bare bracket 1012, the main branch bare bracket 1022, the guiding segment bare bracket 1034, and the connecting segment bare bracket 1036 includes at least one wave ring, and each waveform ring is end to end. Closed loops.
  • the transition segment bare stent 1042 includes at least one corrugated annulus, each corrugated loop being open loop, ie, end to end unconnected.
  • the main bare bracket 1012, the main branch bare bracket 1022, the guiding segment bare bracket 1034, the connecting segment bare bracket 1036, and the transition portion bare bracket 1042 are respectively attached to the main body film 1011 by suturing together along the corrugated rings.
  • the bare stent can also be attached to the film by other means, such as sticking, pressing, and the like.
  • the film can also be placed on the bare stent by bonding, pressing, sewing, etc., in this case, it can also be understood that the bare stent is disposed on the film.
  • the guiding segment 1031 can also include only the guiding segment coating 1033, and does not include the guiding segment bare bracket 1034. Only the transition segment bare bracket 1042 can support the proximal end of the guiding segment coating 1033 while connecting the segment bare bracket. 1036 can support the distal end of the guiding segment coating 1033 to ensure that the guiding segment coating 1033 does not collapse so as to cover the proximal opening of the guiding segment coating 1033.
  • the main body film 1011, the main branch film 1021, and the connecting portion film 1035 are each substantially a hollow straight cylindrical film having both ends open.
  • Both the guiding section film 1033 and the transition section film 1041 are substantially hollow frustum-shaped coatings which are open at both ends, and the truncated cone shape refers to a shape in which the cone top of the cone is cut off, that is, the guiding section coating 1033 And the diameter of the transition section film 1041 decreases from the proximal end to the distal end.
  • the outer peripheral surface of the transition piece film 1041 is respectively connected to the main body film 1011 and the main branch film 1021 along the longitudinal direction of the bracket 100, and the outer peripheral surface of the transition piece film 1041 is provided with a through hole (not labeled).
  • the through hole has a boundary line 1044 at a certain angle with the axis of the bracket 100 along the longitudinal direction, and the boundary line 1044 is the intersection of the transition section film 1041 and the proximal end of the guiding section film 1033.
  • the profile of the proximal end of the guide segment coating 1033 matches the contour of the boundary line 1044, and the side branch 103 is coupled to the transition segment 104 by the connection of the guide segment coating 1033 to the transition segment film 1041 at the boundary line 1044.
  • the main body film 1011, the main branch film 1021, the guide film 1033, the connecting film 1035, and the transition film 1041 may be integrally formed, or may be joined by sewing or pasting.
  • the main body film 1011, the main branch film 1021 and the transition film 1041 are integrally formed
  • the guiding segment film 1033 and the connecting segment film 1035 are integrally formed
  • the guiding segment film 1033 is stitched and transitioned.
  • the film 1041 is connected.
  • the shape of the main body film 1011, the main branch film 1021, and the connecting portion film 1035 is not limited to a straight shape, and may be a shape such as a curved tube shape or a conical tube shape, that is, a main body film 1011 and a main branch.
  • the shape of the film 1021 and the connecting section film 1035 depends on the shape of the blood vessel to which each film is adapted.
  • the proximal end of the transition portion film 1041 is connected to the main body film 1011, that is, the diameter of the proximal opening of the transition portion film 1041 is equal to the diameter of the main body film 1011; the transition portion of the film 1041 is The distal end is connected to the main branch membrane 1021, that is, the distal opening diameter of the transition section membrane 1041 is equal to the diameter of the main branch membrane 1021; the guiding section coating 1033 is at the boundary line 1044 of the transition section membrane 1041 and the transition section.
  • the film 1041 is connected. As can be seen from the top view of the longitudinal direction of the stent 100 of FIG.
  • the boundary line 1044 has a projection 1044' on a plane perpendicular to the axis of the body film 1011, and the main branch film 1021 has a plane perpendicular to the axis of the body film 1011.
  • Projection 1021 ', body film 1011 has a projection 1011 ' on a plane perpendicular to its axis.
  • the projection 1044' of the boundary line 1044 is located within the projection 1011' of the main body film 1011, and the contour of the projection 1044' of the boundary line 1044, the outline of the projection 1021' of the main branching film 1021, and the main body film 1011
  • the outline of the projection 1011' is substantially circular.
  • Projection 1044' is inscribed with projection 1011'
  • projection 1011' is inscribed with projection 1021'
  • projection 1044' is circumscribed with projection 1021'.
  • the connecting section film 1035 has a central axis 6, and the guiding section coating 1033 and the connecting section coating 1035 have a connecting surface surrounded by the intersection lines of the two (Fig. Undefined), it is now defined that the stent graft 100 has a projection surface (not shown) that passes through the intersection of the central axis 6 and the connecting surface and is perpendicular to the central axis 6, and the distal end of the guiding segment 1033 is The projection surface has a projection 1035', and the proximal end of the guiding segment coating 1033 has a projection 1033' on the projection surface.
  • the contours of projection 1033' and projection 1035' are both substantially circular, and the contour of projection 1035' is completely within the contour of projection 1033'. That is, the area of the projection 1033' of the proximal end of the guide segment coating 1033 on the projection surface is larger than the area of the projection 1035' of the distal end of the guide segment coating 1033 on the projection surface.
  • the main body bare cover 1012 is attached to the main body film 1011, respectively, on the main branch.
  • the main branch bare bracket 1022 is attached to the film 1021
  • the transition portion bare bracket 1042 is attached to the transition portion film 1041
  • the guiding portion bare bracket 1042 is attached to the guiding portion film 1033
  • the connecting portion is barely attached to the connecting portion film 1035.
  • the stent 1036 is completed to complete the preparation of the branched stent graft 100.
  • the branch-type stent graft 100 of the present embodiment is first implanted into the aneurysm 17 by a delivery device (not shown), wherein the main body 101, the side branches 103, and the transition section 104 are all released in the right common iliac artery 11
  • the distal end of the main branch 102 is released within the right external iliac artery 13
  • the lateral branch 103 is released within the tumor cavity of the aneurysm 17 of the right common iliac artery 11, i.e., the proximal end of the guiding segment 1031 of the lateral branch 103
  • Located below the aneurysm initiation site 18 herein “below” refers to the direction of the aneurysm initiation site 18 toward the aneurysm end site 19
  • the distal end of the junction segment 1032 of the lateral branch 103 is located above the aneurysm end site 19
  • “above” refers to the direction in which the aneurys
  • the guidewire 4 is then punctured from the left femoral artery (not shown) and into the right common iliac artery 11. Further, the guidewire 4 passes from the body 101 and the transition section 104 and smoothly passes through the lateral branch 103 into the right internal iliac artery 12 Inside. Finally, referring to Fig. 10, along the guide rail established by the guide wire 4, a peripheral stent graft 5 is delivered to the side branch 103 and the right internal iliac artery 12 by a delivery device (not shown) and released, and the peripheral stent graft 5 is overlapped with the connecting section 1032. This completes the revascularization at 17 of the aneurysm.
  • the contour of the projection 1035' of the distal end of the guiding segment coating 1033 is completely within the contour of the projection 1033' of the proximal end of the guiding segmental coating 1033, That is, the area of the projection 1033' of the proximal end of the guiding segment coating 1033 on the projection surface is larger than the area of the projection 1035' of the distal end of the guiding segment coating 1033 on the projection surface, and therefore, the guide wire 4 is As the body 101 passes through the transition section 104 into the side branch 103, the guidewire 4 easily enters the guide section 1031 from the transition section 104 and continues into the smaller diameter connection section 1035 until the guidewire 4 passes out of the side branch 103 and enters the right
  • the internal iliac artery 12 ensures the smooth establishment of the guidewire track.
  • the contour of the projection 1035' of the distal end of the guiding segment coating 1033 may not be completely within the contour of the projection 1033' of the proximal end of the guiding segment coating 1033, that is, the projection 1035' may also be associated with the projection 1033'
  • the intersection, or projection 1035' can also be completely separated from the projection 1033', only the area of the projection 1033' of the proximal end of the segmental coating 1033 on the projection surface is greater than the distal end of the guiding segmental coating 1033 at the projection The area of the projection 1035' on the surface is large.
  • the blood vessel may not have the desired ideal shape.
  • the right common iliac artery 11 of the radial artery is severely distorted at the aneurysm 17, that is, the right internal iliac artery 12 and the right external iliac artery 13 Both are close to the direction of the left common iliac artery 14.
  • FIG. 12 when the branch-type stent graft 100 is implanted at the aneurysm 17, the main body 101 and the transition portion 104 are released in the right common iliac artery 11, and the distal end of the main branch 102 is released in the right external iliac artery 13.
  • the dimension defined to be compressed in a direction perpendicular to the central axis 6 of the connecting section 1032 is reduced in compression. Since the proximal opening of the guiding segment is larger at the same compression amount, the influence of the compression amount on the proximal opening of the guiding segment is smaller, and therefore, in the present embodiment, when the main branch 102 is opposite to the main body 101 When the bending occurs and is compressed to the proximal opening of the side branch 103, since the proximal end opening of the guiding section 1031 of the side branch 103 is large, even if it is compressed to the proximal end of the guiding section 1031 due to the distortion of the blood vessel, the guiding section 1031 is near. The end opening still ensures smooth entry of the guide wire 4, thereby ensuring that the peripheral stent-graft 5 is smoothly implanted along the guide wire into the lateral branch 103 and the right internal iliac artery 12, as shown in FIG.
  • At least one of the transition section bare brackets 1042 of the transition section 104 can also be made.
  • the annulus is integrated with at least one corrugated ring of the leading segment bare bracket 1034 of the guiding segment 1031, ie, the corrugated annulus of the at least one transition segment bare stent 1042 and the corrugated ring of the at least one guiding segment bare stent 1034
  • the skin is combined into at least one closed loop that simultaneously spans and adheres to the proximal end of the transition segment film 1041 and the guide segment coating 1033.
  • the proximal end of the guiding section 1031 is bent along with the transition section 104 and the main body 101 by the transition section bare bracket 1042, thereby between the main branch 102 and the main body 101.
  • the relative bending has less influence on the proximal opening of the guiding segment 1031, that is, the proximal opening of the guiding segment 1031 can still ensure the smooth entry of the guide wire 4, thereby ensuring that the peripheral stent-graft 5 is smoothly implanted along the guide wire to the side branch 103.
  • the right internal iliac artery 12 is arranged in the right internal iliac artery 12 .
  • one side of the side segment guide segment coating 1033a is flush with the side surface of the connecting segment film 1035a, which may be replaced by a map.
  • the side branch also has a projection surface which is the same as the definition of the projection surface in the side branch 103, that is, the projection surface in this embodiment is the over center axis 6a and the guide segment coating 1033a and the connecting portion film.
  • the projection 1035a' of the distal end of the guiding segment coating 1033a is completely located in the projection 1033a' of the proximal end of the guiding segment coating 1033a, and One side of projection 1035a' is inscribed in projection 1033a'.
  • both the guiding segment film 1033 and the main branching film 1021 intersect only at the proximal end through the transition portion 104, and the remaining portions are spaced apart. Therefore, both the guiding section 1031 and the connecting section 1032 of the side branch 103 have a certain bending property to accommodate the position of the different right internal iliac artery 12. It can be understood that the guiding segment film 1033 and the main branching film 1021 can also be in non-contact at the proximal end, that is, the side branches 103 are completely isolated from the main branch 102, for example, the guiding segment film 1033 is perpendicular to the length of the stent 100.
  • the projections inside are spaced apart from the projection of the main branching film 1021 in a plane perpendicular to the longitudinal direction of the stent 100.
  • a part of the side of the guiding section film 1033 is in contact with a part of the side of the main branching film 1021, and is sewn by a suture, thereby making the guiding section film 1033 fixed by the suture It is not possible to twist at will, thereby ensuring that the proximal opening of the guiding segment 1031 is not compressed as the connecting segment 1032 is twisted.
  • the projection of the boundary line 1044 on a plane perpendicular to the axis of the main body film may not be circumscribed with the projection of the main branch film on a plane perpendicular to the axis of the main body film, that is,
  • the diameter of the main branch membrane can be selected according to actual needs.
  • the main branch membrane of a suitable diameter is selected according to the size of the right external artery 13 to avoid endoleak.
  • the main body cover film 1011b and the main branch cover film 1021b of the branch type stent graft are straight cylindrical films, and the diameter of the main branch film 1021b and the diameter of the main body film 1011b. equal.
  • the proximal end of the transition section membrane 1041b is connected to the distal end of the main body membrane 1011b, and the distal end of the transition section membrane 1041b is connected to the proximal end of the main branch membrane 1021b, and the diameter of the intermediate portion of the transition section membrane 1041b is smaller than the transition section.
  • the diameter of the proximal end of the membrane 1041b and the diameter of the distal end of the transition section membrane 1041b, that is, the transition section membrane 1041b are substantially a lumbar drum-shaped membrane which is open at both ends and narrow at both ends.
  • the through hole of the transition piece film 1041b is opened between the proximal end and the intermediate part of the transition piece film 1041b, and the boundary line 1044b of the through hole is vertical.
  • the projection 1044b' on the plane of the axis of the main body film 1011b is located within the projection 1011b' of the body film 1011b on a plane perpendicular to the axis of the body film 1011b.
  • the projection of the main branch film 1021b on a plane perpendicular to the axis of the body film 1011b coincides with the projection 1011b' of the body film 1011b on a plane perpendicular to the axis of the body film 1011b.
  • the guiding segment film 1033b and the connecting segment film 1035b have a connecting surface which is an intersection of the over-center axis 6b and the connecting surface and is perpendicular to the central axis 6a.
  • a plane on the projection surface, the projection 1035b' of the distal end of the guiding segment coating 1033b is completely located in the projection 1033b' of the proximal end of the guiding segment coating 1033b.
  • the guide segment film 1033b is connected to the transition portion film 1041b at the boundary line 1044b, and then guided.
  • the side surface of the segment coating 1033b is in contact with the side surface of the transition film 1041b.
  • the side surface of the guiding section coating 1033b and the side surface of the transition section coating 1041b are suture-fixed at the contact portion, so that the guiding section coating 1033b and the transition section coating 1041b are integrally formed.
  • the transition section bare bracket and the guiding section bare bracket may be separated two a segment bare bracket, that is, attaching the transition segment bare bracket to the transition portion film 1041b and attaching the guiding segment bare bracket to the guiding segment film 1033b, respectively, and then contacting the transition portion and the guiding segment
  • the parts are fixed by suture stitching.
  • transitional segment bare stent and the guiding segment bare stent are also an integral bare stent, that is, after the transition portion film 1041b and the guiding segment film 1033b are sutured by suture, and then the film is laminated in the transition portion.
  • the transition piece bare bracket and the guiding section bare bracket as a whole are attached to the 1041b and the guiding section film 1033b.
  • the transition piece bare bracket and the guiding section bare bracket are integrally attached to the transition section film 1041b and the guiding section film 1033b, and therefore, between the main branch and the body
  • the guiding section is bent together with the transition section under the driving of the transition section bare bracket and the guiding section bare bracket, so that the relative bending between the main branch and the body
  • the proximal opening of the guiding segment has less influence, that is, the proximal opening of the guiding segment can still ensure the smooth entry of the guide wire, thereby ensuring that the peripheral stent graft is smoothly implanted along the guide wire In the lateral branch and the right internal iliac artery.
  • the structure of the coating film of the branch type stent graft according to the second embodiment of the present invention is substantially the same as the structure of the coating film of the branch type stent graft 100 of the first embodiment, and includes a main body coating 1011c and a main branch film. 1021c, transition section film 1041c, guide section film 1033c, and connecting section film 1035c.
  • the main body film 1011c, the main branch film 1021c, and the transition film 1041c are each substantially a hollow straight cylindrical film having both ends open.
  • the outer peripheral surface of the transition piece film 1041c is respectively connected to the main body film 1011c and the main branch film 1021c along the longitudinal direction of the bracket, and the outer peripheral surface of the transition piece film 1041c is provided with a through hole (not shown).
  • the through hole has a boundary line 1044c parallel to the axis of the holder in the longitudinal direction, that is, an intersection of the proximal end of the guiding section coating 1033c and the transition section film 1041c.
  • the structure of the coating film of the branch type stent graft in the present embodiment is different from the structure of the film of the branch type stent graft 100 of the first embodiment.
  • the projection of the boundary line 1044c on a plane perpendicular to the axis of the body film 1011c falls on the boundary line of the projection 1011c' of the body film 1011c on a plane perpendicular to its axis.
  • the guiding segment film 1033c and the connecting segment film 1035c have a connecting surface which is an intersection of the over-center axis 6c and the connecting surface and is perpendicular to the central axis 6c.
  • the projection 1035c' of the distal end of the guiding segment coating 1033c is completely located in the projection 1033c' of the proximal end of the guiding segment coating 1033c, ie the proximal end of the guiding segment coating 1033c is in the projection
  • the area of the projection 1033c' on the face is larger than the area of the projection 1035c' of the distal end of the guide segment coating 1033c on the projection surface, thus, when the guide wire is inserted from the body through the transition section
  • the guide wire easily enters the guiding section from the transition section and continues into the connecting section having a smaller diameter until the guide wire passes out of the side branch and enters the right ankle
  • the artery ensures the smooth establishment of the guide wire track.
  • the guiding segment film 1033c is in contact with the main branch film 1021c only at the proximal end, and the remaining portions are spaced apart. Therefore, both the guiding section and the connecting section of the side branch have a certain bending property to accommodate the position of different right internal iliac artery. It can be understood that the guiding segment film 1033c and the main branching film 1021c can also be in contact at the proximal end, that is, the side branches are completely isolated from the main branch.
  • a part of the side of the guiding section film 1033c is in contact with a part of the side of the main branching film 1021c, and is sewn by a suture, thereby making the guiding section film 1033c fixed by the suture It is not possible to twist at will, thereby ensuring that the proximal opening of the guiding segment is not compressed as the connecting segment is twisted.

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Abstract

一种分支型覆膜支架(100)包括主体(101)、主分支(102)、侧分支(103)和过渡段(104)。主分支(102)和侧分支(103)均通过过渡段(104)与主体贯通连接。侧分支(103)包括直接与过渡段(104)相连的引导段(1031)，和与引导段(1031)相连的连接段(1032)。引导段(1031)包括引导段覆膜(1033)。覆膜支架(100)包括由引导段(1031)与连接段(1032)的相交线围成的连接面，和经过连接段(1032)中心轴线与连接面的交点且与连接段(1032)中心轴线垂直的投影。引导段覆膜(1033)的近端在投影面上的投影面积大于引导段覆膜(1033)的远端在投影面上的投影面积。该分支型覆膜支架植入血管后，导丝很容易从过渡段进入引导段，并继续进入连接段，保证了导丝轨道的顺利建立。

Description

分支型覆膜支架
【技术领域】
本发明涉及介入医疗器械技术领域，尤其涉及一种分支型覆膜支架。
【背景技术】
随着高血压发病率的急剧上升，动脉相关疾病发病率显著上升。随着医学的发展，现已采用覆膜支架来治疗动脉瘤，具体地，将压缩后的覆膜支架装入输送系统，并沿导丝输送到病变位置后释放，形成新的血流通道，动脉瘤在丧失了血流后，扩张状态的瘤壁受负压而收缩，恢复到原始形态，从而达到治疗动脉瘤的目的。
对于动脉瘤在分支血管部位的病例，由于采用直管型覆膜支架不能进行动脉瘤的治疗，现已出现了很多分支型覆膜支架来治疗这种病例。如图1所示为一种累及到髂内动脉的髂总动脉瘤的示意图，髂动脉包括右髂总动脉11、右髂内动脉12、右髂外动脉13、左髂总动脉14、左髂内动脉15和左髂外动脉16。动脉瘤17发生在右髂总动脉11处且累及右髂内动脉12，动脉瘤17包括动脉瘤起始部位18和动脉瘤结束部位19，其中动脉瘤起始部位18位于右髂总动脉11，动脉瘤结束部位19部分位于右髂内动脉12，且部分位于右髂外动脉13，动脉瘤起始部位18至动脉瘤结束部位19之间的空间构成瘤腔。
现有技术采用分支型覆膜支架来治疗分支血管部位的动脉瘤，如图2所示，分支型覆膜支架2包括主体21、主分支22和侧分支23。其中，主体21和侧分支23释放在右髂总动脉11，主体21覆盖住动脉瘤起始部位18，且主体21的近端锚定在右髂总动脉11的正常血管壁上；主分支22的远端释放在右髂外动脉13内；侧分支23与主体21相连的近端位于动脉瘤起始部位18以下，侧分支23的远端位于动脉瘤结束部位19以上，即侧分支23容纳于瘤腔内，且侧分支23的内径从近端至远端为定值。由于侧分支23位于瘤腔内，所以侧分支23的近端开口可以正常打开，且侧分支23的远端可以根据分支血管的位置改变一定的角度。
如图3所示，分支型覆膜支架2释放完成后，通过侧分支23释放一外周覆膜支架24到右髂内动脉12内，并与侧分支23连接。这样就保证了右髂内动脉12的通畅和动脉瘤17的完全隔绝。
由于有些动脉瘤直径和分支血管的直径较小，为了保证手术顺利进行，会将侧分支23的外径设计的较小，以使侧分支23可以在瘤腔内顺利展开，进而可以在侧分支23中接入外周覆膜支架24，完成动脉重建。但是，因为侧分支23的外径较小，直接导致侧分支23近端的内径较小，进而使得导丝插入侧分支23中建立轨道非常困难，甚至可能导致手术失败。
而且，有些动脉瘤位于的血管比较扭曲，使得放置于所述扭曲部位的所述分支型覆膜支架也发生扭曲，容易导致所述侧分支与所述主体相连的近端开口被压缩甚至被封闭，这也使得导丝无法顺利穿过所述侧分支的近端开口建立导丝轨道，甚至可能导致手术失败。
【发明内容】
基于此，有必要提供一种能够顺利建立导丝轨道的分支型覆膜支架。
本发明提供一种分支型覆膜支架，包括主体、主分支、侧分支和过渡段，所述主分支和所述侧分支均通过所述过渡段与所述主体贯通连接，所述侧分支包括直接与所述过渡段相连的引导段，和与所述引导段相连的连接段，所述引导段包括引导段覆膜，所述覆膜支架包括由所述引导段与所述连接段的相交线围成的连接面，和经过所述连接段中心轴线与所述连接面的交点且与所述连接段中心轴线垂直的投影面，所述引导段覆膜的近端在所述投影面上的投影面积大于所述引导段覆膜的远端在所述投影面上的投影面积。
在其中一个实施例中，所述引导段覆膜远端在所述投影面上的投影位于所述引导段覆膜的近端在所述投影面上的投影内。
在其中一个实施例中，所述引导段覆膜远端在所述投影面上的投影内切于所述引导段覆膜的近端在所述投影面上的投影。
在其中一个实施例中，所述引导段还包括引导段裸支架，所述过渡段包括过渡段覆膜和过渡段裸支架，所述过渡段裸支架中的至少一个波形环状物与所述引导段裸支架中的至少一个波形环状物结合为一个封闭环，所述封闭环同时附着在所述过渡段覆膜和所述引导段覆膜上。
在其中一个实施例中，所述引导段的近端与所述过渡段的交汇线在垂直于所述主体轴线的平面上的投影位于所述主体在垂直于其轴线的平面上的投影内。
在其中一个实施例中，所述主分支在垂直于所述主体轴线的平面上的投影外切于所述引导段的近端与所述过渡段的交汇线在垂直于所述主体轴线的平面上的投影。
在其中一个实施例中，所述主分支在垂直于所述主体轴线的平面上的投影与所述主体在垂直于其轴线的平面上的投影重合。
在其中一个实施例中，所述引导段的近端与所述过渡段的交汇线在垂直于所述主体轴线的平面上的投影落在所述主体在垂直于其轴线的平面上的投影的边界线上。
在其中一个实施例中，所述主分支包括主分支覆膜和设于所述主分支覆膜上的主分支裸支架，所述引导段覆膜的近端与所述主分支覆膜的近端相连接。
在其中一个实施例中，所述引导段覆膜的部分侧边与所述主分支覆膜的部分侧边相连。
本发明的分支型覆膜支架，由于所述侧分支包括所述引导段和所述连接段，且所述引导段覆膜的近端在所述投影面上的投影面积大于所述引导段覆膜的远端在所述投影面上的投影面积，因此，当所述分支型覆膜支架植入血管中后，导丝从所述主体经过所述过渡段穿进所述侧分支时，所述导丝很容易从所述过渡段进入所述引导段，并继续进入所述连接段，直至所述导丝穿出所述侧分支并进入右髂内动脉，保证了所述导丝轨道的顺利建立。
【附图说明】
图1为累及到髂内动脉的髂总动脉瘤的示意图。
图2为现有技术的分支型覆膜支架植入图1所示髂总动脉瘤的效果图。
图3为图2所示分支型覆膜支架结合外周覆膜支架植入图1所示髂总动脉瘤的效果图。
图4为本发明实施例1的分支型覆膜支架的示意图。
图5为图4所示分支型覆膜支架的覆膜的示意图。
图6为图5所示分支型覆膜支架的覆膜的主体覆膜、主分支覆膜和过渡段覆膜的示意图。
图7为图6的俯视图。
图8（a）-图8（b）为图5所示覆膜的引导段覆膜和连接段覆膜的示意图；其中图8（a）为主视图，图8（b）为俯视图。
图9为图4所示分支型覆膜支架植入图1所示髂总动脉瘤的效果图。
图10为在图9的基础上进一步结合外周覆膜支架的效果图。
图11为一扭曲的具有累及到髂内动脉的髂总动脉瘤的髂动脉示意图。
图12为图4所示分支型覆膜支架植入图11所示髂总动脉瘤的效果图。
图13为在图12的基础上进一步结合外周覆膜支架的效果图。
图14（a）-图14（b）为图8（a）-图8（b）所示引导段覆膜和连接段覆膜的一种变形示意图；其中图14（a）为主视图，图14（b）为俯视图。
图15为图4所示分支型覆膜支架的覆膜的另一结构示意图。
图16（a）-图16（c）为图15所示分支型覆膜支架的覆膜的主体覆膜、主分支覆膜和过渡段覆膜的示意图；其中，图16（a）为主视图，图16（b）为左视图，图16（c）为俯视图。
图17（a）-图17（b）为图15所示分支型覆膜支架的覆膜的引导段覆膜和连接段覆膜的示意图；其中图17（a）为主视图，图17（b）为俯视图。
图18为本发明实施例2的分支型覆膜支架的覆膜的示意图。
图19（a）-图19（c）为图18所示分支型覆膜支架的覆膜的主体覆膜、主分支覆膜和过渡段覆膜的示意图；其中，图19（a）为主视图，图19（b）为左视图，图19（c）为俯视图。
图20（a）-图20（b）为图18所示分支型覆膜支架的覆膜的引导段覆膜和连接段覆膜的示意图；其中图20（a）为主视图，图20（b）为俯视图。
【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。
需要说明的是，当元件被称为“固定于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。
在覆膜支架领域，将覆膜支架植入血管后，定义血流从覆膜支架的近端流向该覆膜支架的远端。
本申请中“覆膜支架”是指裸支架表面覆盖有薄膜后的结构，裸支架是指沿长度方向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4，分支型覆膜支架100包括主体101、主分支102、侧分支103和过渡段104，主分支102和侧分支103均通过过渡段104与主体101贯通连接。主体101包括主体覆膜1011和设于主体覆膜1011上的主体裸支架1012；主分支102包括主分支覆膜1021和设于主分支覆膜1021上的主分支裸支架1022；过渡段104包括过渡段覆膜1041和设于过渡段覆膜1041上的过渡段裸支架1042。侧分支103包括引导段1031和连接段1032，引导段1031的近端与过渡段104连接，引导段1031的远端与连接段1032的近端相连，也就是说，连接段1032通过引导段1031与过渡段104相连；引导段1031包括引导段覆膜1033和设于引导段覆膜1033上的至少一个引导段裸支架1034，连接段1032包括连接段覆膜1035和设于连接段覆膜1035上的至少一个连接段裸支架1036。
本实施例中，主体裸支架1012、主分支裸支架1022、引导段裸支架1034和连接段裸支架1036中每一个裸支架都包括至少一个波形环状物，每个波形环状物均为首尾相接的封闭环。过渡段裸支架1042包括至少一个波形环状物，每个波形环状物为开环，即首尾未连接。主体裸支架1012、主分支裸支架1022、引导段裸支架1034、连接段裸支架1036和过渡段裸支架1042均通过沿各波形环状物连续绕线的缝合方式分别附着在主体覆膜1011、主分支覆膜1021、引导段覆膜1033、连接段覆膜1035和过渡段覆膜1041上。可以理解的是，裸支架还可以通过其他方式附着于覆膜上，例如粘贴、压合等方式。还可以理解的是，覆膜也可以通过粘合、压合、缝合等方式设于裸支架上，此时，也可以理解为，裸支架设于覆膜上。
可以理解的是，引导段1031也可以仅包括引导段覆膜1033，不包括引导段裸支架1034，只需过渡段裸支架1042可以将引导段覆膜1033的近端支撑，同时连接段裸支架1036可以将引导段覆膜1033的远端支撑，保证引导段覆膜1033不会塌陷以致覆盖住引导段覆膜1033的近端开口即可。
请参阅图5至图7，主体覆膜1011、主分支覆膜1021和连接段覆膜1035均大致为两端开口的中空的直筒状覆膜。引导段覆膜1033和过渡段覆膜1041均大致为两端开口的中空的锥台状覆膜，所述锥台状是指圆锥的锥顶被截除后的形状，即引导段覆膜1033和过渡段覆膜1041的直径皆从近端向远端递减。过渡段覆膜1041的外周表面沿支架100的长度方向分别与主体覆膜1011和主分支覆膜1021相连，且过渡段覆膜1041的外周表面上开设有通孔（图未标），所述通孔具有与支架100沿长度方向的轴线成一定夹角的边界线1044，边界线1044即为过渡段覆膜1041与引导段覆膜1033近端的交汇线。引导段覆膜1033近端的轮廓与边界线1044的轮廓相匹配，侧分支103通过引导段覆膜1033在边界线1044处与过渡段覆膜1041的连接而与过渡段104连接。
可以理解的是，主体覆膜1011、主分支覆膜1021、引导段覆膜1033、连接段覆膜1035和过渡段覆膜1041可以一体成型，也可以通过缝合或粘贴等方式进行连接。本实施例中，主体覆膜1011、主分支覆膜1021和过渡段覆膜1041一体成型，引导段覆膜1033和连接段覆膜1035一体成型，引导段覆膜1033通过缝合的方式与过渡段覆膜1041连接。
可以理解的是，主体覆膜1011、主分支覆膜1021和连接段覆膜1035的形状不仅局限于直筒状，还可以为弯曲筒状、圆锥筒状等形状，即主体覆膜1011、主分支覆膜1021和连接段覆膜1035的形状取决于每段覆膜适应的血管的形状。
请同时参阅图5至图7，过渡段覆膜1041的近端与主体覆膜1011相连，即过渡段覆膜1041的近端开口直径与主体覆膜1011的直径相等；过渡段覆膜1041的远端与主分支覆膜1021相连，即过渡段覆膜1041的远端开口直径与主分支覆膜1021的直径相等；引导段覆膜1033在过渡段覆膜1041的边界线1044处与过渡段覆膜1041相连接。从图7的沿支架100长度方向的俯视图中可见，边界线1044在垂直于主体覆膜1011轴线的平面上具有投影1044’，主分支覆膜1021在垂直于主体覆膜1011轴线的平面上具有投影1021’，主体覆膜1011在垂直于其轴线的平面上具有投影1011’。本实施例中，边界线1044的投影1044’位于主体覆膜1011的投影1011’内，且边界线1044的投影1044’的轮廓、主分支覆膜1021的投影1021’的轮廓以及主体覆膜1011的投影1011’的轮廓均大致为圆形。投影1044’与投影1011’内切，投影1011’与投影1021’内切，且投影1044’与投影1021’外切。
请同时参阅图8（a）和图8（b），连接段覆膜1035具有一中心轴线6，引导段覆膜1033与连接段覆膜1035具有由两者相交线围成的连接面（图未标），现定义覆膜支架100具有一投影面（图未示），该投影面经过中心轴线6与所述连接面的交点且与中心轴线6垂直，引导段覆膜1033的远端在所述投影面上具有投影1035’，引导段覆膜1033的近端在所述投影面上具有投影1033’。本实施例中，投影1033’和投影1035’的轮廓均大致为圆形，投影1035’的轮廓完全位于投影1033’的轮廓内。也就是说，引导段覆膜1033的近端在所述投影面上的投影1033’的面积比引导段覆膜1033的远端在所述投影面上的投影1035’的面积大。
主体覆膜1011、主分支覆膜1021、过渡段覆膜1041、引导段覆膜1033和连接段覆膜1035成型为一个整体后，分别在主体覆膜1011上附着主体裸支架1012，在主分支覆膜1021上附着主分支裸支架1022，在过渡段覆膜1041上附着过渡段裸支架1042，在引导段覆膜1033上附着引导段裸支架1042，在连接段覆膜1035上附着连接段裸支架1036，从而完成分支型覆膜支架100的制备。
请参阅图9，本实施例的分支型覆膜支架100首先通过输送器械（图未示）植入动脉瘤17处，其中主体101、侧分支103和过渡段104均释放在右髂总动脉11中，主分支102的远端释放在右髂外动脉13内；进一步地，侧分支103释放在右髂总动脉11的动脉瘤17的瘤腔内，即侧分支103的引导段1031的近端位于动脉瘤起始部位18以下（此处“以下”是指动脉瘤起始部位18朝向动脉瘤结束部位19的方向），侧分支103的连接段1032的远端位于动脉瘤结束部位19以上（此处“以上”是指动脉瘤结束部位19朝向动脉瘤起始部位18的方向）。然后导丝4从左股动脉（图未标）穿刺并进入右髂总动脉11中，进一步地，导丝4从主体101和过渡段104经过，并顺利通过侧分支103进入右髂内动脉12内。最后，请参阅图10，沿着导丝4建立的输送轨道，一外周覆膜支架5通过输送器械（图未示）输送至侧分支103和右髂内动脉12内并释放，外周覆膜支架5与连接段1032重叠连接。至此完成动脉瘤17处的血管重建。
本实施例中，由于侧分支103包括引导段1031和连接段1032，引导段覆膜1033的远端的投影1035’的轮廓完全位于引导段覆膜1033的近端的投影1033’的轮廓内，即引导段覆膜1033的近端在所述投影面上的投影1033’的面积比引导段覆膜1033的远端在所述投影面上的投影1035’的面积大，因此，导丝4从主体101经过渡段104穿进侧分支103时，导丝4很容易从过渡段104进入引导段1031，并继续进入直径较小的连接段1035，直至导丝4穿出侧分支103并进入右髂内动脉12，保证了导丝轨道的顺利建立。
可以理解的是，引导段覆膜1033的远端的投影1035’的轮廓还可以不完全位于引导段覆膜1033的近端的投影1033’的轮廓内，即投影1035’还可以与投影1033’交叉，或者投影1035’还可以与投影1033’完全分离，只需引导段覆膜1033的近端在所述投影面上的投影1033’的面积比引导段覆膜1033的远端在所述投影面上的投影1035’的面积大即可。
然而在实际情况中，血管可能并不具有预想的理想形状，请参阅图11，髂动脉的右髂总动脉11在动脉瘤17处发生严重扭曲，即右髂内动脉12和右髂外动脉13均向左髂总动脉14的方向靠近。请参阅图12，当分支型覆膜支架100植入动脉瘤17处后，主体101和过渡段104释放在右髂总动脉11中，主分支102的远端释放在右髂外动脉13中，由于右髂外动脉13向左髂总动脉14的方向靠近，因此主分支102和主体101之间发生相对弯曲，从而对过渡段104的所述通孔进行压缩，即对侧分支103与过渡段104连接的近端开口进行压缩。
本发明中，定义在垂直于连接段1032中心轴线6的方向上被压缩而减小的尺寸为压缩量。由于在相同的压缩量下，所述引导段的近端开口越大，则该压缩量对所述引导段的近端开口的影响越小，因此，本实施例中，当主分支102相对主体101发生弯曲而压缩到侧分支103的近端开口时，由于侧分支103的引导段1031的近端开口较大，因此，即使因为血管扭曲而压缩到引导段1031的近端，引导段1031的近端开口仍然可以保证导丝4的顺利进入，进而保证外周覆膜支架5沿导丝顺利地植入侧分支103和右髂内动脉12中，如图13所示。
可以理解，为了进一步地减小主分支102和主体101之间的弯曲对侧分支103的引导段1031的近端开口的影响，还可以使过渡段104的过渡段裸支架1042中的至少一个波形环状物与引导段1031的引导段裸支架1034中的至少一个波形环状物结合为一个整体，即至少一个过渡段裸支架1042的波形环状物和至少一个引导段裸支架1034的波形环状物相结合为至少一个封闭环，该封闭环同时跨越并附着在过渡段覆膜1041和引导段覆膜1033的近端。因此，当主分支102和主体101之间相对弯曲时，引导段1031的近端在过渡段裸支架1042的带动下随着过渡段104和主体101一起弯曲，从而主分支102和主体101之间的相对弯曲对引导段1031的近端开口的影响较小，即引导段1031的近端开口仍然可以保证导丝4的顺利进入，进而保证外周覆膜支架5沿导丝顺利地植入侧分支103和右髂内动脉12中。
优选地，如图14（a）和图14（b）所示，其他实施例中，侧分支的引导段覆膜1033a的一侧边与连接段覆膜1035a的侧面平齐，其可以替换图5中的引导段覆膜1033和连接段覆膜1035。所述侧分支同样具有一投影面，所述投影面与侧分支103中的投影面的定义相同，即本实施例中的投影面为过中心轴线6a与引导段覆膜1033a和连接段覆膜1035a的连接面的交点且与中心轴线6a垂直的平面，在所述投影面上，引导段覆膜1033a远端的投影1035a’完全位于引导段覆膜1033a的近端的投影1033a’中，且投影1035a’的一侧内切于投影1033a’。当导丝4进入引导段覆膜1033a后，由于引导段覆膜1033a的一侧边与连接段覆膜1035a的侧面平齐，使得导丝4更容易从引导段1031a进入到连接段1032a中。
本实施例中，引导段覆膜1033与主分支覆膜1021通过过渡段104只在近端交汇，其余部分均相隔开。因此，侧分支103的引导段1031和连接段1032均具有一定的弯曲性能，以适应不同的右髂内动脉12的位置。可以理解，引导段覆膜1033与主分支覆膜1021还可以在近端不相接触，即侧分支103与主分支102完全隔离开，例如引导段覆膜1033在垂直于支架100长度方向的平面内的投影与主分支覆膜1021在垂直于支架100长度方向的平面内的投影相互隔开。优选地，本实施例中，引导段覆膜1033的部分侧边与主分支覆膜1021的部分侧边相接触，且通过缝合线缝合，因此使得所述由缝合线固定的引导段覆膜1033不能够随意扭曲，从而保证了引导段1031的近端开口不会随着连接段1032的扭曲而被压缩。
可以理解，所述边界线1044在垂直于所述主体覆膜轴线的平面上的投影也可以不与所述主分支覆膜在垂直于所述主体覆膜轴线的平面上的投影外切，即所述主分支覆膜的直径可以根据实际需求选择大小，比如根据右髂外动脉13的尺寸选择合适直径的所述主分支覆膜，以避免出现内漏。
请参阅图15，其他实施例中，所述分支型覆膜支架的主体覆膜1011b和主分支覆膜1021b均为直筒状覆膜，且主分支覆膜1021b的直径与主体覆膜1011b的直径相等。过渡段覆膜1041b的近端与主体覆膜1011b的远端相连，过渡段覆膜1041b的远端与主分支覆膜1021b的近端相连，过渡段覆膜1041b的中间部位的直径小于过渡段覆膜1041b近端的直径和过渡段覆膜1041b远端的直径，即过渡段覆膜1041b大致为两端开口且两端宽中间窄的腰鼓状覆膜。
请同时参阅图16（a）至图16（c）,过渡段覆膜1041b的通孔开设于过渡段覆膜1041b的近端和中间部位之间，且所述通孔的边界线1044b在垂直于主体覆膜1011b轴线的平面上的投影1044b’位于主体覆膜1011b在垂直于主体覆膜1011b轴线的平面上的投影1011b’内。主分支覆膜1021b在垂直于主体覆膜1011b轴线的平面上的投影与主体覆膜1011b在垂直于主体覆膜1011b轴线的平面上的投影1011b’重合。
请参阅图17（a）和图17（b），引导段覆膜1033b和连接段覆膜1035b具有一连接面，投影面为过中心轴线6b与所述连接面的交点且与中心轴线6a垂直的平面，在所述投影面上，引导段覆膜1033b远端的投影1035b’完全位于引导段覆膜1033b的近端的投影1033b’中。请再同时参阅图15，本实施方式中，由于过渡段覆膜1041b为两端宽中间窄的腰鼓状覆膜，引导段覆膜1033b在边界线1044b处与过渡段覆膜1041b连接后，引导段覆膜1033b的侧面与过渡段覆膜1041b的侧面相接触。优选地，本实施方式中，引导段覆膜1033b的侧面与过渡段覆膜1041b的侧面在接触部位采用缝合线缝合固定，从而使引导段覆膜1033b与过渡段覆膜1041b形成一个整体。
可以理解，在过渡段覆膜1041b和引导段覆膜1033b上附着所述过渡段裸支架和所述引导段裸支架时，所述过渡段裸支架和所述引导段裸支架可以为分离的两段裸支架，即分别在过渡段覆膜1041b上附着所述过渡段裸支架和在引导段覆膜1033b上附着所述引导段裸支架后，再将所述过渡段和所述引导段相接触的部位采用缝合线缝合固定。还可以理解，所述过渡段裸支架和所述引导段裸支架也为一个整体的裸支架，即在过渡段覆膜1041b和引导段覆膜1033b采用缝合线缝合后，再在过渡段覆膜1041b和引导段覆膜1033b上附着作为一个整体的所述过渡段裸支架和所述引导段裸支架。本实施方式中，优选所述过渡段裸支架和所述引导段裸支架为一个整体附着在过渡段覆膜1041b和引导段覆膜1033b上，因此，当所述主分支和所述主体之间相对弯曲时，在所述过渡段裸支架和所述引导段裸支架的带动下，所述引导段随着所述过渡段一起弯曲，从而所述主分支和所述主体之间的相对弯曲对所述引导段的近端开口的影响较小，即所述引导段的近端开口仍然可以保证所述导丝的顺利进入，进而保证所述外周覆膜支架沿所述导丝顺利地植入所述侧分支和右髂内动脉中。
实施例2
请参阅图18，本发明实施例2的分支型覆膜支架的覆膜的结构与实施例1的分支型覆膜支架100的覆膜的结构大致相同，包括主体覆膜1011c、主分支覆膜1021c、过渡段覆膜1041c、引导段覆膜1033c和连接段覆膜1035c。
主体覆膜1011c、主分支覆膜1021c和过渡段覆膜1041c均大致为两端开口的中空的直筒状覆膜。过渡段覆膜1041c的外周面沿所述支架的长度方向分别与主体覆膜1011c和主分支覆膜1021c相连，且过渡段覆膜1041c的外周表面上开设有通孔（图未标），所述通孔具有与所述支架沿长度方向的轴线平行的边界线1044c，即所述引导段覆膜1033c的近端与过渡段覆膜1041c的交汇线。
请参阅图19（a）至图19（c），本实施例中的分支型覆膜支架的覆膜的结构与实施例1的分支型覆膜支架100的覆膜的结构的不同之处在于，边界线1044c在垂直于主体覆膜1011c轴线的平面上的投影落在主体覆膜1011c在垂直于其轴线的平面上的投影1011c’的边界线上。
请参阅图20（a）和图20（b），引导段覆膜1033c和连接段覆膜1035c具有一连接面，投影面为过中心轴线6c与所述连接面的交点且与中心轴线6c垂直的平面，在所述投影面上，引导段覆膜1033c远端的投影1035c’完全位于引导段覆膜1033c的近端的投影1033c’中，即引导段覆膜1033c的近端在所述投影面上的投影1033c’的面积比引导段覆膜1033c的远端在所述投影面上的投影1035c’的面积大，因此，当所述导丝从所述主体经所述过渡段穿进所述侧分支时，所述导丝很容易从所述过渡段进入所述引导段，并继续进入直径较小的所述连接段，直至所述导丝穿出所述侧分支并进入右髂内动脉，保证了导丝轨道的顺利建立。
本实施例中，引导段覆膜1033c与主分支覆膜1021c只在近端相接触，其余部分均相隔开。因此，所述侧分支的引导段和连接段均具有一定地弯曲性能，以适应不同的右髂内动脉的位置。可以理解，引导段覆膜1033c与主分支覆膜1021c还可以在近端不相接触，即所述侧分支与所述主分支完全隔离开。优选地，本实施例中，引导段覆膜1033c的部分侧边与主分支覆膜1021c的部分侧边相接触，且通过缝合线缝合，因此使得所述由缝合线固定的引导段覆膜1033c不能够随意扭曲，从而保证了所述引导段的近端开口不会随着所述连接段的扭曲而被压缩。
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. 一种分支型覆膜支架，包括主体、主分支、侧分支和过渡段，所述主分支和所述侧分支均通过所述过渡段与所述主体贯通连接，其特征在于，所述侧分支包括直接与所述过渡段相连的引导段，和与所述引导段相连的连接段，所述引导段包括引导段覆膜，所述覆膜支架包括由所述引导段与所述连接段的相交线围成的连接面，和经过所述连接段中心轴线与所述连接面的交点且与所述连接段中心轴线垂直的投影面，所述引导段覆膜的近端在所述投影面上的投影面积大于所述引导段覆膜的远端在所述投影面上的投影面积。
  2. 根据权利要求1所述的分支型覆膜支架，其特征在于，所述引导段覆膜远端在所述投影面上的投影位于所述引导段覆膜的近端在所述投影面上的投影内。
  3. 根据权利要求2所述的分支型覆膜支架，其特征在于，所述引导段覆膜远端在所述投影面上的投影内切于所述引导段覆膜的近端在所述投影面上的投影。
  4. 根据权利要求1所述的分支型覆膜支架，其特征在于，所述引导段还包括引导段裸支架，所述过渡段包括过渡段覆膜和过渡段裸支架，所述过渡段裸支架中的至少一个波形环状物与所述引导段裸支架中的至少一个波形环状物结合为一个封闭环，所述封闭环同时附着在所述过渡段覆膜和所述引导段覆膜上。
  5. 根据权利要求1所述的分支型覆膜支架，其特征在于，所述引导段的近端与所述过渡段的交汇线在垂直于所述主体轴线的平面上的投影位于所述主体在垂直于其轴线的平面上的投影内。
  6. 根据权利要求1所述的分支型覆膜支架，其特征在于，所述主分支在垂直于所述主体轴线的平面上的投影外切于所述引导段的近端与所述过渡段的交汇线在垂直于所述主体轴线的平面上的投影。
  7. 根据权利要求5所述的分支型覆膜支架，其特征在于，所述主分支在垂直于所述主体轴线的平面上的投影与所述主体在垂直于其轴线的平面上的投影重合。
  8. 根据权利要求1所述的分支型覆膜支架，其特征在于，所述引导段的近端与所述过渡段的交汇线在垂直于所述主体轴线的平面上的投影落在所述主体在垂直于其轴线的平面上的投影的边界线上。
  9. 根据权利要求1所述的分支型覆膜支架，其特征在于，所述主分支包括主分支覆膜和设于所述主分支覆膜上的主分支裸支架，所述引导段覆膜的近端与所述主分支覆膜的近端相连接。
  10. 根据权利要求9所述的分支型覆膜支架，其特征在于，所述引导段覆膜的部分侧边与所述主分支覆膜的部分侧边相连。
PCT/CN2017/090588 2016-07-13 2017-06-28 分支型覆膜支架 Ceased WO2018010546A1 (zh)

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