WO2019129151A1 - 可用于腹主动脉疾病介入治疗的覆膜支架 - Google Patents

可用于腹主动脉疾病介入治疗的覆膜支架 Download PDF

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Publication number
WO2019129151A1
WO2019129151A1 PCT/CN2018/124414 CN2018124414W WO2019129151A1 WO 2019129151 A1 WO2019129151 A1 WO 2019129151A1 CN 2018124414 W CN2018124414 W CN 2018124414W WO 2019129151 A1 WO2019129151 A1 WO 2019129151A1
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WIPO (PCT)
Prior art keywords
stent
abdominal aortic
stent graft
interventional treatment
diameter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2018/124414
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English (en)
French (fr)
Inventor
王永胜
李安伟
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Hangzhou Endonom Medtech Co Ltd
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Hangzhou Endonom Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hangzhou Endonom Medtech Co Ltd filed Critical Hangzhou Endonom Medtech Co Ltd
Priority to EP18896687.3A priority Critical patent/EP3733125A4/en
Priority to US16/958,328 priority patent/US11678971B2/en
Publication of WO2019129151A1 publication Critical patent/WO2019129151A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the invention belongs to the technical field of medical instruments, and particularly relates to a stent graft, in particular to a stent graft which can be used for interventional treatment of abdominal aortic diseases.
  • Abdominal aortic aneurysm is a common aortic disease
  • epidemiological studies show that the incidence of abdominal aortic aneurysm in men is 5%, but in patients aged 80 years and older, the incidence increased to 10%, and The risk of tumor rupture is higher than in other populations. It is predicted that by 2020, China's population over 80 years old will reach 30 million, and over 90 years old will exceed 12 million. In the future, more and more elderly AAA patients will need treatment.
  • the current main methods of treating abdominal aortic aneurysm include traditional open surgery and endovascular repair of abdominal aortic aneurysm, both of which have advantages.
  • Abdominal aortic endovascular repair since the first report in the 1990s for the treatment of abdominal aortic aneurysms, due to small trauma, short surgery and hospital stay, rapid postoperative recovery, perioperative mortality and complications The low rate and other advantages have developed rapidly in just 20 years.
  • the biggest advantage of endovascular repair of abdominal aortic aneurysm is that there is no need to open the chest and open the abdomen, no need to clamp the blood vessels, no visceral ischemia during the operation, and fewer complications.
  • the biggest limitation is that the visceral aorta cannot be covered, especially the superior mesenteric artery and renal artery. It is still difficult to repair the abdominal aortic aneurysm in the field of renal artery.
  • the "window stent type blood vessel” is used to implant the stent-type blood vessel in such a patient, that is, the main aorta is implanted in the abdominal aorta, the window is opened in the main body bracket, and the branch stent blood vessel is installed in the window to the branch.
  • the stent-type blood vessel implanted in the endovascular treatment of the abdominal aortic aneurysm involves the reconstruction of the four branches of the celiac trunk artery, the superior mesenteric artery, and the left and right renal artery.
  • Implantation of the fenestration-type vessels requires accurate detection and localization of the lesions and peripheral vessels of each patient, and the stent vessels are tested according to the test results. Design, production. This kind of detection, design and production for individual patients is not only complicated, but also affected by the precision of the instrument and the proficiency of the operator. The stent blood vessels are often poorly accurate, which makes the treatment effect greatly reduced.
  • the technical problem to be solved by the present invention is that, in view of the defects of the prior art, a stent graft which can be used for interventional treatment of abdominal aortic diseases with a small diameter near the branch segment and having more space for accommodating the branch vessel stent is provided. .
  • a stent graft for interventional treatment of abdominal aortic diseases comprising a tubular body composed of a tubular membrane and a plurality of annular stents, the tubular body comprising a first tubular body disposed in sequence from a proximal end to a distal end, a second tube body, the first tube body diameter being larger than the second tube body diameter;
  • the first tube body and the second tube body are connected as a whole through a transition portion; the middle portion of the transition portion has a diameter smaller than a proximal end of the transition portion and a distal end diameter of the transition portion;
  • a plurality of windows are opened on the first pipe body and the transition portion.
  • the window comprises a front wall window and a side wall window; the front wall window is disposed on the front wall of the film, the side wall The window is placed on the side of the film.
  • the front wall window is provided with at least two, all the front wall windows are on the same axis, and at least one front wall window is located in the first tube. Physically.
  • the side wall window is disposed on each of the two side wall surfaces of the film, and the two side wall windows are located at the same height.
  • the inner wall surface or the outer wall surface of the coating film is fixed at least one axis along the circumferential direction of the coating at least at the proximal end of the first tubular body. To the set of support bars.
  • the support rod is fixed on the wall surface of the membrane by suturing, heat sealing or bonding.
  • the support rod is provided with at least one fixing point for fixed connection with the coating, and the fixing point is provided on the support rod. Connection hole or open groove with opening.
  • the support rods are arranged parallel to the central axis of the stent; or the support rods are arranged between eight or eight characters.
  • the connector is provided with a connecting member for wearing the release guide wire from the proximal end to the distal end, the connecting member.
  • the axial spacing is set in at least two rows.
  • the connecting member is a closed loop structure or an open loop structure for the release or winding of the release guide wire;
  • the closed loop structure is a connecting strip a through hole for releasing the guide wire or the connecting member and the film to form a through hole or a gap for the release guide wire to pass through, the open ring structure having a limiting groove for releasing the guide wire .
  • the connecting member of the closed loop structure is a coil fixed on the outer wall surface of the film; or the connecting member of the closed loop structure is an axial direction a wire that is fixed at intervals, and a gap is formed between the wire and the film to allow the release guide wire to pass through; or the connection member of the closed loop structure is a through hole disposed on the film; or the open ring structure
  • the connecting members are at least two rows of soft connecting buckles with finite slots, and the different limiting slots are arranged facing away from each other.
  • the inner wall surface or the outer wall surface of the membrane is fixed with at least one axially disposed support rod, and the support rod or the corresponding support rod A connector for wearing a release guide wire is provided on the film.
  • the first tubular body, the second tubular body and the transition portion are each composed of a tubular coating and a ring-shaped stent.
  • the proximal end of the first tubular body is provided with a bare stent, and the bare stent is provided with an outwardly folded barb, the barb The free end faces the distal end of the stent.
  • the transition portion sequentially comprises a proximal extension portion, a transition body segment and a distal extension portion connected to the first tubular body, Among the three parts, the transition body segment has the smallest diameter.
  • the transition body segment is of an equal diameter structure, and the proximal extension segment and the distal extension segment are non-equal diameter structures.
  • the stent graft of the present invention is a dumbbell-shaped structure with a thick central end and a thick end, wherein the diameter of the first tubular body is larger than the diameter of the second tubular body, and the diameter of the central portion of the transition portion is smaller than the diameter of the proximal end of the transition portion and the distal end of the transition portion.
  • the stent graft of the present invention can achieve intraluminal repair of the abdominal aortic aneurysm involving the renal artery, and the transition portion has the smallest diameter, and can provide a rich space for the implantation of the renal artery branch stent without being squeezed into the blood vessel.
  • a plurality of windows are opened on the first tube body and the transition portion for respectively communicating with the abdominal trunk artery, the superior mesenteric artery, and the left and right renal artery.
  • the window provided on the front side of the stent graft does not cover the superior mesenteric artery and the celiac trunk artery.
  • a connecting member for wearing the release guide wire is axially disposed from the proximal end to the distal end of the coating, and the connecting member is axially disposed at least two rows apart.
  • the connector cooperates with the release guide wire to constrain the radial dimension of the stent, so that the stent exhibits a semi-expanded state, and the diameter of the semi-expanded state is smaller than the diameter of the blood vessel, and can be freely rotated and longitudinally moved in the blood vessel to adjust the position, so that the stent can be released during the release process. Precise positioning.
  • the rear wall of the film is provided with at least one support rod, and the support rod can be used as a mast when the bracket is assembled, which can ensure the stability of the bracket during assembly and ensure the circumferential direction after the bracket portion is released. A structurally stable semi-expanded state.
  • FIG. 1 is a schematic structural view of a stent graft according to Embodiment 1 of the present invention.
  • FIG. 2 is a schematic structural view of a single-ring annular support in a first pipe body according to Embodiment 1 of the present invention
  • FIG. 3 is a schematic structural view of a window-opening annular bracket in a first pipe body according to Embodiment 1 of the present invention
  • FIG. 4 is a schematic structural view of a tapered annular bracket in a transition portion of Embodiment 1 of the present invention
  • Figure 5 is a schematic side view showing the structure of a stent graft according to Embodiment 1 of the present invention.
  • FIG. 6 is a schematic structural view of a side wall window according to Embodiment 1 of the present invention.
  • Figure 7 is a schematic view showing the structure of the stent implanted into the blood vessel according to the embodiment 1 of the present invention.
  • Figure 8 is a schematic view showing the structure of a stent graft according to Embodiment 2 of the present invention.
  • Figure 9 is a front view showing the structure of the second embodiment of the present invention in a restrained lower half-expanded state
  • Figure 10 is a schematic structural view of the second embodiment of the present invention in a restrained lower half-expanded state
  • Figure 11 is a schematic view showing the structure of a support rod according to Embodiment 2 of the present invention.
  • Figure 12 is a schematic view showing the structure of a stent graft according to Embodiment 3 of the present invention.
  • Figure 13 is a schematic view showing the structure of the third embodiment of the present invention in a restrained lower half-expanded state
  • Figure 14 is a schematic view showing the structure of a stent graft according to Embodiment 4 of the present invention.
  • Figure 15 is a schematic view showing the structure of the fourth embodiment of the present invention in a restrained lower half-expanded state
  • Figure 16A is a schematic view showing the back structure of only the proximal coating portion released during the release process of the stent graft of Example 4;
  • Figure 16B is a front view showing the release of only the proximal coating portion during the release of the stent graft of Example 4.
  • Figure 17 is a schematic view showing the structure of a stent graft according to Embodiment 5 of the present invention.
  • Figure 18 is a schematic view showing the structure of a bare stent with barbs according to Embodiment 5 of the present invention.
  • proximal refers to the portion of the stent or stent component that is adjacent to the patient's heart in the direction of blood flow
  • distal refers to the portion of the stent or stent component that is remote from the patient's heart.
  • Front and rear definitions the support tube surface with the window is the front wall, the opposite tube surface of the window is the rear wall, and the support tube surface between the front wall and the rear wall is the side wall.
  • a stent graft that can be used for interventional treatment of abdominal aortic diseases, comprising a tubular body composed of a tubular membrane and a plurality of annular stents, the tubular body including from the proximal end to the distal end
  • the first tube body 101 and the second tube body 103 are disposed in the end, and the diameter of the first tube body 101 is larger than the diameter of the second tube body 103; the first tube body 101 and the second tube body 103 are connected by the transition portion 102.
  • the central portion of the transition portion 102 has a smaller diameter than the proximal end of the transition portion 102 and the distal end of the transition portion 102; the first tubular body 101 and the transition portion 102 are provided with a plurality of windows 200.
  • the stent of the present invention is divided into three parts, a first tube body 101, a second tube body 103 and a transition portion 102, which are fixedly connected in one piece or in a unitary structure.
  • the stent as a whole exhibits a dumbbell shape, i.e., the central portion of the transition portion 102 has the smallest diameter, and the diameter of the first tubular body 101 is larger than the diameter of the second tubular body 103.
  • Each of the first pipe body 101 and the second pipe body 103 is an equal diameter pipe body or a non-equal diameter pipe body.
  • the equal diameter pipe body means that the pipe body diameter is constant, and the non-equal diameter pipe body means that the pipe body diameter changes from the proximal end to the distal end, and preferably a cone or a frustum.
  • the first pipe body 101 and the second pipe body 103 are both equal-diameter pipes.
  • the first tube body 101, the second tube body 103 and the transition portion 102 are each formed by a tubular coating and an annular bracket; the annular bracket is a contour wave ring bracket or a non-equal wave ring bracket; the ring bracket is all Stitching the stent or partially suturing the stent.
  • the shape, position, and number of the annular stents in the three sections are determined according to the stent structure, particularly the shape and length of the coating of the corresponding portion.
  • the transition portion 102 in turn includes three portions of a proximal extension 102A, a transition body segment 102C, and a distal extension segment 102B that are coupled to the first tubular body 101, wherein the transition body segment 102C has the smallest diameter among the three portions.
  • the first tube body 101 of the stent graft 100 has a diameter of 30 mm and a length of 35 mm, the total length of the transition portion 102 is 40 mm, the diameter of the transition body segment 102C is 18 mm, and the diameter of the second tube body 103 is 22 mm. It is 25mm.
  • the tubular film is made of a polymer material having good biocompatibility. In this embodiment, a PET film is preferably used, and the film thickness is 0.07 mm to 0.1 mm. The tubular film has good mechanical strength and anti-leakage performance.
  • the first tube body 101 is composed of a tubular coating film 115 and a plurality of independent annular brackets which are sequentially and evenly sewn on the tubular coating film 115 in the axial direction.
  • the annular bracket includes a bare bracket 110 and two windowed annular brackets 120 that are sequentially disposed from the proximal end to the distal end of the first tubular body 101.
  • the bare stent 110 is located at the proximal end of the stent graft, and the peak of the bare stent 110 is not sewn on the membrane 115. The peak of the bare stent 110 is used for fixation with the conveyor during assembly.
  • the bare bracket 110 has a vertical height of 18 mm and a diameter of 30 mm.
  • the bare metal support 110 is tubular and consists of a plurality of Z-shaped or sinusoidal waves. Each Z-shaped or sinusoidal wave has a peak 111 and an adjacent valley 112, a peak 111 and a phase. There is a connecting rod 113 between the adjacent troughs 112.
  • the windowed annular bracket 120 is composed of a plurality of Z-shaped or sinusoidal waves 120A and a window-shaped corrugation 120B, each of which has a crest 111 and an adjacent trough 112. There is a connecting rod 113 between the peak 111 and the adjacent trough 112.
  • This structure is the same as the bare bracket 110; the window-shaped corrugation 120B has two peaks 121 and one trough 122, and the window-shaped corrugation 120B is located in the Z-shaped or sine wave 120A. Between the peaks 111. The peaks 121 and troughs 122 of the window-shaped corrugations 120B have two connecting rods 123.
  • the peaks 121 and the Z-shaped or sinusoidal 120A peaks 111 have two connecting rods 124.
  • the window opening ring bracket 120 is woven by a superelastic nickel-titanium wire with a wire diameter ranging from 0.2 to 0.5 mm, preferably 0.45 mm in this embodiment, and the number of set peaks is six, and the vertical height of the window ring bracket 120 is set. It is 15mm.
  • the window ring bracket 120 has a connecting steel sleeve 114. The two ends of the nickel-titanium wire are connected inside the steel sleeve 114, and then the two ends of the nickel-titanium wire are fixed inside the steel sleeve by mechanical pressing or welding.
  • the window opening ring bracket 120 has two turns and is evenly arranged on the first pipe body 101, and the window-shaped corrugation 120B reserves enough space for the opening window 200.
  • the bare bracket 110 and the two windowed ring brackets 120 are respectively woven by a superelastic nickel-titanium wire.
  • the diameter of the nickel-titanium wire is selected from 0.2 to 0.5 mm, which is preferred in this embodiment.
  • a 0.45 mm diameter nickel-titanium wire has a number of Z-shaped or sine waves of six.
  • the bare bracket 110 and the two windowed annular brackets 120 each have a connecting steel sleeve 114.
  • the two ends of the nickel-titanium wire are connected inside the steel sleeve 114, and then two of the nickel-titanium wires are mechanically pressed or welded.
  • the end points are fixed inside the steel sleeve.
  • the bare stent 110 and the two windowed annular stents 120 are respectively fixed on the outer surface of the coating material by a stitching process, and the stent graft has good resilience.
  • the transition portion 102 includes a proximal extension 102A that connects the first tubular body 101, a distal extension 102B that connects the second tubular body 103, and a transition body segment 102C, wherein the transition body segment 102C of the three portions
  • the diameter is the smallest, wherein the proximal extension 102A and the distal extension 102B have a tapered structure, and the transition body section 102C has a straight cylindrical structure with a vertical height of 10 mm and a diameter of 18 mm.
  • the proximal extension 102A is provided with an annular bracket 122
  • the distal extension 102B is provided with an annular bracket 123. As shown in FIGS.
  • the annular bracket 122 and the annular bracket 123 are both tapered in shape and extend proximally with the taper. Segment 102A and tapered distal extension 102B are sized to match. As shown in FIG. 1, the annular bracket 121 disposed on the transition body segment 102C is an equal-diameter annular bracket.
  • the tubular coating 125 of the transition portion 102 is dumbbell-shaped, the tubular coating 125 at the proximal extension 102A and the distal extension 102B is tapered, and the tubular coating 125 of the transition body segment 102C is straight.
  • the tubular stent 125 of the present invention is sutured together or integrated.
  • the diameter of the straight tubular transition body segment 102C of the stent graft of the present invention near the renal artery is the smallest diameter in the stent, and can be implanted into the renal artery branch stent. Provides ample space that does not squeeze into the branch vessel stent.
  • the diameter of the proximal extension 102A of the proximal end of the transition portion 102 is gradually increased from the position where it meets 102C to the diameter of the first tube 101; the diameter of the distal extension 102B at the distal end of the transition portion 102 is The position where the 102C is joined gradually becomes larger to the diameter of the second pipe body 103.
  • the second tubular body 103 is composed of a tubular coating 135 and a plurality of independent annular stents 131 which are sequentially and evenly sewn to the tubular coating 135 in the axial direction.
  • one annular bracket 131 is provided.
  • a plurality of windows 200 are opened on the first pipe body 101 and the transition portion 102.
  • the window 200 includes a front wall window 201 and a side wall window 202; wherein a front wall window 201 is shown in FIG. 1, the front wall window 201 is disposed on the front wall of the film, and the front wall window 201 is provided with at least two All of the anterior wall windows 201 are generally arranged in the axial direction. Since the anterior wall window 201 is used to connect the celiac trunk artery and the superior mesenteric artery, the position of the celiac trunk artery and the superior mesenteric artery is preferred.
  • the wall window 201 and preferably the two front wall windows 201, are located on the same axis, ie the two front wall windows 201 are symmetrically arranged about the same axis. Also according to the position of the stent in the abdominal aorta, at least one anterior wall window 201 is located on the first tubular body 101. In this embodiment, both front wall windows 201 are located on the first pipe body 101, a front wall window 201 disposed at the proximal end of the first pipe body 101, and the other is disposed in the middle of the first pipe body 101.
  • front wall window 201 wherein the front wall window 201 of the proximal end of the first pipe body 101 is a groove type structure with an opening, and the groove is a square, U-shaped or semi-circular structure, this embodiment
  • a U-shaped front wall window 201 is selected.
  • the front wall window 201 in the middle of the first pipe body 101 is circular or elliptical, and the port edge of the front wall window 201 is provided with a metal ring 130.
  • the metal ring 130 is preferably circular, and its center is close to the proximal body.
  • the film end face is 20 mm and the ring diameter is about 11 mm.
  • the metal ring 130 is preferably a developing wire having a wire diameter of 0.35 mm for displaying the window position during surgery.
  • the U-shaped front wall window 201 has a width of 12 mm and a depth of 12 mm.
  • the side wall window 202 is disposed on the side of the film, and the side wall window 202 is disposed on each of the two side wall surfaces of the film, and the two side wall windows 202 are located at the same height.
  • the sidewall window 202 is connected to the embedded tubular body 152.
  • the embedded tubular body 152 is disposed within the stent and extends toward the proximal end of the stent.
  • the shape of the sidewall window 202 may be circular, elliptical or other shapes.
  • the sidewall window 202 has a V-shaped structure and is located at the proximal extension 102A and is connected to the embedded tubular body 152.
  • the side wall window 202 may be opened directly on the tubular film 125, or a metal ring 151 for supporting may be provided at the edge of the side wall window 202, and the metal ring 151 has the same shape as the side wall window 202.
  • the inner tubular body 152 extends from the side wall window 202 to the proximal end of the main body bracket to the cavity of the first pipe body 101, and has a cylindrical structure.
  • the inner tubular body 152 of the cylindrical structure is embedded in the first pipe body 101.
  • the material of the embedded tube body 152 is a polymer material having good biocompatibility, and this embodiment is preferably a PET film.
  • the outer surface of the inner tubular body 152 may be provided with a small metal support frame 152A of a Z-wave structure, which ensures good resilience of the inner tubular body 152.
  • the diameter of the embedded tubular body 152 ranges from 6 mm to 12 mm, and the length ranges from 5 mm to 20 mm.
  • the diameter of the embodiment is preferably 8 mm and the length is 12 mm.
  • the diameter of the metal small support frame 152A ranges from 0.2 mm to 0.4 mm.
  • the wire diameter is preferably 0.25 mm.
  • the anterior wall opening window corresponds to the celiac trunk 901 and the superior mesenteric artery 902, respectively, to ensure the patency of the peritoneal trunk and superior mesenteric artery, located on the side of the stent graft 100.
  • the two fenestrations 202 of the wall are located above the left and right renal arteries 903 and 904, respectively.
  • the stent graft 100 has a dumbbell-shaped structure, that is, the diameter of the middle portion of the transition region of the stent graft 100 is small, and the stent graft 100 is implanted in the diseased celiac artery, and the transition region is located in the renal artery segment to ensure the renal artery.
  • the vessel wall and the stent graft transition zone which not only facilitates the guidewire approach during the intervention of the small stent cavity, shortens the operation time, and ensures a larger space after the small stent graft is implanted.
  • Preventing the deformation of the main artery stent after the stent implantation of the renal artery can reduce the stimulation of the blood vessel wall, thereby achieving a more ideal intracavitary intervention effect, and better protecting the renal artery and peripheral blood vessels.
  • Embodiment 2 This embodiment is an improvement on the basis of Embodiment 1.
  • Embodiment 1 The difference from Embodiment 1 is that the support rod 160 is added to the embodiment 1. As shown in FIGS. 8-10, at least one axially disposed support rod 160 is fixed to the inner wall surface or the outer wall surface of the film at least at the proximal end along the circumferential direction of the film.
  • the first function of the support rod 160 that is, the most important function is to form a bracket in a semi-expanded state, that is, the adjacent two or more support rods 160 are drawn side by side and the wear-release guide wire 141 is fixed, in the process of zooming in.
  • the support rod 160 can always maintain the flatness of the film and the stability of the overall structure of the stent, and the tubular film and the ring bracket between the support rods 160 are folded, the diameter of the bracket is reduced, and the semi-expanded state and the semi-expanded state are formed.
  • the diameter is smaller than the diameter of the blood vessel, and the position can be adjusted freely in the blood vessel by free rotation and longitudinal movement, thereby facilitating accurate positioning of the stent during the release process. As shown in FIG.
  • the stent on the rear side of the window 200 is in a restrained state, and the overall diameter of the stent is small, and the two fronts are
  • the wall window 201 is in an unfolded state, which is in a clinical application process, because the stent graft is not fully deployed, and the overall diameter is small, and can be easily and axially and circumferentially rotated in the blood vessel by the delivery system, which can be more quickly and accurately
  • the accurate position of the front wall window 201 is positioned, so that the branch vessel can be smoothly fitted, thereby shortening the operation time and improving the success rate of the operation.
  • the support rods 160 are disposed along the axial direction of the tubular coating film in the axial direction of the tubular coating film, preferably in an axially symmetric manner. There are two kinds of positional relationship between the support rods 160: one is that the support rods 160 are parallel to the central axis of the bracket. The other is non-parallel to the central axis of the bracket, that is, the support rods 160 are arranged in a splayed or inverted eight-word manner, and preferably the angle between the support rods 160 and the central axis of the bracket is less than 30°.
  • the support rods 160 disposed on the central axis of the parallel brackets are respectively shown in FIG.
  • the diameter of the stent is simultaneously reduced.
  • the first tubular body 101 and the second tubular body 103 are originally straight cylindrical, and the semi-expanded state is also a straight cylindrical shape.
  • the transition portion 102 is scaled down and the transition portion 102 also maintains a dumbbell-shaped configuration.
  • the stent as a whole has a tapered shape with a slight change in diameter, and the angle of the taper is not too large to prevent the sheath from being able to be collected.
  • This embodiment preferably provides a support rod 160 parallel to the central axis of the stent.
  • the number of support rods 160 is generally 2-6, preferably 2-3. When more than two support rods 160 are provided, all of the support rods 160 are pulled in close proximity and worn to release the guide wire 141 to form a semi-expanded state of the stent.
  • the support rod 160 is disposed at least at the proximal end of the tubular coating of the first tube body 101, which means that the proximal end of the support rod 160 is disposed at the proximal end of the tubular coating of the first tube body 101, and the support rod 160 can extend toward the distal end of the stent, and the extension rod extends
  • the length may extend to the axially middle portion of the stent as needed, or may extend to the distal end of the stent axially.
  • the inner surface of the tubular film of the cylindrical structure is fixed with two support rods 160 which are disposed near the rear wall of the tubular film between the side wall windows 202.
  • the spacing between the two support rods 160 is 1/3 of the circumferential length of the first tubular body, and the side wall window 202 is located at the front wall.
  • the support rods 160 are distributed on the first tube body 101 of the stent graft, and are fixed on the inner wall or the outer wall of the tubular coating 115 by a process such as suturing, heat sealing or bonding, preferably by stitching.
  • the embodiment is fixed by a stitching process.
  • the inner surface of the stent graft is selected from a metal or polymer material having a certain supporting strength, preferably a metal material such as a nickel-titanium alloy wire having a wire diameter ranging from 0.3 mm to 0.6 mm. In this embodiment, the wire diameter is preferred. 0.45mm.
  • the structure of the support rod 160 is as shown in FIG. 11.
  • the support rod 160 shown in the figure is a straight rod structure, and the support rod 160 is provided with at least one fixing point for fixed connection with the film, and the support rod 160 passes through
  • the fixed point is sutured, heat sealed or adhesively fixed on the inner wall or the outer wall of the tubular film.
  • the fixing point is a connecting hole provided on the support rod 160 or an open groove with an opening.
  • the fixed point of the embodiment is two limit round heads 161 with connecting holes.
  • the two ends of the support rod 160 are formed by curling, and the limit is limited.
  • the diameter of the round head 161 ranges from 1.5 mm to 3.5 mm.
  • the priority limit of the round head 161 is 2.5 mm.
  • the limit round head 161 is fixed to the proximal end of the tubular coating in a suture manner to prevent the support rod 160 from slipping axially within the stent.
  • the fixing point may also be a non-closed loop structure, or may be an open groove with an opening, for example, bending the support rod 160 to form a semicircular or curved open groove, after being fixed at the open groove, The support rod 160 cannot move axially.
  • the support rod 160 plays a supporting role in the axial direction, and also serves as a stud in the assembly of the stent graft, and the release guide wire is fixed on the support rod by other connection means such as wearing or winding.
  • the stability of the stent during assembly is ensured, and the semi-expanded state of the circumferential structure after the stent portion is released can be ensured.
  • the stent diameter in the semi-expanded state is smaller than the diameter of the blood vessel, and can be freely rotated and longitudinally moved in the blood vessel. The position is adjusted to facilitate precise positioning of the stent during the release process.
  • Embodiment 3 This embodiment is an improvement on the basis of Embodiment 1.
  • the connecting member 140 for axially disposing the guide wire 141 is axially disposed from the proximal end to the distal end, and the connecting member 140 is axially disposed. Set at least two rows at intervals.
  • the connecting member 140 is used for the axial insertion of the stent to release the guide wire 141, and as the assisting release guide wire 141 is restrained in the radial direction to form a semi-expanded state, the connector 140 structure needs to meet the above purpose at the same time, so the connecting member 140 can Two structures are selected: a closed loop structure or an open loop structure for the release guide wire 141 to be worn or wound; in the first structural formula, the closed loop structure is a through hole or a joint for the release guide wire 141 to pass through.
  • the connecting member 140 is engaged with the film to form a through hole or gap through which the guide wire 141 is passed.
  • the first embodiment is that the connecting member 140 is a coil fixed on the outer wall surface of the film; in the second embodiment, the connecting member 140 is a line of axially fixed wires, and the wire is fixed at intervals. A gap is formed between the film and the cover for the release of the guide wire 141; in the third embodiment, the connector 140 is a through hole that is directly formed on the film.
  • the open-loop structure has a limiting slot for the release guide wire 141 to pass through, that is, the connecting member 140 is at least two rows of soft connecting buckles with a limited position slot, and the limiting slot opening of the different rows of soft connecting buckles Back to the setting.
  • the connecting member 140 is a soft connecting buckle disposed on the film or attachable to the film, preferably a biocompatible polymer material, such as a polymer. Ester, you can also choose a wire.
  • the connecting member 140 is a coil with a through hole, and the through hole can pass the release guide wire 141 having a wire diameter of 0.5 mm to 1.5 mm.
  • the guide wire 141 is released.
  • the material is preferably nickel-titanium alloy wire, the wire diameter is 0.5mm, the number of connecting members 140 is six, and the two rows are evenly fixed on the film 120, and each row has three connecting members 140.
  • the stent graft is kept in a semi-expanded state under the restraint of the release guide wire 141, and then the stent is fully crimped. In the conveyor sheath. When released, the portion of the stent graft that is not bound by the connector 140 is first released.
  • the membrane between the connectors 140 is still in a restrained state, the stent graft is not completely released, and the overall diameter of the stent is small, and the two front walls are
  • the window 201 is in an unfolded state, which is in the clinical application process, because the stent graft is not fully deployed, the overall diameter is small, and the axial and circumferential rotation in the blood vessel can be conveniently performed by the delivery system, which can be positioned more quickly and accurately.
  • the exact position of the anterior wall window 201 enables smooth anastomosis of the branch vessels, thereby shortening the operation time and improving the success rate of the surgery.
  • the release guidewire 141 is withdrawn and the stent graft is fully released and firmly adhered to the blood vessel.
  • Embodiment 4 this embodiment is an improvement on the basis of Embodiment 1-3.
  • Embodiment 1 the difference from Embodiment 1 is that the present embodiment is based on Embodiment 1, and the support rod 160 described in Embodiment 2 and the connecting member described in Embodiment 3 are simultaneously added. 140. That is, at least one axially disposed support rod 160 is fixed to the inner wall surface or the outer wall surface of the film, and the connecting rod 140 for wearing the release guide wire 141 is disposed on the support rod 160 or the corresponding support rod 160. .
  • the structure of the support rod 160 and the connecting member 140 itself, and the position of the coating film are the same as those of the embodiment 2-3, and details are not described herein again.
  • the relative position between the support rod 160 and the connecting member 140 is as shown in FIGS. 14-15, and the connecting member 140 is disposed on the outer side wall surface of the coating corresponding to the supporting rod 160, or the outer side wall surface of the coating adjacent to the supporting rod 160.
  • the number of the connecting members 140 in the embodiment is six, and the two rows are fixed in two rows at both ends and the intermediate position of the metal support bar 160.
  • the proximal bare stent 110 is still restrained in the TIP head 10 of the conveyor, and has a small overall diameter, which can be easily and axially and circumferentially rotated in the blood vessel by the delivery system, and can locate the front wall more quickly and accurately.
  • the exact position of the window 201 enables smooth anastomosis of the branch vessels, shortens the operation time, and improves the success rate of the operation.
  • the support rod 160 can also be used as a stud in the assembly of the stent graft, which can ensure the stability of the stent during the assembly process, and can also ensure the stable semi-expanded state of the circumferential structure after the stent portion is released, and prevent the stent from being supported.
  • the front wall window 201 is deformed in a semi-assembled or semi-released state, resulting in inaccurate positioning.
  • Embodiment 5 this embodiment is an improvement on the basis of Embodiments 1-4.
  • the bare bracket 110 connected to the first pipe body 101 has a barb 119 structure.
  • the bare stent 110 with the barb 119 has the same structure as the bare stent 110 of the first tubular body 101 of the first embodiment, except that the bare stent 110 is provided with an outwardly folded barb 119.
  • the barb 119 has a free end facing the distal end of the stent.
  • the bare bracket 110 is a laser cutting bracket, and the barb 119 is a one-piece barb 119 formed by the connecting rod 113 of the bare bracket 110 longitudinally cut and outwardly folded by the connecting rod 113, specifically near the crest. There is a barb 119 at the connecting rod 113.
  • the bare stent 110 with barbs 119 can further provide anchoring of the stent graft.

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Abstract

一种可用于腹主动脉疾病介入治疗的覆膜支架，包括由管状覆膜和多个环形支架组成的管体，管体包括由近端向远端依次设置的第一管体(101)、第二管体(103)，第一管体(101)直径大于第二管体直径(103)；第一管体(101)、第二管体(103)之间通过过渡部(102)连接成为一个整体；过渡部(102)中部直径小于过渡部(102)近端和远端直径；第一管体(101)和过渡部(102)上开设有多个窗口(200)。提供一种释放后靠近分支段部分直径较小，有更多空间容纳分支血管或者分支支架的可用于腹主动脉疾病介入治疗的覆膜支架。

Description

可用于腹主动脉疾病介入治疗的覆膜支架 技术领域
本发明属于医疗器械技术领域，具体涉及一种覆膜支架，尤其涉及一种可用于腹主动脉疾病介入治疗的覆膜支架。
背景技术
腹主动脉瘤是一种常见的主动脉疾病，流行病学研究显示，腹主动脉瘤在男性中的发病率为5％，但在80岁及以上患者中，发病率增长到10％，而且其瘤体破裂的风险较其他人群更高。据预测，到2020年，我国80岁以上人口将达到3000万，90岁以上的将超过1200万，在未来将有越来越多的高龄AAA患者需要接受治疗。
现有治疗腹主动脉瘤的主要方式包括传统的开放手术及腹主动脉瘤腔内修复术，两种方式各有优势。腹主动脉腔内修复术自20世纪90年代报道首例被用于治疗腹主动脉瘤以来，因其创伤小、手术及住院时间短、术后恢复快、围手术期病死率及并发症发生率低等优点，在短短的20年内迅速发展。
腹主动脉瘤腔内修复手术最大的优势在于不需要开胸开腹，无需钳夹阻断血管，术中无内脏器官缺血，并发症少。然而最大的限制是内脏大动脉不能被覆盖，尤其是肠系膜上动脉和肾动脉，累及肾动脉领域的腹主动脉瘤腔内修复仍是难点。
目前，采用“开窗支架型血管”对这类病人实施支架型血管的植入治疗，即在腹主动脉植入主体支架，在主体支架开设窗口，在窗口再安装分支支架血管，通往分支血管。对腹主动脉瘤实施腔内治疗所植入的支架型血管涉及腹腔干动脉、肠系膜上动脉和左右肾动脉四条分支动脉血管的重建。但实际操作中，在不同病人，这四条内脏动脉的空间位置存在个体差异，植入开窗支架型血管需要对每个患者的病变部位和周边血管进行准确的检测定位，按检测结果进行支架血管的设计、制作。这种针对个体患者的检测、设计、制作，不但程序复杂，而且受仪器精密程度和操纵人员熟练程度的影响，所制作的支架血管常常精确 度差，使得治疗效果大打折扣。
另一方面，在当前支架释放过程中，尤其在形态较为复杂的病变血管段，部分支架存在移位或释放过程定位不准确的现象，从而导致释放后内漏，封堵分支血管等问题，严重者甚至造成截瘫或死亡等医疗事故，不但不能达到理想的治疗效果，而且对病人的身心造成较大不良影响。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种释放后靠近分支段部分直径较小，有更多空间容纳分支血管支架的可用于腹主动脉疾病介入治疗的覆膜支架。
本发明解决其技术问题所采用的技术方案是：
一种可用于腹主动脉疾病介入治疗的覆膜支架，包括由管状覆膜和多个环形支架组成的管体，所述管体包括由近端向远端依次设置的第一管体、第二管体，所述第一管体直径大于第二管体直径；
第一管体、第二管体之间通过过渡部连接成为一个整体；所述过渡部中部直径小于过渡部近端和过渡部远端直径；
所述第一管体和过渡部上开设有多个窗口。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述窗口包括前壁窗口和侧壁窗口；所述前壁窗口设置在覆膜前壁上，所述侧壁窗口设置在覆膜侧面。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述前壁窗口设置至少两个，所有前壁窗口位于同一轴线上，且至少一个前壁窗口位于第一管体上。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述侧壁窗口在覆膜两侧壁面各设置一个，两个侧壁窗口位于同一高度。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述覆膜的内壁面或外壁面至少在第一管体近端沿覆膜周向固定有至少一根轴向设置的支撑杆。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述支撑杆通过缝合、热合或粘接固定在覆膜壁面上。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述支撑杆上设置至少一个用于与覆膜固定连接的固定点，所述固定点为支撑杆上设置的连接孔或带有开口的开口槽。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述支撑杆平行于支架中轴线设置；或者所述支撑杆之间呈八字或倒八字设置。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述覆膜上由近端向远端轴向设置有用于穿装释放导丝的连接件，所述连接件轴向间隔设置至少两排。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述连接件为供释放导丝穿装或缠绕的闭环结构或开环结构；所述闭环结构是连接件带有供释放导丝穿过的通孔或者所述连接件与覆膜配合合围形成供释放导丝穿过的通孔或间隙，所述开环结构带有供释放导丝穿过的限位槽。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述闭环结构的连接件为固定在覆膜外侧壁面的线圈；或者所述闭环结构的连接件为一段轴向间隔固定的线绳，且间隔固定在线绳与覆膜之间形成有供释放导丝穿过的间隙；或者闭环结构的连接件是设置在覆膜上的通孔；或是所述开环结构的连接件为至少两排带有限位槽的软性连接扣，不同排的限位槽开口背向设置。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述覆膜内壁面或外壁面固定有至少一根轴向设置的支撑杆，所述支撑杆或对应支撑杆的覆膜上设有用于穿装释放导丝的连接件。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述第一管体、第二管体和过渡部均由管状覆膜和环形支架构成。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选第一管体近端设有裸支架，所述裸支架设有向外翻折的倒刺，所述倒刺自由端朝向支架远端。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述过渡部依次包括与第一管体连接的近端延伸段、过渡主体段和远端延伸段三部分，其中三部分中过渡主体段直径最小。
进一步地，所述的可用于腹主动脉疾病介入治疗的覆膜支架中，优选所述 过渡主体段为等径结构，所述近端延伸段和远端延伸段为非等径结构。
本发明的覆膜支架为中部细两端粗的哑铃形结构，其中，所述第一管体直径大于第二管体直径，所述过渡部中部直径小于过渡部近端和过渡部远端直径；本发明的覆膜支架能够实现累及肾动脉领域的腹主动脉瘤腔内修复，过渡部直径最小，能够为肾动脉分支支架的植入提供富裕的空间，不会挤压到血管。另一方面，第一管体和过渡部上开设有多个窗口，用于分别与腹腔干动脉、肠系膜上动脉、左右肾动脉吻合联通。覆膜支架前侧壁设有的窗口，不会覆盖肠系膜上动脉和腹腔干动脉。
另外，所述覆膜上由近端向远端轴向设置有用于穿装释放导丝的连接件，所述连接件轴向设置间隔至少两排。连接件配合释放导丝约束支架径向尺寸，使支架呈现半展开状态，半展开状态的直径直径小于血管直径，能够在所述血管中自由旋转和纵向移动而调整位置，便于支架在释放过程中的精确定位。
再者，覆膜后壁设有至少一根支撑杆，所述支撑杆可以作为支架装配时的拴柱，既能保证支架在装配过程中的稳定性，也能够保证支架部分释放后的周向结构稳定的半展开状态。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明实施例1覆膜支架结构示意图；
图2是本发明实施例1第一管体中单圈环形支架结构示意图；
图3是本发明实施例1第一管体中开窗环形支架结构示意图；
图4是本发明实施例1过渡部中锥形的环形支架结构示意图；
图5是本发明实施例1覆膜支架侧面结构示意图；
图6是本发明实施例1侧壁窗口结构示意图；
图7是本发明实施例1支架植入血管内结构示意图；
图8是本发明实施例2覆膜支架结构示意图；
图9是本发明实施例2在束缚下半展开状态前面结构示意图；
图10是本发明实施例2在束缚下半展开状态后面结构示意图；
图11是本发明实施例2支撑杆结构示意图；
图12是本发明实施例3覆膜支架结构示意图；
图13是本发明实施例3在束缚下半展开状态后面结构示意图；
图14是本发明实施例4覆膜支架结构示意图；
图15是本发明实施例4在束缚下半展开状态后面结构示意图；
图16A是实施例4覆膜支架释放过程中仅近端覆膜部分释放的背面结构示意图；
图16B是实施例4覆膜支架释放过程中仅近端覆膜部分释放的正面结构示意图；
图17是本发明实施例5覆膜支架结构示意图；
图18是本发明实施例5带有倒刺的裸支架结构示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
本发明所述“近端”是指沿血流方向，靠近患者心脏的支架或支架部件的部分，而所述“远端”是指远离患者心脏的支架或支架部件的部分。
前、后定义：设有窗口的支架管面为前壁，窗口相对的支架管面为后壁，前壁与后壁之间的支架管面为侧壁。
实施例1，如图1所示，一种可用于腹主动脉疾病介入治疗的覆膜支架，包括由管状覆膜和多个环形支架组成的管体，所述管体包括由近端向远端依次设置的第一管体101、第二管体103，所述第一管体101直径大于第二管体103直径；第一管体101、第二管体103之间通过过渡部102连接成为一个整体；所述过渡部102中部直径小于过渡部102近端直径和过渡部102远端直径；所述第一管体101和过渡部102上开设有多个窗口200。
本发明支架共分为三部分，第一管体101、第二管体103和过渡部102，这三部分为固定连接成一个整体或者是一体结构。支架整体呈现为哑铃形，即 过渡部102中部直径最小，另外所述第一管体101直径大于第二管体103直径。第一管体101、第二管体103各自分别为等径管体或非等径管体。等径管体是指管体直径不变，非等径管体是指管体直径从近端到远端发生变化，优选锥形或锥台。如图1-2所示，本实施例中，第一管体101和第二管体103都采用等径管体。
所述第一管体101、第二管体103和过渡部102均由管状覆膜和环形支架构成；所述环形支架为等高波环形支架或者非等高波的环形支架；所述环形支架为全部缝合支架或者部分缝合支架。三部分中的环形支架形状、位置、数量根据支架结构，尤其是对应部分的覆膜形状和长度来决定。
所述过渡部102依次包括与第一管体101连接的近端延伸段102A、过渡主体段102C和远端延伸段102B三部分，其中三部分中过渡主体段102C直径最小。本实施例中，覆膜支架100第一管体101直径为30mm，长度为35mm，过渡部102总长度为40mm，过渡主体段102C的直径为18mm，第二管体103的直径为22mm，长度为25mm。管状覆膜选用具有良好生物相容性的高分子材料制成，本实施例中优选PET膜，膜厚0.07mm～0.1mm，管状覆膜具有良好的力学强度和防内漏性能。
以下具体对管体的三部分进行详细说明：
如图1所示，本实施例中，所述第一管体101由管状覆膜115以及沿轴向依次间隔均匀缝合在管状覆膜115上的多个独立的环形支架组成。环形支架包括第一管体101的近端至远端依次设置的裸支架110、两个开窗环形支架120。所述裸支架110位于覆膜支架近端，所述裸支架110的波峰未缝合在覆膜115上，裸支架110的波峰用于装配时与输送器固定。此处裸支架110垂直高度为18mm，直径为30mm。如图2所示，金属的裸支架110为管柱状，由多个Z形或正弦波组成，每个Z形或正弦波有1个波峰111和1个相邻的波谷112，波峰111和相邻的波谷112之间有1条连接杆113。
如图3所示，开窗环形支架120由多个Z形或正弦波120A和一个窗口形波纹120B组成，每个Z形或正弦波120A有1个波峰111和1个相邻的波谷112，波峰111和相邻的波谷112之间有1条连接杆113，这个结构同裸支架110；窗口形波纹120B有两个波峰121和一个波谷122，窗口形波纹120B位 于Z形或正弦波120A两波峰111之间。窗口形波纹120B的波峰121和波谷122有两条连接杆123，波峰121与Z形或正弦波120A两波峰111有两条连接杆124。开窗环形支架120采用一条超弹性镍钛丝编织而成，丝径范围在0.2～0.5mm之间，本实施例优选0.45mm，设定波峰数量为6个，开窗环形支架120的垂直高度为15mm。开窗环形支架120上有1个连接钢套114，镍钛丝的两个端点在连接钢套114内部，然后通过机械压紧或者焊接方式将镍钛丝的两个端点固定在钢套内部。开窗环形支架120有两圈，均匀排布于第一管体101，窗口形波纹120B给开设窗口200预留出足够的空间。
如图2-3所示，裸支架110、两个开窗环形支架120都分别采用一条超弹性镍钛丝编织而成，镍钛丝丝径选择范围为0.2～0.5mm，本实施例中优选0.45mm直径的镍钛丝，Z形或正弦波数量为6个。裸支架110、两个开窗环形支架120都分别有1个连接钢套114，镍钛丝的两个端点在连接钢套114内部，然后通过机械压紧或者焊接方式将镍钛丝的两个端点固定在钢套内部。裸支架110、两个开窗环形支架120都分别采用缝合工艺固定在覆膜材料外表面，覆膜支架具有良好的回弹性。
如图1所示，过渡部102包括连接第一管体101的近端延伸段102A，连接第二管体103的远端延伸段102B，以及过渡主体段102C，其中三部分中过渡主体段102C直径最小，其中近端延伸段102A和远端延伸段102B呈锥形结构，过渡主体段102C呈直筒状结构，其垂直高度为10mm，直径为18mm。近端延伸段102A设有环形支架122，远端延伸段102B设有环形支架123，如图1、4所示，环形支架122和环形支架123的形状都为锥形，与锥形近端延伸段102A和锥形远端延伸段102B尺寸相吻合。如图1所示，设置于过渡主体段102C的环形支架121为等径环形支架。
如图1所示，过渡部102的管状覆膜125为哑铃形，位于近端延伸段102A和远端延伸段102B的管状覆膜125为锥形，过渡主体段102C的管状覆膜125为直筒形，管状覆膜125各部分缝合在一起或是一体结构，本发明的覆膜支架在肾动脉附近的直筒状过渡主体段102C的直径为支架中的最小直径，能够为肾动脉分支支架植入提供富裕的空间，不会挤压到分支血管支架。过渡部102近端的近端延伸段102A的直径分别从与102C相接的位置逐渐变大至与第一 管体101直径相当；过渡部102远端的远端延伸段102B的直径则从与102C相接的位置逐渐变大至与第二管体103的直径相当。如图1所示，第二管体103为由管状覆膜135以及沿轴向依次间隔均匀缝合在管状覆膜135上的多个独立的环形支架131组成。本实施例中，环形支架131设置一个。
如图1、5所示，所述第一管体101和过渡部102上开设有多个窗口200。所述窗口200包括前壁窗口201和侧壁窗口202；其中图1中显示有前壁窗口201，所述前壁窗口201设置在覆膜前壁上，所述前壁窗口201设置至少两个，所有前壁窗口201一般在轴向上顺序排布，由于前壁窗口201用于对应连接腹腔干动脉和肠系膜上动脉，针对腹腔干动脉和肠系膜上动脉的位置，本实施例优选两个前壁窗口201，并优选两个前壁窗口201位于同一轴线上，即两个前壁窗口201关于同一轴向对称设置。同样根据支架在腹主动脉中的位置，至少一个前壁窗口201位于第一管体101上。本实施例中，两个前壁窗口201都位于第一管体101上，一个在第一管体101的近端端部设置的前壁窗口201，另一个是在第一管体101中部设有的前壁窗口201，其中第一管体101近端端部的前壁窗口201为带有开口的凹槽型结构，所述凹槽为方形、U形或者半圆形结构，本实施例选择U形的前壁窗口201。第一管体101中部的前壁窗口201为圆形或椭圆形，所述前壁窗口201的端口边缘设有金属环130，所述金属环130优选为圆形，其圆心距离近端主体覆膜端面20mm，圆环直径约11mm，本实施例中金属环130优选丝径为0.35mm的显影丝，用于在手术中显示窗口位置。所述U形的前壁窗口201宽度为12mm，深度为12mm。
如图5所示，所述侧壁窗口202设置在覆膜侧面，所述侧壁窗口202在覆膜两侧壁面各设置一个，两个侧壁窗口202位于同一高度。
如图5-6所示，所述侧壁窗口202连接有内嵌管体152。内嵌管体152设置在支架内，向支架近端延伸。侧壁窗口202的形状可以是圆形、椭圆形或其他形状，本实施例中，侧壁窗口202呈V型结构，位于近端延伸段102A且与内嵌管体152相连。侧壁窗口202可以直接在管状覆膜125上开设，也可以在侧壁窗口202边缘设置用于支撑的金属环151，金属环151形状跟侧壁窗口202相同。内嵌管体152从侧壁窗口202向主体支架近端延伸至第一管体101的腔体内，呈筒状结构，该筒状结构的内嵌管体152内嵌于第一管体101的内表面。 内嵌管体152材料为具有良好生物相容性的高分子材料，该实施例优选PET膜。内嵌管体152的外表面可设置Z型波结构的小金属支撑架152A，其可保证内嵌管体152具有良好的回弹性。内嵌管体152的直径范围为6mm～12mm，长度范围为5mm～20mm，本实施例优选直径为8mm，长度为12mm；金属小支撑架152A丝径选择范围为0.2mm～0.4mm，本实施例优选丝径0.25mm。
如图7所示，覆膜支架100植入腹腔动脉900后，前壁开窗口分别与腹腔干901和肠系膜上动脉902对应，保证腹腔干和肠系膜上动脉的通畅性，位于覆膜支架100侧壁的两个开窗202分别位于左右肾动脉903和904的上方。此时，若腹主动脉瘤累及肾动脉，则需通过腔内介入的方式在左右开窗202植入覆膜小支架，以保证肾动脉的通畅性。本实施例中所述覆膜支架100呈哑铃状结构，即覆膜支架100过渡区域中段的直径较小，覆膜支架100植入病变的腹腔动脉后其过渡区域位于肾动脉段，保证肾动脉血管壁与覆膜支架过渡区支架有较大空间，不但便于覆膜小支架腔内介入过程中的导丝入路，缩短手术时间，而且保证覆膜小支架植入后拥有更大的空间，防止肾动脉分支支架植入后受到主体支架的挤压导致变形，也能够减少其对血管壁的刺激，进而达到更加理想的腔内介入手术效果，更好地保护肾动脉及周边血管。
实施例2，本实施例是在实施例1基础上的改进。
与实施例1的区别是在实施例1的基础上增加了支撑杆160。如图8-10所示，所述覆膜内侧壁面或外侧壁面至少在近端沿覆膜周向固定有至少一根轴向设置的支撑杆160。支撑杆160的第一功能，即最主要功能是形成半展开状态的支架，即将相邻的两个或多个支撑杆160拉近并列并穿装释放导丝141固定，在拉近的过程中，支撑杆160能够始终保持覆膜的平整与支架整体结构的稳定性，在支撑杆160之间的管状覆膜和环形支架折叠，减少了支架的直径，形成半展开状态，半展开状态的支架直径小于血管直径，能够在所述血管中自由旋转和纵向移动而调整位置，便于支架在释放过程中的精确定位。如图9-10所示，覆膜支架在释放导丝141(输送器上的)束缚下处于半释放状态后，窗口200后侧的支架处于束缚状态，支架整体直径较小，而两个前壁窗口201处于展开状态，该状态在临床应用过程中，因覆膜支架未完全展开，整体直径 较小，可以通过输送系统在血管内方便的轴向和周向旋转，能够更快速、精确地定位前壁窗口201的准确位置，从而能够顺利和分支血管吻合，从而缩短手术时间，提高手术成功率。
所述支撑杆160在管状覆膜周向上沿管状覆膜轴向设置，优选轴向对称设置，支撑杆160之间相互位置关系有两种：一种是所述支撑杆160平行于支架中轴线设置；另一种是非平行于支架中轴线，即所述支撑杆160之间呈八字或倒八字设置，优选支撑杆160与支架中轴线的夹角小于30°。平行支架中轴线设置的支撑杆160，如图9-10所示分别是：支撑杆160平行设置情况下，支架在束缚下半展开状态前面结构示意图和在束缚下半展开状态后面结构示意图，图中所示束缚固定后，支架直径同步缩小，例如第一管体101和第二管体103原为直筒形，半展开状态也是直筒形。过渡部102同比例缩小，过渡部102还保持哑铃形结构。第二种情况下，支架整体呈直径稍有变化的锥形，锥形夹角不可过大，以防止无法收入鞘管。本实施例优选平行于支架中轴线设置支撑杆160。支撑杆160设置数量一般在2-6个，优选设置2-3个。设置超过两个的支撑杆160时，将所有的支撑杆160全部拉近并列并穿装释放导丝141固定，以形成支架的半展开状态。
支撑杆160至少设置在第一管体101管状覆膜近端，是指支撑杆160近端设置在第一管体101管状覆膜近端，支撑杆160可以向支架远端方向延伸，其延伸长度根据需要，可以延伸至支架轴向中部，也可以延伸至支架轴向的远端。
如图8所示，优选所述筒状结构的管状覆膜的内表面固定有两根支撑杆160，所述两根支撑杆160设置在侧壁窗口202之间的管状覆膜后壁的近端上，且相对于两个前壁窗口201的中轴线对称排布，优选两个支撑杆160之间的间距是第一管体周向弧长的1/3，侧壁窗口202位于前壁窗口201与支撑杆160之间的覆膜上，两个支撑杆160拉近时，前壁窗口201、侧壁窗口202都处于展开状态，不会因支架折叠后被遮挡。支撑杆160分布在覆膜支架的第一管体101上，通过缝合、热合或粘接等工艺固定在管状覆膜115内壁或外壁上，优选缝合的方式固定，本实施例通过缝合工艺固定在覆膜支架内表面，支撑杆160选材为具有一定支撑强度的金属或高分子材料，优选金属材料，例如镍钛合金丝，丝径范围为0.3mm～0.6mm，在本实施例中丝径优选0.45mm。
所述支撑杆160结构如图11所示，图中显示的支撑杆160为直杆结构，所述支撑杆160上设置至少一个用于与覆膜固定连接的固定点，所述支撑杆160通过固定点缝合、热合或粘接固定在管状覆膜内壁或外壁上。所述固定点为支撑杆160上设置的连接孔或带有开口的开口槽。本实施例中在支撑杆160的两端分别有两个固定点，本实施例的固定点为两个带有连接孔的限位圆头161，通过将支撑杆160两端卷曲形成，限位圆头161直径范围为1.5mm～3.5mm，本实施例优先限位圆头161直径2.5mm。限位圆头161以缝合的方式固定于管状覆膜近端，防止支撑杆160在支架内沿轴向滑脱。除了连接孔外，固定点也可以为非闭环结构，还可以是带有开口的开口槽，例如：将支撑杆160某处弯曲，形成半圆或弧形的开口槽，在开口槽处固定后，支撑杆160就无法轴向移动。
在本实施例中支撑杆160在轴向起到支撑作用的同时，也作为覆膜支架装配时的栓柱，将释放导丝通过穿装或者缠绕等其它连接方式固定在支撑杆上，既能保证支架在装配过程中的稳定性，也能够保证支架部分释放后的周向结构稳定的半展开状态，所述半展开状态的支架直径小于血管直径，能够在所述血管中自由旋转和纵向移动而调整位置，便于支架在释放过程中的精确定位。
其余结构同实施例1，在此不再赘述。
实施例3，本实施例是实施例1的基础上的改进。
如图12-13所示，与实施例1的区别是：所述覆膜上由近端向远端轴向设置有用于穿装释放导丝141的连接件140，所述连接件140轴向间隔设置至少两排。
所述连接件140用于支架轴向穿装释放导丝141，且作为协助释放导丝141在径向上束缚支架形成半展开状态，则连接件140结构需同时满足上述目的，因此连接件140可以选择两种结构：供释放导丝141穿装或缠绕的闭环结构或开环结构；第一种结构式中，所述闭环结构是连接件140带有供释放导丝141穿过的通孔或者所述连接件140与覆膜配合合围形成供释放导丝141穿过的通孔或间隙。具体第一种实施方式为：所述连接件140为固定在覆膜外侧壁面的线圈；第二种实施方式为：所述连接件140为一段轴向间隔固定的线绳，且间 隔固定在线绳与覆膜之间形成有供释放导丝141穿过的间隙；第三种实施方式为：连接件140是直接设置在覆膜上开设的通孔。
所述开环结构带有供释放导丝141穿过的限位槽，即所述连接件140为至少两排带有限位槽的软性连接扣，不同排软性连接扣的限位槽开口背向设置。
为了防止在支架释放过程中连接件140损伤血管，所述连接件140为设置在覆膜上或可贴附在覆膜上的软性连接扣，优选生物相容性的高分子材料，例如聚酯，也可以选择金属丝。
如图12-13所示，本实施例中，连接件140为带有通孔的线圈，通孔可通过丝径为0.5mm～1.5mm的释放导丝141，本实施例中释放导丝141材质优先选用镍钛合金丝，丝径为0.5mm，连接件140数量为6个，分两排均匀固定在覆膜120上，每排有三个连接件140，装配时，首先将两排连接件140拉向一起，在输送器的固定释放导丝141依次穿过不同排的连接件140，所述覆膜支架在释放导丝141的束缚下保持半展开状态，再将所述支架全部压握在输送器鞘管中。释放时，首先释放覆膜支架未被连接件140束缚的部分，此时连接件140之间的覆膜仍处于束缚状态，覆膜支架未完全释放，支架整体直径较小，而两个前壁窗口201处于展开状态，该状态在临床应用过程中，因覆膜支架未完全展开，整体直径较小，可以通过输送系统在血管内方便的轴向和周向旋转，能够更快速、精确地定位前壁窗口201的准确位置，从而能够顺利和分支血管吻合，从而缩短手术时间，提高手术成功率。在找到支架的正确释放位置后，撤出释放导丝141，覆膜支架完全释放并牢牢贴合在血管内。
其余结构同实施例1，在此不再赘述。
实施例4，本实施例是实施例1-3的基础上的改进。
如图14-15所示，与实施例1的区别是：本实施例在实施例1的基础上，同时增加了实施例2中所述的支撑杆160和实施例3中所述的连接件140。即所述覆膜内壁面或外壁面固定有至少一根轴向设置的支撑杆160，所述支撑杆160或对应支撑杆160的覆膜上设有用于穿装释放导丝141的连接件140。
其中，支撑杆160和连接件140本身的结构，以及在覆膜的位置同实施例2-3，在此不再赘述。
支撑杆160与连接件140之间的相对位置如图14-15所示，连接件140设置在支撑杆160所对应的覆膜外侧壁面上，或支撑杆160临近的覆膜外侧壁面上。
如图14-15所示，本实施例中连接件140的数量为6个，均分两排固定在金属支撑杆160的两端和中间位置。
如图16A-16B所示，所述覆膜支架释放时，在释放导丝141束缚下处于半释放状态，覆膜支支架近端前壁窗口201和侧壁窗口202后方的部分支架仍处于束缚状态，支架整体直径较小，而U形的前壁窗口201和环形的前壁窗口201处于展开状态，该状态在临床应用过程中，因覆膜支架未完全展开，远端覆膜收束在外鞘管20中，近端裸支架110仍束缚在输送器TIP头10中，整体直径较小，可以通过输送系统在血管内方便的轴向和周向旋转，能够更快速、精确地定位前壁窗口201的准确位置，从而能够顺利和分支血管吻合，缩短手术时间，提高手术成功率。另一方面，支撑杆160还可作为覆膜支架装配时的栓柱，既能保证支架在装配过程中的稳定性，也能够保证支架部分释放后的周向结构稳定的半展开状态，防止支架在处于半装配或者半释放状态时前壁窗口201变形，而导致定位的不准确。
其余结构同实施例1-3，在此不再赘述。
实施例5，本实施例是在实施例1-4的基础上的改进。
本实施例与实施例1-4的区别在于与第一管体101连接的裸支架110呈带倒刺119结构。如图17-18所示，带倒刺119的裸支架110与实施例1中第一管体101的裸支架110主体结构相同，只是所述裸支架110设有向外翻折的倒刺119，所述倒刺119自由端朝向支架远端。裸支架110是一种激光切割支架，所述倒刺119是由裸支架110的连接杆113顺连接杆113纵向切割并向外翻折形成的一体结构的倒刺119，具体是在靠近波峰的连接杆113处存在倒刺119。带倒刺119的裸支架110可以进一步提供覆膜支架的锚定性。
其余结构同实施例1-4，在此不再赘述。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本 领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。

Claims (15)

  1. 一种可用于腹主动脉疾病介入治疗的覆膜支架，包括由管状覆膜和多个环形支架组成的管体，其特征在于，所述管体包括由近端向远端依次设置的第一管体、第二管体，所述第一管体直径大于第二管体直径；
    第一管体、第二管体之间通过过渡部连接成为一个整体；所述过渡部中部直径小于过渡部近端和过渡部远端直径；
    所述第一管体和过渡部上开设有多个窗口。
  2. 根据权利要求1所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述窗口包括前壁窗口和侧壁窗口；所述前壁窗口设置在覆膜前壁上，所述侧壁窗口设置在覆膜侧面。
  3. 根据权利要求2所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述前壁窗口设置至少两个，所有前壁窗口位于同一轴线上，且至少一个前壁窗口位于第一管体上。
  4. 根据权利要求2所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述侧壁窗口在覆膜两侧壁面各设置一个，两个侧壁窗口位于同一高度。
  5. 根据权利要求1所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述覆膜的内壁面或外壁面至少在第一管体近端沿覆膜周向固定有至少一根轴向设置的支撑杆。
  6. 根据权利要求5所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述支撑杆通过缝合、热合或粘接固定在覆膜壁面上。
  7. 根据权利要求6所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述支撑杆上设置至少一个用于与覆膜固定连接的固定点，所述固定点为支撑杆上设置的连接孔或带有开口的开口槽。
  8. 根据权利要求5所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述支撑杆平行于支架中轴线设置；或者所述支撑杆之 间呈八字或倒八字设置。
  9. 根据权利要求1所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述覆膜上由近端向远端轴向设置有用于穿装释放导丝的连接件，所述连接件轴向间隔设置至少两排。
  10. 根据权利要求9所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述连接件为供释放导丝穿装或缠绕的闭环结构或开环结构；所述闭环结构是连接件带有供释放导丝穿过的通孔或者所述连接件与覆膜配合合围形成供释放导丝穿过的通孔或间隙，所述开环结构带有供释放导丝穿过的限位槽。
  11. 根据权利要求10所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述闭环结构的连接件为固定在覆膜外侧壁面的线圈；或者所述闭环结构的连接件为一段轴向间隔固定的线绳，且间隔固定在线绳与覆膜之间形成有供释放导丝穿过的间隙；或者闭环结构的连接件是设置在覆膜上的通孔；或是所述开环结构的连接件为至少两排带有限位槽的软性连接扣，不同排的限位槽开口背向设置。
  12. 根据权利要求1所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述覆膜内壁面或外壁面固定有至少一根轴向设置的支撑杆，所述支撑杆或对应支撑杆的覆膜上设有用于穿装释放导丝的连接件。
  13. 根据权利要求1-12任意一项所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述第一管体近端设有裸支架，所述裸支架设有向外翻折的倒刺，所述倒刺自由端朝向支架远端。
  14. 根据权利要求1-12任意一项所述的可用于腹主动脉疾病介入治疗的覆膜支架，其特征在于，所述过渡部依次包括与第一管体连接的近端延伸段、过渡主体段和远端延伸段三部分，其中三部分中过渡主体段直径最小。
  15. 根据权利要求14所述的可用于腹主动脉疾病介入治疗的覆膜支 架，其特征在于，所述过渡主体段为等径结构，所述近端延伸段和远端延伸段为非等径结构。
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