WO2015196948A1 - 分叉型覆膜支架 - Google Patents

分叉型覆膜支架 Download PDF

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Publication number
WO2015196948A1
WO2015196948A1 PCT/CN2015/081893 CN2015081893W WO2015196948A1 WO 2015196948 A1 WO2015196948 A1 WO 2015196948A1 CN 2015081893 W CN2015081893 W CN 2015081893W WO 2015196948 A1 WO2015196948 A1 WO 2015196948A1
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WO
WIPO (PCT)
Prior art keywords
bare
stent
stent graft
side branch
distal
Prior art date
Application number
PCT/CN2015/081893
Other languages
English (en)
French (fr)
Inventor
王永胜
刘彩萍
张德元
郭伟
Original Assignee
先健科技(深圳)有限公司
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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to ES15811786T priority Critical patent/ES2874885T3/es
Priority to PL15811786T priority patent/PL3162322T3/pl
Priority to EP15811786.1A priority patent/EP3162322B1/en
Priority to US15/320,901 priority patent/US10188501B2/en
Publication of WO2015196948A1 publication Critical patent/WO2015196948A1/zh

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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/02—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
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-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
    • A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a bifurcated stent graft.
  • An aneurysm is a permanent, limited expansion of a blood vessel that is called an aneurysm when the diameter of the blood vessel increases beyond 50% of its normal value.
  • an abdominal aortic aneurysm is formed.
  • a radial aneurysm is usually defined as a localized diameter of the radial artery that exceeds 1.5 cm.
  • the iliac aneurysm is divided into isolated iliac aneurysms, see Figure 1; independent iliac aneurysms, see Figure 2; iliac aneurysms with abdominal aneurysms, see Figure 3. In 75% of cases, radial aneurysms are associated with the abdominal artery.
  • the iliac artery 1 includes the renal artery 11 on the abdominal aorta, the abdominal aorta 12, the right common sacral artery 13, the right internal iliac artery 14, the right external iliac artery 15, and the left common iliac artery. 16, left internal iliac artery 17, left external iliac artery 18. Due to protein degradation, inflammation and immune response of the connective tissue of the arterial wall and other factors, the loss of the middle and outer membrane elastin causes tumor-like expansion. A single iliac aneurysm is not associated with an abdominal aortic aneurysm, known as a solitary aneurysm, as shown in Figure 1 of the right aneurysm.
  • iliac aneurysms do not have an abdominal aortic aneurysm, called an independent iliac aneurysm, as shown in Figure 2, right aneurysm 19 and left aneurysm 20.
  • abdominal aorta and radial artery in the aneurysm which is called a radial aneurysm with an abdominal aneurysm, as shown in Figure 3, right aneurysm 19, left aneurysm 20 and abdominal aortic aneurysm 21.
  • An aneurysm can be repaired by open surgery or endovascular surgery. All anatomical conditions of the iliac aneurysm can be open repair, completely replace the diseased artery segment with artificial blood vessels, and have a good long-term effect, but the complications and mortality of iliac aneurysm open repair is equivalent to large vascular surgery .
  • a stent graft is usually used to cover the aneurysm.
  • the coated stent is mainly composed of a metal wire and a PET (polyethylene terephthalate resin) film or an ePTFE (polytetrafluoroethylene) film covered thereon, and the metal stent is formed into a cylindrical shape or a sub-division. Fork metal frame.
  • the delivery system is used to deliver the compressed stent graft to the lesion site with the help of the development system, and to accurately release the aneurysm, isolate the lesion and form a new blood flow channel, and isolate the aneurysm from the arterial pressure.
  • the residual blood gradually forms a thrombus and muscles to form vascular tissue, and the expanded wall of the tumor wall shrinks due to negative pressure, thereby eliminating the hidden danger of tumor rupture and bleeding, and achieving the purpose of healing.
  • the blood flow flows from the proximal end to the distal end of the stent according to the flow direction of the blood flow defining the proximal and distal ends of the stent.
  • the stent grafts for the interventional treatment of the common iliac aneurysm involving the internal iliac artery mainly include two types: a straight tube type stent graft and a bifurcated stent graft, wherein the straight tube type stent graft It includes two types: the distal end without a bell mouth and the bell mouth.
  • a straight tube type stent refers to a stent having a proximal end and a distal end.
  • a bifurcated stent refers to a stent having a proximal end of the body and two distal ends of the branches.
  • a straight-tube stent graft with a distal end without a bell mouth is required to release the distal end of the stent to the external iliac artery in order to ensure reliable anchoring of the distal end of the stent without endoleaking.
  • Such a stent graft will seal the internal iliac artery, which may lead to pelvic ischemia, causing complications such as gluteal muscle spasm, colon ischemia, spinal cord ischemia, perineal necrosis, and sexual dysfunction.
  • the distal tube-shaped stent graft with a distal end can be used to release the distal end of the stent near the opening of the internal iliac artery, and the distal horn stent is attached to the wall of the common iliac artery. This ensures the patency of the internal iliac artery, but the stent does not completely isolate the common iliac aneurysm, and there is still a risk of rupture of the common iliac aneurysm.
  • the bifurcated stent graft is composed of a main body, a main branch and a side branch portion.
  • the main and lateral branches are released in the common iliac artery, the distal end of the lateral branch is close to the internal iliac artery, and the distal end of the main branch is released in the external iliac artery without aneurysm involvement.
  • a peripheral stent graft is released through the lateral branch into the internal iliac artery and connected to the lateral branch. This ensures the patency of the internal iliac artery and the complete isolation of the common iliac artery aneurysm.
  • a typical bifurcated stent graft includes a body and side branches, with a separate coil that spans the connecting portion of the stent body and the side branches and is wrapped in a circle.
  • the independent corrugation is difficult to shape; and the axial starting portion of the side branch is sufficiently attached due to the absence of the corrugation, so that the side branch cannot obtain sufficient portion at this portion.
  • the radial supporting force causes the film to be insufficiently supported and easily shortened, and the problem that the guide wire enters the side branch through the main body is difficult.
  • a bifurcated stent graft comprising a body and a side branch forming an acute angle with the body, the side branch comprising a coating and a first bare stent disposed only on the coating, the first bare stent A portion is adjacent to a boundary line between the body and the film, and is within a vertex area of the acute angle.
  • the first bare stent includes a plurality of proximal vertices and a plurality of distal vertices, the lines of the plurality of distal vertices being annular, and at least one of the plurality of proximal vertices A portion is located within the apex region.
  • the first bare stent includes a plurality of proximal vertices and a plurality of distal vertices, the lines of the plurality of distal vertices being on the same circumference, among the plurality of proximal vertices At least a portion is located within the apex region.
  • the plurality of distal vertices are flush with the distal end of the membrane.
  • the body includes a second bare bracket adjacent the boundary line, the second bare bracket includes two end support bars on opposite sides of the side branch, two of the ends The support rods are parallel to each other or symmetrical with respect to the side branches.
  • the tail of the end support bar is substantially rounded.
  • the first bare stent is a wave open-loop structure; the side branch further includes a third bare stent disposed on the coating, the third bare stent is a waveform closed loop structure, and Connected to the first bare bracket.
  • the body includes a second bare bracket adjacent the boundary line, the second bare bracket includes two end support bars on opposite sides of the side branch, two of the ends The support rods are parallel to each other or symmetrical with respect to the side branches.
  • the tail of the end support bar is substantially rounded.
  • the angle between the main body and the side branch is an acute angle
  • the apical region of the side branch is not supported by the bare stent and the film is shortened, which not only causes the blood flow channel to be narrowed, but also It will also hinder the smooth entry of the guide wire.
  • a portion of the first bare stent is attached in the apex region, and the portion of the first bare stent that is self-expanding after the stent is released enables the apex region of the side branch to be effectively supported, so that the film is not easily shortened. And easy to guide the wire into.
  • Figure 1 is a schematic view of an isolated iliac artery aneurysm
  • Figure 2 is a schematic view of an independent iliac artery aneurysm
  • Figure 3 is a schematic view of a iliac artery aneurysm accompanied by an abdominal aneurysm
  • Figure 4 is a schematic view of a bifurcated stent graft of an embodiment
  • Figure 5 is a schematic view of the coating film and the main body coating of the bifurcated stent graft shown in Figure 4;
  • FIG. 6 is a schematic view of the first bare stent and the main bare stent of the bifurcated stent graft shown in FIG. 4;
  • Figure 7 is a schematic view of the first bare stent of the bifurcated stent graft of Figure 4;
  • Figure 8 is a perspective view of the second bare stent of the bifurcated stent graft of Figure 4;
  • Figure 9 is a side view of the second bare stent of the bifurcated stent graft of Figure 4.
  • Figure 10 is a schematic view showing the first waveform of the bifurcated stent graft shown in Figure 4;
  • Figure 11 is a schematic view showing the first waveform and the position of the coating of the bifurcated stent graft shown in Figure 10;
  • Figure 12 is a schematic view showing a second waveform of the bifurcated stent graft shown in Figure 4;
  • Figure 13 is a schematic view showing the second waveform and the position of the coating of the bifurcated stent graft shown in Figure 12;
  • Figure 14 is another schematic view showing the second waveform and the position of the coating of the bifurcated stent graft shown in Figure 12;
  • Figure 15 is a schematic view showing the second waveform and the position of the film of the bifurcated stent graft shown in Figure 12;
  • Figure 16 is a schematic view showing a third waveform of the bifurcated stent graft shown in Figure 4.
  • Figure 17 is a schematic view showing a third waveform and a film position of the bifurcated stent graft shown in Figure 16;
  • Figure 18 is a plan view of the second bare stent of the bifurcated stent graft of Figure 4;
  • Figure 19 is a schematic view of the first bare stent and the second bare stent of the bifurcated stent graft of Figure 4;
  • Figure 20 is a perspective view of the main metal ring of the bifurcated stent graft of Figure 4;
  • Figure 21 is a side view of the main metal ring of the bifurcated stent graft of Figure 4;
  • Figure 22 is a plan view of the main metal ring of the bifurcated stent graft of Figure 4;
  • Figure 23 is a diagram showing the effect of the bifurcated stent graft of Figure 4 implanted in a single-sided isolated iliac artery aneurysm;
  • Figure 24 is a view showing the effect of the bifurcated stent graft shown in Figure 4 implanted in a bilateral isolated iliac artery aneurysm;
  • Figure 25 is a view showing the effect of the bifurcated stent graft shown in Fig. 4 combined with the abdominal main bifurcation stent for curing an abdominal aneurysm with abdominal aortic aneurysm;
  • Figure 26 is a schematic view of a bifurcated stent graft of still another embodiment
  • Figure 27 is a schematic view of a bifurcated stent graft of still another embodiment
  • FIG. 28 is a schematic view of a bifurcated stent graft according to still another embodiment
  • Figure 29 is a schematic view of a bifurcated stent graft of still another embodiment.
  • bifurcated stent graft will be described more fully hereinafter with reference to the associated drawings.
  • a preferred embodiment of a bifurcated stent graft is given in the drawings.
  • the bifurcated stent graft can be implemented in many different forms and is not limited to the embodiments described herein. Rather, the purpose of providing these embodiments is to make the disclosure of the bifurcated stent graft more thorough and comprehensive.
  • a bifurcated stent graft 10 (hereinafter simply referred to as a stent 10) according to an embodiment includes a main body 100 and a side branch 200 that forms an acute angle with the main body 100.
  • the side branch 200 includes a coating 220 and is provided only on the cover.
  • the first bare bracket 240 on the film 220, a portion of the first bare bracket 240 is adjacent to the boundary line 230 of the body 100 and the film 220, and is located in the acute angled corner region 250.
  • the boundary line 230 refers to a boundary line connecting the main body 100 and the coating 220; the apex angle area 250 is a partial area of the side branch 200, see the position shown by the broken line in FIG.
  • the apex region 250 is a curved surface formed by the boundary line 230 of the body 100 and the side branches 200 and the section ring of the distal apex 270 located on the side branch 200 and passing the acute angle, the section ring preferably being parallel to The distal end of the side branch 200.
  • the first bare bracket 240 may be attached to the film 220 by stitching or pasting.
  • the stent 10 has a compressed state and a released state, and the compressed stent 10 is restrained in the sheath of the conveyor for delivery in the blood vessel. After reaching the target disease site, the self-expansion of each bare stent on each of the membranes is released, and the diameter of the stent 10 after release is usually slightly larger than the diameter of the blood vessel, so that the stent 10 closely adheres to the blood vessel wall to form a new blood flow. aisle.
  • the angle between the main body 100 and the side branch 200 is an acute angle
  • the coating 220 is shortened.
  • a portion of the first bare bracket 240 is attached in the apex region 250, and the portion of the first bare bracket 240 that is self-expanding after the stent 10 is released allows the apex region 250 of the side branch 200 to be effectively supported. Thereby, the film 240 is not easily shortened, and the guide wire is easily entered.
  • first bare bracket 240 can support other portions of the film 220 of the side branch 200, thereby eliminating the need to additionally add a bare bracket specifically attached to the corner region 250 on the basis of the first bare bracket 240, thus simplifying
  • the preparation process of the bare bracket, and the first bare bracket 240 is only disposed on the side branch 200, and does not need to cross the connecting portion of the main body 100 and the side branch 200, and the waveform shaping is simple.
  • the main body 100 may include a main body cover 120 and a main body bare bracket 140 attached to the main body cover 120.
  • the main body cover 120 includes a main body segment 122 in the axial direction.
  • the connecting section 124 and the long branch section 126, the main body section 122 and the long branch section 126 are all in communication with the connecting section 124.
  • the respective membranes enclose a channel through which blood flows.
  • the two ends of the connecting section 124 are respectively connected to the main body section 122 and the long branching section 126, and the three can be integrally formed.
  • the coating 220 of the side branch 200 communicates with the connecting section 124, and the inner and outer surfaces of the connecting section 124 are incomplete cylindrical surfaces.
  • the main body bare bracket 140 includes a main metal ring 142 disposed on the main body segment 122, a second bare bracket 144 disposed on the connecting portion 124, and a long branch metal ring 146 disposed on the long branch portion 126, the main metal ring 142 and the long
  • the branch metal rings 146 may each be a multi-turn metal ring
  • the second bare bracket 144 may be a single-turn metal ring
  • the multi-turn main metal ring 142, the single-ring second bare bracket 144, and the multi-turn long branch metal ring 146 are sequentially arranged.
  • the first bare bracket 240 may be a single-turn metal ring.
  • the structure of the main body 100 does not limit the scope of protection of the present invention. In other embodiments, the main body 100 may also have other structures.
  • the first bare stent 240 includes a plurality of proximal vertices 242a, 242b, 242c and a plurality of distal vertices 244, the proximal apex and the distal apex 244 being coupled by a support portion.
  • the connecting lines of the plurality of distal vertices 244 are annular, open loop or closed loop.
  • the connecting lines of the plurality of distal vertices 244 are on the same circumference, and at least a part of the plurality of proximal vertices are at the top corner.
  • the plurality of distal vertices 244 are flush with the distal end of the membrane 220.
  • a portion of the proximal apex of the first bare stent 240 is located within the apex region 250, such as the proximal vertices 242a and 242b, such that the first bare stent 240 has a different waveform height in the axial length direction of the membrane 220 of the side branch 200.
  • the waveform height referred to herein refers to the axial distance between the proximal vertex and the distal vertex 244. As shown in FIG.
  • the axial distance h1 between the proximal vertex 242a and the distal vertex 244 is greater than the axial distance h2 between the proximal vertex 242b and the distal vertex 244 according to the position distribution in the proximal apex region 250, the proximal end.
  • the axial distance h2 between the vertex 242b and the distal vertex 244 is greater than the axial distance h3 between the proximal vertex 242c and the distal vertex 244.
  • the first bare bracket 240 is designed as a metal ring of unequal length waveform, so that no additional metal ring is needed, and only the existing first bare bracket 240 can be used.
  • the portions of the branch lumen 220 are sufficiently supported, and the second bare stent 144 fully supports the connecting section 124.
  • the guidewire is more likely to enter the side branch lumen 220.
  • the boundary line 230 and the apex angle region 250 can be well supported, and there is no possibility that the vascular passage is narrowed due to the shrinkage of the coating film 220.
  • the first bare bracket 240 and the second bare bracket 144 are independent of each other, so the waveform is easy to shape and the process is simple.
  • the second bare bracket may also be a wave structure of other structures or materials, such as an elastic ring having a swelling property of the material itself, a wave ring of a polymer material, or the like.
  • the second bare bracket 144 is an open loop single-turn waveform, and the second bare bracket 144 includes an end end 1442 and a waveform, and the waveform includes a plurality of proximal vertexes. 1444a and a plurality of distal vertices 1444b, the proximal vertex 1444a and the distal vertex 1444b are connected by a support portion.
  • the second bare bracket 144 is adjacent to the boundary line 230 and includes two end support bars 1446 on opposite sides of the side branches 200 to support the boundary line 230.
  • a section of the waveform connected to the end 1442 forms an end support rod 1446, which is the tail of the end support rod 1446.
  • the two end support rods 1446 of the second bare bracket 144 may be parallel to each other and/or opposite to the side branches 200, and the two end support rods 1446 may be parallel to the axial direction of the second bare bracket 144, or may be The axial direction of the second bare bracket 144 is not parallel.
  • one end support rod 1446 may be parallel to the axial direction of the second bare bracket 144, and the other end support rod 1446 may not be parallel to the axial direction of the second bare bracket 144.
  • the end end 1442 can be fixed to the position of the connecting section 124 near the long branch section 126, and can be fixed at a position close to the main body section 122, or an end end 1442 can be fixed at a position close to the long branch section 126, and the other end end 1442 can be fixed. At a position close to the body segment 122.
  • the waveform of the second bare bracket 144 may be the first waveform shown in FIG. 10 and FIG. 11 , and the two end support rods 1446 are not parallel to the axial direction of the second bare bracket 144 , and the two ends are The support rods 1446 are also not parallel to each other.
  • the two end support bars 1446 are symmetrical with respect to the side branches 200, and the two end ends 1442 are fixed to the position of the connection section 124 near the long branch section 126.
  • one end end 1442 is fixed adjacent to the long branch section 126, and the other end end 1442 is fixed in a position close to the main body section 122.
  • the end support rod 1446 is parallel to the axial direction of the metal ring, so that the end support rods 1446 on both sides of the opening of the side branch lumen 220 are not only symmetrical with respect to the opening, but also symmetric with respect to the cross section of the lumen, so that the side branch tube can be well supported.
  • the lumen 220 facilitates access of the guidewire into the lateral branch lumen 220.
  • the waveform of the second bare bracket 144 may also be the third waveform shown in FIGS. 16 and 17, wherein one end support rod 1446 is parallel to the axial direction of the second bare bracket 144, and the other end supports the rod 1446 and the second.
  • the axial direction of the bare bracket 144 is not parallel.
  • the two end support bars 1446 are not parallel to each other and the two end support bars 1446 are asymmetrical with respect to the side branches 200. Compared to the embodiment shown in Figures 10 to 15, the two end support bars 1446 are not symmetrical with respect to the side branches 200, so the support effect is slightly inferior.
  • the inner surface 1444c of the second bare bracket 144 is on a cylindrical surface
  • the outer surface 1444d of the second bare bracket 144 is on the other cylindrical surface
  • the outer surface 1444d of 144 occupies only a portion of the cylindrical surface.
  • the second bare bracket 144 is only fixed at the position of the connecting section 124, and does not extend to the side branching lumen 220, that is, both ending ends 1442 terminate at the boundary between the two sides of the main body 100 and the side branch 200, and the connecting section 124 can be fully Support, forming a smooth blood flow channel. Referring to FIG.
  • the two end ends 1442 of the second bare bracket 144 may be respectively adjacent to the two bare brackets 240.
  • the end vertex 242b abuts.
  • the end end 1442 can be designed as a rounded structure, and the rounded structure can be substantially circular, elliptical, arbitrary curved or the like. Specifically, the end end 1442 may be substantially in the shape of a ring. In the above embodiment, the end end 1442 is in a loop shape.
  • the multi-turn metal ring of the main metal ring 142 and the long branch metal ring 146 may be closed independent wave rings. If there are other metal rings on the bracket 10, the other metal rings may also be closed independent wave rings.
  • the main metal ring 142 includes a plurality of proximal vertices 1422a and a plurality of distal vertices 1422b.
  • the proximal apex 1422a and the distal apex 1422b are connected by a support portion. Referring also to Fig.
  • the inner surface 1422c of the main metal ring 142 is on a cylindrical surface, and the outer surface 1422d of the main metal ring 142 is on the other cylindrical surface.
  • the multi-turn metal rings of the main metal ring 142 and the long branch metal ring 146 have the same or similar shapes, such as Z-shaped waves or other waveforms.
  • the wire may be woven or cut into a desired waveform, and after the wire is heat-set by the mold, the drawing is performed in FIG. 7 and FIG.
  • the illustrated steel sleeve 300 is sleeved at both ends of the wire and fixed by mechanical compression to fasten the wire and the steel sleeve 300 to form a metal ring.
  • the wire may be a nickel-titanium alloy wire such as a nickel-titanium alloy wire having a wire diameter of 0.40 mm.
  • the surface of the multi-ring metal ring arranged in the order of the rings is coated, and the film can be selected from PET (polyethylene).
  • PET polyethylene
  • Terephthalate polyethylene terephthalate
  • PTFE Polytetrafluoroethene, polytetrafluoroethylene
  • FIG. 23 is a schematic view showing the opening of the right internal iliac artery of the radial bifurcation stent 10 of Figure 4 in conjunction with the peripheral stent graft 30.
  • Fig. 24 is a view showing the bifurcation of the radial artery of the radial artery bifurcation stent 10 of Fig. 4 in combination with the peripheral stent graft 30.
  • Figure 25 is a schematic view showing the treatment of the common iliac artery aneurysm with abdominal aortic aneurysm with the radial bifurcation stent 10 of Figure 4 in combination with the peripheral stent graft 30 and the abdominal main bifurcation stent 50.
  • the stent 10 can effectively isolate the blood flow from the aneurysm, and the radial support force of the bifurcation portion can continuously maintain the lumen of the stent 10 to ensure smooth flow of blood in each lumen.
  • the diameter of the lumen of the body segment 122 and the long segment stent 10 can be as large.
  • the diameter dimensions of the body section 122 and the long branch section 126 can also be designed to be different as desired, for example, the diameter dimension of the body section 122 is greater than the diameter dimension of the long branch section 126.
  • the first bare bracket 260 may also be a wave open-loop structure.
  • the side branch 200 further includes a third bare bracket 280 disposed on the coating 220.
  • the third bare bracket 280 is a wave closed loop structure and is connected to the first bare bracket 260.
  • the first bare bracket 260 and the third bare bracket 280 are combined to achieve the effect of fully supporting the side branch 200.
  • the first bare bracket 260 is disposed mostly or entirely within the corner region 250 for supporting the corner region 250, and the second bare bracket 280 is for supporting other regions of the side branch 200.
  • first bare bracket 260 and the second bare bracket 280 may be fixed together by a steel sleeve 300.
  • the first bare bracket 260 may be a non-isolong wave coil and/or a non-equal wave coil.
  • the distal vertex of the first bare bracket 260, that is, the end adjacent to the second bare bracket 280 is perpendicular to the axis of the side branch 200. In a plane.
  • the proximal end apex of the first bare bracket 260 may be one or more.
  • the first bare bracket 260 has a plurality of proximal vertices, and the proximal vertex of the intermediate position is in a plane perpendicular to the axis of the side branch 200. The height above is greater than the proximal vertex of both sides.
  • the second bare bracket 280 may have one or more. In the embodiment, the second bare bracket 280 is one, and the second bare bracket 280 is a uniform isometric wave coil and/or a non-equal wave coil.
  • the first bare bracket 260 and the second bare bracket 280 are both fixed to the side branch lumen 220, and the side branch lumen 220 can be fully supported. Other parts of this embodiment can be the same as the embodiment shown in Figs. 4 to 27 .

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Abstract

一种分叉型覆膜支架（10），包括主体（100）和与主体（100）形成锐角的侧分支（200），侧分支（200）包括覆膜（220）及仅设于覆膜（220）上的第一裸支架（240），第一裸支架（240）的一部分靠近主体（100）与覆膜（220）的交界线（230），且位于锐角的顶角区域（250）内。因顶角区域（250）中有第一裸支架（240）的一部分附着，支架（10）释放后自膨胀的第一裸支架（240）的该部分使得侧分支（200）的顶角区域（250）能得到有效支撑，从而覆膜不易短缩，且易于导丝进入。同时，不需要在第一裸支架（240）的基础上额外增设专门附着顶角区域（250）的裸支架，因此简化了裸支架的制备工艺，且第一裸支架（240）仅设于侧分支（200）上，无需跨越主体（100）和侧分支（200）的连接部分，波形定型简单。

Description

分叉型覆膜支架
【技术领域】
本发明涉及医疗器械的技术领域，特别是涉及一种分叉型覆膜支架。
【背景技术】
动脉瘤是血管永久性的局限性扩张，当血管直径增长超过其正常值的50%时就称之为动脉瘤。动脉瘤发生于腹主动脉时，形成腹主动脉瘤。髂动脉瘤通常定义为髂动脉局部扩张直径超过1.5cm。髂动脉瘤分为孤立髂动脉瘤，参见图1；独立髂动脉瘤，参见图2；伴随有腹动脉瘤的髂动脉瘤，参见图3。在75%的病例中髂动脉瘤与腹动脉有关。有大约7.5%的病例为孤立髂动脉瘤。剩余的是独立髂动脉瘤。在美国，每年约有15000人死于腹主动脉瘤（Abdominal aortic aneurysm，AAA）破裂。早期报道认为直径超过3cm的髂动脉瘤可以致命，建议手术治疗。尽管这类疾病被认为仅累及总体人群的2%，但它好发于老年人，随着中国老龄化趋势的到来，其发病率将不断攀升。
如图1至图3所示，腹髂动脉1包括腹主动脉上的肾动脉11，腹主动脉12，右髂总动脉13，右髂内动脉14，右髂外动脉15，左髂总动脉16，左髂内动脉17，左髂外动脉18。由于动脉壁结缔组织的蛋白降解、炎症及免疫反应及其它因素，造成中层及外膜弹力蛋白丢失引起瘤样扩张。单个髂动脉瘤没有伴随腹主动脉瘤，称为孤立髂动脉瘤，如图1所示的右髂动脉瘤19。多个髂动脉瘤没有伴随腹主动脉瘤，称为独立髂动脉瘤，如图2所示的右髂动脉瘤19和左髂动脉瘤20。动脉瘤存在腹主动脉和髂动脉，称为伴随有腹动脉瘤的髂动脉瘤，如图3所示的右髂动脉瘤19、左髂动脉瘤20和腹主动脉瘤21。
开放手术或腔内手术都可以修复髂动脉瘤。所有解剖条件下的髂动脉瘤都可以行开放修复术，通过人工血管完全替换病变动脉段，并且有良好的远期效果，但髂动脉瘤开放修复术的并发症和死亡率相当于大血管手术。
利用腔内隔绝原理的微创伤介入治疗技术中，通常采用覆膜支架覆盖动脉瘤。目前上市场上覆膜支架主要由金属丝及覆盖在其上的PET（聚对苯二甲酸乙二醇酯树脂）膜或ePTFE（聚四氟乙烯）膜组成，金属支架制成圆柱形或分叉型金属骨架。用输送系统将压缩态的覆膜支架，在显影系统的帮助下，送达病变位置并准确释放，覆盖动脉瘤，隔绝病变并形成新的血流通道，使动脉瘤与动脉压力隔离，瘤腔内残留血液逐渐形成血栓并肌化形成血管组织，扩张状态的瘤壁，扩张状态的瘤壁因受负压而收缩，从而消除瘤体破裂、出血的隐患，达到治愈的目的。
比较而言，目前采用腔内修复术治疗髂动脉瘤，仅能封闭双侧髂内动脉或单侧髂内动脉，将带来阳萎、臀肌跛行及盆腔缺血并发症的发生，由多项临床研究资料表明，至少保留一侧髂内动脉可明显减少的上述并发症发生机率。而目前有文献报道，髂内分叉支架在治疗髂动脉瘤中，可开通双侧髂内动脉，明显减少或避免因髂内动脉封闭而带来的并发症，优势凸显。
根据血流流向定义支架的近端和远端，血流从支架的近端流向远端。
目前用于累及到髂内动脉的髂总动脉瘤腔内介入治疗的覆膜支架主要包括两种，分别为直管型覆膜支架和分叉型覆膜支架，其中直管型覆膜支架又包括远端不带喇叭口和带喇叭口两种类型。直管型支架指支架具有近端和远端。分叉型支架指支架具有主体近端和两个分支远端。
采用远端不带喇叭口的的直管型覆膜支架，为了保证支架远端可靠的锚定且不发生内漏，则需要将支架远端释放在髂外动脉。这样覆膜支架会将髂内动脉封闭，会导致盆腔缺血，引起臀肌跛行、结肠缺血、脊髓缺血、会阴坏死、性功能障碍等并发症的产生。
采用远端带喇叭口的直管型覆膜支架，可以将支架远端释放在靠近髂内动脉开口的位置，远端喇叭口支架与髂总动脉瘤壁贴附。这样保证了髂内动脉的通畅，但是支架没有将髂总动脉瘤完全隔绝，髂总动脉瘤仍然有破裂的风险存在。
分叉型覆膜支架由主体、主分支和侧分支部分组成。主体和侧分支释放在髂总动脉，侧分支远端靠近髂内动脉，主分支远端释放在无动脉瘤累及的髂外动脉内。分叉型覆膜支架释放完成后，通过侧分支释放一外周覆膜支架到髂内动脉内，并与侧分支连接。这样就保证了髂内动脉的通畅和髂总动脉瘤的完全隔绝。
综上所述，采用分叉型覆膜支架治疗累及到髂内动脉的髂总动脉瘤是较佳选择。一般的分叉型覆膜支架包括主体和侧分支，采用一个独立的波圈跨过支架主体和侧分支的连接部分并环绕成一圈。但是，因为主体与侧分支交界线形状的不规则，该独立的波圈定型难度大；且在侧分支的轴向起始部位因无波圈充分附着，使得侧分支在此部位无法获得足够的径向支撑力，导致此处覆膜不能被充分支撑而易短缩，导丝通过主体进入侧分支困难等问题的出现。
【发明内容】
基于此，有必要针对主体和侧分支的交界线支撑力不足，导丝进入困难的问题，提供一种分叉型覆膜支架。
一种分叉型覆膜支架，包括主体和与所述主体形成锐角的侧分支，所述侧分支包括覆膜及仅设于所述覆膜上的第一裸支架，所述第一裸支架的一部分靠近所述主体与所述覆膜的交界线，且所述锐角的顶角区域内。
在其中一个实施例中，所述第一裸支架包括多个近端顶点和多个远端顶点，所述多个远端顶点的连线呈环状，所述多个近端顶点中的至少一部分位于所述顶角区域内。
在其中一个实施例中，所述第一裸支架包括多个近端顶点和多个远端顶点，所述多个远端顶点的连线位于同一圆周上，所述多个近端顶点中的至少一部分位于所述顶角区域内。
在其中一个实施例中，所述多个远端顶点与所述覆膜的远端端部齐平。
在其中一个实施例中，所述主体包括靠近所述交界线的第二裸支架，所述第二裸支架包括两个位于所述侧分支相对两侧的端部支撑杆，两个所述端部支撑杆相互平行或者相对所述侧分支对称。
在其中一个实施例中，所述端部支撑杆的尾部大致呈圆滑状。
在其中一个实施例中，所述第一裸支架为波形开环结构；所述侧分支还包括设于所述覆膜上的第三裸支架，所述第三裸支架为波形闭环结构，且与所述第一裸支架相连。
在其中一个实施例中，所述主体包括靠近所述交界线的第二裸支架，所述第二裸支架包括两个位于所述侧分支相对两侧的端部支撑杆，两个所述端部支撑杆相互平行或者相对所述侧分支对称。
在其中一个实施例中，所述端部支撑杆的尾部大致呈圆滑状。
上述分叉型覆膜支架中，因主体与侧分支之间的夹角为锐角，使得侧分支的顶角区域内无裸支架支撑而覆膜短缩，不仅易造成血流通道变窄，而且还将阻碍导丝顺利进入。此发明中，在该顶角区域中有第一裸支架的一部分附着，支架释放后自膨胀的第一裸支架的该部分使得侧分支的顶角区域能得到有效支撑，从而覆膜不易短缩，且易于导丝进入。同时，不需要在第一裸支架的基础上额外增设专门附着顶角区域的裸支架，因此简化了裸支架的制备工艺，且第一裸支架仅设于侧分支上，无需跨越主体和侧分支的连接部分，波形定型简单。
【附图说明】
图1为孤立髂动脉瘤的示意图；
图2为独立髂动脉瘤的示意图；
图3为伴随有腹动脉瘤的髂动脉瘤的示意图；
图4为一实施例分叉型覆膜支架的示意图；
图5为图4所示分叉型覆膜支架的覆膜和主体覆膜的示意图；
图6为图4所示分叉型覆膜支架的第一裸支架和主体裸支架的示意图；
图7为图4所示分叉型覆膜支架的第一裸支架的示意图；
图8为图4所示分叉型覆膜支架的第二裸支架的立体图；
图9为图4所示分叉型覆膜支架的第二裸支架的侧视图；
图10为图4所示分叉型覆膜支架的第一波形的示意图；
图11为图10所示分叉型覆膜支架的第一波形与覆膜位置的示意图；
图12为图4所示分叉型覆膜支架的第二波形的示意图；
图13为图12所示分叉型覆膜支架的第二波形与覆膜位置的示意图；
图14为图12所示分叉型覆膜支架的第二波形与覆膜位置的另一示意图；
图15为图12所示分叉型覆膜支架的第二波形与覆膜位置的又一示意图；
图16为图4所示分叉型覆膜支架的第三波形的示意图；
图17为图16所示分叉型覆膜支架的第三波形与覆膜位置的示意图；
图18为图4所示分叉型覆膜支架的第二裸支架的俯视图；
图19为图4所示分叉型覆膜支架的第一裸支架和第二裸支架的示意图；
图20为图4所示分叉型覆膜支架的主体金属环的立体图；
图21为图4所示分叉型覆膜支架的主体金属环的侧视图；
图22为图4所示分叉型覆膜支架的连主体金属环的俯视图；
图23为图4所示分叉型覆膜支架植入单侧孤立型髂总动脉瘤的效果图；
图24为图4所示分叉型覆膜支架植入双侧孤立型髂总动脉瘤的效果图；
图25为图4所示分叉型覆膜支架结合腹主分叉支架治愈伴有腹主动脉瘤的腹髂动脉瘤的效果图；
图26为又一实施例分叉型覆膜支架的示意图；
图27为又一实施例分叉型覆膜支架的示意图；
图28为又一实施例分叉型覆膜支架的示意图；
图29为又一实施例分叉型覆膜支架的示意图。
【具体实施方式】
为了便于理解本发明，下面将参照相关附图对分叉型覆膜支架进行更全面的描述。附图中给出了分叉型覆膜支架的首选实施例。但是，分叉型覆膜支架可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对分叉型覆膜支架的公开内容更加透彻全面。
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。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在分叉型覆膜支架的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及／或”包括一个或多个相关的所列项目的任意的和所有的组合。
如图4所示，一实施方式的分叉型覆膜支架10（以下简称为支架10）包括主体100和与主体100形成锐角的侧分支200，侧分支200包括覆膜220以及仅设于覆膜220上的第一裸支架240，第一裸支架240的一部分靠近主体100与覆膜220的交界线230，且位于锐角的顶角区域250内。
交界线230是指主体100和覆膜220连接边界线；顶角区域250为侧分支200的一部分区域，参见图4中虚线所示的位置。顶角区域250为一个曲面，该曲面由主体100和侧分支200的交界线230与位于侧分支200上且通过锐角的远端顶点270的截面圆环围合形成，该截面圆环优选平行于侧分支200远端端面。在一实施例中，第一裸支架240可以通过缝合或粘贴的方式附着在覆膜220上。支架10具有压缩状态和释放状态，压缩后的支架10束缚在输送器的鞘管中，用于在血管中输送。到达靶病位置后通过各个覆膜上的各个裸支架的自膨胀释放，通常释放后的支架10的径长略大于血管的径长，从而使得支架10紧密贴覆血管壁，形成新的血流通道。
因主体100与侧分支200之间的夹角为锐角，当侧分支200在两者的近端连接交界线230附近（即顶角区域250）内无裸支架支撑时将导致覆膜220短缩，不仅易造成血流通道变窄，而且还将阻碍导丝顺利进入。此发明中，在该顶角区域250中有第一裸支架240的一部分附着，支架10释放后自膨胀的第一裸支架240的该部分使得侧分支200的顶角区域250能得到有效支撑，从而覆膜240不易短缩，且易于导丝进入。同时，第一裸支架240的另一部分可支撑侧分支200的覆膜220的其它部分，从而不需要在第一裸支架240的基础上额外增设专门附着顶角区域250的裸支架，因此简化了裸支架的制备工艺，且第一裸支架240仅设于侧分支200上，无需跨越主体100和侧分支200的连接部分，波形定型简单。
同时参见图5、图6，在其中一个实施例中，主体100可以包括主体覆膜120和附着在主体覆膜120上的主体裸支架140，主体覆膜120沿轴向依次包括主体段122、连接段124和长分支段126，主体段122和长分支段126均与连接段124相通，当支架10植入血管后，各覆膜围合形成血流流过的通道。连接段124的两端分别连接主体段122和长分支段126，三者可一体成型形成。侧分支200的覆膜220与连接段124连通，连接段124内外表面为不完整圆柱面。
主体裸支架140包括设于主体段122上的主体金属环142、设于连接段124上的第二裸支架144和设于长分支段126上的长分支金属环146，主体金属环142和长分支金属环146均可以是多圈金属环，第二裸支架144可以是单圈金属环，多圈主体金属环142、单圈第二裸支架144和多圈长分支金属环146依次排列。在本实施例中，第一裸支架240可以是一个单圈金属环。需要说明的是，主体100的结构并不限制本发明保护的范围，在其他实施例中，主体100也可以是其他结构。
同时参见图7，第一裸支架240包括多个近端顶点242a、242b、242c和多个远端顶点244，近端顶点和远端顶点244通过支撑部分连接。多个远端顶点244的连线呈环状，开环或闭环均可，较佳地，多个远端顶点244的连线位于同一圆周上，多个近端顶点中的至少一部分位于顶角区域250内。更佳地，多个远端顶点244与覆膜220的远端端部齐平。
第一裸支架240的一部分近端顶点位于顶角区域250内，例如近端顶点242a和242b，因此第一裸支架240在侧分支200的覆膜220的轴向长度方向上具有不同的波形高度，此处所说的波形高度指的是近端顶点与远端顶点244的轴向距离。如图7所示，根据近端顶点相对顶角区域250内的位置分布，近端顶点242a与远端顶点244轴向距离h1大于近端顶点242b与远端顶点244轴向距离h2，近端顶点242b与远端顶点244轴向距离h2大于近端顶点242c与远端顶点244轴向距离h3。根据侧分支管腔220轴向长度的不同，将第一裸支架240设计为不等长波形的金属环，这样不需要附加其它金属环，仅通过现有的第一裸支架240即可将侧分支管腔220各部分充分支撑，第二裸支架144将连接段124充分支撑，在侧分支200和连接段124充分支撑下，一方面，导丝更易于进入侧分支管腔220。另一方面，交界线230及顶角区域250能得到较好地支撑，不会出现因覆膜220短缩而导致血管通道变窄的情况发生。同时，第一裸支架240与第二裸支架144彼此相互独立，因此波形易于定型，工艺简单。
在其他实施例中，第二裸支架也可以是其他结构或材质的波形结构，例如材料本身具有膨胀能力的弹性圈、高分子材料的波形环等。在本实施例中，同时参见图8和图9，具体的，第二裸支架144为一个开环的单圈波形，第二裸支架144包括结束端1442和波形，波形包括多个近端顶点1444a和多个远端顶点1444b，近端顶点1444a和远端顶点1444b通过支撑部分连接。第二裸支架144靠近交界线230，包括两个位于侧分支200相对两侧的端部支撑杆1446，以支持交界线230。与结束端1442相连的一段波形形成端部支撑杆1446，结束端1442即为端部支撑杆1446的尾部。
进一步的，第二裸支架144的两个端部支撑杆1446可以相互平行和/或相对侧分支200对称，两个端部支撑杆1446可以与第二裸支架144的轴线方向平行，也可以与第二裸支架144的轴线方向不平行，当然也可以一个端部支撑杆1446与第二裸支架144的轴线方向平行，另一个端部支撑杆1446与第二裸支架144的轴线方向不平行。结束端1442可以固定在连接段124上靠近长分支段126的位置，可以固定在靠近主体段122的位置，也可以一个结束端1442固定在靠近长分支段126的位置，另一个结束端1442固定在靠近主体段122的位置。
在一实施例中，第二裸支架144的波形可以是图10、图11所示的第一波形，两个端部支撑杆1446与第二裸支架144的轴线方向不平行，且两个端部支撑杆1446相互之间也不平行。两个端部支撑杆1446相对侧分支200对称，两个结束端1442固定在连接段124上靠近长分支段126的位置。
第二裸支架144的波形也可以是图12至图15所示的第二波形，两个端部支撑杆1446与第二裸支架144的轴线方向平行，两个端部支撑杆1446相互之间也平行，两个端部支撑杆1446相对侧分支200对称。图13中的实施例，两个结束端1442固定在连接段124上靠近主体段122的位置。图14中的实施例，两个结束端1442固定在连接段124上靠近长分支段126的位置。图15中的实施例，一个结束端1442固定在靠近长分支段126的位置，另一个结束端1442固定在靠近主体段122的位置。端部支撑杆1446平行于金属环轴向方向，使得侧分支管腔220开口两侧的端部支撑杆1446不仅相对该开口对称，还相对管腔截面对称，从而可以很好的支撑侧分支管腔220，有利于导丝进入侧分支管腔220。
第二裸支架144的波形还可以是图16、图17所示的第三波形，其中一个端部支撑杆1446与第二裸支架144的轴线方向平行，另一个端部支撑杆1446与第二裸支架144的轴线方向不平行。两个端部支撑杆1446相互之间不平行，两个端部支撑杆1446相对侧分支200不对称。与图10至图15所示的实施方式相比，两个端部支撑杆1446相对侧分支200无法实现对称，因此支撑效果稍劣。
同时参见图18，第二裸支架144的内表面1444c在一个圆柱面上，第二裸支架144的外表面1444d在另一个圆柱面上，第二裸支架144的内表面1444c和第二裸支架144的外表面1444d只占据部分圆柱面。第二裸支架144仅固定在连接段124的位置，未延伸到侧分支管腔220，即两个结束端1442均终止于主体100与侧分支200的两侧交界处，可以将连接段124充分支撑，形成通畅的血流通道。同时参见图19，在结束端1442固定在连接段124上靠近长分支段126的位置的实施例中，第二裸支架144的两个结束端1442可以分别与第一裸支架240的两个近端顶点242b抵接。
为了避免刮伤血管，第二裸支架144上要尽量避免形成较尖锐的部分，结束端1442可以设计为圆滑结构，该圆滑结构可以大致呈圆圈状，椭圆状，任意曲线状等。具体的，结束端1442可以大致呈圈状，在上述实施例中，结束端1442呈圈状。
主体金属环142和长分支金属环146的多圈金属环均可以是闭合独立波圈，若支架10上还有其他金属环，其他金属环也可以是闭合独立波圈。同时参见图20和图21，以主体金属环142为例，主体金属环142包括多个近端顶点1422a和多个远端顶点1422b，近端顶点1422a和远端顶点1422b通过支撑部分连接。同时参见图22，主体金属环142的内表面1422c在一个圆柱面上，主体金属环142的外表面1422d在另一个圆柱面上。主体金属环142和长分支金属环146的多圈金属环具有相同或相似的形状，例如Z形波或其他波形。
在上述第一裸支架240、主体金属环142和长分支金属环146的制备过程中，可以将金属丝编织或切割成所需波形，金属丝经模具热定型后，采用图7、图21中所示的钢套300套接金属丝的两端，并通过机械压紧的方式固定，使金属丝和钢套300连接紧固，从而形成金属环。金属丝可采用镍钛合金丝，例如丝径为0.40mm的镍钛合金丝。多圈金属环制作完成后，在依次间隔排布的多圈金属环的表面覆膜，覆膜可选用PET（polyethylene terephthalate，聚对苯二甲酸乙二醇酯）或者PTFE（Polytetrafluoroethene，聚四氟乙烯）作为覆膜材料。
图23，图24及图25示出了图4中的分叉型覆膜支架10植入到腹髂动脉中的示意图。图23示出了图4中的髂动脉分叉支架10配合外周覆膜支架30开通右髂内动脉示意图。图24示出了图4中的髂动脉分叉支架10配合外周覆膜支架30开通双侧髂动脉示意图。图25示出了图4中的髂动脉分叉支架10配合外周覆膜支架30及腹主分叉支架50治疗伴有腹主动脉瘤的髂总动脉瘤示意图。支架10可有效将血流与动脉瘤隔绝，分叉部位较好的径向支撑力，可持续保持支架10管腔通畅，保证血流在各个管腔中通畅。
在其中一个实施例中，同时参见图26，主体段122和长分支架10管腔的直径尺寸可以一样大。在另一实施例中，同时参见图27，主体段122和长分支段126的直径尺寸也可以根据需要设计为不一样大，例如主体段122的直径尺寸大于长分支段126的直径尺寸。
如图28、图29所示，在另一个实施例中，第一裸支架260还可以是波形开环结构。侧分支200还包括设于覆膜220上的第三裸支架280，第三裸支架280为波形闭环结构，且与第一裸支架260相连。第一裸支架260和第三裸支架280组合，达到完全支撑侧分支200的效果。较佳地，第一裸支架260大部分或全部设置在顶角区域250内，用于支撑顶角区域250，第二裸支架280用于支撑侧分支200的其他区域。
在一实施例中，第一裸支架260和第二裸支架280可以通过钢套300连接固定在一起。第一裸支架260可以是非等长波的波圈和/或非等高的波圈，第一裸支架260的远端顶点，即靠近第二裸支架280的一端在垂直于侧分支200轴线的同一个平面内。第一裸支架260的近端顶点可以为一个或多个，本实施例中，第一裸支架260的近端顶点为多个，且中间位置的近端顶点在垂直于侧分支200轴线的平面上的高度大于两边位置的近端顶点。第二裸支架280可以有一个或多个，在本实施例中，第二裸支架280为一个，且第二裸支架280为均匀等长波的波圈和/或非等高的波圈。第一裸支架260和第二裸支架280均固定在侧分支管腔220，可以将侧分支管腔220完全支撑。本实施例的其他部分，可以与图4至图27所示的实施例相同。
以上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。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (9)

  1. 一种分叉型覆膜支架，其特征在于，包括主体和与所述主体形成锐角的侧分支，所述侧分支包括覆膜以及仅设于所述覆膜上的第一裸支架，所述第一裸支架的一部分靠近所述主体与所述覆膜的交界线，且位于所述锐角的顶角区域内。
  2. 根据权利要求1所述的分叉型覆膜支架，其特征在于，所述第一裸支架包括多个近端顶点和多个远端顶点，所述多个远端顶点的连线呈环状，所述多个近端顶点中的至少一部分位于所述顶角区域内。
  3. 根据权利要求1所述的分叉型覆膜支架，其特征在于，所述第一裸支架包括多个近端顶点和多个远端顶点，所述多个远端顶点的连线位于同一圆周上，所述多个近端顶点中的至少一部分位于所述顶角区域内。
  4. 根据权利要求3所述的分叉型覆膜支架，其特征在于，所述多个远端顶点与所述覆膜的远端端部齐平。
  5. 根据权利要求1至4任一项所述的分叉型覆膜支架，其特征在于，所述主体包括靠近所述交界线的第二裸支架，所述第二裸支架包括两个位于所述侧分支相对两侧的端部支撑杆，两个所述端部支撑杆相互平行或者相对所述侧分支对称。
  6. 根据权利要求5所述的分叉型覆膜支架，其特征在于，所述端部支撑杆的尾部呈圆滑状。
  7. 根据权利要求1至3任一项所述的分叉型覆膜支架，其特征在于，所述第一裸支架为波形开环结构；所述侧分支还包括设于所述覆膜上的第三裸支架，所述第三裸支架为波形闭环结构，且与所述第一裸支架相连。
  8. 根据权利要求7所述的分叉型覆膜支架，其特征在于，所述主体包括靠近所述交界线的第二裸支架，所述第二裸支架包括两个位于所述侧分支相对两侧的端部支撑杆，两个所述端部支撑杆相互平行或者相对所述侧分支对称。
  9. 根据权利要求8所述的分叉型覆膜支架，其特征在于，所述端部支撑杆的尾部呈圆滑状。
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