WO2023137616A1 - 覆膜血管支架及膜外形成血栓的方法 - Google Patents

覆膜血管支架及膜外形成血栓的方法 Download PDF

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Publication number
WO2023137616A1
WO2023137616A1 PCT/CN2022/072692 CN2022072692W WO2023137616A1 WO 2023137616 A1 WO2023137616 A1 WO 2023137616A1 CN 2022072692 W CN2022072692 W CN 2022072692W WO 2023137616 A1 WO2023137616 A1 WO 2023137616A1
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Prior art keywords
stent
covered
implant unit
axial direction
radially
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PCT/CN2022/072692
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English (en)
French (fr)
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黄重礼
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黄重礼
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Priority to PCT/CN2022/072692 priority Critical patent/WO2023137616A1/zh
Publication of WO2023137616A1 publication Critical patent/WO2023137616A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Definitions

  • the present invention relates to a covered vessel stent and a method for forming thrombus outside the membrane.
  • the main purpose of the present invention is to provide a covered vascular stent and a method for forming thrombus outside the membrane, which can be stretched and expanded to fill the space outside the membrane of the vessel wall and membrane tube to form thrombus.
  • the present invention provides a covered vascular stent, comprising:
  • a stent graft body A stent graft body
  • An extramembrane stuffing part is combined with the covered vessel stent body, and the extramembrane stuffing part includes a stuffing part, and the stuffing part is located outside the covered vessel stent body.
  • the covered vessel stent body includes a membrane tube body and a stent body, the bracket body is combined with the membrane tube body, and the stuffing part of the outer membrane packing member and the membrane tube body are respectively arranged on two opposite sides of the stent body.
  • the membrane body is arranged in a lumen of a blood vessel, and each of the outer packing pieces is stuffed between the stent-graft body and a wall of the blood vessel.
  • the stent-graft body extends along an axial direction, the stent-graft body includes at least one end portion located in the axial direction, the at least one end portion protrudes from the outer packing member in the axial direction, the outer packing member corresponds to the diseased segment, and the at least one end portion radially supports the at least one normal segment.
  • a first axial length of the stent-graft body along the axial direction is greater than a second axial length of the overmembrane packing part along the axial direction.
  • the outer membrane packing is made of deformable material.
  • the outer membrane packing includes at least one deformable thread and a plurality of through holes, and each of the thread is wound to form the plurality of through holes.
  • the covered vascular stent described therein is characterized in that it further includes an expansion piece, which can be contracted and expanded by itself.
  • the outer packing piece is a set, and the outer packing piece and the covered vessel stent body are nested together.
  • the stent-graft body is radially condensable and radially expandable, the membrane tube body is arranged in the lumen of a blood vessel, and each of the extramembrane packings is stuffed between the body of the stent-graft and a wall of the blood vessel;
  • the blood vessel includes a diseased segment and two normal segments, the body of the stent-graft extends along an axial direction, the body of the stent-graft includes two end portions located on two opposite sides of the axial direction, and the two end portions respectively protrude from two opposite ends of the outer packing member in the axial direction,
  • the outer membrane stuffing part is supplied corresponding to the diseased segment, and the two ends radially support the two normal segments;
  • the stent body includes two stent rings, the two stent rings are respectively arranged on the two end parts, and each stent ring is provided with a positioning end, and the positioning end protrudes from the membrane tube body in the axial direction, and the positioning
  • the present invention further provides a method for extramembranous thrombus formation, comprising the following steps: prepare a guide wire, and use the guide wire to pass into a lumen of a blood vessel; prepare a delivery group, the delivery group can move along the guide wire, the delivery group includes at least one first delivery member and at least one second delivery member, the first delivery member and the second delivery member are respectively arranged along an extension direction of the guide wire; configure at least one first implant unit and at least one second implant unit, and the at least one first implant unit is detachably arranged on the guide wire At least one first delivery unit and the at least one second implant unit are detachably arranged on the at least one second delivery unit; assemble the at least one first implant unit and the at least one second implant unit, and when the at least one first delivery unit can carry the at least one first implant unit to a diseased segment in the lumen, the at least one first implant unit can be expanded from a radially contracted state to a radially expanded
  • the covered vessel stent of the present invention can be stretched and expanded to fill the space outside the membrane of the vessel wall and membrane tube body to form thrombus.
  • Fig. 1 is a perspective view of a preferred embodiment of the present invention.
  • Fig. 2 is an exploded view of a preferred embodiment of the present invention.
  • Fig. 3 is one of the installation flowcharts of the preferred embodiment of the present invention.
  • Fig. 4 is the second installation flowchart of the preferred embodiment of the present invention.
  • Fig. 5 is the third installation flow chart of the preferred embodiment of the present invention.
  • FIG. 6 is a block diagram of steps of a preferred embodiment of the present invention.
  • 1-covered vessel stent 10-covered vessel stent body; 11-membrane tube body; 12-stent body; 13-drain hole; 14-end part;
  • 8-sleeve 80-conveying group; 81-first conveying part; 811-first head; 812-first body; 82-second conveying part; 821-second head; 822-second body;
  • the stent graft 1 of the present invention includes a stent graft body 10 and an outer packing 20 .
  • the covered vascular stent body 10 extends along an axial direction E.
  • the covered vascular stent body 10 includes a membrane tube body 11 and a stent body 12.
  • the bracket body 12 is combined with the membrane tube body 11 (such as being combined with the outside, inside, inside and outside, but not limited to this).
  • the shape of the mesh of the bracket body 12 has an open design (open cell) or a closed design (close cell); 12 is located outside the guide hole 13.
  • the stent body 12 can be fixedly bonded to the membrane tube body 11 by suturing or other bonding methods; the stent body 12 has the characteristic of being able to contract freely and expand radially.
  • the outer packing part 20 is combined with the stent graft body 10, and the packing part 20 includes a packing part 22, and the packing part 22 is located outside the main body 10 of the stent graft.
  • the stent-graft body 10 can be radially condensed and expanded, the tube body 11 is provided in the lumen 2 of a blood vessel 4 , and each of the outer packing pieces 20 is used to stuff between the stent-graft body 10 and a wall 5 of the blood vessel 4 .
  • the outer packing part 20 can be welded, sewn, tied or fixed on the membrane tube body 11 or the stent body 12, and the outer packing part 20 can also be detachably nested with the covered vessel stent body 10 as a two-piece design.
  • the blood vessel 4 includes a diseased segment 3 and at least one normal segment 6
  • the stent graft body 10 includes at least one end portion 14 located on the axial direction E, the at least one end portion 14 protrudes from the outer membrane packing 20 on the axial direction E, the outer membrane packing 20 is provided for the diseased segment 3 , and the at least one end portion 14 radially supports the at least one normal segment 6 .
  • the blood vessel 4 includes two normal sections 6, and the stent-graft body 10 includes two end portions 14 located on two opposite sides of the axial direction E.
  • the two end portions 14 respectively protrude from opposite ends of the outer packing member 20 on the axial direction E, and the two end portions 14 radially support the two normal sections 6;
  • the length is greater than the second axial length of the outer packing member 20 in the axial direction E; accordingly, the two end portions 14 can be radially expanded outside the outer packing member 20 and positioned on the two normal segments 6, and the outer packing member 20 can radially expand the lesion segment 3 to fill the gap between the blood vessel 4 and the vascular stent graft 1.
  • the outer membrane packing 20 is made of a deformable material.
  • the outer membrane packing 20 includes at least one deformable thread 21 and a plurality of through holes 23.
  • Each of the silk threads 21 is wound to form the plurality of through holes 23.
  • the outer film packing 20 can be irregular.
  • the outer film packing 20 includes a plurality of deformable silk threads 21 and a plurality of through holes 23.
  • Each of the through holes 23 has an aperture smaller than that of the diversion hole 13; by means of radial shrinkage and radial expansion deformation, the blood flow velocity is reduced by the tiny through holes 23 to form a thrombus, and can be deformed arbitrarily to conform to the size, range, and shape of the gap between the covered vessel stent body 10 and the tube wall 5 of the blood vessel 4.
  • Each of the wires 21 can be metal wires, such as steel wool, but not limited thereto, and can also be other deformable materials.
  • the covered vessel stent 1 when the covered vessel stent 1 is implanted in the lumen 2 (such as the lumen of a vessel), the covered vessel stent 1 will change from the contracted state to the expanded state to expand the lesion segment 3 (such as an aneurysm) of the lumen 2, and each of the extramembrane packing parts 20 can be filled between the covered vessel stent body 10 and the lumen 2 (such as the lesion segment 3) to fill the gap formed between the covered vessel stent body 10 and the lumen 2. 0 to form a thrombus to fill the gap.
  • the covered vessel stent 1 when the covered vessel stent 1 is implanted in the lumen 2 (such as the lumen of a vessel), the covered vessel stent 1 will change from the contracted state to the expanded state to expand the lesion segment 3 (such as an aneurysm) of the lumen 2, and each of the extramembrane packing parts 20 can be filled between the covered vessel stent body 10 and the lumen 2 (such as
  • the outer packing part 20 is a body that can shrink and expand in diameter, and the outer packing part 20 is sheathed on the main body of the stent graft 10; in other embodiments, the packing part can also be in the shape of a wire or a ring or other shapes.
  • the support body 12 includes two support rings 15, the two support rings 15 are respectively arranged on the two end portions 14, each of the support rings 15 is provided with a positioning end 151, and the positioning end 151 protrudes from the membrane tube body 11 on the axial direction E, and the positioning end 151 and the membrane tube body 11 form a plurality of hollow parts 16, and the two support rings 15 can be radially expanded and positioned on the two normal sections 6 respectively, so that the two opposite ends of the membrane tube body 11 can be held Expanded, the plurality of hollow parts 16 can allow blood to pass through.
  • each of the support rings 15 extends circumferentially in a meandering path.
  • the covered vascular stent 1 further includes an expander 90, the expander 90 can shrink and expand by itself, the outer packing 20 is a set, the outer packing 20 is nested with the covered stent body 10, the expanding member 90 is combined with the outer packing 20, the expanding member 90 can shrink or expand synchronously with the outer packing 20, so as to achieve the effect of expanding the outer packing 20.
  • the present invention also provides a method for forming thrombus outside the membrane as described above, comprising the following steps:
  • Step S1 prepare a guide wire 70, and feed the guide wire 70 into the lumen 2 of the blood vessel 4;
  • Step S2 Prepare a conveying group 80, the conveying group 80 can move along the guide line 70, the conveying group 80 includes at least one first conveying member 81 and at least one second conveying member 82, the first conveying member 81 and the second conveying member 82 are respectively arranged along an extension direction C of the guide wire 70;
  • Step S3 configuring at least one first implant unit and at least one second implant unit, detachably disposing the at least one first implant unit on the at least one first conveying member 81 and detachably disposing the at least one second implant unit on the at least one second conveying member 82;
  • Step S4 Assemble the at least one first implant unit and the at least one second implant unit.
  • the at least one first implant unit 81 can carry the at least one first implant unit to the diseased segment 3 (such as an aneurysm) in the lumen 2, the at least one first implant unit can be expanded from a radially contracted state to a radially expanded state to radially support and expand the lesion segment 3.
  • the at least one second transport member 82 transports the at least one second implant unit to penetrate the at least one first implant unit so that the at least one second implant unit can be deployed from a radially contracted state to a radially expanded state.
  • the sleeve 8 is sleeved on the first implant unit to shrink the diameter of the first implant unit, and sleeved on the second implant unit to shrink the diameter of the second implant unit, and the sleeve 8 is sequentially detached from the first implant unit and the second implant unit at the time of the lesion 3, so that the first and second implant tube units are automatically radially expanded, but not limited to this method;
  • Step S5 Thrombus formation, at least one thrombus is formed on the at least one first implant unit, and the at least one thrombus is used to fill the at least one first implant unit and a tube wall 5 of the blood vessel 4; wherein, the at least one first implant unit is the outer packing 20 and the at least one second implant unit is the stent graft body 10.
  • the stent-graft body 10 includes the tubular body 11 and the stent body 12, the stent body 12 is combined on the outside of the tubular body 11; the outer packing 20 is sleeved on the stent-graft body 10 and extends around the axis E, and each outer packing 20 is made of steel wool, but is not limited thereto.
  • the first delivery member 81 includes a first head 811 and a first body 812 with an outer diameter smaller than the first head 811
  • the second delivery member 82 includes a second head 821 and a second body 822 with an outer diameter smaller than the second head 821
  • the first implant unit is sleeved on the first body 812
  • the second implant unit is sleeved on the second body 822 .
  • Each of the first implant units includes the extramembranous stuffing part 20 and the expansion part 90, the expansion part 90 is combined with the extramembranous stuffing part 20, and the expansion part 90 is shrinkable and self-expanding (such as memory metal material, but not limited thereto).
  • the outer membrane packing itself can also be made of a material that can expand and contract radially.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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Abstract

一种覆膜血管支架(1)及膜外形成血栓的方法，覆膜血管支架(1)包括：覆膜血管支架本体(10)；及膜外填塞件(20)，各膜外填塞件(20)结合于覆膜血管支架本体(10)，通过各膜外填塞件(20)伸展扩张填充于血管(4)的管壁(5)及覆膜血管支架本体(10)之间，以于覆膜血管支架本体(10)外形成血栓。

Description

覆膜血管支架及膜外形成血栓的方法 技术领域
本发明特别是有关于一种覆膜血管支架及膜外形成血栓的方法。
背景技术
腹部主动脉瘤接受覆膜血管支架置放术后，有20％-50％的机率因血管内膜渗漏，以致动脉瘤持续扩大甚至破裂，导致需再次处置。
因此，有必要提供一种新的覆膜血管支架及膜外形成血栓的方法，以解决上述的问题。
发明内容
有鉴于此，本发明的主要目的在于提供一种覆膜血管支架及膜外形成血栓的方法，可伸展扩张填充于血管壁及膜管体的膜外侧的空间，以形成血栓。
为了达成上述的目的，本发明提供一种覆膜血管支架，包括：
一覆膜血管支架本体；及
一膜外填塞件，结合于该覆膜血管支架本体，该膜外填塞件包括一填塞部，该填塞部位于该覆膜血管支架本体的外侧。
进一步地，其中该覆膜血管支架本体包括一膜管体及一支架体，该支架体结合于该膜管体，该膜外填塞件的填塞部与该膜管体分别设于该支架体的相对二侧。
进一步地，其中该覆膜血管支架本体为可径向缩合及径向扩张的，该膜管体设于一血管的管腔内，各该膜外填塞件填塞于该覆膜血管支架本体及该血管的一管壁之间。
进一步地，其中该血管包括一病变段及至少一正常段，该覆膜血管支架本体沿一轴向延伸，该覆膜血管支架本体包括至少一位于该轴向上的末端部，该至少一末端部于该轴向上凸出该膜外填塞件，该膜外填塞件对应该病变段，该至少一末端部径向撑抵于该至少一正常段。
进一步地，其中该覆膜血管支架本体沿一轴向延伸，该覆膜血管支架本体于该轴向上的一第一轴向长度大于该膜外填塞件于该轴向上的第二轴向长度。
进一步地，其中该膜外填塞件由可变形材质制成。
进一步地，其中该膜外填塞件包括至少一可变形的丝线及复数个通孔，各该丝线 缠绕构成该复数个通孔。
进一步地，其中所述的覆膜血管支架，其特征在于，另包括一扩撑件，该扩撑件为可自行径缩及径扩的，该膜外填塞件为一套体，该膜外填塞件与该覆膜血管支架本体相互套设，该扩撑件结合于该膜外填塞件，该扩撑件能与该膜外填塞件同动地径缩或径扩。
进一步地，其中该覆膜血管支架本体为可径向缩合及径向扩张的，该膜管体设于一血管的管腔内，各该膜外填塞件填塞于该覆膜血管支架本体及该血管的一管壁之间；该血管包括一病变段及二正常段，该覆膜血管支架本体沿一轴向延伸，该覆膜血管支架本体包括二位于该轴向上相对二侧的末端部，该二末端部分别于该轴向上凸出该膜外填塞件的相对二端，该膜外填塞件供对应该病变段，该二末端部径向撑抵于该二正常段；该支架体包括二支架环，该二支架环分别设于该二末端部，各该支架环设有一定位端部，该定位端部于该轴向上凸出该膜管体，该定位端部与该膜管体共构复数个镂空部；该膜外填塞件为可变形材质制成；该膜外填塞件包括复数个可变形的丝线及复数通孔，各该丝线缠绕构成该复数个通孔；该膜外填塞件为一可径缩及径扩的一套体，该膜外填塞件套设于该覆膜血管支架本体；该膜管体包括一于该轴向上延伸开放的导流孔，该支架体设于该导流孔外，各该通孔的一孔径小于该导流孔的一孔径。
为了达成上述的目的，本发明再提供一种膜外形成血栓的方法，包含以下步骤：备一导引线，将该导引线供通入一血管的一管腔内；备一输送组，该输送组可沿该导引线移动，该输送组包括至少一第一输送件及至少一第二输送件，该第一输送件及该第二输送件分别沿该导引线的一延伸方向设置；配置至少一第一植入单元及至少一第二植入单元，将该至少一第一植入单元可脱离地设于该至少一第一输送件及该至少一第二植入单元可脱离地设于该至少一第二输送件；组装该至少一第一植入单元及该至少一第二植入单元，待该至少一第一输送件于该管腔内可携带该至少一第一植入单元至一病变段，该至少一第一植入单元可由一径缩状态展开至径向扩张状态而径向撑底扩张该病变段，该至少一第二输送件输送该至少一第二植入单元穿入该至少一第一植入单元而使该至少一第二植入单元自径向收缩状态展开至径向扩张状态而撑抵该至少一第一植入单元；形成血栓，该至少一第一植入单元上形成至少一血栓，该至少一血栓供填塞于该至少一第一植入单元及该血管的一管壁；其中，该至少一第一植入单元及该至少一第二植入单元各分别可为一膜外填塞件或一覆膜血管支架本体。
本发明所述的覆膜血管支架可伸展扩张填充于血管壁及膜管体的膜外侧的空间，以形成血栓。
附图说明
图1为本发明一较佳实施例的立体图。
图2为本发明一较佳实施例的分解图。
图3为本发明较佳实施例的安装流程图之一。
图4为本发明较佳实施例的安装流程图之二。
图5为本发明较佳实施例的安装流程图之三。
图6为本发明较佳实施例的步骤方块图。
1-覆膜血管支架；10-覆膜血管支架本体；11-膜管体；12-支架体；13-导流孔；14-末端部；15-支架环；151-定位端部；16-镂空部；
2-管腔；20-膜外填塞件；21-丝线；22-填塞部；23-通孔；
3-病变段；
4-血管；
5-管壁；
6-正常段；
70-导引线；
8-套管；80-输送组；81-第一输送件；811-第一头部；812-第一身部；82-第二输送件；821-第二头部；822-第二身部；
90-扩撑件；
C-延伸方向；E-轴向；
S1～S5-步骤。
具体实施方式
以下仅以实施例说明本发明可能的实施状态，并非用以限制本发明所欲保护的范围，合先叙明。
请参考图1至图5，其显示本发明的一较佳实施例，本发明的覆膜血管支架1包括一覆膜血管支架本体10及一膜外填塞件20。
该覆膜血管支架本体10沿一轴向E延伸，该覆膜血管支架本体10包括一膜管体11及一支架体12，该支架体12结合于该膜管体11(如结合于外侧、内侧、内外侧，但 不限于此)，该支架体12的网孔的形状有开放设计(open cell)或闭合设计(close cell)；该膜管体11包括一于该轴向E上延伸开放的导流孔13，该支架体12设于该导流孔13外。该支架体12可以缝合或其他结合方式固定结合于该膜管体11上；该支架体12具有可自行由收缩至径向扩张的特性。该膜外填塞件20结合于该覆膜血管支架本体10，该膜外填塞件20包括一填塞部22，该填塞部22位于该覆膜血管支架本体10的外侧，于本实施例中，该膜外填塞件20的填塞部22与该膜管体11分别设于该支架体12的相对二侧。具体地说，该覆膜血管支架本体10可径向缩合及径向扩张，该膜管体11供设于一血管4的管腔2内，各该膜外填塞件20供填塞于该覆膜血管支架本体10及该血管4的一管壁5之间。该膜外填塞件20可以熔接、缝接、绑结或其他方式固接于该膜管体11或该支架体12上，该膜外填塞件20亦可与该覆膜血管支架本体10可拆卸地相互套设作为两件式设计。
该血管4包括一病变段3及至少一正常段6，该覆膜血管支架本体10包括至少一位于该轴向E上的末端部14，该至少一末端部14于该轴向E上凸出该膜外填塞件20，该膜外填塞件20供对应该病变段3，该至少一末端部14径向撑抵于该至少一正常段6。于本实施例中，该血管4包括二该正常段6，该覆膜血管支架本体10包括二位于该轴向E上相对二侧的该末端部14，该二末端部14分别于该轴向E上凸出该膜外填塞件20的相对二端，该二末端部14径向撑抵于该二正常段6；于本实施例中，该覆膜血管支架本体10沿该轴向E延伸，该覆膜血管支架本体10于该轴向E上的一第一轴向长度大于该膜外填塞件20于该轴向E上的第二轴向长度；据此，该二末端部14于该膜外填塞件20外可径向扩撑定位于该二正常段6，该膜外填塞件20可径向扩撑该病变段3，以填补该血管4与该覆膜血管支架1之间的缝隙。
该膜外填塞件20为由可变形材质制成，该膜外填塞件20包括至少一可变形的丝线21及复数个通孔23，各该丝线21缠绕构成该复数个通孔23，据此该膜外填塞件20可呈不规则状；较佳地，该膜外填塞件20包括复数个可变形的该丝线21及复数个该通孔23，各该丝线21缠绕构成该复数个通孔23，各该通孔23的一孔径小于该导流孔13的一孔径；借以可径向收缩及径向扩张变形，以微小的该通孔23降低血流速度而得以形成血栓，并可任意变形以符合该覆膜血管支架本体10及该血管4的该管壁5之间的间隙的尺寸、范围、形状。各该丝线21可为金属丝线，如钢丝绒，但不限于此，亦可为其他可变形的材质。具体地说，该覆膜血管支架1供植入该管腔2(如血管腔)中时，该 覆膜血管支架1会由缩合状态变扩张的状态以撑开该管腔2的病变段3(如动脉瘤)，而各该膜外填塞件20可供填塞于该覆膜血管支架本体10与该管腔2之间(如该病变段3)，以填塞该覆膜血管支架本体10与该管腔2之间形成的间隙，可于该膜外填塞件20上形成血栓以填塞间隙。
该膜外填塞件20为一可径缩及径扩的一套体，该膜外填塞件20套设于该覆膜血管支架本体10；于其他实施例中该填塞件亦可呈丝状或圈状或其他形状。
该支架体12包括二支架环15，该二支架环15分别设于该二末端部14，各该支架环15设有一定位端部151，该定位端部151于该轴向E上凸出该膜管体11，该定位端部151与该膜管体11共构复数个镂空部16，该二支架环15分别可径向扩撑于该二正常段6定位且令该膜管体11的二相对端部可保持扩撑状，该复数个镂空部16可供血液通过。于本实施例中，各该支架环15系以蜿蜒路径朝周向延伸。
该覆膜血管支架1另包括一扩撑件90，该扩撑件90可自行径缩及径扩，该膜外填塞件20为一套体，该膜外填塞件20与该覆膜血管支架本体10相互套设，该扩撑件90结合于该膜外填塞件20，该扩撑件90可与该膜外填塞件20同动地径缩或径扩，得以达到扩撑该膜外填塞件20的效果。
请参考图3至图6，本发明又提供一种如前述的膜外形成血栓的方法，包含以下步骤：
步骤S1：备一导引线70，将该导引线70供通入该血管4的该管腔2内；
步骤S2：备一输送组80，该输送组80可沿该导引线70移动，该输送组80包括至少一第一输送件81及至少一第二输送件82，该第一输送件81及该第二输送件82分别沿该导引线70的一延伸方向C设置；
步骤S3：配置至少一第一植入单元及至少一第二植入单元，将该至少一第一植入单元可脱离地设于该至少一第一输送件81及该至少一第二植入单元可脱离地设于该至少一第二输送件82；
步骤S4：组装该至少一第一植入单元及该至少一第二植入单元，待该至少一第一输送件81于该管腔2内可携带该至少一第一植入单元至该病变段3(如动脉瘤)，该至少一第一植入单元可由一径缩状态展开至径向扩张状态而径向撑底扩张该病变段3，该至少一第二输送件82输送该至少一第二植入单元穿入该至少一第一植入单元而使该至少一第二植入单元自径向收缩状态展开至径向扩张状态而撑抵该至少一第一植入单元，具 体地说，一套管8套设该第一植入单元使该第一植入单元径缩，及套设于该第二植入单元使该第二植入单元径缩，而于该病变段3时依序拆离该套管8脱离该第一植入单元及该第二植入单元，而使该第一、二植入管单元自动径向扩张，但不限于此种方式；
步骤S5：形成血栓，该至少一第一植入单元上形成至少一血栓，该至少血栓供填塞于该至少一第一植入单元及该血管4的一管壁5；其中，该至少一第一植入单元为该膜外填塞件20及该至少一第二植入单元为该覆膜血管支架本体10。于本实施例中，该覆膜血管支架本体10包括该膜管体11及该支架体12，该支架体12结合于该膜管体11外侧；该膜外填塞件20套设于该覆膜血管支架本体10且绕该轴向E延伸，各该膜外填塞件20为钢丝绒材质制成，但不限于此。进一步说明，该第一输送件81包括一第一头部811及一外径小于该第一头部811的第一身部812，该第二输送件82包括一第二头部821及一外径小于该第二头部821的第二身部822；该第一植入单元套设于该第一身部812，该第二植入单元套设于该第二身部822。据此，可于管腔2中达到多段组合及多段式扩撑该管腔2的效果，及该覆膜血管支架1及该膜外填塞件20可于管腔2中相互套组并共同扩撑该管腔2的目的。各该第一植入单元包括该膜外填塞件20及该扩撑件90，该扩撑件90结合该膜外填塞件20，该扩撑件90可收缩及自行扩张(例如记忆金属材质，但不限于此)。于其他实施例中，该膜外填塞件本身亦可为可自行径扩及径缩的材质制成。
以上所述，仅为本发明的较佳实施例而已，并非用来限定本发明专利实施的范围，即大凡依本发明专利申请保护范围及发明说明内容所作的简单的均等变化与修饰，皆仍属于本发明专利涵盖的范围内。

Claims (10)

  1. 一种覆膜血管支架，其特征在于，包括：
    一覆膜血管支架本体；及
    一膜外填塞件，结合于该覆膜血管支架本体，该膜外填塞件包括一填塞部，该填塞部位于该覆膜血管支架本体的外侧。
  2. 如权利要求书1所述的覆膜血管支架，其特征在于，该覆膜血管支架本体包括一膜管体及一支架体，该支架体结合于该膜管体，该膜外填塞件的填塞部与该膜管体分别设于该支架体的相对二侧。
  3. 如权利要求书1所述的覆膜血管支架，其特征在于，该覆膜血管支架本体为可径向缩合及径向扩张的，该膜管体设于一血管的管腔内，各该膜外填塞件填塞于该覆膜血管支架本体及该血管的一管壁之间。
  4. 如权利要求书3所述的覆膜血管支架，其特征在于，该血管包括一病变段及至少一正常段，该覆膜血管支架本体沿一轴向延伸，该覆膜血管支架本体包括至少一位于该轴向上的末端部，该至少一末端部于该轴向上凸出该膜外填塞件，该膜外填塞件对应该病变段，该至少一末端部径向撑抵于该至少一正常段。
  5. 如权利要求书1所述的覆膜血管支架，其特征在于，该覆膜血管支架本体沿一轴向延伸，该覆膜血管支架本体于该轴向上的一第一轴向长度大于该膜外填塞件于该轴向上的第二轴向长度。
  6. 如权利要求书1所述的覆膜血管支架，其特征在于，该膜外填塞件由可变形材质制成。
  7. 如权利要求书1所述的覆膜血管支架，其特征在于，该膜外填塞件包括至少一可变形的丝线及复数个通孔，各该丝线缠绕构成该复数个通孔。
  8. 如权利要求书1所述的覆膜血管支架，其特征在于，另包括一扩撑件，该扩撑件为可自行径缩及径扩的，该膜外填塞件为一套体，该膜外填塞件与该覆膜血管支架本体相互套设，该扩撑件结合于该膜外填塞件，该扩撑件能与该膜外填塞件同动地径缩或径扩。
  9. 如权利要求书2所述的覆膜血管支架，其特征在于，该覆膜血管支架本体为可径向缩合及径向扩张的，该膜管体设于一血管的管腔内，各该膜外填塞件填塞 于该覆膜血管支架本体及该血管的一管壁之间；该血管包括一病变段及二正常段，该覆膜血管支架本体沿一轴向延伸，该覆膜血管支架本体包括二位于该轴向上相对二侧的末端部，该二末端部分别于该轴向上凸出该膜外填塞件的相对二端，该膜外填塞件供对应该病变段，该二末端部径向撑抵于该二正常段；该支架体包括二支架环，该二支架环分别设于该二末端部，各该支架环设有一定位端部，该定位端部于该轴向上凸出该膜管体，该定位端部与该膜管体共构复数个镂空部；该膜外填塞件为可变形材质制成；该膜外填塞件包括复数个可变形的丝线及复数个通孔，各该丝线缠绕构成该复数个通孔；该膜外填塞件为一可径缩及径扩的一套体，该膜外填塞件套设于该覆膜血管支架本体；该膜管体包括一于该轴向上延伸开放的导流孔，该支架体设于该导流孔外，各该通孔的一孔径小于该导流孔的一孔径。
  10. 一种膜外形成血栓的方法，其特征在于，包含以下步骤：
    备一导引线，将该导引线供通入一血管的一管腔内；
    备一输送组，该输送组可沿该导引线移动，该输送组包括至少一第一输送件及至少一第二输送件，该第一输送件及该第二输送件分别沿该导引线的一延伸方向设置；
    配置至少一第一植入单元及至少一第二植入单元，将该至少一第一植入单元可脱离地设于该至少一第一输送件及该至少一第二植入单元可脱离地设于该至少一第二输送件；
    组装该至少一第一植入单元及该至少一第二植入单元，待该至少一第一输送件于该管腔内可携带该至少一第一植入单元至一病变位置，该至少一第一植入单元可由一径缩状态展开至径向扩张状态而径向撑底扩张一病变段，该至少一第二输送件输送该至少一第二植入单元穿入该至少一第一植入单元而使该至少一第二植入单元自径向收缩状态展开至径向扩张状态而撑抵该至少一第一植入单元；
    形成血栓，该至少一第一植入单元上形成至少一血栓，该至少一血栓供填塞于该至少一第一植入单元及该血管的一管壁；
    其中，该至少一第一植入单元及该至少一第二植入单元各分别为一膜外填塞件或一覆膜血管支架本体。
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