WO2019085981A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2019085981A1
WO2019085981A1 PCT/CN2018/113565 CN2018113565W WO2019085981A1 WO 2019085981 A1 WO2019085981 A1 WO 2019085981A1 CN 2018113565 W CN2018113565 W CN 2018113565W WO 2019085981 A1 WO2019085981 A1 WO 2019085981A1
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WO
WIPO (PCT)
Prior art keywords
stent graft
membrane
diaphragm
stent
graft according
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PCT/CN2018/113565
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English (en)
French (fr)
Inventor
肖本好
李达
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先健科技(深圳)有限公司
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Publication of WO2019085981A1 publication Critical patent/WO2019085981A1/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 the field of medical devices, and in particular to a stent graft.
  • aortic diseases mainly includes aortic dissection and aortic aneurysm.
  • Aortic aneurysm and aortic dissection are extremely dangerous diseases with a mortality rate greater than 50% within 48 hours after onset and a mortality rate greater than 85% within two weeks, which has seriously threatened human health.
  • the principle of endovascular isolation is usually used, that is, the graft is used to isolate blood flow from the aortic aneurysm or aortic dissection. Specifically, the stent graft is compression-assembled into the sheath tube, and the stent graft is released from the sheath tube at the lesion position, and the stent graft is isolated from the lesion site to reconstruct the blood flow channel, and the lesion position is thrombotic and the muscle is cured.
  • Such surgery has developed rapidly due to small trauma and rapid recovery.
  • a bifurcated stent graft and a straight tubular stent graft are often used for the socket.
  • it is mainly used to increase the barbs on the socketed brackets, or to fold at one end of the socket brackets or to increase the bell mouth at one end of the socket brackets to increase the two. Connection strength.
  • both methods have certain flaws.
  • the barb when the barb is added to the socket, the barb will pierce the socket. Under the long-term flushing of the blood flow, the barb may break the film on the socket to cause endoleak; The end of the necking will increase the difficulty of entering the guide wire and increase the difficulty of operation; in addition, the bell mouth is designed on the sleeved bracket, and the sleeve is compressed to form a wrinkle, which easily leads to the connection between the socket bracket and the socketed bracket. The gap leads to an internal leak.
  • a stent graft comprising a tubular body and a membrane fixedly disposed on the inner surface of the body, the membrane and the body forming a bag body having an opening at one end, and an opening direction of the bag body and the body The opening direction is the same.
  • the diaphragm is an annular structure surrounding the inner surface of the body, the diaphragm includes a first end and a second end disposed opposite the first end, the first end The inner surface of the body is sealingly connected, and the second end is provided with at least two circumferentially distributed fixing portions, and the fixing portion is fixedly connected with the inner surface of the body to form the second end opening Said bag body.
  • the fixing surface and the fixing surface of the inner surface of the body are point-like.
  • the fixing portion extends from the second end of the diaphragm to the first end.
  • the fixing portion is fixedly coupled to the inner surface of the body by a suture.
  • the circumference of the first end of the diaphragm is equal to or close to the circumference of the junction of the body and the diaphragm, and the circumference of the second end of the diaphragm is larger than The circumference of the body and the fixed portion of the diaphragm.
  • the thickness of the second end of the diaphragm is greater than the thickness of the first end.
  • the diaphragm includes a first end, a second end disposed opposite the first end, and two oppositely disposed sides connecting the first end and the second end.
  • the first end and the two sides of the diaphragm are respectively sealingly connected to an inner surface of the body to form the bag body with the second end opening.
  • the plurality of diaphragms are evenly distributed along a circumferential direction of an inner surface of the body, and the first ends of the plurality of diaphragms are perpendicular to The same circumferential surface of the axis of the body.
  • the thickness of the second end of the diaphragm is greater than the thickness of the first end.
  • the diaphragm is located at an end of the body, and the opening of the pocket faces an end of the body away from the diaphragm.
  • the distance of one end of the diaphragm away from the opening from one end of the body is less than or equal to 30 mm.
  • the body includes a bare stent and a coating overlying the bare stent, and one end of the coating is folded over the inner surface of the body to form the membrane beyond the bare stent.
  • the diaphragm has a length of 4-20 mm on the axis of the body.
  • the bag body formed by the diaphragm and the body can be punched out, and a corresponding neck is formed at a corresponding position of the body, when being sleeved with other brackets, It can generate a certain radial force, and can also cause the bracket that is sleeved to be stuck at the position, thereby increasing the strength of the stent graft when being sleeved with other stents, and reducing the detachment of the socketed stent from the stent graft. Probability.
  • FIG. 1 is a schematic structural view of a stent graft according to an embodiment of the present invention
  • FIG. 2 is a partial structural schematic view of the stent graft shown in FIG. 1;
  • FIG. 3 is a schematic structural view of another view of the stent graft shown in FIG. 2;
  • Figure 4 is a schematic view showing the structure of the stent graft shown in Figure 2 after blood flow impact;
  • FIG. 5 is a partial structural schematic view of a stent graft according to a second embodiment of the present invention.
  • FIG. 6 is a partial structural schematic view of a stent graft according to a third embodiment of the present invention.
  • Fig. 7 is a partial structural view showing a stent graft according to a fourth embodiment of the present invention.
  • the structure of the stent graft 10 will be described by taking an abdominal aortic stent graft as an example.
  • the stent graft 10 is not limited to the abdominal aortic stent graft shown in FIG. 1, and may be other types of stent grafts, such as an aortic arch stent graft, a radial artery stent, and the like.
  • the stent graft 10 can include all intravascular stents without departing from the invention.
  • the stent graft 10 includes a tubular body 100 and a membrane 200 fixedly disposed on the inner surface of the body 100.
  • the membrane 200 and the body 100 form a bag body with an open end, and the opening direction of the bag body is
  • the opening direction of the body 100 is the same, that is, the open end of the bag body faces the open end of the body 100.
  • the open end of the bag body may be the same as the direction of any one of the two open ends of the body.
  • the opening direction of the bag body is opposite to the direction of blood flow, and the bag body can be punched under the impact of blood flow. Referring to FIG.
  • the bag body formed by the diaphragm 200 and the body 100 can be punched out, and a corresponding neck is formed at a corresponding position on the body.
  • a certain radial force can be generated, and the brackets that are sleeved can be stuck at the position, thereby increasing the strength of the stent graft 10 when it is sleeved with other brackets, and reducing The probability of being detached from the stent graft 10 by the socketed stent.
  • the body 100 includes a trunk 110 and a first branch 111 and a second branch 112 disposed on the trunk 110.
  • the diaphragm 200 is disposed on an inner surface of the first branch 111.
  • the first branch 111 is a short branch and the second branch 112 is a long branch.
  • the structure of the body 100 is not limited to the above structure.
  • the body 100 when the body 100 is a straight tube type structure, the body 100 may include only the trunk 110, and the diaphragm 200 is disposed on the inner surface of the trunk 110. It can also be understood that the diaphragm 200 can also be disposed on the inner surface of the second branch 112 when the second branch 112 needs to be nested with other brackets.
  • the diaphragm 200 is an annular structure surrounding the inner surface of the body 100.
  • the diaphragm 200 includes a first end and a second end disposed opposite the first end, the first end and the body
  • the inner surface is sealingly connected, and the second end is provided with at least two circumferentially distributed fixing portions 210 fixedly connected with the inner surface of the body 100 to form the bag body with the second end opening.
  • the sealed connection means that the flow of blood from the second end and the bag body after the blood vessel is implanted is much larger than the flow rate of the bag from the first end, and the sealing connection can be achieved by stitching or bonding. .
  • the circumference of the diaphragm 200 may be equal to the circumference of the body 100 at the junction with the diaphragm 200, or may be slightly smaller or slightly larger than the circumference of the body 100 at the junction with the diaphragm 200.
  • the circumference of the first end of the diaphragm 200 is equal to or close to the circumference of the junction of the body 100 and the diaphragm 200, which facilitates passage of the delivery sheath from within the body 100.
  • the circumference of the second end of the diaphragm 200 is greater than the circumference of the fixed portion of the body 100 and the diaphragm 200, so that the diaphragm 200 is in a pleated state after release, preventing adhesion between the diaphragm 200 and the body 100, in the blood. Under the impact of the flow, the flap in the pleated state is more likely to form a pocket-like membrane.
  • the fixing portion 210 extends from the second end of the diaphragm 200 to the first end, and the diaphragm 210 is divided into at least two separate pockets, and the fixing surface of the fixing portion 210 and the body 100 is a line. shape.
  • the fixing portion 210 may not extend to the first end, and the fixing portion 210 may divide the diaphragm 210 into at least two mutually communicating pockets.
  • the fixing portions 210 are three, and the three fixing portions 210 are evenly distributed along the inner surface of the body 100 to divide the diaphragm 200 into three pockets.
  • two or more fixing portions 210 may be disposed on the diaphragm 200 as needed.
  • the fixing portion 210 is fixedly connected to the inner surface of the body 100 by a suture, that is, the fixing portion 210 is fixedly connected to the inner surface of the body 100 by stitching.
  • the fixing portion 210 can also be fixedly connected to the inner surface of the body 100 by other methods.
  • the fixing portion 210 is bonded to the inner surface of the body 100 by an adhesive.
  • the diaphragm 200 is located at the end of the body 100 , and the opening direction of the bag body faces the end of the body 100 away from the diaphragm 200 .
  • the first end of the diaphragm 200 is connected to the end of the body 100, and the opening direction of the second end is toward the end of the body 100 away from the first end.
  • the first end of the diaphragm 200 is coupled to an end of the first branch 111 that is remote from the body 110.
  • the diaphragm 200 can also be located at other positions of the body 100.
  • the diaphragm 200 can also be at a certain distance from the end of the body 100, such as the end of the diaphragm 200 away from the opening and the body.
  • the distance between one end of 100 is less than or equal to 30 mm, which facilitates the entry of the guide wire.
  • the body 100 includes a bare bracket 101 and a film 102 covering the bare bracket 101.
  • One end of the film 102 is folded over the inner surface of the body 100 beyond the bare bracket 101 to form a diaphragm 200, that is, the diaphragm 200 and the cover.
  • the film 102 is an integrally formed structure, and the first end of the film 200 and the film 102 have a continuous structure.
  • the nickel-titanium wire braided heat setting or nickel-titanium tube can be used to cut into the bare stent 101, and then the outer surface of the bare stent 101 is coated.
  • the material of the coating 102 can also be The polytetrafluoroethylene film, for example, may be integrally covered with a polytetrafluoroethylene film on the inner surface and the outer surface of the bare stent 101.
  • the length of the polytetrafluoroethylene film is greater than the length of the bare stent 101, and the bare stent 101 is located in the middle of the two layers of the film.
  • the Teflon film of the inner and outer layers is bonded together by high temperature pressing, thereby fixing the bare bracket 101 between the coatings 102, and the film 102 beyond the bare stent 101 is turned into a diaphragm. 200.
  • At least two sutures are stitched from the second end of the diaphragm 200 to the first end to form at least two fixing portions 210.
  • the material of the film 102 may be a PET film, and the bare stent 101 is fixed on the film 102 by PET stitching.
  • the diaphragm 200 and the coating 102 can also be independent structures, and the first end of the diaphragm 200 can be disposed on the inner surface of the body 10 by gluing, sewing, or the like.
  • the present application also provides a method for preparing a stent graft 10, which mainly comprises the steps of: coating a film 200 formed on a coated mold bar according to requirements, and covering the foil paper or the like on the same.
  • the foil paper exposes one end of the film 200, and then covers the inner film, and then the bare film 101 is loaded on the inner film, and then the outer film is coated on the bare support 101, and the bare support 101 is fixed by high temperature and pressure.
  • the body 100 is obtained, and the film 200 of the uncoated tin foil is bonded to the inner and outer films to remove the tin foil.
  • the second end of the film 200 is separated from the body 100.
  • the second end of the diaphragm 200 is fixed on the body 100 to form a stent graft 10.
  • the diaphragm 200 can be located at any position of the body 100, and the process is simple and convenient.
  • the thickness of the diaphragm 200 may be uniform and may be the same as the thickness of the coating 102.
  • the thickness of the second end of the diaphragm 200 is greater than the thickness of the first end.
  • the thickness of the diaphragm 200 is gradually thinned from the second end to the first end, and the thickness of the first end of the diaphragm 200 is small, which may be advantageous for overlaying.
  • the length of the diaphragm 200 on the axis of the body 100 is 4-20 mm, that is, the length of the first end and the second end of the diaphragm 200 on the axis of the body 100 is 4-20 mm, without adding two
  • the connection strength of the two brackets is increased to a large extent.
  • the first end and the second end of the diaphragm 200 are respectively located on two circumferential surfaces perpendicular to the axis of the body 100, that is, the respective positions of the first end of the diaphragm 200 and the respective positions of the second end.
  • the lengths in the direction parallel to the axis of the body 100 are equal.
  • first end and the second end of the diaphragm 200 may also not be perpendicular to the circumferential surface of the axis of the body 100.
  • the second end of the diaphragm 200 may also have a structure such as a zigzag shape.
  • the stent graft 10a of the second embodiment of the present application has substantially the same structure as the stent graft 10, except that the fixing surface 210a and the inner surface of the body 100a have a fixed surface, that is, a diaphragm.
  • the contact surface of the second end of the 200a and the inner surface of the body 100a is a dot shape, and the diaphragm 200a and the body 100a form a bag body which communicates with each other, and the structure is simpler and is convenient for production and processing.
  • the fixing portions 210a are three, and the three fixing portions 210a are evenly distributed along the inner surface of the body 100, and the three fixing portions 210a are fixedly coupled to the body 100a by stitching points.
  • the stent graft 10b of the third embodiment of the present application has substantially the same structure as the stent graft 10, except that the plurality of membranes 200b are plural and the plurality of membranes 200b are spaced apart.
  • the diaphragm 200b includes a first end, a second end disposed opposite the first end, and two oppositely disposed sides connecting the first end and the second end, the first end and the two sides of the diaphragm 200b Separately connected to the inner surface of the body to form the bag body with the second end opening.
  • the sealed connection means that after the blood vessel is implanted, the flow rate of blood flow from the second end into the bag body is much larger than the flow rate from the first end and the two side edges, and the sealed connection can be stitched and glued. Implementation in a similar manner.
  • a plurality of diaphragms 200b are distributed, and the plurality of diaphragms 200b are evenly distributed along the circumferential direction of the inner surface of the body 100b.
  • the first ends of the plurality of diaphragms 200b are located on the same circumferential surface perpendicular to the axis of the body 100b.
  • each of the diaphragms 200b forms a pocket with the body 100b.
  • the first end of the plurality of diaphragms 200b is located at the end of the body 100b, and the plurality of diaphragms 200b are all formed by the inward folding of the coating of the body 100b, and the second end of the plurality of diaphragms 200b Located on the same circumferential surface perpendicular to the axis of the body 100b.
  • only one diaphragm 200b may be provided as needed, and one diaphragm 200b forms a bag body with the body 100b.
  • first ends of the plurality of diaphragms 200b may also not be on the same circumferential surface that is perpendicular to the axis of the body 100, for example, the first ends of the plurality of diaphragms 200b have a height difference on the body 100.
  • the plurality of diaphragms 200b may also be non-uniformly distributed along the circumferential direction of the inner surface of the body 100b.
  • the stent graft 10c of the fourth embodiment of the present application has substantially the same structure as that of the third embodiment 10b, except that the second end of the plurality of diaphragms 200b has a height difference on the body 100b, that is, The second ends of the plurality of diaphragms 200b are not on the same circumferential surface.
  • the lengths of the first end and the second end of the plurality of diaphragms 200c in the axial direction of the body 100c are not equal, and the first ends of the plurality of diaphragms 200c are all located in the same axis perpendicular to the axis of the body 100c.
  • the second ends of the plurality of diaphragms 200c are located on two circumferential faces perpendicular to the axis of the body 100c.
  • the mouth forms a larger constriction between the second end of the shorter diaphragm and the first end to form a step effect, further increasing the strength of the stent graft 10c when being sleeved with other stents, and reducing the coverage of the sheathed stent The probability of shedding on the membrane stent 10c.
  • the larger length diaphragm 200c and the smaller length diaphragm 200c are alternately arranged.
  • the larger length of the diaphragm 200c and the smaller length of the diaphragm 200c may be in other arrangements.
  • the larger length of the diaphragm 200c is located on one side of the body 100c, and the length is smaller.
  • the diaphragms 200c are all located on the other side of the body 100c.
  • the plurality of diaphragms 200c may also be two or more diaphragms 200c of different lengths, and two or more cutouts may be formed on the body 100c.

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  • Health & Medical Sciences (AREA)
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  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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  • Prostheses (AREA)

Abstract

一种覆膜支架（10），包括管状本体（100）及固定设置于所述本体内表面的膜片（200），所述膜片与所述本体形成一端开口的袋体，且所述袋体的开口方向与所述本体（100）的开口方向相同。覆膜支架植入血管后，膜片与本体形成的袋体可以被冲开，在本体的相应位置相当于形成了一个缩口，当与其他支架套接时，可产生一定的径向力，从而增加覆膜支架与其他支架套接时的强度。

Description

覆膜支架 技术领域
本发明涉及医疗器械领域，特别是涉及一种覆膜支架。
背景技术
随着高血压发病率的急剧上升，动脉相关疾病发病率显著上升。在主动脉疾病中，主要包括主动脉夹层和主动脉瘤两类疾病。主动脉瘤和主动脉夹层是极为凶险的疾病，发病后48小时内的死亡率大于50％，两周内的死亡率大于85％，已经严重威胁人类健康。
目前外科治疗这类疾病主要包括传统的外科手术治疗和微创介入治疗。外科手术治疗的手术难度大，操作困难，手术时间长，对病人的创伤大，且死亡率高。
在微创介入治疗主动脉疾病的过程中，通常利用腔内隔绝原理，即采用覆膜支架隔绝血流与主动脉瘤或主动脉夹层来治疗。具体的，将覆膜支架压缩装配到鞘管中，在病变位置将覆膜支架从鞘管内释放，覆膜支架隔绝病变部位重构血流通道，病变位置血栓化并肌化达到治愈目的。此类手术由于创伤小、恢复快，得到了快速发展。
目前，微创介入治疗主动脉疾病过程中，常需要进行两个覆膜支架的套接。例如，针对腹主动脉瘤，常采用一个分叉型覆膜支架和一个直管型覆膜支架进行套接。为了防止两个覆膜支架在连接处松脱，目前主要采用在被套接支架上增加倒刺，或者在套接支架的一端进行缩口或在被套接支架的一端增加喇叭口，来增加两者的连接强度。
但是这两种方法都存在着一定的缺陷。例如，在被套接支架上增加倒刺，倒刺会扎穿套接支架，在血流的长期冲刷下，倒刺可能划破套接支架上的覆膜 而引起内漏；而在套接支架的一端进行缩口，会增加导丝进入的困难，增加手术难度；另外，在被套接支架上设计喇叭口，被套接支架压缩后形成褶皱，容易导致套接支架与被套接支架的连接处出现缝隙而导致内漏。
发明内容
基于此，针对上述问题，有必要提供一种覆膜支架，能够较好地解决覆膜支架套接的问题。
一种覆膜支架，包括管状本体及固定设置于所述本体内表面的膜片，所述膜片与所述本体形成一端开口的袋体，且所述袋体的开口方向与所述本体的开口方向相同。
在其中一个实施例中，所述膜片为环绕所述本体内表面的环形结构，所述膜片包括第一端及与所述第一端相对设置的第二端，所述第一端与所述本体的内表面密封连接，所述第二端设置至少两个沿周向分布的固定部，所述固定部与所述本体的内表面固定连接，以形成所述第二端开口的所述袋体。
在其中一个实施例中，所述固定部与所述本体内表面的固定面为点状。
在其中一个实施例中，所述固定部从所述膜片的所述第二端延伸至所述第一端。
在其中一个实施例中，所述固定部通过缝线与所述本体内表面固定连接。
在其中一个实施例，所述膜片的所述第一端的周长等于或接近所述本体与所述膜片连接处的周长，所述膜片的所述第二端的周长大于所述本体与所述膜片固定处的周长。
在其中一个实施例，所述膜片的所述第二端的厚度大于所述第一端的厚度。
在其中一个实施例中，所述膜片包括第一端、与所述第一端相对设置的第二端及连接所述第一端与所述第二端之间的两个相对设置的侧边，所述膜片的所述第一端及两个所述侧边分别与所述本体的内表面密封连接，以形成所述第二端开口的所述袋体。
在其中一个实施例中，所述膜片为多个，多个所述膜片沿所述本体的内表面的周向均匀分布，且多个所述膜片的所述第一端位于垂直于所述本体的轴线 的同一圆周面上。
在其中一个实施例，所述膜片的所述第二端的厚度大于所述第一端的厚度。
在其中一个实施例中，所述膜片位于所述本体的端部，且所述袋体的开口朝向于所述本体远离所述膜片的一端。
在其中一个实施例中，所述膜片远离开口的一端与所述本体的一端部的距离小于等于30mm。
在其中一个实施例中，所述本体包括裸支架及覆盖在裸支架上的覆膜，所述覆膜的一端超出所述裸支架向所述本体的内表面翻折形成所述膜片。
在其中一个实施例中，所述膜片在所述本体的轴线上的长度为4-20mm。
上述覆膜支架植入血管后，在血流的冲击下，膜片与本体形成的袋体可以被冲开，在本体的相应位置相当于形成了一个缩口，当与其他支架套接时，可以产生一定的径向力，而且还可以使得被套接在内的支架在该位置被卡住，从而增加覆膜支架与其他支架套接时的强度，降低被套接支架从覆膜支架上脱落的概率。
附图说明
图1为本发明一实施例的覆膜支架的结构示意图；
图2为图1所示的覆膜支架的局部结构示意图；
图3为图2所示的覆膜支架另一视角的结构示意图；
图4为图2所示的覆膜支架在血流冲击后的结构示意图；
图5为本发明第二实施例的覆膜支架的局部结构示意图；
图6为本发明第三实施例的覆膜支架的局部结构示意图；
图7为本发明第四实施例的覆膜支架的局部结构示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实 施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”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。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，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。
请参阅图1，在本实施方式中，以腹主动脉覆膜支架为例对覆膜支架10的结构进行说明。当然，在其他实施方式中，覆膜支架10不限于图1所示的腹主动脉覆膜支架，还可以为其他类型的覆膜支架，例如，主动脉弓覆膜支架，髂动脉支架等。在不违背本发明的基础上，覆膜支架10可以包括所有血管内支架。
请同时参阅图1至图3，覆膜支架10包括管状本体100及固定设置于本体100内表面的膜片200，膜片200与本体100形成一端开口的袋体，且袋体的开口方向与本体100的开口方向相同，即，袋体的开口端朝向于本体100的开口端。袋体的开口端可以与本体的两个开口端中任意一个开口端的方向相同即可。在实际使用过程中，袋体的开口方向与血流方向相反，在血流的冲击下，袋体可以被冲开。请参阅图4，上述覆膜支架10，植入血管后，在血流的冲击下，膜片200与本体100形成的袋体可以被冲开，在本体的相应位置相当于形成了一个缩口，当与其他支架套接时，可以产生一定的径向力，而且还可以使得被套接在内的支架在该位置被卡住，从而增加覆膜支架10与其他支架套接时的强度，降低被套接支架从覆膜支架10上脱落的概率。
在图示的实施例中，本体100包括主干110及设置于主干110上的第一分支111及第二分支112，膜片200设置于第一分支111的内表面。在本实施例中，第一分支111为短分支，第二分支112为长分支。
可以理解的是，本体100的结构并不局限于上述结构，例如，当本体100为直管型结构时，本体100可以只包括主干110，膜片200设置于主干110的内表面。还可以理解的是，当第二分支112需要与其他支架套接时，膜片200也可以设置于第二分支112的内表面。
请继续参阅图2，膜片200为环绕本体100内表面的环形结构，膜片200包括第一端及与所述第一端相对设置的第二端，所述第一端与所述本体的内表面密封连接，所述第二端设置至少两个沿周向分布的固定部210，固定部210与本体100内表面固定连接，以形成所述第二端开口的所述袋体。需要说明的是，密封连接是指，植入血管后血流从第二端进而袋体的流量远大于从第一端流出袋体的流量即可，密封连接可以通过缝合、粘合等方式实现。
可以理解的是，膜片200的周长可以与本体100上与膜片200连接处的周长相等，也可以稍小于或者稍大于本体100上与膜片200连接处的周长。在其中一个实施例中，膜片200第一端的周长等于或接近本体100与膜片200连接处的周长，可以方便输送鞘管从本体100内通过。膜片200的第二端的周长大于本体100与膜片200固定处的周长，这样可以保证膜片200在释放后处于褶皱状态，防止膜片200与本体100之间出现粘合，在血流的冲击下，褶皱状态的膜片更容易形成口袋状膜片。
具体在本实施例中，固定部210从膜片200的第二端开始延伸到第一端，将膜片210分割成至少两个单独的袋体，固定部210与本体100的固定面为线状。当然，在其他实施例中，固定部210也可以不延伸至第一端，固定部210可以将膜片210分割成至少两个相互连通的袋体。
在本实施例中，固定部210为三个，三个固定部210沿本体100的内表面均匀分布，将膜片200分割成三个袋体。当然，在其他实施例中，也可以根据需要在膜片200上设置两个或两个以上的固定部210。
请继续参阅图2，固定部210通过缝线与本体100的内表面固定连接，即，固定部210通过缝合的方法与本体100内表面固定连接。当然，在其他实施例中，固定部210也可以通过其他方法与本体100内表面固定连接。例如，固定部210通过粘结剂粘合在本体100内表面。
请继续参阅图1及图2，膜片200位于本体100的端部，且袋体的开口方向朝向于本体100远离膜片200的一端。具体的，膜片200的第一端与本体100的端部连接，第二端的开口方向朝向本体100远离第一端的一端。在图示的实施例中，膜片200的第一端与第一分支111远离主体110的一端连接。
可以理解的是，在其他实施例中，膜片200还可以位于本体100的其他位置，例如，膜片200还可以距离本体100的端部一定的距离，如膜片200远离开口的一端与本体100的一端部的距离小于等于30mm，这样可以方便导丝进入。
具体的，本体100包括裸支架101及覆盖在裸支架101上的覆膜102，覆膜102的一端超出裸支架101向本体100的内表面翻折形成膜片200，即，膜片200与覆膜102为一体成型结构，膜片200的第一端与覆膜102为连续结构。在实际制备过程中，可以采用镍钛丝编织热定型或镍钛管切割定型成裸支架101，再在裸支架101的外表面覆膜，在本实施方式中，覆膜102的材料也可以为聚四氟乙烯膜，例如，可以在裸支架101的内表面和外表面整体覆盖聚四氟乙烯膜，聚四氟乙烯膜的长度大于裸支架101的长度，裸支架101位于两层覆膜中间，通过高温加压的方式，将内外层的聚四氟乙烯覆膜粘接在一起，从而将裸支架101固定在覆膜102之间，超出裸支架101部分的覆膜102内翻形成膜片200，再从膜片200的第二端向第一端缝合至少两条缝线，形成至少两个固定部210。当然，在其他实施方式中，覆膜102的材料可以为PET膜，采用PET缝线将裸支架101固定在覆膜102上。
还可以理解的是，膜片200与覆膜102也可以为独立的结构，膜片200的第一端可以通过粘贴、缝合等方法设置于本体10的内表面。
本申请还提供一种覆膜支架10的制备方法，其主要包括如下步骤：在覆膜模棒上根据需要形成的膜片200的要求覆膜，并在其上覆盖锡箔纸或其他类似材料，锡箔纸露出膜片200的一端，然后覆内层膜，接着在内层膜上装载裸支架101，随后在裸支架101上覆外层膜，通过高温加压的方式，将裸支架101固定在内外层膜之间，得到本体100，并将未覆盖锡箔纸的膜片200与内外层膜粘结，除去锡箔纸，此时膜片200的第二端与本体100之间是分离开的，最后将 膜片200的第二端固定在本体100上，形成覆膜支架10。通过此方法，可以使得膜片200可以位于本体100的任意位置，工艺较简单方便。
在本实施例中，膜片200的厚度可以是均匀的，可以与覆膜102的厚度相同。优选的，膜片200第二端的厚度大于第一端的厚度，如膜片200的厚度从第二端到第一端逐渐变薄，膜片200第一端的厚度较小，可以有利于覆膜支架10在与延长支架对接时，输送鞘管从本体100内穿过，而由于延长支架与膜片200对接时，受力位置主要集中在第二端，第二端的厚度较大，可以有效防止延长支架从膜片200上脱落。
请参阅图2，膜片200在本体100轴线上的长度为4-20mm，即，膜片200的第一端与第二端在本体100轴线上的长度为4-20mm，在不增加两个支架套接长度的情况下，较大程度地增加两个支架的连接强度。具体到本实施例中，膜片200的第一端与第二端分别位于两个垂直于本体100的轴线的圆周面上，即膜片200的第一端的各个位置与第二端的各个位置在平行于本体100的轴线的方向上的长度均相等。当然，在其他实施例中，膜片200的第一端与第二端也可以不垂直于本体100的轴线的圆周面。例如，膜片200的第二端也可以为锯齿状等结构。
请参阅图5，本申请第二实施例的覆膜支架10a与覆膜支架10的结构大致相同，不同之处在于，固定部210a与本体100a内表面的固定面为点状，即，膜片200a的第二端与本体100a的内表面的接触面为点状，膜片200a与本体100a形成相互连通的袋体，结构更加简单，便于生产加工。在图示的实施例中，固定部210a为三个，三个固定部210a沿本体100的内表面均匀分布，三个固定部210a通过缝合点固定在本体100a固定连接。
请参阅图6，本申请第三实施例的覆膜支架10b与覆膜支架10的结构大致相同，不同之处在于，膜片200b为多个，多个膜片200b间隔设置。
膜片200b包括第一端、与第一端相对设置的第二端及连接第一端与第二端之间的两个相对设置的侧边，膜片200b的第一端及两个侧边分别与本体的内表面密封连接，以形成第二端开口的所述袋体。需要说明的是，密封连接是指，植入血管后，血流从第二端流入袋体的流量远大于从第一端及两个侧边流出袋 体的量，密封连接可以通过缝合、粘合等方式实现。
请继续参阅图6，膜片200b为多个，多个膜片200b沿本体100b的内表面的周向均匀分布，多个膜片200b的第一端位于垂直于本体100b的轴线的同一圆周面上，每一个膜片200b与本体100b形成一个袋体。具体到本实施例中，多个膜片200b的第一端位于本体100b的端部，多个膜片200b均由本体100b的覆膜向内翻折形成，多个膜片200b的第二端位于垂直于本体100b的轴线的同一圆周面上。
可以理解的是，在其他实施例中，根据需要也可以只设置一个膜片200b，一个膜片200b与本体100b形成一个袋体。
还可以理解的是，多个膜片200b的第一端也可以不在垂直于本体100的轴线的同一圆周面上，例如，多个膜片200b的第一端在本体100上具有高度差。
还可以理解的是，多个膜片200b沿本体100b的内表面的周向也可以非均匀分布。
请参阅图7，本申请第四实施例的覆膜支架10c与第三实施例10b的结构大致相同，不同之处在于，多个膜片200b的第二端在本体100b上具有高度差，即，多个膜片200b的第二端不在同一圆周面上。
请继续参阅图7，多个膜片200c的第一端与第二端在本体100c的轴线方向上的长度不相等，多个膜片200c的第一端均位于垂直于本体100c的轴线的同一圆周面上，多个膜片200c的第二端位于两个垂直于本体100c的轴线的圆周面上。植入血管后，在血流的冲击下，可以形成两个大小不同的缩口，即，在较长膜片的第二端到较短膜片的第二端之间形成一个较小的缩口，在较短膜片的第二端到第一端之间形成一个较大的缩口，形成台阶效应，进一步增加覆膜支架10c与其他支架套接时的强度，降低被套接支架从覆膜支架10c上脱落的概率。
在图示的实施例中，长度较大的膜片200c与长度较小的膜片200c交替排列。当然，在其他实施例中，长度较大的膜片200c与长度较小的膜片200c也可以呈其他排列方式，例如，长度较大的膜片200c全部位于本体100c的一侧，长度较小的膜片200c全部位于本体100c的另外一侧。可以理解的是，多个膜片200c还可以是两个以上的不同长度的膜片200c，在本体100c上可以形成两个以上的 缩口。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (14)

  1. 一种覆膜支架，其特征在于，包括管状本体及固定设置于所述本体内表面的膜片，所述膜片与所述本体形成一端开口的袋体，且所述袋体的开口方向与所述本体的开口方向相同。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述膜片为环绕所述本体内表面的环形结构，所述膜片包括第一端及与所述第一端相对设置的第二端，所述第一端与所述本体的内表面密封连接，所述第二端设置至少两个沿周向分布的固定部，所述固定部与所述本体的内表面固定连接，以形成所述第二端开口的所述袋体。
  3. 根据权利要求2所述的覆膜支架，其特征在于，所述固定部与所述本体内表面的固定面为点状。
  4. 根据权利要求2所述的覆膜支架，其特征在于，所述固定部从所述膜片的所述第二端延伸至所述第一端。
  5. 根据权利要求3或4任一所述的覆膜支架，其特征在于，所述固定部通过缝线与所述本体内表面固定连接。
  6. 根据权利要求2所述的覆膜支架，其特征在于，所述膜片的所述第一端的周长等于或接近所述本体与所述膜片连接处的周长，所述膜片的所述第二端的周长大于所述本体与所述膜片固定处的周长。
  7. 根据权利要求2所述的覆膜支架，其特征在于，所述膜片的所述第二端的厚度大于所述第一端的厚度。
  8. 根据权利要求1所述的覆膜支架，其特征在于，所述膜片包括第一端、与所述第一端相对设置的第二端及连接所述第一端与所述第二端之间的两个相对设置的侧边，所述膜片的所述第一端及两个所述侧边分别与所述本体的内表面密封连接，以形成所述第二端开口的所述袋体。
  9. 根据权利要求8所述的覆膜支架，其特征在于，所述膜片为多个，多个 所述膜片沿所述本体的内表面的周向均匀分布，且多个所述膜片的所述第一端位于垂直于所述本体的轴线的同一圆周面上。
  10. 根据权利要求8所述的覆膜支架，其特征在于，所述膜片的所述第二端的厚度大于所述第一端的厚度。
  11. 根据权利要求1所述的覆膜支架，其特征在于，所述膜片位于所述本体的端部，且所述袋体的开口朝向于所述本体远离所述膜片的一端。
  12. 根据权利要求1所述的覆膜支架，其特征在于，所述膜片远离开口的一端与所述本体的一端部的距离小于等于30mm。
  13. 根据权利要求1所述的覆膜支架，其特征在于，所述本体包括裸支架及覆盖在裸支架上的覆膜，所述覆膜的一端超出所述裸支架向所述本体的内表面翻折形成所述膜片。
  14. 根据权利要求1所述的覆膜支架，其特征在于，所述膜片在所述本体的轴线上的长度为4-20mm。
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