WO2018001133A1 - 覆膜支架及其制造方法 - Google Patents

覆膜支架及其制造方法 Download PDF

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Publication number
WO2018001133A1
WO2018001133A1 PCT/CN2017/089021 CN2017089021W WO2018001133A1 WO 2018001133 A1 WO2018001133 A1 WO 2018001133A1 CN 2017089021 W CN2017089021 W CN 2017089021W WO 2018001133 A1 WO2018001133 A1 WO 2018001133A1
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WIPO (PCT)
Prior art keywords
stent graft
film
fibers
stent
fiber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/CN2017/089021
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English (en)
French (fr)
Inventor
夏顺
邢智凯
刘梦钦
袁振宇
朱清
李中华
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MICROPORT ENDOVASCULAR (SHANGHAI) Co Ltd
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MICROPORT ENDOVASCULAR (SHANGHAI) Co Ltd
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Priority to EP17819130.0A priority Critical patent/EP3476369B1/en
Publication of WO2018001133A1 publication Critical patent/WO2018001133A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof

Definitions

  • the present invention relates to the field of medical device technology, and in particular, to a stent graft and a method of manufacturing the same.
  • stents coated with ePTFE expanded polytetrafluoroethylene
  • ePTFE expanded polytetrafluoroethylene
  • advantages include excellent biocompatibility and superslip.
  • Indications for this type of stent graft include peripheral vascular embolization, aortic and branch dissection, aortic and branch true aneurysms, aortic and branch pseudoaneurysms, aortic and branch penetrating ulcers. This technique greatly reduces operative mortality and postoperative complications, reduces surgical trauma, and recovers patients faster.
  • the mechanism is to spread the stent graft after being sent to the lesion through a special delivery system, to open the blood vessel blocked by the thrombus or to isolate the tumor from the blood, to eliminate the risk of death caused by the bleeding of the aneurysm, or the tumor. Compression of surrounding tissues and organs.
  • Gore Viabahn in foreign countries, Bard Fluency, domestic Aegis, Ankura and so on.
  • the stent graft installation method usually adopts squeeze push or squeeze pull to enter the transport system, and the stent graft is released from the delivery system by pulling the stent graft or pushing the stent graft.
  • the coated stent of ePTFE-based material is very susceptible to creep under stress. This phenomenon has great limitations on the traditional installation of the stent graft.
  • the traditional installation method produces a large force on the stent graft, which causes the stent graft to be deformed, and the size is greatly deviated from the original calibration size.
  • the stent graft 1 includes a reinforcing rib 10, and the reinforcing rib 10 is connected to the bracket 11 at both ends by a small stainless steel tube. Together, the axial rigidity of the stent graft 1 can be improved to prevent shortening or elongation.
  • the present invention provides a stent graft comprising: a first film and a second film located outside the first film, wherein the first film and the second film Fibers and a holder are disposed between the films, and the fibers, the first film, and the second film are fixed to the holder.
  • the material of the fiber is ePTFE, PTFE or FEP.
  • the thickness of the fibers along the radial direction of the stent graft is smaller than the width of the fibers along the circumferential direction of the stent graft.
  • the number of the fibers is plural, each of the fibers is parallel to the axis of the stent graft, and a plurality of fibers are distributed along the circumferential direction of the stent graft. .
  • the number of the fibers is one or more, and each of the fibers is spirally wound along an axial direction of the stent graft.
  • the plurality of fibers are twisted in the same direction or in the opposite direction, and each of the fibers is clamped to the axis of the stent graft.
  • the angle is the same.
  • the fiber is located in the first film and the branch Between the shelves, the fibers are inserted into the holder and/or the fibers are positioned between the holder and the second film.
  • the materials of the first film and the second film are both ePTFE.
  • the invention also provides a method for manufacturing a stent graft, comprising:
  • a styling process is performed on the stent graft and removed from the liner.
  • the material of the fiber is ePTFE, PTFE or FEP.
  • the thickness of the fiber along the radial direction of the stent graft is smaller than the width of the fiber along the circumferential direction of the stent graft.
  • the number of the fibers is plural, each fiber is parallel to the axis of the stent graft, and a plurality of fibers are along the circumferential direction of the stent graft. distributed.
  • the number of the fibers is one or more, and each fiber is spirally wound along the axial direction of the stent graft.
  • the plurality of fibers are twisted in the same direction or in the opposite direction, and each fiber has the same angle with the axis of the core. .
  • the forming the fiber and the stent outside the first film comprises:
  • a bracket is disposed on the first film jacket
  • a bracket is disposed on the first film jacket
  • the fibers are laid outside the stent.
  • the method further includes:
  • a pressure tube is disposed on the dustproof membrane.
  • the materials of the first film and the second film are both ePTFE.
  • the invention also provides a method for manufacturing a stent graft, the method for manufacturing the stent graft comprising:
  • a first film and a second film are formed on the inner side and the outer side of the fiber and the holder, respectively.
  • the first film and the second film are respectively formed on the inner side and the outer side of the fiber and the stent by an electrospinning process.
  • the fibers are disposed in the two layers of the film, and the fiber stent has better flexibility and higher strength, so that the film stent can have better flexibility.
  • high strength effectively preventing creep of the stent graft, and has little effect on the outer diameter of the stent graft, and is more conducive to loading into the delivery system, including maintaining the product in a non-destructive state during loading and release.
  • Great help and the possibility to install the stent into a smaller gauge catheter, and further provide more room for the operability of the doctor's surgery.
  • Figure 1 is a schematic view showing the structure of a conventional stent graft
  • FIG. 2 is a schematic cross-sectional structural view of a stent graft according to a first embodiment of the present invention
  • Figure 3 is a front elevational view showing the stent graft of the first embodiment of the present invention.
  • FIG. 4 is a schematic view showing a state of use of the stent graft according to the first embodiment of the present invention
  • Figure 5 is a schematic view showing another use state of the stent graft according to the first embodiment of the present invention.
  • FIG. 6 is a schematic flow chart showing a method of manufacturing a stent graft according to a first embodiment of the present invention
  • Figure 7 is a front elevational view showing a stent graft according to a third embodiment of the present invention.
  • Fig. 8 is a front elevational view showing the stent graft of the fourth embodiment of the present invention.
  • FIG. 2 is a schematic cross-sectional view of a stent graft according to a first embodiment of the present invention
  • FIG. 3 is a front elevational view of the stent graft according to the first embodiment of the present invention.
  • the stent graft 2 includes: a first film 20 and a second film 23 located outside the first film 20, wherein the first film A fiber 21 and a bracket 22 are disposed between the 20 and the second film 23, and the fiber 21, the first film 20, and the second film 23 are fixed to the bracket 22.
  • the materials of the first film 20 and the second film 23 are both ePTFE
  • the bracket 22 is a metal bracket.
  • the fibers 21 are located between the first film 20 and the bracket 22, that is, the fibers 21 are located inside the bracket (side).
  • the material of the fiber 21 is ePTFE, PTFE or FEP.
  • the fiber 21 has a flat structure, that is, the thickness of the fiber 21 along the radial direction of the stent graft 2 is small. The width of the fiber 21 along the circumferential direction of the stent graft 2.
  • the film holder 2 can be combined with the better flexibility and higher strength of the fibers 21. Better flexibility and higher strength. Further, the fiber 21 has a flat structure, whereby the stent graft 2 can have a small outer diameter, thereby making the stent graft 2 easy to use.
  • the number of the fibers 21 is plural, and each of the fibers 21 is parallel to the axis of the stent graft 2, and a plurality of fibers 21 are along the coating.
  • the circumference of the stent 2 is evenly distributed. Thereby, the stent graft 2 can be made to have better flexibility and higher strength everywhere.
  • FIG. 4 and FIG. 5 are schematic diagrams showing the use state of the stent graft according to the first embodiment of the present invention.
  • the stent graft 2 is placed in the delivery catheter 3 and then delivered by the delivery catheter 3 to a place where the stent graft 2 is to be placed, such as the iliac artery 4 embolization, followed by The stent graft 2 can be released.
  • the first embodiment further provides a method for manufacturing the above-mentioned stent graft 2.
  • FIG. 6 is a schematic flow chart of a method for manufacturing a stent graft according to a first embodiment of the present invention.
  • the stent graft 2 can be manufactured by the following method:
  • step S10 is performed to coat the first film on a core.
  • the material of the first film is ePTFE, which may be coated with one or more layers as needed; meanwhile, the thickness of the first film may also be adjusted accordingly.
  • the size of the core can be selected according to the inner (straight) diameter of the stent graft to be manufactured. For example, if a stent graft having an inner diameter of 16 mm is required, a cylinder having a diameter of 16 mm can be selected.
  • the structure acts as a core.
  • the core may be first cleaned with alcohol to ensure the cleanliness of the core. Among them, the alcohol can be selected to have a concentration of 75% alcohol. After cleaning the core, the core Allow to dry for a while until dry.
  • a dust-proof film is coated on the core before the first film is wrapped, so that the cleanliness of the core can be further improved, thereby improving the prepared The quality of the stent graft.
  • the dustproof film may be aluminum foil paper, tin foil paper or silver foil paper.
  • step S11 is performed to form fibers and supports outside the first film.
  • the fiber is located in the bracket (ie, between the first film and the bracket), and therefore, forming the fiber and the bracket outside the first film specifically includes the following two steps: Laying the fibers outside the first film; and providing a bracket on the fiber jacket. specific:
  • the material of the fiber is ePTFE, PTFE or FEP.
  • the fibers may be laid one or more layers; at the same time, the thickness of the fibers may also be adjusted accordingly.
  • the fibers may be laid flat or multi-layered, and the laying density and thickness may be correspondingly larger;
  • the fiber can be laid only one layer or the number of laid, the laying density, The thickness can be correspondingly small.
  • the fibers are of a flat structure so that the resulting stent graft has a smaller outer diameter/volume.
  • the number of the fibers is plural, wherein a plurality of fibers are evenly distributed in the circumferential direction of the core, that is, along the circumferential direction of the core (in the first film).
  • the outer side is laid with fibers while the fibers extend along the axial direction of the core. That is, the plurality of fibers are parallel to the axis of the core.
  • a length of the coated stent to be manufactured is 15 cm
  • a width ie, a width of the fiber along the circumference of the core
  • a thickness ie, the fiber edge
  • the thickness of the core in the radial direction is 0.02 mm, and then uniformly laid along the circumferential direction of the core. It can be seen that the interval between each adjacent two fibers is 60 degrees.
  • the material of the bracket may be stainless steel, Cobalt-chromium alloy, nickel-titanium alloy, etc., or other materials that meet biocompatibility and mechanical properties.
  • the corrugated skeleton can be made of a wire of a material such as stainless steel, cobalt chrome alloy or nickel titanium alloy; then the scaffold having the wavy skeleton is sleeved outside the fiber.
  • the waveform skeleton can be processed in advance, and it can be used as a stocking. When manufacturing a stent graft, a stent having a suitable wave skeleton can be directly used.
  • step S12 is performed to coat the second film on the outside of the fiber and the stent to form a stent graft.
  • the second film may be coated with one or more layers as needed; meanwhile, the thickness of the second film may also be adjusted accordingly.
  • step S13 is performed to perform a shaping process on the stent graft and remove it from the liner.
  • the coating stent is heat-treated to achieve shaping of the stent graft; in other embodiments of the present application, high pressure heat treatment, vacuum extrusion treatment or adhesive may also be used. Processing achieves shaping of the stent graft. More preferably, before the shaping treatment is performed on the stent graft, a dustproof membrane is wrapped on the outer surface of the stent graft; and a pressure tube is disposed on the dustproof membrane.
  • aluminum foil paper, tin foil paper or silver foil paper can be selected as the dustproof film, and a PTFE heat-shrinkable tube or the like is selected as the pressure tube.
  • the condition for heat-treating the stent graft may be: heat treatment in an oven at a temperature of 350 ° C to 400 ° C for 10 minutes to 15 minutes.
  • the coating film holder is prevented from being contaminated with dust or the like by coating the dust-proof film on the outside of the film-covered stent, thereby improving the quality and reliability of the stent-covered stent;
  • the jacket is provided with a pressure tube, so that the stent graft can be uniformly pressed during the setting (curing) process, thereby improving the quality and reliability of the stent graft.
  • a stent graft having better flexibility and higher strength can be obtained. After the stent graft is removed from the liner, the stent graft can be used freely.
  • the difference between the second embodiment and the first embodiment is that, in the first embodiment, the fiber 21 is located in the first film 20 and the bracket 22. In the second embodiment, the fiber 21 is inserted into the bracket 22, and at this time, Often the fibers 21 are partially located within the stent 22 and partially outside of the stent 22, i.e., the fibers 21 are interdigitated with the stent 22. Therefore, correspondingly, the fiber laying method in the second embodiment differs from the fiber laying method in the first embodiment.
  • forming the fiber and the bracket outside the first film specifically includes the following steps: providing a bracket on the first film; and inserting fibers into the bracket.
  • the bracket includes a plurality of bracket rings (waveform skeletons), and the plurality of bracket rings are sequentially arranged coaxially, and the fibers may be located inside the first bracket ring, outside the second bracket ring, and the third bracket ring The inside is interspersed in such a way that the fibers are interspersed inside and outside (or up and down) in the stent.
  • the fibers 21 may also be located outside (side) of the stent 22, i.e., the fibers 21 are located between the stent 22 and the second membrane 23.
  • Forming the fibers and the support outside the first film specifically includes the following steps: laying a bracket on the first film; and laying fibers outside the bracket.
  • FIG. 7 is a front view of a stent graft according to a third embodiment of the present invention.
  • the stent graft 5 includes: a first film (not shown in FIG. 7) and a second film (not shown in FIG. 7) outside the first film, wherein A fiber 51 and a bracket 52 are disposed between the first film and the second film, and both ends of the fiber 51 are connected to both ends of the bracket 52.
  • the materials of the first film and the second film are both ePTFE
  • the bracket 52 is a cobalt chromium alloy bracket.
  • the difference between the third embodiment and the first embodiment is that in the first embodiment, a plurality of fibers are laid on the outside of the first film, each fiber is parallel to the axis of the core, and a plurality of fibers are evenly distributed in the The circumferential direction of the core is described; and in the third embodiment, a plurality of fibers are wound around the first film, that is, the plurality of fibers are spirally wound along the axial direction of the core.
  • the fiber laying method is also different from the fiber laying method in the first embodiment.
  • laying the fiber outside the first film comprises: winding a plurality of fibers outside the first film, and the plurality of fibers are wound in the same direction, and each fiber and the axis of the core The angle is the same.
  • each fiber has an angle of 45 with the axis of the core.
  • a fiber may be wound around the first film.
  • the angle between the fiber and the axis of the core may be 45°.
  • the number of the fibers is preferably plural; when the strength/tensile resistance of the obtained stent graft is obtained The creep performance is not required, and when the flexibility is required to be high, the number of the fibers is preferably one.
  • FIG. 8 is a front view of a stent graft according to a fourth embodiment of the present invention.
  • the stent graft 6 includes: a first film (not shown in FIG. 8) and a second film (not shown in FIG. 8) outside the first film, wherein A fiber 61 and a bracket 62 are disposed between the first film and the second film, and both ends of the fiber 61 are connected to both ends of the bracket 62.
  • the materials of the first film and the second film are both ePTFE
  • the bracket 62 is a nickel-titanium alloy bracket.
  • the difference between the fourth embodiment and the third embodiment is that in the third embodiment, a plurality of fibers are wound around the first film, and the plurality of fibers are wound in the same direction, and each fiber has the same angle with the axis of the core. In the fourth embodiment, a plurality of fibers are wound around the first film, and the plurality of fibers are reversely wound, and each of the fibers has the same angle with the axis of the core.
  • both fibers are wound around the first film.
  • both fibers are wound from the upper right corner of the core; in the fourth embodiment, one fiber is wound from the upper right corner of the core, and the other fiber is from the upper left corner of the core. Circling. Thereby, the same direction winding and the reverse winding are realized respectively.
  • the stent graft can also be fabricated by the following process, specifically The method comprises: fixing the fiber to the bracket; forming a first film and a second film on the inner side and the outer side of the fiber and the bracket, respectively. Wherein, the first film and the second film are respectively formed on the inner side and the outer side of the fiber and the support by an electrospinning process.
  • the fibers are laid in the two layers of the film, and the coated stent can be combined with the better flexibility and high strength of the fiber. It has better flexibility and higher strength, effectively prevents creep of the stent graft, and has little influence on the outer diameter of the stent graft, and is also more suitable for loading into the delivery system.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Laminated Bodies (AREA)

Abstract

一种覆膜支架(2)及其制造方法，其中，覆膜支架(2)包括：第一薄膜(20)及位于第一薄膜(20)外的第二薄膜(23)，其中，第一薄膜(20)和第二薄膜(23)之间设置有纤维(21)和支架(22)，且纤维(21)、第一薄膜(20)和第二薄膜(23)固定于支架(22)上。覆膜支架(2)的制造方法包括：在一衬芯上裹覆第一薄膜(20)(S10)；在第一薄膜(20)外形成纤维(21)和支架(22)(S11)；在纤维(21)和支架(22)外裹覆第二薄膜(23)，形成覆膜支架(2)(S12)；及对覆膜支架(2)执行定型处理并从衬芯上取下(S13)。在覆膜支架(2)及其制造方法中，在两层薄膜(20，23)中设置有纤维(21)，利用纤维(21)较佳的柔顺性和较高的强度而使得覆膜支架(2)能兼具较佳的柔顺性和较高的强度。

Description

覆膜支架及其制造方法 技术领域
本发明涉及医疗器械技术领域，特别涉及一种覆膜支架及其制造方法。
背景技术
覆膜采用ePTFE(膨体聚四氟乙烯)类材料的覆膜支架近年来被广泛认可用于植入医疗器械领域，其优点包括优异的生物相容性和超滑性。该类型覆膜支架适应症包括外周血管栓塞、主动脉及分支夹层、主动脉及分支真性动脉瘤、主动脉及分支假性动脉瘤、主动脉及分支穿透性溃疡等。这种技术大大降低了手术死亡率以及术后并发症、减轻了手术创伤、患者恢复也较快。其机理是将覆膜支架，通过特制的输送系统送入病变部位后张开，撑开被血栓堵塞的血管或者使瘤体与血液隔绝，消除动脉瘤破裂大出血引起死亡的危险，或是瘤体对周围组织、器官的压迫。目前国内外已有成熟的产品，例如国外的Gore Viabahn，Bard Fluency，国内的Aegis，Ankura等等。
目前覆膜支架安装方式通常采用挤压推入或者挤压拉入方式进入到输送系统，并通过后拉覆膜支架或者前推覆膜支架的方式将覆膜支架从输送系统释放。但ePTFE类材料的覆膜支架在受力的情况下，非常容易产生蠕变现象。该现象对覆膜支架的传统安装方式有很大的限制。传统安装方式对覆膜支架会产生较大的力，从而导致覆膜支架变形，尺寸与原先标定尺寸出现较大偏差。
为此，目前市场上的产品，更为普遍的是牺牲覆膜支架本身的柔顺性，通过更改覆膜支架结构，如设计成“加强筋”形式增加安装性，“加强筋”通常为镍钛合金丝，连接支架首尾两端。如图1所示，覆膜支架1中包括加强筋10，并且加强筋10在两端通过一个很小的不锈钢管与支架11连接 在一起，能提高覆膜支架1轴向刚性，防止短缩或拉长。但是由此将造成覆膜支架没有足够的柔顺性，对其应用适应症有了很大的限制，如无法用于迂曲血管。另外加强筋的存在也给覆膜支架增大了体积，不利于装载。
因此，如何提供一种覆膜支架，其既具有较佳的柔顺性、又具有较高的强度成了本领域技术人员亟待解决的技术难题。
发明内容
本发明的目的在于提供一种覆膜支架及其制造方法，以解决现有技术中的覆膜支架不能兼具较佳的柔顺性和较高的强度的问题。
为解决上述技术问题，本发明提供一种覆膜支架，所述覆膜支架包括：第一薄膜及位于所述第一薄膜外的第二薄膜，其中，所述第一薄膜和所述第二薄膜之间设置有纤维和支架，且所述纤维、所述第一薄膜和所述第二薄膜固定于所述支架上。
可选的，在所述的覆膜支架中，所述纤维的材料为ePTFE、PTFE或者FEP。
可选的，在所述的覆膜支架中，所述纤维沿所述覆膜支架径向的厚度小于所述纤维沿所述覆膜支架周向的宽度。
可选的，在所述的覆膜支架中，所述纤维的数量为多根，每根所述纤维与所述覆膜支架的轴线平行，多根纤维沿所述覆膜支架的周向分布。
可选的，在所述的覆膜支架中，所述纤维的数量为一根或者多根，每根所述纤维沿所述覆膜支架的轴向旋绕。
可选的，在所述的覆膜支架中，当所述纤维的数量为多根时，多根所述纤维同向或者逆向旋绕，每根所述纤维与所述覆膜支架的轴线的夹角相同。
可选的，在所述的覆膜支架中，所述纤维位于所述第一薄膜和所述支 架之间、所述纤维穿插于所述支架中和/或所述纤维位于所述支架和所述第二薄膜之间。
可选的，在所述的覆膜支架中，所述第一薄膜和所述第二薄膜的材料均为ePTFE。
本发明还提供一种覆膜支架的制造方法，包括：
在一衬芯上裹覆第一薄膜；
在所述第一薄膜外形成纤维和支架；
在所述纤维和支架外裹覆第二薄膜，形成覆膜支架；及
对所述覆膜支架执行定型处理并从所述衬芯上取下。
可选的，在所述的覆膜支架的制造方法中，所述纤维的材料为ePTFE、PTFE或者FEP。
可选的，在所述的覆膜支架的制造方法中，所述纤维沿所述覆膜支架径向的厚度小于所述纤维沿所述覆膜支架周向的宽度。
可选的，在所述的覆膜支架的制造方法中，所述纤维的数量为多根，每根纤维与所述覆膜支架的轴线平行，多根纤维沿所述覆膜支架的周向分布。
可选的，在所述的覆膜支架的制造方法中，所述纤维的数量为一根或者多根，每根纤维沿所述覆膜支架的轴向旋绕。
可选的，在所述的覆膜支架的制造方法中，当所述纤维的数量为多根时，多根纤维同向或者逆向旋绕，每根纤维与所述衬芯的轴线的夹角相同。
可选的，在所述的覆膜支架的制造方法中，在所述第一薄膜外形成纤维和支架包括：
在所述第一薄膜外铺设纤维；及
在所述纤维外套设支架；
或者，在所述第一薄膜外套设支架；及
在所述支架中铺设纤维；
或者，在所述第一薄膜外套设支架；及
在所述支架外铺设纤维。
可选的，在所述的覆膜支架的制造方法中，在对所述覆膜支架执行定型处理之前，还包括：
在所述覆膜支架外裹覆防尘膜；及
在所述防尘膜外套设压力管。
可选的，在所述的覆膜支架的制造方法中，所述第一薄膜和所述第二薄膜的材料均为ePTFE。
本发明还提供一种覆膜支架的制造方法，所述覆膜支架的制造方法包括：
将纤维固定于支架上；
在所述纤维和支架的内侧和外侧分别形成第一薄膜和第二薄膜。
可选的，在所述的覆膜支架的制造方法中，通过静电纺工艺在所述纤维和支架的内侧和外侧分别形成第一薄膜和第二薄膜。
在本发明提供的覆膜支架及其制造方法中，在两层薄膜中设置有纤维，利用纤维较佳的柔顺性和较高的强度而使得所述覆膜支架能兼具较佳的柔顺性和较高的强度，有效防止覆膜支架产生蠕变现象，并且对覆膜支架外径的影响很小，也更利于装载至输送系统中，包括对产品在装载和释放过程中保持无损状态有很大帮助，以及为将支架安装进入更小规格的导管中提供可能性，并进一步为医生手术的可操作性提供更大的空间。
附图说明
图1是现有的覆膜支架的结构示意图；
图2是本发明实施例一的覆膜支架的剖面结构示意图；
图3是本发明实施例一的覆膜支架的主视示意图；
图4是本发明实施例一的覆膜支架的一使用状态示意图；
图5是本发明实施例一的覆膜支架的另一使用状态示意图；
图6是本发明实施例一的覆膜支架的制造方法的流程示意图；
图7是本发明实施例三的覆膜支架的主视示意图；
图8是本发明实施例四的覆膜支架的主视示意图。
具体实施方式
以下结合附图和具体实施例对本发明提出的覆膜支架及其制造方法作进一步详细说明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。特别的，由于各附图所要突出的内容不同，往往采用了不同的比例。
【实施例一】
请参考图2和图3，其中，图2为本发明实施例一的覆膜支架的剖面结构示意图；图3为本发明实施例一的覆膜支架的主视示意图。如图2和图3所示，在本实施例一中，所述覆膜支架2包括：第一薄膜20及位于所述第一薄膜20外的第二薄膜23，其中，所述第一薄膜20和所述第二薄膜23之间设置有纤维21和支架22，且所述纤维21、所述第一薄膜20和所述第二薄膜23固定于所述支架22上。在本申请实施例中，所述第一薄膜20和所述第二薄膜23的材料均为ePTFE，所述支架22为金属支架。
请继续参考图2和图3，在本申请实施例中，所述纤维21位于所述第一薄膜20和所述支架22之间，也即所述纤维21位于所述支架内(侧)。
优选的，所述纤维21的材料为ePTFE、PTFE或者FEP。进一步的，所述纤维21为扁平结构，即所述纤维21沿所述覆膜支架2径向的厚度小 于所述纤维21沿所述覆膜支架2周向的宽度。
在此，通过在两层薄膜(即第一薄膜20和第二薄膜23)中设置有纤维21，利用纤维21较佳的柔顺性和较高的强度而使得所述覆膜支架2能兼具较佳的柔顺性和较高的强度。进一步的，所述纤维21为扁平结构，由此可以使得所述覆膜支架2具有较小的外径，进而使得所述覆膜支架2易于被使用。
请继续参考图2和图3，在本申请实施例中，所述纤维21的数量为多根，每根纤维21与所述覆膜支架2的轴线平行，多根纤维21沿所述覆膜支架2的周向均匀地分布。由此，能够使得所述覆膜支架2各处均具有较佳的柔顺性和较高的强度。
请接着参考图4和图5，其为本发明实施例一的覆膜支架的使用状态示意图。如图4和图5所示，使用时，所述覆膜支架2放入到输送导管3中，然后由输送导管3输送至需要设置覆膜支架2的地方，例如髂动脉4栓塞处，接着释放所述覆膜支架2即可。
相应的，本实施例一还提供一种上述覆膜支架2的制造方法。请参考图6，其为本发明实施例一的覆膜支架的制造方法的流程示意图。如图6所示，具体的，所述覆膜支架2可通过如下方法制造：
首先，执行步骤S10，在一衬芯上裹覆第一薄膜。其中，所述第一薄膜的材料为ePTFE，其可以根据需要裹覆一层或者多层；同时，所述第一薄膜的厚度也可根据需要进行相应的调整。
在本申请实施例中，所述衬芯的尺寸可根据待制造的覆膜支架的内(直)径选取，例如，需要制造内径为16mm的覆膜支架，则可选取直径为16mm的圆柱体结构作为衬芯。优选的，在所述衬芯上裹覆第一薄膜之前，可先用酒精对所述衬芯进行清洗，以保证所述衬芯的清洁度。其中，所述酒精可以选取浓度为75％的酒精。在清洗完所述衬芯后，将所述衬芯 晾晒一段时间，直至干燥。更优选的，在酒精清洗衬芯之后，裹覆第一薄膜之前，先在所述衬芯上裹覆一防尘膜，从而可进一步提高所述衬芯的清洁度，进而提高所制得的覆膜支架的质量。其中，所述防尘膜可以是铝箔纸、锡箔纸或者银箔纸等。
其次，执行步骤S11，在所述第一薄膜外形成纤维和支架。在本申请实施例中，所述纤维位于所述支架内(即位于所述第一薄膜和支架之间)，因此，在所述第一薄膜外形成纤维和支架具体包括如下两个步骤：在所述第一薄膜外铺设纤维；及在所述纤维外套设支架。具体的：
首先，在所述第一薄膜外铺设纤维。优选的，所述纤维的材料为ePTFE、PTFE或者FEP。其中，所述纤维可以铺设一层或者多层；同时，所述纤维的厚度也可根据需要进行相应的调整。通常的，当对制得的覆膜支架的强度/抗拉抗蠕变性能有较高要求时，所述纤维可以平铺多根或者铺设多层，其铺设密度、厚度可以相应较大；当对制得的覆膜支架的强度/抗拉抗蠕变性能的要求不高，同时对其柔顺性要求较高时，所述纤维可以仅铺设一层或减少铺设的根数，其铺设密度、厚度可以相应较小。
较佳的，所述纤维为扁平结构，从而可以使制得的覆膜支架具有较小的外径/体积。
在本实施例一中，所述纤维的数量为多根，其中，多根纤维均匀地分布于所述衬芯的周向，即沿着所述衬芯的周向(在所述第一薄膜外侧)铺设纤维，同时所述纤维沿着所述衬芯的轴向延伸。也即多根纤维均与所述衬芯的轴线平行。例如，取六根纤维，每根纤维长15cm(即需要制造的覆膜支架的长度为15cm)、宽(即所述纤维沿所述衬芯周向的宽度)1mm、厚(即所述纤维沿所述衬芯径向的厚度)0.02mm，然后沿着所述衬芯的周向均匀铺设，可知，每相邻两根纤维之间的间隔为60度。
接着，在所述纤维外套设支架。其中，所述支架的材料可以为不锈钢、 钴铬合金、镍钛合金等，或者其它符合生物相容性及力学性能要求的材料。具体的，可先用不锈钢、钴铬合金或者镍钛合金等材料的丝制成波形骨架；然后将具有波形骨架的支架套设于纤维外。通常的，所述波形骨架可提前加工好，作为备货使用，在制造覆膜支架时，直接选用具有合适的波形骨架的支架即可。接着，执行步骤S12，在所述纤维和支架外裹覆第二薄膜，形成覆膜支架。其中，所述第二薄膜可以根据需要裹覆一层或者多层；同时，所述第二薄膜的厚度也可根据需要进行相应的调整。
最后，执行步骤S13，对所述覆膜支架执行定型处理并从所述衬芯上取下。在本申请实施例中，通过对所述覆膜支架进行热处理以实现对所述覆膜支架的定型；在本申请的其他实施例中，也可以通过高压热处理、真空挤压处理或者粘合剂处理实现对所述覆膜支架的定型。更优的，在对所述覆膜支架执行定型处理之前，在所述覆膜支架外裹覆防尘膜；及在所述防尘膜外套设压力管。具体的，可以选取铝箔纸、锡箔纸或者银箔纸等作为防尘膜，选取PTFE热缩管等作为压力管。其中，对所述覆膜支架进行热处理的条件可以为：在温度为350℃～400℃的烘箱中热处理10分钟～15分钟。在本申请实施例中，通过在所述覆膜支架外裹覆防尘膜可以防止所示覆膜支架沾染灰尘等，提高所述覆膜支架的质量与可靠性；通过在所述防尘膜外套设压力管，可以使得所述覆膜支架在定型(固化)过程中受压均匀，从而提高所述覆膜支架的质量与可靠性。
通过上述过程便可得到兼具较佳的柔顺性和较高的强度的覆膜支架。在从所述衬芯上将所述覆膜支架取下后，便可自由地使用所述覆膜支架。
【实施例二】
在本实施例二中，可同样参考图2和图3，本实施例二与实施例一的差别在于，在实施例一中，所述纤维21位于所述第一薄膜20和所述支架22之间；而在本实施例二中，所述纤维21穿插于所述支架22中，此时，通 常所述纤维21部分位于所述支架22内、部分位于所述支架22外，即所述纤维21与所述支架22交错。由此，相应的，本实施例二中的纤维铺设方法也与实施例一中的纤维铺设方法存在差别。
在本申请实施例二中，在所述第一薄膜外形成纤维和支架具体包括如下两个步骤：在所述第一薄膜外套设支架；及在所述支架中穿插纤维。在此，所述支架包括多个支架圈(波形骨架)，多个支架圈依次同轴排列，所述纤维可以按照位于第一个支架圈内侧、第二个支架圈外侧、第三个支架圈内侧……的方式进行穿插，即所述纤维内外(或者说上下)起伏的在所述支架中穿插。
在此，同样能够得到兼具较佳的柔顺性和较高的强度的覆膜支架。
此外，在本申请的其他实施例中，所述纤维21也可以位于所述支架22外(侧)，即所述纤维21位于所述支架22和所述第二薄膜23之间。则在所述第一薄膜外形成纤维和支架具体包括如下两个步骤：在所述第一薄膜外套设支架；及在所述支架外铺设纤维。
【实施例三】
请参考图7，其为本发明实施例三的覆膜支架的主视示意图。如图7所示，所述覆膜支架5包括：第一薄膜(图7中未示出)及位于所述第一薄膜外的第二薄膜(图7中未示出)，其中，所述第一薄膜和所述第二薄膜之间设置有纤维51和支架52，所述纤维51的两端连接所述支架52的两端。在本申请实施例中，所述第一薄膜和所述第二薄膜的材料均为ePTFE，所述支架52为钴铬合金支架。
本实施例三与实施例一的差别在于，在实施例一中，在第一薄膜外平铺有多根纤维，每根纤维与所述衬芯的轴线平行，多根纤维均匀地分布于所述衬芯的周向；而在本实施例三中，在第一薄膜外旋绕有多根纤维，即所述多根纤维沿所述衬芯的轴向螺旋缠绕。由此，相应的，本实施例三中 的纤维铺设方法也与实施例一中的纤维铺设方法存在差别。
具体的，在本实施例三中，在所述第一薄膜外铺设纤维包括：在所述第一薄膜外旋绕多根纤维，多根纤维同向旋绕，每根纤维与所述衬芯的轴线的夹角相同。优选的，每根纤维与所述衬芯的轴线的夹角为45°。
此外，在本申请的其他实施例中，也可以在第一薄膜外旋绕一根纤维，同样的，该一根纤维与所述衬芯的轴线的夹角也可以为45°。
通常的，当对制得的覆膜支架的强度/抗拉抗蠕变性能有较高要求时，所述纤维的数量优选为多根；当对制得的覆膜支架的强度/抗拉抗蠕变性能的要求不高，同时对其柔顺性要求较高时，所述纤维的数量优选为一根。
【实施例四】
请参考图8，其为本发明实施例四的覆膜支架的主视示意图。如图8所示，所述覆膜支架6包括：第一薄膜(图8中未示出)及位于所述第一薄膜外的第二薄膜(图8中未示出)，其中，所述第一薄膜和所述第二薄膜之间设置有纤维61和支架62，所述纤维61的两端连接所述支架62的两端。在本申请实施例中，所述第一薄膜和所述第二薄膜的材料均为ePTFE，所述支架62为镍钛合金支架。
本实施例四与实施例三的差别在于，在实施例三中，在第一薄膜外旋绕有多根纤维，多根纤维同向旋绕，每根纤维与所述衬芯的轴线的夹角相同；而在本实施例四中，在第一薄膜外旋绕有多根纤维，多根纤维逆向旋绕，每根纤维与所述衬芯的轴线的也夹角相同。
例如，在实施例三与实施例四中，均在第一薄膜外旋绕有两根纤维。在实施例三中，两根纤维均自衬芯的右上角开始旋绕；而在本实施例四中，一根纤维自衬芯的右上角开始旋绕，另一根纤维自衬芯的左上角开始旋绕。从而分别实现了同向旋绕与逆向旋绕。
在本申请的其他实施例中，还可以通过如下工艺制作覆膜支架，具体 包括：将纤维固定于支架上；在所述纤维和支架的内侧和外侧分别形成第一薄膜和第二薄膜。其中，在所述纤维和支架的内侧和外侧分别形成第一薄膜和第二薄膜通过静电纺工艺实现。
综上可见，在本发明实施例提供的覆膜支架及其制造方法中，在两层薄膜中铺设有纤维，利用纤维较佳的柔顺性和较高的强度而使得所述覆膜支架能兼具较佳的柔顺性和较高的强度，有效防止覆膜支架产生蠕变现象，并且对覆膜支架外径的影响很小，也更利于装载至输送系统中。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (19)

  1. 一种覆膜支架，其特征在于，所述覆膜支架包括：第一薄膜及位于所述第一薄膜外的第二薄膜，其中，所述第一薄膜和所述第二薄膜之间设置有纤维和支架，且所述纤维、所述第一薄膜和所述第二薄膜固定于所述支架上。
  2. 如权利要求1所述的覆膜支架，其特征在于，所述纤维的材料为ePTFE、PTFE或者FEP。
  3. 如权利要求1所述的覆膜支架，其特征在于，所述纤维沿所述覆膜支架径向的厚度小于所述纤维沿所述覆膜支架周向的宽度。
  4. 如权利要求1所述的覆膜支架，其特征在于，所述纤维的数量为多根，每根所述纤维与所述覆膜支架的轴线平行，多根纤维沿所述覆膜支架的周向分布。
  5. 如权利要求1所述的覆膜支架，其特征在于，所述纤维的数量为一根或者多根，每根所述纤维沿所述覆膜支架的轴向旋绕。
  6. 如权利要求5所述的覆膜支架，其特征在于，当所述纤维的数量为多根时，多根所述纤维同向或者逆向旋绕，每根所述纤维与所述覆膜支架的轴线的夹角相同。
  7. 如权利要求1～6中任一项所述的覆膜支架，其特征在于，所述纤维位于所述第一薄膜和所述支架之间、所述纤维穿插于所述支架中和/或所述纤维位于所述支架和所述第二薄膜之间。
  8. 如权利要求1～6中任一项所述的覆膜支架，其特征在于，所述第一薄膜和所述第二薄膜的材料均为ePTFE。
  9. 一种覆膜支架的制造方法，其特征在于，包括：
    在一衬芯上裹覆第一薄膜；
    在所述第一薄膜外形成纤维和支架；
    在所述纤维和支架外裹覆第二薄膜，形成覆膜支架；及
    对所述覆膜支架执行定型处理并从所述衬芯上取下。
  10. 如权利要求9所述的覆膜支架的制造方法，其特征在于，所述纤维的材料为ePTFE、PTFE或者FEP。
  11. 如权利要求9所述的覆膜支架的制造方法，其特征在于，所述纤维沿所述覆膜支架径向的厚度小于所述纤维沿所述覆膜支架周向的宽度。
  12. 如权利要求9所述的覆膜支架的制造方法，其特征在于，所述纤维的数量为多根，每根纤维与所述覆膜支架的轴线平行，多根纤维沿所述覆膜支架的周向分布。
  13. 如权利要求9所述的覆膜支架的制造方法，其特征在于，所述纤维的数量为一根或者多根，每根纤维沿所述覆膜支架的轴向旋绕。
  14. 如权利要求13所述的覆膜支架的制造方法，其特征在于，当所述纤维的数量为多根时，多根纤维同向或者逆向旋绕，每根纤维与所述衬芯的轴线的夹角相同。
  15. 如权利要求9所述的覆膜支架的制造方法，其特征在于，在所述第一薄膜外形成纤维和支架包括：
    在所述第一薄膜外铺设纤维；及
    在所述纤维外套设支架；
    或者，在所述第一薄膜外套设支架；及
    在所述支架中铺设纤维；
    或者，在所述第一薄膜外套设支架；及
    在所述支架外铺设纤维。
  16. 如权利要求9所述的覆膜支架的制造方法，其特征在于，在对所述覆膜支架执行定型处理之前，还包括：
    在所述覆膜支架外裹覆防尘膜；及
    在所述防尘膜外套设压力管。
  17. 如权利要求9～16中任一项所述的覆膜支架的制造方法，其特征在于，所述第一薄膜和所述第二薄膜的材料均为ePTFE。
  18. 一种覆膜支架的制造方法，其特征在于，包括：
    将纤维固定于支架上；
    在所述纤维和支架的内侧和外侧分别形成第一薄膜和第二薄膜。
  19. 如权利要求18所述的覆膜支架的制造方法，其特征在于，通过静电纺工艺在所述纤维和支架的内侧和外侧分别形成第一薄膜和第二薄膜。
PCT/CN2017/089021 2016-06-28 2017-06-19 覆膜支架及其制造方法 Ceased WO2018001133A1 (zh)

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