WO2018121364A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2018121364A1
WO2018121364A1 PCT/CN2017/117298 CN2017117298W WO2018121364A1 WO 2018121364 A1 WO2018121364 A1 WO 2018121364A1 CN 2017117298 W CN2017117298 W CN 2017117298W WO 2018121364 A1 WO2018121364 A1 WO 2018121364A1
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WO
WIPO (PCT)
Prior art keywords
coating
film
stent
stent graft
covered
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PCT/CN2017/117298
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English (en)
French (fr)
Inventor
肖本好
何里明
刘彩萍
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 US16/473,359 priority Critical patent/US11273061B2/en
Priority to EP17886902.0A priority patent/EP3563809A4/en
Publication of WO2018121364A1 publication Critical patent/WO2018121364A1/zh
Priority to US17/582,343 priority patent/US20220142796A1/en

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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
    • A61F2/82—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
    • 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
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2240/001—Designing or manufacturing processes

Definitions

  • the present invention relates to the field of implantable medical devices, and more particularly to a stent graft.
  • the existing stent grafts generally adopt a single layer membrane structure or a double layer membrane structure.
  • the metal stent will be exposed to the blood, which will cause corrosion of the metal stent for a long time; the single-layer membrane structure is directly sealed with the inner wall of the blood vessel through the metal stent, and the sealing performance is not strong. And poor biocompatibility.
  • the double-layer coating structure is a structure in which the inner and outer surfaces of the metal stent are coated, and the inner and outer coatings are combined with the metal stent as a whole by high-temperature heat treatment. After the double-layered membrane structure is implanted into the body, the metal stent is prevented from being directly exposed to the blood, preventing corrosion of the metal stent and release of metal ions. Moreover, the proximal end of the stent is directly attached to the inner wall of the blood vessel through the membrane, and the sealing performance is good, and the biocompatibility is high.
  • the double-layered membrane structure combines the inner and outer membranes by heat treatment.
  • the proximal end surface and the distal end surface of the stent graft may cause tearing of the inner and outer membranes due to long-term impact of blood.
  • the tearing of the inner and outer membranes further causes the metal stent to be exposed to the blood, which accelerates the corrosion of the metal stent, thereby releasing metal ions, and the metal ions, especially the nickel ions released from the metal by the nickel-titanium metal stent. It has a carcinogenic effect.
  • the tearing of the inner and outer membranes of the proximal and distal end faces of the stent graft reduces the blood flow rate, and thrombus is easily formed at the tearing opening, and the tearing mouth increases the flow of blood to the membrane.
  • the impact of the stent increases the risk of stent displacement.
  • the technical problem to be solved by the present invention is to provide a stent graft capable of avoiding tearing of the outer and outer membranes in the proximal end surface and the distal end surface of the prior art.
  • the technical solution adopted by the present invention to solve the technical problem is to construct a stent graft having a proximal end surface, a distal end surface, and a circumferential surface between the proximal end surface and the distal end surface, the circumference
  • the surface includes an inner surface and an outer surface opposite to the inner surface, the outer surface is covered with a first coating, the inner surface is covered with a second coating, and the stent graft further comprises a first coating a stent body between the membrane and the second membrane, the stent graft further comprising a stent body disposed between the first membrane and the second membrane, the first membrane and the first At least one of the ends of the second film is folded inwardly or outwardly to wrap at least one of the proximal end face and the distal end face.
  • both ends of the first film and the second film are folded toward the inner surface and connected to the second film through the holder body.
  • both ends of the first film and the second film are folded toward the outer surface and connected to the first film through the holder body.
  • both ends of the second film are folded toward the outer surface and connected to the second film through the holder body, and two of the first film The ends are both folded toward the inner surface and connected to the second coating.
  • Another technical solution adopted by the present invention to solve the technical problem thereof is to provide a film coating method for a stent graft according to the above, comprising the following steps:
  • Another technical solution adopted by the present invention to solve the technical problem thereof is to provide a film coating method for a stent graft according to the above, comprising the following steps:
  • Another technical solution adopted by the present invention to solve the technical problem thereof is to provide a film coating method for a stent graft as described above, comprising the following steps:
  • step S3 heat-treating the stent graft in step S2 such that the proximal ends of the second membrane are adhered to the second membrane through the stent body;
  • step S6 The coated stent in step S5 is heat treated such that both ends of the first coating are bonded to the second coating.
  • the invention can prevent the blood flow directly on the inner and outer surfaces of the proximal end surface and/or the distal end surface by designing the flanging design of the film at the proximal end surface and/or the distal end surface end of the stent graft.
  • the impact avoids tearing of the inner and outer surfaces caused by long-term blood flow impact and a series of adverse effects caused by tearing of the film.
  • FIG. 1 is a schematic structural view of a first embodiment of a stent graft according to the present invention
  • Figure 2 is a cross-sectional view taken along line A-A of Figure 1;
  • FIG. 3 is a schematic structural view of a second embodiment of a stent graft according to the present invention.
  • Figure 4 is a cross-sectional view taken along line B-B of Figure 3;
  • FIG. 5 is a schematic structural view showing a third embodiment of a stent body in which only the inner surface of the stent body is covered with a second coating film according to a third embodiment of the present invention
  • Figure 6 is a cross-sectional view taken along line C-C of Figure 5;
  • Figure 7 is a schematic view showing the structure of the inner and outer surfaces of the stent body in the third embodiment of the stent graft of the present invention.
  • Figure 8 is a cross-sectional view taken along line D-D of Figure 7.
  • a stent graft 10 is a tubular structure having open ends (for forming a blood flow channel) having a proximal end face 11, a distal end face 12, and a proximal end face 11 and a distal end face 12 The circumference between the 13th.
  • the peripheral surface 13 includes an outer surface 131 on either side of the stent body 15 and an inner surface 132 opposite the outer surface 131, respectively.
  • the outer surface 131 is covered with a first coating 141 and the inner surface 132 is covered with a second coating 142.
  • the first coating 141 and the second coating 142 themselves have a certain thickness, and the material is generally made of a biocompatible polymer material such as a PET film or a PTFE film.
  • a holder main body 15 is provided between the first coating film 141 and the second coating film 142, and the first coating film 141 and the second coating film 142 are bonded by heat treatment so that the holder main body 15 is interposed therebetween.
  • the stent body 15 is formed by cutting and expanding a biocompatible plastically expanded material tube known in the art, and the material of the tube may be, for example, medical stainless steel or cobalt-rhodium alloy, or may be a self-expanding material such as nickel-titanium alloy.
  • the stent body 15 When made of a plastically expandable material, the stent body 15 can be radially compressed within the delivery sheath and can be expanded to an original shape and size by an inflatable balloon or equivalent expansion mechanism. When made of a self-expanding material, the stent body 15 can be radially compressed within the delivery sheath and restored to its original shape and size upon loss of compression of the delivery sheath.
  • the bracket body 15 may be cut from a pipe or woven by a wire.
  • both ends of the first film 141 and the second film 142 are folded inwardly (ie, in the lumen of the stent graft) and connected to the second film 142 through the stent body 15 so that The proximal end face 11 and the distal end face 12 of the stent graft 10 are wrapped.
  • the invention also provides a method for manufacturing the above-mentioned stent graft 10, comprising the following steps:
  • the first surface of the stent body 15 is covered with a first coating 141, and the inner surface 132 is covered with a second coating 142;
  • the first coating 141 and the second coating 142 folded toward the inner surface 132 are heat treated such that the coating of the portion is bonded to the second coating 142.
  • the first coating film 141 and the second coating film 142 may be ironed together as a whole by using a Luo iron, or the coating stent 10 may be heat-treated again using a heat treatment furnace. .
  • the invention can prevent the blood flow directly covering the proximal end surface and the distal end surface by designing the fluffing of the coating on the circumferential surface of the stent graft at the proximal end surface and the distal end surface of the stent graft.
  • the membrane causes impact, avoiding tearing of the inner and outer surfaces caused by long-term blood flow impact and a series of adverse effects caused by tearing of the film.
  • a stent graft 20 is a tubular structure having open ends (for forming a blood flow channel) having a proximal end face 21, a distal end face 22, and a proximal end face 21 and a distal end face 22 The circumference between the 23rd.
  • the peripheral surface 23 includes an outer surface 231 and an inner surface 232 opposite the outer surface 231.
  • the outer surface 231 is covered with a first coating 241
  • the inner surface 232 is covered with a second coating 242.
  • the first coating 241 and the second coating 242 themselves have a certain thickness, and the material is generally made of a biocompatible polymer material such as a PET film or a PTFE film.
  • a holder main body 25 is provided between the first coating film 241 and the second coating film 242, and the first coating film 241 and the second coating film 242 are bonded together by heat treatment, thereby sandwiching the holder main body 25.
  • the stent body 25 is formed by cutting and expanding a biocompatible plastic expansion material tube known in the art, and the material of the tube may be, for example, medical stainless steel or cobalt-rhodium alloy, or may be a self-expanding material such as nickel-titanium alloy. When made of a plastically expandable material, the stent body 25 can be radially compressed within the delivery sheath and can be inflated to an original shape and size by an inflatable balloon or equivalent expansion mechanism.
  • the stent body 25 When made of a self-expanding material, the stent body 25 can be radially compressed within the delivery sheath and restored to its original shape and size upon loss of compression of the delivery sheath.
  • the bracket body 25 may be cut from a pipe or may be woven by a wire.
  • both ends of the first covering film 241 and the second covering film 242 are folded outward (ie, outside the lumen of the stent graft) and connected to the first covering film 241 through the stent body 25, thereby The proximal end face 21 and the distal end face 22 of the stent graft 20 are wrapped.
  • the invention also provides a method for manufacturing the above-mentioned stent graft 20, comprising the following steps:
  • the outer surface 231 of the stent body 25 is covered with a first coating 241, and the inner surface 232 is covered with a second coating 242;
  • the first coating 241 and the second coating 242 folded over the outer surface 231 are heat treated such that the coating of the portion is bonded to the first coating 241.
  • the first film 241 and the second film 242 may be ironed together as a whole by using the iron, or the heat treatment furnace may be used to heat the film holder 20 again. .
  • a stent graft 30 is a tubular structure having open ends (for forming a blood flow channel) having a proximal end face 31, a distal end face 32, and a proximal end face 31 and a distal end face 32.
  • the peripheral surface 33 includes an outer surface 331 and an inner surface 332 opposite the outer surface 331.
  • the inner surface 332 is covered with a second coating 342.
  • both ends of the second coating 342 are folded outward (ie, outside the lumen of the stent graft 30).
  • the outer surface 331 is covered with a first coating 341.
  • both ends of the first coating 341 are folded inwardly (i.e., in the lumen of the stent graft 30).
  • a bracket body 35 is further disposed between the first coating film 341 and the second coating film 342, and the first coating film 341 and the second coating film 342 are attached by heat treatment, thereby sandwiching the bracket body 35 therein.
  • the invention also provides a method for manufacturing the above-mentioned stent graft 30, comprising the following steps:
  • the second surface 342 is covered on the inner surface 332, and both ends of the second coating 342 are cut to a required length;
  • step S3 heat treating the stent graft in step S2 such that both ends of the second coating 342 and the gap through the stent body 35 are bonded to the second coating 342;
  • step S6 The coated stent 30 in step S5 is heat treated such that both ends of the first coating 341 are bonded to the second coating 342.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Abstract

一种覆膜支架（10），具有近端端面（11）、远端端面（12）以及位于近端端面（11）和远端端面（12）之间的周面（13），周面（13）包括内表面（132）和与内表面（132）相对的外表面（131）。外表面（131）覆有第一覆膜（141），内表面（132）覆有第二覆膜（142）。该覆膜支架（10）还包括设于第一覆膜（141）和第二覆膜（142）之间的支架主体（15）。第一覆膜（141）和第二覆膜（142）的两端至少有一个向内或向外翻折，从而将近端端面（11）和远端端面（12）中的至少一个包裹。通过在覆膜支架（10）的近端端面（11）和/或远端端面（12）处对覆膜进行翻边设计，能够防止血流直接对近端端面（11）和/或远端端面（12）的内、外表面（131，132）的覆膜（141，142）造成冲击，避免了在长期血流冲击下造成的内、外表面（131，132）的覆膜（141，142）撕裂以及由覆膜（141，142）撕裂造成的一系列不良影响。

Description

覆膜支架 技术领域
本发明涉及植入式医疗器械领域，尤其涉及一种覆膜支架。
背景技术
现有的覆膜支架一般采用单层覆膜结构或使用双层覆膜结构。单层的覆膜结构支架植入体内后，金属支架会在裸露在血液中，长期会造成金属支架的腐蚀；单层覆膜结构直接通过金属支架与血管内壁贴合密封，密封性能不强，并且生物相容性差。
双层覆膜结构是一种在金属支架的内外表面均覆膜的结构，经过高温热处理将内、外覆膜与金属支架结合为一个整体。这种双层覆膜结构植入体内后，避免了金属支架直接暴露在血液中，防止金属支架腐蚀以及金属离子释放。而且支架近端是直接通过覆膜与血管内壁贴合，密封性能较好，而且生物相容性高。
但双层覆膜结构是通过热处理方式将内、外覆膜结合为一体，在覆膜支架的近端端面和远端端面，由于受到血液的长期冲击，会导致内、外覆膜撕裂。而内、外覆膜撕裂则会进一步造成金属支架裸露在血液中，加快了金属支架的腐蚀，从而释放金属离子，金属离子尤其是使用镍钛合金的金属支架在血液中释放出的镍离子有致癌作用。此外，覆膜支架近端端面和远端端面的内、外覆膜撕裂形成的撕裂口会减缓血液流速，在撕裂口处容易形成血栓，且撕裂口会增加流动血液对覆膜支架的冲击力，增加了支架移位的风险。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种能够避免在近端端面和远端端面内、外覆膜撕裂的覆膜支架。
本发明解决其技术问题所采用的技术方案是：构造一种覆膜支架，具有近 端端面、远端端面以及位于所述近端端面和所述远端端面之间的周面，所述周面包括内表面和与所述内表面相对的外表面，所述外表面覆有第一覆膜，所述内表面覆有第二覆膜，该覆膜支架还包括设于所述第一覆膜和所述第二覆膜之间的支架主体，该覆膜支架还包括设于所述第一覆膜和所述第二覆膜之间的支架主体所述第一覆膜和所述第二覆膜的两端至少有一个向内或向外翻折，从而将所述近端端面和所述远端端面中的至少一个包裹。
在本发明的一实施例中，所述第一覆膜和所述第二覆膜的两端均向所述内表面翻折并透过所述支架主体与所述第二覆膜相连。
在本发明的一实施例中，所述第一覆膜和所述第二覆膜的两端均向所述外表面翻折并透过所述支架主体与所述第一覆膜相连。
在本发明的一实施例中，所述第二覆膜的两端均向所述外表面翻折并透过所述支架主体与所述第二覆膜相连，所述第一覆膜的两端均向所述内表面翻折且与所述第二覆膜相连。
本发明解决其技术问题采用的另一技术方案为：提出一种如上述所述的覆膜支架的覆膜方法，包括以下步骤：
S1、在所述覆膜支架的外表面覆第一覆膜，在所述内表面覆第二覆膜；
S2、对包覆有上述覆膜的所述覆膜支架进行热处理从而将所述第一覆膜与所述第二覆膜粘合；
S3、冷却后，将所述第一覆膜与所述第二覆膜的两端剪切到需求的长度；
S4、将所述第一覆膜和所述第二覆膜的两端整体向所述内表面翻折；
S5、对向所述内表面翻折的第一覆膜和第二覆膜进行热处理从而使得该部分的覆膜与所述第二覆膜粘合在一起。
本发明解决其技术问题采用的又一技术方案为：提出一种如上述所述的覆膜支架的覆膜方法，包括以下步骤：
S1、在所述覆膜支架的外表面覆第一覆膜，在所述内表面覆第二覆膜；
S2、对包覆有上述覆膜的所述覆膜支架进行热处理从而将所述第一覆膜与所述第二覆膜粘合；
S3、冷却后，将所述第一覆膜与所述第二覆膜的两端剪切到需求的长度；
S4、将所述第一覆膜和所述第二覆膜的两端整体向所述外表面翻折；
S5、对向所述外表面翻折的第一覆膜和第二覆膜进行热处理从而使得该部分的覆膜与所述第一覆膜粘合在一起。
本发明解决其技术问题采用的再一技术方案为：提出一种如上述所述的覆膜支架的覆膜方法，包括以下步骤：
S1、在所述内表面覆所述第二覆膜，并将所述第二覆膜的两端剪切到需求的长度；
S2、将所述第二覆膜的两端整体向所述外表面翻折；
S3、对步骤S2中的覆膜支架进行热处理从而使得所述第二覆膜的两端近端透过所述支架主体与所述第二覆膜粘合；
S4、在所述外表面覆所述第一覆膜，并将所述第一覆膜的两端剪切到需求的长度；
S5、将所述第一覆膜的两端整体向所述内表面翻折；
S6、对步骤S5中的覆膜支架进行热处理从而使得第一覆膜的两端与所述第二覆膜粘合。
本发明通过在覆膜支架的近端端面和/或远端端面处对覆膜进行翻边设计，能够防止血流直接对近端端面和/或远端端面的内、外表面的覆膜造成冲击，避免了在长期血流冲击下造成的内、外表面的覆膜撕裂以及由覆膜撕裂造成的一系列不良影响。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明一种覆膜支架第一实施例的结构示意图；
图2是图1中A-A向的剖视图；
图3是本发明一种覆膜支架第二实施例的结构示意图；
图4是图3中B-B向的剖视图；
图5是本发明一种覆膜支架第三实施例中支架主体仅内表面覆第二覆膜的结构示意图；
图6是图5中C-C向的剖视图；
图7是本发明的覆膜支架第三实施例中支架主体内、外表面均覆膜的结构示意图；
图8是图7中D-D向的剖视图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
第一实施例：
如图1所示，一种覆膜支架10为两端开口的管状结构(用于形成血流通道)，其具有近端端面11、远端端面12以及位于近端端面11和远端端面12之间的周面13。周面13包括分别位于支架主体15两侧的外表面131和与外表面131相对的内表面132。在本实施例中，外表面131覆有第一覆膜141，内表面132覆有第二覆膜142。第一覆膜141和第二覆膜142本身具有一定的厚度，材料一般采用具有生物相容性的高分子材料制成，例如PET膜或PTFE膜等。第一覆膜141与第二覆膜142之间设有支架主体15，第一覆膜141和第二覆膜142通过热处理贴合，从而将支架主体15夹设其中。支架主体15由本领域已知的具有生物相容性的塑性膨胀材料管材切割扩张而成，管材材质可选择例如医用不锈钢，或钴锘合金，也可以是自膨胀性材料例如镍钛合金等。当由塑性膨胀材料制成时，支架主体15可在输送鞘管内径向压缩，并可通过充气球囊或等效膨胀机构膨胀至初始形状及尺寸。当由自膨胀材料制成时，支架主体15可在输送鞘管内径向压缩，并在失去输送鞘管压缩后恢复至初始形状及尺寸。支架主体15可由管材切割而成，也可通过金属丝编织而成。
如图2所示，第一覆膜141和第二覆膜142的两端均向内(即覆膜支架的管腔内)翻折并透过支架主体15与第二覆膜142相连，从而将覆膜支架10的近端端面11和远端端面12包裹。
本发明还提出了一种上述覆膜支架10的制作方法，包括以下步骤：
S1、在支架主体15的外表面131覆第一覆膜141，在内表面132覆第二覆 膜142；
S2、对包覆有上述覆膜的覆膜支架10进行热处理从而将第一覆膜141与第二覆膜142粘合；
S3、冷却后，将第一覆膜141与第二覆膜142的两端剪切到需求的长度；
S4、将第一覆膜141和第二覆膜142的两端整体向内表面132翻折；
S5、对向内表面132翻折的第一覆膜141和第二覆膜142进行热处理从而使得该部分的覆膜与第二覆膜142粘合在一起。第一覆膜141和第二覆膜142整体内翻后，可以使用洛铁将第一覆膜141和第二覆膜142烫贴为一个整体，或使用热处理炉对覆膜支架10再次进行热处理。
本发明通过在覆膜支架的近端端面和远端端面处对包覆于覆膜支架周面上的覆膜进行翻边设计，能够防止血流直接对近端端面和远端端面的的覆膜造成冲击，避免了在长期血流冲击下造成的内、外表面的覆膜撕裂以及由覆膜撕裂造成的一系列不良影响。
第二实施例：
如图3所示，一种覆膜支架20为两端开口的管状结构(用于形成血流通道)，其具有近端端面21、远端端面22以及位于近端端面21和远端端面22之间的周面23。周面23包括外表面231和与外表面231相对的内表面232。在本实施例中，外表面231覆有第一覆膜241，内表面232覆有第二覆膜242。第一覆膜241和第二覆膜242本身具有一定的厚度，材料一般采用具有生物相容性的高分子材料制成，例如PET膜或PTFE膜等。第一覆膜241与第二覆膜242之间设有支架主体25，第一覆膜241和第二覆膜242通过热处理贴合，从而将支架主体25夹设其中。支架主体25由本领域已知的具有生物相容性的塑性膨胀材料管材切割扩张而成，管材材质可选择例如医用不锈钢，或钴锘合金，也可以是自膨胀性材料例如镍钛合金等。当由塑性膨胀材料制成时，支架主体25可在输送鞘管内径向压缩，并可通过充气球囊或等效膨胀机构膨胀至初始形状及尺寸。当由自膨胀材料制成时，支架主体25可在输送鞘管内径向压缩，并在失去输送鞘管压缩后恢复至初始形状及尺寸。支架主体25可由管材切割而成，也可通过金属丝编织而成。
如图4所示，第一覆膜241和第二覆膜242的两端均向外(即覆膜支架的管腔外)翻折并透过支架主体25与第一覆膜241相连，从而将覆膜支架20的近端端面21和远端端面22包裹。
本发明还提出了一种上述覆膜支架20的制作方法，包括以下步骤：
S1、在支架主体25的外表面231覆第一覆膜241，在内表面232覆第二覆膜242；
S2、对包覆有上述覆膜的覆膜支架20进行热处理从而将第一覆膜241与第二覆膜242粘合；
S3、冷却后，将第一覆膜241与第二覆膜242的两端剪切到需求的长度；
S4、将第一覆膜241和第二覆膜242的两端整体向外表面231翻折；
S5、对向外表面231翻折的第一覆膜241和第二覆膜242进行热处理从而使得该部分的覆膜与第一覆膜241粘合在一起。第一覆膜241和第二覆膜242整体内翻后，可以使用洛铁将第一覆膜241和第二覆膜242烫贴为一个整体，或使用热处理炉对覆膜支架20再次进行热处理。
第三实施例：
如图5所示，一种覆膜支架30为两端开口的管状结构(用于形成血流通道)，其具有近端端面31、远端端面32以及位于近端端面31和远端端面32之间的周面33。周面33包括外表面331和与外表面331相对的内表面332。内表面332覆有第二覆膜342。如图6所示，第二覆膜342的两端向外(即覆膜支架30的管腔外)翻折。如图7所示，外表面331覆有第一覆膜341，如图8所示，第一覆膜341的两端向内(即覆膜支架30的管腔内)翻折。第一覆膜341和第二覆膜342之间还设有支架主体35，第一覆膜341和第二覆膜342通过热处理贴合，从而将支架主体35夹设其中
本发明还提出了一种上述覆膜支架30的制作方法，包括以下步骤：
S1、在内表面332覆所述第二覆膜342，并将第二覆膜342的两端剪切到需求的长度；
S2、将第二覆膜342的两端整体向外表面331翻折；
S3、对步骤S2中的覆膜支架进行热处理从而使得第二覆膜342的两端与 透过支架主体35的空隙与第二覆膜342粘合；
S4、在外表面331覆第一覆膜341，并将第一覆膜341的两端剪切到需求的长度；
S5、将第一覆膜341的两端整体向内表面332翻折；
S6、对步骤S5中的覆膜支架30进行热处理从而使得第一覆膜341的两端与第二覆膜342粘合。
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 (7)

  1. 一种覆膜支架，具有近端端面、远端端面以及位于所述近端端面和所述远端端面之间的周面，所述周面包括内表面和与所述内表面相对的外表面，所述外表面覆有第一覆膜，所述内表面覆有第二覆膜，该覆膜支架还包括设于所述第一覆膜和所述第二覆膜之间的支架主体，其特征在于，所述第一覆膜和所述第二覆膜的两端至少有一个向内或向外翻折，从而将所述近端端面和所述远端端面中的至少一个包裹。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述第一覆膜和所述第二覆膜的两端均向所述内表面翻折并透过所述支架主体与所述第二覆膜相连。
  3. 根据权利要求1所述的覆膜支架，其特征在于，所述第一覆膜和所述第二覆膜的两端均向所述外表面翻折并透过所述支架主体与所述第一覆膜相连。
  4. 根据权利要求1所述的覆膜支架，其特征在于，所述第二覆膜的两端均向所述外表面翻折并透过所述支架主体与所述第二覆膜相连，所述第一覆膜的两端均向所述内表面翻折且与所述第二覆膜相连。
  5. 一种如权利要求2所述的覆膜支架的覆膜方法，其特征在于，包括以下步骤：
    S1、在所述覆膜支架的外表面覆第一覆膜，在所述内表面覆第二覆膜；
    S2、对包覆有上述覆膜的所述覆膜支架进行热处理从而将所述第一覆膜与所述第二覆膜粘合；
    S3、冷却后，将所述第一覆膜与所述第二覆膜的两端剪切到需求的长度；
    S4、将所述第一覆膜和所述第二覆膜的两端整体向所述内表面翻折；
    S5、对向所述内表面翻折的第一覆膜和第二覆膜进行热处理从而使得该部分的覆膜与所述第二覆膜粘合在一起。
  6. 一种如权利要求3所述的覆膜支架的覆膜方法，其特征在于，包括以下步骤：
    S1、在所述覆膜支架的外表面覆第一覆膜，在所述内表面覆第二覆膜；
    S2、对包覆有上述覆膜的所述覆膜支架进行热处理从而将所述第一覆膜与所述第二覆膜粘合；
    S3、冷却后，将所述第一覆膜与所述第二覆膜的两端剪切到需求的长度；
    S4、将所述第一覆膜和所述第二覆膜的两端整体向所述外表面翻折；
    S5、对向所述外表面翻折的第一覆膜和第二覆膜进行热处理从而使得该部分的覆膜与所述第一覆膜粘合在一起。
  7. 一种如权利要求4所述的覆膜支架的覆膜方法，其特征在于，包括以下步骤：
    S1、在所述内表面覆所述第二覆膜，并将所述第二覆膜的两端剪切到需求的长度；
    S2、将所述第二覆膜的两端整体向所述外表面翻折；
    S3、对步骤S2中的覆膜支架进行热处理从而使得所述第二覆膜的两端与所述第二覆膜粘合；
    S4、在所述外表面覆所述第一覆膜，并将所述第一覆膜的两端剪切到需求的长度；
    S5、将所述第一覆膜的两端整体向所述内表面翻折；
    S6、对步骤S5中的覆膜支架进行热处理从而使得第一覆膜的两端与所述第二覆膜粘合。
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CN108245278A (zh) * 2016-12-28 2018-07-06 先健科技(深圳)有限公司 覆膜支架

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CN108245278B (zh) 2020-12-18
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CN108245278A (zh) 2018-07-06
US20200352752A1 (en) 2020-11-12
EP3563809A1 (en) 2019-11-06
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CN112451170A (zh) 2021-03-09
US11273061B2 (en) 2022-03-15

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