WO2018120874A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2018120874A1
WO2018120874A1 PCT/CN2017/099030 CN2017099030W WO2018120874A1 WO 2018120874 A1 WO2018120874 A1 WO 2018120874A1 CN 2017099030 W CN2017099030 W CN 2017099030W WO 2018120874 A1 WO2018120874 A1 WO 2018120874A1
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WO
WIPO (PCT)
Prior art keywords
wire
stent
binding
stent graft
bare
Prior art date
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Ceased
Application number
PCT/CN2017/099030
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English (en)
French (fr)
Inventor
肖本好
何里明
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Publication of WO2018120874A1 publication Critical patent/WO2018120874A1/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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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

Definitions

  • the present invention relates to the field of interventional medical device technology, and in particular to a stent graft.
  • the stent grafts on the market generally include a bare stent and a single layer PET film structure or a double layer ePTFE/PTFE film structure disposed on the bare frame. These stent grafts separate the blood flow from the lesion by the membrane, eliminating the influence of blood pressure on the lesion location, in order to achieve the purpose of healing.
  • the connecting rod of the bare stent of the stent graft is directly exposed in the blood, and the metal ions released by the connecting rod (such as nickel ions released by the nickel-titanium stent in the blood) enter the blood. In the circulation, it will cause adverse effects on the human body, such as carcinogenesis.
  • the single-layer PET film structure is directly sealed by the connecting rod of the stent and the inner wall of the blood vessel, and the sealing performance is not strong, and the biocompatibility is inferior to that of the ePTFE/PTFE/FEP film.
  • the connecting rod of the stent refers to a wire between adjacent peaks and troughs in a corrugated ring (ie, a wave ring) of the bare stent of the stent graft.
  • ePTFE/PTFE/FEP membrane such as The outer membrane 802 and the inner membrane 800 in Fig. 1 have a certain ductility in the circumferential direction, and after long-term impact by high pressure blood flow, the stent (such as the bare stent 801 in Fig. 1) and the ePTFE/PTFE/FEP coating The membrane will have a certain degree of expansion, and in severe cases, the membrane will rupture and the isolation function of the stent will be ineffective.
  • the present invention provides a double-layer coated stent for the above defects, which utilizes the anti-stretching property of the binding wire and effectively suppresses the impact of the ePTFE/PTFE/FEP stent graft in high-pressure blood flow by adding a coating method of the binding wire. Lower expansion, thereby reducing the risk of failure of the stent due to expansion of the membrane.
  • the present invention provides a stent graft comprising an outer membrane, an inner membrane, and a bare stent disposed between the outer membrane and the inner membrane, an outer surface of the outer membrane or/and the outer membrane and the outer membrane At least one tie line is disposed between the inner membranes.
  • the binding wire is wound in an annular or spiral shape on an outer surface of the bare stent, an inner surface of the bare stent, or an outer surface of the inner membrane.
  • the binding line shuttles between an inner surface and an outer surface of the two connecting rods of the bare bracket.
  • the number of the binding wires is plural, and among the plurality of the binding wires, the vertical distance between the adjacent two of the binding wires ranges from 1 mm to 30 mm. If the vertical distance is less than 1 mm, the density of the binding line is too large, which will affect the bending performance of the stent graft; if the vertical distance is greater than 30 mm, the density of the binding wire is too low, and it is difficult to inhibit the expansion of the stent graft.
  • the number of the binding wires is plural, and among the plurality of the binding wires, the vertical distance between the adjacent two of the binding wires ranges from 2 mm to 12 mm.
  • the binding wire is a binding wire having a high temperature resistance of more than 100 ° C and an elongation of less than 50%.
  • the binding wire is a cylindrical binding wire or a flat binding wire.
  • the cylindrical wire has a wire diameter ranging from 0.01 mm to 0.4 mm. If the wire diameter is less than 0.01 mm, the tensile strength of the binding wire is poor; if the wire diameter is larger than 0.4 mm, the elongation of the binding wire is poor.
  • the cylindrical wire has a wire diameter ranging from 0.05 mm to 0.2 mm.
  • the flat tie wires have a width ranging from 0.05 mm to 2 mm and a thickness ranging from 0.01 mm to 0.2 mm.
  • the flat tie wires have a width ranging from 0.1 mm to 1 mm and a thickness ranging from 0.02 mm to 0.2 mm.
  • the binding wire may be a single binding wire, a plurality of binding wires or a plurality of fastening wires.
  • the binding wire is a PTFE wire.
  • the outer film is an ePTFE, PTFE or FEP film and the inner film is an ePTFE, PTFE or FEP film.
  • the bare stent is a self-expanding bare stent.
  • the invention utilizes the anti-stretching property of the binding wire, and effectively increases the swelling of the stent graft under the impact of high-pressure blood flow by adding the filming method of the binding wire, thereby reducing the risk of the stent function failing due to the expansion of the stent or the film.
  • FIG. 1 is a schematic structural view of a double-layer stent graft in the prior art, wherein an inner membrane 800, a bare stent 801, an outer membrane 802;
  • FIG. 2 is a schematic structural view of a stent graft of Embodiment 1;
  • FIG. 3 is a schematic structural view of a stent graft of Embodiment 2;
  • FIG. 4 is a schematic structural view of a stent graft of Embodiment 3.
  • Figure 5 is a schematic view showing the structure of the stent graft of the fourth embodiment
  • FIG. 6 is a schematic structural view of a stent graft of Embodiment 5.
  • Figure 7 is a schematic structural view of a stent graft of Example 6.
  • Figure 7-1 is a partial enlarged view of Figure 7;
  • Figure 7-2 is another partial enlarged view of Figure 7;
  • Figure 8 is a schematic structural view of a stent graft of Embodiment 7.
  • Fig. 9 is a schematic view showing the structure of a stent graft in which a PTFE thread is spirally wound around the outer surface of an ePTFE outer membrane.
  • the tie wires in the present invention are required to have good high temperature resistance and tensile properties in the circumferential direction. It will be appreciated that the tie wires can be wires of various shapes, preferably cylindrical or flat shaped tie wires.
  • the binding line can be wound by a single tie line, or multiple tie lines or multiple tie lines can be wrapped.
  • Pre-tightening means that the inner surface of the binding line and the outer membrane, the inner membrane, the bare stent or the outer surface of the bare stent just fits together, is slightly tight, and is not loose, such as pre-tightening or pre-tightening.
  • Shuttle means that the binding wire is bypassed from the side of the outer surface of a connecting rod of the bare bracket and is fitted to the connecting rod and then passed to the other
  • the inner surface of the connecting rod is attached to the inner surface and is circulated; or the binding wire is wound from one side of the inner surface of one connecting rod of the bare bracket and is fitted to the connecting rod and then passed to the other connecting rod
  • the outer surface is attached to the outer surface and circulated.
  • the binding wire After the binding wire is pre-woundly wound around the outer surface of the outer film, it may be fixed to the outer surface of the outer film by glue bonding, direct firing or heat treatment.
  • the binding wire When a binding wire wound in an annular shape or a spiral shape is disposed between the outer film and the inner film, the binding wire may be pre-woundly wound on an outer surface or an inner surface of the bare bracket, or The binding wire can be pre-tightly shuttled between the inner surface and the outer surface of the connecting rod of the bare bracket, and finally the inner film and the outer film are bonded and fixed together by the inner film and the outer film.
  • the binding wire When a binding wire wound in an annular shape or a spiral shape is disposed between the outer film and the inner film, the binding wire may be wound around an outer surface of the inner film, an outer surface of the bare frame, or On the inner surface of the bare stent. It can be understood that, in one embodiment, the binding wire can be simultaneously wound on the outer surface of the inner film and the outer surface of the bare stent, and the binding wire can also be wound on the outer surface of the inner film and the inner surface of the bare stent at the same time.
  • the tie wires may also be wound individually on the outer surface of the inner film, or separately wound on the outer surface of the bare stent, or separately wound on the inner surface of the bare stent, or in various combinations of the above.
  • the wire When a binding wire wound in a ring shape or a spiral shape is disposed between the outer film and the inner film, the wire is shuttled between the inner surface and the outer surface of the bare frame.
  • the binding wires can be shuttled between the inner surface and the outer surface of the connecting rod of the bare bracket by a connecting rod or two connecting rods or even a plurality of connecting rods.
  • the connecting rod shuttles between the inner surface and the outer surface of the two connecting rods of the bare bracket (for example, in each coil, the connecting wires are separated by a connecting rod and shuttled to the inner surfaces of the other two connecting rods of the bare bracket and Between the outer surfaces, etc., or there are separate tie lines.
  • Two connecting rods are shuttled between the inner surface and the outer surface of the two connecting rods of the bare bracket (for example, in each circle, the binding lines are separated by two connections)
  • the rod travels through the other two of the bare brackets
  • the three or more connecting rods are shuttled between the inner surface and the outer surface of the other two connecting rods of the bare bracket (for example, each turn)
  • the tie lines are separated by three or more connecting rods between the inner surface and the outer surface of the other two connecting rods of the bare bracket, etc., or the binding lines are shuttled to two adjacent ones of the coils.
  • the connecting rod are shuttled between the inner surface and the outer surface of the two connecting rods of the bare bracket, etc.
  • the binding wire when the binding wire is wound around the inner surface or the outer surface of the bare bracket, the binding wire can be wound from one wave of the bare bracket to another coil adjacent to the coil, such as the binding line from the upper wave.
  • the trough position of the circle is wound to the peak position of the lower wave ring adjacent to the upper wave circle;
  • the binding line may also be a plurality of or more binding wires, the multi-segment binding wire is wound on the wave ring of the bare bracket or the plurality of binding wires are wound On the coil of the bare stent; or various combinations of the above.
  • the winding of the multi-segment wire on the wave ring means that the wire is wound on the wave ring by at least two or more wire ends.
  • the winding of the binding wire is not affected by the structure of the bare bracket.
  • the bare bracket can be a bare bracket of various structures, such as a bare bracket of a Z-shaped wave ring or a bare bracket with mutually constrained upper and lower coils.
  • Parallel distance refers to the vertical distance between adjacent two or two tie wires wound in an annular or spiral shape.
  • the ePTFE, FEP or PTFE film has a certain ductility in the circumferential direction. After being subjected to high-pressure blood flow for a long time, it will cause a certain degree of expansion of the stent, and even the stent may be broken, thereby invalidating the isolation function of the stent.
  • the invention utilizes the anti-stretching property of the binding wire, and provides a looping wire or a spirally wound binding line between the outer surface of the outer film of the film-covered stent or the outer membrane and the inner membrane by adding a coating method of the binding wire, which is effective
  • the stent graft is inhibited from expanding under the impact of high pressure blood flow, thereby reducing the risk of failure of the stent due to stent expansion.
  • the wire of the binding wire can be fixed by preventing the wire from sliding by the frictional force of the wire and the film, or the two wire ends of the wire can be wound or fixed to each other or tied and tied. fix.
  • a stent graft includes an ePTFE inner membrane 100, an ePTFE outer membrane 103, and a self-expanding bare stent 101 disposed between the ePTFE outer membrane 103 and the ePTFE inner membrane 100.
  • the self-expanding bare stent 101 is composed of a plurality of Z-shaped wave coils arranged along the longitudinal central axis direction of the stent graft (ie, the axial direction of the stent graft), and the adjacent upper and lower two Z-shaped coils are not in contact with each other;
  • a pre-tightly wound PTFE wire 102 is provided between the ePTFE outer film 103 and the ePTFE inner film 100.
  • the vertical distance b of the adjacent two-stage PTFE thread m and the PTFE thread n ranges from 1 to 30 mm, preferably from 2 to 12 mm.
  • the PTFE wire 102 is wound in a ring shape on the outer surface of the self-expanding bare stent 101 (m in Fig. 2) and the outer surface of the ePTFE inner film (as in Fig. 2).
  • the PTFE wire 102 is a solid cylindrical single-strand wire with good high temperature resistance and tensile resistance in the circumferential direction. Its high temperature resistance is greater than 100 ° C, the elongation is less than 50%, and the wire diameter is 0.01-0.4 mm. It is preferably 0.05-0.2 mm.
  • the PTFE wire 102 can also be a flat shaped tie wire having a width of 0.05-2 mm, thickness 0.01-0.2 mm; preferred width 0.1-1 mm, thickness 0.02-0.2 mm.
  • the number (number) of the PTFE wires 102 and the structure of the self-expanding bare stent 101 can be determined according to actual needs, as long as the PTFE wire with the inner film and the bare stent is provided in the stent graft.
  • the PTFE wire 102 may also be pre-wound by a plurality of segments or a plurality of tie wires, and is not limited to the single ring tie wire in the embodiment.
  • the PTFE wire 102 After the PTFE wire 102 is pre-wound, the PTFE wire 102, the self-expanding bare stent 101, the ePTFE inner film 100, and the ePTFE outer film 103 are bonded together by heat treatment, thereby integrally enhancing the elongation resistance of the ePTFE film, thereby effectively suppressing self-stretching performance. Expanded bare stents and ePTFE membranes swell under the impact of high pressure blood flow.
  • the material of the binding wire may also be ePTFE, PET, etc., as long as the bonding wire has a high temperature resistance of more than 100 ° C and an elongation of less than 50%.
  • the structure of the stent graft of the present embodiment is similar to that of the stent graft of the first embodiment, except that the PTFE thread 200 is spirally pre-wrapped around the self-expanding bare stent 201.
  • the PTFE wire 200 when the PTFE wire 200 is spirally wound on the inner surface or the outer surface of the self-expanding bare stent 201, the PTFE wire 200 can be wound from the coil C of the self-expanding bare stent 201 to the coil C. Neighboring circle D.
  • the PTFE wire 200 is wound from the outer surface of the trough c position of the coil C to the outer surface of the crest d position of the coil D adjacent to the coil C.
  • the PTFE wire 200 can also be a plurality of segments or a plurality of tie wires, respectively wound on the respective coils of the bare stent, or various combinations of the above.
  • the structure of the stent graft of the present embodiment is similar to that of the stent graft of the first embodiment.
  • the only difference is that the PTFE thread 300 of the present embodiment is wound in a ring shape and is wound around the self-expanding bare stent 301.
  • the structure of the stent graft of the present embodiment is similar to that of the stent graft of the third embodiment, except that the PTFE thread 400 of the present embodiment is spirally pre-wound around the self-expanding bare stent 401.
  • a stent graft is composed of an ePTFE outer membrane 503, an ePTFE inner membrane 500, and a self-expanding bare stent 501 disposed between the ePTFE outer membrane 503 and the ePTFE inner membrane 500.
  • the self-expanding bare stent 501 is A plurality of Z-shaped wave coils arranged along the longitudinal central axis direction of the stent graft (ie, the axial direction of the stent graft), the adjacent upper and lower Z-shaped coils are not in contact with each other, the ePTFE outer membrane 503 and the ePTFE inner membrane Between the 500 is provided a PTFE wire 502 which is wound in an annular pretension.
  • the vertical distance k of the adjacent two-stage PTFE thread h and the PTFE thread 1 is from 1 to 30 mm, preferably from 2 to 12 mm.
  • the PTFE wire 502 is pre-tightly shuttled between the inner surface and the outer surface of two adjacent connecting rod connecting rods of one wave of the self-expanding bare bracket 501.
  • the PTFE wire 502 can be shuttled between the inner surface and the outer surface of the other two connecting rods of the self-expanding bare bracket by a connecting rod or two connecting rods or even a plurality of connecting rods.
  • the PTFE wire can be simultaneously separated by a connecting rod, two connecting rods or a plurality of connecting rods to be shuttled between the inner surface and the outer surface of the other two connecting rods of the self-expanding bare bracket.
  • the PTFE wire may be separately connected to the connecting rod connecting rod between the inner surface and the outer surface of the adjacent two connecting rods of one wave of the self-expanding bare bracket (as in the present embodiment), or the PTFE wire may be separately present.
  • the two connecting rods are spaced between the inner surface and the outer surface of the other two connecting rods of the bare bracket, or three or more connecting rods are respectively spaced apart from the inner surface of the other two connecting rods of the bare bracket. Between the surfaces, or various combinations of the above shuttle methods.
  • PTFE wire 502 is a solid cylindrical single wire with good high temperature resistance and tensile strength in the circumferential direction. Its high temperature resistance is greater than 100 ° C, the elongation is less than 50%, and the wire diameter is 0.01-0.4 mm. It is preferably 0.05-0.2 mm. If the wire diameter is less than 0.01 mm, the tensile strength of the binding wire is poor; if the wire diameter is larger than 0.4 mm, the elongation of the binding wire is poor.
  • the PTFE wire 502 can also be a flat-shaped tie wire having a width of 0.05-2 mm and a thickness of 0.01-0.2 mm; preferably a width of 0.1-1 mm and a thickness of 0.02-0.2 mm. This is because, if When the wire diameter is less than 0.01 mm, the tensile strength of the binding wire is poor; if the wire diameter is larger than 0.4 mm, the elongation of the binding wire is poor.
  • the number (number) of the PTFE wires 502 and the structure of the self-expanding bare stent 501 can be determined according to actual needs, as long as the PTFE wire with the inner film and the bare stent is provided in the stent graft.
  • the PTFE wire 502 may also be pre-wound by a plurality of segments or a plurality of tie wires, and is not limited to the single ring tie wire in the embodiment.
  • the PTFE wire 502 After the PTFE wire 502 is pre-tightened, the PTFE wire 502, the self-expanding bare stent 501, the ePTFE inner film 500, and the ePTFE outer film 503 are bonded together by heat treatment to integrally enhance the elongation resistance of the ePTFE film, thereby effectively suppressing self-stretching performance. Expanded bare stents and ePTFE membranes swell under the impact of high pressure blood flow.
  • the structure of the stent graft of the present embodiment is similar to that of the stent graft of the embodiment 5, except that the PTFE thread 602 of the present embodiment is spirally preloaded and shuttled to the self-expanding bare stent. 601 is between the inner surface and the outer surface of the connecting rod.
  • the PTFE wire 602 when the PTFE wire 602 is spirally shuttled to the inner or outer surface of the bare stent, the PTFE wire 602 can be wound from the inner surface of the valley of the a-coil of the bare stent 601 to The outer surface of the peak position of the b-wave coil adjacent to the a-wave coil (see Figure 7-1). It will be appreciated that in another embodiment, the PTFE wire 602 may also be wound from the inner surface of the valley position of the a-coil to the inner surface of the c-wave position adjacent to the a-coil (see Figure 7-2). .
  • a stent graft includes an ePTFE inner membrane 700, an ePTFE outer membrane 703, and a self-expanding bare stent 701 disposed between the ePTFE outer membrane 703 and the ePTFE inner membrane 700.
  • the self-expanding bare stent 701 is a plurality of Z-shaped wave coils arranged along the longitudinal center line direction of the stent graft (ie, the axial direction of the stent graft), the adjacent upper and lower two Z-shaped coils are not in contact with each other; the outer surface of the ePTFE outer membrane 703 is disposed There is a PTFE wire 702 that is pre-wound in a ring shape.
  • the vertical distance t of the adjacent two-stage PTFE line z and the PTFE line w ranges from 1 to 30 mm, preferably from 2 to 12 mm, because if the vertical distance is less than 1 mm, the density of the binding line is too large, which may affect the stent-covered stent. Bending performance; if the vertical distance is greater than 30 mm, the density of the binding wire is too low, and it is difficult to inhibit the expansion of the stent graft.
  • PTFE wire 702 is pre-wound on the outer surface of the outer membrane of ePTFE Thereafter, it can be fixed to the outer surface of the outer film by glue bonding, thereby integrally enhancing the elongation resistance of the ePTFE film, and effectively suppressing the expansion of the self-expanding bare stent and the ePTFE film under the impact of high-pressure blood flow.
  • PTFE wire 702 is a single-shaped wire with a cylindrical shape, which has good high temperature resistance and tensile strength in the circumferential direction. Its high temperature resistance is greater than 100 ° C, the elongation is less than 50%, and the wire diameter is 0.01-0.4 mm. It is 0.05-0.2mm.
  • the PTFE wire 702 may also be a flat shaped tie wire having a width of from 0.05 to 2 mm and a thickness of from 0.01 to 0.2 mm; preferably a width of from 0.1 to 1 mm and a thickness of from 0.02 to 0.2 mm.
  • the number (number) of the PTFE wires 702 and the structure of the self-expanding bare stent 701 can be determined according to actual needs, as long as the PTFE wire with the inner film and the bare stent is provided in the stent graft.
  • the PTFE wire 702 may also be pre-wound by multiple or multiple tie wires, and is not limited to the single loop tie wire in this embodiment.
  • the PTFE thread 702 can also be helically wound onto the outer surface of the outer membrane of the ePTFE.
  • Test method one end of the stent graft is closed with a solid plug, and another plug with a silicone tube (a plug with a silicone tube can be made by the following method: first, a through hole is formed in the geometric center of the solid plug; secondly; Inserting a silicone tube with an interference fit in the through hole, and exposing the plug to a portion of the silicone tube to obtain a plug with a silicone tube) plugging the other end of the stent graft, and the strip is silicone
  • the silicone tube of the plug of the tube is located inside the stent graft, and a part is located outside the stent graft.
  • the outer wall of the silicone tube exposed outside the stent graft is provided with a pressure gauge, and the lumen of the silicone tube exposed outside the stent graft is placed.
  • the mouth is connected to the water source; the water source is opened, the air in the lumen of the silicone tube is discharged, and the water pressure is stabilized at 25 Kpa (188 mmHg), and the stent graft is expanded to a stable state under water pressure, and the initial diameter is recorded. Subsequently, the expanded diameter of the stent graft was tested according to the predetermined time point, and relevant data was recorded. The results are shown in Table 1.

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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)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)

Abstract

一种覆膜支架，其包括外膜（103）、内膜（100）以及设置于外膜（103）与内膜（100）之间的裸支架（101），外膜（103）的外表面或/和外膜（103）与内膜（100）之间设置有至少一根绑线（102）。绑线（102）呈环状或螺旋状地缠绕于裸支架（101）的外表面、裸支架（101）的内表面或内膜（100）的外表面上；或绑线（102）穿梭于裸支架（101）的两根连接杆的内表面与外表面之间。利用绑线（102）的抗延伸性能，通过添加绑线（102）的覆膜方式，有效抑制覆膜支架在高压血流冲击下膨胀，从而减低由于覆膜支架膨胀而使覆膜支架功能失效的风险。

Description

覆膜支架 技术领域
本发明涉及介入医疗器械技术领域，特别是涉及一种覆膜支架。
背景技术
目前市场上的覆膜支架一般包括裸支架和设于裸支架上的单层PET覆膜结构或双层ePTFE/PTFE覆膜结构。这些覆膜支架都是通过覆膜将血流与病变位置隔绝，消除血压对病变位置的影响，以达到治愈的目的。单层的PET覆膜支架植入体内后，覆膜支架的裸支架的连接杆会直接裸露在血液中，连接杆释放的金属离子(如镍钛合金支架在血液中释放的镍离子)进入血液循环中，会对人体造成不良影响，如致癌等。单层PET覆膜结构直接通过支架的连接杆与血管内壁贴合进行密封，密封性能不强，且生物相容性相对ePTFE/PTFE/FEP膜较差。所述支架的连接杆是指，所述覆膜支架的裸支架的波形环状物(即波圈)中相邻的波峰与波谷之间的金属丝。
虽然现有的介入式双层ePTFE/PTFE/FEP覆膜支架可以在一定程度上减少支架的连接杆离子释放以及加强支架与血管内壁的生物相容性，但ePTFE/PTFE/FEP覆膜(如图1中的外膜802和内膜800)在圆周方向上有一定的可延性，且长期受高压血流的冲击后，支架(如图1中的裸支架801)和ePTFE/PTFE/FEP覆膜均会出现一定程度的膨胀，严重时覆膜会发生破裂，支架的隔绝功能失效。
发明内容
基于此，本发明针对上述缺陷提供一种双层覆膜支架，其利用绑线的抗延伸性能，通过添加绑线的覆膜方式，有效抑制ePTFE/PTFE/FEP覆膜支架在高压血流冲击下膨胀，从而减低由于覆膜膨胀而使支架功能失效的风险。
本发明通过如下技术方案实现：
本发明提供一种覆膜支架，包括外膜、内膜以及设置于所述外膜与所述内膜之间的裸支架，所述外膜的外表面或/和所述外膜与所述内膜之间设置有至少一根绑线。
在一实施例中，所述绑线呈环状或螺旋状地缠绕于所述裸支架的外表面、所述裸支架的内表面或所述内膜的外表面上。
在一实施例中，所述绑线穿梭于所述裸支架的两根连接杆的内表面与外表面之间。
在一实施例中，所述绑线的根数为多根，多根所述绑线中，相邻两根所述绑线之间的垂直距离范围为以1毫米至30毫米。若垂直距离小于1毫米，绑线密度太大，会影响覆膜支架的弯曲性能；若垂直距离大于30毫米，绑线的密度太低，难以抑制覆膜支架的膨胀。
在一实施例中，所述绑线的根数为多根，多根所述绑线中，相邻两根所述绑线之间的垂直距离范围为以2毫米至12毫米。
在一实施例中，所述绑线为耐高温大于100℃，可延伸率小于50％的绑线。
在一实施例中，所述绑线为圆柱状绑线或扁平状绑线。
在一实施例中，所述圆柱状绑线的丝径范围为0.01毫米至0.4毫米。若丝径小于0.01毫米，绑线的抗拉伸性能较差；若丝径大于0.4毫米，绑线的可延伸率较差。
在一实施例中，所述圆柱状绑线的丝径范围为0.05毫米至0.2毫米。
在一实施例中，所述扁平状绑线的宽度范围为0.05毫米至2毫米、厚度范围为0.01毫米至0.2毫米。
在一实施例中，所述扁平状绑线的宽度范围为0.1毫米至1毫米、厚度范围为0.02毫米至0.2毫米。
在一实施例中，所述绑线可为单根绑线、多根绑线或多段绑线。
在一实施例中，所述绑线为PTFE线。
在一实施例中，所述外膜为ePTFE、PTFE或FEP膜，所述内膜为ePTFE、PTFE或FEP膜。
在一实施例中，所述裸支架为自膨式裸支架。
本发明利用绑线的抗延伸性能，通过添加绑线的覆膜方式，有效抑制覆膜支架在高压血流冲击下膨胀，从而减低由于支架或覆膜膨胀而使支架功能失效的风险。
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是现有技术中的双层覆膜支架的结构示意图，其中内膜800、裸支架801、外膜802；
图2是实施例1的覆膜支架的结构示意图；
图3是实施例2的覆膜支架的结构示意图；
图4是实施例3的覆膜支架的结构示意图；
图5是实施例4的覆膜支架的结构示意图；
图6是实施例5的覆膜支架的结构示意图；
图7是实施例6的覆膜支架的结构示意图；
图7-1是图7的局部放大示意图；
图7-2是图7的另一局部放大示意图；
图8是实施例7的覆膜支架的结构示意图；
图9是PTFE线呈螺旋状缠绕于ePTFE外膜的外表面上的覆膜支架的结构示意图。
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。
除非另有定义，本文所使用的所有的技术和科学术语属于本发明的技术领域的技术人员通常理解的含义相同。本文在说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
本发明中的绑线需要具有良好的耐高温性能和圆周方向的抗拉伸性能。可以理解的是，绑线可以为各种形状的线，优选为圆柱形状或扁平形状的绑线。绑线可以单根绑线进行缠绕，也可以多根绑线或多段绑线进行缠绕。
预紧指的是绑线与外膜、内膜、裸支架的内表面或裸支架的外表面刚好相互贴合、轻微紧绷、不松动，譬如预紧缠绕或预紧穿梭。
穿梭指的是绑线从裸支架一根连接杆的外表面的一侧绕过并贴合该连接杆后穿到另一 根连接杆的内表面并与该内表面贴合，如此循环；或绑线从裸支架一根连接杆的内表面的一侧绕过并贴合该连接杆后穿到另一根连接杆的外表面并与该外表面贴合，如此循环。
绑线预紧缠绕于所述外膜的外表面后，可以采用胶水粘合、直接烧制或热处理方式将其固定于外膜的外表面上。
当所述外膜与所述内膜之间设置有呈环状或螺旋状缠绕的绑线时，所述绑线可预紧缠绕于所述裸支架的外表面或内表面上，或所述绑线可预紧穿梭于所述裸支架的连接杆的内表面与外表面之间，最后通过热处理使内膜与外膜将金属裸支架与绑线粘合固定在一起。
当所述外膜与所述内膜之间设置有呈环状或螺旋状缠绕的绑线时，所述绑线可缠绕于所述内膜的外表面、所述裸支架的外表面或所述裸支架的内表面上。可以理解的是，在一个实施例中，绑线可以同时缠绕于内膜的外表面和裸支架的外表面上，绑线也可以同时缠绕于内膜的外表面和裸支架的内表面上，绑线还可以单独缠绕于内膜的外表面上，或单独缠绕于裸支架的外表面上，或单独缠绕于裸支架的内表面上，或者是上述方式的各种组合。
当所述外膜与所述内膜之间设置有呈环状或螺旋状缠绕的绑线时，所述绑线穿梭于所述裸支架的内表面与外表面之间。绑线可以间隔一根连接杆或两根连接杆甚至多根连接杆穿梭于裸支架的连接杆的内表面和外表面之间。可以理解，在一个实施例中，可以同时存在绑线间隔一根连接杆、两根连接杆或多根连接杆穿梭于裸支架的其他两根连接杆的内表面与外表面之间(比如，一圈波圈中，绑线间隔一根连接杆穿梭于裸支架的其他两根连接杆的内外表面之间；另一圈波圈中，绑线间隔两根连接杆穿梭于裸支架的其他两根连接杆的内外表面之间；再一圈波圈中，绑线间隔三根连接杆穿梭于裸支架的其他两根连接杆的内外表面之间等)，也可以单独存在绑线只间隔一根连接杆穿梭于裸支架的两根连接杆的内表面与外表面之间(比如，每圈波圈中，绑线均间隔一根连接杆穿梭于裸支架的其他两根连接杆的内表面与外表面之间等)，或单独存在绑线间隔两根连接杆穿梭于裸支架的两根连接杆的内表面与外表面之间(比如，每圈波圈中，绑线均间隔两根连接杆穿梭于裸支架的其他两根连接杆的内表面与外表面之间等)，或单独存绑线在间隔三根或者更多根连接杆穿梭于裸支架的其他两根连接杆的内表面与外表面之间(比如，每圈波圈中，绑线均间隔三根或者更多根连接杆穿梭于裸支架的其他两根连接杆的内表面与外表面之间等)，或绑线穿梭于一个波圈的相邻的两根连接杆的内表面和外表面之间，或者是上述方式的各种组合。
需要说明的是，当绑线缠绕于裸支架的内表面或外表面时，绑线可以从裸支架的一个波圈缠绕至与该波圈相邻的另一波圈，如绑线从上波圈的波谷位置缠绕至与该上波圈相邻的下波圈的波峰位置；绑线也可以为多段或多根绑线，多段绑线缠绕于裸支架的波圈上或者多根绑线缠绕于裸支架的波圈上；或者是上述方式的各种组合。多段绑线缠绕于波圈上是指由至少两段以上绑线头尾相连地缠绕于波圈上。
绑线的缠绕并不受裸支架结构的影响，裸支架可以为各种结构的裸支架，譬如Z形波圈的裸支架或上下波圈相互约束的裸支架等等。
平行距离指的是呈环状或螺旋状缠绕的相邻的两根或两段绑线之间的垂直距离。
ePTFE、FEP或PTFE覆膜在圆周方向上有一定的可延性，长期受高压血流的冲击后，会导致支架出现一定程度的膨胀，甚至发生支架破裂，从而使支架的隔绝功能失效。本发明利用绑线的抗延伸性能，通过添加绑线的覆膜方式，在覆膜支架的外膜的外表面或外膜与内膜之间设置呈环状或螺旋状缠绕的绑线，有效抑制覆膜支架在高压血流的冲击下膨胀，从而减低由于支架膨胀而使支架功能失效的风险。
需要说明的是，本发明可通过绑线与覆膜的摩擦力防止绑线滑动而将绑线的线头固定住，也可以将绑线的两个线头互相缠绕固定或者打结绑定而将线头固定住。
实施例1
请参见图2，一种覆膜支架，包括ePTFE内膜100、ePTFE外膜103以及设置于ePTFE外膜103与ePTFE内膜100之间的自膨式裸支架101。自膨式裸支架101由多个沿覆膜支架的纵向中心轴线方向(即覆膜支架的轴向)间隔排列的Z形波圈组成，相邻的上下两个Z形波圈互不接触；ePTFE外膜103与ePTFE内膜100之间设置有呈环状的预紧缠绕的PTFE线102。相邻的两段PTFE线m和PTFE线n的垂直距离b范围为1-30mm，优选为2-12mm。PTFE线102呈环状预紧缠绕于自膨式裸支架101的外表面(如图2中的m)和ePTFE内膜的外表面上(如图2中的n)。
PTFE线102为实心的圆柱形状的单根绑线，具有良好的耐高温性能和圆周方向的抗拉伸性能，其耐高温大于100℃、可延伸率小于50％；丝径为0.01-0.4mm，优选为0.05-0.2mm。
可以理解，在其他实施例中，PTFE线102也可以为扁平形状的绑线，其宽度为 0.05-2mm，厚度为0.01-0.2mm；优选宽度为0.1-1mm，厚度为0.02-0.2mm。
需要说明的是，PTFE线102的数量(根数)和自膨式裸支架101的结构可以根据实际需要来确定，只要覆膜支架内设有绑内膜及裸支架的PTFE线即可。其他实施例中，PTFE线102也可以为通过多段或多根绑线的形式进行预紧缠绕，不限于本实施例中的单根环形绑线。
PTFE线102预紧缠绕后，通过热处理将PTFE线102、自膨式裸支架101、ePTFE内膜100以及ePTFE外膜103粘结为一个整体，从而整体增强ePTFE膜的抗延伸性能，有效抑制自膨式裸支架和ePTFE膜在高压血流的冲击下膨胀。
可以理解的是，其他实施例中，绑线的材料还可以为ePTFE、PET等材料，只要绑线的耐高温大于100℃、可延伸率小于50％。
实施例2
请参见图3，本实施例的覆膜支架的结构与实施例1的覆膜支架的结构类似，不同之处仅在于，PTFE线200呈螺旋状预紧缠绕于自膨式裸支架201的外表面和ePTFE内膜202的外表面上。
需要说明的是，当PTFE线200呈螺旋状缠绕于自膨式裸支架201的内表面或外表面时，PTFE线200可以从自膨式裸支架201的波圈C缠绕至与波圈C相邻的波圈D。例如，请再次参见图3，PTFE线200从波圈C的波谷c位置的外表面缠绕至与波圈C相邻的波圈D的波峰d位置的外表面。
可以理解，在其他实施例中，PTFE线200也可以为多段或多根绑线，分别缠绕于裸支架的各个波圈上，或者是上述方式的各种组合。
实施例3
请参见图4，本实施例的覆膜支架的结构与实施例1的覆膜支架的结构类似，区别仅仅在于，本实施例的PTFE线300呈环状预紧缠绕于自膨式裸支架301的内表面和ePTFE内膜302的外表面上。
实施例4
请参见图5，本实施例的覆膜支架的结构与实施例3的覆膜支架的结构类似，区别仅仅在于，本实施例的PTFE线400呈螺旋状预紧缠绕于自膨式裸支架401的内表面和ePTFE内膜402的外表面上。
实施例5
请参见图6，一种覆膜支架，由ePTFE外膜503、ePTFE内膜500以及设置于ePTFE外膜503与ePTFE内膜500之间的自膨式裸支架501，自膨式裸支架501由多个沿覆膜支架的纵向中心轴方向(即覆膜支架的轴向)排列的Z形波圈组成，相邻的上下两个Z形波圈互不接触，ePTFE外膜503与ePTFE内膜500之间设置有呈环状预紧缠绕的PTFE线502。相邻的两段PTFE线h和PTFE线1的垂直距离k为1-30mm，优选为2-12mm。PTFE线502呈环状预紧穿梭于自膨式裸支架501的一个波圈的相邻两根连接杆连接杆的内表面与外表面之间。
需要说明的是，其他实施例中，PTFE线502可以间隔一根连接杆或两根连接杆甚至多根连接杆穿梭于自膨式裸支架的其他两根连接杆的内表面与外表面之间。可以理解，在一个实施例中，可以同时存在PTFE线间隔一根连接杆、两根连接杆或多根连接杆穿梭于自膨式裸支架的其他两根连接杆的内表面与外表面之间，也可以单独存在PTFE线穿梭于自膨式裸支架的一个波圈的相邻的两条连接杆的内表面与外表面之间连接杆连接杆(如本实施例)，或单独存在PTFE线间隔两根连接杆穿梭于裸支架其他两根连接杆的内表面与外表面之间，或单独存在PTFE线间隔三根或者更多根连接杆穿梭于裸支架其他两根连接杆的内表面与外表面之间，或者是上述穿梭方式的各种组合。
PTFE线502为实心的圆柱形状的单根绑线，具有良好的耐高温性能和圆周方向的抗拉伸性能，其耐高温大于100℃、可延伸率小于50％；丝径为0.01-0.4mm，优选为0.05-0.2mm。若丝径小于0.01毫米，绑线的抗拉伸性能较差；若丝径大于0.4毫米，绑线的可延伸率较差。
可以理解，在另一个实施例中，PTFE线502也可以为扁平形状的绑线，其宽度为0.05-2mm，厚度为0.01-0.2mm；优选宽度为0.1-1mm，厚度为0.02-0.2mm，这是因为，若 丝径小于0.01毫米，绑线的抗拉伸性能较差；若丝径大于0.4毫米，绑线的可延伸率较差。
需要说明的是，PTFE线502的数量(根数)和自膨式裸支架501的结构可以根据实际需要来确定，只要覆膜支架内设有绑内膜及裸支架的PTFE线即可。其他实施例中，PTFE线502也可以为通过多段或多根绑线的形式进行预紧缠绕，不限于本实施例中的单根环形绑线。
PTFE线502预紧穿梭后，通过热处理将PTFE线502、自膨式裸支架501、ePTFE内膜500以及ePTFE外膜503粘结为一个整体，从而整体增强ePTFE膜的抗延伸性能，有效抑制自膨式裸支架和ePTFE膜在高压血流的冲击下膨胀。
实施例6
请参见图7，本实施例的覆膜支架的结构与实施例5的覆膜支架的结构类似，其区别仅仅在于，本实施例的PTFE线602呈螺旋状预紧穿梭于自膨式裸支架601连接杆的内表面与外表面之间。
请再次参见图7，需要说明的是，当PTFE线602呈螺旋状穿梭于裸支架的内表面或外表面时，PTFE线602可以从裸支架601的a波圈的波谷位置的内表面缠绕至与a波圈相邻的b波圈的波峰位置的外表面(见图7-1)。可以理解，在另一个实施例中，PTFE线602也可以从a波圈的波谷位置的内表面缠绕至与a波圈相邻的b波圈的波峰位置的内表面(见图7-2)。
实施例7
请参见图8，一种覆膜支架，包括ePTFE内膜700、ePTFE外膜703以及设置于ePTFE外膜703与ePTFE内膜700之间的自膨式裸支架701，自膨式裸支架701由多个沿覆膜支架的纵向中心线方向(即覆膜支架的轴向)排列的Z形波圈组成，相邻的上下两个Z形波圈互不接触；ePTFE外膜703的外表面设置有呈环状预紧缠绕的PTFE线702。相邻的两段PTFE线z和PTFE线w的垂直距离t范围为1-30mm，优选为2-12mm，这是因为若垂直距离小于1毫米，绑线密度太大，会影响覆膜支架的弯曲性能；若垂直距离大于30毫米，绑线的密度太低，难以抑制覆膜支架的膨胀。PTFE线702预紧缠绕于ePTFE外膜的外表面 后，可以采用胶水粘合将其固定于外膜的外表面上，从而整体增强ePTFE膜的抗延伸性能，有效抑制自膨式裸支架和ePTFE膜在高压血流的冲击下膨胀。
PTFE线702为圆柱形状的单根绑线，具有良好的耐高温性能和圆周方向的抗拉伸性能，其耐高温大于100℃、可延伸率小于50％；丝径为0.01-0.4mm，优选为0.05-0.2mm。
可以理解，在一个实施例中，PTFE线702也可以为扁平形状的绑线，其宽度为0.05-2mm，厚度为0.01-0.2mm；优选宽度为0.1-1mm，厚度为0.02-0.2mm。
需要说明的是，PTFE线702的数量(根数)和自膨式裸支架701的结构可以根据实际需要确定，只要覆膜支架内设有绑内膜及裸支架的PTFE线即可。在其他实施例中，PTFE线702也可以为通过多段或多根绑线的形式进行预紧缠绕，不限于本实施例中的单根环形绑线。
参见图9，在另一个实施例中，PTFE线702也可以呈螺旋状缠绕于ePTFE外膜的外表面上。
效果实施例
通过测试未添加绑线的覆膜支架和添加绑线的覆膜支架的直径变化，以说明本发明的技术效果。
测试方法：采用一实心的塞子封闭覆膜支架的一端，采用另一带硅胶管的塞子(带硅胶管的塞子可以采用如下方法制成：首先，在实心的塞子的几何中心开设一个通孔；其次，在该通孔中插入一根与塞子过盈配合的硅胶管，且该硅胶管的一段露出该塞子，即可获得带硅胶管的塞子)塞住覆膜支架的另一端，且该带硅胶管的塞子的硅胶管一部分位于覆膜支架内部，一部分位于覆膜支架的外部，露在覆膜支架外的硅胶管的外壁上设置有压力计，露在覆膜支架外的硅胶管的管腔口连接水源；打开水源，排出硅胶管的管腔内的空气，并将水压稳定在25Kpa(188mmHg)，覆膜支架在水压下膨胀至稳定状态，记录下初始直径。后续根据预定时间点测试覆膜支架的膨胀直径，并记录相关的数据，结果如表1所示。
从表1可以看出，加绑线的覆膜支架在加压的状态下，随着时间的推移，其直径变化较小，而普通的覆膜支架在加压状态下，时间越长，其直径增加越大。
表1普通覆膜支架与本发明的覆膜支架的效果对比数据
Figure PCTCN2017099030-appb-000001
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，这些均属于本发明的保护之内。

Claims (13)

  1. 一种覆膜支架，包括外膜、内膜以及设置于所述外膜与所述内膜之间的裸支架，其特征在于，所述外膜的外表面或/和所述外膜与所述内膜之间设置有至少一根绑线。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线呈环状或者螺旋状地缠绕于所述裸支架的外表面、所述裸支架的内表面或所述内膜的外表面上。
  3. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线穿梭于所述裸支架的两根连接杆的内表面与外表面之间。
  4. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线的根数为多根，多根所述绑线中，相邻两根所述绑线之间的垂直距离范围为1毫米至30毫米。
  5. 根据权利要求4所述的覆膜支架，其特征在于，所述绑线的根数为多根，多根所述绑线中，相邻两根所述绑线之间的垂直距离范围为2毫米至12毫米。
  6. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线为耐高温大于100℃、可延伸率小于50％的绑线。
  7. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线为圆柱状或扁平状绑线。
  8. 根据权利要求7所述的覆膜支架，其特征在于，所述圆柱状绑线的丝径范围为0.01毫米至0.4毫米。
  9. 根据权利要求7所述的覆膜支架，其特征在于，所述圆柱状绑线的丝径范围为0.05毫米至0.2毫米。
  10. 根据权利要求7所述的覆膜支架，其特征在于，所述扁平状绑线的宽度范围为0.05毫米至2毫米、厚度范围为0.01毫米至0.2毫米。
  11. 根据权利要求7所述的覆膜支架，其特征在于，所述扁平状绑线的宽度范围为0.1毫米至1毫米、厚度范围为0.02毫米至0.2毫米。
  12. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线可为单根绑线、多根或多段绑线。
  13. 根据权利要求1所述的覆膜支架，其特征在于，所述绑线为PTFE线。
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