WO2020125315A1 - 编织支架 - Google Patents

编织支架 Download PDF

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Publication number
WO2020125315A1
WO2020125315A1 PCT/CN2019/120146 CN2019120146W WO2020125315A1 WO 2020125315 A1 WO2020125315 A1 WO 2020125315A1 CN 2019120146 W CN2019120146 W CN 2019120146W WO 2020125315 A1 WO2020125315 A1 WO 2020125315A1
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WO
WIPO (PCT)
Prior art keywords
coil
distal
wave
proximal
braided
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Application number
PCT/CN2019/120146
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English (en)
French (fr)
Inventor
浦文俊
肖本好
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深圳市先健畅通医疗有限公司
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Publication of WO2020125315A1 publication Critical patent/WO2020125315A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—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
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place

Definitions

  • the invention relates to the field of medical equipment, in particular to a braided stent.
  • Stents used in blood vessels especially in the treatment of aortic aneurysms, often require the stent to have a better anti-shrinkage performance, otherwise the part of the lumen stent that isolates the tumor cavity may slip due to shortening Into the tumor cavity, causing failure and even endangering the patient's life.
  • the proximal and distal ends of the luminal stent need to have good flexibility, otherwise due to the impact of blood flow and the periodic pulsation of the blood vessel, the proximal and distal ends of the stent will continue to stimulate the blood vessel wall and cause serious damage to the blood vessel wall. Broken proximal or distal.
  • the existing luminal stent is often designed with a longitudinal connector in the middle of the stent to connect the adjacent waveforms of the luminal stent, which plays a role of overall anti-shortening, and at the same time avoids the connector that runs through the entire luminal stent Designed to avoid damage to the vessel wall caused by the end of the connector.
  • the cutting stent is formed by laser cutting the tube.
  • the fatigue performance of the cutting lumen stent is often weaker than that of the braided stent.
  • the longitudinal connector fatigue breaks, the axial shrinkage resistance of the stent will deteriorate, and at the same time
  • the radial force of the cutting stent is often weak, so it is easier to slip into the tumor cavity.
  • the edge of the cutting stent is often sharper than the braided stent, and the stimulation of the proximal and distal blood vessel walls will be greater.
  • the braided stent is a wire formed by braiding and shaped. Since the wire is generally round, the stimulation of the blood vessel wall will be less than that of the cutting stent.
  • the existing braided support generally includes a plurality of wave coils distributed along the axial direction and a connecting piece connecting the multiple wave coils, and the connecting piece is connected to a wave rod on the wave coil.
  • the existing solution does not use one connector to connect all the coils. The reason is that if one connector penetrates all the coils, one of the two rods near the connector at the proximal or distal end of the stent, one It is directly connected to the wave rod, and the other wave rod is not connected to the connector. When the stent is pressed by the blood vessel wall, it will cause the connector to twist at the distal position, which will increase the risk of fatigue fracture. See Figure 1 section. In order to improve the above problems, the prior art proposes a solution.
  • the braided stent 11 includes a proximal coil 12, a distal coil 13, and a plurality of central coils 14 between the proximal coil 12 and the distal coil 13, the proximal coil 12.
  • the far-end wave coil 13 and the middle wave coil 14 are braided by metal wire.
  • the braided bracket 11 further includes a first connector 15 connecting a plurality of middle wave coils 14 and connecting the far-end wave coil 13 and the middle wave coil 14
  • the second connecting member 16 is generally at least two, and a plurality of second ⁇ connecting members 16 can disperse the force of the blood vessel, thereby increasing the stability of the distal end of the braided stent 11 and reducing the braided stent 11 There is a risk of reversal at the distal end. However, this design will increase the sheath size of the braided stent 11 and may also reduce the flexibility of the distal end of the braided stent 11.
  • the object of the present invention is to solve at least one of the problems in the above-mentioned prior art, and the object is achieved by the following technical solutions:
  • a braided stent includes a body segment, the body segment includes a proximal coil, a plurality of intermediate coils, and a distal coil in turn from a proximal end to a distal end, and the body segment further includes an axis along the body segment A connecting piece extending in the direction, the connecting piece connecting a plurality of the intermediate coils, the connecting piece extends to the intersection of the distal coils, and the braided wire for weaving the connecting piece continues to weave to form the The far-end wave coil, and the intersection point of the connecting member and the far-end wave coil is located at the crest or trough of the far-end wave coil.
  • a braided stent includes a main body segment, the main body segment includes a proximal coil, a plurality of intermediate coils, and a distal coil in turn from a proximal end to a distal end, and the main body segment further includes an axis along the braided stent An extended connector that connects a plurality of intermediate coils, the connector extends until the proximal coil intersects, and the braided wire used to weave the connector continues to weave to form the proximal wave Circle, and make the intersection of the connecting member and the proximal wave circle at the peak or valley of the proximal wave circle.
  • the connecting member extends to intersect the far-end coil/near-end coil, and the intersection point of the connecting member and the far-end coil/near-end coil is at the crest or trough of the far-end coil/near-end coil
  • the distal/proximal end of the braided stent can be substantially symmetrical with respect to the connector, and when the force of the blood vessel wall is applied, the circumferential component of the force can be substantially the same, so the distal/proximal end of the braided stent is not likely to twist Trend, can reduce the risk of fatigue fracture of the connector due to internal torsional stress, and directly connect to the distal coil/proximal coil through a connector to provide more consistent axial force and avoid Assembly problems caused by root connectors.
  • Figure 1 is the effect diagram of the torsion tendency of the assumed braided stent after being stressed
  • FIG. 2 is a schematic structural diagram of a braided stent in the prior art
  • FIG. 3 is a schematic structural view of the braided stent shown in FIG. 1 from another angle (with the cover film removed);
  • FIG. 4 is a schematic structural diagram of a braided stent according to the first embodiment of this application.
  • FIG. 5 is a partial structural schematic diagram of the braided stent shown in FIG. 4;
  • FIG. 6 is a schematic structural diagram of a braided stent according to a second embodiment of this application.
  • FIG. 7 is a schematic structural diagram of a braided stent according to a third embodiment of this application.
  • FIG. 8 is a schematic structural diagram of a braided stent according to a fourth embodiment of the present application.
  • FIG. 9 is a partial schematic structural view of the braided stent shown in FIG. 8.
  • FIG. 10 is a schematic structural view of the intermediate wave circle shown in FIG. 8;
  • FIG. 11 is a schematic structural diagram of a braided stent according to a fifth embodiment of the present application.
  • FIG. 12 is a schematic structural diagram of a braided stent according to a sixth embodiment of the present application.
  • proximal end is the proximal end, that is, the end near the heart after implantation
  • distal end is the distal end, that is, the end far from the heart after implantation.
  • Axial generally refers to the length of the braided stent when it is delivered
  • radial generally refers to the direction perpendicular to the “axial” of the braided stent, and defines the “axial” of any component of the braided stent according to this principle “And “radial”.
  • the braided stent 10 provided in the first embodiment of the present application includes a body segment 100, and the body segment 100 includes a proximal coil 101, a plurality of intermediate coils 102, and a distal coil 103 in sequence from a proximal end to a distal end
  • the main body segment 100 further includes a connecting member 105 extending along the axial direction of the main body segment 100, the connecting member 105 connects a plurality of proximal wave coils 102, the connecting member 102 extends to intersect the distal wave coil 103, and is used to braid the connecting member 105
  • the braided wire continues to weave to form the distal coil 103, and the intersection of the connecting member 105 and the distal coil 103 is located at the peak 1033 of the distal coil 103.
  • each of the near-end wave coil 101 and the far-end wave coil 103 is one, and the middle wave coil 102 includes at least two.
  • the connecting member 105 extends to intersect the distal coil 103, and the intersection of the connecting member 105 and the distal coil 103 is located at the peak 1033 of the distal coil 103, the distal end of the braided stent 10 may be opposite
  • the connecting member 105 is basically symmetrical, when the force of the blood vessel wall is applied, the circumferential component force can be substantially the same, so the tendency of the distal end of the braided stent 10 to twist is less likely to occur, which can reduce the cause of the connecting member 105 due to internal torsional stress There is a risk of fatigue fracture, and the direct connection to the distal coil 103 through a connecting member 105 can provide a more consistent axial force, and can also avoid assembly problems caused by multiple connecting members.
  • the distal coil 103 and the connecting member 105 are woven with a braided wire.
  • the braided wire continues to extend to the distal coil 103, starting from position 1 to the peak 1033, then to the right Weave to position 2, go to the trough in the direction of the arrow, and then go up to the crest, and so on. After reaching position 3, continue knitting in the direction of the arrow until it coincides with 1 and fix the braided wire at the 1 position.
  • the braided wires may be secured together by the steel sleeve 106.
  • the braided wires can also be fixed together by welding. It can be seen from the figure that the position where the braided wire is combined is located in the position of the connecting member 105, rather than in the distal coil 103, and the connection between the connecting member and the distal coil in the prior art is on the distal coil.
  • the connection point of the applied braided wire is located on the connecting piece 105 instead of the distal wave coil 103.
  • the connection point is harder due to the connection of the steel sleeve connection and the like, so the flexibility of the remote wave coil 103 in this application is better , Help absorb the fluctuations of the blood vessel wall, reduce the stimulation of blood vessels.
  • the lengths of the two wave rods 1031 connected to the distal wave coil 103 and the connecting member 105 are equal, so that the force of the wave rods 1031 on both sides of the connecting member 105 will be more uniform, and it is difficult to produce the connecting member 105
  • the twisting force reduces the risk of fatigue fracture of the connecting member 105, and also facilitates sheathing.
  • a rounded corner 1032 is provided at the connection between the distal wave coil 103 and the connecting member 105.
  • both the connecting points of the two wave rods 1031 and the connecting member 105 are provided with rounded corners 1032.
  • the distal wave coil 103 can be provided with elasticity to absorb the force of the distal wave coil 103 with the pulsation of the blood vessel, reduce the stimulation of the blood vessel by the distal wave coil 103, and can also make the distal wave coil 103 The structure is more stable.
  • the apexes of the peaks of the distal wave coils 103 are on the circumferential surface perpendicular to the axial direction of the main body 100, that is, the peaks of the wave peaks of the distal wave coil 103 are substantially flush.
  • the wave height h of the far-end wave circle that is, the distance between the peak of the peak and the peak of the valley in the axial direction of the main body 100, where 6mm ⁇ h ⁇ 20mm.
  • the wave heights of the far-end wave coils 103 are all equal, and 8mm ⁇ h ⁇ 16mm.
  • the wave number n of the far-end coil 103 that is, the number of peaks or troughs of the far-end coil 103, where 6 ⁇ n ⁇ 15, when the wave number is too small, it will affect the sticking of the far-end coil 103 Wall effect, and when the wave number is too large, it will increase the difficulty of sheathing the distal wave coil 103.
  • the radius r of the rounded corner 1032 where 1mm ⁇ r ⁇ 5mm, when the rounded corner is too large, the rounded corner cannot be compressed enough when the sheath is installed, and the rounded corner will occupy more space in the sheath tube and affect the installation.
  • the sheath while the fillet is too small, will affect the fatigue performance.
  • the angle ⁇ between two adjacent wave rods where 30° ⁇ 120°. In this embodiment, 60° ⁇ 100°.
  • the wire diameter of the far-end wave coil 103 is d1
  • the wire diameter of the middle-wave coil 102 is d2, where 0.5 ⁇ d1/d2 ⁇ 0.95, the wire diameter of the far-end wave coil 103 is smaller, which has better
  • the flexibility can absorb the force of a part of the blood vessel wall on the distal coil, and thus can reduce the force transmitted to the connecting member 105, thereby further reducing the risk of fatigue fracture of the connecting member 105.
  • the supporting force of the distal wave coil 103 will be too small, which is insufficient to provide sufficient radial support force to make it closely adhere to the inner wall of the blood vessel, affecting the adhesion of the distal wave coil 103 Wall effect.
  • the wire diameter of the distal wave coil 103 is large, it may cause damage to the blood vessel wall. In one embodiment, 0.75 ⁇ d1/d2 ⁇ 0.9, and 0.35mm ⁇ d1 ⁇ 0.5mm.
  • the wire diameter of the distal wave coil 103 may be the same as the wire diameter of the intermediate wave coil 102.
  • the wire diameter of the proximal wave coil 103 may be the same as the wire diameter of the middle wave coil 102, and the wire diameter of the proximal wave coil 103 may also be the same as the wire diameter of the distal wave coil 102.
  • the braided stent 10 further includes a bare stent segment 130 connected to the body segment 100.
  • the body segment 100 further includes a coating 107.
  • the coating 107 covers the near-end wave coil 101, the middle wave coil 102, the far-end wave coil 103, and the connecting member 105.
  • the proximal coil 101, the intermediate coil 102, the distal coil 103, and the connecting member 105 may use stainless steel, nickel-titanium alloy, or other wire materials as braided wires, and the cross section may be circular, elliptical, or other shapes.
  • the coating 107 may be a polymer material with good biocompatibility such as PTFE, PET, etc.
  • the coating 107 may be fixed to one of the proximal coil 101, the intermediate coil 102, the distal coil 103 and the connecting member 105 by sewing On the side, or by laminating, the near-end coil 101, the middle-wave coil 102, the far-end coil 103, and the connecting member 105 are wrapped between the two layers of coating 107.
  • the structure of the braided stent 20 provided by the second embodiment of the present application is substantially the same as the structure of the braided stent 10 of the first embodiment, the difference is mainly that the intersection of the connecting member 205 and the distal coil 203 is located far The valley 2034 of the end wave circle 203.
  • the weaving of the far-end wave coil 203 refer to Embodiment 1, and details are not described herein again.
  • the structure of the braided stent 30 provided in the third embodiment of the present application is substantially the same as the structure of the braided stent 10, except that the end of the connecting member 305 away from the distal coil 303 also extends to the proximal end
  • the coil 301 intersects, and the braided wire for braiding the connector 305 continues to weave to form the proximal coil 301, and the intersection of the connector 305 and the proximal coil 301 is located at the valley 3011 of the proximal coil 301.
  • the intersection of the connecting member 305 and the proximal coil 301 may also be located at the peak of the proximal coil 301.
  • the above braided stent 30 can improve the stability of the proximal coil 301 and the distal coil 303 of the braided stent 30, and reduce the fatigue risk of the braided stent 30; moreover, the proximal end of the braided stent 30 can be connected to The distal end, relative to the structure of multiple connectors, can reduce the amount of metal at the end of the braided stent 30, which can allow the braided stent 30 to fit into a smaller sheath, and at the same time, the connector 305 can also transmit the action of the braided stent 30 toward The pushing force of the sheath tube can thus facilitate the sheathing.
  • the braided stent 30 can be connected to the proximal coil 301, the intermediate coil 302, and the distal coil 303 through a connecting member 305.
  • the force can pass through the connecting member 305 It is distributed to all the wave circles, so that the resistance of the braided stent 30 to displacement and shrinkage resistance can be improved.
  • the structure of the braided bracket 40 of the fourth embodiment of the present application is substantially the same as the structure of the braided bracket 30 of the third embodiment, the difference is mainly that the intersection of the connecting member 405 and each intermediate coil 402 is located at this The peak 4021 of the middle wave circle 402.
  • the intersection of the connecting member 405 and the intermediate wave circle 402 may also be located at the wave valley of the intermediate wave circle 402.
  • the intermediate coil 402 may be arranged symmetrically with respect to the connecting member 405, which may improve the circumferential stress unevenness of the intermediate region of the braided bracket 40, reduce the tendency of the intermediate region to twist, and thereby reduce the risk of fatigue fracture of the connecting member 405 .
  • the distal coil 403, the proximal coil 401, and the connecting member 405 are woven from the same braided wire.
  • Each intermediate coil 402 is braided by a braided wire, the start end and the end end of the braided wire coincide with each other, and the start end and the end end are parallel to the connecting piece 405, and the intermediate coil 402 is fixed by a steel sleeve through the start end and the end end On the connector 405.
  • the intermediate wave coil 402 is arranged symmetrically with respect to the connecting member 405.
  • the phase difference of the plurality of intermediate wave coils 402 is zero, that is, the connection lines of the peaks corresponding to the plurality of intermediate wave coils 402 are parallel to the axis of the braided bracket 40, and the connection line of the troughs of the plurality of intermediate wave coils 402 and the axis of the braided bracket 40 parallel.
  • the intermediate coil 402 and the connecting member 405 of the braided bracket 40 may be knitted by other methods.
  • the woven bracket 50 provided by the fifth embodiment of the present application includes a main body section 500 and a window opening section 550 connected to the main body section 500.
  • the body segment 500 includes a proximal wave coil 501, a plurality of intermediate wave coils 502, and a distal wave coil 503 in order from the proximal end to the distal end.
  • the body segment 500 further includes a connecting member 505 extending axially along the body segment 500, and the connecting member 505 A plurality of intermediate wave coils 502 are connected, the connecting member 505 extends until the proximal wave coil 501 intersects, and the braided wire for braiding the connecting member 505 continues to weave to form the proximal wave coil 501, and the connecting member 505 and the proximal wave coil
  • the intersection point of 501 is located at the peak 5011 of the proximal wave circle 501.
  • the window opening section 550 is located at the end of the proximal wave circle 501 away from the intermediate wave circle 502, and the window section 550 has a shorter shrinkage ratio than the body section 500.
  • the window opening segment 550 includes a plurality of window opening wave coils 551 distributed along the axial direction of the window opening segment 550, the plurality of window opening wave circles 551 are arranged at intervals, and there is no connection between the plurality of window opening wave circles 551 Pieces connected. Since the main body section 500 has the connecting member 505, its axial shortening rate is zero. Compared with the structure in which the body segment 500 has the connecting piece 505, the window segment 550 can conform to the changes of blood vessels, and the overall flexibility is better.
  • the proximal end of the body segment 500 may be substantially relative to the connector 505 Symmetrical, when the force of the blood vessel wall is applied, the circumferential component force can be basically the same, so the main body segment 500 is not prone to twisting, which can reduce the risk of fatigue fracture of the connector 505 due to internal torsional stress.
  • the axial shortening rate of the window section 550 is 10%-40%.
  • the axial shortening rate of the window opening section 550 is measured by the following method: in a natural state, the window opening section 550 has a length of a and a diameter of d, and the window opening section 550 is set in an inner tube with a diameter of 0.9d.
  • the pressure on the two ends of the window opening section 550 is 1 ⁇ 2N in the axial direction, the length of the first main body section cannot be shortened (no discount) is b, and the axial shortening rate of the window opening section 550 is (ab)* 100%/a.
  • the window opening section 550 When the length of the window opening section 550 reaches (a-b), the window opening section 550 will form a rigid axial support.
  • the window segment 550 is placed in the curved segment of the aortic arch (where the radius of curvature is small), and the body segment 500 is placed in the straight segment of the aortic arch (where the radius of curvature is large), because the window segment 550 can be axis Shortening, that is, the window section 550 has a certain flexibility in the axial direction, so that the window section 550 does not produce straightening force when conforming to the curved shape of the aortic arch, which improves the safety of the operation; while the body section 500 cannot Axial shortening can prevent the main body segment 500 from shortening under the action of blood flow, and prevent the end of the main body segment 500 from retracting into the tumor cavity and endangering the patient's life.
  • the structure of the braided stent 60 provided by the sixth embodiment of the present application is substantially the same as that of the braided stent 50 of the fifth embodiment.
  • the difference is that the end of the connecting member 605 away from the proximal coil 601 also extends to The distal coil 603 intersects, and the braided wire for braiding the connector 605 continues to weave to form the distal coil 603, and the intersection of the connector 605 and the distal coil 603 is located at the peak of the distal coil 603.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
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  • Prostheses (AREA)

Abstract

一种编织支架(10,20,30,40,60)，包括主体段(100)，主体段(100)从近端至远端依次包括近端波圈(101,301,401,601)、多个中间波圈(102,402)及远端波圈(103,203,303,403,603)，主体段(100)还包括沿主体段(100)的轴向延伸的连接件(105, 205,305,405,605)，连接件(105, 205,305,405,605)连接多个中间波圈(102,402)，连接件(105, 205,305,405,605)延伸至远端波圈(103,203,303,403,603)相交，且用于编织连接件(105, 205,305,405,605)的编织丝继续编织以形成远端波圈(103,203,303,403,603)并使连接件(105, 205,305,405,605)与远端波圈(103)的交点位于远端波圈(103,203,303,403,603)的波峰(1033)或波谷处。编织支架(10,20,30,40,60)可以降低连接件(105, 205,305,405,605)由于内部扭转应力的原因发生疲劳断裂的风险，而且可以提供更加一致的轴向力，还可以避免多根连接件带来的装配问题。

Description

编织支架 技术领域
本发明涉及医疗器械领域，特别是涉及一种编织支架。
背景技术
用于血管内的支架，尤其是用于治疗主动脉瘤的情况下，往往需要支架整体有比较好的抗短缩性能，否则管腔支架在隔绝瘤腔的部分可能会由于短缩而滑移进瘤腔，造成失效，甚至危及患者生命。同时管腔支架的近端、远端又需要有很好的柔性，否则由于血流冲击及血管周期性搏动，支架近端、远端会对血管壁造成持续刺激，严重的血管壁损伤，形成近端或者远端破口。因此，现有的管腔支架往往在支架中部设计有纵向的连接件，将管腔支架的相邻波形连接起来，起到整体抗短缩的作用，同时又避免贯穿整个管腔支架的连接件设计，以免连接件的端部对血管壁造成损伤。
目前，管腔支架主要有两大类，一类为切割支架，一类为编织支架。切割支架为管材经激光切割后定型而成，目前情况下切割类管腔支架的疲劳性能往往弱于编织支架，一旦纵向连接件疲劳断裂，支架的轴向抗短缩能力就会变差，同时切割支架的径向力往往较弱，因此更容易滑移进瘤腔。另外，切割支架的边缘往往较编织支架锋利，对近端、远端的血管壁的刺激也会较大。编织支架为金属丝通过编织后定型而成，由于金属丝一般为圆形，因此对血管壁的刺激会小于切割支架。
现有的编织支架一般包括沿轴向分布的多个波圈及连接多个波圈之间的连接件，连接件与波圈上的一波杆连接。但现有方案并不会采用一根连接件连接所有波圈，原因在于：若一根连接件贯穿所有波圈，在支架的近端或远端，靠近连接件的两个波杆中，一个直接与波杆连接，另一波杆并不与连接件连接， 当支架受到血管壁的压力时，会造成连接件在远端位置产生扭转的趋势，进而加剧疲劳断裂的风险，见图1虚线部分。为了改善上述问题，现有技术提出了一种解决方案。请参阅图2及图3，编织支架11包括近端波圈12、远端波圈13及位于近端波圈12与远端波圈13之间的多个中部波圈14，近端波圈12、远端波圈13及中部波圈14均通过金属丝编织而成，编织支架11还包括连接多个中部波圈14的第一连接件15及连接远端波圈13与中间波圈14的第二连接件16，第二连接件16一般至少为两个，多根第二θ连接件16可以分散血管的作用力，由此增加编织支架11的远端的稳定性，降低编织支架11的远端出现扭转的风险。但是这种设计，会增加编织支架11的装鞘尺寸，同时还可能降低编织支架11远端的柔顺性。
发明内容
本发明的目的是至少解决上述现有技术中存在的问题之一，该目的是通过以下技术方案实现的：
一种编织支架，包括主体段，所述主体段从近端至远端依次包括近端波圈、多个中间波圈及远端波圈，所述主体段还包括沿所述主体段的轴向延伸的连接件，所述连接件连接多个所述中间波圈，所述连接件延伸至所述远端波圈相交，且用于编织所述连接件的编织丝继续编织以形成所述远端波圈，并使所述连接件与所述远端波圈的交点位于所述远端波圈的波峰或波谷处。
一种编织支架，包括主体段，所述主体段从近端至远端依次包括近端波圈、多个中间波圈及远端波圈，所述主体段还包括沿所述编织支架轴向延伸的连接件，所述连接件连接多个中间波圈，所述连接件延伸至所述近端波圈相交，且用于编织所述连接件的编织丝继续编织以形成所述近端波圈，并使所述连接件与所述近端波圈的交点位于所述近端波圈的波峰或波谷处。
上述编织支架，由于连接件延伸到与远端波圈/近端波圈相交，且连接件与远端波圈/近端波圈的交点位于远端波圈/近端波圈的波峰或波谷处，编织支架的远端/近端可以相对于连接件基本对称，在受到血管壁的作用力时，其周向的分力可以基本相同，因此编织支架的远端/近端不易发生扭转的趋势，可以降低连 接件由于内部扭转应力的原因发生疲劳断裂的风险，而且通过一根连接件直接连接到远端波圈/近端波圈，可以提供更加一致的轴向力，还可以避免多根连接件带来的装配问题。
附图说明
图1为假定的编织支架在受力后产生扭转趋势的效果图；
图2为现有技术中编织支架的结构示意图；
图3为图1所示的编织支架另一角度的结构示意图(去掉覆膜)；
图4为本申请第一实施例的编织支架的结构示意图；
图5为图4所示的编织支架的局部结构示意图；
图6为本申请第二实施例的编织支架的结构示意图；
图7为本申请第三实施例的编织支架的结构示意图；
图8为本申请第四实施例的编织支架的结构示意图；
图9为图8所示的编织支架的局部结构示意图；
图10为图8所示的中间波圈的结构示意图；
图11为本申请第五实施例的编织支架的结构示意图；
图12为本申请第六实施例的编织支架的结构示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的， 并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
需要说明的是，本申请中，“近端”为近心端，即植入后靠近心脏的一端，“远端”为远心端，即植入后远离心脏的一端。“轴向”一般是指编织支架在被输送时的长度方向，“径向”一般是指编织支架与其“轴向”垂直的方向，并依据此原理定义编织支架的任一部件的“轴向”和“径向”。
请参阅图4，本申请第一实施例提供的编织支架10包括主体段100，主体段100从近端到远端依次包括近端波圈101、多个中间波圈102及远端波圈103，主体段100还包括沿主体段100的轴向延伸的连接件105，连接件105连接多个近端波圈102，连接件102延伸至于远端波圈103相交，且用于编织连接件105的编织丝继续编织以形成远端波圈103，并使连接件105与远端波圈103的交点位于远端波圈103的波峰1033处。在本实施例中，近端波圈101及远端波圈103均为一个，中间波圈102包括至少两个。
上述编织支架10，由于连接件105延伸到与远端波圈103相交，且连接件105与远端波圈103的交点位于远端波圈103的波峰1033处，编织支架10的远端可以相对于连接件105基本对称，在受到血管壁的作用力时，其周向的分力可以基本相同，因此编织支架10的远端不易发生扭转的趋势，可以降低连接件105由于内部扭转应力的原因发生疲劳断裂的风险，而且通过一根连接件105直接连接到远端波圈103，可以提供更加一致的轴向力，还可以避免多根连接件带来的装配问题。
具体地，远端波圈103和连接件105采用一根编织丝编织而成。请参阅图5，用于编织连接件105的编织丝在编织到与最后一个中间波圈102后，编织丝继续向远端波圈103延伸，从位置1开始到波峰1033处后，往右侧编织到位置2，沿着箭头的方向到波谷，然后向上到波峰，如此反复，到达位置3后沿着箭头的方向继续编织至与1重合，并在1的位置将编织丝固定。在一实施例中，可 以通过钢套106将编织丝固定在一起。当然，也可以通过焊接将编织丝固定在一起。从图中可知，编织丝结合的位置位于连接件105的位置，而不是在远端波圈103内，相对于现有技术连接件与远端波圈的连接处在远端波圈上，本申请的编织丝的连接处位于连接件105上，而不是在远端波圈103上，连接处由于钢套连接等连接而硬度较大，因此本申请中远端波圈103的柔韧性较好，有助于吸收血管壁的波动，降低对血管的刺激。
请继续参阅图4，远端波圈103与连接件105相连的两个波杆1031的长度相等，这样连接件105两侧的波杆1031的受力会比较均匀，较难对连接件105产生扭转的力，降低了连接件105疲劳断裂的风险，同时也便于装鞘。远端波圈103与连接件105的连接处设置有圆角1032。在图示的实施例中，两个波杆1031与连接件105的连接处均设置有圆角1032。通过圆角1032过渡，可以给远端波圈103提供弹性以吸收远端波圈103随血管的搏动的作用力，降低远端波圈103对血管的刺激，同时也可以使远端波圈103的结构更加稳定。
在一实施例中，远端波圈103的各波峰的顶点的连线在垂直于主体部100轴向的圆周面上，即，远端波圈103的波峰的顶点基本齐平。在一实施例中，远端波圈的波高h，即波峰顶点与波谷顶点在主体部100轴向方向上的距离，其中6mm≤h≤20mm。在本实施例中，远端波圈103的波高均相等，且8mm≤h≤16mm。在一实施例中，远端波圈103的波数n，即远端波圈103的波峰或波谷的个数，其中6≤n≤15，当波数太小时，会影响远端波圈103的贴壁效果，而波数太大时，则会增加远端波圈103的装鞘难度。在本实施例中，7≤n≤12。在一实施例中，圆角1032的半径r，其中1mm≤r≤5mm，当圆角太大，装鞘时圆角无法被足够的压缩，圆角会占据鞘管较多的空间而影响装鞘，而圆角太小，则会影响疲劳性能。在本实施例中，2mm≤r≤5mm。在一实施例中，相邻两个波杆之间的夹角θ，其中30°≤θ≤120°。在本实施例中，60°≤θ≤100°。
在一实施例中，远端波圈103的丝径为d1，中间波圈102的丝径为d2，其中0.5≤d1/d2≤0.95，远端波圈103的丝径较小，具有较好的柔性，可以吸收部分血管壁对远端波圈的作用力，进而可以减小传递到连接件105上的作用力，从而进一步降低连接件105疲劳断裂的风险。但是当远端波圈103的丝径过小时， 远端波圈103的支撑力会偏小，不足以提供足够的径向支撑力使其紧密贴附血管内壁，影响远端波圈103的贴壁效果。而当远端波圈103的丝径较大时，则有可能会造成血管壁的损伤。在一实施例中，0.75≤d1/d2≤0.9，且0.35mm≤d1≤0.5mm。
需要说明的是，远端波圈103的丝径也可以与中间波圈102的丝径相同。近端波圈103的丝径可以与中间波圈102的丝径相同，近端波圈103的丝径也可以与远端波圈102的丝径相同。
请继续参阅图4，编织支架10还包括与主体段100连接的裸支架段130，裸支架段130与位于近端波圈101远离中间波圈102的一端，主体段100还包括覆膜107，覆膜107覆盖近端波圈101、中间波圈102、远端波圈103及连接件105。近端波圈101、中间波圈102、远端波圈103及连接件105可以使用不锈钢、镍钛合金等丝材作为编织丝，其截面可以是圆形、椭圆或者其他形状。覆膜107可以是PTFE、PET等生物相容性较好的高分子材料，覆膜107可以通过缝合固定在近端波圈101、中间波圈102、远端波圈103及连接件105的一侧，或者通过层压将近端波圈101、中间波圈102、远端波圈103及连接件105包裹在两层覆膜107之间。
请参阅图6，本申请第二实施例提供的编织支架20的结构与实施例一的编织支架10的结构大体相同，不同之处主要在于，连接件205与远端波圈203的交点位于远端波圈203的波谷2034处。远端波圈203的编织可以参照实施例一，在此不再赘述。
请参阅图7，本申请第三实施例提供的编织支架30的结构与编织支架10的结构大体相同，不同之处主要在于，连接件305远离远端波圈303的一端也延伸至与近端波圈301相交，且用于编织连接件305的编织丝继续编织以形成近端波圈301，并使连接件305与近端波圈301的交点位于近端波圈301的波谷3011处。可以理解的是，在其他实施例中，根据具体的要求，连接件305与近端波圈301的交点也可以位于近端波圈301的波峰处。
上述编织支架30，可以提高编织支架30的近端波圈301及远端波圈303的稳定性，降低编织支架30的疲劳风险；而且通过一根连接件305可以连接编织 支架30的近端及远端，相对于多根连接件的结构，可以降低编织支架30的端部的金属量，能够使得编织支架30装入较小的鞘管，同时连接件305还可以传递作用于编织支架30向着鞘管推进的作用力，因而可以有利于装鞘。此外，编织支架30可以通过一根连接件305连接近端波圈301、中间波圈302及远端波圈303，当编织支架30局部受到较大的作用力时，作用力可以通过连接件305分散到所有的波圈上，从而可以提高编织支架30的抗移位和抗短缩能力。
请参阅图8，本申请第四实施例的编织支架40的结构与实施例三的编织支架30的结构大体相同，不同之处主要在于，连接件405与每一中间波圈402的交点位于该中间波圈402的波峰4021处。当然，在其他实施例中，连接件405与中间波圈402的交点也可以位于该中间波圈402的波谷处。
上述编织支架40，中间波圈402可以关于连接件405呈对称设置，可以改善编织支架40的中间区域的周向的应力不均匀，降低中间区域扭转的趋势，从而降低连接件405疲劳断裂的风险。
请一并参阅图9及图10，远端波圈403、近端波圈401及连接件405采用同一编织丝编织而成。每一中间波圈402通过一根编织丝编织，编织丝的起始端与结束端相互重合，且起始端和结束端与连接件405平行，中间波圈402通过起始端与结束端通过钢套固定在连接件405上。在图示的实施例中，中间波圈402关于连接件405呈对称设置。多个中间波圈402的相位差为零，即多个中间波圈402对应的波峰的连线与编织支架40的轴线平行，多个中间波圈402的波谷的连线与编织支架40的轴线平行。
需要说明的是，在其他实施例中，编织支架40的中间波圈402与连接件405也可以通过其他方法编织而成。
请参阅图11，本申请的第五实施例提供的编织支架50包括主体段500及与主体段500连接的开窗段550。主体段500从近端至远端依次包括近端波圈501、多个中间波圈502及远端波圈503，主体段500还包括沿主体段500轴向延伸的连接件505，连接件505连接多个中间波圈502，连接件505延伸至近端波圈501相交，且用于编织连接件505的编织丝继续编织以形成近端波圈501，并使连接件505与近端波圈501的交点位于近端波圈501的波峰5011处。开窗段550位 于近端波圈501远离中间波圈502的一端，开窗段550的短缩率大于主体段500的短缩率。
具体的，开窗段550包括多个沿开窗段550的轴向分布的开窗波圈551，多个开窗波圈551之间间隔设置，而且多个开窗波圈551之间无连接件连接。主体段500由于具有连接件505，其轴向短缩率为零。与主体段500具有连接件505的结构相比，开窗段550可以顺应血管变化，整体柔顺性较好，因此由开窗段550过渡到主体段500时，编织支架50的柔顺性在主体段500与开窗段550的连接处发生突变，编织支架50在主体段500与开窗段550的连接处的受力也会更加集中。通过将连接件505延伸到与近端波圈501相交，且连接件505与近端波圈501的交点位于近端波圈501的波峰处，主体段500的近端可以相对于连接件505基本对称，在受到血管壁的作用力时，其周向的分力可以基本相同，因此主体段500不易发生扭转的趋势，可以降低连接件505由于内部扭转应力的原因发生疲劳断裂的风险，
在一实施例中，开窗段550的轴向短缩率为10％～40％。开窗段550的轴向短缩率通过如下方法测得：在自然状态下，开窗段550的长度为a，直径为d，将开窗段550套在直径为0.9d的内管中，对开窗段550的两端施加沿轴向1～2N的压力第一主体段无法再短缩时(不打折)的长度为b，开窗段550的轴向短缩率为(a-b)*100％/a。当开窗段550的长度达到(a-b)时，开窗段550会形成一个刚性的轴向支撑。使用时，将开窗段550置入主动脉弓的弯曲段(曲率半径较小的位置)，将主体段500置入主动脉弓的平直段(曲率半径较大的位置)，由于开窗段550可以轴向短缩，即开窗段550轴向方向上具有一定的柔性，可以使得开窗段550在顺应主动脉弓部的弯曲形态时不会产生回直力，提高手术的安全性；而主体段500不能轴向短缩，可以避免主体段500在血流作用下发生短缩，避免主体段500的端部回缩至瘤腔而危及患者生命。
请参阅图12，本申请第六实施例提供的编织支架60与实施例五的编织支架50的结构大体相同，不同之处主要在于，连接件605远离近端波圈601的一端也延伸至与远端波圈603相交，且用于编织连接件605的编织丝继续编织以形成远端波圈603，并使连接件605与远端波圈603的交点位于远端波圈603的波 峰处。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种编织支架，包括主体段，所述主体段从近端至远端依次包括近端波圈、多个中间波圈及远端波圈，所述主体段还包括沿所述主体段的轴向延伸的连接件，所述连接件连接多个所述中间波圈，其特征在于，所述连接件延伸至所述远端波圈相交，且用于编织所述连接件的编织丝继续编织以形成所述远端波圈，并使所述连接件与所述远端波圈的交点位于所述远端波圈的波峰或波谷处。
  2. 根据权利要求1所述的编织支架，其特征在于，所述远端波圈与所述连接件相连的两个波杆的长度相等。
  3. 根据权利要求1所述的编织支架，其特征在于，所述远端波圈与所述连接件的连接处设置有圆角。
  4. 根据权利要求1所述的编织支架，其特征在于，所述远端波圈的丝径为d1，所述中间波圈的丝径为d2，其中0.5≤d1/d2≤0.95。
  5. 根据权利要求1所述的编织支架，其特征在于，所述连接件远离所述远端波圈的一端延伸至与所述近端波圈相交，且用于编织所述连接件的编织丝继续编织以形成所述近端波圈，并使所述连接件与所述近端波圈的交点位于所述近端波圈的波峰或波谷处。
  6. 根据权利要求1所述的编织支架，其特征在于，所述连接件与每一所述中间波圈的交点位于该所述中间波圈的波峰或波谷处。
  7. 根据权利要求1～6任一项所述的编织支架，其特征在于，所述编织支架还包括与所述主体段连接的裸支架段，所述裸支架段位于所述近端波圈远离所述中间波圈的一端，所述主体段还包括覆膜，所述覆膜覆盖所述近端波圈、所述中间波圈、所述远端波圈及所述连接件。
  8. 一种编织支架，包括主体段，所述主体段从近端至远端依次包括近端波圈、多个中间波圈及远端波圈，所述主体段还包括沿所述编织支架轴向延伸的 连接件，所述连接件连接多个中间波圈，其特征在于，所述连接件延伸至所述近端波圈相交，且用于编织所述连接件的编织丝继续编织以形成所述近端波圈，并使所述连接件与所述近端波圈的交点位于所述近端波圈的波峰或波谷处。
  9. 根据权利要求8所述的编织支架，其特征在于，所述编织支架还包括与所述主体段连接的开窗段，所述开窗段位于所述近端波圈远离所述中间波圈的一端，所述开窗段的短缩率大于所述主体段的短缩率。
  10. 根据权利要求9所述的编织支架，其特征在于，所述连接件延伸至所述远端波圈相交，且用于编织所述连接件的编织丝继续编织以形成所述远端波圈，并使所述连接件与所述远端波圈的交点位于所述远端波圈的波峰或波谷处。
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