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WO2022179095A1 - 血管支架 - Google Patents

血管支架 Download PDF

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Publication number
WO2022179095A1
WO2022179095A1 PCT/CN2021/119664 CN2021119664W WO2022179095A1 WO 2022179095 A1 WO2022179095 A1 WO 2022179095A1 CN 2021119664 W CN2021119664 W CN 2021119664W WO 2022179095 A1 WO2022179095 A1 WO 2022179095A1
Authority
WO
WIPO (PCT)
Prior art keywords
helical
support frame
support
vascular stent
braided layer
Prior art date
Application number
PCT/CN2021/119664
Other languages
English (en)
French (fr)
Inventor
李峥
刘享承
赵中
Original Assignee
珠海通桥医疗科技有限公司
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 珠海通桥医疗科技有限公司 filed Critical 珠海通桥医疗科技有限公司
Publication of WO2022179095A1 publication Critical patent/WO2022179095A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12159—Solid plugs; being solid before insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a vascular stent, which can be implanted into intracranial arterial vessels for treating diseases such as intracranial aneurysms.
  • Intracranial aneurysm is an abnormal bulge formed by the gradual expansion of intracranial arterial vessels due to congenital abnormality or acquired injury and other factors resulting in local vascular wall damage. Intracranial aneurysm rupture and hemorrhage has acute onset, severe symptoms, no obvious aura, and has a high mortality and morbidity rate.
  • the treatment of intracranial aneurysm is mainly divided into surgical clipping and endovascular interventional embolization, but surgical clipping is not popular with doctors and patients because of its large trauma, many complications, and long operation and recovery time.
  • surgical clipping is not popular with doctors and patients because of its large trauma, many complications, and long operation and recovery time.
  • endovascular interventional treatment technology With the development and progress of minimally invasive endovascular interventional treatment technology, more and more patients with intracranial aneurysm receive endovascular interventional treatment technology, and endovascular interventional embolization technology has gradually become the dominant technology for intracranial aneurysm treatment.
  • Intracranial complex aneurysms such as wide-necked aneurysms, fusiform aneurysms, large or giant aneurysms, and dissecting aneurysms require multiple coils for complete embolization and additional auxiliary devices (balloons) in the actual treatment process. or stent) to provide support for it, which increases the difficulty of the operation and prolongs the operation time on the one hand, and on the other hand, the cost of the whole operation process is also very expensive. Therefore, in order to solve the problems existing in the treatment of complex aneurysms, blood flow diverting devices have been designed and developed.
  • the blood flow guide device is a self-expanding stent with low porosity, which can reduce the blood exchange between the aneurysm body and the parent artery, induce thrombosis in the aneurysm, and promote the intimal hyperplasia at the neck of the aneurysm, so as to achieve the reconstruction of the parent artery. It is convenient and fast, and the immediate embolization rate is high.
  • the current blood flow diversion devices for the treatment of intracranial aneurysms still have the following problems:
  • the stent of the existing blood flow guide device is woven from multiple strands of filaments, and both ends of the stent have scattered braided filaments, which can easily damage the inner wall of the blood vessel during the pushing and releasing process;
  • the main purpose of the present invention is to provide a vascular stent, which solves the problems of obvious decrease in blood flow of collateral vessels or perforator vessels covered by the existing stent, damage to the blood vessels at both ends of the stent, and complicated operation.
  • the present invention provides a blood vessel stent, comprising: a support frame, the support frame is arranged in a tubular shape, and the support frame includes a first support section, a spiral section and a second support connected in sequence in the axial direction of the support frame
  • the helical segment is formed by a plurality of helical ribs extending side by side in the axial direction of the supporting frame;
  • the inner braided layer is tubularly arranged and covered on the inner peripheral wall of the helical segment, and the inner braided layer is composed of multiple braided wires.
  • the axial direction of the support frame is spirally extended and cross-woven.
  • each braided wire includes an inner core and an outer ring wrapped on the outer peripheral wall of the inner core, the inner core is made of a first material visible by X-ray, and the outer ring is made of a second material.
  • the cross-sectional area of the inner core is between 10% and 50% of the cross-sectional area of the braided filaments.
  • a further solution is that the pitches of the plurality of helical bars are equal.
  • a further solution is that a plurality of helical bars are arranged side by side at equal intervals in the axial direction of the support frame.
  • pitch of the helical bars is equal to the pitch of the braided wire.
  • a further solution is that the width of the helical bar in the circumferential direction of the supporting frame is larger than the diameter of the braided wire.
  • a plurality of first developing sleeves are provided at one end of the first support segment away from the helical segment; and/or an end of the second supporting segment away from the helical segment is provided with a plurality of second developing sleeves.
  • a further solution is that the first end of the inner braided layer is connected to the first ends of the plurality of helical ribs through a spring coil; and/or the second end of the inner braided layer is connected to the second end of the helical ribs through a spring coil .
  • a further solution is that the first end of the inner braided layer is clamped on the first end of the spiral rib through the C-shaped ring; and/or the second end of the inner braided layer is clamped on the first end of the spiral rib through the C-shaped ring. on the two ends.
  • the support frame of the vascular stent of the present invention has a helical section in the middle, and the helical section is formed by a plurality of helical ribs extending side by side in the axial direction of the support frame.
  • the radial support performance of the vascular stent is good, and the flexibility of the helical segment is good, which provides expansion space for the self-expanding inner braided layer and improves the self-expanding ability of the vascular stent.
  • the helical section in the middle of the support frame can self-adaptively expand and contract in the axial direction, so that the helical section drives the inner braided layer in the blood vessel.
  • the vascular stent of the present invention is convenient to push in the blood vessel, and the operation is simple during the operation.
  • vascular stent of the present invention to implant intracranial arterial blood vessels for the treatment of diseases such as intracranial aneurysms can solve the obvious decrease in blood flow of collateral vessels or perforating vessels covered by the existing stent, the damage to the blood vessels at both ends of the stent, and the operation of the stent. complex issues.
  • FIG. 1 is a structural diagram of a first embodiment of a blood vessel stent of the present invention.
  • FIG. 2 is a front view of the first embodiment of the vascular stent of the present invention.
  • FIG. 3 is a schematic diagram of a state in which the inner braided layer is imaginatively spread out in the first embodiment of the vascular stent of the present invention.
  • FIG 4 is an axial cross-sectional view of the braided wire in the first embodiment of the blood vessel stent of the present invention.
  • FIG 5 is a radial cross-sectional view of the braided wire in the first embodiment of the blood vessel stent of the present invention.
  • FIG. 6 is a structural diagram of the support frame in the first embodiment of the vascular stent of the present invention.
  • FIG. 7 is a schematic diagram of a state in which the support frame is imaginatively spread out in the first embodiment of the vascular stent of the present invention.
  • FIG. 8 is a partial view of a connection mode of the inner braided layer and the spiral bars in the first embodiment of the vascular stent of the present invention.
  • FIG. 9 is a schematic diagram of a connection mode of the inner braided layer and the spiral bars in the first embodiment of the vascular stent of the present invention.
  • FIG. 10 is a partial view of another connection mode of the inner braided layer and the spiral bars in the first embodiment of the vascular stent of the present invention.
  • FIG. 11 is a schematic diagram of another connection mode of the inner braided layer and the spiral bars in the first embodiment of the vascular stent of the present invention.
  • Fig. 12 is a structural diagram of the second embodiment of the vascular stent of the present invention.
  • FIG. 13 is a structural diagram of a support frame in the second embodiment of the vascular stent of the present invention.
  • FIG. 14 is a schematic diagram of a state in which the support frame is imaginatively spread out in the second embodiment of the vascular stent of the present invention.
  • this embodiment discloses a vascular stent 1 , especially a vascular stent 1 that can be implanted into an intracranial artery for treating diseases such as intracranial aneurysms.
  • the vascular stent 1 includes a support frame 11 and an inner braided layer 12 , and the support frame 11 is a tubular structure formed by laser engraving of a metal tube, and has a relatively low metal coverage.
  • the support frame 11 includes a first support section 112, a helical section 111 and a second support section 113 connected in sequence in its axial direction, and the helical section 111 is spirally extended side by side in the axial direction of the support frame 11 by a plurality of helical ribs 1111. form.
  • the inner braided layer 12 is arranged in a tubular shape and covers the inner peripheral wall of the helical section 111 of the support frame 11.
  • the inner braided layer 12 is made of a plurality of braided wires 121 that are helically extended and cross-braided in the axial direction of the support frame 11. Higher metal coverage.
  • the middle part of the support frame 11 of the vascular stent 1 in this embodiment has a helical section 111 .
  • the braided layer 12 has strong radial support performance in the blood vessel, and the helical segment 111 has good flexibility, which provides an expansion space for the self-expanding inner braided layer 12 and improves the self-expanding ability of the vascular stent 1 .
  • the helical section 111 in the middle of the support frame 11 can self-adaptively expand and contract in the axial direction, so that the helical section 111 drives the inner braided layer 12 to follow when the blood vessel moves while maintaining a good adherent state.
  • the helical segment 111 When the vascular stent 1 is implanted into the parent artery, the helical segment 111 just covers the neck of the tumor. Since the inner braided layer 12 is provided in the helical segment 111, the inner braided layer 12 has a high metal coverage rate, which can effectively change the artery. Hemodynamics in the aneurysm, slow down the blood flow into the aneurysm, and achieve the purpose of curing the aneurysm.
  • the first support section 112 and the second support section 113 of the vascular stent 1 are located at both ends of the aneurysm neck, respectively, so that the stent is firmly anchored in the blood vessel. 113 has a low metal coverage rate, and will not affect the blood flow of collateral and perforating vessels near the tumor neck. occlusion, etc.
  • the vascular stent 1 of this embodiment is convenient to push in the blood vessel, and the operation during the operation is simple.
  • the vascular stent 1 of this embodiment to implant intracranial arteries for the treatment of diseases such as intracranial aneurysms, the blood flow of collateral vessels or perforating vessels covered by the existing stent is significantly reduced, and the damage to the blood vessels at both ends of the stent is solved. and complex operations.
  • the inner braided layer 12 of the blood vessel stent 1 in this embodiment is formed by 24-144 braided wires 121 that are spirally extended in the axial direction of the support frame 11 and are cross-braided.
  • the braided PPI pixel density
  • the braided PPI pixel density
  • Each braided wire 121 of the inner braided layer 12 includes an inner core 1212 and an outer ring 1211 covered on the outer peripheral wall of the inner core 1212. material.
  • each braided wire 121 of the braided layer 12 in this embodiment is 0.02 mm ⁇ 0.06 mm
  • the cross-sectional area of the inner core 1212 of the braided wire 121 is between 10% and 50% of the cross-sectional area of the braided wire 121 .
  • the first material can be selected from platinum, gold, platinum-iridium alloy, pure tantalum and other materials visible in X-rays
  • the second material can be selected from one of cobalt-chromium alloy, nickel-titanium alloy, stainless steel and the like.
  • the inner core 1212 of the inner braided layer 12 of the stent 1 in this embodiment is made of a first material visible by X-rays, and the stent 1 can be accurately placed under X-rays to ensure that the inner braided layer 12 accurately covers the neck of the aneurysm. This slows blood flow into the aneurysm.
  • the pitches of the multiple helical ribs 1111 of the helical segment 111 in the support frame 11 of the vascular stent 1 in this embodiment are equal, and the multiple helical ribs 1111 are arranged side by side at equal intervals in the axial direction of the support frame 11 , and The pitch of the helical rib 1111 is equal to that of the braided wire 121 , and the width L3 of the helical rib 1111 in the circumferential direction of the support frame 11 is greater than the diameter of the braided wire 121 .
  • first ends of the plurality of helical ribs 1111 are connected with the first support section 112 to form a plurality of first connection points 1124, and the plurality of first connection points 1124 are evenly distributed in the circumferential direction of the support frame 11; and/or, a plurality of first connection points 1124 are formed.
  • the second end of the spiral rib 1111 is connected with the second support section 113 to form a plurality of second connection points 1135 , and the plurality of second connection points 1135 are evenly distributed in the circumferential direction of the support frame 11 .
  • the first support section 112 in this embodiment is formed by a plurality of first support rings 1121 and a plurality of first compliance rings 1122 staggered and arranged side by side in the axial direction of the support frame 11 , each of the first support rings 1121 and each of the first compliance rings 1121 .
  • the rings 1122 extend sinusoidally in the circumferential direction of the support frame 11 respectively, and the adjacent first support rings 1121 and the first flexible rings 1122 are connected to form a plurality of first closed cells 1123 .
  • the number of sinusoidal elements of the compliance ring 1122 is greater than the number of sinusoidal elements of the first support ring 1121 , and the first ends of the plurality of helical ribs 1111 are respectively connected to the adjacent first support rings 1121 .
  • the width L1 of the first support ribs of the first support ring 1121 in the circumferential direction of the support frame 11 is greater than the width L2 of the first flexible ribs of the first flexible ring 1122 in the circumferential direction of the support frame 11 .
  • the second support section 113 in this embodiment is formed by a plurality of second support rings 1131 and a plurality of second compliance rings 1132 staggered and arranged side by side in the axial direction of the support frame 11 , each second support ring 1131 and each second compliance ring 1131
  • the rings 1132 respectively extend sinusoidally in the circumferential direction of the support frame 11 , and the adjacent second support rings 1131 and the second compliant rings 1132 are connected to form a plurality of second closed cells 1134 .
  • the number of sinusoidal elements of the compliance ring 1132 is greater than the number of sinusoidal elements of the second support ring 1131 , and the second ends of the plurality of helical ribs 1111 are respectively connected to the adjacent second support rings 1131 .
  • the width L4 of the second support ribs of the second support ring 1131 in the circumferential direction of the support frame 11 is greater than the width L5 of the second flexible ribs of the second flexible ring 1132 in the circumferential direction of the support frame 11 .
  • the second support section 113 in this embodiment further includes a third compliant ring 1133 .
  • the third compliant ring 1133 extends sinusoidally in the circumferential direction of the support frame 11 , and the third compliant ring 1133 is connected to the second compliant ring 1133 away from the helical section 111 .
  • the rings 1132 are connected, and the chord openings of the third compliant ring 1133 and the chord openings of the second compliant ring 1132 correspond to each other to form a diamond-shaped closed cell 1136 .
  • the helical section 111 of the supporting frame 11 in this embodiment is formed by six helical ribs 1111 extending side by side in the axial direction of the supporting frame 11 . Set up side by side at equal intervals. One end of the first support section 112 away from the helical section 111 has a first flared mouth that expands outward.
  • the first support section 112 consists of two first support rings 1121 and two first flexible rings 1122 on the axis of the support frame 11 . Upwardly staggered and arranged side by side, the adjacent first support rings 1121 and the first compliant rings 1122 are connected to form three first closed cells 1123, and the three first closed cells 1123 are evenly arranged in the circumferential direction of the support frame 11.
  • a first closed cell 1123 has three sinusoidal units of the first compliant rings 1122 and two sinusoidal units of the first support rings 1121 . In the axial direction of the support frame 11 , two adjacent first closed cells 1123 are staggered.
  • the first end of the first support section 112 away from the helical section 111 is a first flexible ring 1122 , and the end of the first flexible ring 1122 away from the helical section 111 is provided with three first developing sleeves 2 , and the three first developing sleeves 2 are supporting
  • the skeletons 11 are evenly arranged in the circumferential direction.
  • the second end of the first support segment 112 adjacent to the helical segment 111 is the first support ring 1121 , and the first ends of the six helical ribs 1111 are respectively connected with the six chord peaks on the adjacent side of the first support ring 1121 in a one-to-one correspondence to form six
  • the first connection points 1124 and the six first connection points 1124 are evenly distributed in the circumferential direction of the support frame 11 .
  • the second support section 113 away from the helical section 111 has a second flared mouth
  • the second support section 113 in this embodiment consists of two second support rings 1131 and two second compliant rings 1132 on the axis of the support frame 11
  • a third compliant ring 1133 connected to the second compliant ring 1132 away from the helical segment 111 is formed by being staggered side by side upward, and the connection between the adjacent second supporting rings 1131 and the second compliant rings 1132 forms three second closures Cells 1134, three second closed cells 1134 are evenly arranged in the circumferential direction of the support frame 11, and each second closed cell 1134 has three sinusoidal units of the second compliant ring 1132 and two sinusoidal units of the second support ring 1131 .
  • the third compliant ring 1133 is connected to the second compliant ring 1132 away from the helical segment 111, and the string opening of the third compliant ring 1133 and the string opening of the second compliant ring 1132 correspond to each other to form nine diamond-shaped closed cells 1136.
  • the diamond-shaped closed cells 1136 are evenly arranged in the circumferential direction of the support frame 11 .
  • One end of the third compliant ring 1133 away from the helical segment 111 is provided with three second developing sleeves 3 , and the three second developing sleeves 3 are evenly arranged in the circumferential direction of the supporting frame 11 .
  • One end of the second support segment 113 adjacent to the helical segment 111 is a second support ring 1131 , and the second ends of the six helical ribs 1111 are respectively connected with the six chord peaks on the adjacent side of the second support ring 1131 in a one-to-one correspondence to form six second support rings 1131 .
  • the connection points 1135 and the six second connection points 1135 are evenly distributed in the circumferential direction of the support frame 11 .
  • the first support section 112 of the support frame 11 in the vascular stent 1 of this embodiment is formed by a plurality of first support rings 1121 and a plurality of first flexible rings 1122 staggered and arranged side by side in the axial direction of the support frame 11 .
  • the two supporting segments 113 are staggered and arranged side by side in the axial direction of the supporting frame 11 by a plurality of second supporting rings 1131 and a plurality of second compliant rings 1132 , and a third compliant ring connected to the second compliant rings 1132 away from the helical segment 111 1133 formed.
  • the first support section 112 is pushed out of the catheter first, and the first flexible ring 1122 and the first support ring 1121 of the first support section 112 are opened in turn.
  • the staggered segment design of the support ring 1121 can ensure that the first support segment 112 can fully adhere to the wall of the curved blood vessel. Since the helical section 111 has suitable support and flexibility, the inner braided layer 12 is sheathed in the helical section 111 to ensure the smooth opening of the inner braided layer 12 .
  • the staggered design of the second flexible ring 1132 and the second support ring 1131 can ensure that the second support section 113 can fully adhere to the wall of the curved blood vessel, and at the same time, the chord of the third flexible ring 1133
  • the openings correspond to the chord openings of the second compliant ring 1132 to form a rhombus-shaped closed cell 1136 , which can provide sufficient support in the catheter to ensure smooth pushing of the stent.
  • the vascular stent 1 since the vascular stent 1 has a cut support skeleton 11, it has better operability than the existing pure braided stent, and does not need to slowly release the stent through the push-pull technique like the existing stent, which greatly simplifies the release of the stent during the operation. operation, and reduce the complications of intraoperative operation.
  • a connection method of the inner braided layer 12 and the helical ribs 1111 in this embodiment is that the first end of the inner braided layer 12 is connected to the first end of the helical ribs 1111 through the spring coil 13; and/ Or, the second end of the inner braided layer 12 is connected to the second end of the spiral rib 1111 through the spring coil 13 .
  • the number of the spiral ribs 1111 in this embodiment is six.
  • first ends of the inner braided layer 12 are respectively connected to the first ends of the six spiral ribs 1111 through the six spring coils 13 , and the second ends of the inner braided layer 12 pass through The six spring coils 13 are respectively connected to the second ends of the six helical ribs 1111 .
  • another connection method between the inner braided layer 12 and the helical ribs 1111 in this embodiment is that the first end of the inner braided layer 12 is clamped on the first end of the helical ribs 1111 through the C-ring 14 and/or, the second end of the inner braided layer 12 is clamped on the second end of the spiral rib 1111 through the C-shaped ring 14 .
  • the number of the spiral ribs 1111 in this embodiment is six.
  • first ends of the inner braided layer 12 are respectively engaged with the first ends of the six spiral ribs 1111 through the six C-shaped rings 14, and the second end of the inner braided layer 12 The ends are respectively clamped on the second ends of the six spiral ribs 1111 through the six C-shaped rings 14 .
  • the inner braided layer 12 of the vascular stent 1 not only keeps consistent with the contraction and expansion of the helical segment 111 of the support frame 11 , but also the ends of the braided wires 121 of the inner braided layer 12 are fixed to the helical ribs 1111 of the helical segment 111 .
  • the contact between the filament head of the braided wire 121 and the blood vessel wall is avoided, thereby reducing the stimulation to the blood vessel wall during the pushing and releasing process, and effectively solving the problem that the existing stent damages the blood vessel wall.
  • the support frame 11 of the vascular stent 1 in this embodiment can be used alone, that is, the support frame 11 can be implanted into a blood vessel alone to treat diseases such as vascular stenosis.
  • the support frame 11 meets the support requirements and has good flexibility, which can solve existing problems
  • the radial support force of the vascular stent is too large, and it is easy to squeeze the stenotic plaque, causing the plaque debris to block the branch blood vessels and cause infarction, and to solve the problem that the existing vascular stent has poor compliance and chronic external expansion force, which is easy to cause sticking.
  • the problem of poor wall and restenosis The problem of poor wall and restenosis.
  • the first support section 112 ′ in the support frame 11 ′ of the vascular stent 1 ′ in this embodiment is formed by connecting a plurality of first diamond mesh rings 4 in the axial direction of the support frame 11 ′, and the first support section 112 ′
  • One end of the support segment 112 ′ away from the helical segment 111 has a first flared mouth; and/or, the second support segment 113 ′ in the support frame 11 ′ of the vascular stent 1 ′ is composed of a plurality of second diamond mesh rings 5 It is connected and formed in the axial direction of the support frame 11 ′, and the end of the second support segment 113 ′ away from the helical segment 111 has a second flared mouth that expands outward.
  • the end of the first support segment 112 ′ away from the helical segment 111 is provided with multiple first developing sleeves 2 ; and/or the end of the second support segment 113 ′ away from the helical segment 111 is provided with multiple second
  • the helical section 111 of the supporting frame 11 ′ in this embodiment is spirally extended side by side in the axial direction of the supporting frame 11 ′ by six helical ribs 1111 .
  • the axes are arranged side by side at equal intervals.
  • the first support section 112' is formed by connecting two first diamond mesh rings 4 in the axial direction of the support frame 11'.
  • the end of the first support section 112' away from the helical section 111 is provided with three first developing sleeves 2, three The first developing sleeves 2 are evenly arranged in the circumferential direction of the supporting frame 11'.
  • the first ends of the six helical ribs 1111 are respectively connected with the six water chestnuts on the adjacent side of the first support section 112 ′ to form six first connection points 1124 ′. Evenly distributed around the circumference.
  • the second support section 113 ′ is formed by connecting two second diamond mesh rings 5 in the axial direction of the support frame 11 ′.
  • the end of the second support section 113 ′ away from the spiral section 111 is provided with three second developing sleeves 3 , three The second developing sleeves 3 are evenly arranged in the circumferential direction of the supporting frame 11'.
  • the second ends of the six helical ribs 1111 are respectively connected with the six water chestnuts on the adjacent side of the second support section 113 ′ to form six second connection points 1135 ′. Evenly distributed around the circumference.
  • the first support section 112 ′ of the support frame 11 ′ in the vascular stent 1 ′ in this embodiment is formed by connecting a plurality of first diamond mesh rings 4 in the axial direction of the support frame 11 ′
  • the second support section of the support frame 11 ′ 113' is formed by connecting a plurality of second rhombus mesh rings 5 in the axial direction of the support frame 11', which can provide a good radial support force while providing good wall adhesion, so that the vascular stent 1' can be obtained more moderately. Radial support force and better anchoring force.
  • the middle of the support frame 11 ′ of the blood vessel stent 1 ′ has a helical section 111 , and the helical section 111 is spirally extended side by side in the axial direction of the support frame 11 ′ by a plurality of helical ribs 111 .
  • the inner braided layer has strong radial support performance in the blood vessel, and the helical segment 111 has good flexibility, which provides an expansion space for the self-expanding inner braided layer and improves the self-expanding ability of the vascular stent 1'.
  • the helical section 111 in the middle of the support frame 11' can self-fit in the axial direction Telescopic, so that the inner braided layer driven by the helical segment 111 can follow the movement of the blood vessel while maintaining a good state of adherence to the wall.
  • the vascular stent 1' of this embodiment is convenient to push in the blood vessel, and the operation during the operation is simple.
  • the blood flow of the collateral vessels or perforating vessels covered by the existing stent is significantly reduced, and the two ends of the stent are affected by the blood vessels. damage and complex operation.
  • the support frame 11 ′ of the vascular stent 1 ′ in this embodiment can be used alone, that is, the support frame 11 ′ can be implanted into a blood vessel alone for treating diseases such as vascular stenosis.
  • the support frame 11 ′ meets the support requirements and has good flexibility. It can solve the problem that the existing vascular stents have too much radial support force and easily squeeze the stenotic plaque, causing plaque debris to block branch vessels and cause infarction, and solve the problem that the existing vascular stents have poor compliance and chronic external expansion force. It is easy to lead to the problem of poor adherence and restenosis.
  • the support frame of the vascular stent of the present invention has a helical section in the middle, and the helical section is formed by a plurality of helical ribs extending side by side in the axial direction of the support frame.
  • the radial support performance of the vascular stent is good, and the flexibility of the helical segment is good, which provides expansion space for the self-expanding inner braided layer and improves the self-expanding ability of the vascular stent.
  • the helical section in the middle of the support frame can self-adaptively expand and contract in the axial direction, so that the helical section drives the inner braided layer in the blood vessel.
  • the vascular stent of the present invention is convenient to push in the blood vessel, and the operation is simple during the operation.
  • vascular stent of the present invention to implant intracranial arterial blood vessels for the treatment of diseases such as intracranial aneurysms can solve the obvious decrease in blood flow of collateral vessels or perforating vessels covered by the existing stent, the damage to the blood vessels at both ends of the stent, and the operation of the stent. complex issues.

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Abstract

一种血管支架(1)，包括：支撑骨架(11)，支撑骨架(11)呈管状设置，且支撑骨架(11)在其轴向上包括依次连接的第一支撑段(112)、螺旋段(111)和第二支撑段(113)，螺旋段(111)由多条螺旋筋(1111)在支撑骨架(11)的轴向上并排螺旋延伸形成；内编织层(12)，内编织层(12)呈管状设置并覆盖在螺旋段(111)的内周壁上，内编织层(12)由多股编织丝(121)在支撑骨架(11)的轴向上螺旋延伸并交叉编织而成。

Description

血管支架 技术领域
本发明涉及医疗器械技术领域，尤其是涉及一种血管支架，该血管支架可植入颅内动脉血管用于治疗诸如颅内动脉瘤等疾病。
 背景技术
颅内动脉瘤是颅内动脉血管由于先天异常或后天损伤等因素导致局部的血管壁损害，在血流动力学负荷和其他因素作用下，逐渐扩张形成的异常膨出。颅内动脉瘤破裂出血发病急、症状重、无明显先兆，具有很高的死亡率和致残率。
颅内动脉瘤的治疗主要分外科手术夹闭和血管内介入栓塞治疗，但外科手术夹闭创伤大、并发症多、手术以及恢复时间都很长，不受医生和患者的欢迎。随着微创性的血管内介入治疗技术的发展进步，越来越多的颅内动脉瘤患者接受血管内介入治疗技术，血管内介入栓塞技术也逐渐成为颅内动脉瘤治疗的主导技术。
颅内复杂动脉瘤如宽颈动脉瘤、梭形动脉瘤、大型或巨大动脉瘤、夹层动脉瘤在实际的治疗过程中，需要多根弹簧圈才能栓塞完全，且需要额外的辅助装置(球囊或者支架)为其提供支撑，这一方面增加了手术的难度，延长了手术时间，另一方面整个手术过程的费用也是非常昂贵的。因此，为了解决复杂动脉瘤治疗过程中所存在的问题，人们设计开发了血流导向装置。
血流导向装置为低孔率的自膨胀支架，可以减少动脉瘤体与载瘤动脉之间的血液交换，诱发动脉瘤内血栓形成，促进动脉瘤颈处内膜增生，从而达到载瘤动脉重建作用，且整个手术过程只需放置一个支架即可完成动脉瘤的介入治疗，方便、快速，即刻栓塞率高。
 技术问题
目前治疗颅内动脉瘤的血流导向装置仍然存在以下几个方面的问题：
（一）用现有血流导向装置治疗动脉瘤时，支架覆盖侧支血管或穿支血管是不可避免的，由于支架整体的金属覆盖率较高，这样侧支血管或穿支血管的血流量明显下降，就会出现血管闭塞的风险，给病人带来严重的并发症；
（二）现有血流导向装置的支架由多股细丝编织而成，支架两端均有散开的编织丝头，在推送和释放过程中，极易损伤血管内壁；
（三）纯编织的现有血流导向装置，术中操作较复杂，对术者操作要求较高。
为了解决上述问题，本发明的主要目的是提供一种血管支架，从而解决了现有支架覆盖的侧支血管或穿支血管血流量明显下降、支架两端对血管的损伤以及操作复杂等问题。
 技术解决方案
为了实现本发明的主要目的，本发明提供一种血管支架，包括：支撑骨架，支撑骨架呈管状设置，且支撑骨架在其轴向上包括依次连接的第一支撑段、螺旋段和第二支撑段，螺旋段由多条螺旋筋在支撑骨架的轴向上并排螺旋延伸形成；内编织层，内编织层呈管状设置并覆盖在螺旋段的内周壁上，内编织层由多股编织丝在支撑骨架的轴向上螺旋延伸并交叉编织而成。
一个优选的方案是，每一股编织丝包括内芯和包覆在内芯外周壁上的外环，内芯由X射线可见的第一材料制成，外环由第二材料制成。
更进一步的方案是，内芯的横截面积为编织丝的横截面积的10%至50%之间。
更进一步的方案是，多条螺旋筋的螺距相等。
更进一步的方案是，多条螺旋筋在支撑骨架的轴向上等间距并排设置。
更进一步的方案是，螺旋筋的螺距与编织丝的螺距相等。
更进一步的方案是，螺旋筋在支撑骨架周向上的宽度大于编织丝的直径。
更进一步的方案是，第一支撑段远离螺旋段的一端设置有多个第一显影套；和/或，第二支撑段远离螺旋段的一端设置有多个第二显影套。
进一步的方案是，内编织层的第一端通过弹簧圈连接在多条螺旋筋的第一端上；和/或，内编织层的第二端通过弹簧圈连接在螺旋筋的第二端上。
更进一步的方案是，内编织层的第一端通过C型环卡合在螺旋筋的第一端上；和/或，内编织层的第二端通过C型环卡合在螺旋筋的第二端上。
 有益效果
本发明血管支架的支撑骨架中部具有螺旋段，螺旋段由多条螺旋筋在支撑骨架的轴向上并排螺旋延伸形成，对设置在螺旋段内周壁的自膨胀内编织层在血管中具有较强的径向支撑性能，且螺旋段的柔韧性好，为自膨胀内编织层提供膨胀空间，提高血管支架的自膨胀能力。同时，在血管支架的支撑骨架的两端第一支撑段和第二支撑段锚固稳定的情况下，支撑骨架中部的螺旋段可沿轴向自适配伸缩，使得螺旋段带动内编织层在血管运动时可以保持贴壁良好状态下随动，确保内编织层准确地覆盖动脉瘤颈，从而减缓血流进入动脉瘤内。而且，本发明血管支架在血管内推送方便，术中操作简单。使用本发明血管支架植入颅内动脉血管用于治疗诸如颅内动脉瘤等疾病，解决了现有支架覆盖的侧支血管或穿支血管血流量明显下降、支架两端对血管的损伤以及操作复杂等问题。
 附图说明
图1是本发明血管支架第一实施例的结构图。
图2是本发明血管支架第一实施例的主视图。
图3是本发明血管支架第一实施例中内编织层被假想平铺展开状态下的示意图。
图4是本发明血管支架第一实施例中编织丝的轴向剖视图。
图5是本发明血管支架第一实施例中编织丝的径向横截面剖视图。
图6是本发明血管支架第一实施例中支撑骨架的结构图。
图7是本发明血管支架第一实施例中支撑骨架被假想平铺展开状态下的示意图。
图8是本发明血管支架第一实施例中内编织层与螺旋筋一种连接方式的局部图。
图9是本发明血管支架第一实施例中内编织层与螺旋筋一种连接方式的示意图。
图10是本发明血管支架第一实施例中内编织层与螺旋筋另一种连接方式的局部图。
图11是本发明血管支架第一实施例中内编织层与螺旋筋另一种连接方式的示意图。
图12是本发明血管支架第二实施例的结构图。
图13是本发明血管支架第二实施例中支撑骨架的结构图。
图14是本发明血管支架第二实施例中支撑骨架被假想平铺展开状态下的示意图。
以下结合附图及实施例对本发明作进一步说明。
 本发明的实施方式
血管支架第一实施例：
参见图1和图2，本实施例公开一种血管支架1，尤其是一种可植入颅内动脉血管用于治疗诸如颅内动脉瘤等疾病的血管支架1。血管支架1包括支撑骨架11和内编织层12，支撑骨架11由金属管进行激光雕刻而成的管状结构，具有较低的金属覆盖率。其中，支撑骨架11在其轴向上包括依次连接的第一支撑段112、螺旋段111和第二支撑段113，螺旋段111由多条螺旋筋1111在支撑骨架11的轴向上并排螺旋延伸形成。内编织层12呈管状设置并覆盖在支撑骨架11的螺旋段111的内周壁上，该内编织层12由多股编织丝121在支撑骨架11的轴向上螺旋延伸并交叉编织而成，具有较高的金属覆盖率。
本实施例血管支架1的支撑骨架11中部具有螺旋段111，螺旋段111由多条螺旋筋1111在支撑骨架11的轴向上并排螺旋延伸形成，对设置在螺旋段111内周壁的自膨胀内编织层12在血管中具有较强的径向支撑性能，且螺旋段111的柔韧性好，为自膨胀内编织层12提供膨胀空间，提高血管支架1的自膨胀能力。同时，在血管支架1的支撑骨架11的两端第一支撑段112和第二支撑段113锚固稳定的情况下，支撑骨架11中部的螺旋段111可沿轴向自适配伸缩，使得螺旋段111带动内编织层12在血管运动时可以保持贴壁良好状态下随动。
在血管支架1植入载瘤动脉时，螺旋段111刚好覆盖在瘤颈口位置，由于螺旋段111内设有内编织层12，内编织层12具有较高的金属覆盖率，能够有效改变动脉瘤内的血流动力学，减缓血流进入动脉瘤，达到治愈动脉瘤的目的。在载瘤动脉中，血管支架1的第一支撑段112和第二支撑段113分别位于动脉瘤颈的两端，使得支架在血管中锚定牢靠，由于第一支撑段112和第二支撑段113具有较低的金属覆盖率，对瘤颈口附近的侧支和穿支血管的血流不会产生影响，解决了现有血管支架覆盖侧支或穿支血管，导致血流量明显下降、血管闭塞等问题。
而且，本实施例血管支架1在血管内推送方便，术中操作简单。使用本实施例血管支架1植入颅内动脉血管用于治疗诸如颅内动脉瘤等疾病，解决了现有支架覆盖的侧支血管或穿支血管血流量明显下降、支架两端对血管的损伤以及操作复杂等问题。
参见图3至图5，本实施例血管支架1的内编织层12由24～144股编织丝121在支撑骨架11的轴向上螺旋延伸并交叉编织而成，编织的PPI（像素密度）介于50～300，内编织层12的金属覆盖率在15%～45%之间。内编织层12的每一股编织丝121包括内芯1212和包覆在内芯1212外周壁上的外环1211，内芯1212由X射线可见的第一材料制成，外环1211由第二材料制成。本实施例内编织层12的每一股编织丝121的直径为0.02mm～0.06mm，编织丝121的内芯1212的横截面积为编织丝121的横截面积的10%至50%之间。其中，第一材料可选用铂金、黄金、铂铱合金、纯钽等其中一种在X射线可见的材料，第二材料可选用钴铬合金、镍钛合金、不锈钢等其中一种材料。本实施例血管支架1的内编织层12的内芯1212由X射线可见的第一材料制成，可以在X射线下，精确放置血管支架1，确保内编织层12准确地覆盖动脉瘤颈，从而减缓血流进入动脉瘤内。
参见图6和图7，本实施例血管支架1的支撑骨架11中螺旋段111的多条螺旋筋1111的螺距相等，多条螺旋筋1111在支撑骨架11的轴向上等间距并排设置，且螺旋筋1111的螺距与编织丝121的螺距相等设置，螺旋筋1111在支撑骨架11周向上的宽度L3大于编织丝121的直径。其中，多条螺旋筋1111的第一端与第一支撑段112连接形成多个第一连接点1124，多个第一连接点1124在支撑骨架11的周向上均匀分布；和/或，多条螺旋筋1111的第二端与第二支撑段113连接形成多个第二连接点1135，多个第二连接点1135在支撑骨架11的周向上均匀分布。
本实施例第一支撑段112由多个第一支撑环1121和多个第一柔顺环1122在支撑骨架11的轴向上交错并排设置形成，每一个第一支撑环1121和每一个第一柔顺环1122分别在支撑骨架11的周向上呈正弦曲线延伸，相邻第一支撑环1121和第一柔顺环1122之间连接形成多个第一封闭格1123，每一个第一封闭格1123内第一柔顺环1122的正弦单元数量大于第一支撑环1121的正弦单元数量，多条螺旋筋1111的第一端分别与相邻第一支撑环1121连接。其中，第一支撑环1121的第一支撑筋在支撑骨架11周向上的宽度L1大于第一柔顺环1122的第一柔顺筋在支撑骨架11周向上的宽度L2。
本实施例第二支撑段113由多个第二支撑环1131和多个第二柔顺环1132在支撑骨架11的轴向上交错并排设置形成，每一个第二支撑环1131和每一个第二柔顺环1132分别在支撑骨架11的周向上呈正弦曲线延伸，相邻第二支撑环1131和第二柔顺环1132之间连接形成多个第二封闭格1134，每一个第二封闭格1134内第二柔顺环1132的正弦单元数量大于第二支撑环1131的正弦单元数量，多条螺旋筋1111的第二端分别与相邻第二支撑环1131连接。其中，第二支撑环1131的第二支撑筋在支撑骨架11周向上的宽度L4大于第二柔顺环1132的第二柔顺筋在支撑骨架11周向上的宽度L5。此外，本实施例第二支撑段113还包括第三柔顺环1133，第三柔顺环1133在支撑骨架11的周向上呈正弦曲线延伸，且第三柔顺环1133与远离螺旋段111的第二柔顺环1132相连接，第三柔顺环1133的弦口与第二柔顺环1132的弦口一一对应形成菱形封闭格1136。
具体地，本实施例支撑骨架11的螺旋段111由六条螺旋筋1111在支撑骨架11的轴向上并排螺旋延伸形成，六条螺旋筋1111的螺距相等，且六条螺旋筋1111在支撑骨架11的轴向上等间距并排设置。第一支撑段112远离螺旋段111的一端具有外扩的第一喇叭口，本实施例第一支撑段112由两个第一支撑环1121和两个第一柔顺环1122在支撑骨架11的轴向上交错并排设置形成，相邻第一支撑环1121和第一柔顺环1122之间连接形成三个第一封闭格1123，三个第一封闭格1123在支撑骨架11的周向上均匀布置，每一个第一封闭格1123内具有三个第一柔顺环1122的正弦单元和两个第一支撑环1121的正弦单元。在支撑骨架11的轴向上，相邻两个第一封闭格1123错开设置。第一支撑段112远离螺旋段111的第一端为第一柔顺环1122，该第一柔顺环1122远离螺旋段111的一端设置有三个第一显影套2，三个第一显影套2在支撑骨架11的周向上均匀布置。第一支撑段112邻接螺旋段111的第二端为第一支撑环1121，六条螺旋筋1111的第一端分别与该第一支撑环1121邻接侧的六个弦峰一一对应连接形成六个第一连接点1124，六个第一连接点1124在支撑骨架11的周向上均匀分布。
第二支撑段113远离螺旋段111的一端具有外扩的第二喇叭口，本实施例第二支撑段113由两个第二支撑环1131和两个第二柔顺环1132在支撑骨架11的轴向上交错并排设置以及一个与远离螺旋段111的第二柔顺环1132相连接的第三柔顺环1133形成，相邻第二支撑环1131和第二柔顺环1132之间连接形成三个第二封闭格1134，三个第二封闭格1134在支撑骨架11的周向上均匀布置，每一个第二封闭格1134内具有三个第二柔顺环1132的正弦单元和两个第二支撑环1131的正弦单元。在支撑骨架11的轴向上，相邻两个第二封闭格1134错开设置。其中，第三柔顺环1133与远离螺旋段111的第二柔顺环1132相连接，第三柔顺环1133的弦口与第二柔顺环1132的弦口一一对应形成九个菱形封闭格1136，九个菱形封闭格1136在支撑骨架11的周向上均匀布置。第三柔顺环1133远离螺旋段111的一端设置有三个第二显影套3，三个第二显影套3在支撑骨架11的周向上均匀布置。第二支撑段113邻接螺旋段111的一端为第二支撑环1131，六条螺旋筋1111的第二端分别与该第二支撑环1131邻接侧的六个弦峰一一对应连接形成六个第二连接点1135，六个第二连接点1135在支撑骨架11的周向上均匀分布。
本实施例血管支架1中支撑骨架11的第一支撑段112由多个第一支撑环1121和多个第一柔顺环1122在支撑骨架11的轴向上交错并排设置形成，支撑骨架11的第二支撑段113由多个第二支撑环1131和多个第二柔顺环1132在支撑骨架11的轴向上交错并排设置以及与远离螺旋段111的第二柔顺环1132相连接的第三柔顺环1133形成。血管支架1在释放过程中，第一支撑段112先推出导管，第一支撑段112的第一柔顺环1122和第一支撑环1121依次打开，由于多个第一柔顺环1122和多个第一支撑环1121的交错分节设计，可以确保第一支撑段112弯曲血管贴壁充分。由于螺旋段111具有合适的支撑性和柔顺性，内编织层12内套在螺旋段111内，可保证内编织层12顺利打开。同样的，第二支撑段113中，第二柔顺环1132和第二支撑环1131的交错分节设计，可以确保第二支撑段113在弯曲血管贴壁充分，同时，第三柔顺环1133的弦口与第二柔顺环1132的弦口一一对应形成菱形封闭格1136，能够在导管内提高足够的支撑，确保支架推送顺畅。所以，由于血管支架1具有切割的支撑骨架11，相比现有纯编织的支架具有更好的操作性，不需要像现有支架一样需要通过推拉技术来缓慢释放支架，大大简化术中释放支架的操作，并减小术中操作的并发症。
参见图8和图9，本实施例内编织层12与螺旋筋1111的一种连接方式为，内编织层12的第一端通过弹簧圈13连接在螺旋筋1111的第一端上；和/或，内编织层12的第二端通过弹簧圈13连接在螺旋筋1111的第二端上。本实施例螺旋筋1111的数量为六条，对应地，内编织层12的第一端通过六个弹簧圈13分别连接在六条螺旋筋1111的第一端上，内编织层12的第二端通过六个弹簧圈13分别连接在六条螺旋筋1111的第二端上。
参见图10和图11，本实施例内编织层12与螺旋筋1111的另一种连接方式为，内编织层12的第一端通过C型环14卡合在螺旋筋1111的第一端上；和/或，内编织层12的第二端通过C型环14卡合在螺旋筋1111的第二端上。本实施例螺旋筋1111的数量为六条，对应地，内编织层12的第一端通过六个C型环14分别卡合在六条螺旋筋1111的第一端上，内编织层12的第二端通过六个C型环14分别卡合在六条螺旋筋1111的第二端上。
因此，血管支架1的内编织层12不仅与支撑骨架11的螺旋段111的收缩和扩张保持一致，而且内编织层12的编织丝121的两端丝头被固定在螺旋段111的螺旋筋1111内周壁上，避免了编织丝121的丝头与血管壁的接触，从而减少了推送和释放过程中对血管壁的刺激，有效地解决了现有支架损伤血管内壁的问题。
本实施例血管支架1的支撑骨架11可单独使用，即支撑骨架11可单独植入血管用于治疗血管狭窄等疾病，支撑骨架11在满足支撑性要求的同时且柔韧性好，可解决现有的血管支架径向支撑力太大容易挤压狭窄斑块而使得斑块碎片堵塞分支血管导致梗死的问题，以及解决现有的血管支架顺应性较差以及慢性外扩张力较小而容易导致贴壁不良、再狭窄的问题。
血管支架第二实施例：
作为对本发明血管支架第二实施例的说明，以下仅对与血管支架第一实施例的不同之处进行说明。
参见图12至图14，本实施例血管支架1′的支撑骨架11′中第一支撑段112′由多个第一菱形网格环4在支撑骨架11′的轴向上连接形成，且第一支撑段112′远离螺旋段111的一端具有外扩的第一喇叭口；和/或者，血管支架1′的支撑骨架11′中第二支撑段113′由多个第二菱形网格环5在支撑骨架11′的轴向上连接形成，且第二支撑段113′远离螺旋段111的一端具有外扩的第二喇叭口。其中，第一支撑段112′远离螺旋段111的一端设置有多个第一显影套2；和/或，第二支撑段113′远离螺旋段111的一端设置有多个第二显影套3。
具体地，本实施例支撑骨架11′的螺旋段111由六条螺旋筋1111在支撑骨架11′的轴向上并排螺旋延伸，六条螺旋筋1111的螺距相等，且六条螺旋筋1111在支撑骨架11′的轴向上等间距并排设置。第一支撑段112′由两个第一菱形网格环4在支撑骨架11′的轴向上连接形成，第一支撑段112′远离螺旋段111的一端设置有三个第一显影套2，三个第一显影套2在支撑骨架11′的周向上均匀布置。六条螺旋筋1111的第一端分别与第一支撑段112′邻接侧的六个菱角一一对应连接形成六个第一连接点1124′，六个第一连接点1124′在支撑骨架11′的周向上均匀分布。第二支撑段113′由两个第二菱形网格环5在支撑骨架11′的轴向上连接形成，第二支撑段113′远离螺旋段111的一端设置有三个第二显影套3，三个第二显影套3在支撑骨架11′的周向上均匀布置。六条螺旋筋1111的第二端分别与第二支撑段113′邻接侧的六个菱角一一对应连接形成六个第二连接点1135′，六个第二连接点1135′在支撑骨架11′的周向上均匀分布。
本实施例血管支架1′中支撑骨架11′的第一支撑段112′由多个第一菱形网格环4在支撑骨架11′的轴向上连接形成，支撑骨架11′的第二支撑段113′由多个第二菱形网格环5在支撑骨架11′的轴向上连接形成，在提供良好的径向支撑力同时，能够提供良好的贴壁性，使得血管支架1′获得更适度的径向支撑力和更优良的锚定力。同时，血管支架1′的支撑骨架11′中部具有螺旋段111，螺旋段111由多条螺旋筋1111在支撑骨架11′的轴向上并排螺旋延伸，对设置在螺旋段111内周壁的自膨胀内编织层在血管中具有较强的径向支撑性能，且螺旋段111的柔韧性好，为自膨胀内编织层提供膨胀空间，提高血管支架1′的自膨胀能力。而且，在血管支架1′的支撑骨架11′的两端第一支撑段112′和第二支撑段113′锚固稳定的情况下，支撑骨架11′中部的螺旋段111可沿轴向自适配伸缩，使得螺旋段111带动内编织层在血管运动时可以保持贴壁良好状态下随动。此外，本实施例血管支架1′在血管内推送方便，术中操作简单。使用本实施例血管支架1′植入颅内动脉血管用于治疗诸如颅内动脉瘤等疾病，解决了现有支架覆盖的侧支血管或穿支血管血流量明显下降、支架两端对血管的损伤以及操作复杂等问题。
本实施例血管支架1′的支撑骨架11′可单独使用，即支撑骨架11′可单独植入血管用于治疗血管狭窄等疾病，支撑骨架11′在满足支撑性要求的同时且柔韧性好，可解决现有的血管支架径向支撑力太大容易挤压狭窄斑块而使得斑块碎片堵塞分支血管导致梗死的问题，以及解决现有的血管支架顺应性较差以及慢性外扩张力较小而容易导致贴壁不良、再狭窄的问题。
 工业实用性
本发明血管支架的支撑骨架中部具有螺旋段，螺旋段由多条螺旋筋在支撑骨架的轴向上并排螺旋延伸形成，对设置在螺旋段内周壁的自膨胀内编织层在血管中具有较强的径向支撑性能，且螺旋段的柔韧性好，为自膨胀内编织层提供膨胀空间，提高血管支架的自膨胀能力。同时，在血管支架的支撑骨架的两端第一支撑段和第二支撑段锚固稳定的情况下，支撑骨架中部的螺旋段可沿轴向自适配伸缩，使得螺旋段带动内编织层在血管运动时可以保持贴壁良好状态下随动，确保内编织层准确地覆盖动脉瘤颈，从而减缓血流进入动脉瘤内。而且，本发明血管支架在血管内推送方便，术中操作简单。使用本发明血管支架植入颅内动脉血管用于治疗诸如颅内动脉瘤等疾病，解决了现有支架覆盖的侧支血管或穿支血管血流量明显下降、支架两端对血管的损伤以及操作复杂等问题。
以上实施例，只是本发明的较佳实例，并非来限制本发明实施范围，故凡依本发明申请专利范围的构造、特征及原理所做的等效变化或修饰，均应包括于本发明专利申请范围内。

Claims (10)

  1. 血管支架，其特征在于，包括：
    支撑骨架，所述支撑骨架呈管状设置，且所述支撑骨架在其轴向上包括依次连接的第一支撑段、螺旋段和第二支撑段，所述螺旋段由多条螺旋筋在所述支撑骨架的轴向上并排螺旋延伸形成；
    内编织层，所述内编织层呈管状设置并覆盖在所述螺旋段的内周壁上，所述内编织层由多股编织丝在所述支撑骨架的轴向上螺旋延伸并交叉编织而成。
  2. 根据权利要求1所述的血管支架，其特征在于：
    每一股所述编织丝包括内芯和包覆在所述内芯外周壁上的外环，所述内芯由X射线可见的第一材料制成，所述外环由第二材料制成。
  3. 根据权利要求2所述的血管支架，其特征在于：
    所述内芯的横截面积为所述编织丝的横截面积的10%至50%之间。
  4. 根据权利要求1至3任一项所述的血管支架，其特征在于：
    多条所述螺旋筋的螺距相等。
  5. 根据权利要求1至4任一项所述的血管支架，其特征在于：
    多条所述螺旋筋在所述支撑骨架的轴向上等间距并排设置。
  6. 根据权利要求1至5任一项所述的血管支架，其特征在于：
    所述螺旋筋的螺距与所述编织丝的螺距相等。
  7. 根据权利要求1至6任一项所述的血管支架，其特征在于：
    所述螺旋筋在所述支撑骨架周向上的宽度大于所述编织丝的直径。
  8. 根据权利要求1至7任一项所述的血管支架，其特征在于：
    所述第一支撑段远离所述螺旋段的一端设置有多个第一显影套；和/或，所述第二支撑段远离所述螺旋段的一端设置有多个第二显影套。
  9. 根据权利要求1至8任一项所述的血管支架，其特征在于：
    所述内编织层的第一端通过弹簧圈连接在所述螺旋筋的第一端上；和/或，所述内编织层的第二端通过弹簧圈连接在所述螺旋筋的第二端上。
  10. 根据权利要求1至8任一项所述的血管支架，其特征在于：
    所述内编织层的第一端通过C型环卡合在所述螺旋筋的第一端上；和/或，所述内编织层的第二端通过C型环卡合在所述螺旋筋的第二端上。
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