WO2019128775A1 - 双层血管支架 - Google Patents

双层血管支架 Download PDF

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Publication number
WO2019128775A1
WO2019128775A1 PCT/CN2018/121732 CN2018121732W WO2019128775A1 WO 2019128775 A1 WO2019128775 A1 WO 2019128775A1 CN 2018121732 W CN2018121732 W CN 2018121732W WO 2019128775 A1 WO2019128775 A1 WO 2019128775A1
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WO
WIPO (PCT)
Prior art keywords
developing
developing portion
main body
body bracket
double
Prior art date
Application number
PCT/CN2018/121732
Other languages
English (en)
French (fr)
Inventor
方毅
肖本好
Original Assignee
先健科技(深圳)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to US16/957,883 priority Critical patent/US10993821B2/en
Priority to EP18894612.3A priority patent/EP3733133B1/en
Publication of WO2019128775A1 publication Critical patent/WO2019128775A1/zh

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Classifications

    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a double-walled blood vessel stent.
  • a lumen stent can be used to perform an endovascular exclusion to isolate a lesion in a human lumen.
  • a lumen stent can be used to isolate an arterial dissection or an aneurysm in a blood vessel.
  • Such methods have the advantages of small surgical trauma, low intraoperative blood transfusion, rapid postoperative recovery, and short hospital stay, and thus have gradually replaced traditional open surgery.
  • the lumen stent typically has a radial expansion capability that is secured to the lumen by its radial support against the vessel wall. In order to prevent the bracket from falling off, the bracket needs to have a sufficient radial supporting force, and the greater the radial supporting force, the stronger the rigidity of the bracket after the radial deployment.
  • the shape of the inner wall of the lumen is different, and there may be calcified plaque on the inner wall of the lumen to change the morphology of the inner wall of the lumen.
  • the lumen stent with greater rigidity may cause poor adhesion between the stent and the lumen. So that the stent and the diseased lumen wall cannot be completely closed.
  • one of the methods is to use a double-layer blood vessel stent, that is, a skirt bracket with better deformation ability on the outer layer of the main body bracket, but the double-layer stent has a complicated structure, how to accurately double the blood vessel stent Release into the blood vessels becomes an urgent problem to be solved.
  • a double-layer blood vessel stent comprising a main body bracket, a skirt bracket and a developing member, the main body bracket comprising a first end and a second end opposite to the first end;
  • the skirt bracket is disposed on an outer side of the main body bracket and extends toward the first end, the skirt bracket includes a taper section and an extension section, and the taper section has a connection end and a freedom opposite to the connection end And the connecting end is connected to the main body bracket, the free end is connected to the extension;
  • the developing member comprises a first developing member and a second developing member; the first developing member is located at the first Between the end and the connecting end, the second developing member is located between the first developing member and the first end;
  • the first developing member includes a first developing portion extending in a first direction, the second developing portion extending in a second direction, the second direction and the first portion One direction obliquely intersects, and the lengths of the first developing portion and the second developing portion in the axial direction of the main body bracket are not less than 0.5 mm;
  • the minimum distance between the intersections on the plane perpendicular to the axial direction of the main body bracket is not more than 2 mm;
  • the distance between the first developing portion and the second developing portion near an intersection of one end of the connecting portion on a plane perpendicular to the axial direction of the main body bracket is the smallest.
  • the second developing member includes a third developing portion extending in a third direction, and a fourth developing portion extending in a fourth direction,
  • the fourth direction is obliquely intersected with the third direction, and the lengths of the third developing portion and the fourth developing portion in the axial direction of the main body bracket are not less than 0.5 mm;
  • a distance between the intersection of the third developing portion and the fourth developing portion on a plane perpendicular to the axial direction of the main body bracket from the third developing portion and the fourth developing portion is perpendicular to the main body bracket a position where a distance between intersections on a plane in the axial direction is the smallest to an end of the third developing portion or the fourth developing portion away from the connecting end, and the third developing portion and the fourth developing portion
  • the minimum distance between the intersections on the plane perpendicular to the axial direction of the main body bracket is not more than 2 mm;
  • the distance between the intersection of the third developing portion and the fourth developing portion away from the first end in a plane perpendicular to the axial direction of the main body bracket is the smallest.
  • the main body bracket includes a first bare bracket and a main body film attached to the first bare bracket, the first developing portion, the second developing portion, and the third developing portion And the fourth developing portion is disposed on the first bare bracket.
  • the first bare bracket includes a plurality of axially arranged coils, the coils including a plurality of alternately disposed peaks and troughs, adjacent to the peaks and the valleys
  • the first developing portion and the second developing portion are located on two adjacent poles of the coil, and the third developing portion and the fourth developing portion are located at another
  • the wave coils are adjacent to two of the wave rods.
  • the lengths of the first developing unit, the second developing unit, the third developing unit, and the fourth developing unit are 1/2 of the length of the pole in which the rod is located. 2/3.
  • the distance between the intersection of the first developing portion and the second developing portion in a plane perpendicular to the direction of the main body bracket axis is the smallest to the third developing portion and the The position at which the distance between the intersections of the fourth developing portions in the plane perpendicular to the axial direction of the main body bracket is the smallest in the circumferential direction of the main body bracket is not more than 15°.
  • the first developing portion and the second developing portion are at a position where the distance between the intersections on a plane perpendicular to the main body support axis direction is the smallest to the second developing member away from the The axial distance of one end of the first end is 10 mm to 15 mm.
  • the axial distance between the end of the second developing member away from the first end and the first end is 10-15 mm.
  • the distance between each position on the extension to the longitudinal central axis of the body bracket is equal.
  • the sum of the length of the contour of the taper segment and the length of the contour of the extension is not greater than the axial direction between the connecting end and the first end of the body bracket the distance.
  • the developing member further includes a third developing member and a fourth developing member, the third developing member is disposed at the first end, and the fourth developing member is disposed at the second end .
  • the above double-layer blood vessel stent can conveniently observe the middle portion of the double-layer blood vessel stent by providing a specific first developing member between the first end and the second end, and can be used for the distortion of the double-layer blood vessel stent in the release.
  • the folding is recognized, and the gradient of the first developing member facilitates the observation of the position of the skirt bracket in the sheath, thereby ensuring the complete release of the extension of the skirt bracket, which facilitates subsequent double-tube stents. Accurate positioning.
  • the second developing member at a specific position, accurate positioning of the double-layered blood vessel stent can be facilitated.
  • FIG. 1 is a schematic structural view of a double-walled blood vessel stent according to an embodiment in a natural state
  • FIG. 2 is a schematic structural view of a skirt bracket of the double-layer blood vessel stent shown in FIG. 1 during sheathing;
  • FIG. 3 is a schematic structural view of the skirt bracket of the double-layer blood vessel stent shown in FIG. 1 when the sheathing is completed;
  • FIG. 4 is a schematic view showing the structure of the double-walled blood vessel stent shown in FIG. 1 when performing branch vessel reconstruction;
  • FIG. 5 is a schematic structural view of the double-walled blood vessel stent shown in FIG. 1 when performing branch vessel reconstruction according to another embodiment
  • Fig. 6 is a schematic view showing the structure of a double-layer blood vessel stent according to another embodiment in a natural state.
  • the double-walled blood vessel stent 300 of one embodiment includes a main body bracket 310 , a skirt bracket 330 , and a developing member 320 .
  • the skirt bracket 330 is sleeved on the body bracket 310.
  • the developing member 320 is disposed on the main body bracket 310.
  • the main body bracket 310 has a first end 317 and a second end 318 disposed opposite to the first end 317. It can be understood that the first end 317 can be the proximal end of the body bracket 310 and the second end 318 can be the distal end of the body bracket 310.
  • the main body bracket 310 includes a first bare bracket and a main body cover 319.
  • the main body film 319 is attached to the first bare bracket.
  • the body bracket includes a plurality of wave coils arranged in the axial direction.
  • the wave circle includes a first wave ring 313, a second wave ring 314, a third wave ring 315, and a fourth wave ring 316.
  • the third wave ring 315 is disposed at the first end 317
  • the fourth wave ring 316 is disposed at the second end 318
  • the first wave ring 313 is disposed between the third wave ring 315 and the fourth wave ring 316
  • second The wave ring 314 is disposed between the first wave ring 313 and the third wave ring 315.
  • the wave circle includes a plurality of peaks and troughs alternately arranged, and adjacent peaks and troughs are connected by a wave rod. Further, the angle formed by the extension lines of the adjacent two wave rods is 30° to 120°.
  • the main body bracket 310 is formed with a proximal end portion 3101, a connecting portion 3102 and a distal end portion 3103 which are sequentially connected.
  • the first end 317 is formed at one end of the proximal end portion 3101 away from the connecting portion 3102, and the second end 318 is formed at one end of the distal end portion 3103 away from the connecting portion 3102.
  • the film of the first end 317 forms a petal-shaped structure to facilitate blood flow from the first end; the film of the second end 318 is of a flush structure.
  • the cross-sectional area of the proximal portion 3101 is less than the cross-sectional area of the distal portion 3103.
  • the cross-sectional area of the connecting portion 3102 near the end of the proximal portion 3101 is less than or equal to the cross-sectional area of the end of the connecting portion 3102 near the distal end portion 3103, and the connecting portion 3102 is near the end of the proximal portion 3101 and the connecting portion 3102 is near the distal end.
  • the line connecting one end of the portion 3103 forms an angle of 0 to 30° with respect to the axial direction.
  • a line connecting the one end of the connecting portion 3102 near the proximal end portion 3101 and the end portion of the connecting portion 3102 near the distal end portion 3103 forms an angle of 15° to 25° with the axial direction of the main body bracket 310.
  • the above structure allows the main body bracket 310 to form a tapered structure, which can increase the anchoring force of the distal end portion 3103 while suppressing the aortic pulsation from being transmitted to the distal end portion 3103 of the stent for branching blood vessels.
  • the skirt bracket 330 is sleeved on the outer side of the body bracket 310 and extends toward the first end 317.
  • the skirt bracket 330 includes a tapered section 332 and an extension 336 that are interconnected.
  • the tapered section 332 has a connecting end 333 and a free end 334 opposite the connecting end 333.
  • the connecting end 333 of the tapered section 332 is coupled to the body bracket 310, and the free end 334 is coupled to the extending section 336. Further, the distance between each position on the extension section 336 to the longitudinal central axis of the main body bracket 310 is equal, that is, the extension section 336 is disposed in parallel with the main body bracket 310.
  • the length of the outline of the tapered section 332 and the length of the outline of the extended section 336 are not greater than the axial distance between the connecting section 333 and the first end 317 of the main body bracket 310, thereby avoiding the skirt when sheathing
  • the stent 330 extends beyond the body stent 310, reducing the length of the sheath, reducing the release stroke, and at the same time facilitating the deployed configuration of the skirt bracket 330 after opening from the sheath.
  • the outline of the tapered section 332 can be understood as the length of the curve between the connecting end 333 and the free end 334 when the plane passing through the axis of the main body bracket 310 intersects the tapered section 332.
  • the outline of the extension section 336 can be understood as the length of the curve between the free end of the plane passing through the axis of the body bracket 310 and the end of the extension section 336 away from the free end 334 when the extension section 336 intersects.
  • the contour of the tapered section 332 is a curve.
  • the skirt bracket 330 includes a second bare bracket (not shown) and a skirt film (not shown), and the skirt film is attached to the second bare bracket.
  • the radial deformation ability of the skirt bracket 330 is better than the radial deformation capability of the body bracket 310.
  • the developing assembly 320 is disposed on the main body bracket 310.
  • the developing member 320 includes a first developing member 321, a second developing member 322, a third developing member 323, and a fourth developing member 324.
  • the first developing member 321 is located between the first end 317 and the connecting end 333
  • the second developing member 322 is located between the first developing member 321 and the first end 317.
  • the third developing member 323 is disposed at the first end 317
  • the fourth developing member 324 is disposed at the second end 318.
  • the third developing member 323 is used to characterize the starting end of the double blood vessel stent 300.
  • the fourth developing member 324 is used to characterize the terminating end of the double blood vessel stent 300.
  • the first developing unit 321 includes a first developing unit 3211 and a second developing unit 3212.
  • the first developing unit 3211 extends in the first direction, and one end of the first developing unit 3211 is adjacent to the first end 317, and the other end is away from the first end.
  • One end 317; the second developing portion 3212 extends along the second direction, the first direction is obliquely intersected with the second direction, and the second developing portion 3212 has one end near the first end 317 and the other end away from the first end 317.
  • the lengths of the first developing portion 3211 and the second developing portion 3212 in the axial direction of the main body bracket are not less than 0.5 mm.
  • the distance between the intersection of the first developing portion 3211 and the second developing portion 3212 on a plane perpendicular to the axial direction of the main body bracket is from the first developing portion 3211 and the second developing portion 3212 in a plane perpendicular to the axial direction of the main body bracket 310.
  • the position where the distance between the intersections is the smallest is gradually increased to the end of the first developing portion 3211 or the second developing portion 3212 away from the connecting end 333, and the first developing portion 3211 and the second developing portion 3212 are perpendicular to the main body bracket 310.
  • the minimum distance between the intersections on the plane in the axial direction is not more than 2 mm.
  • the first developing portion 3211 and the second developing portion 3212 are flush with the free end at a position where the distance between the intersections on the plane perpendicular to the axial direction of the main body bracket 310 is the smallest.
  • the first developing member 321 can be prevented from being blocked by the developing ring in the sheath tube, and then passed through the gradual first developing member 321, It is advantageous to observe the position of the skirt holder 330 in the sheath, so that the complete release of the extension 336 of the skirt bracket 330 can be ensured, which facilitates the subsequent accurate positioning of the double vessel stent 300.
  • the distance between the intersection of the first developing portion 3211 and the second developing portion 3212 near the connecting end 333 on the plane perpendicular to the axial direction of the main body bracket 310 is the smallest, the first developing portion 3211 and the second The developing portion 3212 is symmetrical about the axis of the body holder 310.
  • the minimum distance between the intersection of the first developing portion 3211 and the second developing portion 3212 near the connecting end 333 on the plane perpendicular to the axial direction of the main body bracket 310 may also be located at the first development.
  • the second developing member 322 includes a third developing portion 3221 and a fourth developing portion 3222.
  • the third developing portion 3221 extends in the third direction, and one end of the third developing portion 3221 is adjacent to the first end 317. The other end is away from the first end 317; the fourth developing portion 3222 extends in the fourth direction, the third direction is obliquely intersected with the fourth direction, and the fourth developing portion 3222 has one end close to the first end 317 and the other end away from the first end 317 .
  • the lengths of the third developing unit 3221 and the fourth developing unit 3222 in the axial direction of the main body bracket are not less than 0.5 mm.
  • the distance between the intersection of the third developing portion 3221 and the fourth developing portion 3222 on a plane perpendicular to the axial direction of the main body bracket 310 is from a plane perpendicular to the axial direction of the main body bracket 310 from the third developing portion 3221 and the fourth developing portion 3222.
  • the position where the distance between the upper intersections is the smallest is gradually increased to the end of the third developing portion 3221 or the fourth developing portion 3222 away from the connecting end 333, and the third developing portion 3221 and the fourth developing portion 3222 are perpendicular to the axis of the main body bracket 310.
  • the minimum distance between the intersections on the plane of the direction is no more than 2 mm.
  • the distance between the intersection of the third developing portion 3221 and the fourth developing portion 3222 near the connecting end 333 in the plane perpendicular to the axial direction of the main body bracket 310 is the smallest.
  • the third developing unit 3221 and the fourth developing unit 3222 are symmetrical about the axis of the body holder 310.
  • the second developing member 322 can also be any other shape as long as the end of the second developing member 322 away from the first end 317 is flush with the end of the extending portion 336 away from the tapered portion 332.
  • the distance between the first developing portion 3211 and the second developing portion 3212 at the intersection between the intersections on the plane perpendicular to the axial direction of the main body bracket 310 to the third developing portion 3221 and the fourth developing portion 3222 is perpendicular to the main body bracket.
  • the position where the distance between the intersections on the plane in the axial direction of the 310 direction is the smallest in the circumferential direction of the main body bracket 310 is not more than 15°, so that the distance between the first developing member 321 and the second developing member 322 in the circumferential direction can be made. Smaller, it is possible to facilitate the shortening of the main body bracket 310.
  • the distance between the first developing portion 3211 and the second developing portion 3212 at the intersection between the intersections on the plane perpendicular to the axial direction of the main body bracket 310 to the third developing portion 3221 and the fourth developing portion 3222 is perpendicular to the main body bracket.
  • the line between the positions where the distance between the intersections on the plane in the axial direction of the 310 direction is the smallest is parallel to the axis of the body holder 310.
  • the first developing member 321 is provided on the first wave ring 313.
  • the first developing portion 3211 and the second developing portion 3212 are respectively formed by coating, plating or winding a developing material on the wave rod of the first wave ring 313.
  • the first developing unit 3211 and the second developing unit 3212 are located on two adjacent wave bars, and the first developing unit 3211 and the second developing unit 3212 are spaced apart to form a “ ⁇ /” type structure.
  • the pitch formed by the ends of the first developing portion 3211 and the second developing portion 3212 which are close to each other is not more than 2 mm.
  • the first developing portion 3211 is connected to one end of the second developing portion 3212 to form a "V" type structure.
  • the lengths of the first developing unit 3211 and the second developing unit 3212 are respectively 2 mm to 4 mm; the length of the first developing unit 3211 is 1/2 to 2/3 of the length of the rod in which the rod is located, and the second developing unit 3212 The length is 1/2 to 2/3 of the length of the pole.
  • the second developing member 322 is disposed on the second wave ring 314. Further, the third developing portion 3221 and the fourth developing portion 3222 are respectively formed by coating, plating or winding a developing material on the wave rod of the second wave ring 314. Further, the third developing unit 3221 and the fourth developing unit 3222 are located on the adjacent two wave rods, and the third developing unit 3221 and the fourth developing unit 3222 are spaced apart to form a " ⁇ /" type structure. At this time, the pitch formed by the ends of the first developing portion 3211 and the second developing portion 3212 which are close to each other is not more than 2 mm. It can be understood that in other embodiments, the third developing portion 3221 and the fourth developing portion 3222 are connected at one end to form a "V" type structure.
  • the lengths of the third developing unit 3221 and the fourth developing unit 3222 are respectively 2 mm to 4 mm; the length of the third developing unit 3221 is 1/2 to 2/3 of the length of the rod in which the rod is located, and the fourth developing unit 3222 The length is 1/2 to 2/3 of the length of the pole.
  • the third developing member 323 is disposed on the third wave ring 315. Further, the third developing member 323 is formed by coating, plating or winding a developing material on the wave rod of the third wave ring 315. Specifically, the third developing member 323 is of the "I" type. Further, the length of the third developing member 323 is 2 mm to 4 mm; and the third developing member 323 is 1/2 to 2/3 of the length of the rod in which it is placed.
  • the fourth developing member 324 is disposed on the fourth wave ring 316. Further, the fourth developing member 324 is formed by coating, plating or winding a developing material on the wave rod of the fourth wave ring 316. Specifically, the fourth developing member 324 is of the "I" type. Further, the length of the fourth developing member 324 is 2 mm to 4 mm; and the fourth developing member 324 is 1/2 to 2/3 of the length of the wave rod where it is located.
  • the developing member 320 can also be formed on the film 319. It will also be appreciated that the first developing member 321 may also be located on the skirt bracket 330.
  • the distance between the end of the second developing member 322 away from the first end 317 and the first end 317 is 10 mm to 15 mm, and the second developing member 322 can be released away from the end of the first end 317 and the end of the main blood vessel bracket. Flush, this can facilitate the control of one end of the double-walled stent beyond the length of the main stent is 10 to 15 mm, which can reduce the risk of the double-tube stent falling off the main vessel stent.
  • the double-layer developing bracket 300 is in a free state, and the tapered section 332 is bent and extended from the connecting end 333 toward the free end 334. Further, the distance between one end of the first developing member 321 near the first end 317 and the connecting end 333 is equal to the length of the contour line of the tapered section 332. One end of the extending portion 336 away from the tapered portion 332 is flush with the end of the second developing member 321 near the connecting end 333.
  • the free end 334 of the tapered section 332 is movable toward the first developing member 321 to abut the body holder 310.
  • 2 is an intermediate state when the free end 334 is moved in the direction of the first end 317
  • FIG. 3 is a state in which the skirt bracket 330 abuts against the main body bracket 310.
  • the free end 334 is flush with the end of the first developing member 321 away from the connecting end 333.
  • the second end 318 of the main body bracket 310 first enters the sheath tube until the connecting end 333 enters the sheath tube and tapers.
  • the segment 332 is pushed by the inner wall of the sheath such that the free end 334 moves toward the first end 317 until it abuts against the main body bracket 310.
  • the tapered section 332 is in the folded state, and the free end 334 is away from the first developing member 321
  • One end of the connecting end 333 is flushed to achieve the state shown in FIG. 3 to complete the sheathing process of the double-walled blood vessel stent 300.
  • the conveyor equipped with the main blood vessel stent 200 is first placed into the main blood vessel, and is fed from the branch blood vessel.
  • the double-layer blood vessel stent 300 is released until the first developing portion 3211 of the double-layer blood vessel stent 300 and the second developing portion 3212 are released from the conveyor at a position where the distance from the second developing portion 3212 is the smallest in the plane perpendicular to the axial direction of the body bracket 310.
  • the position of the double-layer blood vessel stent 300 is adjusted so that the first developing portion 3211 of the double-layer blood vessel stent 300 and the second developing portion 3212 have the smallest distance from the plane perpendicular to the axial direction of the body stent 310 and the main position.
  • the proximal end 210 of the blood vessel stent 200 When the proximal end 210 of the blood vessel stent 200 is flush, the initial positioning of the insertion is completed, the deployment of the extension section 336 can be ensured, and the stroke of dragging the double-layer blood vessel stent from the end to the final position can be shortened; and the release device of the sheath tube is locked again.
  • the drag sheath and the double blood vessel stent 300 are moved in the direction of the branch vessel in the main vessel stent 200, and moved to a plane intersection between the third developing portion 3221 and the fourth developing portion 3222 in the direction perpendicular to the axial direction of the body holder 310.
  • the drag is stopped and the double vessel stent 300 is completely released from the sheath.
  • the skirt branch 330 remote from the connecting end and a proximal end 333 of the main vessel stent 200 is flush 210, in order to achieve the reconstruction branch blood flow.
  • FIG. 5 shows that one end of the skirt holder 330 away from the connection end 333 is flush with the distal end 220 of the main blood vessel support 200 when the blood vessel reconstruction is performed by the above-described double-layer blood vessel stent 300 to realize reconstruction of the branch blood vessel.
  • the implementation process is similar to that in FIG. 4, and details are not described herein again.
  • the double-layer blood vessel stent 300 can conveniently observe the middle portion of the double-layer blood vessel stent 300 by providing a specific first developing member 321 between the first end 317 and the second end 318, and can be used for the double-layer blood vessel stent 300. Distortion and folding occurring in the release are recognized, and by the gradual first developing member 321, it is advantageous to observe the position in which the skirt holder 330 is released in the sheath, so that the complete release of the extension 336 of the skirt holder 330 can be ensured. It facilitates the subsequent accurate positioning of the double vessel stent 300. Further, by providing the second developing member 322 at a specific position, accurate positioning of the double-layered blood vessel stent 300 can be facilitated.
  • the structure of the double-layer developing bracket 400 of another embodiment is substantially the same as that of the double-layer developing bracket 300, and details are not described herein again.
  • the difference is that the taper section 432 of the double-layer developing bracket 400 extends obliquely from the connecting end 433 toward the free end 434, and the line connecting the connecting end 433 and the free end 434 forms an angle ⁇ with the axis of the main body bracket 410, 0 ⁇ ⁇ ⁇ 90 °.

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Abstract

一种双层血管支架（300），在主体支架（310）上设有裙边支架（330），在主体支架（310）上设有第一显影件（321）和第二显影件（322），第一显影件（321）包括第一显影部（3211）及第二显影部（3212），第一显影部（3211）及第二显影部（3212）在垂直于主体支架（310）轴线方向的平面上的交点之间距离最小的位置与自由端（334）齐平，第二显影件（322）远离第一端（317）的一端与延伸段远离锥度段（332）的一端齐平，该结构能够实现双层血管支架（300）的准确定位。

Description

双层血管支架 技术领域
本发明涉及医疗器械领域，特别是涉及双层血管支架。
背景技术
目前可采用管腔支架实施腔内隔绝术来隔离人体管腔内的病变区域，例如，可采用管腔支架在血管中隔绝动脉夹层或动脉瘤。此类方法具有手术创伤小、术中输血量少、术后恢复快及住院时间短等优点，因此已逐步取代传统的开腔手术。管腔支架通常具有径向膨胀能力，利用其径向支撑力紧贴血管腔壁而固定于管腔中。为防止支架脱落，支架需具有足够大的径向支撑力，而径向支撑力越大，支架径向展开后的刚性越强。然而，由于个体差异，管腔内壁形态各异，且管腔内壁还可能存在钙化斑块而改变管腔内壁的形貌，具有较大刚性的管腔支架有可能造成支架与管腔贴壁不良，使得支架与病变管腔壁之间无法完全封闭。
为了解决上述问题，其中一种方法就是使用双层血管支架，即，在主体支架外层设置变形能力较好的裙边支架，但是双层支架由于结构较复杂，如何准确地将双层血管支架释放到血管中成为急需解决的问题。
发明内容
基于此，有必要针对上述问题，提供一种有助于准确定位的双层血管支架。
一种双层血管支架，包括主体支架、裙边支架及显影件，所述主体支架包括第一端及与所述第一端相对设置的第二端；
所述裙边支架设于所述主体支架的外侧且向所述第一端延伸，所述裙边支架包括锥度段及延伸段，所述锥度段具有连接端及与所述连接端相对的自由端，所述连接端与所述主体支架连接，所述自由端与所述延伸段连接；所述显影件包括第一显影件及第二显影件；所述第一显影件位于所述第一端与所述连接端 之间，所述第二显影件位于所述第一显影件与所述第一端之间；
所述第一显影件包括第一显影部及第二显影部，所述第一显影部沿第一方向延伸，所述第二显影部沿第二方向延伸，所述第二方向与所述第一方向倾斜相交，且所述第一显影部及所述第二显影部在所述主体支架轴线方向上的长度均不小于0.5mm；
所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间的距离从所述第一显影部与第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第一显影部或所述第二显影部远离所述连接端的一端逐渐增大，且所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间的最小距离不大于2mm；
所述第一显影部及所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置与所述自由端的一端齐平，所述第二显影件远离所述第一端的一端与所述延伸段远离所述锥度段的一端齐平。
在其中一个实施例中，所述第一显影部及所述第二显影部靠近所述连接段的一端在垂直于所述主体支架轴线方向的平面上的交点之间的距离最小。
在其中一个实施例中，所述第二显影件包括第三显影部及第四显影部，所述第三显影部沿第三方向延伸，所述第四显影部沿第四方向延伸，所述第四方向与所述第三方向倾斜相交，且所述第三显影部及所述第四显影部在所述主体支架轴线方向上的长度均不小于0.5mm；
所述第三显影部与所述第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间的距离从所述第三显影部与第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第三显影部或所述第四显影部远离所述连接端的一端逐渐增大，且所述第三显影部与所述第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间的最小距离不大于2mm；
所述第三显影部及所述第四显影部远离所述第一端的一端在垂直于所述主体支架轴线方向的平面上的交点之间距离最小。
在其中一个实施例中，所述主体支架包括第一裸支架及附着于所述第一裸支架的主体覆膜，所述第一显影部、所述第二显影部、所述第三显影部及所述 第四显影部均设置于所述第一裸支架上。
在其中一个实施例中，所述第一裸支架包括多个沿轴向排布的波圈，所述波圈包括若干交替设置的波峰和波谷，相邻所述波峰与所述波谷之间通过波杆连接；所述第一显影部及所述第二显影部位于一所述波圈相邻的两个所述波杆上，所述第三显影部及所述第四显影部位于另一所述波圈相邻的两个所述波杆上。
在其中一个实施例中，所述第一显影部、所述第二显影部、所述第三显影部及所述第四显影部的长度为所在的所述波杆的长度的1/2～2/3。
在其中一个实施例中，所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第三显影部与所述第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置在所述主体支架的圆周方向上覆盖的夹角不大于15°。
在其中一个实施例中，所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第二显影件远离所述第一端的一端的轴向距离为10mm～15mm。
在其中一个实施例中，所述第二显影件远离所述第一端的一端与所述第一端的轴向距离为10～15mm。
在其中一个实施例中，所述延伸段上的各个位置到所述主体支架的纵向中心轴之间的距离均相等。
在其中一个实施例中，所述锥度段的轮廓线的长度与所述延伸段的轮廓线的长度之和不大于所述连接端与所述主体支架的所述第一端之间沿轴向的距离。
在其中一个实施例中，所述显影件还包括第三显影件及第四显影件，所述第三显影件设于所述第一端，所述第四显影件设于所述第二端。
上述双层血管支架通过在第一端和第二端之间设置特定的第一显影件，可以方便观测双层血管支架的中部的情况，能够用于双层血管支架在释放中出现的扭曲和打折进行识别，而且通过渐变的第一显影件，有利于观察裙边支架在鞘管中释放的位置，从而可以保证裙边支架的延伸段的完全释放，有助于后续 对双层血管支架进行准确定位。此外，再通过在特定位置设置第二显影件，可以便于实现双层血管支架的准确定位。
附图说明
图1为一实施方式的双层血管支架在自然状态下的结构示意图；
图2为图1所示的双层血管支架的裙边支架在进行装鞘过程中的结构示意图；
图3为图1所示的双层血管支架的裙边支架在装鞘完成时的结构示意图；
图4为一实施方式的图1所示的双层血管支架在进行分支血管重建时的结构示意图；
图5为另一实施方式的图1所示的双层血管支架在进行分支血管重建时的结构示意图；
图6为另一实施方式的双层血管支架在自然状态下的结构示意图。
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”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例的目的，不是旨在于限制本发明。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。
请参阅图1及图2，一实施方式的双层血管支架300包括主体支架310、裙边支架330及显影件320。裙边支架330套设于主体支架310上。显影件320设于主体支架310上，主体支架310具有第一端317及与第一端317相对设置的第二端318。可以理解的是，第一端317可以为主体支架310的近端，第二端318可以为主体支架310的远端。
进一步的，主体支架310包括第一裸支架及主体覆膜319。主体覆膜319附着于第一裸支架上。主体支架包括多个沿轴向排布的波圈。波圈包括第一波圈313、第二波圈314、第三波圈315及第四波圈316。进一步的，第三波圈315设于第一端317，第四波圈316设于第二端318，第一波圈313设于第三波圈315与第四波圈316之间，第二波圈314设于第一波圈313与第三波圈315之间。
具体的，波圈包括若干相互交替设置的波峰和波谷，相邻波峰与波谷之间通过波杆连接。进一步的，相邻两个波杆的延长线所形成的夹角的角度为30°～120°。
请一并参阅图3，主体支架310形成有依次连接的近端部3101、连接部3102及远端部3103。其中，近端部3101远离连接部3102的一端形成有第一端317，远端部3103远离连接部3102的一端形成有第二端318。第一端317的覆膜形成花瓣形结构，有利于血液从第一端通过；第二端318的覆膜为平齐结构。
在其中一个实施方式中，近端部3101的横截面积小于远端部3103的横截面积。连接部3102靠近近端部3101的一端的横截面积小于或等于连接部3102靠近远端部3103的一端的横截面积，且连接部3102靠近近端部3101的一端与连接部3102靠近远端部3103的一端的连线与轴向形成0～30°的夹角。进一步的，连接部3102靠近近端部3101的一端与连接部3102靠近远端部3103的一端的连线与主体支架310的轴向形成15°～25°的夹角。上述结构使得主体支架310形成锥形结构，可以增大远端部3103的锚定力，同时可以抑制主动脉博动被传递到用于分支血管的支架的远端部3103。
裙边支架330套设于主体支架310的外侧且向第一端317延伸。裙边支架330包括相互连接的锥度段332及延伸段336。锥度段332具有连接端333及与连接端333相对的自由端334。锥度段332的连接端333与主体支架310连接，自由端334与延伸段336连接。进一步的，所述延伸段336上的各个位置到主体支架310的纵向中心轴之间的距离相等，即，延伸段336与主体支架310平行设置。进一步的，锥度段332的轮廓线的长度与延伸段336的轮廓线的长度不大于连接段333与主体支架310的第一端317之间沿轴向的距离，可以避免在装鞘时裙边支架330超过主体支架310，降低装鞘长度，减少释放行程，同时有助于裙边支架330从鞘管中打开后的展开形态。需要说明的是，锥度段332的轮廓线可以理解为过主体支架310的轴线的平面与锥度段332相交时所截的连接端333至自由端334之间的曲线的长度。延伸段336的轮廓线可以理解为过主体支架310的轴线的平面与延伸段336相交时所截的自由端与延伸段336远离自由端334的一端之间的曲线的长度。在图示的实施例中，锥度段332的轮廓线为曲线。
在本实施例中，裙边支架330包括第二裸支架(图未示)及裙边覆膜(图未标)，裙边覆膜附着于第二裸支架上。裙边支架330的径向变形能力较主体支架310的径向变形能力好。
请同时参阅图1及图2，显影组件320设于主体支架310上。具体的，显影件320包括第一显影件321、第二显影件322、第三显影件323及第四显影件324。第一显影件321位于第一端317与连接端333之间，第二显影件322位于第一显影件321和第一端317之间。第三显影件323设于第一端317，第四显影件324设于第二端318。第三显影件323用于表征双层血管支架300的起始端。第四显影件324用于表征双层血管支架300的终止端。
进一步的，第一显影件321包括第一显影部3211及第二显影部3212，第一显影部3211沿第一方向延伸，且第一显影部3211的一端靠近第一端317，另一端远离第一端317；第二显影部3212沿着第二方向延伸，第一方向与第二方向倾斜相交，第二显影部3212的一端靠近第一端317，另一端远离第一端317。具体的，第一显影部3211及第二显影部3212在主体支架轴线方向上的长度均 不小于0.5mm。第一显影部3211与第二显影部3212在垂直于主体支架轴线方向的平面上的交点之间的距离从第一显影部3211与第二显影部3212在垂直于主体支架310轴线方向的平面上的交点之间距离最小的位置到第一显影部3211或第二显影部3212远离连接端333的一端逐渐增大，且第一显影部3211与第二显影部3212在垂直于所述主体支架310轴线方向的平面上的交点之间的最小距离不大于2mm。第一显影部3211与第二显影部3212在垂直于主体支架310轴线方向上的平面上交点之间距离最小的位置与自由端齐平。在手术时，当第一显影部3211及第二显影部3212逐渐从鞘管中释放出来，可以避免第一显影件321被鞘管中的显影环遮挡，再通过渐变的第一显影件321，有利于观察裙边支架330在鞘管中释放的位置，从而可以保证裙边支架330的延伸段336的完全释放，有助于后续对双层血管支架300进行准确定位。
在本实施例中，第一显影部3211及第二显影部3212靠近连接端333的一端在垂直于主体支架310轴线方向的平面上的交点之间的距离最小，第一显影部3211及第二显影部3212关于主体支架310的轴线对称。当然，在其他实施例中，第一显影部3211及第二显影部3212靠近连接端333的一端在垂直于主体支架310轴线方向的平面上的交点之间的距离最小位置也可以位于第一显影部3211和/或第二显影部3212的中部。
请继续参阅图1，第二显影件322远离第一端的一端与延伸段336远离锥度段332的一端齐平，可以方便对双层血管支架300进行准确定位。在图示的实施方式中，第二显影件322包括第三显影部3221及第四显影部3222，第三显影部3221沿第三方向延伸，且第三显影部3221的一端靠近第一端317，另一端远离第一端317；第四显影部3222沿第四方向延伸，第三方向与第四方向倾斜相交，第四显影部3222的一端靠近第一端317，另一端远离第一端317。第三显影部3221及第四显影部3222在主体支架轴线方向上的长度均不小于0.5mm。第三显影部3221与第四显影部3222在垂直于主体支架310轴线方向的平面上的交点之间的距离从第三显影部3221与第四显影部3222在垂直于主体支架310轴线方向的平面上的交点之间距离最小的位置到第三显影部3221或第四显影部3222远离连接端333的一端逐渐增大，且第三显影部3221与第四显影部3222 在垂直于主体支架310轴线方向的平面上的交点之间的最小距离不大于2mm。第三显影部3221及第四显影部3222靠近连接端333的一端在垂直于主体支架310轴线方向的平面上的交点之间的距离最小。具体的，第三显影部3221及第四显影部3222关于主体支架310的轴线对称。
可以理解的是，在其他实施例中，第二显影件322还可以为其他任意形状，只要第二显影件322远离第一端317的一端与延伸段336远离锥度段332的一端齐平。
进一步的，第一显影部3211与第二显影部3212在垂直于主体支架310轴线方向的平面上的交点之间距离最小的位置到第三显影部3221与第四显影部3222在垂直于主体支架310轴线方向的平面上交点之间距离最小的位置在主体支架310的圆周方向上覆盖的夹角不大于15°，这样可以使得第一显影件321与第二显影件322在圆周方向上的距离较小，可以便于主体支架310是否出现短缩。优选的，第一显影部3211与第二显影部3212在垂直于主体支架310轴线方向的平面上的交点之间距离最小的位置到第三显影部3221与第四显影部3222在垂直于主体支架310轴线方向的平面上交点之间距离最小的位置之间的连线与主体支架310的轴线平行。
具体到本实施方式中，第一显影件321设于第一波圈313上。进一步的，第一显影部3211及第二显影部3212分别为通过在第一波圈313的波杆上涂覆、镀膜或缠绕显影材料形成。进一步的，第一显影部3211与第二显影部3212位于相邻的两个波杆上，第一显影部3211与第二显影部3212间隔从而形成“\/”型结构。此时，第一显影部3211与第二显影部3212相互靠近的一端所形成的间距不大于2mm。可以理解的是，在其他实施方式中，第一显影部3211与第二显影部3212一端连接从而形成“V”型结构。具体的，第一显影部3211及第二显影部3212的长度分别为2mm～4mm；第一显影部3211的长度为所在的波杆的长度的1/2～2/3，第二显影部3212的长度为所在的波杆的长度的1/2～2/3。
第二显影件322设于第二波圈314上。进一步的，第三显影部3221及第四显影部3222分别通过在第二波圈314的波杆上涂覆、镀膜或缠绕显影材料形成。进一步的，第三显影部3221及第四显影部3222位于相邻的两个波杆上，第三 显影部3221与第四显影部3222间隔从而形成“\/”型结构。此时，第一显影部3211与第二显影部3212相互靠近的一端所形成的间距不大于2mm。可以理解的是，在其他实施方式中，第三显影部3221与第四显影部3222一端连接从而形成“V”型结构。具体的，第三显影部3221及第四显影部3222的长度分别为2mm～4mm；第三显影部3221的长度为所在的波杆的长度的1/2～2/3，第四显影部3222的长度为所在的波杆的长度的1/2～2/3。
第三显影件323设于第三波圈315上。进一步的，第三显影件323为通过在第三波圈315的波杆上涂覆、镀膜或缠绕显影材料形成。具体的，第三显影件323为“I”型。进一步的，第三显影件323的长度为2mm～4mm；第三显影件323为所在的波杆的长度的1/2～2/3。
第四显影件324设于第四波圈316上。进一步的，第四显影件324为通过在第四波圈316的波杆上涂覆、镀膜或缠绕显影材料形成。具体的，第四显影件324为“I”型。进一步的，第四显影件324的长度为2mm～4mm；第四显影件324为所在的波杆的长度的1/2～2/3。
可以理解的是，在其他实施例中，显影件320还可以形成于覆膜319上。还可以理解的是，第一显影件321还可以位于裙边支架330上。
进一步的，第二显影件322远离第一端317的一端与第一端317的距离为10mm～15mm，释放时可以使得第二显影件322远离第一端317的一端与主血管支架的端部齐平，这样可以便于控制双层血管支架的一端超出主血管支架的长度为10～15mm，这样可以降低双层血管支架从主血管支架上脱落的风险。
进一步的，第一显影部3211与第二显影部3212在垂直于主体支架310轴线方向的平面上的交点之间距离最小的位置到第二显影件322远离第一端317的一端的轴向距离为10mm～15mm。
请再次参阅图1，双层显影支架300处于自由状态，锥度段332自连接端333向着自由端334弯折延伸。进一步的，第一显影件321靠近第一端317的一端与连接端333的距离与锥度段332的轮廓线的长度相等。延伸段336远离锥度段332的一端与第二显影件321靠近连接端333的一端齐平。
请一并参阅图2及图3，锥度段332的自由端334能够向着靠近第一显影件 321的方向移动至与主体支架310相抵接。图2为自由端334靠着第一端317的方向移动时的中间状态，图3为裙边支架330与主体支架310相抵接时的状态。当自由端334与主体支架310相抵接时，自由端334与第一显影件321远离连接端333的一端齐平。
请一并参阅图1至图3，在将上述自然状态下的双层血管支架300进行装鞘时，主体支架310的第二端318首先进入鞘管，直至连接端333进入鞘管后，锥度段332在鞘管内壁的推动下使得自由端334向着靠近第一端317的方向移动直至与主体支架310相抵接，此时，锥度段332处于收拢状态，自由端334与第一显影件321远离连接端333的一端齐平从而达到图3所示的状态完成双层血管支架300的装鞘过程。
请一并参阅图4，当上述双层血管支架300运用到烟囱技术中作为烟囱支架进行血管重建时，首先向主血管中置入装有主血管支架200的输送器，从分支血管送入装有双层血管支架300的输送器，并使两个输送器的近端相交，然后释放主血管支架200，在置入双层血管支架300时，第一端317为双层血管支架300移动的前端。接着再释放双层血管支架300直至双层血管支架300的第一显影部3211与第二显影部3212在垂直于主体支架310轴向方向的平面上交点距离最小的位置从输送器中刚好释放出来时停止释放，调整双层血管支架300的位置，使双层血管支架300的第一显影部3211与第二显影部3212在垂直于主体支架310轴向方向的平面上交点距离最小的位置与主血管支架200的近端210齐平时完成置入的初始定位，可以保证延伸段336的展开，且能够缩短从此处拖动双层血管支架至最终位置的行程；再锁紧鞘管的释放装置，拖动鞘管和双层血管支架300在主血管支架200中向着分支血管的方向移动，移动至第三显影部3221与第四显影部3222在垂直于主体支架310轴线方向上的平面交点之间距离最小的位置与主血管支架200的近端210齐平时，停止拖动，并将双层血管支架300完全从鞘管中释放，此时，裙边支架330远离连接端333的一端与主血管支架200的近端210齐平，以实现分支血流的重建。
图5为采用上述双层血管支架300进行血管重建时使得裙边支架330远离连接端333的一端与主血管支架200的远端220齐平，以实现分支血管的重建。 其实现过程与图4中相似，在此不再赘述。
上述双层血管支架300通过在第一端317和第二端318之间设置特定的第一显影件321，可以方便观测双层血管支架300的中部的情况，能够用于双层血管支架300在释放中出现的扭曲和打折进行识别，而且通过渐变的第一显影件321，有利于观察裙边支架330在鞘管中释放的位置，从而可以保证裙边支架330的延伸段336的完全释放，有助于后续对双层血管支架300进行准确定位。此外，通过在特定位置设置第二显影件322，可以便于实现双层血管支架300的准确定位。
请进一步参阅图6，另一实施方式的双层显影支架400的结构与双层显影支架300的结构大体相同，在此不再赘述。其不同之处在于，双层显影支架400的锥度段432自连接端433向着自由端434倾斜延伸，且连接端433与自由端434的连线与主体支架410的轴线形成夹角γ，0<γ<90°。
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 (12)

  1. 一种双层血管支架，其特征在于，包括主体支架、裙边支架及显影件，所述主体支架包括第一端及与所述第一端相对设置的第二端；
    所述裙边支架设于所述主体支架的外侧且向所述第一端延伸，所述裙边支架包括锥度段及延伸段，所述锥度段具有连接端及与所述连接端相对的自由端，所述连接端与所述主体支架连接，所述自由端与所述延伸段连接；所述显影件包括第一显影件及第二显影件；所述第一显影件位于所述第一端与所述连接端之间，所述第二显影件位于所述第一显影件与所述第一端之间；
    所述第一显影件包括第一显影部及第二显影部，所述第一显影部沿第一方向延伸，所述第二显影部沿第二方向延伸，所述第二方向与所述第一方向倾斜相交，且所述第一显影部及所述第二显影部在所述主体支架轴线方向上的长度均不小于0.5mm；
    所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间的距离从所述第一显影部与第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第一显影部或所述第二显影部远离所述连接端的一端逐渐增大，且所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间的最小距离不大于2mm；
    所述第一显影部及所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置与所述自由端的一端齐平，所述第二显影件远离所述第一端的一端与所述延伸段远离所述锥度段的一端齐平。
  2. 根据权利要求1所述的双层血管支架，其特征在于，所述第一显影部及所述第二显影部靠近所述连接段的一端在垂直于所述主体支架轴线方向的平面上的交点之间的距离最小。
  3. 根据权利要求1所述的双层血管支架，其特征在于，所述第二显影件包括第三显影部及第四显影部，所述第三显影部沿第三方向延伸，所述第四显影部沿第四方向延伸，所述第四方向与所述第三方向倾斜相交，且所述第三显影部及所述第四显影部在所述主体支架轴线方向上的长度均不小于0.5mm；
    所述第三显影部与所述第四显影部在垂直于所述主体支架轴线方向的平面 上的交点之间的距离从所述第三显影部与第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第三显影部或所述第四显影部远离所述连接端的一端逐渐增大，且所述第三显影部与所述第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间的最小距离不大于2mm；
    所述第三显影部及所述第四显影部远离所述第一端的一端在垂直于所述主体支架轴线方向的平面上的交点之间距离最小。
  4. 根据权利要求3所述的双层血管支架，其特征在于，所述主体支架包括第一裸支架及附着于所述第一裸支架的主体覆膜，所述第一显影部、所述第二显影部、所述第三显影部及所述第四显影部均设置于所述第一裸支架上。
  5. 根据权利要求4所述的双层血管支架，其特征在于，所述第一裸支架包括多个沿轴向排布的波圈，所述波圈包括若干交替设置的波峰和波谷，相邻所述波峰与所述波谷之间通过波杆连接；所述第一显影部及所述第二显影部位于一所述波圈相邻的两个所述波杆上，所述第三显影部及所述第四显影部位于另一所述波圈相邻的两个所述波杆上。
  6. 根据权利要求5所述的双层血管支架，其特征在于，所述第一显影部、所述第二显影部、所述第三显影部及所述第四显影部的长度为所在的所述波杆的长度的1/2～2/3。
  7. 根据权利要求3所述的双层血管支架，其特征在于，所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第三显影部与所述第四显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置在所述主体支架的圆周方向上覆盖的夹角不大于15°。
  8. 根据权利要求1所述的双层血管支架，其特征在于，所述第一显影部与所述第二显影部在垂直于所述主体支架轴线方向的平面上的交点之间距离最小的位置到所述第二显影件远离所述第一端的一端的轴向距离为10mm～15mm。
  9. 根据权利要求1所述的双层血管支架，其特征在于，所述第二显影件远离所述第一端的一端与所述第一端的轴向距离为10～15mm。
  10. 根据权利要求1所述的双层血管支架，其特征在于，所述延伸段上的 各个位置到所述主体支架的纵向中心轴之间的距离均相等。
  11. 根据权利要求1所述的双层支架，其特征在于，所述锥度段的轮廓线的长度与所述延伸段的轮廓线的长度之和不大于所述连接端与所述主体支架的所述第一端之间沿轴向的距离。
  12. 根据权利要求1～11任一项所述的双层血管支架，其特征在于，所述显影件还包括第三显影件及第四显影件，所述第三显影件设于所述第一端，所述第四显影件设于所述第二端。
PCT/CN2018/121732 2017-12-29 2018-12-18 双层血管支架 WO2019128775A1 (zh)

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