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WO2015062531A1 - 一种覆膜支架 - Google Patents

一种覆膜支架 Download PDF

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Publication number
WO2015062531A1
WO2015062531A1 PCT/CN2014/089968 CN2014089968W WO2015062531A1 WO 2015062531 A1 WO2015062531 A1 WO 2015062531A1 CN 2014089968 W CN2014089968 W CN 2014089968W WO 2015062531 A1 WO2015062531 A1 WO 2015062531A1
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WO
WIPO (PCT)
Prior art keywords
stent graft
stent
segment
bare
section
Prior art date
Application number
PCT/CN2014/089968
Other languages
English (en)
French (fr)
Inventor
李中华
朱清
王丽文
邢智凯
朱永锋
严冬梅
Original Assignee
微创心脉医疗科技（上海）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 微创心脉医疗科技（上海）有限公司 filed Critical 微创心脉医疗科技（上海）有限公司
Priority to PL14858484.0T priority Critical patent/PL3064172T3/pl
Priority to ES14858484T priority patent/ES2929190T3/es
Priority to EP14858484.0A priority patent/EP3064172B1/en
Priority to BR112016009186-8A priority patent/BR112016009186B1/pt
Publication of WO2015062531A1 publication Critical patent/WO2015062531A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483—Barbs
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0023—Angular shapes triangular
    • 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
    • A61F2250/0036—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 thickness
    • 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

Definitions

  • the present invention relates to a stent graft that can be used to treat abdominal aortic aneurysms.
  • the stent graft used for the treatment of abdominal aortic aneurysm should have the following characteristics: the stent graft should be adapted to the curved neck, and should be adapted to the smaller neck length, and should have better adherence and roundness. Good bending performance, moderate support strength, and prevention of long-term shifting.
  • the evaluation of such stent grafts mainly has the following performance indicators: 1 sealing: evaluation of the effectiveness of the stent to isolate the tumor cavity and blood; 2 anti-displacement: preventing displacement after stent placement; 3 release resistance: appropriate release resistance can make the stent release smoothly and avoid stent displacement; 4 positioning accuracy: evaluation of the degree of deviation of the position of the stent graft after release and release; 5 stent compliance: evaluation of the film The ability of the stent to flexibly bend in a curved vessel; 6 to accommodate a curved neck; 7 to a smaller neck length.
  • the patent document EP 2 301 476 A1 discloses a suture knotting method for a stent graft, wherein the knotting method is used to fix the stent segment and the laminating tube, so that the stent graft is prevented from being displaced after being placed in the blood vessel, such knotting The method can increase the pull-out force of the main stent graft and the branch stent graft.
  • the patent document US 2008/0114443 A1 discloses a proximal structure of a bare section barbed stent graft and a fixed barb delivery system in which the bare segments and barbs are cut.
  • the knotting method in the patent document EP 2 301 476 A1 can improve the pull-out force, but the knotting method is complicated, and the work time is low, and the production efficiency is low.
  • the patent document US 2008/0114443 A1 there are more barbs in the bare section, and there are two barbs on one vertex, and the barbs are adjacent to each other and placed in the blood. After the tube, it may cause tearing of the blood vessel wall.
  • the positioning and suturing of the stent segment is inconvenient, and the bending performance and the adherence performance of the stent segment also need to be further improved.
  • the object of the present invention is to develop a stent graft which can buffer the damage of the apex of the stent segment to the film, and facilitate the positioning and stitching of the stent segment, and can also improve the bending of the stent segment. Performance and adherence performance.
  • the present invention provides a stent graft comprising: a stent portion including a bare segment and a body segment; and a laminating tube secured to the body segment, wherein
  • the body segment includes a plurality of bracket segments along its axial direction, wherein the stent graft further includes a plurality of circumferential bosses, the circumferential bosses being disposed on the film in the axial direction An outer circumference of the tube, and the circumferential boss and the bracket section are alternately arranged in the axial direction.
  • the plurality of circumferential bosses are arranged at equal intervals in the axial direction on the outer circumference of the film tube.
  • the outer diameter of the circumferential boss is 1 mm - 3 mm larger than the outer diameter of the coating tube, and the width of the circumferential boss is between 0.5 mm - 1.5 mm.
  • the bare segment includes a plurality of stent rods, the plurality of stent rods form a wavy structure, and at least a portion of the bare segments are located outside the laminating tube, and the bare segments further include: a shoulder a portion located at a proximal intersection of each two adjacent stent rods; a posterior release aperture connected to a proximal end of each of the shoulders, the posterior release aperture for transporting the bare segment and stent delivery system a rear release device connection; and a barb extending from each of the shoulders toward the distal end and between the corresponding two adjacent stent rods.
  • the rear release hole is an elliptical hole, a circular hole, a triangular hole, a rectangular hole, a trapezoidal hole or a shaped hole.
  • the rear release hole Having a rear release hole length along an axial direction of the stent graft, and having a posterior release hole width in a circumferential direction of the stent graft, and the posterior release hole is in a circumferential direction of the stent graft
  • the thickness of the two outer walls plus the width of the rear release hole is the outer contour width, wherein the length of the rear release hole is between 1.0 mm and 4.0 mm, and the width of the rear release hole is between 0.1 mm and 0.6 mm.
  • the outer contour width is between 0.8 mm and 1.5 mm.
  • the diameter of the proximal portion of the bare segment is greater than the diameter of the distal portion of the bare segment.
  • the thickness of the bare segment is between 0.2 mm and 0.8 mm.
  • the thickness of the bare segment is between 0.4 mm and 0.6 mm.
  • the bare segment is a cutting stent segment, and the remaining stent segments are fabricated stent segments.
  • the bracket portion further includes at least two branch segments, and a proximal end of the branch segment is coupled to a distal end of the body segment.
  • the bracket portion further includes a transition section between the body section and the at least two branch sections and for transitioning the body section to the at least two branch sections.
  • the diameter of the proximal end portion of the transition section is the same as the diameter of the distal end portion of the body segment, and the transition section tapers conically from its proximal end portion toward its distal end portion to smoothly Transitioning to the at least two branch segments.
  • the body segment further includes a small band, and the small band is disposed adjacent to the bare segment.
  • the waveform of the small band is designed to be a contoured structure or a high-rise structure.
  • the small band is made of filaments having a wire diameter of 0.2032 to 0.254 mm.
  • the stent graft is provided with a circumferential boss which can buffer the damage of the apex of the stent segment to the film, and facilitate the positioning and stitching of the stent segment, and can also improve the bending performance of the stent segment and Adhesion performance.
  • the transition section adopts a tapered transition shape, which can effectively alleviate the impact of blood flow on the film and suture of the bifurcation area;
  • the bare section of the stent graft has barbs to prevent long-term displacement after implantation;
  • the proximal part of the stent graft is provided with a small band to improve the adherence and roundness; the whole stent graft is prepared in addition to the bare section, which can reduce the cost and improve the production efficiency.
  • FIG. 1 is an overall schematic view of a stent graft in accordance with an embodiment of the present invention.
  • Fig. 2 is a plan view showing the structure of the bare section of the stent graft of the present invention in an enlarged view.
  • Fig. 3 is a plan view showing a structure of a rear release hole.
  • Fig. 4 is a plan view showing another rear release hole structure.
  • FIG. 5 is a schematic perspective view showing the naked structure of the stent graft of the present invention after being implanted into a human blood vessel and the bare segment is shaped.
  • Fig. 6 is a schematic view showing the structure of a circumferential boss of the stent graft of the present invention.
  • Figure 7 is a schematic illustration of a stent graft with circumferential bosses prior to bending.
  • Figure 8 is a schematic view of a stent graft with a circumferential boss after bending, wherein Figure 8(a) shows the stent graft in a generally curved configuration, and Figure 8(b) shows the stent in a bending extreme configuration. support.
  • Figure 9 shows a schematic diagram of a small band with a contour structure.
  • Fig. 10 shows a schematic diagram of a small band having a variable height structure.
  • Figure 11 is an exploded detail view of the transition section.
  • the stent graft 1 of the present invention comprises: a stent portion 16 comprising a bare segment 2 and a body segment 15; and a laminating tube 11 secured to the body segment 15, wherein the body segment 15 is along
  • the axial direction comprises a plurality of stent segments 17, which are tubular structures formed from one or more layers of film.
  • the stent portion 16 comprises, in order from the proximal end to the distal end of the stent graft 1, a bare segment 2, a body segment 15, a transition segment 4 and two branch segments 5.
  • the bare section 2 includes a plurality of first stent rods 6, the plurality of first stent rods 6 forming a wavy structure, and at least a portion of the bare segments 2 being located outside the coating tube 11.
  • Each of the stent segments 17 is arranged in an annular shape around the central axis of the stent graft 1.
  • Each of the stent segments 17 is composed of a plurality of second stent rods, that is, a plurality of second stent rods form a loop around the central axis of the stent graft 1 to form a stent segment 17.
  • the transition section 4 is located between the body section 15 and the branch section 5 for transitioning the body section 15 to the branch section 5.
  • the proximal end refers to the end closer to the heart after the stent is implanted into the human body
  • the distal end refers to the end of the stent that is further away from the heart after being implanted into the human body.
  • the proximal end refers to the upper end of the drawing
  • the distal end refers to the lower end of the drawing.
  • Fig. 2 is a plan view showing the structure of the bare section 2 of the stent graft 1 of the present invention in an enlarged view. As shown in FIG.
  • the bare section 2 in addition to the first support rod 6, the bare section 2 further includes a rear release hole 9, a shoulder 8 and a barb 7, the shoulder 8 being located at two adjacent first support rods At the proximal intersection of 6 and connecting the first stent rod 6 and the rear release aperture 9, the rear release aperture 9 is used to release the bare section 2 and a poster release device of the stent delivery system (not Graphic) Connected, the barbs 7 extend from the shoulder 8 towards the distal end and are located between the two adjacent first stent rods 6.
  • the proximal end refers to the right end of the drawing and the distal end refers to the left end of the drawing.
  • the proximal end of the bare section 2 has a rear release hole 9 which is released by the posterior release device of the stent delivery system when the stent graft is released, and the membrane is covered by a guide wire (not shown) on the posterior release device.
  • the bare section 2 of the stent and the posterior release device are coupled together with the guidewire passing through the posterior release aperture 9.
  • the bare section 2 is a cutting bracket section.
  • the shoulder 8 of the bare section 2 is used to carry the force applied from the barb 7 and the rear release aperture 9.
  • the barbs 7 are inserted into the high-quality blood vessel wall of the human body by the tension of the bare segment 2, thereby preventing the stent graft from being displaced.
  • the first stent rod 6 constitutes a support structure for the integral stent graft.
  • Fig. 3 is a plan view showing a structure of a rear release hole.
  • the shape of the rear release hole 9 is elliptical.
  • the term "elliptical-like" is a commonly used term in the art, and generally refers to a shape similar to an ellipse, such as the shape shown in Fig. 3, which can be clearly understood by those skilled in the art.
  • FIG. 3 the term “elliptical-like" is a commonly used term in the art, and generally refers to a shape similar to an ellipse, such as the shape shown in Fig. 3, which can be clearly understood by those skilled in the art.
  • the rear release hole 9 has a rear release hole length L1 in the axial direction of the stent graft, and has a rear release hole width L2 in the circumferential direction of the stent graft, and the rear release hole 9
  • the thickness of the two outer walls in the circumferential direction of the stent graft plus the posterior release aperture width L2 is the outer contour width L3.
  • the length of the rear release hole L1 is preferably between 1.0 mm and 4.0 mm; if the length L1 of the rear release hole is too short, the guide wire may be severely discounted after the guide wire is inserted, resulting in incomplete release or guide wire.
  • the rear release hole width L2 is preferably between 0.1 mm and 0.6 mm; if the rear release hole width L2 is too narrow, the diameter of the threaded guide wire may be too thin, so that the bare segment 2 and the guide penetrating the bare segment 2 The strength of the wire is not enough, so that the release is incomplete or the guide wire is broken during release; if the width L2 of the release hole is too wide, the overall contour of the stent graft may be increased, so that the supporting delivery system may not be installed. in.
  • the outer contour width L3 is preferably between 0.8 mm and 1.5 mm; if the outer contour width L3 is too narrow, the two outer walls of the rear release hole 9 in the lateral direction thereof may be too thin to be easily broken. Risk; if external The profile width L3 is too wide and may cause an increase in the overall contour of the stent graft, which may result in failure to fit into the associated delivery system.
  • Fig. 4 is a plan view showing another rear release hole structure.
  • the shape of the rear release hole 9 is substantially triangular.
  • the rear release hole 9 may be a rectangular hole, a circular hole, a trapezoidal hole or a profiled hole or the like depending on the type of the rear release device and the overall performance.
  • Shaped holes are common technical terms in the art, which generally refer to holes that differ from the general type or style, for example, other irregularly shaped holes other than elliptical, circular, triangular, rectangular, and trapezoidal. .
  • FIG. 5 is a schematic perspective view showing the naked structure of the stent graft of the present invention after being implanted into a human blood vessel and the bare segment is shaped.
  • the bare segment 2 is shaped, that is, in a case where the stent graft 1 is in an expanded state, the bare segment 2 encloses a ring shape, and the bare segment
  • the diameter D1 of the proximal end portion of 2 is larger than the diameter D2 of the distal end portion of the bare segment 2, so that the baffle 7 can be inserted into the blood vessel after the stent graft 1 is released from the delivery system and smoothly extended, thereby preventing the stent graft 1 shift.
  • the thickness T1 of the bare section 2 is between 0.2 mm and 0.8 mm, preferably between 0.4 mm and 0.6 mm. If the thickness T1 of the bare segment 2 is too thin, the support strength of the bare segment 2 is weak; if the thickness T1 of the bare segment 2 is too thick, the bare segment 2 may be too thick or too hard to cause the release back support. It does not open and will cause the overall contour of the bracket to increase, making assembly difficult. Note that in FIG.
  • the thickness of the bare segment 2 refers to the thickness dimension of the bare segment 2 in the radial direction of the stent graft 1
  • the proximal end refers to the upper end of the drawing
  • the distal end refers to the lower end of the drawing.
  • Fig. 6 is a schematic view showing the structure of a circumferential boss of the stent graft of the present invention.
  • a plurality of circumferential bosses 10 are integrally formed with the membrane tube 11 outside the membrane tube 11 (in the embodiment of FIGS. 1 and 6)
  • Three circumferential bosses are shown, that is, the material of the circumferential boss 10 is the same as that of the coating tube 11, and is a flexible material.
  • Each of the plurality of circumferential bosses 10 extends circumferentially around the outer peripheral surface of the film tube 11 and protrudes toward the outer side of the film tube 11.
  • the circumferential boss 10 and the bracket segments 17 of the body section 15 are alternately arranged in the axial direction of the body section 15.
  • a plurality of circumferential bosses 10 are arranged at equal intervals on the outer circumference of the coating tube 11 in the axial direction of the body section 15.
  • the plurality of circumferential bosses 10 may not be equal to each other.
  • the circumferential boss 10 of the present invention has the following characteristics:
  • the stent graft After the stent graft is implanted into the human body, there may be plaque on the blood vessel wall of the implanted site. After the plaque is encountered in the portion with the metal stent, it may easily cause adverse effects such as poor adherence and internal leakage.
  • the stent graft 1 with the circumferential boss 10 of the present invention is implanted into the hemangioma cavity, the contact of the film material of the circumferential boss structure with the blood vessel wall is increased as the blood flow impacts. Therefore, the adherence performance of the integral stent graft can be increased, and the endoleak can be reduced.
  • the stent graft 1 of the present invention is provided with a plurality of circumferential bosses 10, so that when the stent graft 1 is bent, the shape of the stent is bent as a whole, so that the overall bending of the stent graft can be increased after suturing the stent segment. Sex.
  • the outer diameter W2 of the circumferential boss 10 is larger than the outer diameter W1 of the coating tube 11 of the stent graft 1 by 1 mm - 3 mm (see FIG. 6), and the width H1 of the circumferential boss 10 is Between 0.5mm and 1.5mm. If the width H1 of the circumferential boss 10 is too narrow, it is possible that the circumferential boss 10 cannot effectively reduce the abrasion between the stent segment and the film and does not have the effect of bending flexibility; if the circumferential direction The width H1 of the boss 10 is too wide, which may cause the spacing between the bracket segments to be too large, and it is more likely to cause a discount.
  • the outer diameter of the circumferential boss 10 refers to the outermost diameter of the circumferential boss 10 extending around the central axis of the stent graft 1
  • the width of the circumferential boss 10 refers to the along the circumferential boss 10. The axial dimension of the central axis of the stent graft 1 is measured.
  • FIG. 7 is a schematic illustration of a stent graft with a circumferential boss 10 prior to bending, wherein the stent graft of the stent graft is straight.
  • Figure 8 is a schematic view of a stent graft with a circumferential boss 10 after bending, wherein the stent graft of the stent graft 1 has a curved shape, and Figure 8 (a) shows the stent graft 1 in a generally curved configuration.
  • Fig. 8(b) shows the stent graft 1 in a bending limit configuration.
  • the coating tube 11 with the circumferential boss 10 when the coating tube 11 with the circumferential boss 10 is bent, the coating tube 11 is bent along with the circumferential projection, and as the degree of bending increases, the circumferential projection
  • the curved small curved side (the left side in Fig. 8(b), that is, the inner side of the curved portion) is compressed, and the upper and lower edges of the inner circumference of the circumferential boss 10 are brought into contact with the deepening of the degree of bending, as shown in the figure. 8(b), in this case, since the circumferential boss 10 is located outside the entire stent graft, it does not affect the blood flow; the curved side of the circumferential boss 10 is curved (Fig.
  • the right side of the middle that is, the outside of the curved portion, is fully opened to increase its amount of bending. If there is no circumferential boss 10, in the case where the large curved side of the film is completely opened, the film on the small curved side is bound to wrinkle, and the wrinkles inside the film tube affect the blood flow velocity.
  • the small curved side with the circumferential boss 10 increases as the degree of bending increases, and the upper and lower edges of the inner circumferential boss 10 of the small curved side are brought into contact with each other.
  • the membrane is supported by the stent segments so that the inner coating does not create excess wrinkles and thus affects blood flow.
  • Increasing the circumferential boss 10 can facilitate the positioning of the bracket segments and facilitate precision sewing, which greatly increases the feasibility of the stitching process.
  • the stent segments used for the treatment of abdominal aortic aneurysms are larger in diameter, while large cutting machines are more expensive, and the stent segments need to be post-treated after cutting, such as polishing, shaping, sandblasting, etc., so cutting
  • the bracket segments are expensive.
  • the preparation of the bracket section only needs to be shaped by various sizing molds to shape the required bracket section, that is, the use of the bracket section can reduce the cost and ensure the same performance.
  • the bare segment 2 may be formed as a cutting stent segment, and the remaining stent segments include, but are not limited to, the aforementioned stent segment 3, the stent segment 17, and the branch segment 5 which will be mentioned below.
  • the middle section 13 of the bracket section and the transition section are both braided sections, thereby To reduce costs.
  • the bracket portion 16 further includes at least two branch segments 5, and the proximal end of the branch segment 5 is coupled to the distal end of the body segment 15.
  • the bracket portion 16 further includes a transition section 4 between the body section 15 and the branch section 5 and for transitioning the body section 15 to the branch section 5.
  • the design of the transition section 4 in the stent portion 16 of the stent graft is shown in FIG. Figure 11 is an exploded detail view of the transition section 4.
  • the main body section 15 of the stent graft 1 has a large diameter and the diameter of the branch section 5 is small, if the main body section of the stent graft 1 is directly connected to the branch section, the joint film, especially the bifurcation film And the nearby sutures will be greatly impacted by the blood flow, which will cause the membrane of the bifurcation area to be damaged by the severe impact of the blood flow, and will cause the seams of the first section of the main section and the branch section to be worn seriously. It may cause the stent segment to fall off and the blood leakage at the bifurcation to cause serious consequences.
  • the present invention contemplates a transition section 4 that can smoothly and smoothly transition the large diameter portion of the proximal stent graft to the small diameter portion of the distal two branch segments.
  • the diameter of the proximal portion 12 of the transition section 4 is the same as the diameter of the distal end portion of the body section 15, and the transition section 4 is from its proximal end portion 12 toward its distal end.
  • the end portion 14 tapers conically to smoothly transition to the two branch segments 5, wherein reference numeral 13 denotes the middle structure of the transition segment.
  • the proximal end refers to the upper end of the drawing
  • the distal end refers to the lower end of the drawing.
  • the small band 3 having a braided structure can increase the proximal adherence and roundness of the stent graft.
  • the body segment 15 can also include a small band 3 that is disposed adjacent to the bare segment 2.
  • the small band 3 is located at a proximal edge portion of the film tube 11 formed of a film material.
  • the small band 3 is used to improve the proximal adhesion of the stent graft and prevent the occurrence of endoleak.
  • the waveform structure of the small band 3 is smaller in size than the waveform structure of the other bracket segments in the bracket portion 16.
  • the waveform of the small band 3 can be designed as a contour structure or a high structure. Small band wire diameter is fine.
  • FIG. 9 shows a small band 3 with a contour structure schematic diagram.
  • the small-band structure 3 has a contour structure, that is, all the upper vertices are on the same plane, and all the lower vertices are on the same plane, and the lengths of the respective bracket rods are the same, that is, the contour structure.
  • Fig. 10 shows a schematic diagram of a small band 3 having a variable height structure. In the variable height structure of the small band 3 shown in FIG. 10, all the upper vertices are on the same plane, but all the lower vertices are not all on the same plane, and the height structure of the vertices not in the same plane has It is beneficial to reduce the contour of the integral stent graft.
  • the wire diameter of the small band 3 is relatively fine, and the wire diameter of 0.2032-0.254 mm (0.008-0.010 inch) is generally selected, which is much smaller than the stent segment of the main body segment.
  • the stent graft of the present invention is suitable for treating abdominal aortic aneurysms.
  • the stent graft is introduced into the lesion and released, and the metal stent supports the membrane material on the normal blood vessel wall at both ends of the diseased vessel, so that the stent graft can treat the aneurysm and blood flow in the lumen of the vessel.
  • the invention can be applied to a case of abdominal aortic aneurysm with short neck and curved neck, that is, the stent graft of the invention is more suitable for a shorter neck length, a more curved neck, and better adhesion. And roundness, and it also has a moderate support strength, can also prevent the long-term displacement of the stent graft after implantation of the stent graft.
  • the stent graft is provided with a circumferential boss which can buffer the damage of the apex of the stent segment to the film, and also facilitates the positioning and stitching of the stent segment, and can also improve the bending performance and the adhering performance;
  • the transition section adopts a tapered transition shape, which can effectively alleviate the impact of blood flow on the film and suture of the bifurcation area.
  • the bare section of the stent graft is provided with barbs to prevent long-term displacement after implantation;
  • the proximal part of the stent graft is provided with a small band to improve the adherence and roundness;
  • the whole stent graft is prepared, which can reduce costs and improve production efficiency.
  • the stent graft of the invention can meet the performance indexes mentioned in the previous part of the specification for evaluating such a stent graft, has good sealing property, can isolate the tumor cavity and blood; the bare segment has barbs, thereby preventing The stent is displaced after implantation; the appropriate release resistance can make the stent release smoothly and avoid the stent displacement; the posterior release function of the stent can accurately position the stent graft; the stent graft has lower rib height and good flexibility; And can adapt to a smaller neck length.
  • the present invention can be adapted to various types of abdominal aortic aneurysms.

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Abstract

一种覆膜支架（1）包括：支架部分（16），该支架部分（16）包括裸段（2）和主体段（15）；以及固定于该主体段（15）上的覆膜管（11）。主体段（15）沿其轴向方向包括多个支架段（17）。覆膜管（11）沿该轴向方向设有多个周向凸台（10）。该周向凸台（10）与支架段（17）在轴向方向上交替地排列。该覆膜支架（1）设置的周向凸台（10）能缓冲支架段顶点对覆膜的损伤。

Description

一种覆膜支架 技术领域
本发明涉及一种覆膜支架，该覆膜支架可以用于治疗腹主动脉瘤。
背景技术
目前市场上的用于治疗腹主动脉瘤和髂动脉瘤的覆膜支架的种类很多，各类产品的优缺点不一，治疗点也不同。用于治疗腹主动脉瘤的覆膜支架主要应具有以下特性：覆膜支架要适应弯曲瘤颈，要适应更小的瘤颈长度，要具有较好的贴壁性和圆整性，要具有良好的弯曲性能，要具有适中的支撑强度，并且要能防止远期移位等。
目前，在国内国际市场上，评价此类覆膜支架主要有如下的性能指标：①密封性：评价支架隔绝瘤腔与血液的有效性；②抗移位性：防止支架放置后发生移位；③释放阻力：适当的释放阻力可使支架顺利释放且避免支架移位；④定位准确性：评价释放前的定位与释放后覆膜支架的位置的偏移程度；⑤支架柔顺性：评价覆膜支架在弯曲血管中顺应性弯曲的能力；⑥适应弯曲瘤颈；⑦更小的瘤颈长度。
现有技术中公开了多种覆膜支架。例如，专利文献EP2301476A1公开了一种覆膜支架的缝合打结方法，其中该打结方法用于固定支架段与覆膜管，使覆膜支架放置到血管后避免其移位，此种打结方法可以使主体覆膜支架和分支覆膜支架的拉脱力增加。此外，专利文献US2008/0114443A1公开了一种裸段带倒钩的覆膜支架及固定倒钩的输送系统的近端结构，其中裸段和倒钩是切割而成的。
但是，专利文献EP2301476A1中的打结方法虽然可以提高拉脱力，但打结方式复杂，耽误工时，生产效率较低。在专利文献US2008/0114443A1中的方案中，裸段倒钩较多，一个顶点上有两个倒钩，倒钩相邻较近，放置到血 管后，可能会造成血管壁撕裂等情况。而且，在上述现有技术的覆膜支架的使用中，支架段的定位和缝合不方便，且支架段的弯曲性能和贴壁性能也有待进一步提高。
发明内容
鉴于现有技术的上述技术问题，本发明的目的在于开发一种覆膜支架，其能缓冲支架段顶点对覆膜的损伤，并便于支架段的定位和缝合，且还可以提高支架段的弯曲性能和贴壁性能。
具体而言，本发明提供了一种覆膜支架，所述覆膜支架包括：支架部分，所述支架部分包括裸段和主体段；以及固定于所述主体段上的覆膜管，其中所述主体段沿其轴向方向包括多个支架段，其特征在于，所述覆膜支架还包括多个周向凸台，所述周向凸台沿所述轴向方向布置于所述覆膜管的外周，且所述周向凸台与所述支架段在所述轴向方向上交替地排列。
优选的是，所述多个周向凸台在所述轴向方向上等间距地布置在所述覆膜管的外周上。
优选的是，所述周向凸台的外径比所述覆膜管的外径大1mm—3mm，并且所述周向凸台的宽度在0.5mm—1.5mm之间。
优选的是，所述裸段包括多个支架杆，所述多个支架杆形成波状结构，并且所述裸段的至少一部分位于所述覆膜管之外，并且所述裸段还包括：肩部，位于每两个相邻的支架杆的近端交点部位处；后释放孔，连接至每个所述肩部的近端，所述后释放孔用于将所述裸段和支架输送系统的后释放装置连接；以及倒钩，从每个所述肩部朝向远端延伸且位于对应的两个相邻的支架杆之间。
优选的是，所述后释放孔是类椭圆形孔、圆形孔、三角形孔、矩形孔、梯形孔或异型孔。
优选的是，在所述后释放孔的形状是类椭圆形的情况下，所述后释放孔 沿所述覆膜支架的轴向方向具有后释放孔长度，且沿所述覆膜支架的周向方向具有后释放孔宽度，且所述后释放孔在所述覆膜支架的周向方向上的两个外壁的厚度加上所述后释放孔宽度为外部轮廓宽度，其中所述后释放孔长度在1.0mm—4.0mm之间，所述后释放孔宽度在0.1mm—0.6mm之间，且所述外部轮廓宽度在0.8mm—1.5mm之间。
优选的是，在所述覆膜支架处于扩张状态的情况下，所述裸段的近端部分的直径大于所述裸段的远端部分的直径。
优选的是，所述裸段的厚度在0.2mm—0.8mm之间。
优选的是，所述裸段的厚度在0.4mm—0.6mm之间。
优选的是，在所述覆膜支架的所述支架部分中，仅所述裸段是切割支架段，而其余支架段均为编制支架段。
优选的是，所述支架部分还包括至少两个分支段，且所述分支段的近端与所述主体段的远端相连。
优选的是，所述支架部分还包括过渡段，所述过渡段位于所述主体段与所述至少两个分支段之间，并用于将所述主体段过渡至所述至少两个分支段。
优选的是，所述过渡段的近端部分的直径和所述主体段的远端部分的直径相同，并且所述过渡段从其近端部分朝向其远端部分锥形地逐渐缩小从而平滑地过渡到所述至少两个分支段。
优选的是，所述主体段还包括有小波段，所述小波段靠近所述裸段设置。
优选的是，所述小波段的波形设计成等高结构或者变高结构。
优选的是，所述小波段由丝径为0.2032—0.254毫米的细丝制成。
根据本发明，覆膜支架上设有周向凸台，该周向凸台可以缓冲支架段顶点对覆膜的损伤，并便于支架段的定位和缝合，且还可以提高支架段的弯曲性能和贴壁性能。
此外，过渡段采用锥形过渡形状，因而可以有效缓解血流对分叉处区域覆膜和缝合线的冲击；覆膜支架的裸段带有倒钩，可以防止植入后远期移位； 覆膜支架的近端部分设有小波段，可以提高贴壁性和圆整性；整体覆膜支架除裸段外，其余支架段均为编制而成，这样可以降低成本、提高生产效率。
附图说明
为了更清楚地说明本发明实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍。显而易见的是，下面描述中的附图仅仅是本申请中记载的一些特定实施例，其不是对本发明的保护范围的限制。对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，当然还可以根据本发明的这些实施例及其附图获得一些其它的实施例和附图。
图1为根据本发明的一个实施例的覆膜支架的整体示意图。
图2为以放大图示出了本发明的覆膜支架的裸段的结构的平面图。
图3为示出了一种后释放孔结构的平面图。
图4为示出了另外一种后释放孔结构的平面图。
图5为在本发明的覆膜支架植入人体血管且裸段定型后的裸段的立体结构示意图。
图6为示出了本发明的覆膜支架的周向凸台结构的示意图。
图7为弯曲之前的带有周向凸台的覆膜支架的示意图。
图8为弯曲之后的带有周向凸台的覆膜支架的示意图，其中图8(a)显示了处于通常弯曲形态的覆膜支架，图8(b)显示了处于弯曲极限形态的覆膜支架。
图9示出了具有等高结构的小波段的示意图。
图10示出了具有变高结构的小波段的示意图。
图11为过渡段的分解细节图。
具体实施方式
为了使本领域技术人员更好地理解本申请中的技术方案，下面将结合本 发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述。显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请下面所描述的具体实施例，本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其它实施例，都应当落在本发明构思范围之内。
图1为根据本发明的一个实施例的覆膜支架1的整体示意图。本发明的覆膜支架1包括：支架部分16，所述支架部分16包括裸段2和主体段15；以及固定于所述主体段15上的覆膜管11，其中所述主体段15沿其轴向方向包括多个支架段17，所述覆膜管11为由一层或多层覆膜形成的管状结构。在如图1所示的实施例中，所述支架部分16从所述覆膜支架1的近端到远端依次包括裸段2、主体段15、过渡段4和两个分支段5。所述裸段2包括多个第一支架杆6，所述多个第一支架杆6形成波状结构，并且所述裸段2的至少一部分位于所述覆膜管11之外。每个支架段17围绕覆膜支架1的中心轴线以环状布置。每个支架段17由多个第二支架杆组成，即，多个第二支架杆围绕覆膜支架1的中心轴线形成一个环而构成一个支架段17。过渡段4位于主体段15与分支段5之间，用于将主体段15过渡到分支段5。在图1的实施例中，仅仅示出了覆膜支架的两个分支段5，但是本领域技术人员应该理解，本发明还可以适用于具有多于两个的分支段的覆膜支架。此外，在本发明中，近端是指支架植入人体后距离心脏更近的一端，而远端则是指支架植入人体后距离心脏更远的一端。具体地，在图1中，近端是指附图的上端，远端是指附图的下端。
在本发明的覆膜支架1中，为了防止覆膜支架远期移位，覆膜支架近端的裸段2设计为带倒钩7的裸支架结构。图2为以放大图示出本发明的覆膜支架1的裸段2的结构的平面图。如图2所示，除了第一支架杆6之外，所述裸段2还包括后释放孔9、肩部8和倒钩7，所述肩部8位于两个相邻的第一支架杆6的近端交点部位处并将所述第一支架杆6和所述后释放孔9连接，所述后释放孔9用于将所述裸段2和一支架输送系统的后释放装置(未图示) 连接，所述倒钩7从所述肩部8朝向远端延伸且位于所述两个相邻的第一支架杆6之间。在图2中，近端是指附图的右端，远端是指附图的左端。
裸段2的近端有后释放孔9，在覆膜支架释放时，使用支架输送系统的后释放装置释放该覆膜支架1，通过后释放装置上的导丝(未图示)将覆膜支架的裸段2和后释放装置联接在一起，其中导丝要穿过上述后释放孔9。所述裸段2为切割支架段。
裸段2的肩部8用于承载从倒钩7和后释放孔9施加的力。在覆膜支架1释放后，倒钩7通过裸段2的张力扎入人体的优质血管壁，从而防止覆膜支架移位。第一支架杆6构成整体覆膜支架的支撑结构。
图3为示出了一种后释放孔结构的平面图。如图3所示，后释放孔9的形状是类椭圆形。此处，术语“类椭圆形”是本领域内的常用术语，其通常是指类似椭圆形的形状，例如图3中所示的形状，本领域普通技术人员能够清楚地理解其含义。在图3中，后释放孔9沿所述覆膜支架的轴向方向具有后释放孔长度L1，且沿所述覆膜支架的周向方向具有后释放孔宽度L2，且所述后释放孔9在所述覆膜支架的周向方向上的两个外壁的厚度加上所述后释放孔宽度L2为外部轮廓宽度L3。所述后释放孔长度L1优选地在1.0mm—4.0mm之间；如果所述后释放孔长度L1太短，导丝穿进去后可能会造成导丝严重打折，致使后期释放不完全或者导丝不能回撤；如果所述后释放孔长度L1太长，可能会使整个裸段2的长度增加，致使配套的输送系统内相关部件增加长度，从而增加整体输送系统的长度。后释放孔宽度L2优选地在0.1mm—0.6mm之间；如果后释放孔宽度L2太窄，可能会导致穿入的导丝丝径太细，从而裸段2和穿入裸段2的导丝的强度均不够，以致会发生释放不完全或者在释放中导丝断裂的情况；如果后释放孔宽度L2太宽，可能会造成覆膜支架整体轮廓增大，致使可能装不进配套输送系统中。所述外部轮廓宽度L3优选地在0.8mm—1.5mm之间；如果外部轮廓宽度L3太窄，可能会导致所述后释放孔9在其横向方向上的两个外壁太薄，从而容易发生断裂风险；如果外部 轮廓宽度L3太宽，可能会造成覆膜支架整体轮廓增大，致使可能装不进配套输送系统中。
图4为示出了另外一种后释放孔结构的平面图。如图4所示，后释放孔9的形状大致是三角形。此外，根据后释放装置的不同类型和整体性能的考虑，后释放孔9还可以是矩形孔、圆形孔、梯形孔或异型孔等等。“异型孔”是本领域内的常用技术术语，其通常是指不同于一般类型或样式的孔，例如，不同于类椭圆形、圆形、三角形、矩形和梯形的其它一些不规则形状的孔。
图5为在本发明的覆膜支架植入人体血管且裸段定型后的裸段的立体结构示意图。如图5所示，在所述覆膜支架1植入血管且所述裸段2定型后、即在覆膜支架1处于扩张状态的情况下，裸段2围成一个环形，所述裸段2的近端部分的直径D1大于所述裸段2的远端部分的直径D2，这样便于覆膜支架1从输送系统释放并顺利撑开后倒钩7能扎入血管，从而防止覆膜支架1移位。如图5所示，所述裸段2的厚度T1在0.2mm—0.8mm之间，优选地在0.4mm—0.6mm之间。如果所述裸段2的厚度T1太薄，会致使裸段2的支撑强度较弱；如果所述裸段2的厚度T1太厚，会致使裸段2太厚或太硬从而导致释放后撑不开，并且会导致支架整体轮廓增大，组装较困难。请注意，在图5中，裸段2的厚度是指裸段2在覆膜支架1的径向方向上的厚度尺寸，并且近端是指附图的上端，远端是指附图的下端。
图6为示出了本发明的覆膜支架的周向凸台结构的示意图。如图1和图6所示，在覆膜支架1中，在覆膜管11外侧，与覆膜管11一体地形成有多个周向凸台10(在图1和图6的实施例中显示了三个周向凸台)，即所述周向凸台10的材质与覆膜管11的材质相同，均为柔性材质。多个周向凸台10中的每一个均绕覆膜管11的外周面周向延伸，朝向覆膜管11的外侧凸出。所述周向凸台10与主体段15的支架段17在主体段15的轴向方向上交替地排列。优选地，多个周向凸台10在所述主体段15的轴向方向上等间距地布置在所述覆膜管11的外周上。但是，本领域技术人员能够理解，在本发明的其它一 些实施例中，所述多个周向凸台10彼此间的间隔距离也可以不相等。
本发明的周向凸台10具有以下几个特点：
①减缓支架段顶点的疲劳磨损：
覆膜支架在被轴向压缩时，如果没有周向凸台10，支架段17之间的压缩会没有规律，且由于支架段支撑强度大，支架段顶点对覆膜管11的覆膜的冲击较强，长期磨损可能会致使支架段顶点顶破覆膜，因而可能造成覆膜支架渗漏；增加周向凸台10后，在覆膜支架受到轴向压缩力后，整体覆膜支架会沿着周向凸台10的痕迹压缩，因而可以减缓支架段顶点对覆膜的磨损。
②增加贴壁性：
覆膜支架植入人体后，可能会遇到植入部位的血管壁上有斑块，在有金属支架的部分遇到斑块后，容易造成贴壁不良和内漏等不良后果。与之相比，本发明的带有周向凸台10的覆膜支架1植入血管瘤腔后，随着血流冲击，会增加周向凸台结构的覆膜材料与血管壁的接触，因而可以增加整体覆膜支架的贴壁性能，减小内漏。
③利于弯曲，增加血流通畅性：
本发明的覆膜支架1设有多个周向凸台10，因而，覆膜支架1弯曲时整体随周向凸台10的形状弯曲，因而在缝合支架段后可以增加覆膜支架整体的弯曲性。
通常，所述周向凸台10的外径W2比所述覆膜支架1的覆膜管11的外径W1大1mm—3mm(见图6)，所述周向凸台10的宽度H1在0.5mm—1.5mm之间。如果所述周向凸台10的宽度H1太窄，可能使得所述周向凸台10不能有效降低支架段与覆膜之间的磨损且起不到弯曲柔顺性的效果；如果所述周向凸台10的宽度H1太宽，可能会导致支架段间间距太大，反而更容易引起打折。这里，周向凸台10的外径是指绕覆膜支架1的中心轴线延伸的周向凸台10的最外部的直径，周向凸台10的宽度是指周向凸台10的沿着覆膜支架1的中心轴线测量出来的轴向尺寸。
带有周向凸台10的覆膜支架1的弯曲前后形态在图7和图8中示出。图7为弯曲之前的带有周向凸台10的覆膜支架的示意图，其中覆膜支架的覆膜管呈直形。图8为弯曲之后的带有周向凸台10的覆膜支架的示意图，其中覆膜支架1的覆膜管呈弯曲形状，并且图8(a)显示了处于通常弯曲形态的覆膜支架1，图8(b)显示了处于弯曲极限形态的覆膜支架1。
如图7和图8所示，在带有周向凸台10的覆膜管11弯曲时，覆膜管11会随着周向凸台痕迹弯曲，随着弯曲程度加大，周向凸台10弯曲的小弯侧(图8(b)中的左侧，即弯曲部分内侧)被压缩，周向凸台10的内部的上边缘与下边缘随弯曲程度的加深而接触在一起，如图8(b)所示，在此情况下，由于周向凸台10位于整体覆膜支架的外侧，所以不会影响血流；周向凸台10的弯曲的大弯侧(图8(b)中的右侧，即弯曲部分外侧)会完全张开以便增加其弯曲量。如果没有周向凸台10，在覆膜的大弯侧完全张开的情况下，小弯侧的覆膜势必会发生褶皱，而覆膜管内部的褶皱会影响血流速度。与之相比，在本发明中，带有周向凸台10的小弯侧随着弯曲程度增加，小弯侧的周向凸台10内部的上边缘与下边缘会接触在一起，其余覆膜由支架段支撑，因而内部覆膜不会产生多余褶皱从而影响血流。
④精确定位支架段：
增加周向凸台10可以利于支架段的定位，并且便于精密缝制，使缝合工艺可行性大大增加。
用于治疗腹主动脉瘤的支架段均直径较大，而大型切割机较昂贵，且支架段经切割后需要做一些后处理的工作，例如抛光、定型、喷砂等后续处理工作，所以切割支架段的价格昂贵。编制支架段仅需要通过各种编制定型模具即可定型出所需支架段外形，即采用编制支架段既能降低成本又能保证相同的性能。在本发明的覆膜支架1中，可以仅仅将所述裸段2形成为切割支架段，而其余支架段，包括但不限于前述支架段3、支架段17以及下文将提到的分支段5中的支架段和过渡段的中部结构13，均为编制支架段，由此可 以降低成本。
如图1所示，支架部分16还包括至少两个分支段5，且所述分支段5的近端与所述主体段15的远端相连。所述支架部分16还包括过渡段4，所述过渡段4位于所述主体段15与所述分支段5之间，并用于将所述主体段15过渡至所述分支段5。覆膜支架的支架部分16中的过渡段4的设计如图11所示。图11为过渡段4的分解细节图。由于覆膜支架1的主体段15直径较大，而分支段5的直径较小，如果从覆膜支架1的主体段直接连接到分支段，则连接处覆膜、尤其是分叉处覆膜和附近缝合线受血流冲击会很大，会造成分叉处区域的覆膜受血流严重冲击而受损，并且会导致主体段和分支段的第一段支架段缝合处磨损严重，因而有可能会导致支架段脱落、分叉处漏血从而造成严重后果。
针对以上问题，本发明设计了一种过渡段4，其可以将近端覆膜支架的大直径部分圆滑平稳地过渡至远端的两条分支段的小直径部分。如图1和图11所示，所述过渡段4的近端部分12的直径和所述主体段15的远端部分的直径相同，并且所述过渡段4从其近端部分12朝向其远端部分14锥形地逐渐缩小从而平滑地过渡到两个分支段5，其中附图标记13表示过渡段的中部结构。应注意，在图11中，近端是指附图的上端，远端是指附图的下端。通过本发明的上述设计，可以使整体覆膜支架在植入后减小血流冲击对覆膜支架的影响。
在本发明中，具有编制结构的小波段3可以增加覆膜支架的近端贴壁性和圆整性。如图1所示，主体段15还可包括有小波段3，所述小波段3靠近裸段2设置。在图1中，所述小波段3位于由覆膜材料形成的覆膜管11的近端边缘部分处。所述小波段3用于提高覆膜支架的近端贴壁性和防止内漏的产生。小波段3的波形结构在尺寸上要小于支架部分16中的其它支架段的波形结构。小波段3的波形可以设计成等高结构或者变高结构。小波段丝径较细。小波段结构如图9和图10所示。图9示出了具有等高结构的小波段3的 示意图。小波段结构3具有等高结构，即所有上顶点均在同一平面上，所有下顶点均在另外的同一个平面上，各个支架杆的长度相同，即为等高结构。图10示出了具有变高结构的小波段3的示意图。在图10所示的小波段3的变高结构中，所有上顶点均在同一平面上，但是所有下顶点并不都在另外的同一平面上，这种不在同一平面的顶点的变高结构有利于减小整体覆膜支架的轮廓。
由于小波段3的作用是增加贴壁性和圆整性，所以小波段3的丝径选择较细，一般选择0.2032—0.254毫米(0.008—0.010英寸)的丝径，远小于主体段的支架段的丝经。
本发明的覆膜支架适用于治疗腹主动脉瘤。在手术中，将覆膜支架导入到病变部位后进行释放，金属材质的支架将覆膜材料支撑在病变血管两端的正常血管壁上，使覆膜支架在血管管腔内将动脉瘤与血流隔绝，从而消除血管破裂的危险，达到维持主动脉血流通畅的目的；血管外壁因负压而回缩，可慢慢恢复正常血管形态，且血管内膜细胞渗透覆膜材料中的微孔，最终完全覆盖覆膜支架，使覆膜支架内皮化。并且本发明可以适用于瘤颈短且瘤颈弯曲的腹主动脉瘤病例，即，本发明的覆膜支架更适合较短的瘤颈长度，更弯曲的瘤颈，具有更好的贴壁性和圆整性，并且它还具有适中的支撑强度，还可以防止覆膜支架植入后覆膜支架的远期移位等。
与现有技术中的覆膜支架相比，本发明的覆膜支架的有益技术效果表现在以下方面：
1.覆膜支架设有周向凸台，该周向凸台可以缓冲支架段顶点对覆膜的损伤，也便于支架段的定位和缝合，还可以提高弯曲性能和贴壁性能；
2.过渡段采用锥形过渡形状，因而可以有效缓解血流对分叉处区域覆膜和缝合线的冲击。
3.覆膜支架的裸段带有倒钩，可以防止植入后远期移位；
4.覆膜支架的近端部分设有小波段，可以提高贴壁性和圆整性；
5.整体覆膜支架除裸段外，其余支架段均为编制而成，这样可以降低成本、提高生产效率。
本发明的覆膜支架可以满足说明书前面部分提及的评价此类覆膜支架的各项性能指标，有很好的密封性，可以隔绝瘤腔与血液；裸段带有倒钩，因而可以防止支架植入后发生移位；采用适当的释放阻力，可以使得支架顺利释放且避免支架移位；该支架的后释放功能能精确定位覆膜支架；覆膜支架棱高较低，柔顺性佳；并且可以适应更小的瘤颈长度。综上所述，本发明可以适应各种类型的腹主动脉瘤。
以上所述仅是本申请的一些具体实施例。应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请发明原理和发明构思的前提下，还可以对上述实施例进行各种组合或做出若干改进和变型，这些组合、改进和变型也应视为落在本申请的保护范围和发明构思之内。

Claims (16)

  1. 一种覆膜支架(1)，包括：支架部分(16)，所述支架部分(16)包括裸段(2)和主体段(15)；以及固定于所述主体段(15)上的覆膜管(11)，其中所述主体段(15)沿其轴向方向包括多个支架段(17)，
    其特征在于，所述覆膜支架(1)还包括多个周向凸台(10)，所述周向凸台(10)沿所述轴向方向布置于所述覆膜管(11)的外周，且所述周向凸台(10)与所述支架段(17)在所述轴向方向上交替地排列。
  2. 根据权利要求1所述的覆膜支架(1)，其特征在于，所述多个周向凸台(10)在所述轴向方向上等间距地布置在所述覆膜管(11)的外周上。
  3. 根据权利要求1或2所述的覆膜支架(1)，其特征在于，所述周向凸台(10)的外径(W2)比所述覆膜管(11)的外径(W1)大1mm—3mm，并且所述周向凸台(10)的宽度(H1)在0.5mm—1.5mm之间。
  4. 根据权利要求1或2所述的覆膜支架(1)，其特征在于：
    所述裸段(2)包括多个支架杆(6)，所述多个支架杆(6)形成波状结构，并且所述裸段(2)的至少一部分位于所述覆膜管(11)之外，并且
    所述裸段(2)还包括：
    肩部(8)，位于每两个相邻的支架杆(6)的近端交点部位处；
    后释放孔(9)，连接至每个所述肩部(8)的近端，所述后释放孔(9)用于将所述裸段(2)和支架输送系统的后释放装置连接；以及
    倒钩(7)，从每个所述肩部(8)朝向远端延伸且位于对应的两个相邻的支架杆(6)之间。
  5. 根据权利要求4所述的覆膜支架(1)，其特征在于，所述后释放孔(9)是类椭圆形孔、圆形孔、三角形孔、矩形孔、梯形孔或异型孔。
  6. 根据权利要求5所述的覆膜支架(1)，其特征在于，在所述后释放孔(9)的形状是类椭圆形的情况下，所述后释放孔(9)沿所述覆膜支架的轴 向方向具有后释放孔长度(L1)，且沿所述覆膜支架的周向方向具有后释放孔宽度(L2)，且所述后释放孔(9)在所述覆膜支架的周向方向上的两个外壁的厚度加上所述后释放孔宽度(L2)为外部轮廓宽度(L3)，其中所述后释放孔长度(L1)在1.0mm—4.0mm之间，所述后释放孔宽度(L2)在0.1mm—0.6mm之间，且所述外部轮廓宽度(L3)在0.8mm—1.5mm之间。
  7. 根据权利要求1或2所述的覆膜支架(1)，其特征在于，在所述覆膜支架(1)处于扩张状态的情况下，所述裸段(2)的近端部分的直径(D1)大于所述裸段(2)的远端部分的直径(D2)。
  8. 根据权利要求1或2所述的覆膜支架(1)，其特征在于，所述裸段(2)的厚度(T1)在0.2mm—0.8mm之间。
  9. 根据权利要求8所述的覆膜支架(1)，其特征在于，所述裸段(2)的厚度(T1)在0.4mm—0.6mm之间。
  10. 根据权利要求1或2所述的覆膜支架(1)，其特征在于，在所述覆膜支架(1)的所述支架部分(16)中，仅所述裸段(2)是切割支架段，而其余支架段均为编制支架段。
  11. 根据权利要求1或2所述的覆膜支架(1)，其特征在于，所述支架部分(16)还包括至少两个分支段(5)，且所述分支段(5)的近端与所述主体段(15)的远端相连。
  12. 根据权利要求11所述的覆膜支架(1)，其特征在于，所述支架部分(16)还包括过渡段(4)，所述过渡段(4)位于所述主体段(15)与所述至少两个分支段(5)之间，并用于将所述主体段(15)过渡至所述至少两个分支段(5)。
  13. 根据权利要求12所述的覆膜支架(1)，其特征在于，所述过渡段(4)的近端部分(12)的直径和所述主体段(15)的远端部分的直径相同，并且所述过渡段(4)从其近端部分(12)朝向其远端部分(14)锥形地逐渐缩小从而平滑地过渡到所述至少两个分支段(5)。
  14. 根据权利要求1或2所述的覆膜支架(1)，其特征在于，所述主体段(15)还包括有小波段(3)，所述小波段(3)靠近所述裸段(2)设置。
  15. 根据权利要求14所述的覆膜支架(1)，其特征在于，所述小波段(3)的波形设计成等高结构或者变高结构。
  16. 根据权利要求14所述的覆膜支架(1)，其特征在于，所述小波段(3)由丝径为0.2032—0.254毫米的细丝制成。
PCT/CN2014/089968 2013-10-31 2014-10-31 一种覆膜支架 WO2015062531A1 (zh)

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ES14858484T ES2929190T3 (es) 2013-10-31 2014-10-31 Injerto de endoprótesis recubierto
EP14858484.0A EP3064172B1 (en) 2013-10-31 2014-10-31 Coated stent graft
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CN105853023B (zh) * 2016-04-18 2019-07-05 谷涌泉 一种开窗覆膜支架
CN107569311A (zh) * 2017-07-05 2018-01-12 杭州唯强医疗科技有限公司 环形支撑架
CN107397610A (zh) * 2017-08-25 2017-11-28 杭州唯强医疗科技有限公司 覆膜支架
CN109567981B (zh) * 2017-09-29 2024-09-20 上海微创心脉医疗科技股份有限公司 支架系统及其输送装置、后释放结构与支架
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WO2021129286A1 (zh) * 2019-12-23 2021-07-01 杭州唯强医疗科技有限公司 覆膜支架系统及其覆膜支架
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CN114569299A (zh) * 2020-12-02 2022-06-03 先健科技(深圳)有限公司 覆膜支架
CN114681115B (zh) * 2020-12-30 2025-03-28 浙江脉通智造科技(集团)有限公司 覆膜管定型装置及定型方法、覆膜支架的制备方法
CN113876467B (zh) * 2021-12-08 2022-04-15 上海微创心脉医疗科技(集团)股份有限公司 覆膜支架
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BR112016009186A2 (zh) 2017-08-01
BR112016009186B1 (pt) 2022-10-11
PT3064172T (pt) 2022-11-03
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EP3064172B1 (en) 2022-10-05
AR100664A1 (es) 2016-10-26

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