WO2019129153A1 - 可分步释放的主动脉覆膜支架 - Google Patents

可分步释放的主动脉覆膜支架 Download PDF

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Publication number
WO2019129153A1
WO2019129153A1 PCT/CN2018/124416 CN2018124416W WO2019129153A1 WO 2019129153 A1 WO2019129153 A1 WO 2019129153A1 CN 2018124416 W CN2018124416 W CN 2018124416W WO 2019129153 A1 WO2019129153 A1 WO 2019129153A1
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WO
WIPO (PCT)
Prior art keywords
release
stent graft
film
support rod
connecting member
Prior art date
Application number
PCT/CN2018/124416
Other languages
English (en)
French (fr)
Inventor
王永胜
李安伟
吴世超
Original Assignee
杭州唯强医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Priority to EP18896530.5A priority Critical patent/EP3733124A4/en
Priority to US16/958,111 priority patent/US20200360127A1/en
Publication of WO2019129153A1 publication Critical patent/WO2019129153A1/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/02—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
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the invention belongs to the technical field of medical instruments, and particularly relates to a stent graft, in particular to a step-release aortic stent graft which can be used for interventional treatment of aortic diseases.
  • Aortic aneurysm refers to a local or diffuse abnormal expansion of the aortic wall, which causes symptoms by compressing surrounding organs. According to the structure, aortic aneurysm can be divided into true aortic aneurysm, pseudo aortic aneurysm and dissecting aortic aneurysm. Aortic aneurysm causes an increase in intravascular pressure, so it is progressively enlarged. If it develops for a long time, it will eventually rupture. The larger the tumor, the more likely it is to rupture. According to statistics, 90% of thoracic aortic aneurysms die within 5 years without surgery, and 3/4 abdominal aortic aneurysms die within 5 years.
  • Thoracic aortic endovascular repair has been used to treat aortic dissection, aortic penetrating ulcer, aortic wall hematoma, thoracic aortic aneurysm and pseudoaneurysm.
  • the abdominal aortic endovascular repair since the first report in the 1990s was used to treat abdominal aortic aneurysms because of minimal trauma, short surgery and hospital stay, rapid postoperative recovery, perioperative mortality, and concurrent The low incidence of symptoms has developed rapidly in just 20 years.
  • Aortic endoluminal repair often uses an expandable stent graft as a therapeutic device.
  • the diameter of the stent graft after release is generally greater than about 10% of the diameter of the vessel, and is completely released.
  • After the posterior stent is in close contact with the blood vessel, it cannot be readjusted even if the release position is inaccurate.
  • the person requiring the operation has rich experience and spends more time to accurately position the stent before the stent is released.
  • the angle of release so it is necessary to develop a stent that can still adjust its position in the blood vessel while the stent is released.
  • the technical problem to be solved by the present invention is to provide a step-release aortic stent graft which can be accurately positioned and assembled with high stability during the release process in view of the defects of the prior art.
  • a step-release aortic stent graft comprising a tubular membrane and an annular support frame, wherein the membrane is axially disposed from a proximal end to a distal end with a connector for wearing a release guide wire, the connection Set at least two rows in the circumferential interval.
  • the connecting member is a closed-loop structure or an open-loop structure for the release or winding of the release guide wire;
  • the closed-loop structure is provided with a connector The through hole through which the guide wire is released or the connecting member is engaged with the film to form a through hole or a gap through which the guide wire is passed;
  • the open ring structure has a limiting groove through which the guide wire is passed.
  • the connecting member is a soft connecting buckle disposed on the film or attachable to the film.
  • the connecting member is a coil fixed to an outer wall surface of the coating film; or the connecting member is a line of axially spaced fixed wires and spaced apart a gap is formed between the fixed wire and the film for releasing the guide wire; or the connecting member is a through hole disposed on the film; or the connecting member is at least two rows of soft with a limited groove
  • the connecting buckles are arranged with the opening of the limit slots of different rows facing away.
  • a plurality of axially disposed support rods are fixed on the membrane at least at a proximal end along a circumferential interval of the membrane.
  • the support rod is fixed on the outer wall or the inner wall surface of the coating
  • the connecting member is fixed on the outer side wall of the coating corresponding support rod The position, or the connector is placed on the support rod or on the film near the support rod.
  • the support rod is fixed on the membrane by suturing, heat sealing or bonding.
  • At least one fixing point for fixingly connecting with the coating film is disposed on the support rod, and the fixing point is a connecting hole provided on the support rod. Or an open slot with an opening.
  • the support rod is disposed parallel to the central axis of the stent; or the support rods are arranged between eight or eight characters.
  • the stent is a tubular structure of equal diameter extension or a tubular structure of non-equal diameter extension.
  • the proximal or middle portion of the stent is provided with a window for placing a branch stent or a branch vessel.
  • the connecting member is disposed at two sides of the window for restraining a part of the bracket behind the window.
  • the stent is a non-equal length extending tubular structure, comprising a main body segment and an extension segment, the main body segment having a diameter larger than the extension segment diameter, the main body segment A transition section is provided between the extension section and the extension section; the body section or/and the transition section are provided with a window for placing a branch bracket or a branch vessel.
  • the connecting member is disposed at a position on both sides of the main body segment and the connecting segment window for binding a part of the bracket behind the window.
  • a plurality of axially disposed support rods are fixed on the membrane at least at a proximal end along a circumferential interval of the membrane, and the support rods are fixed.
  • the connecting member is fixed on the outer wall or the inner wall surface of the film, or the connecting member is disposed on the support rod or the film near the support rod.
  • the invention provides a film-covered stent, wherein a plurality of connecting members are arranged on the film, and the brackets between the two rows of connecting members are folded, that is, the adjacent two or more connecting members are brought close, and the connecting member is passed through the connecting member
  • the dressing is mounted on a release guide wire of the delivery device; after the binding is fixed, the stent can maintain a semi-expanded state in the blood vessel to be repaired, and the stent diameter in the semi-expanded state is smaller than the diameter of the blood vessel, and can be freely rotated and longitudinally moved in the blood vessel. The position is adjusted to facilitate precise positioning of the stent during the release process.
  • a support rod is arranged in the film or outside the film.
  • the support rod can facilitate the folding of the bracket on the one hand, and the support rod can be used as a mast when the bracket is assembled, which can ensure the stability of the bracket during assembly. It is also possible to ensure a semi-expanded state in which the circumferential structure after the stent portion is released is stable.
  • FIG. 1 is a schematic structural view of a stent graft according to Embodiment 1 of the present invention.
  • Figure 2 is a schematic view showing the structure of the stent graft of the first embodiment of the present invention in the lower half of the stent graft;
  • FIG. 3 is a schematic structural view of a single-ring annular support frame according to Embodiment 1 of the present invention.
  • FIG. 4 is a schematic view showing the release of only the proximal coating portion during the release process of the stent graft of the embodiment 1 of the present invention
  • Figure 5 is a schematic view showing the structure of a stent graft according to Embodiment 2 of the present invention.
  • Figure 6 is a schematic structural view of a support rod according to Embodiment 2 of the present invention.
  • Figure 7 is a schematic view showing the structure of the stent graft of the second embodiment of the present invention in the second half of the restraint;
  • Figure 8 is a schematic view showing the structure of the stent graft of the third embodiment
  • Figure 9 is a schematic view showing the structure of a funnel-shaped annular support frame of Embodiment 3.
  • Figure 10 is a schematic view showing the structure of the stent graft of the fourth embodiment.
  • Figure 11 is a schematic view showing the structure of the stent graft of the embodiment 5.
  • Figure 12 is a schematic structural view of a window support frame of Embodiment 5.
  • FIG. 13A is a schematic view showing the back structure of only the proximal coating portion released during the release process of the stent graft of Example 5; FIG.
  • Fig. 13B is a front view showing the release of only the proximal coating portion during the release of the stent graft of Example 5.
  • proximal refers to the portion of the stent or stent component that is adjacent to the patient's heart in the direction of blood flow
  • distal refers to the portion of the stent or stent component that is remote from the patient's heart.
  • the tube surface of the bracket with the window is the front wall
  • the opposite tube surface of the window is the rear wall
  • the tube surface on both sides of the bracket between the front wall and the rear wall is the side wall.
  • Embodiment 1 as shown in FIG. 1, a step-release aortic stent graft comprising a tubular membrane 120 and an annular support frame 110, the membrane 120 being axially disposed from the proximal end to the distal end
  • the connector 142 is configured to release the guide wire, and the connector 142 is axially spaced apart by at least two rows.
  • the shape of the tubular coating 120 may be a straight cylindrical shape of equal diameter, or may be a funnel shape, a dumbbell shape or other suitable shape of a non-equal diameter structure.
  • This embodiment is a straight cylindrical shape of an equal diameter structure.
  • the film 120 is made of a polymer material having good biocompatibility. In this embodiment, the PET film is preferred, and the film thickness is 0.07 mm to 0.1 mm. The film 120 has good mechanical strength and anti-leakage performance.
  • the annular support frame 110 plays a supporting role for the coating film 120.
  • the plurality of annular support frames 110 are sequentially and evenly spaced along the axial direction of the film 120 on the film 120.
  • the proximal end and/or the distal end of the frame are annular.
  • the support frame 110 is a bare bracket partially sewn on the film 120.
  • a plurality of annular support frames 110 are sequentially disposed from the proximal end to the distal end of the film 120.
  • the annular support frame 110 at the proximal end of the stent graft is a semi-stitched stent, and the extension portion is sutured on the membrane 120. As shown in FIG.
  • each annular support frame 110 is tubular and consists of a plurality of Z-shaped or sinusoidal waves.
  • Each Z-shaped or sinusoidal wave has a peak 111 and an adjacent valley 112, and a peak 111 and There is a connecting rod 113 between the adjacent troughs 112.
  • Each ring of annular support frame 110 is woven by a superelastic nickel-titanium wire.
  • the diameter of the nickel-titanium wire is relatively small, and can be between 0.2 and 0.5 mm. In this embodiment, a 0.45 mm diameter nickel-titanium wire is used for weaving.
  • the number of Z-shaped or sine waves is six, and the vertical height of the annular support bracket is 12 mm. As shown in FIG.
  • each annular support frame 110 has a connecting steel sleeve 114.
  • the two ends of the nickel-titanium wire are connected inside the steel sleeve 114, and then the two end points of the nickel-titanium wire are mechanically pressed or welded. It is fixed inside the steel sleeve.
  • the annular support frame 110 is fixed on the inner surface or the outer surface of the film 120 by other processes such as stitching, heat sealing or bonding; the bracket size of the embodiment is 30 specifications, that is, the annular support frame 110 and the film 120 have a diameter of 30 mm.
  • the annular support frame 110 is fixed on the outer surface of the film 120 by a stitching process, and the film holder is maintained to have good resilience as a whole.
  • the connecting member 142 is used for axially wearing the release guide wire 141, and is configured to assist the release guide wire 141 to form a semi-expanded state in the radial direction.
  • the stent graft of the embodiment 1 of the present invention is connected to the connector.
  • the lower half releases the rear structure.
  • the structure of the connecting member 142 needs to meet the above purpose at the same time, so the connecting member 142 can select two structures: a closed loop structure or an open loop structure for the release guide wire 141 to be worn or wound; in the first structural formula, the closed loop structure is connected.
  • the piece 142 has a through hole through which the guide wire 141 is passed, or the connecting piece 142 is engaged with the film to surround a through hole or gap through which the guide wire 141 is passed.
  • the first embodiment is that the connecting member 142 is a coil fixed on the outer wall surface of the film; the second embodiment is that the connecting member 142 is a line of axially spaced fixed lines and fixed lines. A gap is formed between the rope and the film to allow the release guide wire 141 to pass through; in the third embodiment, the connecting member 142 is a through hole formed directly on the film;
  • the open-loop structure has a limiting slot for the release guide wire 141 to pass through, that is, the connecting member 142 is at least two rows of flexible connecting buckles with a finite slot, and the limiting slot openings of the different rows are disposed away from each other.
  • the release guide wire 141 sequentially bypasses the limit grooves of the different rows of soft connecting buckles to bind the bracket.
  • the connector 142 is a soft connecting buckle disposed on the film or attachable to the film, preferably made of a biocompatible polymer material.
  • a biocompatible polymer material preferably polyester, metal materials such as wire can also be selected.
  • the connecting member 142 is a coil with a through hole, and the through hole can pass the release guide wire 141 having a wire diameter of 0.5 mm to 1.5 mm.
  • the material of the release guide wire 141 is preferably a nickel-titanium alloy wire.
  • the wire diameter is 0.5 mm
  • the number of the connecting members 142 is six
  • the two rows are evenly fixed on the film 120.
  • Each row has three connecting members 142, and the three connecting members 142 are axially spaced apart. As shown in FIG. 2, when assembling, the two rows of connecting members 142 are first pulled together, and the fixed release guide wires 141 of the conveyor are sequentially passed through the different rows of connecting members 142 to form a binding to the bracket.
  • the semi-expanded state is maintained under the restraint of the release guidewire 141, and the stent is then fully crimped into the conveyor sheath.
  • the portion of the proximal end of the stent graft that is not bound by the guide wire 141 is first released.
  • the membrane 120 between the connectors 142 is still in a restrained state, and the distal membrane is constricted in the outer sheath.
  • the annular support frame 110 which is a proximal end as a bare support, is still restrained in the TIP head 10 of the conveyor.
  • the stent graft is not completely released, and the overall diameter is smaller than the diameter of the blood vessel, and can be freely rotated and longitudinally moved within the blood vessel, facilitating the stent.
  • the release guide wire 141 is withdrawn and the stent graft is completely released and firmly fitted into the blood vessel.
  • Embodiment 2 as shown in FIG. 5, this embodiment is an improvement on the basis of Embodiment 1.
  • a step-release aortic stent graft comprising a tubular membrane 120 and an annular support frame 110 fixed to the membrane 120, the surface of the membrane 120, preferably the lumen wall, at least at the proximal end along the membrane
  • a plurality of axially disposed support rods 130 are fixed at 120 degrees, and a connecting member 142 for fixing the release guide wire is disposed on the outer support rod 130 on the outer side of the cover film 120.
  • the first function of the support rod 130 that is, the most important function is to form a bracket in a semi-expanded state, that is, the adjacent two or more support rods 130 are drawn side by side and fixed by the connecting member 142, and are supported during the drawing process.
  • the rod 130 can always maintain the flatness of the film and the stability of the overall structure of the stent, and the film 120 and the annular support frame 110 between the support bars 130 are folded, the diameter of the bracket is reduced, and the semi-expanded state and the semi-expanded state are formed.
  • the diameter is smaller than the diameter of the blood vessel, and the position can be adjusted freely in the blood vessel by free rotation and longitudinal movement, thereby facilitating accurate positioning of the stent during the release process.
  • the support rods 130 are disposed along the axial direction of the film 120 in the circumferential direction of the film 120.
  • the plurality of support rods 130 are preferably axially symmetrically arranged.
  • the support rods 130 disposed on the central axis of the parallel brackets are constrained and fixed, and the diameters of the brackets are simultaneously reduced, for example, the original straight cylindrical brackets, and the semi-expanded state is also a straight cylindrical shape.
  • the support rods 130 which are not arranged parallel to the central axis of the stent, are restrained and reduced in diameter when the binding is fixed, for example, a straight cylindrical bracket, and the semi-expanded state is tapered.
  • This embodiment preferably provides the support rod 130 parallel to the central axis of the stent.
  • the number of support rods 130 is generally 2-6, preferably 2-3.
  • the support rod 130 is disposed at least at the proximal end of the coating 120, which means that the proximal end of the support rod 130 is disposed at the proximal end of the coating 120, and the support rod 130 can extend toward the distal end of the stent, and the extension length can extend to the axial direction of the stent as needed.
  • the middle portion can also extend to the distal end of the stent in the axial direction.
  • the inner surface of the tubular structure 120 of the tubular structure is fixed with two support rods 130, and the two support rods 130 are located at the rear end of the proximal end of the coating film 120, by suturing, A process such as heat sealing or bonding is fixed on the inner wall of the film 120, preferably by stitching.
  • the support rod 130 is selected from a metal or polymer material having a certain supporting strength, preferably a metal material such as a nickel-titanium alloy wire having a wire diameter ranging from 0.3 mm to 0.6 mm, and in the present embodiment, the wire diameter is preferably 0.45 mm.
  • the structure of the support rod 130 is as shown in FIG. 6.
  • the support rod 130 is a straight rod structure.
  • the support rod 130 is provided with at least one fixing point.
  • the support rod 130 is stitched, heat sealed or bonded by a fixed point. It is fixed on the inner wall of the film 120.
  • the fixing point is a connecting hole provided on the support rod 130 or an open groove with an opening. In this embodiment, there are two fixed points on the two ends of the support rod 130.
  • the fixed point of the embodiment is two limit round heads 131 with connecting holes, and the two ends of the support rod 130 are formed by curling, and the limit is limited.
  • the diameter of the round head 131 ranges from 1.5 mm to 3.5 mm.
  • the priority limit of the round head 131 is 2.5 mm.
  • the limiting round head 131 is fixed to the proximal end of the coating film 120 in a suture manner to prevent the support rod 130 from slipping off in the axial direction inside the bracket.
  • the fixing point may also be a non-closed loop structure, or may be an open groove with an opening, for example, bending the support rod 130 somewhere to form a semicircular or curved open groove, after being fixed at the open groove, The support rod 130 cannot move axially.
  • the support rod 130 plays a supporting role in the axial direction, and also serves as a stud when the stent graft 100 is assembled, which can ensure the stability of the stent during the assembly process.
  • a semi-expanded state in which the circumferential structure after the stent portion is released is stabilized, and the stent diameter in the semi-expanded state is smaller than the diameter of the blood vessel, and the position can be adjusted in the blood vessel by free rotation and longitudinal movement, thereby facilitating the accuracy of the stent during the release process. Positioning.
  • Embodiment 3 This embodiment is an improvement on the basis of Embodiment 2.
  • the stent graft of the embodiment 2 of the present invention comprises a multi-turn annular support frame 110.
  • the funnel-shaped coating 120 includes annular support frames 110 and 140 fixed on the coating film 120.
  • Two support rods 130 are fixedly disposed on the inner wall surface of the coating film 120.
  • the arrangement of the support rods 130 of the embodiment 2 is the same as that of the support rods 130 of the first embodiment, and details are not described herein again.
  • the stent graft has a funnel-like structure and includes a body segment 100A and an extension segment 100C.
  • a transition section 100B is provided between the main body section 100A and the extension section 100C, and the diameter of the extension section 100C is smaller than the diameter of the main body section 100A.
  • the main body section 100A and the extension section 100C each include a straight cylindrical coating 120 and an annular support frame 110.
  • the transition section 100B includes a frustum-shaped coating 190 and a funnel-shaped annular support 140.
  • the funnel-shaped annular support frame 140 is composed of a plurality of Z-shaped or sinusoidal waves, each of which has a peak 111 and an adjacent valley 112, a peak 111 and adjacent There is a connecting rod 113 between the troughs 112.
  • the annular support frame 140 differs from the annular support frame 110 in the embodiment in that the annular support frame 140 has a taper, and the difference in diameter between the two ends of the annular support frame 140 is 10 mm.
  • Embodiment 4 this embodiment is an improvement on the basis of Embodiment 2.
  • the stent graft of the embodiment is further provided with a long branch section 102A and a short branch section 102B at the distal end of the stent graft of the embodiment 2. That is, as shown in FIG. 10, the stent graft of the second embodiment is the main body bracket 101 of the fourth embodiment.
  • the main body bracket 101 is disposed in the same manner as the second embodiment.
  • a connecting member 142 for fixing the release guide wire is disposed on the outer support rod 130 of the outer surface of the coating film 120.
  • the arrangement of the support rod 130 and the connecting member 142 of the embodiment 4 is the same as that of the embodiment 2, and details are not described herein again.
  • the distal end of the main body bracket 101 is connected with two branch segments, which are a long branch segment 102A and a short branch segment 102B, respectively.
  • the long branch section 102A and the short branch section 102B are respectively provided with a branch section coating 120A and a branch section coating 120B in the circumferential direction, and the branch section coating 120A and the branch section coating 120B are sewn to the coating 120 of the main body bracket 101.
  • the unitary structure is formed together or integrally formed with the film 120.
  • the branch film 120A has a straight cylindrical structure with a diameter ranging from 10 mm to 14 mm and a length of 70 mm.
  • the branch film 120B also has a straight cylindrical structure with a diameter ranging from 10 mm to 14 mm and a length of 30 mm.
  • a transition zone may also be disposed between the film 120 and the branch section film 120A and the branch section film 120B for connecting the body bracket and the long branch section 102A and the short branch section 102B.
  • the length of the transition zone ranges from 10 mm to 20 mm, preferably 15mm.
  • the material of the coating 120, the branching film 120A and the branching film 120B may be selected from the group consisting of polyester, polyurethane, ePTFE, PET or other polymer materials. In this embodiment, the material is selected as a PET film, and the thickness of the PET film is 0.07 mm. ⁇ 0.12 mm, preferably 0.1 mm.
  • the outer wall or the inner wall of the branch segment coating 120A and the branch segment coating 120B are respectively arranged and stitched by a plurality of branch annular brackets 121A and branch annular brackets 121B of different numbers, respectively, and the branched annular bracket 121A and the branch annular bracket 121B are arranged.
  • the scaffolding material is preferably a nitinol wire having good biocompatibility and superelasticity.
  • Embodiment 5 this embodiment is an improvement on the basis of Embodiment 2 or 3. The difference is that a window 300 for setting branch blood vessels is opened on the film 120.
  • the film 120 has two structures, and there are two cases in which the window 300 is opened.
  • the film 120 is an equal-diameter tubular structure as shown in FIG. 11, and the window 120 is provided with a window 300 for setting branch blood vessels at the proximal end or the middle portion; the window 300 is located at two adjacent supports.
  • a window support 120 is placed between the rods and the window support 180 surrounding the window is disposed away from the window 300.
  • Two or more windows 300 are simultaneously disposed in the same area between the two support bars 130, preferably on the front wall of the bracket, and the centerlines of the two windows are on the same axis.
  • the coating film 120 is a non-equal length extending tubular structure, including a main body segment and an extension portion, the main body segment diameter is larger than the extension portion diameter, and a transition portion is provided between the main body segment and the extension portion;
  • the segment or transition segment is provided with a window 300 for setting branch blood vessels.
  • the annular support frame includes an annular support frame 110 as a main body, and a window support frame 180 corresponding to the window 300.
  • the corresponding window 300 is provided with a window 300 wave unit.
  • the annular support frame 110 of the present embodiment includes an annular support frame 110 having a multi-turn structure with a uniform diameter, a window support frame 180, and a single-ring metal ring 160 disposed at the window 300, and the inner surface of the film 120 Two support rods 130 are fixedly disposed. As shown in FIG.
  • the window support frame 180 is composed of a plurality of Z-shaped or sinusoidal waves and a window waveform unit, and each Z-shaped or sinusoidal wave has a peak 111 and an adjacent valley 112, a peak 111 and a phase.
  • the peaks 121 and troughs 122 of the window waveform unit have two connecting rods 123, and the peaks 121 and the Z-shaped or sinusoidal two peaks 111 have two connecting rods 124.
  • the window support frame 180 is woven by a superelastic nickel-titanium wire having a wire diameter ranging from 0.2 to 0.5 mm, preferably 0.45 mm in this embodiment.
  • the number of Z-shaped or sine waves is six, and the vertical height of the window support frame 180 is 15 mm.
  • the window support frame 180 has a connecting steel sleeve 314. The two ends of the nickel-titanium wire are connected inside the steel sleeve 114, and then the two ends of the nickel-titanium wire are fixed inside the steel sleeve by mechanical pressing or welding.
  • the stent graft is held in a semi-release state under the restraint of the fixed release guide wire 141 on the conveyor, and the release guide wire 141 is sequentially passed through the connector 142.
  • the guide wire 141 is preferentially made of nickel-titanium alloy wire, the wire diameter is 0.5 mm, the number of the connecting members 142 is six, and the two rows are fixed on the support rod 130, and each row has three connecting members 142, three connections.
  • the piece 142 is located at both ends and in the middle of the support rod 130.
  • the stent graft when the stent graft is released, it is in a semi-release state under the restraint of the guide wire 141, and a part of the stent behind the proximal end window 300 of the stent graft is still in a restrained state, and the overall diameter of the stent is small.
  • the front annular window 300 is in an unfolded state, which is in the clinical application process, because the stent graft is not fully deployed, the distal membrane is converged in the outer sheath tube 20, and the proximal bare stent 110 is still bound to the conveyor TIP.
  • the overall diameter is small, and the axial and circumferential rotation in the blood vessel can be conveniently performed by the delivery system, so that the accurate position of the annular window 300 can be positioned more quickly and accurately, so that the branch vessel can be smoothly matched and the operation time can be shortened. Improve the success rate of surgery.
  • the support rod 130 can also be used as a stud in the assembly of the stent graft, which can ensure the stability of the stent during the assembly process, and can also ensure the stable semi-expanded state of the circumferential structure after the stent portion is released, and prevent the stent from being supported.
  • the window 300 is deformed when in a semi-assembled or semi-released state, resulting in inaccurate positioning.

Abstract

一种可分步释放的主动脉覆膜支架，包括管状覆膜（120）和环形支撑架（110），覆膜（120）上由近端向远端轴向设置有用于穿装释放导丝（141）的连接件（142），连接件（142）轴向间隔设置至少两排。本覆膜支架在释放过程中能精确定位、装配时稳定性高、可分步释放。

Description

可分步释放的主动脉覆膜支架 技术领域
本发明属于医疗器械技术领域，具体涉及一种覆膜支架，尤其涉及一种可用于主动脉疾病介入治疗的可分步释放的主动脉覆膜支架。
背景技术
主动脉瘤是指主动脉壁局部或弥漫性的异常扩张，压迫周围器官而引起症状。主动脉瘤按结构主要可分为真性主动脉瘤、假性主动脉瘤和夹层主动脉瘤。主动脉瘤引起血管内侧压增高，故呈进行性膨大，若长期发展，最后终归破裂，瘤体越大，破裂的可能性越大。据统计，若不作手术治疗，90％胸主动脉瘤在5年内死亡，3/4腹主动脉瘤在5年内死亡。
胸主动脉腔内修复术目前已用于治疗主动脉夹层、主动脉穿通性溃疡、主动脉壁间血肿、胸主动脉瘤及假性动脉瘤等多种主动脉扩张性病变。而而腹主动脉腔内修复术自20世纪90年代报道首例被用于治疗腹主动脉瘤以来，因其创伤小、手术及住院时间短、术后恢复快、围手术期病死率及并发症发生率低等优点，在短短的20年内迅速发展。
主动脉腔内修复常采用可膨胀的覆膜支架作为治疗器械，为了与待修复的血管保持良好的贴壁性，覆膜支架释放后的直径一般要大于血管直径的10％左右，而完全释放后的覆膜支架由于与血管紧贴，即使在释放位置不准确的情况下，也无法重新调整，要求手术操作的人员具有丰富的经验，并在支架释放前花费较多的时间去精确定位支架的释放角度，因此我们有必要开发一种可以在支架释放在血管中仍能够调节其位置的支架。
发明内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种在释放过程中能精确定位、装配时稳定性高的可分步释放的主动脉覆膜支架。
本发明解决其技术问题所采用的技术方案是：
一种可分步释放的主动脉覆膜支架，包括管状覆膜和环形支撑架，所述覆 膜上由近端向远端轴向设置有用于穿装释放导丝的连接件，所述连接件周向间隔设置至少两排。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述连接件为供释放导丝穿装或缠绕的闭环结构或开环结构；所述闭环结构是连接件带有供释放导丝穿过的通孔或者所述连接件与覆膜配合合围形成供释放导丝穿过的通孔或间隙；所述开环结构带有供释放导丝穿过的限位槽。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述连接件为设置在覆膜上或可贴附在覆膜上的软性连接扣。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述连接件为固定在覆膜外侧壁面的线圈；或者所述连接件为一段轴向间隔固定的线绳，且间隔固定的线绳与覆膜之间形成有供释放导丝穿过的间隙；或者连接件是设置在覆膜上的通孔；或是所述连接件为至少两排带有限位槽的软性连接扣，不同排的限位槽开口背向设置。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述覆膜上至少在近端沿覆膜周向间隔固定有多根轴向设置的支撑杆。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述支撑杆固定在覆膜的外壁或内腔壁面上，所述连接件固定在所述覆膜外侧壁面对应支撑杆的位置，或者所述连接件设置在支撑杆上或支撑杆附近的覆膜上。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述支撑杆通过缝合、热合或粘接固定在覆膜上。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述支撑杆上至少设置一个用于与覆膜固定连接的固定点，所述固定点为支撑杆上设置的连接孔或带有开口的开口槽。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选，所述支撑杆平行于支架中轴线设置；或者所述支撑杆之间呈八字或倒八字设置。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述支架为等径延伸的管状结构或非等径延伸的管状结构。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述支架的近端或中部设有用于放置分支支架或者分支血管的窗口。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述连接件设置 在所述窗口两侧的位置，用于束缚窗口后方的部分支架。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述支架为非等径延伸的管状结构，包括主体段和延伸段，所述主体段直径大于延伸段直径，主体段与延伸段之间设有过渡段；所述主体段或/和过渡段设有用于放置分支支架或者分支血管的窗口。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述连接件设置在所述主体段和连接段窗口两侧的位置，用于束缚窗口后方的部分支架。
进一步地，所述的可分步释放的主动脉覆膜支架中，优选所述覆膜上至少在近端沿覆膜周向间隔固定有多根轴向设置的支撑杆，所述支撑杆固定在覆膜的外壁或内腔壁面上，所述连接件固定在所述覆膜外侧壁面对应支撑杆的位置，或者所述连接件设置在支撑杆上或支撑杆附近的覆膜上。
本发明提供了一种覆膜支架，在覆膜上设有数个连接件，将两排连接件之间的支架折叠，即将相邻两个或多个连接件拉近，并通过所述连接件穿装在输送装置的一根释放导丝上；束缚固定后，支架可在待修复血管内维持半展开状态，半展开状态的支架直径小于血管直径，能够在所述血管中自由旋转和纵向移动而调整位置，便于支架在释放过程中的精确定位。
在覆膜内或覆膜外设有支撑杆，支撑杆一方面能方便支架折叠，另一方面所述支撑杆可以作为支架装配时的拴柱，既能保证支架在装配过程中的稳定性，也能够保证支架部分释放后的周向结构稳定的半展开状态。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明实施例1覆膜支架结构示意图；
图2是本发明实施例1覆膜支架在束缚下半释放的覆膜支架后面结构示意图；
图3是本发明实施例1单圈环形支撑架的结构示意图；
图4是本发明实施例1覆膜支架释放过程中仅近端覆膜部分释放的示意图；
图5是本发明实施例2覆膜支架结构示意图；
图6是本发明实施例2支撑杆结构示意图；
图7是本发明实施例2覆膜支架在束缚下半释放的覆膜支架后面结构示意图；
图8是实施例3覆膜支架结构示意图；
图9是实施例3漏斗状的环形支撑架结构示意图；
图10是实施例4覆膜支架结构示意图；
图11是实施例5覆膜支架结构示意图；
图12是实施例5窗口支撑架结构示意图；
图13A是实施例5覆膜支架释放过程中仅近端覆膜部分释放的背面结构示意图；
图13B是实施例5覆膜支架释放过程中仅近端覆膜部分释放的正面结构示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
本发明所述“近端”是指沿血流方向，靠近患者心脏的支架或支架部件的部分，而所述“远端”是指远离患者心脏的支架或支架部件的部分。
前、后定义：设有窗口的支架管面为前壁，窗口相对的支架管面为后壁，前壁与后壁之间的支架两侧管面为侧壁。
实施例1，如图1所示，一种可分步释放的主动脉覆膜支架，包括管状覆膜120和环形支撑架110，所述覆膜120上由近端向远端轴向设置有用于穿装释放导丝的连接件142，所述连接件142轴向间隔设置至少两排。
管状的覆膜120形状可以是等径的直筒状，也可以是非等径结构的漏斗形、哑铃形或其他适用的形状。本实施例为等径结构的直筒形。覆膜120选用具有良好生物相容性的高分子材料制成，本实施例中优先PET膜，膜厚 0.07mm～0.1mm，覆膜120具有良好的力学强度和防内漏性能。
环形支撑架110起到对覆膜120的支撑作用，多个环形支撑架110沿覆膜120轴向依次平行间隔均匀缝合在覆膜120上，所述支架的近端和/或远端的环形支撑架110为部分缝合在覆膜120上的裸支架。如图1所示，由覆膜120的近端至远端依次设有多个环形支撑架110。其中位于覆膜支架近端的所述环形支撑架110为半缝合支架，其延伸段分缝合在覆膜120上。如图3所示，每圈环形支撑架110为管柱状，由多个Z形或正弦波组成，每个Z形或正弦波有1个波峰111和1个相邻的波谷112，波峰111和相邻的波谷112之间有1条连接杆113。每圈环形支撑架110采用一条超弹性镍钛丝编织而成，镍钛丝丝径较细，可在0.2～0.5mm之间，本实施例中采用0.45mm直径的镍钛丝编织而成，Z形或正弦波数量为6个，环状支撑体支架的垂直高度为12mm。如图3所示每圈环形支撑架110上有1个连接钢套114，镍钛丝的两个端点在连接钢套114内部，然后通过机械压紧或者焊接方式将镍钛丝的两个端点固定在钢套内部。所述环形支撑架110通过缝合、热合或者粘接等其它工艺固定在覆膜120内表面或外表面；本实施例支架规格为30规格，即环形支撑架110和覆膜120直径均为30mm。环形支撑架110采用缝合工艺固定在覆膜120外表面上，保持覆膜支架整体具有良好的回弹性。
所述连接件142用于轴向穿装释放导丝141，且作为协助释放导丝141在径向上束缚支架形成半展开状态，如图2所示，本发明实施例1覆膜支架在连接件处穿装释放导丝束缚下半释放后面结构示意图。则连接件142结构需同时满足上述目的，因此连接件142可以选择两种结构：供释放导丝141穿装或缠绕的闭环结构或开环结构；第一种结构式中，所述闭环结构是连接件142带有供释放导丝141穿过的通孔、或者所述连接件142与覆膜配合合围有供释放导丝141穿过的通孔或间隙。具体第一种实施方式为：所述连接件142为固定在覆膜外侧壁面的线圈；第二种实施方式为：所述连接件142为一段轴向间隔固定的线绳，且间隔固定的线绳与覆膜之间形成有供释放导丝141穿过的间隙；第三种实施方式为：连接件142是直接设置在覆膜上开设的通孔；
所述开环结构带有供释放导丝141穿过的限位槽，即所述连接件142为至少两排带有限位槽的软性连接扣，不同排的限位槽开口背向设置，释放导丝 141依次绕过不同排软性连接扣的限位槽中，将支架束缚。
为了防止在支架释放过程中连接件损伤血管，所述连接件142为设置在覆膜上或可贴附固定在覆膜上的软性连接扣，优选生物相容性的高分子材料制成，例如聚酯，也可以选择金属材质，例如金属丝。
本实施例中，连接件142为带有通孔的线圈，通孔可通过丝径为0.5mm～1.5mm的释放导丝141，本实施例中释放导丝141材质优先选用镍钛合金丝，丝径为0.5mm，连接件142数量为6个，分两排均匀固定在覆膜120上，每排有三个连接件142，三个连接件142轴向间隔设置。如图2所示，装配时，首先将两排连接件142拉向一起，在输送器的固定释放导丝141依次分别穿过不同排的连接件142形成对支架的束缚，所述覆膜支架在释放导丝141的束缚下保持半展开状态，再将所述支架全部压握在输送器鞘管中。如图4所示，释放时，首先释放覆膜支架近端未被释放导丝141束缚的部分，此时连接件142之间的覆膜120仍处于束缚状态，远端覆膜收束在外鞘管20中，近端作为裸支架的环形支撑架110仍束缚在输送器TIP头10中，覆膜支架未完全释放，整体直径小于血管直径，可以在血管内自由旋转和纵向移动，方便支架的精确定位，在找到支架的正确释放位置后，撤出释放导丝141，覆膜支架完全释放并牢牢贴合在血管内。
实施例2，如图5所示，本实施例是在实施例1的基础上的改进。
一种可分步释放的主动脉覆膜支架，包括管状覆膜120和固定在覆膜120上固定的环形支撑架110，所述覆膜120表面，优选内腔壁面至少在近端沿覆膜120周向固定有多根轴向设置的支撑杆130，所述覆膜120外侧对应支撑杆130上设有用于固定释放导丝的连接件142。
支撑杆130的第一功能，即最主要功能是形成半展开状态的支架，即将相邻的两个或多个支撑杆130拉近并列并通过连接件142固定，在拉近的过程中，支撑杆130能够始终保持覆膜的平整与支架整体结构的稳定性，在支撑杆130之间的覆膜120和环形支撑架110折叠，减少了支架的直径，形成半展开状态，半展开状态的支架直径小于血管直径，能够在所述血管中自由旋转和纵向移动而调整位置，便于支架在释放过程中的精确定位。
所述支撑杆130在覆膜120周向上沿覆膜120轴向设置，多个支撑杆130优选轴向对称设置，支撑杆130之间相互位置关系有两种：一种是所述支撑杆130平行于支架中轴线设置；另一种是非平行于支架中轴线，即所述支撑杆130之间呈八字或倒八字设置。如图7所示，平行支架中轴线设置的支撑杆130，束缚固定后，支架直径同步缩小，例如原为直筒形支架，半展开状态也是直筒形。非平行于支架中轴线设置的支撑杆130，束缚固定后，支架直径非同步缩小，例如原为直筒形支架，半展开状态为锥形。本实施例优选平行于支架中轴线设置支撑杆130。支撑杆130设置数量一般在2-6个，优选设置2-3个。
支撑杆130至少设置在覆膜120近端，是指支撑杆130近端设置在覆膜120近端，支撑杆130可以向支架远端方向延伸，其延伸长度根据需要，可以延伸至支架轴向中部，也可以延伸至支架轴向的远端。
如图5所示，本实施例优选所述筒状结构的覆膜120的内表面固定有两根支撑杆130，所述两根支撑杆130位于覆膜120近端的后部，通过缝合、热合或粘接等工艺固定在覆膜120内壁上，优选缝合的方式固定。
支撑杆130选材为具有一定支撑强度的金属或高分子材料，优选金属材料，例如镍钛合金丝，丝径范围为0.3mm～0.6mm，在本实施例中丝径优选0.45mm。所述支撑杆130结构如图6所示，图中显示的支撑杆130为直杆结构，所述支撑杆130上设置至少一个固定点，所述支撑杆130通过固定点缝合、热合或粘接固定在覆膜120内壁上。所述固定点为支撑杆130上设置的连接孔或带有开口的开口槽。本实施例中在支撑杆130的两端分别有两个固定点，本实施例的固定点为两个带有连接孔的限位圆头131，通过将支撑杆130两端卷曲形成，限位圆头131直径范围为1.5mm～3.5mm，本实施例优先限位圆头131直径2.5mm。限位圆头131以缝合的方式固定于覆膜120近端，防止支撑杆130在支架内沿轴向滑脱。除了连接孔外，固定点也可以为非闭环结构，还可以是带有开口的开口槽，例如：将支撑杆130某处弯曲，形成半圆或弧形的开口槽，在开口槽处固定后，支撑杆130就无法轴向移动。
如图7所示，在本实施例中支撑杆130在轴向起到支撑作用的同时，也作为覆膜支架100装配时的栓柱，既能保证支架在装配过程中的稳定性，也能够保证支架部分释放后的周向结构稳定的半展开状态，所述半展开状态的支架直 径小于血管直径，能够在所述血管中自由旋转和纵向移动而调整位置，便于支架在释放过程中的精确定位。
其余结构同实施例1，在此不再赘述。
实施例3，本实施例是在实施例2的基础上的改进。两者区别：本实施例的覆膜120为非等径延伸的管状结构。
如图8所示，本发明实施例2覆膜支架包括多圈环形支撑架110。包括漏斗状的覆膜120、固定在覆膜120上的环形支撑架110、140，所述覆膜120内腔壁面固定设置两根支撑杆130。实施例2的支撑杆130的设置与实施例1的支撑杆130相同，在此不再赘述。
覆膜支架呈漏斗状结构，包括主体段100A、延伸段100C。主体段100A、延伸段100C之间设有过渡段100B，延伸段100C的直径小于主体段100A直径。主体段100A和延伸段100C都分别包括直筒形覆膜120、环形支撑架110，过渡段100B包括锥台形的覆膜190和漏斗形的环形支撑架140。
如图9所示，漏斗形的环形支撑架140，由多个Z形或正弦波组成，每个Z形或正弦波有1个波峰111和1个相邻的波谷112，波峰111和相邻的波谷112之间有1条连接杆113。环形支撑架140与实施例中环形支撑架110的区别在于环形支撑架140存在锥度，环形支撑架140两端的直径差值为10mm。
其余结构同实施例2，在此不再赘述。
实施例4，本实施例是在实施例2的基础上的改进。
两者区别：本实施例覆膜支架是在实施例2覆膜支架的远端还设有长分支段102A和短分支段102B。即如图10所示，实施例2的覆膜支架为本实施例4的主体支架101，主体支架101的设置与实施例2相同，所述覆膜120内腔壁面固定设置两根支撑杆130，所述覆膜120外侧对应支撑杆130上设有用于固定释放导丝的连接件142。实施例4的支撑杆130和连接件142的设置与实施例2相同，在此不再赘述。
主体支架101的远端连接有两个分支段，分别为长分支段102A和短分支段102B。
长分支段102A和短分支段102B周向分别都设有分支段覆膜120A和分支段覆膜120B，所述分支段覆膜120A和分支段覆膜120B与主体支架101的覆膜120缝合在一起形成整体结构，或与覆膜120为一体成型的一体结构。分支覆膜120A呈直筒状结构，直径范围为10mm～14mm，长度为70mm；分支覆膜120B也呈直筒状结构，直径范围为10mm～14mm，长度为30mm。覆膜120与分支段覆膜120A和分支段覆膜120B之间也可设置过渡区，用于连接主体支架和长分支段102A和短分支段102B，过渡区的长度范围为10mm～20mm，优选15mm。覆膜120、分支段覆膜120A和分支段覆膜120B的材料可选自涤纶、聚氨酯、ePTFE、PET或者其他高分子材料，本实施例中选材为PET膜，PET膜的厚度范围为0.07mm～0.12mm，优选0.1mm。
分支段覆膜120A和分支段覆膜120B外壁或内壁分别由数量不等的多个分支环形支架121A和分支环形支架121B分别间隔顺序排布缝合固定，所分支环形支架121A和分支环形支架121B的支架材料优选为具有良好生物相容性和超弹性的镍钛合金丝。
其余结构同实施例2，在此不再赘述。
实施例5，本实施例是在实施例2或3的基础上的改进。区别是在覆膜120上开设用于设置分支血管的窗口300。
覆膜120有两种结构，开设窗口300也有两种情形。一种是如图11所示所述覆膜120为等径延伸的管状结构，所述覆膜120近端或中部设有用于设置分支血管的窗口300；所述窗口300位于相邻两个支撑杆之间覆膜120上，且围绕窗口的窗口支撑架180避开窗口300设置。两个或多个的窗口300同时设置在两个支撑杆130之间的同一区域，优选位于支架前壁上，且两个窗口的中心线位于同一轴线上。另一种是所述覆膜120为非等径延伸的管状结构，包括主体段和延伸段，所述主体段直径大于延伸段直径，主体段与延伸段之间设有过渡段；所述主体段或过渡段设有用于设置分支血管的窗口300。
如图12所示，本发明是在实施例2的基础上的改进。环形支撑架包括作为主体的环形支撑架110、对应窗口300设置的窗口支撑架180，所述窗口支撑架180中，对应窗口300设有窗口300波形单元。即本实施例的环形支撑架 110包括在覆膜支架包括多圈结构直径均匀的环形支撑架110，窗口支撑架180，在窗口300处设置有单圈金属环160，所述覆膜120内表面固定设置两根支撑杆130。如图12所示，窗口支撑架180由多个Z形或正弦波和一个窗口波形单元组成，每个Z形或正弦波有1个波峰111和1个相邻的波谷112，波峰111和相邻的波谷112之间有1条连接杆113；窗口波形单元有两个波峰121和一个波谷122，窗口波形单元位于Z形或正弦波两波峰111之间。窗口波形单元的波峰121和波谷122有两条连接杆123，波峰121与Z形或正弦波两波峰111有两条连接杆124。窗口支撑架180采用一条超弹性镍钛丝编织而成，丝径范围在0.2～0.5mm之间，本实施例优选0.45mm。Z形或正弦波数量为6个，窗口支撑架180的垂直高度为15mm。窗口支撑架180上有1个连接钢套314，镍钛丝的两个端点在连接钢套114内部，然后通过机械压紧或者焊接方式将镍钛丝的两个端点固定在钢套内部。
如图13A所示，覆膜支架在输送器上的固定释放导丝141的束缚下保持半释放状态，释放导丝141依次穿过连接件142。本实施例中释放导丝141材质优先镍钛合金丝，丝径为0.5mm，连接件142数量为6个，分两排固定在支撑杆130上，每排有三个连接件142，三个连接件142位于支撑杆130两端和中间的位置。
如图13A-13B所示，所述覆膜支架释放时，在导丝141束缚下处于半释放状态，覆膜支支架近端窗口300后方的部分支架仍处于束缚状态，支架整体直径较小，而前部的环形窗口300处于展开状态，该状态在临床应用过程中，因覆膜支架未完全展开，远端覆膜收束在外鞘管20中，近端裸支架110仍束缚在输送器TIP头10中，整体直径较小，可以通过输送系统在血管内方便的轴向和周向旋转，能够更快速、精确地定位环形窗口300的准确位置，从而能够顺利和分支血管吻合，缩短手术时间，提高手术成功率。另一方面，支撑杆130还可作为覆膜支架装配时的栓柱，既能保证支架在装配过程中的稳定性，也能够保证支架部分释放后的周向结构稳定的半展开状态，防止支架在处于半装配或者半释放状态时窗口300变形，而导致定位的不准确。
其余结构同实施例2或3，在此不再赘述。
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本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。

Claims (15)

  1. 一种可分步释放的主动脉覆膜支架，包括管状覆膜和环形支撑架，其特征在于，所述覆膜上由近端向远端轴向设置有用于穿装释放导丝的连接件，所述连接件轴向间隔设置至少两排。
  2. 根据权利要求1所述的可分步释放的主动脉覆膜支架，其特征在于，所述连接件为供释放导丝穿装或缠绕的闭环结构或开环结构；所述闭环结构是连接件带有供释放导丝穿过的通孔或者所述连接件与覆膜配合合围形成供释放导丝穿过的通孔或间隙；所述开环结构带有供释放导丝穿过的限位槽。
  3. 根据权利要求2所述的可分步释放的主动脉覆膜支架，其特征在于，所述连接件为设置在覆膜上或可贴附固定在覆膜上的软性连接扣。
  4. 根据权利要求3所述的可分步释放的主动脉覆膜支架，其特征在于，所述连接件为固定在覆膜外侧壁面的线圈；或者所述连接件为一段轴向间隔固定的线绳，且间隔固定的线绳与覆膜之间形成有供释放导丝穿过的间隙；或者连接件是设置在覆膜上的通孔；或是所述连接件为至少两排带有限位槽的软性连接扣，不同排的限位槽开口背向设置。
  5. 根据权利要求1-4任意一项所述的可分步释放的主动脉覆膜支架，其特征在于，所述覆膜上至少在近端沿覆膜周向间隔固定有多根轴向设置的支撑杆。
  6. 根据权利要求5所述的可分步释放的主动脉覆膜支架，其特征在于，所述支撑杆固定在覆膜的外壁或内腔壁面上，所述连接件固定在所述覆膜外侧壁面对应支撑杆的位置，或者所述连接件设置在支撑杆上或支撑杆附近的覆膜上。
  7. 根据权利要求5所述的可分步释放的主动脉覆膜支架，其特征在于，所述支撑杆通过缝合、热合或粘接固定在覆膜上。
  8. 根据权利要求5所述的可分步释放的主动脉覆膜支架，其特征在 于，所述支撑杆至少设置一个用于与覆膜固定连接的固定点，所述固定点为支撑杆上设置的连接孔或带有开口的开口槽。
  9. 根据权利要求5所述的可分步释放的主动脉覆膜支架，其特征在于，所述支撑杆平行于支架中轴线设置；或者所述支撑杆之间呈八字或倒八字设置。
  10. 根据权利要求1-4任意一项所述的可分步释放的主动脉覆膜支架，其特征在于，所述支架为等径延伸或者非等径延伸的管状结构。
  11. 根据权利要求10任意一项所述的可分步释放的主动脉覆膜支架，其特征在于，所述支架的近端或中部设有用于放置分支支架或者分支血管的窗口。
  12. 根据权利要求11所述的可分步释放的主动脉覆膜支架，其特征在于，所述连接件设置在所述窗口两侧的位置，用于束缚窗口后方的部分支架。
  13. 根据权利要求10所述的可分步释放的主动脉覆膜支架，其特征在于，所述支架为非等径延伸的管状结构，包括主体段和延伸段，所述主体段直径大于延伸段直径，主体段与延伸段之间设有过渡段；所述主体段或/和过渡段设有用于放置分支支架或者分支血管的窗口。
  14. 根据权利要求10所述的可分步释放的主动脉覆膜支架，其特征在于，所述连接件设置在所述主体段和连接段窗口两侧的位置，用于束缚窗口后方的部分支架。
  15. 根据权利要求10所述的可分步释放的主动脉覆膜支架，其特征在于，所述覆膜上至少在近端沿覆膜周向间隔固定有多根轴向设置的支撑杆，所述支撑杆固定在覆膜的外壁或内腔壁面上，所述连接件固定在所述覆膜外侧壁面对应支撑杆的位置，或者所述连接件设置在支撑杆上或支撑杆附近的覆膜上。
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