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WO2019128780A1 - 管腔支架 - Google Patents

管腔支架 Download PDF

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Publication number
WO2019128780A1
WO2019128780A1 PCT/CN2018/121744 CN2018121744W WO2019128780A1 WO 2019128780 A1 WO2019128780 A1 WO 2019128780A1 CN 2018121744 W CN2018121744 W CN 2018121744W WO 2019128780 A1 WO2019128780 A1 WO 2019128780A1
Authority
WO
WIPO (PCT)
Prior art keywords
skirt
support structure
proximal
tubular body
central axis
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2018/121744
Other languages
English (en)
French (fr)
Inventor
肖本好
吴轩
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
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 Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to US16/954,347 priority Critical patent/US12220332B2/en
Priority to ES18897682T priority patent/ES2973836T3/es
Priority to EP18897682.3A priority patent/EP3733127B1/en
Publication of WO2019128780A1 publication Critical patent/WO2019128780A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/02—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
    • A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
    • 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
    • A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0083—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using hook and loop-type fasteners
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped

Definitions

  • the present invention relates to the field of implantable medical devices, and more particularly to a lumen stent.
  • aortic stent graft endovascular grafting has been widely used in aortic aneurysms and arterial dissections of the thoracic and abdominal aorta. Its curative effect is small, the trauma is small, the recovery is quick, and the complications are few. The treatment. However, for special lesions such as the aortic arch, the celiac trunk, the bilateral renal artery, or the superior mesenteric artery, the use of a stent graft affects the blood supply to the arterial branch vessel.
  • the in-situ fenestration of the stent graft is often performed by laser or mechanical means during the operation, so that the stent graft produces the desired hole, and then the branch stent is transported to the hole to be docked with the stent graft.
  • the treatment protocol overcomes the dependence on the anatomy of the branching blood vessels of the human body.
  • the branch bracket includes at least a tubular body 10 and a skirt 20 sleeved outside the tubular body 10.
  • the skirt 20 includes a metal bracket 21 and a coating 22 covering the metal bracket 21.
  • the skirt of the branch bracket is firstly provided with a mold bar 40 on the tubular body 10, and at least one inner film 221 and a metal bracket 21 are attached to the mold bar 40 in turn. At least one outer mold 222; then, the mold bar 40 and the skirt 20 thereon are heat treated together, so that the inner film 221 and the outer mold 222 are fused together under a certain temperature and pressure.
  • the side of the skirt 20 against the mold bar 40 is flat and smooth, and the metal bracket 21 protrudes from the side of the skirt 20 away from the mold bar 40, so that the skirt 20 The outer surface away from the side of the mold bar 40 is uneven.
  • the skirt needs to be everted. Compared with FIG. 2 and FIG. 4, the side of the skirt which is close to the mold bar becomes the outer surface of the skirt, and the outer surface is smooth and smooth. Skirt. However, due to the specific structure of the skirt, some skirts cannot be everted, or can only be turned over on the basis of stretching or bending the skirt, so that the coating structure of the skirt is damaged.
  • the technical problem to be solved by the present invention is to provide a lumen bracket for facilitating cuffing in view of the defect that the prior art skirt is inconvenient to eversion.
  • a lumen support comprising a tubular body and a skirt sleeved on the outside of the tubular body, one end of the skirt is a fixed end, and the fixed end is sealingly connected with an outer surface of the tubular body, the skirt The other end of the side is a free end, and the distance between the fixed end and the free end on the same side of the central axis of the tube body in the cross section passing through the central axis of the tube body is in the tube body
  • the ratio of the free ends of the free ends on either side of the axis along the radial direction of the skirt is less than 1/2.
  • the vertical distance of the free ends on both sides of the central axis of the tubular body in the radial direction of the skirt and the fixed ends on both sides of the central axis of the tubular body is greater than or equal to 3/2.
  • the angle between the line connecting the free end and the fixed end on the same side of the central axis of the tube body and the central axis of the tube body is not less than 30°.
  • the tubular body includes a first radial support structure
  • the skirt includes a second radial support structure, the second radial support structure and the first radial direction
  • the support structure is rotatably connected.
  • the second radial support structure includes at least one wavy ring, the undulating ring including a plurality of proximal vertices, a plurality of distal vertices, and a connection phase a proximal end apex of the adjacent and a support of the distal apex, the corrugated annulus being rotatably coupled to the first radial support structure at a location of at least one of the proximal vertices.
  • an angle between the support bodies connected to both sides of the proximal vertex is greater than an angle between the support bodies connected to both sides of the distal vertex .
  • the plurality of proximal vertices include at least one first proximal vertex and a plurality of second proximal vertices, the corrugated annulus at the first proximal vertex The position is rotatably coupled to the first radial support structure.
  • the distance between the first proximal vertex and the distal vertex is greater than the distance between the second proximal vertex and the distal vertex.
  • an angle between the support bodies connected to both sides of the first proximal vertex is smaller than the support body connected to both sides of the second proximal vertex The angle between the two.
  • the distal apex is located in the same plane perpendicular to the central axis of the skirt.
  • the angle between the supports attached to both sides of the distal apex is 10° to 30°.
  • the corrugated ring has a wire diameter of 0.05 mm to 0.15 mm.
  • the second radial support structure and the first radial support structure are entangled with each other or connected by a connecting ring.
  • a lumen stent embodying the present invention has the following beneficial effects: the present application adjusts the distance between the fixed end and the free end on the same side of the tubular body and the radial direction of the two free ends along the skirt. The ratio of the vertical distance of the direction allows the skirt to be everted without stretching or bending in the case of radially compressing the two fixed ends.
  • Figure 1 is a perspective view of a prior art branch bracket
  • Figure 2 is a cross-sectional view of the branch bracket of Figure 1;
  • Figure 3 is a schematic structural view of the skirt of the branch bracket shown in Figure 1;
  • Figure 4 is a cross-sectional view of the skirt of the branch bracket of Figure 2 after the flange has been turned;
  • Figure 5 is a schematic view of a lumen stent provided by one of the preferred embodiments of the present invention.
  • Figure 6 is a schematic view of the lumen bracket of Figure 5 in a section through the central axis of the skirt, the vertical distance of the two fixed ends along the radial direction of the skirt is constant;
  • Figure 7 is a schematic view of the lumen support of Figure 5 in a section through the central axis of the skirt, radially compressing the two fixed ends and flanging;
  • Figure 8 is a schematic view showing the outline of the skirt of the lumen bracket of Figure 5 in a cross section through the central axis of the skirt;
  • Figure 9 is a schematic view of the mixing section of the lumen stent of Figure 5 in a section through the central axis of the skirt, the outline of the skirt being a straight line and a straight line;
  • Figure 10 is a schematic structural view of the skirt of the lumen stent shown in Figure 5;
  • Figure 11 is a schematic view of the second radial support structure of the lumen stent of Figure 5 and the first radial support structure;
  • Figure 12 is a schematic view showing the second radial support structure of the lumen stent of Figure 5 connected to the first radial support structure by a connecting ring;
  • Figure 13 is a schematic view showing the structure of the second radial support structure of the skirt shown in Figure 10;
  • Figure 14 is a schematic view showing the structure of the second radial support structure shown in Figure 13 after radially compressing the skirt;
  • Figure 15 is a schematic view of a lumen stent provided by the second preferred embodiment of the present invention.
  • Figure 16 is a schematic view showing the structure of the skirt of the lumen stent shown in Figure 15.
  • the blood vessel is taken as an example to describe the lumen, and the blood vessel may be an aortic arch, or a thoracic aorta, or an abdominal aorta.
  • the use of blood vessels is merely illustrative and not limiting of the invention, and that the present invention is applicable to a variety of human lumens, such as digestive tract lumens, etc., based on the teachings of the present invention. Improvements and modifications are within the scope of the invention.
  • the orientation can be defined in terms of blood flow direction, and in the present invention, blood flow is defined from the proximal end to the distal end.
  • the radial support structure described herein refers to a closed, wave-shaped annulus that is axially disposed along the stent graft as is conventional in the art.
  • one of the preferred embodiments of the present invention provides a lumen support 100 comprising a tubular body 10 and a skirt 20 sleeved outside the tubular body 10.
  • the tubular body 10 has an axial tubular structure which can serve as a new blood flow passage after implantation into a blood vessel.
  • the tubular body 10 includes at least a first radial support structure 11 and a first coating 12 covering the first radial support structure 11, the first radial support structure 11 cooperating with the first coating 12 to form the side of the tubular body 10. wall.
  • the first radial support structure 11 can be made of various biocompatible materials such as nickel titanium, stainless steel, and the like.
  • the first radial support structure 11 may include a plurality of circular corrugated rings in the axial direction, such as a multi-turn Z-shaped wave, an M-shaped wave, or other structure that can be radially compressed into a small diameter, etc.; or include a spiral wound structure; Or include a mesh structure.
  • the first radial support structure 11 may be formed by winding a metal wire or by cutting a metal tube.
  • the first film 12 is made of a polymer material having good biocompatibility, such as a PET film, a PTFE film, etc., and the first film 12 can be covered on the first radial support structure 11 by stitching or hot melting. .
  • the tubular body 10 has a radial expansion capability, can be compressed under an external force and self-expands after the external force is withdrawn or restored to the original shape by mechanical expansion (for example, balloon expansion) and remains The initial shape whereby the tubular body 10 can be secured within the lumen by its radial support against the lumen wall after implantation into the lumen. It should be understood that, unless otherwise stated, the initial shape of the lumen stent after radial deployment is described.
  • the tubular body 10 can isolate the lesion area of the lumen, for example, after the artery is implanted, the arterial dissection or aneurysm can be isolated.
  • the skirt 20 includes at least a second radial support structure 21, and a second coating 22 covering the second radial support structure 21, the second radial support structure 21 and the second coating 22 of the skirt 20.
  • a radial support structure and a film which are the same as or similar to the above-described pipe body 10 can be employed, and will not be described herein.
  • the skirt 20 has a radial expansion capability by the second radial support structure 21.
  • One end of the skirt 20 is a fixed end 20a, and the fixed end 20a can be sealedly connected to the outer surface of the pipe body 10 by stitching or hot-melting, for example, the second film 22 of the fixed end 20a and the pipe body 10 can be A film 11 is thermally fused together to achieve a sealed connection.
  • the other end of the skirt 20 is a free end 20b, and the free end 20b radiates outwardly, so that the skirt 20 forms an approximately conical structure, that is, the cross section of the skirt 20 gradually increases along the direction from the fixed end 20a to the free end 20b. .
  • the free end 20b is rotated about the fixed end 20a of the same side in the direction away from the tubular body 10, and the vertical distance h of the free end 20b to the outer surface of the tubular body 10 is continuously increased, when the free end 20b
  • the line connecting the fixed end 20a on the same side thereof is perpendicular to the central axis of the lumen bracket, as shown by the dashed line in Fig. 6, the vertical distance from the free end 20b' to the outer surface of the tube body 10 is maximized, and the two free ends are at this time.
  • the vertical distance of 20b' along the radial direction of the skirt 20 is D'.
  • the skirt 20 does not elastically deform, and the vertical distance between the two fixed ends 20a along the radial direction of the skirt 20 In the case where d is constant, it is necessary to stretch the skirt 20, gradually increase D to D', or bend the skirt 20 so that the vertical distance h of the free end 20b to the outer surface of the pipe body 10 does not increase, but pulls Stretching or bending the skirt 20 will destroy the coating structure of the skirt 20 and cause irreversible damage to the skirt 20.
  • the two fixed ends 20a can be radially compressed to make D' not larger than D. Flanging can be achieved without stretching or bending the skirt 20.
  • the direction indicated by the arrow in Fig. 7 is the direction in which the two fixed ends 20a are radially compressed, and the broken line portion is the radial compression of the two fixed ends 20a, and the line connecting the free end 20b and the fixed end 20a on the same side thereof is perpendicular to the lumen bracket.
  • the skirt 20 can be everted without being stretched or bent in the case where the two fixed ends 20a are compressed in the radial direction.
  • the ratio of the vertical distance D of the two free ends 20b along the radial direction of the skirt 20 to the vertical distance d of the two fixed ends 20a along the radial direction of the skirt 20 is greater than or equal to 3/2. It should be understood that the vertical distance D of the two free ends 20b along the radial direction of the skirt 20 and the vertical distance d of the two fixed ends 20a along the radial direction of the skirt 20 are based on the radial expansion of the lumen support. After the initial shape.
  • the skirt 20 is mainly used to fill the gap between the tube body 10 and the hole of the stent graft, the inner leakage is prevented, if the two free ends 20b are along the radial direction of the skirt 20 in the radial direction D and the two fixed ends 20a along the skirt The ratio of the vertical distance d in the radial direction of the edge 20 is too small, causing the skirt 20 to not completely fill the gap, resulting in a Type III internal leak.
  • the angle ⁇ between the line connecting the free end 20b and the fixed end 20a on the same side of the pipe body 10 and the central axis of the skirt 20 is not less than 30°. It can be understood that the angle ⁇ on both sides of the pipe body 10 may be the same or different in the cross section passing through the central axis of the skirt 20 .
  • the tubular body 10 is a straight tubular shape
  • the skirt 20 is in the shape of a truncated cone.
  • the outline of the skirt 20 is straight, and the vertical distance d between the two fixed ends 20a in the radial direction of the skirt 20 is the outer diameter of the tubular body 10.
  • the contour of the skirt 20 may be a curved line, a mixed line segment of a straight line and a straight line, a combined line segment of a straight line and an arc, or a cross section passing through the central axis of the skirt 20 or Other irregular segments. As shown in Fig.
  • the outline of the skirt 20 is curved in a section passing through the central axis of the skirt 20; or, as shown in Fig. 9, on the section passing through the central axis of the skirt 20, the skirt
  • the outline of 20 is a mixed line segment of a straight line and a straight line.
  • the second radial support structure 21 includes at least one turn of the wave ring 210, and each turn of the wave ring 210 is a closed loop structure including a plurality of proximal vertices 211, a plurality of far The end vertex 212, and the support 213 connecting the adjacent proximal vertex 211 and the distal vertex 212, the proximal vertex 211 and the distal vertex 213 respectively correspond to peaks or troughs of the waveform.
  • the second radial support structure 21 includes a ring of corrugated rings 210, and the plurality of proximal vertices 211 of the corrugated ring 210 are located in the same plane perpendicular to the central axis of the skirt 20, and a plurality of The distal apex 212 is also located in the same plane that is perpendicular to the central axis of the skirt 20.
  • the second radial support structure 21 may further include a multi-turn corrugated ring 210, which is sequentially arranged along the axial direction of the skirt 20, preferably parallel. The spacers are arranged, or the multi-turn corrugated ring 210 is connected in a mesh structure.
  • the second radial support structure 21 can be distributed over a portion of the skirt 20, i.e., along the central axis of the skirt 20, the maximum length of the ends of the second radial support structure 21 being less than the length of the skirt 20.
  • the second radial support structure 21 can also be distributed over the entire skirt 20, i.e., along the central axis of the skirt 20, the maximum length of the ends of the second radial support structure 21 being equal to the length of the skirt 20.
  • the second radial support structure 21 is distributed over the entire skirt 20, and the end of the second radial support structure 21 near the free end 20b is flush with the free end 20b of the skirt 20, the second diameter One end of the support structure 21 near the fixed end 20a is flush with the fixed end 10a of the skirt 20.
  • one end of the second radial support structure 21 near the fixed end 20a is rotatably connected to the first radial support structure 11 of the pipe body 10. Since the mechanical properties of the film are poor, if the skirt 20 and the pipe body 10 are only connected by the film, the skirt 10 is easily deformed or broken when being flanged, and the second radial support structure 21 is connected to the first.
  • the radial support structure 11 can increase the connection strength between the skirt 20 and the pipe body 10, avoiding the skirt 10 being pulled or deformed when being flanged, and also facilitating the flipping of the skirt. It will be appreciated that the invention does not limit the particular manner in which the second radial support structure 21 is rotationally coupled to the first radial support structure 11. As shown in FIG.
  • At least one peak (or trough) of the second radial support structure 21 is intertwined with at least one trough or (peak) of the first radial support structure 11.
  • at least one peak (or trough) of the second radial support structure 21 is connected to at least one trough or (crest) of the first radial support structure 11 through a connecting ring 30, which may be It is wound by a flexible wire or a metal ring made of a biocompatible material such as nickel titanium, stainless steel or the like.
  • all the peaks (or troughs) of the second radial support structure 21 near one side of the fixed end 20a are connected to the first radial support structure 11.
  • a partial peak (or trough) of the second radial support structure 21 near one side of the fixed end 20a can be connected to the first radial support structure 11.
  • the corrugated ring 210 is substantially a frustum structure, and the waveform angle a1 of the side of the corrugated ring 210 near the fixed end 20a is larger than the far angle of the corrugated ring 210 away from the fixed end 20a.
  • the angle a2 of the waveform on one side that is, the angle a1 of the waveform corresponding to the proximal vertex 211 is larger than the angle a2 of the waveform corresponding to the distal vertex 212.
  • the angle of the waveform refers to the angle between the supports 104 connected to the same proximal vertex 102 or the distal vertex 103.
  • the plurality of proximal apexes 211 of the corrugated ring 210 converge toward one side of the central axis of the skirt 20, the undulating ring 210
  • the angle a2 of the waveform corresponding to the distal vertex 212 gradually decreases and tends to 0°.
  • the distal end apex 212 of the corrugated ring 210 corresponds to a waveform angle a2 of 10° to 30°.
  • the wire diameter of the corrugated ring 210 is in the range of 0.05 mm to 0.15 mm, preferably 0.07 mm to 0.13 mm.
  • a preferred embodiment of the present invention provides a lumen stent that differs from one of the embodiments in the structure of the second radial support structure 21.
  • the second radial support structure 21 includes a corrugated annulus 210 that is rotatably coupled to the first radial support structure 11.
  • the corrugated ring 210 is a closed annular structure including at least one first proximal vertex 211a, a plurality of second proximal vertex 211b, a plurality of distal vertices 212, and a first adjacent adjacent one.
  • the first proximal vertex 211a and the second proximal vertex 211b correspond to a wave crest of the waveform
  • the distal vertex 212 corresponds to a trough of the waveform.
  • the first proximal end apex 211a extends to the fixed end 10a of the skirt 20 and is rotatably coupled to the first radial support structure 11.
  • one of the plurality of distal vertices 212, the distance between the first proximal vertex 211a and the reference distal vertex is greater than the second proximal vertex 211b and the direction along the central axis of the skirt 20
  • the distance between the apexes of the reference distal ends, the angle between the supports 104 connected to both sides of the first proximal apex 211a is smaller than the angle between the supports 104 connected to both sides of the second proximal apex 211b.
  • the wave height of the corrugated ring 210 is constant, the larger the angle of the waveform, the larger the radial supporting force of the corrugated ring 210, but if the angle of the waveform is too large, it is not suitable for loading. sheath.
  • the waveform angle of the corrugated ring 210 is constant, the smaller the wave height is, the larger the radial supporting force corresponding to the corrugated ring 210 is, but the wave height is too small, and the roundness of the skirt 20 cannot be maintained. , hindering the sealing effect of the skirt 20 .
  • the radial supporting force of the skirt 20 can be increased while the first proximal vertex 211a and the first radial direction are made.
  • the support structure 11 is connected to increase the strength of the connection between the skirt 10 and the tubular body 20.
  • the ratio of the distance between the first proximal vertex 211a and the reference distal vertex to the distance between the second proximal vertex 211b and the reference distal vertex is 0.3-0.8, and the second proximal vertex 211b is on both sides.
  • the angle between the support bodies 213 is 30° to 150°.
  • the plurality of distal apexes 212 of the corrugated annulus 210 are located in the same plane perpendicular to the central axis of the skirt 20 and are flush with the free end 20b of the skirt 20, the first proximal apex 211a extending
  • the fixed end 10a of the skirt 20 is rotatably coupled to the first radial support structure 11.
  • the present invention does not limit the specific number of first proximal vertices 211a.
  • the first proximal apex 211a may include one or more.
  • the first first proximal apex 211a includes a plurality, the first first The end vertices 211a are evenly distributed along the circumferential direction of the skirt 21.
  • the number of first proximal vertices 211a is less than or equal to the number of second proximal vertices 211b to increase the radial support of the skirt 20.
  • the second radial support structure 21 may further include other corrugated loop structures, spiral wound structures, or mesh structures.

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Abstract

一种管腔支架（100），包括管体（10）和套设于管体（10）外的裙边（20），裙边（20）的一端为固定端（20a），固定端（20a）与管体（10）的外表面密封连接，裙边（20）的另一端为自由端（20b），在经过管体（10）中轴线的截面上，位于管体（10）的中轴线同侧的固定端（20a）与自由端（20b）之间的距离（L)与管体（10）中轴线两侧的自由端（20b）沿裙边（20）的径向方向的垂直距离（D)的比值小于1/2。有益效果：管腔支架（100）可以在径向压缩两个固定端（20a）的情况下，使裙边（20）在不拉伸或折弯的情况下外翻，同时不影响裙边（20）的防内漏效果。

Description

管腔支架 技术领域
本发明涉及植入医疗器械领域，尤其涉及一种管腔支架。
背景技术
近十余年来，主动脉覆膜支架腔内隔绝术已经广泛应用于胸、腹主动脉的动脉瘤和动脉夹层等病变，其疗效确切、创伤小、恢复快、并发症少，已成为一线的治疗方法。但是对于主动脉弓部、腹腔动脉干、双侧肾动脉或者肠系膜上动脉等特殊病变部位，使用覆膜支架会影响动脉分支血管的血液供应。针对这种情况，常通过激光或机械方式在手术过程中对覆膜支架进行原位开窗，使覆膜支架产生预期的孔洞，再将分支支架输送至该孔洞处与覆膜支架对接，这种治疗方案克服了对人体分支血管解剖结构的依赖性。
如图1所示，分支支架至少包括管体10和套设于该管体10外的裙边20，裙边20包括金属支架21以及覆盖在该金属支架21上的覆膜22。当分支支架植入覆膜支架的孔洞后，裙边20可以填充管体与孔洞的间隙，防止内漏。
结合图2和图3所示，分支支架的裙边在制作过程中，首先在管体10外套设模棒40，并依次在模棒40上附上至少一层内膜221、金属支架21以及至少一层外模222；然后，将模棒40及其上的裙边20一起进行热处理，使内膜221与外模222在一定温度和压力作用下相互融合粘接。参见图3，受上述制作方法的限制，会导致裙边20贴紧模棒40的一侧平整光滑，而金属支架21从裙边20的远离模棒40的一侧凸出，使裙边20远离模棒40的一侧的外表面凹凸不平。若直接将制作好的分支支架装入鞘管，由于该裙边的外表面凹凸不平，很容易划伤鞘管内壁则，不仅会损伤裙边，还会使裙边与鞘管之间的摩檫力增大，导致释放力增大，使分支支架不容易出鞘。因此，在将分支支架装入鞘管之前，需要将裙边外翻，对比图2和图4，使裙边的紧贴模棒的一侧成为裙边的外表面，得到外表面平整光滑的裙边。但是，受限于裙边的具体结构， 一些裙边无法外翻，或者只有在拉伸或折弯裙边的基础上才能外翻，使裙边的覆膜结构受损。
发明内容
本发明要解决的技术问题在于，针对现有技术裙边不方便外翻的缺陷，提供一种利于翻边的管腔支架。
本发明解决其技术问题所采用的技术方案是：
提供一种管腔支架，包括管体和套设于所述管体外的裙边，所述裙边的一端为固定端，所述固定端与所述管体的外表面密封连接，所述裙边的另一端为自由端，在经过所述管体中轴线的截面上，位于所述管体的中轴线同侧的所述固定端与所述自由端之间的距离与所述管体中轴线两侧的自由端沿所述裙边的径向方向的垂直距离的比值小于1/2。
在本发明所述的管腔支架中，沿所述裙边的径向方向，所述管体中轴线两侧的所述自由端的垂直距离与所述管体中轴线两侧的所述固定端的垂直距离的比值大于或等于3/2。
在本发明所述的管腔支架中，位于所述管体中轴线同侧的所述自由端与所述固定端的连线与所述管体的中轴线的夹角不小于30°。
在本发明所述的管腔支架中，所述管体包括第一径向支撑结构，所述裙边包括第二径向支撑结构，所述第二径向支撑结构与所述第一径向支撑结构转动连接。
在本发明所述的管腔支架中，所述第二径向支撑结构包括至少一圈波形环状物，所述波形环状物包括多个近端顶点、多个远端顶点，以及连接相邻的所述近端顶点与所述远端顶点的支撑体，所述波形环状物在至少一个所述近端顶点的位置处与所述第一径向支撑结构转动连接。
在本发明所述的管腔支架中，连接在所述近端顶点两侧的所述支撑体之间的夹角大于连接在所述远端顶点两侧的所述支撑体之间的夹角。
在本发明所述的管腔支架中，多个所述近端顶点包括至少一个第一近端顶点以及多个第二近端顶点，所述波形环状物在所述第一近端顶点的位置处与所 述第一径向支撑结构转动连接。
在本发明所述的管腔支架中，所述第一近端顶点与所述远端顶点之间的距离大于所述第二近端顶点与该远端顶点之间的距离。
在本发明所述的管腔支架中，连接在所述第一近端顶点两侧的所述支撑体之间的夹角小于连接在所述第二近端顶点两侧的所述支撑体之间的夹角。
在本发明所述的管腔支架中，所述远端顶点位于垂直与所述裙边的中轴线的同一平面内。
在本发明所述的管腔支架中，连接在所述远端顶点两侧的所述支撑体之间的夹角为10°～30°。
在本发明所述的管腔支架中，所述波形环状物的丝径为0.05mm～0.15mm。
在本发明所述的管腔支架中，所述第二径向支撑结构与所述第一径向支撑结构相互勾绕或通过连接环连接。
综上所述，实施本发明的一种管腔支架，具有以下有益效果：本申请通过调整位于管体同侧的固定端与自由端之间的距离与两个自由端沿裙边的径向方向的垂直距离的比值，可以在径向压缩两个固定端的情况下，使裙边在不拉伸或折弯的情况下外翻。
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是现有技术中分支支架的立体图；
图2是图1所示分支支架的剖视图；
图3是1所示分支支架的裙边的结构示意图；
图4是图2所示分支支架的裙边翻边后的剖视图；
图5是本发明较佳实施例之一提供的一种管腔支架的示意图；
图6是图5所示管腔支架在经过裙边的中轴线的截面上，两个固定端沿裙边的径向方向的垂直距离不变时翻边的示意图；
图7是图5所示管腔支架在经过裙边的中轴线的截面上，径向压缩两个固定端后翻边的示意图；
图8是图5所示管腔支架在经过裙边的中轴线的截面上，裙边的轮廓线为弧形的示意图；
图9是图5所示管腔支架在经过裙边的中轴线的截面上，裙边的轮廓线为直线与直线连接的混合线段的示意图；
图10是图5所示管腔支架的裙边的结构示意图；
图11是图5所示管腔支架的第二径向支撑结构与第一径向支撑结构相互勾绕的示意图；
图12是图5所示管腔支架的第二径向支撑结构与第一径向支撑结构通过连接环连接的示意图；
图13是图10所示裙边的第二径向支撑结构的结构示意图；
图14是图13所示第二径向支撑结构在径向压缩裙边后的结构示意图；
图15是本发明较佳实施例之二提供的一种管腔支架的示意图；
图16是图15所示管腔支架的裙边的结构示意图。
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。
为方便描述，以血管为例来阐述管腔，该血管可以是主动脉弓，或胸主动脉，或腹主动脉等。本领域的普通技术人员应当知晓，采用血管来阐述仅用作举例，并不是对本发明的限制，本发明的方案适用于各种人体管腔，例如消化道管腔等，基于本发明教导的各种改进和变形均在本发明的保护范围之内。另外，在阐述血管中，可按照血流方向定义方位，本发明中定义血流从近端流向远端。除非特别说明，本申请所述径向支撑结构是指本领域常见的沿覆膜支架轴向排布的闭合状波形环状物。
如图5所示，本发明较佳实施例之一提供了一种管腔支架100，包括管体10和套设于管体10外的裙边20。
管体10为具有轴向的管状结构，植入血管后该管状结构可作为新的血流通道。管体10至少包括第一径向支撑结构11，以及覆盖该第一径向支撑结构 11的第一覆膜12，第一径向支撑结构11与第一覆膜12配合形成管体10的侧壁。
第一径向支撑结构11可由各种生物相容的材料制成，如镍钛、不锈钢等材料。第一径向支撑结构11可沿轴向包括多圈波形环状物，例如多圈Z形波、M形波、或其它可径向压缩为很小直径的结构等；或者包括螺旋缠绕结构；或者包括网状结构。第一径向支撑结构11可以由金属线绕制而成或由金属管切割形成。第一覆膜12采用具有良好生物相容性的高分子材料制成，如PET膜、PTFE膜等，第一覆膜12可以通过缝合或热熔等方式覆盖在第一径向支撑结构11上。
通过上述第一径向支撑结构11，管体10具有径向膨胀能力，可在外力作用下被压缩并在外力撤销后自膨胀或通过机械膨胀(例如球囊扩张膨胀)恢复至初始形状并保持初始形状，由此管体10在植入管腔后可通过其径向支撑力紧贴管腔壁而固定于管腔内。应当知晓，后续若无特别说明，文中描述的是管腔支架径向展开后的初始形状。通过上述第一覆膜12，管体10可隔离管腔的病变区域，例如，植入动脉血管后可隔离动脉夹层或动脉瘤。
裙边20至少包括第二径向支撑结构21，以及覆盖在该第二径向支撑结构21上的第二覆膜22，该裙边20的第二径向支撑结构21与第二覆膜22可采用与上述管体10相同或类似的径向支撑结构和覆膜，此处不再赘述。通过第二径向支撑结构21，裙边20具有径向膨胀能力。
裙边20的一端为固定端20a，固定端20a可通过缝合或热熔等方式与管体10的外表面密封连接，例如，可将固定端20a的第二覆膜22与管体10的第一覆膜11热熔在一起而实现密封连接。裙边20的另一端为自由端20b，自由端20b向外辐射展开，使裙边20形成近似锥形结构，即沿固定端20a到自由端20b的方向，裙边20的横截面逐渐增大。
参见图6，在经过管体10的中轴线的截面上，位于管体10的中轴线同侧的固定端20a与自由端20b之间的距离L与两个自由端20b沿裙边20的径向方向的垂直距离D的比值小于1/2。
裙边20在外翻过程中，自由端20b朝远离管体10的方向绕与其同侧的固 定端20a转动，自由端20b到管体10的外表面的垂直距离h不断增大，当自由端20b与其同侧的固定端20a的连线垂直于管腔支架的中轴线时，如图6虚线所示，自由端20b’到管体10的外表面的垂直距离达到最大，此时两个自由端20b’沿裙边20的径向方向的垂直距离为D’。可以理解的是，由于第二径向支撑结构21与第二覆膜22均没有延展性，裙边20不会发生弹性变形，在两个固定端20a沿裙边20的径向方向的垂直距离d不变的情况下，需要拉伸裙边20，使D逐渐增大为D’，或者折弯裙边20，使自由端20b到管体10的外表面的垂直距离h不增加，但是拉伸或折弯裙边20均会破坏裙边20的覆膜结构，对裙边20造成不可逆的损坏。
一并参见图7，当位于管体10同侧的固定端20a与自由端20b之间的距离L小于D/2时，可以通过径向压缩两个固定端20a，使D’不大于D，即可实现在不拉伸或折弯裙边20的情况下翻边。图7箭头所示方向为径向压缩两个固定端20a的方向，虚线部分为径向压缩两个固定端20a后，自由端20b与其同侧的固定端20a的连线垂直于管腔支架的中轴线时，管腔支架的示意图。
由上述可知，本申请通过调整L与D的比值，可以在径向压缩两个固定端20a的情况下，使裙边20在不拉伸或折弯的情况下外翻。
进一步的，两个自由端20b沿裙边20的径向方向的垂直距离D与两个固定端20a沿裙边20的径向方向的垂直距离d的比值大于或等于3/2。应当知晓，此处两个自由端20b沿裙边20的径向方向的垂直距离D，及两个固定端20a沿裙边20的径向方向的垂直距离d，均基于管腔支架径向展开后的初始形状。
由于裙边20主要用于填充管体10与覆膜支架的孔洞的间隙，防止内漏，若两个自由端20b沿裙边20的径向方向的垂直距离D与两个固定端20a沿裙边20的径向方向的垂直距离d的比值太小，会导致裙边20无法完全填充间隙，造成Ⅲ型内漏。
裙边20在制作过程中，需要在管体10外套设模棒，若位于管体10同侧的固定端20a与自由端20b的连线与裙边20的中轴线的夹角α太小，则对应的模棒的夹角也较小，而夹角较小的模棒不方便加工。故为了加工方便，位于管体10同侧的自由端20b与固定端20a的连线与裙边20的中轴线的夹角α不 小于30°。可以理解的是，在经过裙边20的中轴线的截面上，管体10两侧的夹角α可以相同，也可以不同。
本实施例中，管体10为直管状，裙边20为锥台状。在经过裙边20的中轴线的截面上，裙边20的轮廓线为直线，两个固定端20a沿裙边20的径向方向的垂直距离d即为管体10的外径。可以理解的是，在其它实施例中，在经过裙边20的中轴线的截面上，裙边20的轮廓线还可以为弧线、直线与直线的混合线段、直线与弧线的组合线段或其它不规则线段。如图8所示，在经过裙边20的中轴线的截面上，裙边20的轮廓线为弧形；或者，如图9所示，在经过裙边20的中轴线的截面上，裙边20的轮廓线为直线与直线的混合线段。
如图10所示，第二径向支撑结构21包括至少一圈波形环状物210，每一圈波形环状物210为闭合的环状结构，其包括多个近端顶点211、多个远端顶点212、以及连接相邻的近端顶点211与远端顶点212的支撑体213，近端顶点211与远端顶点213分别对应为波形的波峰或波谷。本实施例中，第二径向支撑结构21包括一圈波形环状物210，该波形环状物210的多个近端顶点211位于垂直于裙边20的中轴线的同一平面内，多个远端顶点212也位于垂直于裙边20的中轴线的同一平面内。可以理解的是，在其它实施例中，第二径向支撑结构21还可以包括多圈波形环状物210，多圈波形环状物210沿裙边20的轴向依次排布，优选为平行间隔排布，或者多圈波形环状物210连接成网状结构。
第二径向支撑结构21可以分布在裙边20的局部，即沿裙边20的中轴线方向，第二径向支撑结构21两端的最大长度小于裙边20的长度。第二径向支撑结构21也可以分布在整个裙边20上，即沿裙边20的中轴线方向，第二径向支撑结构21两端的最大长度等于裙边20的长度。本实施例中，第二径向支撑结构21分布在整个裙边20上，且第二径向支撑结构21的靠近自由端端20b的一端与裙边20的自由端20b齐平，第二径向支撑结构21的靠近固定端20a的一端与裙边20的固定端10a齐平。
进一步的，第二径向支撑结构21的靠近固定端20a的一端与管体10的第一径向支撑结构11可转动的连接。由于覆膜的力学性能较差，若裙边20与管 体10仅靠覆膜连接，裙边10在翻边时容易被拉变形或拉断，将第二径向支撑结构21连接至第一径向支撑结构11，可以增加裙边20与管体10之间的连接强度，避免裙边10在翻边时被拉变形或拉断，同时也有利于裙边的翻转。可以理解的是，本发明并不限定第二径向支撑结构21与第一径向支撑结构11之间转动连接的具体方式。如图11所示，第二径向支撑结构21的至少一个波峰(或波谷)与第一径向支撑结构11的至少一个波谷或(波峰)相互勾绕。或者，如图12所示，第二径向支撑结构21的至少一个波峰(或波谷)与第一径向支撑结构11的至少一个波谷或(波峰)通过连接环30连接，该连接环30可以由柔性线缠绕而成，或者为由生物相容的材料制成的金属环，如镍钛、不锈钢等材料。本实施例中，第二径向支撑结构21靠近固定端20a的一侧的全部波峰(或波谷)均与第一径向支撑结构11连接。可以理解的是，在其它实施例中，可以使第二径向支撑结构21靠近固定端20a的一侧的部分波峰(或波谷)与第一径向支撑结构11连接。
结合图10和图13所示，波形环状物210大致为锥台结构，波形环状物210的靠近固定端20a的一侧的波形夹角a1大于波形环状物210的远离固定端20a的一侧的波形夹角a2，即近端顶点211对应的波形夹角a1大于远端顶点212对应的波形夹角a2。所说的波形夹角指的是连接在同一近端顶点102或远端顶点103两侧的支撑体104间的夹角。
可以理解的是，波形环状物210的波形夹角越大，挤压该波形环状物210所需的径向力也越大，并且波形环状物210在挤压过程中容易发生塑性变形或断裂，而若波形夹角太小，不利于加工。一并参见图14，当沿径向压缩裙边20的固定端20a时，波形环状物210的多个近端顶点211朝向裙边20的中轴线的一侧汇聚，波形环状物210的远端顶点212对应的波形夹角a2逐渐减小，并趋向于0°。为了方便沿径向压缩裙边20的固定端20a，波形环状物210的远端顶点212对应的波形夹角a2为10°～30°。
还可以理解的是，若波形环状物210的丝径太小，则会影响第二径向支撑结构21的径向支撑力，但是波形环状物210的丝径越大，挤压该波形环状物210所需的径向力也越大，并且波形环状物210在挤压过程中容易发生塑性变 形或断裂。故波形环状物210的丝径在0.05mm～0.15mm范围内，优选为0.07mm～0.13mm。
如图15～16所示，本发明较佳实施例之二提供一种管腔支架，其与实施例之一的不同之处在于第二径向支撑结构21的结构不同。
如图16所示，第二径向支撑结构21包括波形环状物210，该波形环状物210与第一径向支撑结构11转动连接。具体的，波形环状物210为闭合的环状结构，其包括至少一个第一近端顶点211a、多个第二近端顶点211b、多个远端顶点212，以及连接相邻的第一近端顶点211a与远端顶点212或相邻的第二近端顶点211b与远端顶点212的支撑体213。第一近端顶点211a与第二近端顶点211b对应为波形的波峰，远端顶点212对应为波形的波谷。
其中，第一近端顶点211a延伸至裙边20的固定端10a，与第一径向支撑结构11可转动的连接。在多个远端顶点212中任选一个基准远端顶点，沿裙边20的中轴线方向，第一近端顶点211a与该基准远端顶点之间的距离大于第二近端顶点211b与该基准远端顶点之间的距离，连接在第一近端顶点211a两侧的支撑体104间的夹角小于连接在第二近端顶点211b两侧的支撑体104间的夹角。
可以理解的是，在波形环状物210的波高一定的情况下，波形夹角越大，该波形环状物210的径向支撑力越大，但是若波形夹角过大，则不利于裝鞘。同样，在波形环状物210的波形夹角一定的情况下，波高越小，该波形环状物210对应的径向支撑力越大，但是波高太小，则无法维持裙边20的圆度，妨碍裙边20的封堵效果。故本发明通过设置多个波高相对较小，波形夹角相对较大的第二近端顶点211b，可以增加裙边20的径向支撑力，同时使第一近端顶点211a与第一径向支撑结构11连接，可以增加裙边10与管体20的连接强度。优选的，第一近端顶点211a与基准远端顶点之间的距离与第二近端顶点211b与该基准远端顶点之间的距离的比值为0.3～0.8，第二近端顶点211b两侧的支撑体213间的夹角为30°～150°。
本实施例中，波形环状物210的多个远端顶点212位于垂直于裙边20的中轴线的同一平面内，且与裙边20的自由端20b齐平，第一近端顶点211a延 伸至裙边20的固定端10a，与第一径向支撑结构11可转动的连接。
可以理解的是，本发明并不限定第一近端顶点211a的具体数量，第一近端顶端211a可以包括一个或多个，当第一近端顶点211a包括多个时，多个第一近端顶点211a沿裙边21的周向均匀分布。优选的，第一近端顶点211a的数量小于或等于第二近端顶点211b的数量，以增加裙边20的径向支撑力。
还可以理解的是，在其它实施例中，第二径向支撑结构21还可以进一步包括其它波形环状物结构、螺旋缠绕结构或者网状结构。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (13)

  1. 一种管腔支架，包括管体和套设于所述管体外的裙边，所述裙边的一端为固定端，所述固定端与所述管体的外表面密封连接，所述裙边的另一端为自由端，其特征在于，在经过所述管体中轴线的截面上，位于所述管体的中轴线同侧的所述固定端与所述自由端之间的距离与所述管体中轴线两侧的自由端沿所述裙边的径向方向的垂直距离的比值小于1/2。
  2. 根据权利要求1所述的管腔支架，其特征在于，沿所述裙边的径向方向，所述管体中轴线两侧的所述自由端的垂直距离与所述管体中轴线两侧的所述固定端的垂直距离的比值大于或等于3/2。
  3. 根据权利要求1所述的管腔支架，其特征在于，位于所述管体中轴线同侧的所述自由端与所述固定端的连线与所述管体的中轴线的夹角不小于30°。
  4. 根据权利要求1所述的管腔支架，其特征在于，所述管体包括第一径向支撑结构，所述裙边包括第二径向支撑结构，所述第二径向支撑结构与所述第一径向支撑结构转动连接。
  5. 根据权利要求4所述的管腔支架，其特征在于，所述第二径向支撑结构包括至少一圈波形环状物，所述波形环状物包括多个近端顶点、多个远端顶点，以及连接相邻的所述近端顶点与所述远端顶点的支撑体，所述波形环状物在至少一个所述近端顶点的位置处与所述第一径向支撑结构转动连接。
  6. 根据权利要求5所述的管腔支架，其特征在于，连接在所述近端顶点两侧的所述支撑体之间的夹角大于连接在所述远端顶点两侧的所述支撑体之间的夹角。
  7. 根据权利要求5所述的管腔支架，其特征在于，多个所述近端顶点包括至少一个第一近端顶点以及多个第二近端顶点，所述波形环状物在所述第一近端顶点的位置处与所述第一径向支撑结构转动连接。
  8. 根据权利要求7所述的管腔支架，其特征在于，所述第一近端顶点与所述远端顶点之间的距离大于所述第二近端顶点与该远端顶点之间的距离。
  9. 根据权利要求7所述的管腔支架，其特征在于，连接在所述第一近端 顶点两侧的所述支撑体之间的夹角小于连接在所述第二近端顶点两侧的所述支撑体之间的夹角。
  10. 根据权利要求5所述的管腔支架，其特征在于，所述远端顶点位于垂直与所述裙边的中轴线的同一平面内。
  11. 根据权利要求5所述的管腔支架，其特征在于，连接在所述远端顶点两侧的所述支撑体之间的夹角为10°～30°。
  12. 根据权利要求5所述的管腔支架，其特征在于，所述波形环状物的丝径为0.05mm～0.15mm。
  13. 根据权利要求4所述的管腔支架，其特征在于，所述第二径向支撑结构与所述第一径向支撑结构相互勾绕或通过连接环连接。
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