WO2023104001A1 - 覆膜支架 - Google Patents

覆膜支架 Download PDF

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Publication number
WO2023104001A1
WO2023104001A1 PCT/CN2022/136747 CN2022136747W WO2023104001A1 WO 2023104001 A1 WO2023104001 A1 WO 2023104001A1 CN 2022136747 W CN2022136747 W CN 2022136747W WO 2023104001 A1 WO2023104001 A1 WO 2023104001A1
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WO
WIPO (PCT)
Prior art keywords
stent
proximal
main body
segment
graft
Prior art date
Application number
PCT/CN2022/136747
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English (en)
French (fr)
Inventor
朱清
朱永锋
徐健伟
奚利峰
王哲恺
刘金宏
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Publication of WO2023104001A1 publication Critical patent/WO2023104001A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the invention belongs to the technical field of medical devices, in particular to a covered stent.
  • vascular interventional therapy improves the survival probability for patients with vascular diseases who cannot tolerate surgery.
  • vascular interventional therapy improves the survival probability for patients with vascular diseases who cannot tolerate surgery.
  • abdominal aorta the distal end of the abdominal aorta bifurcates into two iliac arteries.
  • the object of the present invention is to provide a stent-graft that can improve the flexibility of the stent-graft with branches, and can also reduce the size of the stent-graft for crimping, while The risk of endoleak and long-term displacement is reduced.
  • the present invention provides a stent graft, comprising a stent body and a film, the film is arranged on the surface of the stent body, and the stent body includes a main body stent part and a branch stent part, two branch bracket parts and one main body bracket part are fixedly connected with the covering film and form a Y-shaped structure, and the bracket body includes several annular bracket segments arranged at intervals in the axial direction;
  • the main body bracket part includes a proximal sealing area, a main body area and a transition area arranged in sequence from the proximal end to the distal end; the main body area has the same outer diameter; the outer diameter of the transition area is from the proximal end to the distal end decreasing in turn; the outer diameter of the proximal end of the transition zone is the same as the outer diameter of the main body zone;
  • the stent segment includes a proximal sealing stent segment, a transitional stent segment, a main body stent segment, and a branch stent segment;
  • the proximal sealing area includes the proximal sealing stent segment, and the transition area includes the transition a stent segment, the body region comprising the body stent segment;
  • the maximum length of the probe of the proximal seal stent segment is less than the length of the probe of the main body stent segment.
  • the stent-graft further includes reinforcing ribs fixedly connected to the stent-graft, and the reinforcing ribs are arranged along the axial extension of the main body stent;
  • the proximal end of the reinforcing rib is disposed on the main body region, the distal end of the reinforcing rib is disposed on the proximal end of the transition region, and the reinforcing rib can limit the axial retraction of the main body support portion .
  • the length of the reinforcing rib is 1% to 80% of the axial length of the main body region.
  • the distal end of the reinforcing rib is disposed on the crest of the first transition stent segment at the proximal end of the transition zone, and/or, the proximal end of the reinforcing rib is disposed on the main body region proximal to the first of the body stent segments.
  • the proximal sealing area includes at least one variable height proximal sealing stent segment and at least one equal height proximal sealing stent segment;
  • the at least one variable-height proximal sealing support segment and the at least one equal-height proximal sealing support segment are arranged at intervals in the axial direction of the main body support part, and are aligned in the circumferential direction of the main body support part;
  • the at least one elevated proximal seal stent segment is disposed at a proximal-most end of the proximal seal area
  • At least one high trough is arranged between any two adjacent low troughs in the at least one heightened proximal sealing stent segment.
  • the main body stent part also includes a bare section, the bare section includes an annular stent section, the distal end of the bare section is fixedly connected to the membrane, and the proximal end of the bare section extends axially upwards.
  • the bare section is configured to adhere to the vessel wall for anchoring after expansion, and the bare section is provided with a post-release structure for cooperating with the transporter to achieve post-release of the stent-graft.
  • a groove structure is arranged on the bare segment, and a developing component is arranged in the groove structure.
  • the groove structure includes a first groove structure and a second groove structure, the length of the first groove structure is greater than the length of the second groove structure, and the first groove structure and The second groove structure is arranged on a different pole of the bare section, and the lower edge of the first groove structure is flush with the lower edge of the second groove structure, so that the developing member The lower edge coincides with the proximal edge of the membrane.
  • the length of the first groove structure is 1.5 to 3 times the length of the second groove structure.
  • the proximal sealing area includes a variable-height proximal sealing bracket segment and at least one equal-height proximal sealing bracket segment, and the one variable-height proximal sealing bracket segment and the most proximal equal-height proximal
  • the sealing support segments are arranged overlappingly in the axial direction of the main body support part, and are arranged staggered in the circumferential direction of the main body support part;
  • the at least one elevated proximal seal stent segment is disposed at a proximal-most end of the proximal seal area
  • At least one high peak is arranged between any two adjacent short peaks in the at least one heightened proximal sealing stent segment.
  • the proximal end of the high crest of the most proximal variable-height proximal sealing stent segment axially protrudes from the membrane to form a protruding segment, and the protruding segment is configured to adhere to the vessel wall after expansion.
  • a post-release structure is provided on the protruding section for cooperating with the conveyor to realize post-release of the stent-graft.
  • the length of the protruding section is 1.5mm-5.0mm.
  • the cross-sectional shape of the main body area is circular
  • the cross-sectional shape of the proximal end of the transition area is circular
  • the cross-sectional shape of the distal end of the transition area is elliptical.
  • the stent-graft further includes a branch binding coil configured to bind each stent segment of the branch stent part on the same side, and each stent segment of the branch stent part on the same side is composed of at least two of the Branch bondage coils for tying.
  • the stent graft has an integrated stent structure, and the two branch stent parts and one main stent part are integrally connected with the stent graft to form the Y-shaped structure.
  • the bifurcation point of the stent-graft is adapted to the bifurcation point of the blood vessel, so that the stent-graft can straddle the bifurcation point of the blood vessel.
  • the length of the branch stent part is 20mm-80mm, and the outer diameter of the branch stent part is small at the proximal end and large at the distal end.
  • the ring-shaped stent-graft is connected by the film to form an integrated Y-shaped stent-graft.
  • This stent-graft greatly reduces the operation cost and reduces the cost of splicing between traditional surgical stents. The risk of endoleak is also reduced, while also reducing the operation time.
  • the distal end of the stent part of the main body "rides" on the bifurcation point of the blood vessel. This fixing method conforms to the natural direction of the blood vessels of the human body, and the bifurcation point of the stent will not be displaced.
  • the ring-shaped stent segment has a smaller crimping size and a smaller introduction path, and the ring-shaped stent segments are flexibly connected by a membrane, which increases the flexibility of the stent compared with the braided structure and can better integrate with the human body. Tortuous vessels are matched.
  • the stent part of the main body also includes a transition zone, the outer diameter of the transition zone gradually decreases from the proximal end to the distal end, so that it can fit better with the membrane, and is more in line with the natural variation of human blood vessel diameter. trend, further reducing the risk of internal leakage.
  • the main body stent portion also includes a proximal sealing area
  • the proximal sealing area includes at least one elevated proximal sealing stent segment
  • the at least one elevated proximal sealing stent segment can enable the stent to have a better proximal
  • the end roundness and greater radial support force can effectively prevent type I endoleak caused by the lax fit of the proximal end of the stent and the blood vessel.
  • the structural design of the first segment of the proximal end can also be released after matching. The stent is released accurately, and the release accuracy is further improved.
  • the axial retraction of the stent portion of the main body is limited by the ribs, which effectively reduces the risk of proximal displacement of the stent without affecting the flexibility of the stent, and makes the release position more accurate.
  • the main body stent part further includes a bare segment or an extended segment, and a post-release structure is preferably provided on the bare segment or the extended segment, which can be matched with the conveyor to realize the post-release function.
  • the back release can effectively reduce the forward and backward jumps during the release process of the bracket, making the release position more accurate.
  • the positioning effect is better, and the barb is not required for the bare section or the extended section, and the stent can be anchored at the proximal end without damaging the blood vessel.
  • the branch binding coil such as a butterfly coil can be used to bind the branch stent on the same side, which can effectively avoid the problem that the stent cannot be bounced off caused by the thread node being stuck by the main body during release, and reduces the operation time. Difficulty, further shortening the operation time.
  • Fig. 1 is a schematic structural view of a stent graft according to a preferred embodiment 1 of the present invention.
  • Fig. 2 is a schematic diagram of a partial structure of a bare section in a preferred embodiment 1 of the present invention.
  • Fig. 3 is a schematic structural view of a reinforcing rib in a preferred embodiment 1 of the present invention.
  • Fig. 4 is a schematic structural view of the bracket part of the dental floss binding body according to the preferred embodiment 1 of the present invention.
  • Fig. 5 is a schematic structural view of the branch support part on the same side as the branch binding coil in the preferred embodiment 1 of the present invention.
  • Fig. 6 is a schematic structural view of the stent graft in the second preferred embodiment of the present invention.
  • Fig. 7a is a schematic structural view of the variable-height proximal sealing stent section according to the second preferred embodiment of the present invention.
  • Fig. 7b is a schematic structural view of the equal-height proximal sealing stent segment in the second preferred embodiment of the present invention.
  • Fig. 7c is a schematic diagram of the axially overlapping and circumferentially staggered arrangements of equal-height proximal sealing support segments and variable-height proximal sealing support segments in the preferred embodiment 2 of the present invention.
  • proximal refers to the end close to the heart
  • distal refers to the end close to the operator, that is, the end away from the heart
  • axial refers to the direction parallel to the axis
  • radial refers to the direction perpendicular to the axis
  • circumferential refers to the direction around the axis.
  • wave bar refers to the stent rib
  • the length of the wave bar refers to the dimension of the stent rib in its extending direction.
  • this embodiment provides a stent graft 100, which is an integrated stent structure, that is, the stent graft 100 is not spliced by a plurality of independent stents in vivo, but is fabricated in vitro. Form a scaffold structure with branches.
  • the stent graft 100 is suitable for the situation where the lesion area of the aneurysm or dissection involves the bifurcation point of the blood vessel and its branches, including but not limited to the abdominal aorta. In the following description, the lesion area involves the abdominal aorta and its branches as a schematic illustration, but this does not constitute a limitation of the present invention.
  • the stent graft 100 includes a stent body, the stent body includes a main body stent portion 110 and two branch stent portions 120 , and the stent graft 100 further includes a membrane 130 . Both the two branch stent parts 120 and one main body stent part 110 are fixedly connected with the membrane 130 , so as to be integrally connected to form a Y-shaped membrane stent 100 . It needs to be understood that the stent body and the membrane can be of an integrated structure or a split structure, and whether it is split or integrated, the fixed connection between the stent body and the membrane can be realized.
  • the two branch bracket parts 120 constitute the branch bracket on the same side and the branch bracket on the opposite side respectively, and for the convenience of explanation, the two branch bracket parts 120 are defined as the first branch bracket part 121 and the second branch bracket part 122 , the first branch bracket part 121 constitutes the branch bracket on the same side, and the second branch bracket part 122 constitutes the branch bracket on the opposite side.
  • the outer diameter of the branch stent part 120 can be smaller at the proximal end and larger at the distal end, or the outer diameter of the branch stent part 120 is constant.
  • Both the main frame part 110 and the branch frame parts 120 are hollow tubular structures, and the lumen of the main frame part 110 communicates with the lumens of the two branch frame parts 120 .
  • Both the main body stent part 110 and the branch stent part 120 include a number of annular stent segments (referred to as stent segments) arranged at intervals in the axial direction. Except for the ribs 105, the stent segments are flexibly connected only by the membrane 130.
  • “flexible connection” can be understood as that the ring-shaped stent segments are only fixedly connected to the membrane 130 , and there is no rigid connection between any two adjacent ring-shaped stent segments in the axial direction.
  • the present application does not limit the waveform shape of the annular stent segment, which may be zigzag or arc or other suitable shapes.
  • the present application does not impose special restrictions on the metal material used to make the stent body, as long as it is a medical metal material with good biocompatibility, such as 316 stainless steel, cobalt-chromium alloy or nickel-titanium alloy and other medical metal materials.
  • the coating 130 is a soft polymer material with good biocompatibility, which can make the stent body form a closed inner cavity in the axial direction, and the coating 130 can be arranged on the inner surface or the outer surface of the stent body.
  • the stent graft 100 of the present invention not only avoids the risk of endoleak caused by the splicing of multiple independent stents in the body, but also shortens the operation time and greatly reduces the operation cost.
  • the distal end of the main body stent part 110 is positioned on the bifurcation point of the abdominal aorta in a "straddling" manner. This fixing method conforms to the natural direction of human blood vessels, and the bifurcation point of the stent graft 100 will not shift , which can effectively reduce the risk of stent graft displacement.
  • the covered stent 100 is different from the overall braided stent structure, the wave-shaped annular stent segment has a smaller crimping size, which means a smaller introduction path and less damage to the patient. Moreover, there is no rigid connection between the wave-shaped ring-shaped stent segments or no rigid connection except for the reinforcing ribs. Compared with the overall braided structure, the flexibility of the stent is increased, and it can better match the tortuous blood vessels of the human body, and the treatment effect is better. good.
  • the main body stent part 110 preferably includes a bare section 101, a proximal sealing area 102 and a main body area 103 arranged in sequence from the proximal end to the distal end, all of which are fixedly connected with the covering film 130, such as being sutured with the covering film 130 and / hot melt fixed connection.
  • the annular stent section includes a bare section 101, a proximal sealing stent section a2 and a main body stent section a3; the bare section 101 can also be understood as comprising an annular stent section; the proximal sealing area 102 includes several proximal The specific number of the end seal bracket sections a2 is not limited; the main body area 103 includes several main body bracket sections a3, the specific number is also not limited. It should be understood that the bare section 101 is not covered with the coating film 130 , and the coating film 130 is provided on both the proximal sealing area 102 and the main body area 103 . It should also be understood that the annular stent segment also includes a branch stent segment, and each of the branch stent portions includes a branch stent segment.
  • the bare section 101 can be made by a cutting process, and the bare section 101 is a wave-shaped annular stent section.
  • the covering film 130 protrudes upward.
  • the bare section 101 is configured to adhere to the vessel wall for anchoring after expansion, so that the anchoring area at the proximal end of the main body stent part 110 can be extended, and the bare section 101 has no barbs, so that the stent can be anchored at the proximal end without damage blood vessels.
  • the bare segment 101 is provided with a post-release structure for cooperating with the conveyor to realize post-release of the stent graft.
  • the post-release structure includes a hole structure 1011, and the hole structure 1011 is set on at least part of the wave peak of the bare section 101, and the hole structure 1011 is used to match with the conveyor to realize film coating. Post-release of the bracket.
  • a developing component (not shown) is provided on the bare segment 101, and the developing component is made of metal developing material, so as to distinguish the position and shape of the stent graft 100 according to the developing property of the developing component under X-ray.
  • the rod 1012 of the bare section 101 is provided with a groove structure, and the groove structure is used for fixing the developing component.
  • the groove structure may include several first groove structures 1013 and several second groove structures 1014, the first groove structures 1013 may fix the first developing component, and the second groove structures 1014 may fix the second developing component.
  • the first groove structure 1013 and the second groove structure 1014 are arranged on the surface of the probe 1012 of the bare section 101, and the first groove structure 1013 and the second groove structure 1014 are arranged on different probes of the bare section 101 1012 on.
  • the surface of the rod 1012 of the bare section 101 is raised, so that a groove structure is formed between the protrusions, so as to ensure the strength of the bare section 101 .
  • the length of the first groove structure 1013 is greater than the length of the second groove structure 1014, therefore, the length of the first developing component is greater than the length of the second developing component. It should be understood that the length of the groove structure is the dimension along the extending direction of the probe 1012 .
  • the lower edge of the first groove structure 1013 is flush with the lower edge of the second groove structure 1014 to ensure that the lower edge of the developing component coincides with the edge of the film 130, making it easier to identify the position of the proximal end of the stent graft and form.
  • the lower edge of the groove structure refers to the distal edge of the groove structure.
  • the length of the second groove structure 1014 may be 1 mm to 3 mm, and the length of the first groove structure 1013 may be 2 mm to 6 mm. Further, the length of the first groove structure 1013 is 1.5 times to 3 times the length of the second groove structure 1014 to ensure that the position and shape of the proximal end of the stent graft can be identified under X-rays.
  • a first groove structure 1013 is set on the opposite side of the bracket to fix the first developing component
  • a second groove structure 1014 is set to fix the second developing component in other positions according to the requirement, for X-ray Next, identify the direction and shape of the stent.
  • the proximal sealing area 102 includes at least one variable-height proximal sealing support segment 1021 and at least one equal-height proximal sealing support segment 1022 .
  • the troughs in the heightened proximal sealing bracket section 1021 have different depths, and at least one high trough is arranged between any two adjacent short troughs in the at least one elevated proximal sealing bracket section 1021 .
  • the troughs in the equal height proximal seal stent segments 1022 are all the same depth. "Depth of a trough” refers to the vertical distance between adjacent peaks to troughs.
  • At least one elevated proximal seal support segment 1021 is disposed at the proximalmost end of the proximal seal area 102 .
  • the number of equal-height sealing support segments 1022 in the proximal sealing area 102 is not limited, and may be one or more.
  • the number of the variable-height proximal sealing bracket segment 1021 may be one or more.
  • At least one variable-height proximal sealing support segment 1021 and at least one equal-height proximal sealing support segment 1022 are arranged at intervals in the axial direction of the main body support part 110 and aligned in the circumferential direction of the main body support part 110 .
  • the quantity of variable height proximal end sealing support section 1021 is 1
  • the quantity of equal height proximal sealing support section 1022 is 3
  • the equal-height seal bracket sections 1022 are arranged at intervals along the axial direction of the main body bracket part 110 from the proximal end to the distal end in sequence, and the variable-height proximal seal bracket section 1021 and the equal-height seal bracket section 1022 are aligned in the circumferential direction of the main body bracket part 110 layout.
  • "alignment" means, as shown in FIG.
  • the projection of the wave crests of the variable-height proximal sealing stent segment 1021 is aligned with the wave crest of the equal-height sealing stent segment 1022.
  • the line of projection is parallel to the axis of the main body bracket part.
  • the line connecting the projection of the trough of the variable height proximal sealing bracket section 1021 and the projection of the trough of the equal height sealing bracket section 1022 is parallel to the axis of the main body bracket part.
  • the combined configuration of the stent segments with variable height and equal height can make the proximal end of the stent-graft 100 more closely adhere to the blood vessel, thereby effectively preventing the proximal end of the stent-graft 100 from adhering to the blood vessel.
  • the resulting type Ia endoleak is not tight.
  • the maximum length of the probe of the proximal sealing bracket section a2 is smaller than the length of the probe in the main bracket section a3, for example, the probe length of the proximal sealing bracket section a2 is 4 mm to 14 mm, and the probe length of the main bracket section a3 16mm to 24mm. Therefore, the waveform of the proximal sealing area 102 is denser than that of the main body area 103 , and has a better bonding effect with blood vessels.
  • the main body area 103 includes several main body stent segments a3 arranged in sequence in the axial direction, and the number of main body stent segments a3 is set according to the length of the lesion area.
  • the heights of the peaks of the body bracket segments a3 constituting the body region 103 are the same.
  • the function of the main body area 103 is to support the blood flow channel and make the stent graft 100 adhere to the wall.
  • Both the proximal sealing area 102 and the main body area 103 are generally cylindrical in shape with the same outer diameter.
  • the main body stent portion 110 preferably further includes a transition region 104, the bare section 101, the proximal sealing region 102, the main body region 103 and the transition region 104 are arranged sequentially from the proximal end to the distal end, so that the main body region 103 and the branch stent portion 120 A transition zone 104 is provided in between.
  • the outer diameter of the transition zone 104 decreases sequentially from the proximal end to the distal end, and the outer diameter of the proximal end of the transition zone 104 is the same as that of the main body zone 103, and the main body zone 103 has the same outer diameter.
  • the annular bracket segment also includes a transition bracket segment a4, and the transition zone 104 includes several transition bracket segments a4.
  • the cross-sectional shape of the main body region 103 is circular; preferably, the cross-sectional shape of the proximal end of the transition region 104 is circular, the cross-sectional shape of the distal end of the transition region 104 is elliptical, and the major axis of the ellipse and the minor axis decrease sequentially.
  • the number of transition bracket sections a4 forming the transition zone 104 is not limited, including but not limited to one transition bracket section a4 , usually only one transition bracket section a4 is sufficient. Therefore, in a preferred situation, the proximal cross-section of the main body support portion 110 is circular, and the distal cross-section is elliptical.
  • the function of the transition area 104 is to make the transition between the main body bracket part 110 and the two branch bracket parts 120 smooth, so as to conform to the anatomical structure of human blood vessels, and the bonding effect is good.
  • the transition zone 104 adopts a variable-diameter structure, which can fit better with the variable-diameter section of the coating 130 and is more in line with the natural variation trend of human blood vessel diameter. Therefore, compared with the traditional equal-diameter structure, the setting of the transition zone 104 can make the stent-graft have better lumen retention, and effectively avoid the problem of occlusion of the branches of the stent due to tortuous blood vessels.
  • the stent-graft 100 preferably further includes a reinforcing rib 105 fixedly connected to the stent-graft 130 , and the reinforcing rib 105 is configured to limit retraction of the main body stent part 110 in the axial direction.
  • the rib 105 on the basis of retaining the flexibility of the stent graft 100 as much as possible, the axial shortening of the stent graft 100 can be effectively prevented, and the risk of proximal displacement of the stent graft 100 can be effectively reduced.
  • the material of the reinforcing rib 105 is a metal material with good biodegradability, including but not limited to nickel-titanium, cobalt-chromium alloy or 316 stainless steel.
  • the reinforcing rib 105 is a slender rod-shaped structure extending along the axial direction of the main frame part 110, and the proximal end and the distal end of the reinforcing rib 105 are fixedly connected to the coating 130, Such as sutures and/or hot melt joints.
  • the proximal end of the reinforcing rib 105 is disposed on the main body area 103 , and the distal end is disposed on the proximal end of the transition area 104 to limit the axial shortening of the main body area 103 .
  • the reinforcing rib 105 is actually fixedly connected to the covering film 130, but the fixed position of the reinforcing rib 105 and the covering film 130 needs to ensure that the distal end of the reinforcing rib 105 is at the proximal end of the transition zone 104, and the proximal end of the reinforcing rib 105 on the main body area 103 .
  • the proximal end of the reinforcing rib 105 is disposed on the first main body bracket segment a3 at the proximal end of the main body area 103, such as the crest, trough or peak fixed on the first main body bracket segment a3 at the proximal end of the main body area 103 and the position between the trough.
  • the number of reinforcing ribs 105 is preferably one to ensure the flexibility of the stent graft.
  • the distal end of the reinforcing rib 105 is arranged on the first transition bracket section a4 at the proximal end of the transition zone 104, more preferably, the distal end of the reinforcing rib 105 is arranged on the first transition bracket at the proximal end of the transition zone 104 On the crest of segment a4.
  • the present application does not specifically limit the length of the reinforcing rib 105 , and the length of the reinforcing rib 105 is specifically determined according to the specifications of the main frame part 110 .
  • the length of the reinforcing rib 105 is 1%-80% of the axial length of the main body region 103 .
  • fixing holes 1051 may be provided at both ends of the reinforcing rib 105 , and the reinforcing rib 105 is connected to the covering film 130 by sewing and/or heat-melting through the fixing holes 1051 at both ends.
  • the setting of the fixing hole 1051 can ensure that both ends of the reinforcing rib 105 and the film 130 are firmly fixed and not easy to slip off.
  • the positioning method of the stent graft 100 is that the bifurcation point of the stent "rides over" the bifurcation point of the abdominal aorta, and the reinforcing rib 105 can effectively prevent the stent graft from shortening in the tortuous abdominal aorta and ensure accurate positioning sex.
  • the protruding portion of the annular stent segment toward the proximal end is referred to as a “peak”, and vice versa is referred to as a “trough”.
  • the stent graft 100 preferably further includes a dental floss 140 made of soft polymer materials with good biocompatibility such as PTFE, PET or ultra-high molecular weight polyethylene.
  • the proximal end of the dental floss 140 is fixedly connected with the membrane 130, and is used to bind each annular bracket segment of the main body bracket part 110, so as to reduce the size of the bracket and facilitate the position adjustment of the bracket in the body.
  • the floss 140 is knotted, and a plurality of body binding coils 141 are formed at the knotted places.
  • the quantity and position of the body-binding coils 141 correspond one-to-one to the quantity and position of the ring-shaped stent segments on the body stent part 110 to be bound.
  • the main body binding coil 141 passes through the binding coil 106 at the corresponding position on the stent segment to minimize the diameter of the main body stent part 110 , which is about 10% to 20% of the nominal diameter of the stent.
  • the binding coil 106 plays the role of limiting the position of the binding coil 141 of the main body, and the binding is more reliable and firm.
  • the number and position of the restraint coils 106 can be set according to requirements. This binding structure is reliable and strong.
  • the structure of the binding coil 106 is not limited, and the binding coil 106 may be formed by additional suturing on the stent.
  • the stent graft 100 may further include a branched tethering coil 150 made of a soft polymer material with good biocompatibility, such as PTFE, PET or ultrahigh molecular weight polyethylene.
  • the branch bondage coil 150 is a butterfly-shaped coil, that is, an "8"-shaped coil.
  • each annular stent segment of the first branch stent part 121 is provided with at least 2 branch restraint coils 150, and at least 2 branch restraint coils 150 of each annular stent segment are preferably fixed in the same circumferential direction of the stent segment, At least two branched tethering coils 150 respectively surround the stent segment from both sides.
  • the second branch stent part 122 on the opposite side does not need to bind the branch binding coil 150 .
  • the "mountain turning" operation method here is a well-known technique in the art, that is, it can be understood that the abdominal aorta and bilateral iliac arteries have an inverted Y-shaped structure, and turning the mountain means using a guide wire catheter from one side of the iliac artery. and other consumables to establish access to the bilateral iliac arteries, which looks like climbing a mountain.
  • the branch binding coil 150 adopts the method of binding the first branch support part 121 around both sides, that is, the two branch binding coils 150 starting from the same point embrace the first branch support part 121" from both sides. ", in order to achieve the effect of tying and restraining.
  • the structure is simple, easy to operate, and the binding effect is firm.
  • the branch binding coil 150 can be used in conjunction with the binding coil 106 (not shown in FIG. 5 ) on the stent section of the first branch stent part 121.
  • the binding coil 106 plays a role in limiting the branch binding coil 150, and the binding is more reliable. .
  • the size of the stent graft 100 can be selected according to the blood vessel size of the patient.
  • the length L1 of the main body support part 110 is 30 mm to 130 mm
  • the diameter D1 of the main body support part 110 is 16 mm to 34 mm
  • the length L2 of the first branch support part 121 is 20 mm to 130 mm.
  • the length L3 of the second branch bracket part 122 is 20mm-80mm
  • the diameter D2 of the first branch bracket part 121 is 8mm-24mm
  • the diameter D3 of the second branch bracket part 122 is 8mm-24mm.
  • the size of the branch stent part 120 can still be adjusted according to the special situation of the patient, and finally an integrated stent-graft 100 is made. That is, the sum of the diameters of the two branch bracket parts 120 may be larger than the diameter of the main bracket part 110 , and of course may be smaller than or equal to the diameter of the main bracket part 110 .
  • a stent-graft 100' is also provided.
  • the stent-graft 100' cancels the bare section, and the The proximal part 110 is directly configured with a proximal sealing area 102', that is, the main body stent part 110 of the stent graft 100' of this embodiment includes a proximal sealing area 102', a main body zone 103 and transition zone 104.
  • Another difference is that the relative positions of the variable-height proximal sealing bracket section 1021 and the equal-height proximal sealing bracket section 122 in the proximal sealing area 102' are adjusted.
  • the proximal sealing area 102' includes a variable-height proximal sealing support segment 1021 and at least one equal-height proximal sealing support segment 1022.
  • a variable-height proximal sealing bracket section 1021 and a near-end equal-height sealing bracket section 1022 are arranged overlappingly in the axial direction of the main body bracket part 110, and are arranged staggered in the circumferential direction of the main body bracket part 110, so that at the proximal end
  • the proximal end of the sealing area 102 forms a stent segment that becomes taller and overlaps at the same height. At least one high peak is arranged between any two adjacent short peaks in the annular stent segment formed after overlapping.
  • the lower apex of the high crest is aligned with the lower apex of the short crest and is on the same circumference. Therefore, the lower vertices of the ring-shaped stent segments formed after overlapping are aligned, and the upper vertices show a change in height.
  • the "overlapping in the axial direction” means that a variable-height proximal sealing support segment 1021 and at least one equal-height proximal sealing support segment 1022 are in the same circumferential direction; "circumferentially staggered” means Yes, one variable-height proximal sealing support segment 1021 and at least one equal-height proximal sealing support segment 1022 are staggered and not overlapped between peaks in the same circumferential direction, see FIG. 7c for details.
  • at least one heightened proximal sealing bracket section 1021 is arranged at the proximal end of the proximal sealing area 102', and at least one high crest.
  • the staggered structure design of the heightened and equal height of the main body stent part 110 at the most proximal end can make the proximal end of the stent closely fit the blood vessel, which can effectively prevent the type Ia caused by the loose fit between the proximal end of the stent and the blood vessel. endoleak, and also enables the stent to have better proximal roundness and greater radial support, thereby effectively preventing Type I endoleaks caused by lax fit between the proximal end of the stent and the blood vessel.
  • the structural design of the heightened end section can also be combined with the rear release to make the stent release accurate.
  • the proximal end of the high crest of a variable-height proximal sealing stent segment 1021 extends axially from the part of the film 130 to form an extended section.
  • the length of the extended section is preferably 1.5 mm. ⁇ 5mm
  • the number of high crests in the variable-height proximal sealing stent section 1021 is about 3-6, and a hole structure can be set on the high crests to cooperate with the conveyor to realize the post-release function, which can effectively reduce the stent release process.
  • the forward jump and backward jump make the release position more accurate.
  • this structure is convenient to be used in conjunction with a cylindrical support (CUFF).
  • perforated CUFFs can recreate blood flow channels in branch vessels in the proximal visceral region. The usage and size are very flexible.
  • the rest of the structure of the stent-graft 100' shown in this embodiment is basically the same as that of the stent-graft 100 in the first embodiment, and the same parts will not be described in detail. For details, please refer to the first embodiment above.
  • the bifurcation point of the stent graft coincides with the bifurcation point of the human iliac artery, that is, the distal end of the stent main body straddles the bifurcation point of the iliac artery.
  • This fixing method is in line with the natural direction of human blood vessels, and the bifurcation point of the stent will not be displaced.
  • the distal end of the reinforcing rib is set at the proximal end of the transition zone, which effectively reduces the risk of stent shortening and proximal displacement. .
  • the barb-free design of the bare section or the extended section avoids the damage of the barb to the blood vessel on the one hand, and on the other hand extends the anchoring area of the proximal end of the stent, thereby widening the scope of use of the stent and enabling the proximal end of the stent to Anchors well to blood vessels.
  • the special structural design of the proximal sealing area and the transition area can make the main body stent closely fit the blood vessel, greatly reducing the risk of type Ia endoleak. Since the distal end of the abdominal aorta bifurcates into the bilateral iliac arteries, the stent graft of the present invention is particularly suitable for the abdominal aorta. At the same time, the risk of endoleak and long-term displacement of the present application is low, effectively making up for the current situation. There are disadvantages of stent grafts.

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Abstract

一种覆膜支架(100)，包括支架本体和覆膜(130)，覆膜(130)设置在支架本体的表面，支架本体包括主体支架部(110)和分支支架部(120)，两个分支支架部(120)和一个主体支架部(110)均与覆膜(130)固定连接并形成Y形结构，支架本体包括若干轴向依次间隔排布的环形支架段，主体支架部(110)包括从近端至远端依次排布的近端密封区(102)、主体区(103)和过渡区(104)；过渡区(104)的外径由近端向远端依次减小；主体区(103)具有相同的外径；过渡区(104)的近端的外径与主体区(103)的外径相同；近端密封区(102)包括近端密封支架段(a2)，过渡区(104)包括过渡支架段(a4)，主体区(103)包括主体支架段(a3)；近端密封支架段(a2)的波杆的最大长度小于主体支架段(a3)的波杆的长度；如此配置，改善覆膜支架(100)的柔顺性，并降低内漏和移位的风险。

Description

覆膜支架 技术领域
本发明属于医疗器械技术领域，特别涉及一种覆膜支架。
背景技术
血管介入治疗作为一种微创伤的治疗方式，为不能耐受外科手术的血管疾病患者提升了生存概率。人体血管分叉点众多，一些动脉瘤或夹层的病变区域会累及到血管分叉点及其分支。以腹主动脉为例，腹主动脉远端分叉成为两侧髂动脉。针对腹主动脉动脉瘤或夹层病例，常规的血管介入治疗手术，会在病变区域采用主体支架(置于腹主动脉病变处)和分支支架(置于双侧髂动脉病变处)在体内拼接的方式重建血流通道，尤其是病变累及到髂动脉处时，这种治疗方法更为有效。其中主体支架多数采用倒钩设计，倒钩刺破血管以进行锚定，但是这种治疗方法需要3个独立成型的支架，增加了手术成本，而且支架间的拼接也增加了拼接处内漏的风险，同时也延长了手术时间，对患者不利。目前也有极少量的一体式支架产品，但这些产品整体采用编织结构，压握尺寸大，柔顺性差，而且内漏风险高，也存在着远期移位等缺点。
因此有必要提供一种新型的覆膜支架，以克服现有治疗病变区域累及到血管分叉点及分支的支架所存在的问题。
发明内容
为了解决现有技术中所存在的技术问题，本发明的目的在于提供一种覆膜支架，能够改善带有分支的覆膜支架的柔顺性，还能够减小覆膜支架的压握尺寸，同时降低了内漏以及远期移位的风险。
为实现上述目的及其它相关目的，本发明提供了一种覆膜支架，包括支架本体和覆膜，所述覆膜设置在所述支架本体的表面，所述支架本体包括主体支架部和分支支架部，两个所述分支支架部和一个所述主体支架部均与所述覆膜固定连接并形成Y形结构，所述支架本体包括若干轴向依次间隔排布的环形支架段；
所述主体支架部包括从近端至远端依次排布的近端密封区、主体区和过渡区；所述主体区具有相同的外径；所述过渡区的外径由近端向远端依次减小；所述过渡区的近端的外径与所述主体区的外径相同；
可选的，所述支架段包括近端密封支架段、过渡支架段、主体支架段和分支支架段；所述近端密封区包括所述近端密封支架段，所述过渡区包括所述过渡支架段，所述主体区包括所述主体支架段；
所述近端密封支架段的波杆的最大长度小于所述主体支架段的波杆的长度。
可选的，所述覆膜支架还包括加强筋，与所述覆膜固定连接，所述加强筋沿所述主体支架部的轴向延伸设置；
所述加强筋的近端设置于所述主体区上，所述加强筋的远端设置于所述过渡区的近端，所述加强筋能够限制所述主体支架部在轴向上的回缩。
可选的，所述加强筋的长度为所述主体区的轴向长度的1％～80％。
可选的，所述加强筋的远端设置于在所述过渡区的近端的第一个所述过渡支架段的波峰上，和/或，所述加强筋的近端设置于所述主体区的近端的第一个所述主体支架段上。
可选的，所述近端密封区包括至少一个变高近端密封支架段和至少一个等高近端密封支架段；
所述至少一个变高近端密封支架段和所述至少一个等高近端密封支架段 在所述主体支架部的轴向上间隔排列，且在所述主体支架部的周向上对齐布置；
所述至少一个变高近端密封支架段设置在所述近端密封区的最近端；
所述至少一个变高近端密封支架段中的任意相邻两个矮波谷间设置至少一个高波谷。
可选的，所述主体支架部还包括裸段，所述裸段包括一个环形支架段，所述裸段的远端与所述覆膜固定连接，所述裸段的近端轴向上伸出所述覆膜，所述裸段被配置为扩张后与血管壁贴合进行锚定，所述裸段上设置有后释放结构，用于与输送器配合以实现覆膜支架的后释放。
可选的，所述裸段上设置有凹槽结构，所述凹槽结构内设置有显影部件。
可选的，所述凹槽结构包括第一凹槽结构和第二凹槽结构，所述第一凹槽结构的长度大于所述第二凹槽结构的长度，所述第一凹槽结构和所述第二凹槽结构设置在所述裸段的不同的波杆上，所述第一凹槽结构的下边缘与所述第二凹槽结构的下边缘平齐，以使所述显影部件的下边缘与所述覆膜的近端边缘重合。
可选的，所述第一凹槽结构的长度为所述第二凹槽结构的长度的1.5倍～3倍。
可选的，所述近端密封区包括一个变高近端密封支架段和至少一个等高近端密封支架段，所述一个变高近端密封支架段和最近端的所述一个等高近端密封支架段在所述主体支架部的轴向上重叠排列，且在所述主体支架部的周向上错开布置；
所述至少一个变高近端密封支架段设置在所述近端密封区的最近端；
所述至少一个变高近端密封支架段中的任意相邻两个矮波峰间设置至少一个高波峰。
可选的，最近端的所述一个变高近端密封支架段的高波峰的近端轴向上伸出所述覆膜形成伸出段，所述伸出段被配置为扩张后与血管壁贴合进行锚定，所述伸出段上设置有后释放结构，用于与输送器配合以实现覆膜支架的后释放。
可选的，所述伸出段的长度为1.5mm～5.0mm。
可选的，所述主体区的横截面形状为圆形，所述过渡区的近端的横截面形状为圆形，所述过渡区的远端的横截面形状为椭圆形。
可选的，所述覆膜支架还包括分支束缚线圈，被配置为用于绑扎同侧的分支支架部的每个支架段，同侧的分支支架部的每个支架段由至少两个所述分支束缚线圈进行绑扎。
可选的，所述覆膜支架为一体式支架结构，两个所述分支支架部和一个所述主体支架部均与所述覆膜一体连接形成所述Y形结构。
可选的，所述加强筋的数量为一根并设置于覆膜支架的对侧。
可选的，所述覆膜支架的分叉点用于适配血管分叉点，以使所述覆膜支架能够骑跨在血管分叉点上。
可选的，所述分支支架部的长度为20mm～80mm，所述分支支架部的外径为近端小、远端大。
在上述覆膜支架中，利用覆膜将环形支架段进行连接而形成一体式的Y形覆膜支架，这种覆膜支架大大降低了手术成本，减少了传统术式支架间的拼接所拥有的内漏的风险，同时也降低了手术时间。此外，该一体式覆膜支架在释放后主体支架部的远端“骑跨”在血管分叉点上，这种固定方式符合人体血管的自然走向，支架分叉点不会发生移位。另外，环形支架段具有更小的压握尺寸，更小的导入路径，而且环形支架段之间通过覆膜柔性连接，相比于编织结构，增加了支架的柔顺性，能更好的与人体迂曲的血管进行匹 配。再者，所述主体支架部还包括过渡区，所述过渡区的外径从近端至远端逐渐减小，使其可以与覆膜贴合的更好，也更符合人体血管直径自然变化趋势，进一步减小内漏的风险。再次，所述主体支架部还包括近端密封区，所述近端密封区包括至少一个变高近端密封支架段，所述至少一个变高近端密封支架段可使支架拥有更好的近端圆整性和更大的径向支撑力，可有效地预防由支架近端与血管贴合不严造成的I型内漏，同时近端第一段变高的结构设计也可配合后释放使支架释放精准，进一步提升释放精度。
在上述覆膜支架中，利用加强筋限制主体支架部在轴向上的回缩，在不影响支架柔顺性的情况下，有效的降低了支架近端移位的风险，使释放位置更加精准。
在上述覆膜支架中，所述主体支架部还包括裸段或伸出段，裸段或伸出段上优选设置后释放结构，可与输送器匹配以实现后释放的功能。后释放可有效的减少支架释放过程中的前跳与后跳，使释放位置更加准确。同时配合“骑跨式定位”和加强筋的设置，定位效果更好，而且裸段或伸出段无需倒钩，可以既在近端锚定支架，又不损伤血管。
在上述覆膜支架中，可利用分支束缚线圈如蝴蝶型线圈，对同侧的分支支架部进行绑扎，可有效避免释放时线结点被卡主导致的支架无法弹开的问题，降低了手术难度，进一步缩短了手术时间。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本发明优选实施例一的覆膜支架的结构示意图。
图2是本发明优选实施例一的裸段的局部结构示意图。
图3是本发明优选实施例一的加强筋的结构示意图。
图4是本发明优选实施例一的牙线绑扎主体支架部的结构示意图。
图5是本发明优选实施例一的分支束缚线圈绑扎同侧的分支支架部的结构示意图。
图6是本发明优选实施例二的覆膜支架的结构示意图。
图7a是本发明优选实施例二的变高近端密封支架段的结构示意图。
图7b是本发明优选实施例二的等高近端密封支架段的结构示意图。
图7c是本发明优选实施例二的等高近端密封支架段和变高近端密封支架段在轴向上重叠且在周向上交错布置的示意图。
具体实施方式
为使本发明的内容更加清楚易懂，以下结合说明书附图本发明做进一步说明。当然本发明并不局限于该具体实施例，本领域的技术人员所熟知的一般替换也涵盖在本发明的保护范围内。在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。
在本申请使用的术语是仅仅出于描述特定实施方式的目的，而非旨在限制本申请。在本申请中所使用的单数形式的“一种”、“所述”和“该”也旨在包括多数形式，除非上下文清楚地表示其他含义。应当理解，“一个”或者“一”等类似词语也不表示数量限制，而是表示存在至少一个；“多个”表示两个及两个以上的数量。“包括”或者“包含”等类似词语意指出现在“包括”或者“包含”前面的元件或者物件涵盖出现在“包括”或者“包含”后面列举的元件或者物件及其等同，并不排除其他元件或者物件。其次，本发明利 用示意图进行了详细的表述，但这些示意图仅为了便于详述本发明实例，不应对此作为本发明的限定。如在本文中“近端”是指靠近心脏的一端；“远端”是指靠近操作者的一端，也即远离心脏的一端；“轴向”是指平行于轴线的方向；“径向”是指垂直于轴线的方向；“周向”是指围绕轴线的方向。如在本文中“波杆”即为支架棱，“波杆的长度”是指支架棱在其延伸方向上的尺寸。
<实施例一>
如图1所示，本实施例提供一种覆膜支架100，为一体式支架结构，也即，该覆膜支架100并非由多个独立的支架在体内拼接而成，而是在体外便制作形成一个带有分支的支架结构。该覆膜支架100适用于动脉瘤或夹层的病变区域累及血管分叉点及其分支的情况，包括但不限于腹主动脉。以下描述中，主要以病变区域累及腹主动脉及其分支作为示意进行说明，但不构成对本发明的限定。
具体地，所述覆膜支架100包括支架本体，所述支架本体包括主体支架部110和两个分支支架部120，所述覆膜支架100还包括覆膜130。两个分支支架部120和一个主体支架部110都与覆膜130固定连接，从而一体连接成Y形的覆膜支架100。所需理解，支架本体与覆膜可以是一体式结构，也可以是分体式结构，无论是分体还是一体都可以实现支架本体与覆膜之间的固定连接。本文中，两个分支支架部120分别构成同侧的分支支架和对侧的分支支架，且为了便于解释说明，两个分支支架部120定义为第一分支支架部121和第二分支支架部122，第一分支支架部121构成同侧的分支支架，第二分支支架部122构成对侧的分支支架。分支支架部120的外径可以是近端小、远端大，或者分支支架部120的外径不变。
主体支架部110和分支支架部120都为中空的管状结构，主体支架部110的内腔与两个分支支架部120的内腔连通。主体支架部110和分支支架部120 都包括若干轴向依次间隔排布的环形支架段(简称支架段)，环形支架段为波浪形结构，且环形支架段之间通过覆膜130柔性连接，或者支架段之间除加强筋105外仅通过覆膜130柔性连接。此处“柔性连接”可以理解为环形支架段都仅与覆膜130固定连接，而在轴向方向上任意相邻两个环形支架段之间没有刚性连接件进行连接。如图1所示，在优选情况下，环形支架段之间除加强筋105外无刚性连接，也即，环形支架段之间仅通过覆膜130连接，而覆膜130较为柔软可实现柔性连接。所应理解，“刚性连接”是指当覆膜支架产生位移或受力时，覆膜支架中的环形支架段之间不产生相对位移或变形；“柔性连接”是指覆膜支架产生位移或受力时，覆膜支架中的环形支架段之间可产生相对位移或变形，此时，柔顺性好。
本申请对环形支架段上的波形形状不作限制，可以是锯齿形或弧形或其他合适形状。本申请对制作支架本体的金属材料不作特别的限制，只要是生物相容性好的医用金属材料即可，如316不锈钢、钴铬合金或镍钛合金等医用金属材料。覆膜130为生物相容性好的高分子软性材料，可使支架本体在轴向上形成封闭的内腔，覆膜130可以设置在支架本体的内表面或外表面。
与现有技术相比，本发明的覆膜支架100不但避免了多个独立支架在体内进行拼接所引起的内漏风险，而且缩短了手术时间，极大降低了手术成本。尤其主体支架部110的远端以“骑跨”的方式定位在腹主动脉血管分叉点上，这种固定方式符合人体血管的自然走向，覆膜支架100的分叉点不会发生移位，可有效的降低覆膜支架移位的风险。此外，该覆膜支架100与整体编织的支架结构不同，波浪形的环形支架段具有更小的压握尺寸，这意味着更小的导入路径，对患者的损伤小。而且波浪形的环形支架段之间无刚性连接或除加强筋外无刚性连接，相比于整体编织结构，增加了支架的柔顺性，能更好的与人体迂曲的血管进行匹配，治疗效果更好。
继续参考图1，主体支架部110优选包括从近端至远端依次排布的裸段101、近端密封区102和主体区103，都与覆膜130固定连接，如与覆膜130缝合和/热熔固定连接。具体地，所述环形支架段包括裸段101、近端密封支架段a2和主体支架段a3；所述裸段101也可以理解为包括一个环形支架段；所述近端密封区102包括若干近端密封支架段a2，具体数量不作限定；所述主体区103包括若干主体支架段a3，具体数量亦不限定。应理解，裸段101上不覆盖覆膜130，近端密封区102和主体区103上都设置有覆膜130。还需理解，所述环形支架段还包括分支支架段，且每个所述分支支架部包括分支支架段。
如图2所示，可通过切割工艺制成裸段101，该裸段101即为一个波浪形的环形支架段，裸段101的远端与覆膜130固定连接，裸段101的近端轴向上伸出覆膜130。裸段101被配置为扩张后与血管壁贴合进行锚定，从而可以延长主体支架部110近端的锚定区，而且裸段101无倒钩，可以既在近端锚定支架，又不损伤血管。优选的，裸段101上设置有后释放结构，用于与输送器配合以实现覆膜支架的后释放。后释放可有效的减少支架释放过程中的前跳与后跳，使释放位置更加精确，治疗效果更好。本申请对后释放的方式不加限制。在一实施例中，如图2所示，所述后释放结构包括孔洞结构1011，裸段101的至少部分波峰上设置孔洞结构1011，该孔洞结构1011用于与输送器匹配，以实现覆膜支架的后释放。
优选的，裸段101上设置有显影部件(未图示)，所述显影部件由金属显影材料制成，以便根据显影部件在X射线下的显影性辨别覆膜支架100的位置和形态。进一步的，裸段101的波杆1012上设置有凹槽结构，所述凹槽结构用于固定显影部件。所述凹槽结构可包括若干第一凹槽结构1013和若干第二凹槽结构1014，第一凹槽结构1013可以固定第一显影部件，第二凹槽结构 1014可以固定第二显影部件。第一凹槽结构1013和第二凹槽结构1014设置在裸段101的波杆1012的表面上，且第一凹槽结构1013和第二凹槽结构1014设置在裸段101的不同的波杆1012上。优选的，裸段101的波杆1012的表面凸起，从而在凸起之间形成凹槽结构，从而保证裸段101的强度。所述第一凹槽结构1013的长度大于第二凹槽结构1014的长度，因此，第一显影部件的长度大于第二显影部件的长度。应理解，所述凹槽结构的长度即为沿波杆1012的延伸方向的尺寸。优选的，第一凹槽结构1013的下边缘与第二凹槽结构1014的下边缘平齐，确保显影部件的下边缘与覆膜130的边缘重合，更方便识别覆膜支架近端的位置及形态。所述凹槽结构的下边缘指的是凹槽结构的远端边缘。可选的，第二凹槽结构1014的长度可为1mm～3mm，第一凹槽结构1013的长度可为2mm～6mm。进一步的，第一凹槽结构1013的长度为第二凹槽结构1014的长度的1.5倍～3倍，保证支架覆膜近端的位置及形态可在X射线下被识别。本实施例中，在支架的对侧设置了第一凹槽结构1013来固定第一显影部件，其他方位根据需求设置了第二凹槽结构1014来固定第二显影部件，以用于在X射线下识别支架方向及形态。
请参考图1，近端密封区102包括至少一个变高近端密封支架段1021和至少一个等高近端密封支架段1022。变高近端密封支架段1021中的波谷的深度不相同，且至少一个变高近端密封支架段1021中的任意相邻两个矮波谷之间设置至少一个高波谷。等高近端密封支架段1022中的波谷的深度都相同。“波谷的深度”是指相邻波峰到波谷之间的垂直距离。至少一个变高近端密封支架段1021设置在近端密封区102的最近端。近端密封区102中的等高密封支架段1022的数量不限定，可以是一个或多个。同理，变高近端密封支架段1021的数量可以是一个或多个。至少一个变高近端密封支架段1021和至少一个等高近端密封支架段1022在主体支架部110的轴向上间隔排列，且在 主体支架部110的周向上对齐布置。
在图1示出的实施例中，变高近端密封支架段1021的数量为1个，等高近端密封支架段1022的数量为3个，一个变高近端密封支架段1021和三个等高密封支架段1022依次由近端至远端沿主体支架部110的轴向间隔排布，且变高近端密封支架段1021和等高密封支架段1022在主体支架部110的周向上对齐布置。此处，“对齐”是指，如图1所示，在平行于主体支架部的轴线的投影平面上，变高近端密封支架段1021的波峰的投影与等高密封支架段1022的波峰的投影的连线平行于主体支架部的轴线，同样的，变高近端密封支架段1021的波谷的投影与等高密封支架段1022的波谷的投影的连线平行于主体支架部的轴线。应理解，采用变高和等高两种高度的支架段的组合设置，可使覆膜支架100的近端与血管贴合更加紧密，从而有效防止由覆膜支架100的近端与血管贴合不紧所产生的Ia型内漏。
此外，近端密封支架段a2的波杆的最大长度小于主体支架段a3中的波杆长度，例如近端密封支架段a2的波杆长度为4mm～14mm，主体支架段a3中的波杆长度为16mm～24mm。因此，近端密封区102相比于主体区103的波形更为密集，与血管的贴合效果更好。
继续参考图1，主体区103包括若干轴向依次排布的主体支架段a3，主体支架段a3的数量根据病变区域的长度进行设置。组成主体区103的主体支架段a3的波峰的高度相同。主体区103的作用是支撑血流通道，使覆膜支架100贴壁。近端密封区102和主体区103都大体为圆柱形状，两者的外径相同。
主体支架部110优选还包括过渡区104，所述裸段101、近端密封区102、主体区103和过渡区104从近端至远端依次排布，从而在主体区103和分支支架部120之间设置有过渡区104。过渡区104的外径从近端至远端依次减小，所述过渡区104的近端的外径与主体区103的外径相同，所述主体区103具 有相同的外径。此外，所述环形支架段还包括过渡支架段a4，所述过渡区104包括若干过渡支架段a4。优选的，主体区103的横截面形状为圆形；优选的，过渡区104的近端的横截面形状为圆形，过渡区104的远端的横截面形状为椭圆形，椭圆形的长轴和短轴都依次减小。组成过渡区104的过渡支架段a4的数量不做限制，包括但不限于一个过渡支架段a4，通常为一个过渡支架段a4即可。因此，在优选情况下，主体支架部110的近端横截面为圆形，远端横截面为椭圆形。过渡区104的作用在于使主体支架部110与两个分支支架部120过渡平滑，以符合人体血管解剖构造，贴合效果好。此外，过渡区104采用了变径结构，能够与覆膜130的变径段贴合的更好，也更符合人体血管直径自然变化趋势。故相比于传统的等径结构，过渡区104的设置，可以使覆膜支架具有更好的内腔保持性，有效避免了支架的分支随着血管迂曲而产生闭塞的问题。
所述覆膜支架100优选还包括加强筋105，与覆膜130固定连接，所述加强筋105被配置用于限制主体支架部110在轴向上的回缩。使用加强筋105后，在尽可能保留覆膜支架100的柔顺性能的基础上，可有效防止覆膜支架100轴向短缩，有效降低覆膜支架100的近端移位的风险。优选的，所述加强筋105的材料为生物形容性好的金属材料，包括且不限于镍钛、钴铬合金或316不锈钢。
请参考图3，并结合图1，加强筋105为细长的杆状结构并沿主体支架部110的轴向延伸设置，且加强筋105的近端和远端均与覆膜130固定连接，如缝合和/或热熔连接。其中加强筋105的近端设置在主体区103上，远端设置在过渡区104的近端，以限制主体区103的轴向缩短。此处，应理解，加强筋105实际与覆膜130固定连接，但加强筋105与覆膜130的固定位置需要确保加强筋105的远端在过渡区104的近端，加强筋105的近端在主体区103 上。优选的，加强筋105的近端设置于主体区103的近端的第一个主体支架段a3上，如固定在主体区103的近端的第一个主体支架段a3的波峰、波谷或波峰与波谷之间的位置。
加强筋105的数量优选为一根，以确保覆膜支架的柔顺性。优选的，加强筋105的远端设置于过渡区104的近端的第一个过渡支架段a4上，更优选，加强筋105的远端设置在过渡区104的近端的第一个过渡支架段a4的波峰上。本申请对加强筋105的长度不作特别的限定，具体根据主体支架部110的规格来确定加强筋105的长度。例如在一具体的实施例中，加强筋105的长度为主体区103的轴向长度的1％～80％。
进一步的，如图3所示，加强筋105的两端可设置固定孔1051，所述加强筋105通过两端的固定孔1051与覆膜130缝合连接和/或热熔连接。固定孔1051的设置，可保证加强筋105的两端与覆膜130固定牢靠，不易滑脱。覆膜支架100的定位方式为支架分叉点“骑跨”在腹主动脉分叉点，配合加强筋105，可有效防止覆膜支架在迂曲的腹主动脉中发生短缩，确保定位的精确性。还应理解，本文中，环形支架段朝向近端凸起的为“波峰”，反之为“波谷”。
返回参考图1，所述覆膜支架100优选还包括牙线140，由PTFE、PET或超高分子聚乙烯等具有良好生物相容性的软性高分子材料制成。牙线140的近端与覆膜130固定连接，并用于绑扎主体支架部110的每个环形支架段，以减小支架的尺寸，便于在体内进行支架的位置调整。
请参考图1，将牙线140进行打结，在打结处形成若干主体束缚线圈141。主体束缚线圈141的数量和位置与需要绑扎的主体支架部110上的环形支架段的数量和位置一一对应。绑扎时，如图4所示，优选主体束缚线圈141穿过支架段上对应位置的束缚线圈106，可将主体支架部110的直径束缚最小， 约为支架名义直径的10％～20％。其中束缚线圈106起到对主体束缚线圈141限位的作用，绑扎更为可靠和牢固。束缚线圈106的数量和位置可根据需求进行设置。这种绑扎结构可靠且强度高。束缚线圈106的结构不作限定，可以是在支架上额外缝合形成束缚线圈106。
参考图1，所述覆膜支架100还可包括分支束缚线圈150，由PTFE、PET或超高分子聚乙烯等具有良好生物相容性的软性高分子材料制成。可选的，所述分支束缚线圈150为蝴蝶型线圈，即“8”字形线圈。其中，第一分支支架部121的每个环形支架段上设置至少2个分支束缚线圈150，且每个环形支架段的至少2个分支束缚线圈150优选固定在该支架段的同一圆周方向上，至少2个分支束缚线圈150分别从两侧环抱支架段。由于采用翻山的手术方式，使得对侧的第二分支支架部122无需绑扎分支束缚线圈150。此处的“翻山”的手术方式为本领域的公知技术，即可以理解为，腹主动脉与双侧髂动脉为倒Y字型结构，翻山即为从一侧髂动脉采用导丝导管等耗材建立双侧髂动脉的通路，形似翻山。
请参考图5，分支束缚线圈150采用两侧环绕对第一分支支架部121进行绑扎的方式，即2个从同一点出发的分支束缚线圈150从两侧将第一分支支架部121“抱住”，以达到绑扎束缚的效果。该结构简单，易操作，绑扎效果牢靠。采用这种绑扎结构，拉动束缚导丝，即可实现第一分支支架部121的释放，可有效避免释放时线结点被卡住导致的支架无法弹开。同样地，分支束缚线圈150可以配合第一分支支架部121的支架段上的束缚线圈106(图5未示出)使用，束缚线圈106起到对分支束缚线圈150限位的作用，绑扎更可靠。
人的血管尺寸及分布特征个体差异性较大，为此，覆膜支架100的尺寸可按照患者的血管尺寸进行选择。在一示意性实施例中，如图1所示，主体 支架部110的长度L1为30mm～130mm，主体支架部110的直径D1为16mm～34mm，第一分支支架部121的长度L2为20mm～80mm，第二分支支架部122的长度L3为20mm～80mm，第一分支支架部121的直径D2为8mm～24mm，第二分支支架部122的直径D3为8mm～24mm。与传统覆膜支架不同的是，当患者髂动脉病变处血管直径很大时，仍然可根据患者的特殊情况调整分支支架部120的大小，最终做成一体式覆膜支架100。即两分支支架部120的直径之和可大于主体支架部110的直径，当然也可小于或等于主体支架部110的直径。
<实施例二>
请参考图6、图7a、图7b和图7c，在本发明的另一个实施例中，还提供了一种覆膜支架100’，该覆膜支架100’取消了裸段，而在主体支架部110的近端直接配置近端密封区102’，也即，本实施例的覆膜支架100’的主体支架部110包括从近端至远端依次排布的近端密封区102’、主体区103和过渡区104。另外的不同是，该近端密封区102’中的变高近端密封支架段1021和等高近端密封支架段122的相对位置有所调整。
具体地，在本实施例中，近端密封区102’包括一个变高近端密封支架段1021和至少一个等高近端密封支架段1022。将一个变高近端密封支架段1021和最近端的一个等高近端密封支架段1022在主体支架部110的轴向上重叠排列，且在主体支架部110的周向上错开布置，从而在近端密封区102的最近端形成一个变高和等高交叠设置的支架段。交叠后形成的环形支架段中任意相邻两个矮波峰之间设置至少一个高波峰。其中高波峰的下顶点与矮波峰的下顶点对齐并在同一圆周上。因此，交叠后形成的环形支架段的下顶点对齐，上顶点呈现高矮变化。还应理解，所述“轴向上重叠”指的是，一个变高近端密封支架段1021和至少一个等高近端密封支架段1022在同一圆周方向上； “周向上错开布置”指的是，一个变高近端密封支架段1021和至少一个等高近端密封支架段1022在同一圆周方向上的波峰之间错开而不重叠，具体见图7c。该方案中，至少一个变高近端密封支架段1021设置在近端密封区102’的最近端，至少一个变高近端密封支架段1021中的任意相邻两个矮波峰间设置至少一个高波峰。
此时，主体支架部110在最近端的变高和等高的交错式结构设计，可使支架近端与血管紧密贴合，可有效防止由支架近端与血管贴合不紧所产生的Ia型内漏，同时也可使支架拥有更好的近端圆整性和更大的径向支撑力，从而可有效地预防由支架近端与血管贴合不严造成的I型内漏，同时近端首段变高的结构设计也可配合后释放使支架释放精准。
如图6所示，最近端的一个变高近端密封支架段1021的高波峰的近端轴向上伸出覆膜130的部分形成伸出段，此时，伸出段的长度优选为1.5mm～5mm，变高近端密封支架段1021中的高波峰的数量约为3-6个，而且高波峰上可设置孔洞结构来配合输送器实现后释放的功能，可有效的减少支架释放过程中的前跳与后跳，使释放位置更加准确。而且这种结构方便与圆筒状支架(CUFF)配合使用。与普通CUFF配合使用可增加治疗区域的长度。与各种开孔CUFF配合使用时，开孔CUFF可重建近端内脏区分支血管的血流通道。使用方式及尺寸十分灵活。
本实施例所示出的覆膜支架100’的其余结构与实施例一中的覆膜支架100的结构基本相同，对于相同部分，不再详细描述，具体可参阅上述实施例一。
应理解，本发明的覆膜支架在释放后，覆膜支架的分叉点与人体髂动脉分叉点重合，即支架主体支架部的远端骑跨在髂动脉分叉点上。这种固定方式符合人体血管的自然走向，支架分叉点不会发生移位，尤其配合加强筋时， 加强筋远端设置于过渡区近端，有效降低支架短缩和近端移位的风险。同时裸段或伸出段的无倒钩设计一方面避免了倒钩对血管的损伤，另一方面延长了支架近端的锚定区，从而可以拓宽支架的使用范围，也使支架近端可以很好地与血管锚定。此外，近端密封区和过渡区的特殊结构设计可以使主体支架部与血管紧密贴合，极大地降低了Ia型内漏的风险。由于人体腹主动脉远端分叉成为两侧髂动脉，故，本发明的覆膜支架特别适合于腹主动脉，同时本申请的内漏风险和远期移位风险低，有效的弥补了现有覆膜支架所存在的缺点。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明的保护范围。

Claims (18)

  1. 一种覆膜支架，包括支架本体和覆膜；所述覆膜设置在所述支架本体的表面；所述支架本体包括主体支架部和分支支架部；两个所述分支支架部和一个所述主体支架部均与所述覆膜固定连接并形成Y形结构；所述支架本体包括若干轴向依次间隔排布的环形支架段；
    所述主体支架部包括从近端至远端依次排布的近端密封区、主体区和过渡区；所述主体区具有相同的外径；所述过渡区的外径由近端向远端依次减小；所述过渡区的近端的外径与所述主体区的外径相同；
    所述支架段包括近端密封支架段、过渡支架段、主体支架段和分支支架段；所述近端密封区包括所述近端密封支架段，所述过渡区包括所述过渡支架段，所述主体区包括所述主体支架段；
    所述近端密封支架段的波杆的最大长度小于所述主体支架段的波杆的长度。
  2. 如权利要求1所述的覆膜支架，其特征在于，还包括加强筋，与所述覆膜固定连接，所述加强筋沿所述主体支架部的轴向延伸设置；
    所述加强筋的近端设置于所述主体区上，所述加强筋的远端设置于所述过渡区的近端，所述加强筋能够限制所述主体支架部在轴向上的回缩。
  3. 如权利要求2所述的覆膜支架，其特征在于，所述加强筋的长度为所述主体区的轴向长度的1％～80％。
  4. 如权利要求2所述的覆膜支架，其特征在于，所述加强筋的远端设置于所述过渡区的近端的第一个所述过渡支架段的波峰上，和/或，所述加强筋的近端设置于所述主体区的近端的第一个所述主体支架段上。
  5. 如权利要求1所述的覆膜支架，其特征在于，所述近端密封区包括至少一个变高近端密封支架段和至少一个等高近端密封支架段；
    所述至少一个变高近端密封支架段和所述至少一个等高近端密封支架段在所述主体支架部的轴向上间隔排列，且在所述主体支架部的周向上对齐布置；
    所述至少一个变高近端密封支架段设置在所述近端密封区的最近端；
    所述至少一个变高近端密封支架段中的任意相邻两个矮波谷间设置至少一个高波谷。
  6. 如权利要求5所述的覆膜支架，其特征在于，所述主体支架部还包括裸段，所述裸段包括一个环形支架段，所述裸段的远端与所述覆膜固定连接，所述裸段的近端轴向上伸出所述覆膜，所述裸段被配置为扩张后与血管壁贴合进行锚定，所述裸段上设置有后释放结构，用于与输送器配合以实现覆膜支架的后释放。
  7. 如权利要求6所述的覆膜支架，其特征在于，所述裸段上设置有凹槽结构，所述凹槽结构内设置有显影部件。
  8. 如权利要求7所述的覆膜支架，其特征在于，所述凹槽结构包括第一凹槽结构和第二凹槽结构，所述第一凹槽结构的长度大于所述第二凹槽结构的长度，所述第一凹槽结构和所述第二凹槽结构设置在所述裸段的不同的波杆上，所述第一凹槽结构的下边缘与所述第二凹槽结构的下边缘平齐，以使所述显影部件的下边缘与所述覆膜的近端边缘重合。
  9. 如权利要求8所述的覆膜支架，其特征在于，所述第一凹槽结构的长度为所述第二凹槽结构的长度的1.5倍～3倍。
  10. 如权利要求1或4所述的覆膜支架，其特征在于，所述近端密封区包括一个变高近端密封支架段和至少一个等高近端密封支架段，所述一个变高近端密封支架段和最近端的所述一个等高近端密封支架段在所述主体支架部的轴向上重叠排列，且在所述主体支架部的周向上错开布置；
    所述至少一个变高近端密封支架段设置在所述近端密封区的最近端；
    所述至少一个变高近端密封支架段中的任意相邻两个矮波峰间设置至少一个高波峰。
  11. 如权利要求10所述的覆膜支架，其特征在于，最近端的所述一个变高近端密封支架段的高波峰的近端轴向上伸出所述覆膜形成伸出段，所述伸出段被配置为扩张后与血管壁贴合进行锚定，所述伸出段上设置有后释放结构，用于与输送器配合以实现覆膜支架的后释放。
  12. 如权利要求11所述的覆膜支架，其特征在于，所述伸出段的长度为1.5mm～5.0mm。
  13. 如权利要求1所述的覆膜支架，其特征在于，所述主体区的横截面形状为圆形，所述过渡区的近端的横截面形状为圆形，所述过渡区的远端的横截面形状为椭圆形。
  14. 如权利要求1所述的覆膜支架，其特征在于，还包括分支束缚线圈，被配置为用于绑扎同侧的分支支架部的每个支架段，同侧的分支支架部的每个支架段由至少两个所述分支束缚线圈进行绑扎。
  15. 如权利要求1所述的覆膜支架，其特征在于，所述覆膜支架为一体式支架结构，两个所述分支支架部和一个所述主体支架部均与所述覆膜一体连接形成所述Y形结构。
  16. 如权利要求10所述的覆膜支架，其特征在于，所述加强筋的数量为一根并设置于覆膜支架的对侧。
  17. 如权利要求16所述的覆膜支架，其特征在于，所述覆膜支架的分叉点用于适配血管分叉点，以使所述覆膜支架能够骑跨在血管分叉点上。
  18. 如权利要求1所述的覆膜支架，其特征在于，所述分支支架部的长度为20mm～80mm，所述分支支架部的外径为近端小、远端大。
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