WO2014135118A1 - A new type of double-layer covered stent - Google Patents

A new type of double-layer covered stent Download PDF

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Publication number
WO2014135118A1
WO2014135118A1 PCT/CN2014/073056 CN2014073056W WO2014135118A1 WO 2014135118 A1 WO2014135118 A1 WO 2014135118A1 CN 2014073056 W CN2014073056 W CN 2014073056W WO 2014135118 A1 WO2014135118 A1 WO 2014135118A1
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WIPO (PCT)
Prior art keywords
stent
coating
stent graft
inner layer
layer coating
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PCT/CN2014/073056
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French (fr)
Chinese (zh)
Inventor
朱清
邢智凯
高峰
李中华
罗七一
Original Assignee
上海微创医疗器械（集团）有限公司
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Publication of WO2014135118A1 publication Critical patent/WO2014135118A1/en

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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • 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

Definitions

  • the present invention relates to a stent graft for use in the treatment of aortic diseases and related vascular diseases.
  • the stent graft is formed by processing a metal stent and a coating material by sewing or cross-linking (for example, thermal crosslinking, chemical crosslinking, etc.).
  • the proximal end of the stent graft provides radial support through the stent body to conform the membrane to the vessel wall to create a occlusion effect.
  • the blood vessel wall will lose its elasticity, so the proximal end of the stent graft and the vessel wall may not be completely fitted, resulting in type I endoleak (see Figure 1). With Figure 2).
  • Figure 1 is a schematic illustration of a prior art stent graft in a blood vessel.
  • reference numeral 1 denotes an internal leak.
  • Figure 2 is a cross-sectional view of the proximal portion of the stent graft of Figure 1.
  • reference numeral 2 denotes a stent body
  • reference numeral 3 denotes a blood vessel wall
  • reference numeral 4 denotes a film
  • reference numeral 5 denotes a plaque
  • reference numeral 6 denotes a gap.
  • a gap 6 is generated between the plaque 5 of the blood vessel and the membrane 4, so that the type I endoleak is easily caused.
  • Option One is generally available in the prior art.
  • the stent graft is attached to the vessel wall by expanding the proximal end of the stent graft through the balloon.
  • the method is more operability, but the method can only provide an auxiliary effect on the proximal end of the stent graft to the vessel wall, especially the blood vessel with more calcification. Therefore, the method is ineffective, and the use of the balloon also imposes an economic burden on the patient.
  • Option II The proximal end plus a short section of the stent (cuff). This method has a good effect on type I internal leakage. However, a new short-segment with a stent is needed, which not only economically burdens the patient, but also may bring new risks, such as risk of reflexion and displacement.
  • the conventional stent in the prior art has only a single layer of film, and the radial supporting force of the stent is relatively low, and there is a case where the proximal end is poorly attached and the type I endoleak is often caused.
  • some prior art solutions can provide some compensation, they do not completely cover all the lesions, and may also cause new risks. This not only requires a higher level of doctor's operation, but also increases the operation time and the risk of surgery, and at the same time imposes an economic burden on the patient.
  • Some related prior art is also disclosed in the Chinese patent documents CN2741534Y, CN201445575U, CN201602915U and US Pat. No. 8,118,856 B2. Summary of the invention
  • a stent graft which can increase the proximal end adherence of the stent and reduce the risk of a type I endoleak caused by poor proximal attachment.
  • a stent graft comprising:
  • the stent graft further includes an outer layer coating disposed at a proximal end portion of the stent body, the outer layer coating being located outside the inner layer coating, and the proximal end of the outer layer coating And the distal end is in close contact with the inner layer coating, and the inner layer coating is provided with holes.
  • the proximal end and the distal end of the outer layer membrane are fused to the inner layer coating, or the proximal and distal ends of the outer layer coating are sutured to the inner layer by medical suture .
  • a plurality of said holes are formed in a proximal end portion of said inner layer film along a circumferential direction of said inner layer film.
  • the holes are circular holes.
  • the outer layer coating film is made of a polytetrafluoroethylene material
  • the inner layer coating film is made of a polyethylene terephthalate woven structure.
  • the outer layer coating film is composed of a polyethylene terephthalate woven structure
  • the inner layer coating film is formed of a polyethylene terephthalate woven structure.
  • the outer layer coating film is composed of a polyethylene terephthalate woven structure
  • the inner layer coating film is made of a polytetrafluoroethylene material.
  • the stent graft of the invention can increase the proximal adherence of the stent and reduce the risk of type I endoleak caused by poor proximal attachment.
  • the stent graft of the present invention can greatly reduce the risk of proximal endoleak, and thus the stent graft of the present invention solves the type I endoleak caused by poor adhesion of the proximal end of the stent graft to the vessel wall.
  • the stent graft of the present invention can be formed by adding an outer layer coating to the outer layer without changing the overall structure of the main body stent graft of the prior art, so that the same production process as before can be used without improving the process difficulty.
  • the risk of endoleak is greatly reduced, and thus the product of the present invention is more competitive in the market.
  • the stent graft of the present invention can cover most aortic cases, and can also reduce the use of other auxiliary equipment, reducing the risk of surgery and surgery.
  • Figure 1 is a schematic illustration of a prior art stent graft in a blood vessel.
  • Figure 2 is a cross-sectional view of the proximal portion of the stent graft of Figure 1.
  • Figure 3 is a schematic cross-sectional view of the proximal end of a two-layer stent graft in accordance with one embodiment of the present invention.
  • Figure 4 is a schematic longitudinal cross-sectional view of the two-layer stent graft of the present invention in Figure 3.
  • Figure 5 is a schematic longitudinal cross-sectional view of a two-layer stent graft of another embodiment of the present invention. detailed description
  • the present invention generally provides a novel bilayer stent graft for use in the treatment of aortic diseases and related diseases. Preferred embodiments of the present invention are described in detail below with reference to FIGS. 3 through 5.
  • FIGS. 3 and 4 are schematic cross-sectional views of the proximal end of a two-layer stent graft in accordance with one embodiment of the present invention.
  • Figure 4 is a schematic longitudinal cross-sectional view of the two-layer stent graft of the present invention of Figure 3.
  • the proximal end portion of the stent graft of the present invention comprises a double layer coating, that is, an inner layer coating 14 and an outer layer coating 16.
  • a hole 17 is formed in the inner layer film 14, and the outer layer film 16 has a larger size than the inner layer film 14.
  • the proximal and distal ends of the outer layer coating 16 are in close contact with the inner layer coating 14.
  • FIGS. 1 is a schematic cross-sectional view of the proximal end of a two-layer stent graft in accordance with one embodiment of the present invention.
  • Figure 4 is a schematic longitudinal cross-sectional view of the two-layer stent graft of the present invention of Figure 3.
  • the stent graft of the present invention comprises: a stent body 12; An inner layer coating 14 covering the stent body 12 is provided.
  • the stent graft further includes an outer layer coating 16 disposed at a proximal end portion of the stent body 12, the outer layer coating 16 being located outside the inner layer coating 14, and the outer layer covering
  • the proximal and distal ends of the membrane 16 are in close contact with the inner layer coating 14, and the inner layer coating 14 is provided with a hole 17.
  • blood flows in the blood vessel wall 13 along the blood flow direction indicated by reference numeral 11. Due to the presence of the holes 17, blood can pass through the holes 17 into the space between the outer layer film 16 and the inner layer film 14.
  • the outer membrane 16 will bulge to form a compliant balloon and adhere to the plaque 15 of the blood vessel.
  • the bare portion of the stent body 12 outside the outer layer coating 16 and the inner layer coating 14 also abuts against the blood vessel wall 13, and the portion of the inner layer coating 14 that is not provided with the outer layer coating 16 also abuts Blood vessel wall 13.
  • the stent graft of the invention solves the type I endoleak caused by poor adhesion between the proximal end of the stent graft and the vessel wall.
  • the stent graft of the present invention can be formed by adding an outer layer coating to the outer layer without changing the overall structure of the main body stent graft of the prior art, so that the same production process as before can be used without improving the process difficulty. However, the risk of endoleak is greatly reduced, and thus the product of the present invention is more competitive in the market. Three examples are used below to further illustrate the solution of the present invention.
  • Example 1
  • the stent graft adopts a double-layered membrane structure.
  • the outer layer is made of ePTFE material (polytetrafluoroethylene material) with a diameter of 22mm and a length of 25mm .
  • the inner layer is made of PET (polyethylene terephthalate) woven structure with a diameter of 20mm.
  • Four circular holes 27 having a diameter of 5 mm are uniformly opened along the proximal end of the inner layer coating, as shown in FIG.
  • the inner layer coating 24 is overlaid on the holder body 22. Blood can enter the space between the outer layer coating 26 and the inner layer coating 24 through the holes 27.
  • the proximal end of the inner layer coating 24 and the proximal end of the outer layer coating 26 are fused together by a fusion technique, and the inner layer of the inner layer coating 24 is fused at a distance of 20 mm from the proximal end thereof and the distal end of the outer layer coating 26 by a fusion technique. together. Due to the presence of blood pressure, the outer membrane 26 will bulge to form a compliant balloon that fits snugly against the inner wall of the vessel.
  • Example 2 Example 2:
  • the stent graft adopts a double-layered membrane structure.
  • the outer layer coating is made of PET (polyethylene terephthalate) woven structure with a diameter of 34mm and a length of 35mm .
  • the inner layer is made of PET (polyethylene terephthalate) woven structure.
  • the diameter is 30mm, and six circular holes with a diameter of 6mm are uniformly opened along the proximal end of the inner layer. Blood can pass through the hole into the space between the outer layer film and the inner layer film.
  • the proximal end of the inner layer coating and the proximal end of the outer layer coating were sutured with a medical suture, and the inner layer of the inner layer was sutured 30 mm from the proximal end and the distal end of the outer layer was sutured with a medical suture. Due to the presence of blood pressure, the outer membrane will bulge to form a compliant balloon that fits snugly against the inner wall of the vessel.
  • Example three Example three:
  • the stent graft adopts a double-layered membrane structure.
  • the outer layer is made of PET (polyethylene terephthalate) woven structure with a diameter of 48mm and a length of 45mm.
  • the inner layer is made of e-PTFE material (polytetrafluoroethylene material) with a diameter of 44mm.
  • 8 circular holes with a diameter of 6 mm are opened in the inner layer film at a distance of 10 mm from the proximal end of the stent. Blood can pass through the hole into the space between the outer layer film and the inner layer film.
  • the proximal end of the inner layer film and the proximal end of the outer layer film are fused together by a fusion technique, and the inner layer film is fused together by a fusion technique 40 mm from the proximal end and the outer layer of the outer layer film. Due to the presence of blood pressure, the outer membrane will bulge to form a compliant balloon that fits snugly against the inner wall of the vessel.
  • the stent graft of the present invention can greatly reduce the risk of proximal endoleak. Moreover, the stent graft of the present invention can cover most aortic cases, and can also reduce the use of other auxiliary equipment, reducing the risk of surgery and surgery.
  • the stent graft of the present invention can be applied to the treatment of aortic diseases, SP, which can be a stent graft of the aorta, but the invention is not limited thereto.
  • the stent graft of the present invention can also be applied to the treatment of diseases of other blood vessels.
  • proximal refers to the end near the heart.

Abstract

A new type of double-layer covered stent, comprising a main body of the stent (12, 22); and an inner cover (14, 24)covering the main body of the stent (12, 22), which characterized in that: the covered stent also comprises an outer cover (16, 26) arranged at the near end of the main body of the stent (12, 22), the outer cover (16, 26) lies in the outside of the inner cover (14, 24), and the near end and the distal end of the outer cover (16, 26) adheres to the inner cover (14, 24) closely, and there is an open hole (17, 27) in the inner cover (14, 24). The covered stent can enhance the adherent performance of the near end of the stent, and reduce the risk of I-shape leak induced by adherence ill of the near end.

Description

一种新型双层覆膜支架 技术领域  Novel double-layer coated stent technical field
本发明涉及一种应用于主动脉疾病及相关血管疾病的治疗的覆膜 支架。 背景技术  The present invention relates to a stent graft for use in the treatment of aortic diseases and related vascular diseases. Background technique
目前， 覆膜支架为金属支架与覆膜材料通过缝合或者交联 （例如 热交联、 化学交联等） 加工形成。 覆膜支架的近端通过支架主体提供 径向支撑力， 以将覆膜与血管壁贴合， 从而产生封堵作用。 但是， 由 于血管发生某些病变 （例如钙化等） 后， 血管壁将会失去弹性， 所以 可能会导致覆膜支架的近端与血管壁不能完全贴合， 从而发生 I型内 漏 （见图 1与图 2) 。 图 1是现有技术的覆膜支架在血管中的示意图。 在图 1 中， 附图标记 1表示内漏。 图 2是图 1 中的覆膜支架的近端部 分的横截面图。 在图 2中， 附图标记 2表示支架主体， 附图标记 3表 示血管壁， 附图标记 4表示覆膜， 附图标记 5表示斑块， 附图标记 6 表示间隙。 由图 2可以看出， 在血管的斑块 5和覆膜 4之间产生了间 隙 6， 因而容易导致 I型内漏。 针对图 1中的 I型内漏， 现有技术中通常有如下两种解决方案。 方案一：  At present, the stent graft is formed by processing a metal stent and a coating material by sewing or cross-linking (for example, thermal crosslinking, chemical crosslinking, etc.). The proximal end of the stent graft provides radial support through the stent body to conform the membrane to the vessel wall to create a occlusion effect. However, due to some lesions (such as calcification) in the blood vessels, the blood vessel wall will lose its elasticity, so the proximal end of the stent graft and the vessel wall may not be completely fitted, resulting in type I endoleak (see Figure 1). With Figure 2). BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of a prior art stent graft in a blood vessel. In Fig. 1, reference numeral 1 denotes an internal leak. Figure 2 is a cross-sectional view of the proximal portion of the stent graft of Figure 1. In Fig. 2, reference numeral 2 denotes a stent body, reference numeral 3 denotes a blood vessel wall, reference numeral 4 denotes a film, reference numeral 5 denotes a plaque, and reference numeral 6 denotes a gap. As can be seen from Fig. 2, a gap 6 is generated between the plaque 5 of the blood vessel and the membrane 4, so that the type I endoleak is easily caused. For the type I internal leakage in Fig. 1, the following two solutions are generally available in the prior art. Option One:
通过球囊扩张覆膜支架的近端， 将覆膜支架与血管壁贴合。 该方 法操作性较好， 但是该方法对覆膜支架的近端贴合血管壁仅能提供辅 助作用， 尤其是钙化较严重的血管。 因此， 该方法的效果较差， 同时 使用球囊， 也会给患者带来经济负担。 方案二: 近端加短段带膜支架（cuff)。该方法对 I型内漏有比较好的效果。 但是需要新加短段带膜支架， 这不仅在经济上加重病人的负担， 同时 可能会带来新的风险， 例如会带来反折、 移位等风险。 现有技术中的普通支架只有单层覆膜， 同时支架的径向支撑力比 较低， 存在容易使得近端贴壁不良而经常导致 I型内漏的情况。 通过 一些现有技术的方案， 虽然能够起到一些弥补作用， 但是还不能完全 覆盖所有病变， 同时还有可能会引起新的风险。 这样不仅对医生的操 作要求比较高， 增加手术时间与手术风险， 同时还会给病人带来经济 负担。 中国专利文献 CN2741534Y、 CN201445575U, CN201602915U和 美国专利文献 US8118856B2也公开了一些相关的现有技术。 发明内容 The stent graft is attached to the vessel wall by expanding the proximal end of the stent graft through the balloon. The method is more operability, but the method can only provide an auxiliary effect on the proximal end of the stent graft to the vessel wall, especially the blood vessel with more calcification. Therefore, the method is ineffective, and the use of the balloon also imposes an economic burden on the patient. Option II: The proximal end plus a short section of the stent (cuff). This method has a good effect on type I internal leakage. However, a new short-segment with a stent is needed, which not only economically burdens the patient, but also may bring new risks, such as risk of reflexion and displacement. The conventional stent in the prior art has only a single layer of film, and the radial supporting force of the stent is relatively low, and there is a case where the proximal end is poorly attached and the type I endoleak is often caused. Although some prior art solutions can provide some compensation, they do not completely cover all the lesions, and may also cause new risks. This not only requires a higher level of doctor's operation, but also increases the operation time and the risk of surgery, and at the same time imposes an economic burden on the patient. Some related prior art is also disclosed in the Chinese patent documents CN2741534Y, CN201445575U, CN201602915U and US Pat. No. 8,118,856 B2. Summary of the invention
鉴于现有技术的上述技术问题， 本发明的目的在于开发一种覆膜 支架， 其能增加支架的近端贴壁性， 降低近端贴壁不良而导致 I型内 漏的风险。 根据本发明， 提供了一种覆膜支架， 包括：  In view of the above technical problems of the prior art, it is an object of the present invention to develop a stent graft which can increase the proximal end adherence of the stent and reduce the risk of a type I endoleak caused by poor proximal attachment. According to the present invention, a stent graft is provided, comprising:
支架主体； 以及  Bracket body;
覆盖在所述支架主体上的内层覆膜，  Covering the inner layer of the film on the body of the stent,
其特征在于：  It is characterized by:
所述覆膜支架还包括设置在所述支架主体的近端部分处的外层覆 膜， 所述外层覆膜位于所述内层覆膜的外侧， 且所述外层覆膜的近端 和远端紧密贴合到所述内层覆膜， 并且所述内层覆膜中开有孔洞。 优选的是， 所述外层覆膜的近端和远端熔合到所述内层覆膜， 或 者所述外层覆膜的近端和远端采用医用缝合线缝合到所述内层覆膜。 优选的是， 在所述内层覆膜的近端部分中沿着所述内层覆膜的周 向方向开有若干个所述孔洞。 优选的是， 所述孔洞为圆形孔洞。 优选的是， 所述外层覆膜采用聚四氟乙烯材料构成， 所述内层覆 膜采用聚对苯二甲酸乙二醇酯编织结构构成。 优选的是， 所述外层覆膜采用聚对苯二甲酸乙二醇酯编织结构构 成， 所述内层覆膜采用聚对苯二甲酸乙二醇酯编织结构构成。 优选的是， 所述外层覆膜采用聚对苯二甲酸乙二醇酯编织结构构 成， 所述内层覆膜采用聚四氟乙烯材料构成。 本发明的覆膜支架能增加支架的近端贴壁性， 降低近端贴壁不良 而导致 I型内漏的风险。 具体而言， 本发明的覆膜支架可以极大的降 低近端内漏的风险， 从而本发明的覆膜支架解决了覆膜支架近端与血 管壁贴合不良造成的 I型内漏。 本发明的覆膜支架可以在现有技术的 主体覆膜支架整体结构不变的情况下在外层增加一层外层覆膜而形 成， 这样可以使用和以前一样的生产工艺， 没有提高工艺难度， 但是 却大大降低了内漏的风险， 因而本发明的产品更加具有市场竞争力。 而且， 本发明的覆膜支架可以覆盖绝大多数主动脉病例， 同时还可以 减少其它辅助器材的使用， 降低手术风险与手术费用。 附图说明 The stent graft further includes an outer layer coating disposed at a proximal end portion of the stent body, the outer layer coating being located outside the inner layer coating, and the proximal end of the outer layer coating And the distal end is in close contact with the inner layer coating, and the inner layer coating is provided with holes. Preferably, the proximal end and the distal end of the outer layer membrane are fused to the inner layer coating, or the proximal and distal ends of the outer layer coating are sutured to the inner layer by medical suture . Preferably, a plurality of said holes are formed in a proximal end portion of said inner layer film along a circumferential direction of said inner layer film. Preferably, the holes are circular holes. Preferably, the outer layer coating film is made of a polytetrafluoroethylene material, and the inner layer coating film is made of a polyethylene terephthalate woven structure. Preferably, the outer layer coating film is composed of a polyethylene terephthalate woven structure, and the inner layer coating film is formed of a polyethylene terephthalate woven structure. Preferably, the outer layer coating film is composed of a polyethylene terephthalate woven structure, and the inner layer coating film is made of a polytetrafluoroethylene material. The stent graft of the invention can increase the proximal adherence of the stent and reduce the risk of type I endoleak caused by poor proximal attachment. Specifically, the stent graft of the present invention can greatly reduce the risk of proximal endoleak, and thus the stent graft of the present invention solves the type I endoleak caused by poor adhesion of the proximal end of the stent graft to the vessel wall. The stent graft of the present invention can be formed by adding an outer layer coating to the outer layer without changing the overall structure of the main body stent graft of the prior art, so that the same production process as before can be used without improving the process difficulty. However, the risk of endoleak is greatly reduced, and thus the product of the present invention is more competitive in the market. Moreover, the stent graft of the present invention can cover most aortic cases, and can also reduce the use of other auxiliary equipment, reducing the risk of surgery and surgery. DRAWINGS
为了更清楚地说明本发明实施例的技术方案， 下面将对实施例描 述中所需要使用的附图作简单地介绍。 显而易见的是， 下面描述中的 附图仅仅是本申请中记载的一些特定实施例， 其不是对本发明的保护 范围的限制。 对于本领域普通技术人员来讲， 在不付出创造性劳动的 前提下， 当然还可以根据本发明的这些实施例及其附图获得一些其它 的实施例和附图。 In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings to be used in the description of the embodiments will be briefly described below. It is apparent that the drawings in the following description are only some of the specific embodiments described in the present application, and are not intended to limit the scope of the invention. For those of ordinary skill in the art, it is of course possible to obtain some other things according to the embodiments of the present invention and the drawings thereof without any creative work. Embodiments and figures.
图 1是现有技术的覆膜支架在血管中的示意图。  BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of a prior art stent graft in a blood vessel.
图 2是图 1中的覆膜支架的近端部分的横截面图。  Figure 2 is a cross-sectional view of the proximal portion of the stent graft of Figure 1.
图 3 是本发明的一个实施例的双层覆膜支架的近端的横截面示意 图。  Figure 3 is a schematic cross-sectional view of the proximal end of a two-layer stent graft in accordance with one embodiment of the present invention.
图 4 是图 3中的本发明的双层覆膜支架的纵向截面示意图。  Figure 4 is a schematic longitudinal cross-sectional view of the two-layer stent graft of the present invention in Figure 3.
图 5 是本发明的另一个实施例的双层覆膜支架的纵向截面示意 图。 具体实施方式  Figure 5 is a schematic longitudinal cross-sectional view of a two-layer stent graft of another embodiment of the present invention. detailed description
为了使本领域技术人员更好地理解本申请中的技术方案， 下面将 结合本发明实施例中的附图， 对本发明实施例中的技术方案进行清楚、 完整地描述。 显然， 所描述的实施例仅仅是本申请一部分实施例， 而 不是全部的实施例。 基于本申请所述的具体实施例， 本领域普通技术 人员在没有做出创造性劳动的前提下所获得的所有其它实施例， 都应 当落在本发明构思范围之内。 本发明总体上提供了一种应用于主动脉疾病及相关疾病的治疗的 新型双层覆膜支架。 以下参考图 3~图 5来详细描述本发明的优选实施例。 图 3 是本发明的一个实施例的双层覆膜支架的近端的横截面示意 图。 图 4 是图 3中的本发明的双层覆膜支架的纵向截面示意图。 如图 3和图 4所示， 本发明的覆膜支架的近端部分包括有双层覆膜， 即内层 覆膜 14、 外层覆膜 16。 内层覆膜 14中开有孔洞 17， 外层覆膜 16的尺 寸大于内层覆膜 14的尺寸。 外层覆膜 16的近端和远端与内层覆膜 14 紧密贴合。 如图 3和图 4所示， 本发明的覆膜支架包括： 支架主体 12; 以及 覆盖在所述支架主体 12上的内层覆膜 14。所述覆膜支架还包括设置在 所述支架主体 12的近端部分处的外层覆膜 16， 所述外层覆膜 16位于 所述内层覆膜 14的外侧， 且所述外层覆膜 16 的近端和远端紧密贴合 到所述内层覆膜 14， 并且所述内层覆膜 14中开有孔洞 17。 如图 4所 示， 血液沿着附图标记 11所示的血流方向在血管壁 13 内流动。 由于 孔洞 17的存在，血液可以通过孔洞 17进入外层覆膜 16和内层覆膜 14 之间的空间。 由于血液血压的存在， 外层覆膜 16将会鼓起形成顺应性 球囊， 并紧贴血管的斑块 15上。 同时， 支架主体 12的位于外层覆膜 16和内层覆膜 14之外的裸段部分也贴靠血管壁 13， 且内层覆膜 14的 不设置外层覆膜 16的部分也贴靠血管壁 13。 本发明的覆膜支架解决了覆膜支架近端与血管壁贴合不良造成的 I型内漏。 本发明的覆膜支架可以在现有技术的主体覆膜支架整体结 构不变的情况下在外层增加一层外层覆膜而形成， 这样可以使用和以 前一样的生产工艺， 没有提高工艺难度， 但是却大大降低了内漏的风 险， 因而本发明的产品更加具有市场竞争力。 以下采用三个实例来进一步说明本发明的方案。 实例一： For a better understanding of the technical solutions in the present application, the technical solutions in the embodiments of the present invention will be clearly and completely described in the following with reference to the accompanying drawings. It is apparent that the described embodiments are only a part of the embodiments of the present application, and not all of them. All other embodiments obtained by a person of ordinary skill in the art based on the specific embodiments described herein, without departing from the scope of the invention, should fall within the scope of the present invention. The present invention generally provides a novel bilayer stent graft for use in the treatment of aortic diseases and related diseases. Preferred embodiments of the present invention are described in detail below with reference to FIGS. 3 through 5. 3 is a schematic cross-sectional view of the proximal end of a two-layer stent graft in accordance with one embodiment of the present invention. Figure 4 is a schematic longitudinal cross-sectional view of the two-layer stent graft of the present invention of Figure 3. As shown in FIGS. 3 and 4, the proximal end portion of the stent graft of the present invention comprises a double layer coating, that is, an inner layer coating 14 and an outer layer coating 16. A hole 17 is formed in the inner layer film 14, and the outer layer film 16 has a larger size than the inner layer film 14. The proximal and distal ends of the outer layer coating 16 are in close contact with the inner layer coating 14. As shown in FIGS. 3 and 4, the stent graft of the present invention comprises: a stent body 12; An inner layer coating 14 covering the stent body 12 is provided. The stent graft further includes an outer layer coating 16 disposed at a proximal end portion of the stent body 12, the outer layer coating 16 being located outside the inner layer coating 14, and the outer layer covering The proximal and distal ends of the membrane 16 are in close contact with the inner layer coating 14, and the inner layer coating 14 is provided with a hole 17. As shown in FIG. 4, blood flows in the blood vessel wall 13 along the blood flow direction indicated by reference numeral 11. Due to the presence of the holes 17, blood can pass through the holes 17 into the space between the outer layer film 16 and the inner layer film 14. Due to the presence of blood pressure, the outer membrane 16 will bulge to form a compliant balloon and adhere to the plaque 15 of the blood vessel. At the same time, the bare portion of the stent body 12 outside the outer layer coating 16 and the inner layer coating 14 also abuts against the blood vessel wall 13, and the portion of the inner layer coating 14 that is not provided with the outer layer coating 16 also abuts Blood vessel wall 13. The stent graft of the invention solves the type I endoleak caused by poor adhesion between the proximal end of the stent graft and the vessel wall. The stent graft of the present invention can be formed by adding an outer layer coating to the outer layer without changing the overall structure of the main body stent graft of the prior art, so that the same production process as before can be used without improving the process difficulty. However, the risk of endoleak is greatly reduced, and thus the product of the present invention is more competitive in the market. Three examples are used below to further illustrate the solution of the present invention. Example 1:
覆膜支架采用双层覆膜结构。 外层覆膜采用 ePTFE材料 （聚四氟 乙烯材料）构成，直径为 22mm， 长度为 25mm; 内层覆膜采用 PET (聚 对苯二甲酸乙二醇酯） 编织结构构成， 直径为 20mm， 并沿内层覆膜近 端均匀开有 4个直径 5mm的圆形孔洞 27， 如图 5所示。 内层覆膜 24 覆盖在支架主体 22上。 血液可以通过孔洞 27进入外层覆膜 26和内层 覆膜 24之间的空间。 内层覆膜 24的近端与外层覆膜 26的近端采用熔 合技术熔合在一起， 内层覆膜 24 的距其近端 20mm处与外层覆膜 26 的远端采用熔合技术熔合在一起。 由于血液血压的存在， 外层覆膜 26 将会鼓起形成顺应性球囊， 并紧贴血管内壁上。 实例二： The stent graft adopts a double-layered membrane structure. The outer layer is made of ePTFE material (polytetrafluoroethylene material) with a diameter of 22mm and a length of 25mm . The inner layer is made of PET (polyethylene terephthalate) woven structure with a diameter of 20mm. Four circular holes 27 having a diameter of 5 mm are uniformly opened along the proximal end of the inner layer coating, as shown in FIG. The inner layer coating 24 is overlaid on the holder body 22. Blood can enter the space between the outer layer coating 26 and the inner layer coating 24 through the holes 27. The proximal end of the inner layer coating 24 and the proximal end of the outer layer coating 26 are fused together by a fusion technique, and the inner layer of the inner layer coating 24 is fused at a distance of 20 mm from the proximal end thereof and the distal end of the outer layer coating 26 by a fusion technique. together. Due to the presence of blood pressure, the outer membrane 26 will bulge to form a compliant balloon that fits snugly against the inner wall of the vessel. Example 2:
覆膜支架采用双层覆膜结构。 外层覆膜采用 PET (聚对苯二甲酸 乙二醇酯）编织结构构成， 直径为 34mm，长度为 35mm; 内层覆膜采用 PET (聚对苯二甲酸乙二醇酯） 编织结构构成， 直径为 30mm， 并沿内 层覆膜近端均匀开有 6个直径 6mm的圆形孔洞。 血液可以通过孔洞进 入外层覆膜和内层覆膜之间的空间。 内层覆膜的近端与外层覆膜的近 端用医用缝合线进行缝合， 内层覆膜的距其近端 30mm 处与外层覆膜 的远端用医用缝合线进行缝合。 由于血液血压的存在， 外层覆膜将会 鼓起形成顺应性球囊， 并紧贴血管内壁上。 实例三： The stent graft adopts a double-layered membrane structure. The outer layer coating is made of PET (polyethylene terephthalate) woven structure with a diameter of 34mm and a length of 35mm . The inner layer is made of PET (polyethylene terephthalate) woven structure. The diameter is 30mm, and six circular holes with a diameter of 6mm are uniformly opened along the proximal end of the inner layer. Blood can pass through the hole into the space between the outer layer film and the inner layer film. The proximal end of the inner layer coating and the proximal end of the outer layer coating were sutured with a medical suture, and the inner layer of the inner layer was sutured 30 mm from the proximal end and the distal end of the outer layer was sutured with a medical suture. Due to the presence of blood pressure, the outer membrane will bulge to form a compliant balloon that fits snugly against the inner wall of the vessel. Example three:
覆膜支架采用双层覆膜结构。 外层覆膜采用 PET (聚对苯二甲酸 乙二醇酯） 编织结构构成， 直径为 48mm， 长度为 45mm; 内层覆膜采 用 e-PTFE材料 （聚四氟乙烯材料） 构成， 直径为 44mm， 并在内层覆 膜中在距离支架近端 10mm处开有 8个直径 6mm的圆形孔洞。 血液可 以通过孔洞进入外层覆膜和内层覆膜之间的空间。 内层覆膜近端与外 层覆膜近端采用熔合技术熔合在一起， 内层覆膜的距其近端 40mm 处 与外层覆膜远端采用熔合技术熔合在一起。 由于血液血压的存在， 外 层覆膜将会鼓起形成顺应性球囊， 并紧贴血管内壁上。 本发明的覆膜支架可以极大地降低近端内漏的风险。 而且， 本发 明的覆膜支架可以覆盖绝大多数主动脉病例， 同时还可以减少其它辅 助器材的使用， 降低手术风险与手术费用。 此外， 应该理解， 本发明的覆膜支架可以应用于主动脉疾病的治 疗， SP， 它可以为主动脉覆膜支架， 但是本发明不限于此。 本发明的 覆膜支架也可以应用于其它血管的疾病的治疗中。 在本申请中， "近端" 是指靠近心脏的一端。 以上所述仅是本申请的一些具体实施例。 应当指出， 对于本技术 领域的普通技术人员来说， 在不脱离本申请发明原理和发明构思的前 提下， 还可以对上述实施例进行各种组合或做出若干改进和变型， 这 些组合、 改进和变型也应视为落在本申请的保护范围和发明构思之内。 The stent graft adopts a double-layered membrane structure. The outer layer is made of PET (polyethylene terephthalate) woven structure with a diameter of 48mm and a length of 45mm. The inner layer is made of e-PTFE material (polytetrafluoroethylene material) with a diameter of 44mm. And 8 circular holes with a diameter of 6 mm are opened in the inner layer film at a distance of 10 mm from the proximal end of the stent. Blood can pass through the hole into the space between the outer layer film and the inner layer film. The proximal end of the inner layer film and the proximal end of the outer layer film are fused together by a fusion technique, and the inner layer film is fused together by a fusion technique 40 mm from the proximal end and the outer layer of the outer layer film. Due to the presence of blood pressure, the outer membrane will bulge to form a compliant balloon that fits snugly against the inner wall of the vessel. The stent graft of the present invention can greatly reduce the risk of proximal endoleak. Moreover, the stent graft of the present invention can cover most aortic cases, and can also reduce the use of other auxiliary equipment, reducing the risk of surgery and surgery. Furthermore, it should be understood that the stent graft of the present invention can be applied to the treatment of aortic diseases, SP, which can be a stent graft of the aorta, but the invention is not limited thereto. The stent graft of the present invention can also be applied to the treatment of diseases of other blood vessels. In the present application, "proximal" refers to the end near the heart. The above description is only some specific embodiments of the present application. It should be noted that those skilled in the art can make various combinations or make some improvements and modifications to the above embodiments without departing from the principles and inventive concepts of the present invention. And variations are also considered to fall within the scope of the invention and the inventive concept.

Claims

权 利 要 求 书 claims
1. 一种覆膜支架， 包括： 1. A covered stent, including:
支架主体 （12、 22) ； 以及 Bracket body (12, 22); and
覆盖在所述支架主体 （12、 22) 上的内层覆膜 （14、 24) ， 其特征在于： The inner coating (14, 24) covering the stent body (12, 22) is characterized by:
所述覆膜支架还包括设置在所述支架主体 （12、 22) 的近端部分 处的外层覆膜 （16、 26) ， 所述外层覆膜 （16、 26) 位于所述内层覆 膜 （14、 24) 的外侧， 且所述外层覆膜 （16、 26) 的近端和远端紧密 贴合到所述内层覆膜 （14、 24) ， 并且所述内层覆膜 （14、 24) 中开 有孔洞 (17、 27) 。 The stent graft also includes an outer coating (16, 26) provided at the proximal portion of the stent body (12, 22), and the outer coating (16, 26) is located on the inner layer The outer side of the coating (14, 24), and the proximal and distal ends of the outer coating (16, 26) are closely attached to the inner coating (14, 24), and the inner coating There are holes (17, 27) in the membrane (14, 24).
2. 根据权利要求 1所述的覆膜支架， 其特征在于， 所述外层覆膜 (16、 26) 的近端和远端熔合到所述内层覆膜 （14、 24) ， 或者所述 外层覆膜 （16、 26) 的近端和远端采用医用缝合线缝合到所述内层覆 膜 （14、 24) 。 2. The stent graft according to claim 1, characterized in that the proximal and distal ends of the outer coating (16, 26) are fused to the inner coating (14, 24), or the The proximal and distal ends of the outer covering (16, 26) are sutured to the inner covering (14, 24) using medical sutures.
3. 根据权利要求 1或 2所述的覆膜支架， 其特征在于， 在所述内 层覆膜 （14、 24) 的近端部分中沿着所述内层覆膜 （14、 24) 的周向 方向开有若干个所述孔洞 （17、 27) 。 3. The stent graft according to claim 1 or 2, characterized in that, in the proximal portion of the inner coating (14, 24) along the edges of the inner coating (14, 24) Several holes (17, 27) are opened in the circumferential direction.
4. 根据权利要求 1或 2所述的覆膜支架， 其特征在于， 所述孔洞 (17、 27) 为圆形孔洞。 4. The covered stent according to claim 1 or 2, characterized in that the holes (17, 27) are circular holes.
5. 根据权利要求 1或 2所述的覆膜支架， 其特征在于， 所述外层 覆膜 （16、 26) 采用聚四氟乙烯材料构成， 所述内层覆膜 （14、 24) 采用聚对苯二甲酸乙二醇酯编织结构构成。 5. The covered stent according to claim 1 or 2, characterized in that the outer coating (16, 26) is made of polytetrafluoroethylene material, and the inner coating (14, 24) is made of polytetrafluoroethylene. Made of polyethylene terephthalate woven construction.
6. 根据权利要求 1或 2所述的覆膜支架， 其特征在于， 所述外层 覆膜 （16、 26) 采用聚对苯二甲酸乙二醇酯编织结构构成， 所述内层 覆膜 （14、 24) 采用聚对苯二甲酸乙二醇酯编织结构构成。 6. The covered stent according to claim 1 or 2, characterized in that the outer covering (16, 26) is composed of a polyethylene terephthalate woven structure, and the inner layer The covering film (14, 24) is composed of a polyethylene terephthalate woven structure.
7. 根据权利要求 1或 2所述的覆膜支架， 其特征在于， 所述外层 覆膜 （16、 26) 采用聚对苯二甲酸乙二醇酯编织结构构成， 所述内层 覆膜 （14、 24) 采用聚四氟乙烯材料构成。 7. The covered stent according to claim 1 or 2, characterized in that the outer covering (16, 26) is composed of a polyethylene terephthalate woven structure, and the inner covering (14, 24) Made of polytetrafluoroethylene material.
PCT/CN2014/073056 2013-03-07 2014-03-07 A new type of double-layer covered stent WO2014135118A1 (en)

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CN112451170B (en) * 2016-12-28 2022-09-02 先健科技(深圳)有限公司 Covered stent
CN109717986B (en) * 2017-10-31 2021-07-02 上海微创心脉医疗科技股份有限公司 Branch type tectorial membrane support and branch type tectorial membrane support system
CN114642526A (en) * 2020-12-18 2022-06-21 先健科技(深圳)有限公司 Covered stent
CN114712034A (en) * 2021-01-05 2022-07-08 上海微创心脉医疗科技(集团)股份有限公司 Covered stent
CN113558709B (en) * 2021-09-22 2021-12-28 北京华脉泰科医疗器械股份有限公司 Support anchoring area moves device down

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