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CN101102728B - 具有可自展开部分的支架 - Google Patents

具有可自展开部分的支架 Download PDF

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Publication number
CN101102728B
CN101102728B CN200680001999.5A CN200680001999A CN101102728B CN 101102728 B CN101102728 B CN 101102728B CN 200680001999 A CN200680001999 A CN 200680001999A CN 101102728 B CN101102728 B CN 101102728B
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thumbpiece
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CN101102728A (zh
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T·费尔德
E·康斯坦丁诺
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Trireme Medical LLC
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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
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    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
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    • 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
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    • 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
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    • 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
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    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91508—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a difference in amplitude along the band
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91516—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a change in frequency along the band
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

本发明提供了用于将支架置于分叉损伤处或开口损伤处的方法和设备。所述支架包括主体和外扩部分。该主体设计为可扩展并支承主脉管，而外扩部分至少部分对应于该主体的扩展而展开，并设计为可张开进入侧支或分叉开口区域并对其进行支承。该支架还可包含可递送入血管的治疗剂。

Description

具有可自展开部分的支架
相关申请的相互参照
本申请是非临时申请，其中的揭示内容涉及并请求以下在先临时申请的优先权：于2005年11月29日提交的60/740,935(代理人案卷号022246-000230US)；于2005年8月30日提交的60/712,949(代理人案卷号022246-000220US)；于2005年5月24日提交的60/684,454(代理人案卷号022246-000210US)；以及于2005年1月10日提交的60/643,062(代理人案卷号022246-000200US)，将它们的全部揭示内容纳入本文作为参考。
发明背景
1.技术领域。本发明涉及医疗装置，更具体而言涉及用于治疗分叉损伤处或其邻近处的血管狭窄的医疗装置。
置入支架(stenting)是一种主要用于狭窄血管的血管成形术中的常规医疗方法，在该方法中对阻塞的动脉进行扩张，并将支架置于该动脉中以维持术后血管开放。支架是小的筛网样管状装置，其通常由金属制成，并可涂有药物或含药物的聚合物。
虽然支架在治疗各种脉管系统损伤中获得了成功，但它们的成功在分叉损伤处和开口损伤处(ostial lesion)却受到限制。通常，在将支架放置于主血管中的分叉损伤处的过程中，支架筛网会阻断通往侧支的通路，并由此扰乱了血流模式并且限制了血液流入该侧支。此外，将支架置入分叉损伤处的侧支中常会导致支架突出进入主血管，这会对其后将支架置入主血管造成干扰，并会限制分支血管通路。
除了诸如操作时间长等的棘手问题以外，还会因将支架置于分叉损伤处而导致并发症，这是因为侧支通路受到限制以及需要在违反规定设计和或标识用途的情况下使用这些常规支架。这会使得长期效果大打折扣，导致与将支架植入其它损伤处相比更高比例的再狭窄。
一种在分叉损伤处使用常规支架的方法是将第一支架递送到主血管处，然后将第二支架递送穿过该主血管支架的支柱(strut)而到达侧支处。然而，由于第二支架穿过第一支架会卡住而使得该方法的实施有难度。另一种常用的方法是在放置主血管支架前先放置侧支支架。在这种情况下，两个支架间会存在间隙，而再狭窄则常常会发生在该间隙处。或者，间隙可通过递送一侧支支架而消除，该侧支支架具有一突起进入主血管的突起部分。在这种情况下，该突起的支架会在递送和主血管支架扩展中被压碎。侧支支架被压碎所导致的后果是难以预期的，可能会导致该支架发生不利的变形，也有可能会割破血管。
药物洗脱支架在冠状动脉治疗中已取得了临床成功，然而迄今为止尚未在分叉损伤处的治疗中表现出类似的成功率。这一结果是因为在主血管支架和侧支支架间的间隙处缺少金属支架的覆盖。
现有技术中已很好地揭示了常规支架设计。这些设计包括多种不同的支架结构和几何形状，以及用于制造的各种涂层和材料。球囊扩展支架中常用不锈钢和钴铬合金，而自扩展支架中则常用镍钛合金。然而，自扩展支架在冠状动脉中的使用受到了限制，这是因为需要精确确定大小和定位，以及为了最佳支架定位所需的对递送后支架进行操作的程度是有限的。
已尝试了设计用于分叉损伤处的专用支架。需要对开口侧支进行支承和通过支架涂层而将药物递送定位于分叉区域。然而，目前的方案有很多缺点，例如相对于常规支架的高轮廓(high profile)、需要累赘的递送系统来将该支架放置到适当的部位、以及面向侧支的旋转定位不够精确。
已设计了轮廓减低且挠性提高的支架，并尝试了使用超弹性材料(例如镍钛合金)制成的自扩展支架。这些支架设备无需球囊来扩展支架，从而在轮廓(profile)上可得到减低。然而，自扩展支架仍然难以定位和递送到目标分叉位置。一旦扩展开，就不易于用球囊来操作该镍钛支架，也不能非常有效地进行递送后膨胀。
用于分叉受损处的球囊扩展支架和自扩展支架，其容纳广角分叉的能力是有限的。自扩展镍钛记忆合金(Nitinol)会撑开而形成预设的结构，由此扩展后可能在支架和血管壁之间形成不利的间隙。同时，现有的球囊扩展支架适应局部解剖结构的能力也是有限的。
为了克服这一问题，常采用″吻合球囊″技术。在该技术中，在主血管和侧支中同时使两个血管成形术球囊膨胀，以使支架获得良好的壁附着。该技术是目前可用的最佳方法。然而，这两个球囊是通过常规金属导线而插入动脉的，而常规金属导线会影响分叉部位的局部几何形状并压迫真实的分叉角度。一旦抽出球囊和导线，侧支角会回复到其原先的位置，这会使得支架和动脉壁之间形成间隙。
由于这些原因和其它原因，目前对于分叉损伤处的治疗，在可被治疗的损伤处复杂性和为患者提供长期治疗效果方面是有限的。本发明将满足这些方面中的至少一些方面。
发明概述
本发明提供了用于将支架置于分叉或开口损伤处的方法和装置。术语“分叉”在本专利中包括任何类型的分叉损伤(处)和血管中邻近分叉的损伤(处)。短语“分叉开口区域”和“开口损伤处”应用于所有类型的损伤(处)，包括位于主动脉开口和接合位置的损伤。
球囊扩展支架的主体部分设计为可扩展并支承主血管，而外扩部分(flaringportion)则设计为至少部分对应于该主体扩展而张开进入并支承侧支或分叉开口区域。本申请中所用术语“外扩部分”是指在支架扩展后，从支架表面向外突出的支架部分，即其不再呈放射状地折叠。该外扩部分的扩展可采用排列在支架主体中的单个球囊，而无需置于该外扩部分中的额外球囊。
该支架设计无需采用自扩展材料(例如镍钛合金)，外扩部分的自展开特性是由于支架形状或球囊形状的总体图案而获得的，尽管在本发明的某些实例中可结合使用球囊扩展元件和自扩展材料。
在本发明的第一方面，所述球囊扩展支架包括主体和外扩部分。该外扩部分被设计为至少部分对应于主体的扩展而张开，而不依赖于与使扩展主体膨胀的球囊发生直接接触。该外扩部分可排列于主体的一侧。外扩部分通常包括多个翼形件，它们对应于主体的扩展而放射状地外扩进入侧支血管。外扩部分的翼形件通常以相对于支架中心轴10-150度的角度外扩。
在本发明的第二方面，所述球囊扩展支架包括主体和外扩部分。该外扩部分被设计为至少部分对应于主体的扩展而张开，而不依赖于与使扩展主体膨胀的球囊发生直接接触。该外扩部分可位于主体的末端。外扩部分通常包含多个翼形件，它们对应于主体的扩展而放射状地外扩到侧支血管开口上。外扩部分的翼形件通常以相对于支架中心轴10-150度的角度外扩。
本发明中支架外扩部分的外扩通常是通过杠杆机械件(leverage mechanism)来实现的。该杠杆机械件连接于主体和外扩部分之间，由此当主体扩展时，该杠杆机械件也发生移位。然后，该移位和相应的膨胀力(expansionforce)在扩展期间从主体沿杠杆机械件传递到外扩部分。杠杆机械件可以是设计用于转移力和举起旁侧部分的支架结构中一个部分。杠杆机械件还可为主支架体的一部分或侧支支承结构体的一部分。
支架的外扩部分还可包含近端和远端部分。可对杠杆机械件的尺寸进行改进，以使其更坚硬，从而可在扩展时从主体向远端外扩部分传递更大的力和移位。因此，杠杆机械件对远端部分的移动大于对近端部分的移动，由此使得远端部分展开的角度大于近端部分。
该球囊扩展支架还可包括位于该球囊扩展支架至少一部分之上的治疗剂。该治疗剂可涂覆在支架上或掩蔽在加到球囊扩展支架的聚合物层或其它载体中。该治疗剂被递送到损伤处(尤其是主血管损伤处、侧支损伤处或侧支开口)的至少一个部分，而治疗剂有助于减少支架植入后的再狭窄或炎症。
在本发明的另一方面，提供了一种用于递送球囊扩展支架的方法，该方法包括使具有主体的支架定位于血管中血管侧支的开口(ostialopening)处，和使主体扩展。主体的扩展，使得该主体的一部分以至少部分对应于主体扩展的方式进行外扩。这使得主血管中的支架稳定化，并使该球囊扩展支架的一部分移入开口处。外扩部分可位于主体的一侧或位于主体的一端。治疗剂可位于该球囊扩展支架的至少一部分之上。可将治疗剂涂覆在支架上或掩蔽在加到球囊扩展支架的聚合物层或其它载体中。该治疗剂被递送到损伤处(尤其是主血管损伤处、侧支损伤处或侧支开口)的至少一个部分，而治疗剂有助于减少支架植入后的再狭窄或炎症。
附图简述
图1所示为未卷曲的扁平分叉支架的二维示意图。
图2显示为图1所示支架的翼形件和连接支柱。
图3显示了安装在球囊上的图1的分叉支架。
图4-6显示了扩展前、扩展时和扩展后位于分叉位置的分叉支架。
图7所示为另一种未卷曲的扁平分叉支架设计的二维示意图。
图8显示了支架上的不透射线的标记物。
图8a显示了另一分叉支架设计的二维示意图，该支架延伸，并具有额外的连接支柱和四个不透射线的标记物。
图9显示了开始扩展的分叉支架的中部支架区域。
图10所示为另一种未卷曲的扁平开口支架的二维示意图。
图11显示了图10支架的末端部分。
图12显示了图10支架的翼形件和连接支架。
图13显示了安装在球囊上的图10的开口支架。
图14-16显示了扩展前、扩展时和扩展后位于分叉位置的开口支架。
图17-19显示了扩展前、扩展时和扩展后位于分叉位置且与分支血管成一定角度的开口支架。
图20显示了置于主体一侧时外扩部分的角度。
图21显示了置于主体末端时外扩部分的角度。
发明详述
本发明是一种用于分叉和开口损伤处的球囊扩展支架。本专利中的用语分叉包括所有类型的分叉损伤(处)和血管中邻近分叉的损伤(处)，或所有类型的开口损伤处(包括主动脉开口和接合位置)。
该支架具有管状结构，并包括可由球囊扩展且能支承主血管的主体。其具有能对应于主体的扩展而外扩以至少部分进入侧支血管并支承该侧支开口的部分，该部分的展开无需额外的助张球囊。如果需要的话，可用额外的球囊来实现展开。
图1中显示了分叉支架设计10的一个例子，其为二维的未卷曲扁平状。图2中还显示了支架10的其它结构特征，而图3则显示了安装在球囊20上的同一支架10。图1中的支架10包括设计为放射状扩展的结构件11，以及位于可放射状扩展的结构件11和外扩部分13之间的连接件12。
可放射状扩展的结构件11与连接件12的两侧都连接，但不是必需形成圆环状。结构件11可扩展以支承主血管，同时使得连接件12打开。将连接件12设计为具有优选向外变形的几何形状，而不是沿球囊表面变形。一旦可扩展结构件11扩展并使得连接件12打开，那么连接件12就会向外偏转。
本实例中的外扩部分13包括如图2所示的两个翼形件14，翼形件14与同样示于图2中的连接支柱15相互连接。还可增加其它翼形件。或者，可用弯曲的支柱或任何其它支柱设计来替代该翼形件。翼形件14与连接件12相连，并在连接件12偏转时向外展开进入侧支。本实例中所示的翼形件14是对称的，但是其中任何一个都具有不同的大小或设计，从而可更好地支承不同的分叉角。当翼形件14展开时，连接支柱15被拉动并可加大对侧支开口的覆盖面。该支架还包含如图1中所示的其它可放射状扩展的结构件16，结构件16因球囊的膨胀而扩展，在支架中部区域对主血管进行支承。可将该区域设计为不同图案以覆盖主血管。
图4、5和6显示了扩展过程中的分叉支架设计10。图4显示的支架10包含外扩区域13，其卷曲(crimped)在位于血管(BV)中的球囊20之上，图5显示了扩展期间的支架，其外扩部分13开始对应于主体的扩展而外扩，而图6则显示了完全扩展的支架，其中的外扩部分13扩展到侧支之中。图20显示了角α，即外扩部分相对于支架中轴线所呈的角度，其范围为10-150°，而外扩部分位于支架主体的一侧。
图7显示了另一种支架设计100，其含有与前述图1和2相类似的结构特征，但改变了结构特征的大小。在一个实施方式中，支架主体的近端和远端与支架中部区域相比具有不同的刚度。这就造成了展开时支架中心首先扩展。可通过如图9所示地改变球囊的图案来实现支架中心和外扩部分的展开。一个这样的实例是在接近球囊中心21处采用较薄的球囊壁厚度。这就将外扩部分推抵着侧支开口，并展开到该侧支的内部。靠近外扩部分的早期扩展，可在外扩部分展开之前将支架推到位。可通过壁厚、模具设计或聚合物的热处理等来控制球囊中心区域图案21。
可通过各种方式改变支架不同区域的径向刚度。一种方法是在最接近外扩部分的支架区域中减小支柱(例如106)的宽度或厚度。任选地，当需要较低的刚度时，可采用较长的支柱。另一种可行的方法是在需要较小径向刚度的区域中(例如101、106)中增大交叉的支柱间的间隔。
在一个实施方式中，外扩部分的结构件13设计为可展开到90°。在另一个实施方式中，外扩部分13设计为可展开到预定的角度。在另一实施方式中，外扩部分13以不同的角度倾斜以匹配分叉角的解剖学形态。控制外扩角度的另一种方法是对用于扩展支架的球囊主体施加不同的膨胀压力。
在另一实施方式中，支架是对称的，由此外扩部分13的两个翼形件14以相同的方式展开到相同的角度。或者，支架10可以是不对称的，以使得外扩部分13的远端区域以比外扩部分13近端区域更大角度展开。这可通过如下方式实现：在近端侧对连接支柱12传递较小的力，由此使得近端侧的偏转较少，从而将翼状件14提升到一个较小的角度。
使较小的力沿连接支柱12传递的方法的一个例子，是通过采用更长、更薄或既长又薄的可放射状扩展结构支柱，使得可放射状扩展的结构件11变弱。类似地，加强位于远端侧的连接支柱12，便可传递更多的力，从而展开得更大，以使将远端的翼状件14提升到大于近端翼状件的角度。或者，翼形件14可具有不同的设计以获得不同的特性并获得其它最佳益处，例如选择性药物递送。
在另一个实施方式中，该支架可包括不透射线的标记物来协助支架的精确定位。例如图8中，可将用不透射线的材料(例如金、铂、钽等)制造的不透射线的标记物(30)附着于支架10的不同位置，并可用透视仪(fluoroscopy)观察到。图7显示了支架的一个例子，其中外扩部分翼形件114被设计为包括焊接到或附着于支架的标记物。这些不透射线的标记物的优选位置是位于外扩部分的翼形件114。将不透射线的标记物置于外扩部分的各个翼形件114上，有助于医师确定外扩部分在支架扩展前相对于侧支的定位，并有助于对支架进行精确定位。它还可使得医师能够观察展开进入血管侧支的外扩部分。这是十分有利的，因为其不仅能帮助医师辨别侧支的定位，还有助于在对侧支区域的展开后治疗中置入第二支架或进行再次布入导线(re-guidewiring)。如图8a所示，可将多个不透射线的标记物308附着于外扩区域以进一步提高可见度，其中显示了4个不透射线的标记物。
可用生物相容性合金来制备支架，例如不锈钢、钴铬、钛、镍钛合金、铌合金或其它适用于身体移植物的材料。支架还可包括接枝材料，例如PTFE或聚合物膜。支架还可涂有抗炎药物或其它治疗剂，并且可使用聚合物或不使用聚合物。自扩展材料(例如镍钛合金)的使用，对于支架的功能和外扩部分的自动张开而言是任选而非必需的。可使用可再吸收的(resorbable)或可吸收的材料来制备支架，例如不同的聚合物制剂、镁合金和在躯体条件下可再吸收或可吸收的其它材料。
图1和2还显示了另一实施方式，其中的支架10包括三个部分：支架主体、外扩部分13、以及连接主体和外扩部分13的任选的杠杆机械件12或15。杠杆机械件12或15设计为以如下方式连接外扩部分13和主体：支架主体的部分扩展或主体球囊的膨胀所造成的力和移动，被传递并用于扩展外扩部分13。可使得杠杆机械件12或15与外扩部分13或主体的设计一体化，从而一旦当主体球囊膨胀时，帮助外扩部分13展开，而且还可用制造支架其它部分的同样方法来制造杠杆机械件12或15。例如，可用激光从管状物切割下包括侧面部分和杠杆机械件的整个支架样式。
在本发明的另一实施方式中，主体和外扩部分具有相同的图案(pattern)或相同的图案特征。支架的这两部分被具有不同设计特征的杠杆机械件所连接，其目的是将主体扩展所产生的力和几何变化通过杠杆作用进行传递，从而使外扩部分展开。
在另一个实施方式中，外扩部分的扩展发生在主体扩展完成之前。在该实施方式中，侧支部分的扩展有助于支架在分叉区域的定位和对齐，并使得支架系统获得分叉的角度并与局部解剖相吻合。
在一个实施方式中，支架的主体可具有多种样式。在该情况下，接近于外扩部分的支架区域具有不同于远离外扩部分的支架区域的样式(pattern)。外扩部分可具有这些样式中的任一种、不同的样式或根本无样式。
在另一实施方式中，支架的设计使得采用单球囊递送系统成为可能，而无需使用其他手段来展开外扩部分。在该实施方式中，系统的轮廓与其它分叉支架系统相比可非常之低，典型地低于0.06″，优选低于0.05″，通常低于0.04″，这是非专用于分叉损失处的传统支架的典型轮廓。该低轮廓可通过自展开外扩部分以及支架设计而实现。
在另一个实施方式中，可用各种涂层涂覆支架，这些涂层包括：生物相容性氧化物层(例如氧化铱等)、生物可降解或不可降解的含药物聚合物涂层、或药物分子，它们可有助于减低再狭窄、减少炎症或影响血管中的生物过程，从而为患者带来有益结果。
在另一个实施方式中，支架具有皱缩形态(crimped configuratioin)和扩展形态。通常在皱缩形态中，外扩部分随支架而皱缩，但并不必与皱缩的支架主体齐平(flush)，这是因为外扩部分中的支柱不必与皱缩的支架圆柱状表面齐平。有时，外扩部分可皱缩并与支架主体齐平。
在另一实施方式中，支架具有皱缩形态和扩展形态，在皱缩形态中，支架远端和近端的直径皱缩到小于支架中部区域。
现在来看图8a，该图显示了在外扩区域中具有额外的不透射线的标记物308和使支架主体加长的额外支柱310。图8a显示了二维未卷曲且扁平的分叉支架300。图8a中的支架300包括设计为放射状扩展的结构件301、以及位于可放射状扩展的结构件301和支架外扩部分305及313之间的连接件302。可放射状扩展的结构件301与连接件302的一侧相连，但不是必须形成圆环。可放射状扩展的结构件301扩展以支承主血管，同时使得连接件302张开。将连接件302设计为具有向外变形而不是沿着球囊表面变形的几何优先性。一旦可扩展结构件301扩展并使得连接件302张开，连接件302就向外偏转。
图8a中显示的支架外扩部分包括4个翼形件313，它们与连接支柱305互相连接，支柱305也能外扩并形成外扩部分的一部分。翼形件313与连接件302相连，并在连接302偏转时向外扩展进入侧支。该实例中所示的翼形件313是对称的，虽然其中各个翼形件可具有不同的大小和图案以更好地支持不同的分叉角。当翼形件313展开时，连接支柱305向内拉并对侧支开口提供更多的覆盖。
用于治疗分叉损伤处的许多递送系统，具有置于侧支中的侧支导线或侧部护套(side sheath)。在大多数情况下，侧部护套或侧支导线在支架近端侧的下方通过，从支架的侧部开口处穿出。在该实施方式中，侧支护套或导线在近端的翼形件313的下方和远端的翼形件313上方通过，这可能会干扰远部翼形件的展开。具有4个翼形件313是很有利的，这是因为在翼形件313之间形成了一空间，使得侧支导管护套或导线能扩展入侧支而不干扰到翼形件313。
如图8a所示，支架还可包括另一可放射状扩展的结构件306，该结构件306由于球囊的膨胀而扩展并在支架中部区域支承主血管。可将该区域设计为具有不同的样式以覆盖主血管。
也可对翼形件313进行改动，从而使得该支架还可包含不透射线的标记物以有助于对支架进行精确定位。例如，在图8a中，用不透射线的材料(例如金、铂、钽等)制造的不透射线的标记物物308，可在翼形件313上附着于支架300。标记物308可通过诸如型锻、焊接或熔接的方式附着于翼形件313。
这4个标记物308是有利的，这是因为它们帮助医师在支架扩展之前，相对于侧支观察到支架外扩部分，并有助于对支架进行更精确的定位。其还能使得医师观察到展开到血管侧支中的外扩部分。这是有利的，因为其不仅有助于医师辨别侧支的位置，还有助于在侧支区域的展开处理后置入第二支架或再次布入导线。此外，支架上具有4个标记物可使得医师能够在支架展开之前，在透视仪下确定支架的转动方向。当4个标记物均能被检测到时，这表明了支架的侧部或者面向透视仪荧光屏，或面向与荧光屏呈180度的另一方向。然后医师可扭转该设备，使其旋转到仅可观察到2个标记物，这表明所观察到的是面向开口方向的侧面，由此证实该支架已适当地对齐以供展开。
用本文所述的基本的支架设计所得到的是相对较短的支架，通常为6-8毫米长。此外，支架的结构可被设计为在支架展开期间前缩(foreshortening)，并造成支柱向分叉区域的移动，从而对分叉区域进行更好的支承。
在主血管中，损伤的平均长度约为15毫米，大部分损伤为10-20毫米。将短的支架置于分叉部位，常常需要在分叉支架的远端和近端放置额外的支架。这是很困难且不理想的，因为额外的支架在通过已递送的支架时可能会缠绕。为此，在支架的近端和远端增加长度和提供长多通常在10-20毫米间变化的支架设计是有利的。可为支架增加额外的增长结构件，它可对称地围绕着侧部，或添加在支架的近端部或远端部。该额外的结构件可设计为具有多种不同的几何形状以支承血管壁。
先前已描述了许多如此的几何形状。例如，共同设计可包括多列的正弦环(sinusoidal ring)，它们在扩展之前放射状地收缩，而一旦球囊扩展则放射状地打开。这些正弦环通常与各种不同的连接件设计相互连接。该连接件设计允许支架在扩展中得以前缩(foreshortening)，或该连接件设计允许支架在扩展中得以伸长。例如，当多列的正弦环以“峰对峰”方式排列且连接件将这些列的相邻峰相连时，支架在扩展中会前缩。反之，如果相邻的环与连接件在相邻的谷间相互连接，则支架在扩展时会伸长。因此，可加入额外的列以产生在扩展中能伸长的支架，以补偿支架侧部周围的前缩并提供10-20毫米的长度。
图8a显示了与邻近可放射状扩展的结构件301相连的额外支柱310，从而使得该支架如上所述地在扩展中伸长。图8a显示可放射状扩展的结构件301对称地位于支架300的两侧。然而，近端或远端可包括额外的可放射状扩展的结构件301，而在邻近的可放射状扩展的结构件301之间设有支柱310以产生长度可变的支架。此外，上文所讨论的所有改动和变化都可应用于图8a的实施方式中。
在另一个实施方式中，图10的支架200具有皱缩形态和扩展形态。在皱缩形态中，支架的近端区域皱缩为第一直径，而支架的远端区域皱缩为更小的第二直径。同样，外扩部分203的近部区域与支架的近部区域齐平，而外扩部分203的远部区域也与支架的远部区域齐平。此类支架设计200的例子示于图10-13，其中图10-12显示了支架200的二维视图，而图13显示了安装在球囊20上的同一支架200。
在另一实施方式中，图10-13描述了开口支架设计200的例子，其类似于前面所讨论的分叉设计10。开口支架设计200包括图10中所示的设计为可扩展的结构件201、连接可放射状扩展的结构件201的连接件202、以及图11中所示的边缘部分203。可放射状扩展的结构件201由无需形成圆环状且悬挂在连接件202两侧的元件构成。该结构件扩展并支承侧支血管，同时使得连接件202张开。
连接件202设计为具有向外变形而不是沿球囊表面变形的几何优先性。一旦可扩展结构件201扩展并使得连接件202张开，连接件202会向外偏转。边缘部分203包括图12中所示的2个翼形件204，它们与连接支柱205相互连接。这些翼形件204位于连接件202上，当连接件202偏转时翼形件向外展开进入侧支开口。本实例中所示的翼形件204是对称的，然而各个翼形件可具有不同的大小或设计以更好地支持不同的分叉角。另一种翼形件图案的例子包括弯曲的支柱。当翼形件204展开时，连接支柱205被拉动并可对侧支开口提供更多的覆盖。
支架200还包括图10中所示的另一可放射状扩展的结构件206，该结构件因球囊的膨胀而扩展，并在接近开口的支架区域支承侧支血管。支架的该区域可设计为具有不同的样式以便覆盖侧支血管。
在另一个实施方式中，支架可由一组彼此直接相连且不带有可扩展结构201的连接件202组成。在这种情况下，支架200可包括多于2个的连接件202。连接件的数量可为2-6个，或更多。
图14-16说明了开口支架的扩展过程。图14显示支架200皱缩在位于血管BV中的球囊20之上，而图15则显示了支架200扩展开以后，支架边缘部分203的展开。图16显示了撤去球囊20之后完全展开的支架200。图21显示了角α，即外扩部分相对于支架中轴线所成的角，其范围为10-150度。在图21中，外扩部分位于支架主体的一端。
在另一个实施方式中，支架主体在接近远端处具有与支架较靠近开口的区域不同的刚度。这就使得较靠近开口的支架区域首先扩展。可通过改变球囊的设计来实现支架远端区域和边缘部分的展开，以使得边缘部分区域具有较大的直径。另一个例子是在较靠近支架边缘部分采用较薄的球囊壁厚度。通过这一方法，边缘部分被推抵着侧支开口。靠近边缘部分的区域早期扩展，可支架主体展开之前将支架推到位。可通过壁厚、模具设计或聚合物的热处理来控制球囊远部区域的图案。
可通过不同的方法实现支架不同区域的径向刚度差异。一种方法是减小最接近边缘部分的支架区域中的支柱宽度或厚度。另一种方法是在需要较低刚度处使用较长的支柱。另一种可行的方法是在需要较小径向刚度的区域中增大交叉支柱间的间隔。
在一个实施方式中，将边缘部分结构设计为展开成90度的角。在另一种变化形式中，将边缘部分设计为会以不同的预定角度展开。任选地，边缘部分可以不同角度倾斜以适应微小的分叉角解剖学结构。另一种控制外扩角度的方法，是通过用于扩展支架的球囊，对支架的不同部分施加不同的展开压力。
在另一个实施方式中，支架是对称的，边缘部分203的两个翼形件204均以相同方式和相同的角度展开。或者，支架也可以是不对称的，由此边缘部分203的远端区域会以比外扩部分的近端区域更大的角度展开。这可通过在近端侧将较小的力传递给连接支柱202，然后连接支柱202发生较小的偏转而将翼形件提升较小的角度。
将较小的力传递到连接支柱202的一种方法，是通过使可放射状扩展的结构性支柱更长或更薄或既长且薄，从而弱化可放射状扩展的结构件201。类似地，强化位于远端侧的连接支柱202，可传递更大的力并由此偏转更大，从而使得远端翼形件204比近端翼形件提升更大的角度。或者，翼形件204可具有不同的设计以获得不同的特性，还可使得其它益处最大化(例如选择性药物递送)。图14-16显示了彼此相对的翼形件204。翼形件的数量可在1-8个间变化，优选2-4个翼形件。
当侧支岔开的角度小于90度时，如图17-19所示，开口的形态不是圆柱状对称的。为了适应该形态，支架200可具有成角度的几何形状，这意味着皱缩的支架轮廓在近端处按一定角度切割(图17)。翼形件204可逐渐地不对称地围绕支架轴线，由此一个翼形件会比另一个翼形件更接近支架的远端。如图17-19中所示，当支架200通过球囊(20)在血管(BV)中展开时，翼形件204与开口的角度相匹配。
翼形件的长度也可不同，这是因为开口的远侧比近侧长。开口远侧的轮廓不同于开口近侧的轮廓。翼形件可具有相同或不同的轮廓以适应不同的开口区域。
支架可包括类似于其它实施方式中30的不透射线的标记物，从而有助于支架的精确定位。一个例子是用不透射线的材料(例如金、铂、钽等)制造的不透射线的标记物，它可附着于支架的不同位置并可通过透视仪观察到。这些不透射线的标记物优选位于边缘部分的翼形件204上。将不透射线的标记物置于展开部分各个翼形件204上，将有助于医师在支架扩展前确定边缘部分203相对于开口的位置，并有助于对支架进行精确定位。它还使得医师能够观察到展开在开口之上的边缘部分203。这是有利的，因为其不仅有助于医师鉴别侧支的位置，还有助于在侧支区域的展开处理后，置入第二支架或重新布入导线。
支架可用生物相容性合金(例如不锈钢、钴铬、钛、镍钛合金、铌合金)或适用于植入身体的其它任何材料来制造。支架还可包括接枝材料，例如PTFE或聚合物膜。支架还可涂有抗炎药物或其它治疗剂，并且可使用聚合物或不使用聚合物。使用自扩展材料(例如镍钛合金)，对于支架的功能和边缘部分的自张开而言是任选的而不是必需的。可用能再吸收或可吸收材料来制备支架，这些材料为例如不同的聚合物制剂、镁合金和在身体条件下可再吸收或吸收的其它材料。
在一个实施方式中，支架200包括3个部分：支架主体、边缘部分203、以及连接主体和边缘部分203的任选的杠杆机械件202或205。将杠杆机械件202或205设计为以如下方式连接边缘部分203和主体：主体部分扩展或主体球囊膨胀所造成的力和移位，被传递并用于扩展边缘部分203。或者，杠杆机械件202或205可与边缘部分203或主体的图案一体化，从而一旦主体球囊膨胀时立即帮助边缘部分203展开，该杠杆机械件可用与制造支架其余部分的相同方法来制造。例如，可用激光从管状物中切割出包括侧向部分和杠杆机械件的整个支架样式(或图案)。
在本发明的另一个实施方式中，主体和边缘部分具有相同的图案或相同的图案特征。支架的这两部分被具有不同设计特征的杠杆机械件所连接，其目的是将主体扩展所产生的力和几何变化通过杠杆作用进行传递，从而展开边缘部分。
在另一实施方式中，边缘部分的扩展发生在主体扩展完成之前。这有助于支架在分叉区域的定义和对齐，使得支架系统获得分叉的角度并有助于匹配局部的解剖结构。
或者，在另一个实施方式中，支架的主体可具有多种样式。在这种情况下，靠近边缘部分所在位置的支架区域与远离边缘部分的支架区域具有不同的样式。边缘部分可具有这些样式中的一种样式、不同的样式或根本无样式。
支架设计使得具有单球囊递送系统成为可能，而无需使用其它手段来展开边缘部分。与其它分叉或开口支架系统相比，在该实施方式中系统的轮廓可以非常低，典型地低于0.06″，优选低于0.05″，通常低于0.04″，这是非专用于分叉或开口损伤处的常规支架的典型轮廓。这一低轮廓可通过自展开边缘部分以及支架设计来实现。
在另一实施方式中，可用多种涂层来涂覆支架，所述涂层包括生物相容性氧化物层(例如氧化铱等)、生物可降解或不可降解的含药聚合物涂层、或药物分子，它们可有助于减小再狭窄、减少炎症或影响血管中的生物过程，从而为患者带来有益结果。
在另一实施方式中，支架具有皱缩形态和扩展形态。通常在皱缩形态下，边缘部分随支架而皱缩，但不必与皱缩的主体齐平，这是因为边缘部分的支柱不必与皱缩的圆柱状支架表面齐平。然而，边缘部分可与支架主体皱缩齐平。在另一种变化形式中，支架近端或远端的直径皱缩为小于支架中部区域。
本发明的方法、导管和系统可用于递送各种不同活性物质，包括用于治疗多种腔体疾病和征状的药物。本发明的方法和装置对于递送多种治疗剂和药剂(在此总称为活性物质)尤为有用，尤其是适用于治疗血管和其它腔体病状的治疗剂和药物。例如，诸如紫杉醇等的抗增殖剂和抗有丝分裂剂、抗炎剂、诸如西罗莫司(雷帕霉素)等的免疫抑制剂、诸如叶酸类似物的抗增殖和抗有丝分裂剂，以及能给患者带来益处的任何其它治疗剂。可用多种方式将活性物质置于支架之上或之中。例如，通常可采用浸渍、喷涂、涂抹、等离子沉积、电镀、离心系统等方法，将活性物质涂覆在支架暴露表面的至少一部分之上。然而，更为典型的是将活性物质掺入聚合物载体中。适合的聚合物载体可以是可再吸收的，例如包括：聚乳酸(PLA)、聚乙醇酸(PLG)、胶原等的聚合物载体。或者，聚合物载体可为多孔但非可再吸收性的材料。
上述是本发明优选实施方式的完整描述，可在不脱离本发明范围的进行各种变化、改动、添加和替换，本发明范围由权利要求所限定。

Claims (7)

1.一种球囊扩展支架，其包括：
主体，
位于主体一侧的外扩部分，所述外扩部分包括至少一个翼形件，所述翼形件适于放射状地向外展开进入侧支；
位于主体和各翼形件之间的连接件，所述连接件对应于主体的扩展而变形，从而造成所述翼形件的放射状展开；以及
从所述翼形件各侧部延伸到所述主体的支柱，其中当翼形件展开进入侧支开口时，所述支柱随翼形件展开，从而为所述侧支开口提供覆盖。
2.如权利要求1所述的球囊扩展支架，其特征在于，所述外扩部分相对于所述球囊扩展支架的中轴线以10-150度的角度进行外扩。
3.如权利要求1所述的球囊扩展支架，其还包括位于球囊扩展支架至少一部分之上的治疗剂。
4.如权利要求2所述的球囊扩展支架，其还包括位于球囊扩展支架至少一部分之上的治疗剂。
5.如权利要求3所述的球囊扩展支架，其还包括聚合物层，其中所述治疗剂掩蔽在该聚合物层中。
6.如权利要求4所述的球囊扩展支架，其还包括聚合物层，其中所述治疗剂掩蔽在该聚合物层中。
7.如权利要求1-6中任一项所述的球囊扩展支架，其还包括由外扩部分负载的不透射线的标记物。
CN200680001999.5A 2005-01-10 2006-01-10 具有可自展开部分的支架 Expired - Fee Related CN101102728B (zh)

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US9114033B2 (en) 2015-08-25
ATE508714T1 (de) 2011-05-15
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WO2006074476A2 (en) 2006-07-13
EP1835866A2 (en) 2007-09-26
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