CN105377184B - 栓塞保护装置 - Google Patents

栓塞保护装置 Download PDF

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CN105377184B
CN105377184B CN201480026391.2A CN201480026391A CN105377184B CN 105377184 B CN105377184 B CN 105377184B CN 201480026391 A CN201480026391 A CN 201480026391A CN 105377184 B CN105377184 B CN 105377184B
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filter
transmission line
distal end
joint
protective device
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CN105377184A (zh
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仓·拉姆
普里西拉·蔡
胡安·瓦伦西亚
杰奎琳·马西亚斯
卡西克·乔希
阿诺德·托尔森
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Terumo Corp
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Micro Cents America Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/013Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/0105Open ended, i.e. legs gathered only at one side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/016Filters implantable into blood vessels made from wire-like elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0006Rounded shapes, e.g. with rounded corners circular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0008Rounded shapes, e.g. with rounded corners elliptical or oval
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/005Rosette-shaped, e.g. star-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0076Quadric-shaped ellipsoidal or ovoid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0015Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
    • A61F2250/0017Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight differing in yarn density
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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)
  • Surgical Instruments (AREA)

Abstract

一种栓塞保护装置包括一可展开和可收缩的过滤器,该过滤器能够由一个或多个支柱支撑。该些支柱能够连接到该过滤器或被相互编织到过滤器,从而辅助该过滤器的展开和收缩。在一个实施例中,该些支柱的近端连接到一相对于一传送线定位的接头,而该过滤器的该远端连接到一相对于该传送线滑动的接头。

Description

栓塞保护装置
相关申请
本申请针对2013年3月15日美国临时专利申请序列号61/799,114提出优先权要求,在先申请的全部内容通过引用而结合在本文中。
背景技术
在某些外科手术过程,如基于导管的治疗,医生的手术工具有时可能撞出栓塞微粒。这些栓塞微粒典型地包括血栓、粉瘤和类脂物,它们一旦撞出就可能导致下游血管的堵塞。因此,这些栓塞微粒可能导致严重的手术并发症,例如中风,甚至死亡。
减少这些并发症的风险的一个方法是在手术治疗点的下游配置栓塞过滤器,从而捕捉任何可能被碰撞出去的微粒。一旦被捕捉,过滤器必须小心地关闭并且离开病人,以使得被捕获的微粒不散出。
发明内容
一个实施例涉及一种栓塞保护装置,该栓塞保护装置包括:一过滤器;一个或多个支柱,该支柱连接到该过滤器;一传送线;一滑动接头;一个或多个固定接头;和一柔性构件,该柔性构件在该滑动接头和一固定接头之间。
在一个实施例中,该栓塞保护装置包括一柔性构件,该柔性构件位于相对于该过滤器的远端。
在另一个实施例中,该栓塞保护装置包括一柔性构件,该柔性构件横跨该过滤器和该支柱之间的长度。
在另一个实施例中,该栓塞保护装置包括一柔性构件,该柔性构件横跨该过滤器和该支柱之间的长度的一部分。
在一个实施例中,该栓塞保护装置包括一滑动接头和/或固定接头,该滑动接头和/或固定接头具有适于与一传送装置配合的形状,该传送装置用于传 送该栓塞保护装置。
在一个实施例中,一栓塞保护装置包括一过滤器,其中该过滤器被内翻。
在另一个实施例中,一栓塞保护装置包括过滤器,其中该过滤器被外翻。
在另一个实施例中,一栓塞保护装置包括一快速交换导管。
在另一个实施例中,一栓塞保护装置包括一固定接头,该固定接头能够相对于一传送线旋转。
在另一个实施例中,一栓塞保护装置包括一过滤器,该过滤器由多根粗线和多根细线形成。粗线能够额外形成在该装置的近端上的该些支柱。此外,一近端固定接头和一远端滑动接头布置在一管上,一传送线布置成穿过该管。
在另一个实施例中,一栓塞保护装置包括一过滤器,该过滤器具有一热定型的端部开口的部分,该部分具有相比更远端部分相对渗透性较差或更加压缩的构造。
在另一个实施例中,一栓塞保护装置包括一过滤器,该过滤器具有一热定型的端部开口的部分,该部分具有相比更远端部分相对渗透性较差或更加压缩的构造。当该过滤器的直径减小时,更压缩区域的直径更快地减小,围绕着该过滤器的开口部分地闭合。
在另一个实施例中,一栓塞保护装置包括一过滤器,该过滤器具有远端支柱或环形,其辅助打开或闭合该过滤器。
在另一个实施例中,一栓塞保护装置被构造成作为一快速交换或单轨线路装置操作,容纳该传送线和该引导线。
附图说明
本发明的这些及其他方面、特征和优势将参照附图在本发明的实施例的下述描述中阐述并且是显而易见的,其中:
图1-3示意了在展开状态的栓塞保护装置。
图4-6示意了在压缩状态(即在传送期间)的栓塞保护装置。
图7示意了用在栓塞保护装置中的固定接头。
图8-9示意了用在栓塞保护装置中的过滤器。
图10-11示意了用在栓塞保护装置中的过滤器和支柱。
图12-13示意了用在栓塞保护装置中的支柱。
图14-16示意了滑动栓塞保护装置。
图17-18示意了与栓塞保护装置一起使用的导管。
图19示意了可旋转的栓塞保护装置。
图20-24示意了几个不同的可旋转的接头。
图形25-26示意了展开状态的栓塞保护装置。
图27-28示意了图25的装置的过滤器的放大视图。
图29-31示意了构成图25的装置的各个视图。
图32示意了具有抛物线的过滤器形状的栓塞保护装置。
图33示意了具有多个环状支柱的过滤器的一端视图。
图34-35示意了具有外"足球"形状支柱的栓塞保护装置。
图36示意了栓塞保护装置。
图37-40示意了多种快速交换的栓塞保护装置的横断面视图。
图41-44示意了多种快速交换的栓塞保护装置的侧视图。
图44-45示意了用于打开传送装置的远端的导管切割装置。
图46示意了用于打开传送装置的远端的导管切割装置。
具体实施方式
现在将参照附图描述发明的具体实施方式。但是,本发明可以体现为许多不同形式,而不应被解释为限于这里所阐述的实施例;更确切地说,提供这些实施例使得本公开将是彻底的和完整的,并且将充分地向本领域的技术人员传达本发明的范围。示意在附图中的实施例的详细说明中使用的术语并不是为了限制本发明。在附图中,相同的数字表示相同的元件。
在整个说明书中,使用术语血栓、栓子,栓塞微粒和类似术语。除非额外明确说明,这些术语可互换地被使用,其泛指任何可能位于或导致位于人 体的血管内的有害的不良的或其它危险的微粒。
本说明书和附图包含几个不同的实施例,这些实施例分别包含不同元件和结构。虽然已经描述了这些具体的实施例,但是应当理解这些元件和/或结构中的任一都可以与所述的其他实施例中的任一结合。
栓塞保护装置可以用来在血栓移除过程中束缚被撞出的血栓。在一个实例中,栓塞保护装置被放置在目标区域的远端。气球和/或支架用于撑开阻塞的血管,并且栓塞保护装置捕捉任何被撞出的血栓以防止其迁移到下游。
图1-3显示用于栓塞保护装置的各个实施例,该栓塞保护装置都具有用于束缚栓塞微粒的展开结构和如图4-6所示在通过传送装置30传送时采用的收缩结构。在这些实施例中的每一个中,栓塞保护装置10、11和13位于传送线12上并且包括用于捕获血栓的过滤器20。优选地,过滤器20是由一或多条线(例如,镍钛诺、不锈钢、钴铬和/或聚合材料组成的线)形成的编织物或网。不透辐射的材料(即钽或铂)还可以用于包含网的组成线。这些网或编织物过滤器20可以由单个或多个网或编织物层(例如,较大的多孔层和较小的多孔层)构成。在另一个实施例中,过滤器由单个固体材料(例如,激光切割管)形成。
装置10、11和13中的每一个都包括一个或多个连接到过滤器20上的各个位置的支柱22,以在手术过程中辅助展开和收缩过滤器20。因为支柱22接近或最靠近传送装置30,他们用于在装置10、11和13收缩到传送装置30内部时关闭过滤器20。
支柱22和过滤器20都能经由固定接头14和滑动接头16在传送线12上展开。支柱22连接到固定接头14,该固定接头14相对于传送线12是固定的。滑动接头16连接到过滤器20的远端,允许其在装置展开和收缩时相对于传送线12滑动。
过滤器20形成大致圆锥形,用于捕获血管的更近端部分产生的血栓。因此,过滤器20的打开(扩大)部分相对于过滤器连接到滑动接头16的部分是最接近的,并且支柱22相对于过滤器20是最接近的。
装置10、11和13还可以包括压缩构件18,该压缩构件18能够促使或偏压装置到展开位置。参照图1所示的装置10,压缩构件18设置在传送线12上并且连接到滑动接头16和固定接头15,它们都位于过滤器20的末端。压缩构件18可以包括金属或塑料的类弹簧构件、实心弹性聚合物构件、弹性材料或具有类似性质/功能的材料。
图4显示当栓塞保护装置10位于传送装置30(即微型导管)中时栓塞保护装置的压缩构造。当过滤器20位于传送装置30内部期间而皱缩时,过滤器20和支柱22将对滑动接头16施力。滑动接头16的远端朝向固定接头15移动致使压缩构件18压缩。当栓塞保护装置10从传送装置30释放时,压缩构件18从压缩构造移动到展开构造,紧接着推动过滤器20和支柱22至打开或展开构造。因为过滤器20和/或支柱22可以由被偏压或热定型至展开构造的形状记忆材料构成,这些元件可以在从传送装置30展开后进一步施加可展开力。进一步,固定接头15固定住压缩构件18,该压缩构件18反过来助于生成后退抵挡以防止过滤器20的过度展开。
参照图2的装置11,压缩构件18横跨滑动接头16和固定接头14之间的区域。图5显示当图2的栓塞保护装置11位于传送装置30(即微型导管)中时的压缩构造。当过滤器20在位于传送装置11内部期间皱缩时,过滤器20和压缩构件18对滑动接头16施力,导致滑动接头16在远端方向上滑动,拉伸压缩构件。当装置11从传送装置30移除时,压缩构件18将在接头14和16之间施加无限制的拉力,导致过滤器20展开,并且保持其展开状态。再次,因为过滤器20和/或支柱22可能由被偏压或热定型至展开构造的形状记忆材料组成,这些元件可以在从传送装置30展开后进一步施加可展开力。
参照图3中的装置13,压缩构件18联接在滑动接头16和远端的固定接头15(远端固定接头15相对于固定接头14在远端)之间。与图1所示的装置10实施例相反,压缩构件18位于过滤器20内部。与图2所示的装置11的实施例相反,压缩构件18仅仅在滑动接头16和固定接头14之间部分地展开。
图6显示图3的栓塞保护装置13的压缩构造。当装置13退出传送装置30时,压缩构件18收缩,拉动滑动接头16朝向固定接头15靠近。再次,因为过滤器20和/或支柱22可能由被偏压或热定型至展开构造的形状记忆材料组成,这些元件可以在从传送装置30展开后进一步施加可展开力。
图7显示图1的远端固定接头15的构造的实施例。在本实施例中,远端固定接头15在传送线12和压缩构件18之间具有锥形。固定接头15优选地具有光滑轮廓并且没有尖锐的边缘,以在栓塞保护装置10通过血管时帮助减少血管外伤。该装置的轮廓使其与传送装置30的远端可操作地配合。在图7中,远端固定接头15仅仅坐落到传送装置30的远端并且与传送装置30的远端开口配合。
图7中的远端固定接头所描述的形状可以分别用在图2和图3中的装置11和13的滑动接头16上。用这种方法,当最远端的接头位于传送装置30中时,最远端的接头将有效地用作装置的剩余部分的"密封"。
在图8所示的一个实施例中,装置15包括从外向内翻转的过滤器21,产生逐渐扩展的外层和逐渐减小的内层。过滤器21从单层向内拉动以产生第二个内置层。在一个实施例中,较小直径的管位于形成过滤器20的网或编织物的内部。网或编织物的一部分然后通过该较小直径的管被拉动,从而产生过滤器的较小直径区域。过滤器20可以被热定型为该最终形状,过滤器的自由端可以被插入共有元件(即滑动接头16)中,或同时采用两种技术。可选择地,过滤器21通过在网或编织物的外径上放置较大直径的管,然后在该管上松松地拉动该管以产生较大的逐渐扩展区域。
在图9所示的另一个实施例中,装置17的过滤器23从里向外翻转的,形成内层和外层。过滤器23被向外拉动折叠,自身翻转以产生外部的第二层。外层能够被拉紧以获得图9所示的更长的轮廓或被松开以获得类似于图8所示的轮廓。在一个实施例中,较大直径的管位于形成过滤器的网或编织物的外部。网或编织物的一部分覆盖并且绕着该管的外径移动以产生第二个重叠的区域。过滤器20可以被热定型为该最终形状,过滤器的自由端可以 被插入共有元件(即滑动接头16)中,或同时采用两种技术。可选择地,过滤器23可以通过在网或编织物的下方放置较小直径的管而生成,然后在该管下方拉紧网或编织物以产生位于下方的区域。
如前所述,在本说明书中描述的几个实施例包括连接到和支撑过滤器20的多个支柱22。支柱22能够通过提供被控制的约束力来帮助控制过滤器20的展开。在某些实施例中,因为支柱22连接到固定接头14,所以当再次将过滤器20插入传送装置30中时它们帮助过滤器20皱缩。在重新插入期间,支柱22将与滑动接头16和压缩构件18共同作用,对过滤器20提供约束力。因此,支柱22帮助控制过滤器20展开,并且在插入传送装置30期间帮助过滤器20皱缩。
支柱22能够被构造成多种结构。在一个实例中,金属支柱22能够与图9所示的双层过滤器23一同被采用。在一个实例中,支柱22连接到被内翻或外翻的网的两层,以为连接提供更强的固定点。支柱22可以包括连接构件24(例如,钩状或环状),以连接到过滤器23。连接构件24可以被热定型以形成连接到过滤器23或可以直接视为连接到过滤器23的形状。在一个实例中,连接构件24是线圈,该线圈包围支柱22的端部并且形成穿过过滤器23的孔的环。该线圈帮助支柱22相对于过滤器23固定并且提供较软并且具有较高表面面积的表面,以按压抵靠过滤器。多种材料能够被用于支柱22,包括镍钛金属、不锈钢、聚合物、不透辐射的材料(即钽、铂、或钯)和它们的组合物。
在图11所示的另一个实例中,支柱22都是延伸穿过过滤器23上的孔并且连接回到自身的单线,形成端部环。线的端部能够经由例如卷曲套筒的连接元件被固定到它们自身或能够用胶合剂、焊接或类似的技术彼此连结。
在图12所示的另一个实例中,一个或多个支柱22具有弯曲区域26,该弯曲区域26适于与过滤器20的相应弯曲区域配合。该弯曲区域26能够从单个支柱22或两个支柱22之间延伸,并且能够进一步被焊接或热处理,以固定到过滤器20的相应弯曲区域。该设计允许由于收缩到传送装置30中产 生的力,以遍布过滤器20的较大面积。
在图13所示的另一个实例中,支柱22由管(例如激光切割的镍钛诺管)构造而成,该管的一端为管状端,另一端为多个指状物。这些指状物作为支柱22并且连接到过滤器22的边缘。在该实例中,与指状物相反的管状区域可以被卷曲或被固定到传送线12,从而作为固定接头。
图14显示栓塞保护装置9的另一个实施例,该栓塞保护装置9包括装置9的近端的滑动接头34和装置9的远端的第二滑动接头32。止动部28位于两个止动部32和34之间,其限制装置9的向近端和向远端平移。换句话说,装置的向远端平移通过止动部28与近端的滑动器34相互作用而被限制(见图15),并且装置的向近端平移通过止动部28与末端的滑动器32相互作用而被限制(见图16)。滑动接头32、34绕着传送线12被布置或被捕获但是引起与线的微小摩擦,因此允许接头32、34容易滑动。
图17-18显示快速交换导管31的实施例,该快速交换导管31用于栓塞保护装置10(或说明书中描述的装置中任一个)的传送。导管31包括远端口36,该远端口36用作引导线40的进入口,该引导线40在被插入时用于将导管31引导或直接传送至血管内部的某个目标区域。近端口38被用作栓塞保护装置10的进入口,允许装置10到达由引导线40获得的所需的目标位置。
在一个实例中,引导线40和传送线12的直径都是大约0.014英寸。也可以采用较小或较大的各种直径,并且该值只是用于举例。
本发明的另一个方面能够允许近端接头44和/或远端接头42中的一个或多个可旋转,如图20-24所示。优选地,远端接头42是可旋转的,以当过滤器20展开和收缩时允许过滤器20在血管中转动。这允许装置10更顺应病人的血管并且减少任何导致装置10的不良功能的有害的应力。
图20示意了可旋转接头42A的一个实施例,具有两个放大的部分46A,该部分46A被固定以防止相对传送线12平移和转动。外转动构件42A直接地适配在线12上,从而抓住线12,而放大的部分46A防止区域42A的平移。 因此,外转动构件42A(和任何附着于它的元件)能够原地旋转。
图21示意接头42B的另一个实施例,在该实施例中,外转动构件43包括凹陷的空腔,该空腔容纳固定的、放大的构件46B。如之前的接头42A,固定的放大的构件46B被固定到线12以防止平移或转动位移。构件46B也被制造得足够大,以使得不能穿过外转动构件43的直径减小的部分。因此,外转动构件43有效地捕获构件46B,但是能够原地旋转。
图22示意接头42C的另一个实施例,该接头42C大致类似于接头42A,然而固定的放大的构件46B中的一个包括锥形区域,而外转动构件45包括相反的锥形区域。类似地,图23示意了接头42E的另一个实施例,其中,外转动构件47的两端具有与两个固定的放大的构件46C相反的锥形区域。最后,图24示意了接头42E的再一个实施例,该接头42E大致类似于接头42B,除了外转动构件49包括锥形的凹陷的区域,该区域捕获相反锥形的固定的放大的构件46E。
所述的接头可以由多种材料组成,包括镍钛诺、不锈钢、钴、铬、聚合物、不透辐射的材料(即铂或钽)或它们的多种组合物。如前所述,这些转动接头可以被用于说明书中所述的实施例中的任何一个。另外,放大的构件46A-46E可以偏移(或缩入空腔壳体中)以允许转动之外的少许平移自由。
图25示意了栓塞保护装置50的另一个实施例,该栓塞保护装置50大致类似于前述实施例,其中,装置50包括可展开的圆锥形过滤器64,该过滤器64具有近端固定接头58和远端滑动接头60。不同于前述实施例,过滤器64设置在管56(例如,聚酰亚胺管)上,两个接头58和60都位于管56上,并且该管56允许传送线12和引导线40一起通过。在这方面,装置50起"单轨线路"或快速交换型过滤器的作用。在一个实例中,传送线12坐落在管56的全部或一部分(管56放置在所述传送线上的部分)的内部,在另一个实例中,传送线12在管56的近端终止。
如图25-27中所示,过滤器64优选地由与多条较大直径的线54编织在一起的多条较小直径的线52组成。例如,较小直径的线52可以具有大约 0.0005-0.00225英寸的直径,而较大直径的线54可以具有大约0.00225-0.008英寸的直径。另外,可以使用大约4至6条较大直径的线54,并且可以使用大约72至288条较小直径的线52。如下述更详细的描述中所讨论的,较大直径的线54还可以形成装置50的近端的支柱。在可选择的实施例中,较大直径的线54可以具有与线52相同或类似的直径,但是可以由强度更大或更硬的材料组成(例如,钴铬线54和镍钛诺线52)。
如图25和26中清楚看到,当在展开构造时,过滤器64具有大致圆锥形和渗透性较差的端部64A(即,接近开口端的区域)。装置50在手术过程中捕获微粒并且使用者开始收缩过滤器64之后,该端部64A展开并且直径减小,顺应着近端较粗线54的大致形状。该端部64A的至少部分展开可以在图26中看见。在这方面,在过滤器64的其余的远端部分的直径有任何实质减小之前,过滤器64围绕被捕获在过滤器64内部的任意微粒的近端部分系紧或闭合。换句话说,过滤器64的近端至少部分地首先闭合,防止过滤器64的远端挤出任意微粒到病人的血管中。端部64A能够通过热定形这些区域至比剩余部分更压缩的构造而形成,或能够由变化的不同的编织图案形成。可选择地,端部64A可以具有基本上恒定的直径轮廓而不是所示的减小的轮廓。
图28-31示意多种可以用于制造装置50的步骤。首先参照图29,管状的类支柱结构63能够被首先编织或与前述的线52和54一起编织。中心区域64A(也称为完成的过滤器64中的端部64A)优选地被热定型为比管63的剩余部分更压缩的构造。
参照图30,管63的近端经由固定接头构件58被卷到管56上并且管63的近端相对于管56连接到滑动接头60。该布置生成具有两个圆锥形端部64B的网结构。
参照图31,只有较小直径的线52之后被修剪,以使得只有较大直径的线54保持在装置50的近端上。在一个实例中,线52仅仅在端部64A的近端并且相对于固定接头58被修剪。优选地,如图28所示,线52围绕过滤 器64的开口的自由端被电化抛光,以减小任何创伤或磨损的倾向。最后,第二远端柔性管62(参见图25)被固定到管56的端部,以为装置50提供防损尖端。柔性管62可以是聚合物(即聚四氟乙烯)或金属,并且可以具有一致的或可变的坚硬轮廓。可变的坚硬轮廓将有益于具有沿着管的长度的渐变的硬度,其中最远端(可能接触血管)的部分将更加灵活。该可变的坚硬轮廓能够通过沿着具有不同材料轮廓的管的长度使用多种聚合物或金属而获得。在一个实例中,激光切割螺旋图案被使用在金属或聚合物管上。线圈可以位于管下方,并且聚合物在线圈(即热缩管)上热定型。该线圈将为柔性管部分提供附加的柔性。柔性管62包含引导线穿过的通道,以使其能够通过血管。
可选择地,如图27所示,一个或多个不透辐射的遮蔽物53能够被固定在过滤器64上的多个位置。例如,遮蔽物53能够在接近端部64A或者过滤器64的自由边缘(即接近线52的电化抛光自由端)的位置被固定到较粗线54。
图32示意了栓塞保护装置70再一个实施例,该栓塞保护装置70除了进一步包括过滤器72的大致抛物线状之外,其大致类似于前述的实施例。通过提供更圆的远端72A给过滤器72而不是更直线或线性较小,过滤器的网的孔尺寸可以保留更多一致性并且因此改善通过其的远端血液流动。
图33示意了过滤器76的远端视图,该过滤器76具有多个支柱或较大直径的线,该多个支柱或较大直径的线形成用于过滤器76的网的支撑篮78。通常,篮78提供附加支撑并且甚至辅助过滤器76的展开/收缩。在一个实施例中,篮78的线由镍钛诺组成并且被热定型为所需的“打开”或展开构造。篮78能够位于过滤器76的内部,该篮78在过滤器的网的内部被编织或位于并且被固定到过滤器76的外侧。
图34和35示意了栓塞保护装置80的另一个实施例,具有多个伸长的支柱82,该些支柱82被固定到过滤器84。支柱82能够被热定型为图34的足球/椭圆形或图35的部分地翻转形状的构造,并且能够以这些形状被压缩 和展开。可选择地,支柱82能够被热定型为具有图35的展开的部分地翻转形状,但是能够被以图34的形状被放入传送装置30中,从而在展开后自身翻转为图35的形状。在这些实施例中的任一个中,支柱能够由激光切割镍钛诺管形成,以生成“单片式”框架以助于沿着血管壁平均地分配力。
图36示意了栓塞保护装置86的另一个实施例,该栓塞保护装置86具有大致长圆形或椭圆形。该装置86能够由管状的类支柱的结构生成,具有编织在一起的较大直径的线88和较小直径的线87。对于说明书描述的其他实施例,近端能够经由固定接头被卷曲或连接到传送线12,而远端能够经由滑动接头被连接到传送线12。
如前述的图25的装置50,例如,说明书的装置的最近端部分,比如固定接头58能够容纳传送线12(装置布置在传送线12上)以及引导线40,从而该最近端部分作为单轨线路或快速交换导管。应该理解的是,若干不同的构造都可以容纳这些线12、40,其实例示意在图37-44中。
图37-38示意了快速交换导管口的其他构造,其包括图17-18的变化例。该口将包含分成两个部分的一个大的开口,更远端口(即96)将用于引导线,而更近端口(即98)将用于栓塞保护装置。如图37所示,口中的一个能够被穿过(即更远端口90),以提供少许关于哪个口是用于哪个目的的触觉参考。
图39-40示意了固定接头或具有快速交换能力的装置实施例的最近端部分的多种实例的横截面构造。在图39中,横截面100包括第一通道102和第二通道104,其中,这些通道中的一个可以容纳引导线40并且另一个容纳传送线12。图40示意了横截面106,该横截面106具有用于引导线40的第一圆形通道108和用于传送线12的第二弧形通道110。在该实例中,传送线12也将是大致弧形从而适配在通道110内。通道110也优选地位于相对接近通道108的位置,并且具有内弧形状,该内弧形状稍稍大于通道108的直径,减小了该装置的整个直径。
转到图41-44,这些实施例揭示了多个实例的口和通道位置。转到图41, 示意了固定接头120,该固定接头120具有第一口120C和第二口120B,该第一口120C和第二口120B都导向相同的内部通道120A。因此,在共享穿过装置的相同通道120A的同时,传送线12能够直接穿过口120C,而引导线能够经由口40相对于中心稍微倾斜地穿过。
在图42中,固定接头122包括仅仅单个口122B和穿过装置的单个通道122A。因此,传送线12和引导线40能够共享口122B和通道122A。
现在转到图43,接头124包括开向口124B的第一通道124A和开向口124D的第二通道124C。在这方面,引导线40能够穿过其自身的通道124A和口124B,而传送线12能够在通道124C和通道124D中操作。
最后,图44示意了具有类似于图42中所示的单个通道122A和口122B的接头122。然而,传送线12进一步包含其自己的内部引导线通道12b,该通道12b邻近口12B并且在邻近装置的远端打开。口12A优选地定位成在正常操作期间接近接头122。在这方面,引导线40能够(例如,通过防损端)进入装置并且进入线12的远端,进入线12的通道12B并且最终离开线12的口12A。优选地,通道12B和口12A形成为容纳引导线40的大小。换句话说,接头本身可以包括例如图43的口的口,并且该口导入引导线能够插入的传送线内部的口。
近端接头58和远端接头60可以具有除了之前讨论的固定的近端的、可平移的远端的实例之外的不同的构造。例如,近端接头58可以(经由一个或多个位于所述近端接头的止动部)具有少许平移能力和/或经由不是完全被固定到管56的接头而具有少许转动的能力。远端接头60可以经由一个或多个接近该接头的止动部的组合具有更加限制的平移能力和/或经由不是完全地被固定到管56的接头而具有少许转动的能力。
传送装置的另一个方面,例如微型导管,允许传送装置的远端打开或展开,从而生成稍微锥形的远端以促进说明书的多种栓塞保护装置的缓和展开和收缩。在图45和46所示的一个实例中,传送装置130中的切口或裂缝136可以先于栓塞保护装置的展开被生成。开口装置134,其形成为切开或裂开 传送装置130的壁的形状,并能够位于或接近装置130的最远端。线132连接到开口装置134并且延伸至装置130的近端,允许医生拉动开口装置134,生成切口。在一个实施例中,线132位于传送装置130内部的它自己的通道内部。在另一个实施例,孔沿着传送装置130的壁设置,以辅助切口的生成。在另一个实施例中,传送装置130的远端包括“C”形金属元件,该元件被偏压以随着切口136的生成而向外展开。
虽然本发明已经按照特定实施例和应用被描述,但是本领域的技术人员也可以根据该教导,在不脱离要求保护的发明的主旨和范围内,产生附加实施例和修改例。因此,要理解,本文以举例的方式提供附图和说明书,以促进本发明的理解,而不应被解释为限制其范围。

Claims (17)

1.一种栓塞保护装置,其特征在于,其包含:
一伸长的传送线;
一过滤器,该过滤器连接到该伸长的传送线;该过滤器具有一展开构造和一皱缩构造;
一滑动接头,连接到所述过滤器的远端,其用于相对于传送线滑动且独立于所述栓塞保护装置的近端;
多个支柱,连接到过滤器且布置在所述过滤器近端;
一固定接头,连接到所述多个支柱,该固定接头相对于传送线是固定的;
一压缩构件,设置在所述过滤器的远端的传送线上并连接到所述滑动接头,从而偏压所述过滤器到展开构造。
2.如权利要求1所述的装置,其特征在于,其进一步包含多个支柱,该些支柱布置在该过滤器的近端,并且其中所述多个支柱在邻近该过滤器的近端的位置连结至该过滤器。
3.如权利要求1所述的装置,其特征在于,该过滤器的所述远端连接到该伸长的传送线以便相对于该伸长的传送线滑动。
4.如权利要求1所述的装置,其特征在于,其进一步包含布置在该装置上的快速交换导管。
5.如权利要求1所述的装置,其特征在于,该过滤器包含:由多根第一线和多根第二线形成的相互交织,该多根第一线具有一第一直径,该多根第二线具有一第二直径,该第二直径大于该第一直径。
6.如权利要求1所述的装置,其特征在于,该过滤器包含一热定型中间部分,该热定型中间部分相对于该过滤器的远端部被更加横向压缩。
7.如权利要求1所述的装置,其特征在于,该过滤器具有抛物线形状。
8.如权利要求1所述的装置,其特征在于,该过滤器的一远端进一步包含多个环状支柱。
9.如权利要求1所述的装置,其特征在于,该过滤器布置在多个椭圆形支柱的内部。
10.如权利要求1所述的装置,其特征在于,该装置进一步包含:一第一通道,该第一通道容纳该伸长的传送线:和一第二通道,该第二通道容纳一引导线。
11.如权利要求10所述的装置,其特征在于,该第一通道具有一弧形截面,并且该第二通道具有一圆形截面。
12.如权利要求1所述的装置,其特征在于,该伸长的传送线进一步包含一通道,该通道形成为容纳一引导线的大小。
13.如权利要求1所述的装置,其特征在于,其进一步包含一传送导管,该传送导管进一步具有一可选择性打开的远端。
14.如权利要求1所述的装置,其特征在于,该压缩构件是一弹簧构件、弹性聚合物构件或一弹性体构件。
15.如权利要求1所述的装置,其特征在于,该压缩构件布置在一远端固定接头和一远端滑动接头之间;该远端滑动接头连接到该过滤器的一远端。
16.如权利要求1所述的装置,其特征在于,该多个支柱被偏压以在该过滤器的该近端提供径向的展开力。
17.如权利要求1所述的装置,其特征在于,该接头包含一转动部分,该转动部分具有锥形区域。
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