CN100502806C - 具有非展开支架的气囊导管 - Google Patents

具有非展开支架的气囊导管 Download PDF

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CN100502806C
CN100502806C CN02819948.0A CN02819948A CN100502806C CN 100502806 C CN100502806 C CN 100502806C CN 02819948 A CN02819948 A CN 02819948A CN 100502806 C CN100502806 C CN 100502806C
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罗伯特·C·法南
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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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0058—X-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Abstract

一种血管成形气囊，包括非展开支架，用来防止或减少膨胀气囊相对正被处理的血管壁滑动的可能性。所述气囊包括适于固定在所述气囊或血管成形气囊导管上的非展开支架。所述支架包括一近端；一远端；和至少三个径向间隔放置的支撑，每一个支撑将所述近端与所述远端相连，每一个支撑具有一个或多个弯曲，以允许所述支撑的扩张以容纳所述气囊的膨胀。所述支架由一种材料制成，从而在所述气囊压缩时，使所述支架皱缩。

Description

具有非展开支架的气囊导管
技术领域
当用于经皮腔内血管成形术(PTA)或经皮腔内冠状动脉成形术(PTCA)的气囊膨胀并被迫与斑块(plaque)相接触时，相对损坏或被处理的血管壁来说，所述气囊会有沿纵向移动或滑动的趋势。
背景技术
最近，切割气囊(也称为atherotomy)在防止一些类型的再窄症(特别钙化的损坏和内支架再狭窄)的复发已经显示出临床功效。这种切割气囊是具有沿纵向结合在气囊表面上的3至4个atherotomes(显微外科刀片)。当切割气囊膨胀时，atherotomes沿径向移动，并以可控方式，通过切割和压缩动脉斑块打开堵塞的动脉。所述切割气囊的另一个优点是在其膨胀时，通过在气囊外表面上将金属刀片穿入到组织内部来保持自身的位置，并防止了气囊的移动。
发明内容
因此，本发明的主要目的是提供一种类似切割气囊的PTA或PTCA气囊，使其在血管中膨胀时减少了滑动的可能性。
具体地，本发明提供了一种适于固定在血管成形气囊导管的非展开支架，包括：一近端；一远端；至少三个径向间隔放置的支撑，每一个支撑将所述近端与所述远端相连，每一个支撑具有一个或多个弯曲，以允许所述支撑扩张以容纳所述气囊的膨胀；以及所述支架由具有记忆的材料制成，从而在所述气囊压缩时，使所述支架收缩。
本发明还提供了一种血管成形气囊导管，包括：具有一近端和一远端的可膨胀的/可收缩的气囊；以及适于固定在所述气囊上的非展开支架，包括一近端，一远端，至少三个径向间隔放置的支撑，每一个支撑将所述近端和所述远端相连，每一个支撑具有一个或多个弯曲，以允许所述支撑扩张，以容纳所述气囊的膨胀，所述支架由具有记忆的材料制成，从而在所述气囊压缩时，使所述支架收缩。
附图说明
图1是根据本发明，结合有非展开支架的膨胀的血管成形气囊的透视图；
图2是图1中所述膨胀的血管成形气囊和非展开支架的平面图；
图3是如图1所示的非展开支架，为更清晰示出的非展开支架将所述血管成形气囊移去的扩张状态下的透视图；
图4是图3中非展开支架的平面图；
图5是结合具有较长于图1和图2中所示血管成形气囊的工作长度的血管成形气囊、所述非展开支架的一个可替换的实施方案的透视图；
图6是以平面图示出的，适于与20mm长的血管成形气囊使用的非展开支架的布局的工程图(图中所示所有尺寸都为英寸)；
图7是在用支撑连接的气囊两端部之间结合有不包括任何连接件的非展开支架的一个可替换的实施方案的膨胀血管成形气囊的透视图；
图8是图7中所示，为更清晰地示出所述支架将血管成形气囊移去的透视图；
图9和图10是类似于图1、图5和图7，示出了本发明的进一步的实施方案的透视图；
图11是示出了连接有导管的所述气囊和非展开支架的本发明的进一步实施方案的透视图。
具体实施方式
本发明的非展开支架可用于结合传统的气囊导管。一种PTA或PTCA导管(扩张导管)可以是具有分别包括导线腔和气囊膨胀腔的内部件和外部件的共轴导管。每一个部件可多达3层并用编织加固。导管的近端有用于与膨胀装置连接的路厄式轮毂(luer hub)，一张力释放管从所述路厄式轮毂(luer hub)以一定距离延伸出来。所述内部件和外部件的远端可包括一锥形。导管轴部通过使用传统材料和处理方法制成。导管也可以是一种具有可变硬度技术的多硬度计管道。所述导管应与6F引导导管相兼容。可选择地，所述导管可以是多腔设计。
气囊1可由具有尿烷涂层的尼龙或尼龙共聚物(柔软的，非穿刺的)或PET(高压的，不柔软的)制成以具有胶粘性。气囊可以为从不柔软内层到最柔软外层的多层气囊。例如，PET的最内层提供较高压力气囊，并由尼龙外层包围，这就提供了更易于抵抗穿刺的表面。所述气囊可以是1.5-12mm的直径(1.5-4mm用于冠状血管，4-12mm用于周边血管)和15-60mm的长度(15-40mm用于冠状血管，多达60mm用于周边血管)。依据气囊的壁厚，气囊膨胀压力可为8-20个大气压力。在膨胀时，气囊端部和颈部呈锥形。
为与本发明保持一致，气囊具有镍钛诺(NiTi)结构，通常由2标识，该气囊结合有用于所述镍钛诺结构2在径向和纵向扩张的弯曲，以便响应气囊膨胀过程中的纵向和径向扩张，从而在膨胀过程中，镍钛诺结构2可将气囊保持在所需位置。这种镍钛诺结构2可以为一个非展开或临时支架，所述非展开或临时支架，在血管成形过程中，可允许对堵塞血管的受控破裂并血管壁的抓握。这种镍钛诺结构2包括激光切割海波管，由于镍钛诺材料的超弹特性，在气囊膨胀时扩张，而在气囊压缩时皱缩，而不是如支架在一般情况下保持在展开状态。
镍钛诺结构或非展开支架2具有近端3，远端4以及在两者之间任何位置的3-12个支撑或金属丝5(依据气囊尺寸-但最有可能为3-4个支撑)，它们都设有径向和纵向弯曲形状。在支架制造中与超弹性镍-钛合金镍钛诺的使用(见，例如Huang等申请的美国专利6,312,459)一样，激光切割的使用是众所周知的(见，例如Meridan等申请的美国专利5,994,667)。
如图1-4所示，四个支撑5的每一个具有正弦弯曲6，在气囊1膨胀时，允许激光切割海波管纵向扩张。由于膨胀，正弦弯曲6的直线长度可容纳气囊1的纵向扩张。所述支撑或金属丝5的截面形状可以是圆形，三角形，或长方形。支撑或金属丝5的优选直径范围从0.003英寸到0.010英寸。
在海波管的纵向中心位置，U型圆周连接器7将每一个支撑5和与其相临的支撑5相连。如图3-4中最清晰可见的，所述U型圆周连接器7设在中心轴的相对面上。海波管的远端4与气囊的颈部远端或导管轴的远端粘合，海波管的近端3与气囊的颈部近端相连或与导管轴的近端相连。支撑5可与气囊1的工作区相连，从而在气囊膨胀和压缩时，使海波管与气囊保持在一起。一种粘合剂，例如，氰基丙烯酸盐粘合剂，可用来在不同位置将支撑粘结在气囊上。
与气囊和激光切割海波管相连的导管轴可具有2.5F-8F的直径范围，并且远端可呈锥形，远端直径稍微小于近端直径。
图6中，激光切割海波管的尺寸用于与直径为3mm(0.118英寸)和长度为20mm的气囊的使用。直径为3mm的气囊的周长为πD＝3.14×(3mm)＝9.42mm或0.37英寸。可容易看到的是，所有U型圆周连接器7的总长度(上和后)必须大于膨胀气囊1的周长。每一个U型圆周连接器7的长度(上和后)，可通过下列公式来计算：
πd/n
其中d为膨胀气囊的直径，n为支撑的数量。U型弯曲的总长度(上和后)必须超过此长度。
产生的数除以2而得到一个长度，每一个U型连接器的上面和后面必须超过这个长度。例如，对一个具有4个支撑、直径为3mm的可兼容气囊的激光切割海波管来说，每一个U型连接器的长度(上和后)为0.37英寸除以4＝0.0925英寸。进一步除以2而得到0.04625英寸。这是U型连接器的每一面必须超过的长度。
在正弦弯曲6之间可有一套或多套U型连接器7。所述每一套包括用于每一个支撑的U型连接器(3个支撑-一套3个U型连接器)；(4个支撑-一套4个U型连接器，等等)。U型连接器的套数依据气囊的长度，从而依据激光切割海波管长度。对于一个20mm长的气囊，使用一套U型连接器，其间隔(沿气囊长度的中点位置处的)端部10mm的位置放置。对于一个40mm长的气囊，使用三套间隔10mm放置的U型连接器(第一套距离一端10mm处放置，第二套距离第一套10mm处放置，第三套均距离第二套和另一端10mm放置)。用于U型连接器套数的计算公式为：
L/10-1
其中L＝气囊的长度，以mm计算。在其他实施方案中，如图7和8所示，没有包括中间的U型连接器。

Claims (20)

1.一种适于固定在血管成形气囊导管的非展开支架，包括：
一近端；
一远端；
至少三个径向间隔放置的支撑，每一个支撑将所述近端与所述远端相连，每一个支撑具有一个或多个弯曲，以允许所述支撑扩张以容纳所述气囊的膨胀；以及
所述支架由具有记忆的材料制成，从而在所述气囊压缩时，使所述支架收缩。
2.如权利要求1所述的支架，其特征是，所述支架由钛镍合金制成。
3.如权利要求1所述的支架，其特征是，所述支撑具有0.003英寸到0.010英寸的直径。
4.如权利要求1所述的支架，其特征是，在所述支撑内的所述弯曲为正弦弯曲。
5.如权利要求1所述的支架，其特征是，所述支架由激光切割海波管制成。
6.如权利要求1所述的支架，其特征是，所述支架通过粘合剂固定在所述气囊上。
7.如权利要求6所述的支架，其特征是，所述粘合剂为氰基丙烯酸盐粘合剂。
8.如权利要求1所述的支架，其特征是，所述支撑通过连接器在所述近端和远端的中间彼此连接在一起，所述连接器包括一个弯曲以容纳所述气囊的径向扩张。
9.一种血管成形气囊导管，包括：
具有一近端和一远端的可膨胀的/可收缩的气囊；以及
适于固定在所述气囊上的非展开支架，包括一近端，一远端，至少三个径向间隔放置的支撑，每一个支撑将所述近端和所述远端相连，每一个支撑具有一个或多个弯曲，以允许所述支撑扩张，以容纳所述气囊的膨胀，所述支架由具有记忆的材料制成，从而在所述气囊压缩时，使所述支架收缩。
10.如权利要求9所述的血管成形气囊，其特征是，所述支架由钛镍合金制成。
11.如权利要求9所述的血管成形气囊，其特征是，所述支架的支撑直径为0.003英寸到0.010英寸。
12.如权利要求9所述的血管成形气囊，其特征是，在所述支架的所述支撑内所述弯曲为正弦弯曲。
13.如权利要求9所述的血管成形气囊，其特征是，所述支架由激光切割海波管制成。
14.如权利要求9所述的血管成形气囊，其特征是，所述支架通过粘合剂固定在气囊上。
15.如权利要求14所述的血管成形气囊，其特征是，所述粘合剂为氰基丙烯酸盐粘合剂。
16.如权利要求9所述的血管成形气囊，其特征是，所述支架的所述支撑通过连接器在所述近端和远端中间彼此相连，所述连接器包括一个弯曲以容纳所述气囊的径向扩张。
17.如权利要求1所述的支架，其特征是，所述支撑包括纵向弯曲，以容纳所述气囊的纵向扩张。
18.如权利要求17所述的支架，其特征是，在所述支撑内的所述纵向弯曲为正弦弯曲。
19.如权利要求9所述的支架，其特征是，所述支撑包括纵向弯曲，以容纳所述气囊的纵向扩张。
20.如权利要求19所述的支架，其特征是，所述支撑包括纵向弯曲，以容纳所述气囊的纵向扩张。
CN02819948.0A 2001-11-09 2002-11-06 具有非展开支架的气囊导管 Expired - Lifetime CN100502806C (zh)

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