CN1097633A - 套筒式导管 - Google Patents
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Abstract
在一种用于将药物供应到血管壁或管状器官的
壁中的套筒式导管中,有多个围绕着中心腔纵向伸展
的、在导管头部区域具有径向排出开口的外腔,导管
可滑套在气球式导管上使之能至少部分地设置在气
球式导管的气球上,因而可在其上膨胀来贴靠待膨胀
的血管内壁,从而使药物能在压力下通过在外腔中的
排出开口直接供应到邻接外腔的血管的组织上,从而
将药物只施用到与头部的外表面接合的区域。
Description
本发明涉及一种用于在使用气球式导管进行例行治疗期间用流体、特别是药物来润湿与浸润血管壁的套筒式导管。
为了治疗动脉中的缩窄了的通道,气球扩张术被认为是一种创伤性小但非常有效与细致的方法。但是,经验表明,这种治疗方法具有约30%的高复发率,即是,通道在几个月、例如3至6个月的期间内就会再度缩窄。经已发现,这至少是部分地由通过气球扩张术、即通过组织的膨胀与破裂所引起的细胞生长而导致的。因此希望为经受这样的气球扩张术治疗的血管部位提供抵制这种组织生长的外加治疗。
已知有各种方法来进行生长抑制治疗,特别是例如用激光来施加能量、或用特殊药物进行定域治疗。公知的技术是使用网壁支撑(wire wall support)、即所谓扩张件(stent)来作为药物定域治疗的载体,但是使用方法很复杂并且不能取出。
曾经建议过使用带有多孔气球的气球式导管,使药物能在扩张过程中施用穿入组织内。但是,这个建议证实并不合适,这是因为在气球膨胀的起始时间及膨胀期间不能控制药物的流失量,因此不能将限定份量的药物施用到待治疗的组织壁的部位来润湿组织和浸润到组织壁内。在气球膨胀期间,即在气球壁贴靠血管壁之前已经有相当份量的药物放出,这些提早放出的药物不会到达待治疗的血管层,因而,如果特定的待治疗的血管部位要接受足够的药物份量,那就需要不希望有的高剂量。另一缺点是,用多孔气球只能产生不充足的压力,这种压力可能不足以使缩窄了的血管部位膨胀。
因此希望克服与多孔气球相联的前述缺点,但要保持气球扩张术的有效性和精致性,并且应当在同样的程序中方便组织与血管壁的药物治疗而不会显著地增加时间。因此本发明的目的在于改进现有气球式导管治疗的程序,使得一方面通过同时施药来降低高的复发率,另一方面药物可以按所需剂量施用并且基本上只施加到待治疗的组织部位。
在一种用以将药物供应到血管或管状器官的壁上的套筒式导管中,有多个外腔围绕着一个中心腔纵向伸展,这些外腔在导管的头部区域内具有径向排出开口,这个导管可在一个气球式导管上滑动使之至少部份地设置在气球式导管的气球上、因而可在其上膨胀来贴靠待扩张的血管内壁,从而使药物能在压力下通过在外腔中的排出开口直接供应到邻接外腔的血管的组织上,从而将药物只施用到与头部的外表面接合的区域。
本发明的装置所具有的优点是,此种套筒式导管可在气球式导管的收缩了的气球的一个部分上滑动,因此基本上能保持为导管插入缩窄了血管部位所要求的小的气球截面。气球膨胀迫使套筒式导管的头部跟待治疗的组织接合,因此,在扩张过程中,药物可在压力下通过外腔直接施用到待治疗的组织上,从而使药物只进入该部位的组织。这样,所有用于抑制在治疗部位内的不希望出现的细胞生长的毒性化合物或按其因技术设计的药物可以直接地注射到并只注射到待治疗的组织部位内。
在本发明的另一个实施例中,排出开口预成形成使它们通过气球压力的作用来打开。这些排出开口也可以预成形成使它们对外腔施加额外的压力来打开。
在另一实施例中,为了有利于套筒式导管的头部的膨胀,头部在其外侧在排出开口之间设有纵向伸展的径向凹槽。通过也在邻接导管内腔设置的内壁在外腔之间设置纵向伸展的径向凹槽,可以进一步有助于头部的膨胀。
为了尽可能地定域施药、即只在紧邻着缩窄了的血管部位、或狭窄部位施药,如果排出开口预成形成使它们随着压力的增大而从头部的连端开始到头部的近端逐渐依次打开,这将是有利的。根据套筒式导管跟气球式导管结合使用在血管或器官内的位置,施用不同份量的药物来对组织进行润湿或浸润到组织内将是有利的。因此,在套筒式导管头部圆周上分布设置6至20个外腔也是在本发明的范畴内。
本发明的优点和特征通过下面结合附图对一个实施例的描述而更加清楚。在附图中,
图1示出设置在一个气球式导管的套筒式导管的头部;
图2是其上设置着套筒式导管的头部的气球式导管的前端的纵向剖视图;
图3是带着套筒式导管的膨胀头部的膨胀气球的纵向剖视图;
图4是沿图1的Ⅳ-Ⅳ剖切线看的横向剖视图;
图5示出操作气球式导管和套筒式导管的连接装置。
图1、2与3示出设置在气球式导管11上的套筒式导管10的细节。套筒式导管滑套在气球式导管上,使前者的头部16伸展至少部份地套在安装在一根挠性导杆14上的气球12上,如图2所示。两个导管在此相对位置上插入一根血管内或一个器官内。外腔18终接在套筒式导管的头部上并在套筒式导管的整个长度上伸展,直到在图5内示出并在下面描述的连接装置处为止。如图所示,外腔18围绕着一个中心腔20成一个圆圈布置,可以根据该套筒式导管的大小和应用范围来确定设置6至20个外腔。
也可以只设置一个或两个沿套筒式导管伸展的腔,而在头部分成几个外腔,这些外腔的横截面和布置设计来适应特定的应用。
在取自横切设置在气球式导管11上的头部16的图4的横截面中,有8个设有引到头部外面的排出开口24的外腔18。这些排出开口24设计成使它们只在接近结束施加气球压力时打开并随着将容纳在外腔18内的药物排出。也有可能将排出开口预成形成使它们只通过经由连接结构施加额外的压力来打开。
为了有助于头部16膨胀,头部至少在其外侧设有径向槽22,这些槽22在排出开口24之间纵向伸展并径向伸展到离头部内壁一个距离的受限制的深度,以提供一个只需用较小的压力就能使径向槽22打开并使头部膨胀的铰链结构。为了进一步降低使头部膨胀所需的压力,可以在头部的邻接中心腔20的内侧上再设置有在外腔18之间纵向伸展的径向槽23。如果有两个径向槽23设置在径向槽22的两侧,那就形成有进一步有助于头部膨胀的三铰链结构。
采用这种结构,藉着气球充份膨胀所需的例如5至8巴的压力就能使头部跟血管壁足够紧密地压贴接触,使药物在通过外腔18和排出开口24施药时不会流失,而是以高度定域的方式施加到血管内壁表面,使药物穿透壁面并以足够高的浓度浸润内层。
为了在头部藉着建立在内气球中的压力扩张来紧密地压靠着被胀住的组织时能使药物良好地分布,亦即是,为了将药物基本上注射到待治疗的缩窄部位的中心区域,排出开口24最好预成形成使它们随着压力的增大而从头部的远端开始到头部的近端依次打开。采用这种结构,就可以保证注射的药物不会被带走,而是以足够高的浓度按要求施用到组织层内,并接着浸润到深一些的壁层内。在导管缩小(通常在施药约60秒后)后放入血管中的药物量是比较少的,而且在实际上被稀释了,因此,就剂量而论,即使对治疗的血管部位定域施用大剂量,也不影响到整个身体系统。就其应用而言,基本上用于其效果是确定的经已公知的细胞毒性化合物(cell-toxic compound),但也可以用于按基因技术设计的药物。
通常跟气球扩张结合使用的压力发生器(indeflator)使药物能够以任何所需的压力和任何所需的预定份量注射和浸润进入组织内。
图5 示出用于注射药物的压力发生器和操作机构的连接结构。该连接结构包含一个带有一个清理用的接头32和一个连接压力发生器的接头34的Y形连接器。气球式导管11连接到此Y形连接器上。包围着气球式导管11套筒式导管10在其后端设有一个连接结构36,这个连接结构36具有一个接头37,药物由一个图中未示出的增压装置通过此接着供应。在连接结构36内,接头37连接到套筒式导管的外腔18上。
采用这样布置的连接结构,气球扩张可以独立于药物的施用来进行,因此药物可以独立在按预定份量施用。
对于冠状血管的治疗,本发明提供了一个显著的优点,保持了气球扩张方法的精致性并且施用时间不会拖长,这时因为药物是在正常扩张步骤进行的过程中进行注射,并且,在这过程中,精确限定份量的药物施用到确定好的血管部位上。
但是,本发明的装置不仅适用于治疗冠状血管,而且也适用于治疗肾脏血管或四肢血管,并且根据情况也可适用于头内血管。本发明的装置也可用于将生长抑制化合物润湿和浸湿器官的血管部份或诸如尿道或胆管的管状器或其它血管状器官。本发明的装置还特别适用于使用生长抑制化合物来治疗癌症部位(在此情况下用的是细胞抑制剂)。本发明的装置还使弥漫着癌的管状器官的治疗能够在不危害或不堵塞通过该处的通道的情况下进行,亦即用本发明的装置可以治疗气管部位或肠道部位的恶性疾病而不会干扰通过病患部位的通道。至于前列腺肥大的治疗,可以按前述的方式施用药物。
Claims (7)
1、一种用于使用流体、特别是液体药物对血管壁或其它管状器官进行润湿与浸润的套筒式导管,其特征在于,
该套筒式导管包含一个带有一个中心腔和多个外腔的头部,这些外腔在导管的横截面上沿一个围绕着中心腔的圆来设置并沿导管的纵向伸展,每个外腔具有一个形成在头部上的排出开口,
该套筒式导管设计成可在一个气球式导管上滑动使之可至少部分地设置在该气球式导管的气球上,
该套筒式导管的该头部在该气球膨胀时可膨胀来跟被胀大的血管的内壁接合,
该流体在压力下供应到所述外腔,使之在该头部跟待治疗的血管壁的内壁接合时通过所述排出开口施用到该血管壁上。
2、按权利要求1所述的套筒式导管,其特征在于所述排出开口预成形成使它们通过气球压力的作用来打开。
3、按权利要求1所述的套筒式导管,其特征在于所述排出开口预成形成使它们通过对外腔施加额外的压力来打开。
4、按权利要求1所述的套筒式导管,其特征在于所述头部在其外侧包括设置在所述排出开口之间的纵向伸展的径向槽。
5、按权利要求4所述的套筒式导管,其特征在于还在所述头部的邻接中心腔的内壁内在所述外腔之间设置有纵向伸展的径向槽。
6、按权利要求1所述的套筒式导管,其特征在于所述排出开口预成形成使它们随着压力的增大而从头部的远端开始到头部的近端依次打开。
7、按权利要求1所述的套筒式导管,其特征在于所述头部包括六个至二十个外腔分布在其圆周上。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DEP4324218.9 | 1993-07-19 | ||
DE4324218A DE4324218A1 (de) | 1993-07-19 | 1993-07-19 | Manschettenkatheter |
Publications (1)
Publication Number | Publication Date |
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CN1097633A true CN1097633A (zh) | 1995-01-25 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN94102024A Pending CN1097633A (zh) | 1993-07-19 | 1994-03-02 | 套筒式导管 |
Country Status (21)
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US (1) | US5364356A (zh) |
EP (1) | EP0710132B1 (zh) |
JP (1) | JPH09500303A (zh) |
KR (1) | KR960703634A (zh) |
CN (1) | CN1097633A (zh) |
AT (1) | ATE148352T1 (zh) |
AU (1) | AU5177593A (zh) |
CA (1) | CA2167573A1 (zh) |
CZ (1) | CZ284434B6 (zh) |
DE (2) | DE4324218A1 (zh) |
DK (1) | DK0710132T3 (zh) |
ES (1) | ES2096951T3 (zh) |
FI (1) | FI960219A (zh) |
GR (1) | GR3022431T3 (zh) |
HU (1) | HUT73327A (zh) |
NO (1) | NO960201D0 (zh) |
PL (1) | PL172711B1 (zh) |
SG (1) | SG46505A1 (zh) |
SK (1) | SK8696A3 (zh) |
TW (1) | TW235246B (zh) |
WO (1) | WO1995003081A1 (zh) |
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-
1993
- 1993-07-19 DE DE4324218A patent/DE4324218A1/de not_active Withdrawn
- 1993-10-07 US US08/132,877 patent/US5364356A/en not_active Expired - Fee Related
- 1993-10-13 AT AT93922950T patent/ATE148352T1/de not_active IP Right Cessation
- 1993-10-13 ES ES93922950T patent/ES2096951T3/es not_active Expired - Lifetime
- 1993-10-13 KR KR1019960700100A patent/KR960703634A/ko active IP Right Grant
- 1993-10-13 PL PL93312612A patent/PL172711B1/pl unknown
- 1993-10-13 SK SK86-96A patent/SK8696A3/sk unknown
- 1993-10-13 DK DK93922950.6T patent/DK0710132T3/da active
- 1993-10-13 HU HU9600104A patent/HUT73327A/hu unknown
- 1993-10-13 SG SG1996005328A patent/SG46505A1/en unknown
- 1993-10-13 DE DE59305366T patent/DE59305366D1/de not_active Expired - Fee Related
- 1993-10-13 EP EP93922950A patent/EP0710132B1/de not_active Expired - Lifetime
- 1993-10-13 WO PCT/EP1993/002830 patent/WO1995003081A1/de active IP Right Grant
- 1993-10-13 AU AU51775/93A patent/AU5177593A/en not_active Abandoned
- 1993-10-13 JP JP7504868A patent/JPH09500303A/ja active Pending
- 1993-10-13 CA CA002167573A patent/CA2167573A1/en not_active Abandoned
- 1993-10-13 CZ CZ96116A patent/CZ284434B6/cs unknown
- 1993-10-16 TW TW082108602A patent/TW235246B/zh active
-
1994
- 1994-03-02 CN CN94102024A patent/CN1097633A/zh active Pending
-
1996
- 1996-01-17 FI FI960219A patent/FI960219A/fi not_active Application Discontinuation
- 1996-01-17 NO NO960201A patent/NO960201D0/no unknown
-
1997
- 1997-01-30 GR GR970400073T patent/GR3022431T3/el unknown
Also Published As
Publication number | Publication date |
---|---|
JPH09500303A (ja) | 1997-01-14 |
EP0710132A1 (de) | 1996-05-08 |
HUT73327A (en) | 1996-07-29 |
CZ284434B6 (cs) | 1998-11-11 |
DE4324218A1 (de) | 1995-01-26 |
PL312612A1 (en) | 1996-04-29 |
KR960703634A (ko) | 1996-08-31 |
PL172711B1 (pl) | 1997-11-28 |
WO1995003081A1 (de) | 1995-02-02 |
HU9600104D0 (en) | 1996-03-28 |
ES2096951T3 (es) | 1997-03-16 |
DK0710132T3 (da) | 1997-06-02 |
DE59305366D1 (de) | 1997-03-13 |
CZ11696A3 (en) | 1996-04-17 |
CA2167573A1 (en) | 1995-02-02 |
TW235246B (en) | 1994-12-01 |
ATE148352T1 (de) | 1997-02-15 |
AU5177593A (en) | 1995-02-20 |
SK8696A3 (en) | 1996-05-08 |
FI960219A0 (fi) | 1996-01-17 |
NO960201L (no) | 1996-01-17 |
FI960219A (fi) | 1996-01-17 |
NO960201D0 (no) | 1996-01-17 |
US5364356A (en) | 1994-11-15 |
SG46505A1 (en) | 1998-02-20 |
EP0710132B1 (de) | 1997-01-29 |
GR3022431T3 (en) | 1997-04-30 |
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