CN1020408C - 气球导管 - Google Patents
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Abstract
一种可膨胀的医用气球是由一根端部具有锥形区域的管状预成形件制成。其中,气球的主体和过渡部分具有可控的厚度。其方法包括提供一个厚度和直径适合于形成气球的树脂管,把在形成气球的管的一端或两端中上的确定区域加热到拉制温度并拉伸成一个在其管端具有一个锥形的、小直径区域的预成形件,还公开了一个过渡区域厚度小于0.001英寸的扩张气球导管
Description
本发明涉及医用气球,特别是血管成形术扩张气球导管。
这类气球相对于它们长的支托装置来说意图是被折成较小尺寸。例如在血管成形术气球导管的情况下,为使导管能通过狭窄弯曲的血管进入狭窄区,且要在该区域内吹胀气球,因此,小的尺寸是必需的。用后,气球还必须弄瘪并取出。重要的是在上述操作过程中不能损坏血管壁或人体其它的易损的组织。
制造这类气球的工艺通常从一个给定直径和壁厚的挤制圆柱形管开始。管在非结晶状态被加热到吹制温度并且被吹胀和在纵向上拉伸。这样对一个非结晶的聚乙烯对苯二甲酸酯管被拉伸并伸长到使气球主体上的壁厚小于0.001吋,且壁厚在成锥状的近端和远端的过渡区域内增加。
尽管业已发现这些气球是十分有用的,尤其是采用了高强度树脂,它提供了相当高的膨胀压力,但也存在着过渡区域内由于气球材料的厚度所造成的缺点。
为了插入时使气球有较小的外形尺寸,在气球折叠和绕导管轴卷绕时,在气球的端部会发生凸出的隆起或者变形。由于在这些区域上的材料厚度,变形可能相当严重和剧烈,并且可能导致穿过动脉或其他通道造成外伤。
特别需要在这方面改进的一个领域是大直径、高压的血管扩张术气球导管,即当膨胀时,在气球导管内气球主体的直径在5到12毫
米之间。
因此,先有技术要达到作为其它用途的气球导管是困难的,例如,为了在整个很小的导管上紧密地配合,要求细长的气球导管。
按照本发明的一个方面,一种制造可膨胀的医用气球的方法和按该方法制造的产品,其特征在于具有如下步骤:选择一个适合于形成气球的壁厚和直径的树脂管,有选择地在管上特急部分的一个或两个端部(气球从这些点开始形成)把该管的特定区域加热到拉制温度,沿相反向分别对加热区域的端部施加拉力,把所说区域拉到较小的直径;由此形成一个在管的部分的一端或两端具有锥形的、相对小的直径范围的预型件,所说的范围包含实际上是不具有晶体化成分子取向性的材料;然后把管形预型件加热到吹制温度,且在加热的同时,用拉伸和吹制包括锥形部分的预型件制成一个气球并装气球,从而形上成气球导管装置;在进行锥形端部分的步骤时,使得相应的吹制的气球部分要分别拉制厚度的外形。
在本发明这一部分的最佳实施例中,拉制温度接近或高于玻璃的临界温度但低于它的结晶温度,以便不出现结晶或分子排列;拉制温度接近或高于树脂的熔点并在拉制后,气球被快速冷却;吹制温度接近于玻璃的临界温度,或稍高于该温度,而且在实际上低于树脂的结晶温度;对于双轴定向气球,吹制温度低于拉制温度,在树脂的玻璃临界温度范围内;树脂为非晶体的聚乙烯对苯二甲酸酯,它的拉制温度在105-130℃之间,吹制温度在85-115℃之间;拉制成预型件和拉伸和吹制预型件的步骤因此是与气球主体的壁厚和气球锥形过渡段部分的壁厚实际上是等值的或者过渡段部分的壁厚薄一些;确定区域的加热是按下述方式进行的,形成气体主体部分的管子部分
实际上是不加热的。
按照本发明的另一个方面,所提供的血管扩张术用的扩张气球导管包括一个细长的、小直径的适合于经过人体血管系统到达血管的狭窄闭塞部位的导管,一个安装固定在导管上的可膨胀的扩张气球,适合于在闭塞处扩张细长的血管和解除对血流的阻碍,所说的气球包括一个大直径的主体段和至少有一个在主体部分一端的锥形过渡部分,和吹胀和弄瘪气球的装置,所说的导管其特征在于,气球是由吹制和拉伸预成型的管状件的方法制造的,所说的管状件在相应于吹制气球的过渡部分的区域内具有成锥形的外形。
在本发明这方面的最佳实施例中,预成形的管状件是对一个原来为等直径和等壁厚的挤压管的确定区域进行加热和拉伸而成的。气球的主体部分和成锥形的过渡部分实际上具有相同的壁厚,或者过渡部分稍薄些;气球主体可以膨胀到直径为5毫米或更大些;制造气球的树脂是聚乙烯对苯二甲酸酯。
图1是按照本发明的一个步骤加热和拉伸所选树脂材料的挤压成型管状件的示意图。图1a是管状件拉伸部分的示意图。图1b是类似于图1a的另一张示意图,它具有比图1a更细长的颈缩区域的形状。图1c是有两个相距L的颈缩部的整个预成形件的缩小的示意图。
图2是处在准备吹制成气球位置上的图Ic所示的预成形件的示意图。图3是类似于图2,表示成形的气球横截面的示意图。图3a是图3气球壁的横截面图,表示沿管长度一般所达到的均匀的壁厚。图4是按本发明制造成的气球的侧视图。图5是按本发明的血管扩张术气球导管的示意图。图6是季戊四醇(PET)树脂的热性能分析
曲线。
参照图1,一个适合于吹制8毫米直径医用气球的管子,它由非膨胀树脂,Goodyear′s Clear Tvf8006,聚乙烯对苯二甲酸酯所组成,其外径为0.066吋,壁厚为0.011吋。管的在线B以下的10a部分已经结晶定形,在加热条件下使其尺寸保持稳定的,这样稳定的部分不可能明显地膨胀或拉伸。把管10浸没在加热到拉伸温度在105-130℃之间的(例如,120℃)甘油浴槽12内结晶区域与管10b的非结晶部分的一段Di,例如3毫米,一起全部浸入。在浴槽外面的管子部分由固定夹14夹住,浸没在浴槽中的管的结晶定形部分被一个可活动的夹子16夹住。在适当的浸没一段时间之后,为了确保树脂达到浴槽的温度,夹16沿箭头所示方向向下移动一段预定的距离,例如2mm,其拉伸速度为每分钟1-0.1吋,例如,0.3吋/分,使管的被加热的非结晶部分被拉伸,而结晶部分则拒不变形。参照图1a,即图1中A和B之间的部分,在拉伸下产生颈缩。颈缩以及壁厚变薄的程度明显地取决于拉伸条件,例如,拉制速度、拉伸温度、被拉伸的非晶段的长度和拉伸的距离,对于任何特定的气球,这些值都可通过试验确定。在最佳实施例中,管的外径ODd被颈缩到0.054吋,而管被拉长2毫米。在图1b的另一个实施例中,有更长的非晶体部分被浸没,该管被拉成一个等直径的套19。
在管被次颈缩后,再把它放回浴槽并按相同程序在沿非晶体的管的空间距离为L(例如0.57英寸)的点处进行第二次颈缩,从而得到按形成气球主体拉伸和吹制的两个颈缩部分之间的管子部分。这种方法可以提供一种预成形件,其被拉细变形的区域内的管的壁厚随
直径减小而减小。
当预成形件被制成后,再放入如图2所示的第二个甘油浴槽,这次预成形件被水平放置,管子从两个静止的约束件18中穿过,管的结晶部分被夹具20和22夹住。浴槽12a的温度被调整到相应于所要求的吹制温度上,从85-115℃之间选取,例如90℃。每个约束件18由圆柱形部分18a和锥形部分18b组成,锥形部分的扩口端彼此相对,用来确定气球锥形段的形状。
如图所示,在点C和D的管端部的非晶体区域在图2的初始位置上。在管的温度在浴槽12a中稳定后,两个夹具20和22被拉开,使管通过静止的约束件18滑动,实际上被伸长,同时,气压施加到管内,使其膨胀。管子的L部分在没有约束的情况下膨胀,直到气球壁材料的分子在双轴向条件下稳定为止。最后,气球达到OD为8mm,成锥形部分间的长度增加到L+△L=1.51吋。具有预成形锥度的管端部分也膨胀到受到约束件18的阻碍时为止。最终气球厚度轮廓如图3a所示,其中气球厚度tb为0.0007吋,而锥形部分的壁厚tt与之基本相同,其变化小于0.0001吋。在吹制和拉伸过程中,非晶体部分的长度从L2=0.94吋增加到L2+△L2=2.70吋。
在另一实施例中,在成形予成形件时,例如,对确定区域进行更多拉伸,并进一步拉伸锥形,这就有可能在吹制气球时达到过渡部分的壁厚比主体部分的壁厚还要薄些。
气球成形后,对其进行冷却、干燥,并切去端部,例如,从颈缩区最细处向外延伸的部分,并将气球装配在适当的导管23上,所说的导管23有一个用于膨胀气球的气球膨胀腔25和用于接受导线的
通腔27,见图5。导管上在气球主体端部21上有射线透不过标志29。这样,能得到直径8毫米,能承受8个大气压的大气球,其具有充分薄的过渡区,能实现非常成功的扩张。
本发明再一个优点是可以把较大的气球与较小的导管装配在一起,例如把8毫米气球装在一个5French平位(一个F单位,相当于0.33毫米)的导管上。制成这样一个气球、有利于选择一个比安装在气球的导管的外径大的起始管,利用拉伸成形的预成形件,在确定的加热区,把这些区域的直径拉伸到相应于导管尺寸的大小是完全可能的。
在其他实施例中,锥状部分的壁厚可以按照在制造预成形件过程中的拉长量增加或减少。在某些实施例中,在端部使用的约束件可以省略,而在另外一些实施例中,整个预成形件可以被限制在一个确定最后吹制形状的模具中。只要在本发明概述部分并结合有关树脂的热分析曲线叙述过的一定关系得到保持,在其他实施例中的温度可以不在所提到过的优选范围内。请看最佳实施例,见图6。
为了拓宽本发明的范围,用其他成形技术,如软化管的模制方法来制备带锥形的预成型品也是可能的。
Claims (17)
1、一种形成可扩张的医用气球的方法,包括:
a)提供一个用于气球导管装置的适合于形成气球的选定直径和厚度的树脂管,
b)在形成气球的管的一端上,选择地把所说的管的特定区域,加热到拉伸温度,
c)沿相反方向对所说的加热区的各端施加拉力,把该区域拉伸到较小的直径,以形成一个在所说的管的部分的端部上有一个成锥形的、实际包含没有晶体化或分子取向性材料的小直径区域的预成形件,
d)然后把该管形预成形件加热到吹制温度,另一方面,加热用拉伸和吹制把包括所说的成锥形的部分的预成形件制成气球,和
e)安装所说的气球,以形成一个气球导管装置,
所说的预成形件所说的成锥形的端部区域的步骤使得相应的吹制的气球截面具有分别可控制的厚度的轮廓。
2、根据权利要求1所述的方法,其特征在于上述管的两个确定区域可选择地加热到拉伸温度,并沿相反的方向对上述加热区域的各端施加拉力,以使各区域拉伸到较小的直径和壁厚。
3、按权利要求1或2所述的方法,其中所说的拉伸温度在玻璃临界温度之上,但在实际上不产生结晶化或分子取向性的结晶化温度之下。
4、按权利要求1或2所述的方法,其中该拉伸温度接近或高于该树脂的熔化温度,而且在拉伸后,把所说的预成形件迅速冷却。
5、按权利要求1或2所述的方法,其中所说的吹制温度接近或高于玻璃的临界温度,而实际上所说的树脂的结晶温度之下。
6、按权利要求5所述的方法,其中对于双轴取向的气球,所说的吹制温度是拉伸温度之下,在该树脂的玻璃临界温度范围内。
7、按权利要求1或2所述的方法,其中所说的树脂是非晶化聚乙烯对苯二甲酸酯,所说的拉伸温度在105-130℃之间,所说的吹制温度在85-115℃之间。
8、按权利要求1或2所述的方法,其中拉伸到形成所说的预成形件和所说的位伸和吹制所说的预成形件的步骤是这样关联的,即气球主体壁厚和气球成锥形的端部的壁厚实际上是等值的。
9、按权利要求1或2所述的方法,其中所说的确定区域的所说的加热是以这样的方式进行的,即预成形的气球的主体管的部分的实际上是不加热的。
10、按权利要求1所述的方法制造的气球产品。
11、按权利要求10所述的气球产品,其特征在于构成上述初加工的拉伸,上述拉伸步骤和上述吹制初加工使气体主体壁厚和气球锥形端壁的厚度大致相等。
12、在一种用于血管扩张术的扩张气球导管内,包括:
a)一根适于通过人体血管导流到达血管狭窄的闭塞点的细长的、小直径的导管,
b)一个固定在所说的导管上,适合于在该闭塞点上扩张细长的血管和解除对血液流动的限制的可膨胀的扩张气球,所说的气球包括一个完整的直径的主体部分和在所说的主体部分的一端上至少有一个成锥形的过渡部分,
c)一个吹胀和瘪掉所说的气球的装置,
所说的导管其特征在于,所说的气球是吹制和拉伸具有在相应于被吹制的气球的过渡部分的区域预成形管状件的方法生产的。
13、按权利要求12的扩张气球导管,其中的预成形的管形件是加热和拉伸原来等直径和等壁厚的挤制管的确定区域的产品。
14、按权利要求12所述的扩张气球导管,其中所说的成锥形的过渡部分的壁厚是与气球主体部分的壁厚相同的。
15、按权利要求12所述的扩张气球导管,其中所说的成锥形的过渡部分的壁厚是小于气球主体的壁厚。
16、按权利要求12、13、14或15所述的扩张气球导管,其中所说的气球主体的可吹胀到直径为5毫米或更大。
17、按权利要求12、13、14或15的扩张气球导管,其中的制造气球的树脂是聚乙烯对苯二甲酸乙酯。
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Application Number | Priority Date | Filing Date | Title |
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US07/126,769 US4963313A (en) | 1987-11-30 | 1987-11-30 | Balloon catheter |
US126,769 | 1987-11-30 | ||
US126.769 | 1987-11-30 |
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CN1034315A CN1034315A (zh) | 1989-08-02 |
CN1020408C true CN1020408C (zh) | 1993-05-05 |
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CN88108146A Expired - Fee Related CN1020408C (zh) | 1987-11-30 | 1988-11-29 | 气球导管 |
Country Status (10)
Country | Link |
---|---|
US (1) | US4963313A (zh) |
EP (1) | EP0318919B1 (zh) |
JP (1) | JPH024387A (zh) |
CN (1) | CN1020408C (zh) |
AT (1) | ATE100340T1 (zh) |
CA (1) | CA1303449C (zh) |
DE (1) | DE3887295T2 (zh) |
DK (1) | DK170794B1 (zh) |
ES (1) | ES2048189T3 (zh) |
NO (1) | NO173806C (zh) |
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CN100406079C (zh) * | 1998-10-05 | 2008-07-30 | 钟渊化学工业株式会社 | 气球导管 |
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- 1988-11-29 CA CA000584469A patent/CA1303449C/en not_active Expired - Lifetime
- 1988-11-29 CN CN88108146A patent/CN1020408C/zh not_active Expired - Fee Related
- 1988-11-29 NO NO885312A patent/NO173806C/no unknown
- 1988-11-29 DK DK665288A patent/DK170794B1/da not_active IP Right Cessation
- 1988-11-29 DE DE3887295T patent/DE3887295T2/de not_active Expired - Lifetime
- 1988-11-29 ES ES88119884T patent/ES2048189T3/es not_active Expired - Lifetime
- 1988-11-29 AT AT88119884T patent/ATE100340T1/de not_active IP Right Cessation
- 1988-11-30 JP JP63303883A patent/JPH024387A/ja not_active Expired - Lifetime
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN100406079C (zh) * | 1998-10-05 | 2008-07-30 | 钟渊化学工业株式会社 | 气球导管 |
Also Published As
Publication number | Publication date |
---|---|
JPH024387A (ja) | 1990-01-09 |
NO173806B (no) | 1993-11-01 |
US4963313A (en) | 1990-10-16 |
DK170794B1 (da) | 1996-01-22 |
NO173806C (no) | 1994-02-09 |
NO885312D0 (no) | 1988-11-29 |
CN1034315A (zh) | 1989-08-02 |
NO885312L (no) | 1989-05-31 |
CA1303449C (en) | 1992-06-16 |
ES2048189T3 (es) | 1994-03-16 |
DK665288A (da) | 1989-05-31 |
DE3887295T2 (de) | 1994-06-30 |
EP0318919A2 (en) | 1989-06-07 |
EP0318919B1 (en) | 1994-01-19 |
EP0318919A3 (en) | 1990-01-24 |
ATE100340T1 (de) | 1994-02-15 |
DK665288D0 (da) | 1988-11-29 |
DE3887295D1 (de) | 1994-03-03 |
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