CN1170612A - 可弯曲的自动展开的展伸器及其制造方法 - Google Patents
可弯曲的自动展开的展伸器及其制造方法 Download PDFInfo
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Abstract
一种用弹性的橡胶件套住的Z字形展伸器,它包括至少两个以固定间隔隔开的Z字形单元和一个套住Z字形单元并起到连接元件作用的覆盖件,这样,展伸器在Z字形单元之间不需要单独的连接件并且展伸器呈圆柱形。另外,可用公式确定Z字形单元间的间隔。
Description
本发明涉及一种展伸器,更具体地涉及一种可弯曲的自动展开的展伸器及其制造方法,该展伸器可以提供改进的弯曲性能,因此,当它置于弯曲的管腔内时,可灵活地适应于管腔的曲率,以防止食品或液体倒流。
总的来说,展伸器是用于扩大由于例如,疾病、损伤或外科手术而变窄的内部器官的管腔或血管的医疗装置。这类展伸器通常呈圆柱形的筒状,广义地可以分成以下两类:1)一类是具有预定弹性量的展伸器,亦即当施加外力时可以收缩,而当外力去掉时可以自动展开;2)另一类是由塑料制成的展伸器,亦即,它们在由收缩状态展开后仍保持展开状态。
可采用广泛使用的展伸器插入装置将上述的展伸器插入管腔,以便使展伸器易于定位。这种方法由于是本技术领域的技术人员公知的,所以在此省略介绍。
美国专利US-5,330,500公开了一种如图8所示的展伸器,它包括多个圆柱体的Z字形弹性单元12,这些弹性单元在施加外力时收缩,而当外力去掉时再展开,还有多个用于连接Z字形弹性单元12的连接器13,以保持这些弹性元件呈圆柱形的外形。
尽管这种利用通过连接器13连接的上述Z字形单元12的展伸器能保持稳定的和有力的展开状态,但当它用于扩展已萎陷的管腔时不是可弯曲的且不是非常有效的。且当它用于弯曲的管腔时,这种展伸器不能柔合地弯曲,导致Z字形单元12和连接器13过硬地压在腔管的内壁上,亦即,出现炎症和其它并发症。
图9示出了位于弯曲的腔管内的另一个已有技术的展伸器的示意图。如在附图中所示的,该展伸器包括多个Z字形单元101,多个连接Z字形单元101的带螺纹的(thread)连接器102和一个用聚乙烯材料制成的覆盖Z字形单元101和连接器102的圆柱形覆盖件103。
然而,当上述展伸器用于弯曲的管腔时具有阻塞通道的缺点。亦即,因为Z字形单元101是用带螺纹的连接器102连接,在它们之间不留任何间隙,且Z字形单元101和连接器102是用覆盖件103覆盖,所以当所说的展伸器装在弯曲的管腔内时,它不能响应于管腔的曲率逐渐地弯曲,而是如附图所示折叠或起皱痕,由此,展伸器的通道以及管腔被阻塞。
此外,所有的已有技术的展伸器都具有无阻止食物或液体倒流的装置的缺点。尽管人类具有自然的机制能抑制在该区域例如:胃和食管的食物或液体的倒流,但是当在这个位置上使用已有技术的展伸器时,就有可能由于酸性食物和液体的倒流而给食管带来损害,进而,有可能使倒流的流体进入肺内,导致肺部疾病。因此,在必须避免食物和液体在相反方向上流动的区域使用已有技术的展伸器是不可行的。
另外,在已有技术的展伸器内,Z字形单元是焊接的,这就是说,每个Z字形单元都是单个成形的,整个成形件具有带多个弯头的多个部分。在焊接过程中,通常要使用铅材料,然而,这种铅材料可能在人体内被氧化形成对人体有害的重金属。
本发明所做的努力在于解决已有技术的上述问题。
本发明的一个目的在于提供一种能提供改进的可弯曲性能的展伸器,由此,当它装在弯曲的管腔内时,能随着管腔的弯曲率弯曲而不会阻塞其通道。
为了实现上述第一个目的,本发明提供的展伸器包括:
至少两个径向弹性圆柱形单元;和一个用于包覆和固定径向弹性圆柱形单元、而没有连接元件的圆柱形覆盖固定件。
其中,径向弹性圆柱形单元是通过装在圆柱形覆盖物内而固定的,这就是说,每个圆柱形单元的相邻端沿纵轴按预定的间隔分开,并通过圆柱形覆盖固定件的可弯曲性和弹性,补偿圆柱形单元的展开和收缩。
每个单元被设计成闭合的Z字形结构,在圆柱形内具有一系列带弯头的直的部分。
圆柱形覆盖固定件优选地用具有弯曲性和弹性的材料制成。
圆柱形覆盖固定件优选地用聚合物材料制成。
间隔最好是在0.5I到1.5I的范围内确定,其中I按下列公式确定: 其中:I是间隔;
d是展伸器的直径;
θ是展伸器的弯曲角;以及
η是单元数。
更优选地,间隔是在1mm到20mm的范围内选择的。
本发明的第二个目的在于提供一种当装在管腔内时能防止食物或液体倒流的展伸器,由此避免对食管和肺的损害。
为了实现第二个目的,展伸器进一步包括一个用于防止食物或液体从下游侧向上游侧倒流的倒流防止装置。
倒流防止装置包括一个一致地开闭的三叶片的阀件或双叶片的阀件。
倒流防止装置最好包括一个允许气体从中漏出的开口部分。
倒流防止装置还最好用弹性的且可弯曲的材料制成。
倒流防止装置更优选的是用活组织的部件例如猪的瓣膜或牛的心包膜制成。
本发明的第三个目的在于提供一种能够避免由于有害材料(例如铅)象在已有技术中那样进入人体而引起危险的展伸器。
为实现这个目的,每个单元被设计成开口的Z字形结构,它在圆柱体形状中具有一系列带弯头的直的部分,其中,单元的开口端是不连接的但是毗邻配置的。
按照另一个方面,本发明提供了一种用于制造可弯曲的自动展开的展伸器的方法,它包括如下步骤:
用弹性材料制备圆柱形薄片,该薄片具有一个纵向轴;
连接两个以上的弹性单元到圆柱形的弹性薄片的外壁或内壁上,该单元的直径与圆柱形弹性薄片的直径相同,所说的单元按预定的间隔在纵向轴上彼此隔开;
把圆柱形弹性薄片和单元用聚合物溶液涂覆;以及
使涂覆的溶液变硬。
涂覆步骤优选地是通过把圆柱形弹性薄片和单元用聚合物溶液浸泡完成的。
结合在并构成说明书一部分的附图示出了本发明的实施例,它与描述部分一起用于说明本发明的原理:
图1是按照本发明的一个优选实施例的展伸器的透视图;
图2是说明图1的展伸器装在弯曲的管腔内的示意图;
图3是说明图1中的展伸器的弹性单元之间的间隔的示意图;
图4是说明展伸器的一个透视图,其中设置了按照本发明的实施例的倒流防止装置;
图5是说明图4的倒流防止装置的透视图;
图6是说明按照本发明的另一个实施例的倒流防止装置的透视图;
图7是说明按照本发明的另一个实施例的展伸器的透视图;
图8是说明已有技术的展伸器的示意图;
图9是说明另一个已有技术的展伸器的示意图。
现参照附图说明本发明的优选实施例。
首先参照图1和图2,按照本发明的一个优选实施例的展伸器包括两个或多个圆柱形径向弹性单元1,和一个套在弹性单元1上的圆柱形覆盖固定件3,以便将单元1固定在圆柱体形状中。亦即,覆盖固定件3起到连接弹性单元1的连接元件的作用,这就是说按已有技术的单独的连接元件就不需要了。每个单元1优选地具有在10nm到20nm范围内的长度。
弹性单元1按下列方法用覆盖固定件3覆盖。
首先制备用弹性材料制成的圆柱形弹性薄片,它具有实际上与弹性单元1相同的直径。将两个以上的弹性单元1装在弹性薄片的外壁或内壁上。然后把带有弹性单元1的圆柱形薄片浸泡在弹性材料溶液内,干燥后,完成在弹性单元1上形成覆盖固定件3的过程。然而,应该注意,覆盖的方法不限于上述方法。
当外力施加到弹性单元1上时,它收缩,使展伸器能很容易地插入展伸器插入装置内,而当展伸器插入装置取出时它将展开,由此使管腔扩展。亦即,每一个弹性单元1是按Z字形制作,它具有一系列带多个上下弯头10和10'的直的部分。弹性单元1用圆柱形覆盖固定件3固定,亦即,弹性单元1是彼此隔开的。换句话说,连接一个弹性单元1的下弯头10'的假想圆与连接另一个相邻的弹性单元1的上弯头10的假想圆以间隔I1,I2和I3隔开。间隔I1,I2和I3彼此可以相同或不同。由于圆柱形覆盖固定件3是套在弹性单元1上,这就是说,圆柱形覆盖固定件3和弹性单元1形成一体并呈圆柱形,且覆盖固定件3是用弹性材料制成的,因此当展伸器被置于弯曲的腔体内时,它可以很容易地随之同样地弯曲。如图2所示,当按照本发明的展伸器置入管腔内时,它相应于管腔的曲率逐渐地弯曲。
上述是可能的,因为每个单元1的相邻的上、下弯头10和10'之间的距离在展伸器的外部处(相对于弯曲方向)被拉大,而每个单元1的相邻上下弯头10、10'之间的距离在展伸器的内部处(相对于弯曲方向)则减少。其结果是展伸器如图2所示逐渐弯曲。
因此,制造圆柱形覆盖固定件3优选地使用聚合材料,如聚氨基甲酸乙酯,聚乙烯,聚丙烯,聚异戊二稀,聚丁二烯,聚氯丁烯或聚苯乙烯,所有这些材料都具有供上述弯曲使用的弹性。下表列出用于固定件的材料所应达到的要求。
项目 要求
拉伸模数 当拉伸50%时300-3000PSI
极限拉伸强度 低于4000 PSI
撕裂强度 超过400 Die“C”PLI
弯曲模量 低于10000 PSI
弯曲强度 低于300 PSI
下面参照图3说明如何确定本发明的一个优选实施例的Z字形展伸器的相邻弹性单元的相邻上下弯头之间的间隔I。
间隔I按下列公式确定: 其中:d是展伸器的直径;
θ是展伸器的弯曲角;以及
η是单元数。
下面是上述公式的计算方法。
当展伸器插入弯曲的管腔内时,展伸器形成如图3所示的曲率半径。最好由在曲线内侧的小弧度I1和曲线外侧的大弧度I2之间的差值来确定间隔I。
因此,如果r是小弧度的曲率半径,
I1=rθ ……(1),和
I2=(r+d)θ ……(2)如果由(2)减去(1),
I2-I1=(r+d)θ-rθ=dθ ……(3)
因此,Z字形单元1之间的间隔I是由折叠数除以(3)计算,
I=dθ/(η-1) ……(4)
如θ=2πθ/360
则:
用上述公式计算的Z字形单元1之间的间隔I可以按照展伸器所插入的管腔在±50%之间变化。亦即,可以用于本发明的展伸器的间隔范围PI优选地可如下决定:
0.5×I<PI<1.5×I
当使用上述公式确定相邻弹性单元1的相邻上、下弯头10和10'之间的间隔时,展伸器的制造更加容易,且可以做到与管腔的直径和曲率精确地匹配。
参照图4和图5,提供了一种在本发明的展伸器内的倒流防止装置。倒流防止装置7通过三个叶片的聚合物阀实现。
如图4所示,考虑到食物和液体流动的方向,假定展伸器的上侧(在附图中)是上游,下侧是下游时,倒流防止装置7安装在下游端。
倒流防止装置7包括一个第一板71,该板的一端及侧面连接到展伸器的内壁上,而板的自由端渐进地朝展伸器的中心轴定位,第一板71的连接区域利用展伸器内壁圆周的大约三分之一;第二板73,其连接方式类似于第一板71,并利用展伸器内壁圆周的另一三分之一;以及第三板75,其连接方式也类似于第一板71,且利用展伸器内壁圆周剩余的三分之一。因此,第一、第二和第三板71、73和75如附图所示在它们的自由端彼此相邻。
上述结构的结果是,当食物或液体由于重力或其它力从上游侧向下游侧流动时,板71,73和75被压向一边,这样就形成一个开口,以便使食物或液体能通过该开口。然而,如果食物或液体按相反方向流动(亦即从下游到上游),板71,73和75的自由端被推到一起,这样就形成一个密封体,以阻止食物或液体流动。
板71,73和75最好用类似于用于圆柱形覆盖固定件3的材料制成。亦即,板71,73和75优选地是用聚乙烯,聚氨基甲酸乙酯或其它这样的含树酯材料制成,这就是说,材料能允许板71、73和75自由开启和闭合且对人体是无害的。
此外,在本发明的优选实施例中,尽管倒流防止装置7装在展伸器的一侧,但还可以把倒流防止装置7装到沿展伸器内侧的任何位置上,也可以把展伸器从其一个端部向外突出连接。
在图4和图5中还示出了在接近展伸器的中心轴处板71、73和75之间所形成的开口部分77。开口部分77的结构是当展伸器装在胃和食管之间的区域时能使气体能从中排出。
图6示出了按照本发明的另一个优选实施例的倒流防止装置7'。按照该实施例的倒流防止装置是通过两叶片的聚合物阀实现的。如附图所示,两叶片的聚合物阀包括第一板72和和第二板74。板72,74的一端和侧面连接到展伸器的内侧,而另一端未连接且逐渐朝展伸器的中心轴方向定位,这样,板72和74的自由端彼此毗邻。
如上所述的每个弹性单元1是通过使用例如铅焊接连接各个单元的端部而制成的。因此,当展伸器置入管腔时,有可能使有害物质进入人体。
为了解决这个问题,按照本发明的另一个实施例,如图7所示的弹性元件被设计成具有Z字形,其中,直的部分的开口序列是通过弯头连接的。亦即,部分11的相对端的直的部分11'和11″不是彼此连接的,而是通过提供一个重叠部分15彼此相邻配置,这样,也就无需焊接。
由于本发明的展伸器具有倒流防止装置,因此就可以安全地将展伸器放置到要求防止食物和液体倒流的区域,例如在胃和食管之间。其结果是,由于食物和液体倒流引起的医学上的有危险的情况可以避免。
另外,由于本发明提供的展伸器具有改进的可弯曲性,因此当展伸器置于弯曲的管腔内时,展伸器可以顺应管腔的曲率,而不会阻塞其通道。
最后,由于弹性单元无需焊接,防止了由于有害材料(例如铅)象在已有技术中那样进入人体而引起的有危险的情况的发生。
虽然本发明已联系最实际的优选实施例作出了说明,但应该明白,本发明不限于所公开的实施例,而且,与之相反,还延伸覆盖不同的改进和等同的配置,它们都包括在所附权利要求书的精神和范围内。
Claims (18)
1.一种具有纵轴的可弯曲的自动展开的展伸器,所述展伸器包括:
至少两个径向弹性圆柱形单元;和
一个用于套住和固定径向弹性圆柱形单元的圆柱形覆盖固定件,
其中径向弹性圆柱形单元通过圆柱形覆盖固定件并且装在圆柱形覆盖固定件上而进行固定,这样,每个弹性圆柱形单元的相邻端沿纵轴按预定的间隔隔开。
2.一种具有纵轴的可弯曲的自动展开的展伸器,其中,如果展伸器具有三个以上的径向弹性圆柱形单元,那么各单元之间的间隔是相同的或彼此不同的。
3.按照权利要求1所述的可弯曲的自动展开的展伸器,其中每个单元被设计成闭合的Z字形结构,它具有一系列经弯头连结呈圆柱形的直的部分。
4.按照权利要求1所述的可弯曲的自动展开的展伸器,其中每个单元被设计成开口的Z字形结构,它具有一系列经弯头连结呈圆柱形的直的部分,其中,单元的开口端是不连接的而是毗邻配置的。
5.按照权利要求1所述的可弯曲的自动展开的展伸器,其中圆柱形覆盖固定件是用具有可弯曲性和弹性的材料制成的。
6.按照权利要求1所述的可弯曲的自动展开的展伸器,其中圆柱形覆盖固定件是用聚合物材料制成的。
7.按照权利要求1所述的可弯曲的自动展开的展伸器,其中间隔是在0.5I到1.5I范围内确定的,其中I按下式确定:
式中,I是间隔;
d是展伸器的直径;
θ是展伸器的弯曲角;以及
η是单元数。
8.按照权利要求1所述的可弯曲的自动展开的展伸器,其中间隔在1mm到20mm范围内选取。
9.按照权利要求1所述的可弯曲的自动展开的展伸器,进一步包括一个用于防止食物或液体从下游侧向上游侧倒流的倒流防止装置。
10.按照权利要求9所述的可弯曲的自动展开的展伸器,其中倒流防止装置包括一个三个叶片的阀件。
11.按照权利要求10所述的可弯曲的自动展开的展伸器,其中三个叶片的阀件包括一个第一板,其一端及侧面连接到展伸器的内壁,而其自由端朝展伸器的中心轴渐进地定位且第一板的连接区域大致利用展伸器内壁周边的三分之一,第二板与第一板的连接方式相同并利用展伸器内壁周边的另一三分之一,而第三板也与第一和第二板的连接方式相同并利用展伸器内壁周边剩余的三分之一。
12.按照权利要求9所述的可弯曲的自动展开的展伸器,其中倒流防止装置包括两个叶片的阀件。
13.按照权利要求12所述的可弯曲的自动展开的展伸器,其中两个叶片的阀件包括第一和第二板,板的一端和侧面连接到展伸器的内壁上,另一端是不连接的并朝展伸器的纵轴逐步地定位,这样,两板的自由端彼此相邻。
14.按照权利要求9所述的可弯曲的自动展开的展伸器,其中倒流防止装置包括一个开口部分,以便气体从中反向地排出。
15.按照权利要求9所述的可弯曲的自动展开的展伸器,其中倒流防止装置是由弹性的且可弯曲的材料制成的。
16.按照权利要求9所述的可弯曲的自动展开的展伸器,其中倒流防止装置是由来自活组织的部件例如猪的瓣膜或牛的心包膜制成的。
17.一种用于制造可弯曲的自动展开的展伸器的方法,包括如下步骤:
制备用聚合物材料制作的并具有纵轴的圆柱形薄片;
把两个以上的直径与圆柱形弹性薄片相同的弹性单元装在圆柱形弹性薄片的外壁或内壁上,所说的单元在纵轴上按预定的间隔彼此隔开;
用聚合物溶液涂覆圆柱形弹性薄片和单元;以及
使涂覆溶液硬化。
18.按照权利要求17所述的用于制造可弯曲的自动展开的展伸器的方法,其中涂覆步骤可以通过把圆柱形弹性薄片及单元浸泡到聚合物溶液中来完成。
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-
1997
- 1997-05-22 DE DE69719237T patent/DE69719237T2/de not_active Expired - Fee Related
- 1997-05-22 EP EP97303517A patent/EP0808614B1/en not_active Expired - Lifetime
- 1997-05-23 CN CNB971137749A patent/CN1148232C/zh not_active Expired - Fee Related
- 1997-05-23 US US08/861,818 patent/US6027525A/en not_active Expired - Fee Related
- 1997-05-23 JP JP13406097A patent/JP3798507B2/ja not_active Expired - Fee Related
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WO2015062532A1 (zh) * | 2013-10-31 | 2015-05-07 | 微创心脉医疗科技(上海)有限公司 | 一种覆膜支架 |
Also Published As
Publication number | Publication date |
---|---|
US6027525A (en) | 2000-02-22 |
DE69719237T2 (de) | 2003-11-27 |
DE69719237D1 (de) | 2003-04-03 |
EP0808614B1 (en) | 2003-02-26 |
CN1148232C (zh) | 2004-05-05 |
JPH1043315A (ja) | 1998-02-17 |
JP3798507B2 (ja) | 2006-07-19 |
EP0808614A2 (en) | 1997-11-26 |
EP0808614A3 (en) | 1998-11-11 |
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