CN100522279C - 用于制造导管的方法以及导管 - Google Patents

用于制造导管的方法以及导管 Download PDF

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CN100522279C
CN100522279C CNB028131312A CN02813131A CN100522279C CN 100522279 C CN100522279 C CN 100522279C CN B028131312 A CNB028131312 A CN B028131312A CN 02813131 A CN02813131 A CN 02813131A CN 100522279 C CN100522279 C CN 100522279C
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catheter
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CN1522164A (zh
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阿兰·腾格赫伊
拉尔斯·B·延森
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Coloplast AS
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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    • A61M39/22—Valves or arrangement of valves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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    • A61M25/0043—Catheters; Hollow probes characterised by structural features
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
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    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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    • B29C45/1676—Making multilayered or multicoloured articles using a soft material and a rigid material, e.g. making articles with a sealing part
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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Abstract

本发明涉及一种通过注射模制来制造医用导管的方法，该导管有成一整体部件的导管本体部分和导管顶端；本发明还涉及由该方法制成的导管。本发明特别涉及利用多部件模制技术来制造导管，例如该导管由两种具有不同特性的材料制成。这样的导管可以用于导道管插入和用于类似目的的体液排出。

Description

用于制造导管的方法以及导管
技术领域
本发明涉及一种制造医用导管的方法。特别是，本发明涉及一种方法，其中，通过使流体导管材料在模具中固化来制造导管。
背景技术
通常，医用导管用于排出体液例如血液和尿。医用导管通常提供有管形伸长的导管本体部分，该导管本体部分由具有内部管的柔性医用软管件制成，例如具有基本圆形外部和内部横截面形状的PVC或PU软管。导管在它的可插入端形成一个或多个开口，流体可以通过该开口从体腔内排出，并进入管形本体内。为了便于插入以及避免在导管插入身体开口和通过身体管道例如尿道或血管引导时伤害身体组织，可插入端通常提供有光滑的圆角顶端。在大部分导管中，该顶端通过加热和熔化医用软管的端部并直到它的管密封而形成。即使现有的导管形成有顶端，该顶端的插入具有可接受的安全性和舒适性，但是还希望使导管的插入部分有更大和更弯曲的顶端形状，因为这能够更容易和更安全地插入。不过，形成医用软管顶端的现有技术并不能制造这样的顶端。作为一种选择，某些导管由具有胶接导管顶端的医用软管制成。该方法使得导管有更大和更弯曲的顶端，但是，提供顶端部分和将该部分胶接在医用软管上的附加处理步骤意味着需要附加制造成本。而且，可能有在导管插入过程中该顶端脱落并因此保留在体腔内的危险，例如保留在膀胱中。为了经济和安全，并不希望使用胶接导管顶端。
当形成顶端时，通常在该顶端附近径向钻出或刺出多个排出孔，这些排出孔进入顶端附近的软管内。为了避免在导管插入过程中软管损害身体组织，孔的边缘必须光滑磨圆。因此，制造孔的处理将费时和昂贵。
伸长的导管本体在它的相对端形成有开口，该开口使得液体能够排出导管和排入合适的处理位置中。在该相对端，大部分导管提供有连接器部分。该连接器部分使得导管能够与例如用于收集流体的袋连接。连接器部分通常通过用粘接剂将漏斗形部件粘接到医用软管上而形成。同样，将单独部件胶接到软管上的附加处理没有成本效益，并意味着故障产品的百分率更大。
发明内容
本发明的目的是通过提供一种制造导管的方法来克服上述问题，所述方法包括以下步骤：
将流体导管材料注入模具中，该模具用于将可插入导管顶端和导管本体确定成一个部件；以及随后
在模具中固化该材料。
注入可以在用于注射模制的标准机器中进行。根据导管的尺寸和长度，注入压力可以在500-1500巴的范围内，例如750-1250巴，例如1000巴。
注射模制方法特别适于相对较短的导管，即导管在50-90mm范围内，例如在55-85mm范围内，例如在60-80mm范围内，例如长度为70mm，该长度是适于大部分妇女的可插入长度。对于男人，优选是导管部分的长度在180-250mm的范围内，例如在190-240mm范围内，例如在200-230mm范围内，例如尺寸为220mm。
导管还可以包括连接装置，用于使近端插入部分与其它导管部分相连，或者与尿收集袋相连。连接器部分可以由与近端插入部分相同的材料制成，因此，在形成近端插入部分的步骤中，该近端插入部分和连接器部分可以基本同时形成。也可选择，连接器部分可以由与近端插入部分的材料不同的材料制成，因此，连接器部分和近端插入部分在不同的处理步骤中形成，例如在多部件注射模制处理中形成。
模具可以形成为使本体部分确定为伸长、空心、管形的部分，并具有内部管，该内部管的尺寸使得体液能够通过该导管本体排出。也可选择，本体部分可以成伸长的实心核的形状，具有一个或多个从该核沿整个长度径向延伸的叶片。因此，该叶片确定了多个排出通道，用于使尿从该核与身体排出通道(例如尿道)之间排出。
为了使体液例如来自膀胱的尿能够进入空心的导管管形本体部分，模具能够用于构成在顶端附近的至少一个排出孔。
连接器部分可以用于使导管与软管连接，以便延长导管的长度，或者使该导管与处理装置例如尿收集袋连接。连接器部分优选是与导管本体和顶端形成为一个部件。连接器部件可以由与近端插入部分相同的材料制成，并优选是例如在相同注入步骤过程中与该近端插入部分基本同时制成。也可选择，连接器部分可以由与近端插入部分的材料不同的材料制成。因此，连接器部分和近端插入部分在不同的处理步骤中形成，例如在多部件注射模制处理中形成。连接器部分还可以在导管材料注入之前布置成在注射模具中的单独部件，这样，在导管本体部分的注射模制过程中，该连接器部分模制成与导管本体部分啮合。同样，导管顶端可以布置成在模具中的单独部件，并在导管本体部分注射模制过程中模制到导管内。同样，另外的部件也可以在导管本体的注射模制之前布置在模具中。例如，可以布置有一个或多个环形彩色部件，以便能看见导管的特定长度，例如看见将插入的长度。在另一实例中，在导管本体的注射模制之前，由能够提高导管在x-射线或超声波图像中的可视性的材料制成的一个或多个物体可以布置在模具中。
为了使导管的用户能够更好地抓住，该导管可以提供有用于将该导管安装在外周物件例如把手上的装置，以便牢固抓住该导管。用于将导管安装在外周物件上的装置可以是向外或向内延伸的凸起。还可选择，导管可以与在插入过程中用于操作该导管的装置(例如手柄部分)形成为一个部件，该手柄部分用于牢固手握。例如，导管的直径可以为允许插入尿道中，并有不用于插入的导管部分，该部分的直径大得多，以便能牢固手握该导管。
根据导管插入的类型，体液通常可以排入处理位置例如马桶内，或者可以排入用于收集流体的储存器或容器中。因此，模具可以形成为还确定有用于收集体液的储存器。该储存器可以是与导管模制成一个部件的塑料袋，例如通过组合注射和吹塑模制方法。
为了将导管固定在身体通道内，该导管可以在插入顶端附近提供有气球。该气球可以与导管模制成一个部件。
有时，希望导管的不同部分提供有不同特性，例如，对于导尿管，可能希望可插入部分相对较软和柔韧，从而使该导管可以通过尿道的弯曲通道。另一方面，不用于插入尿道的导管部分优选是可以有相对较差的柔韧性，从而更容易抓住，并能够通过非插入部分来操作导管的插入部分。
同样，通常希望导管的外表面布置为低摩擦材料，以便更容易和更舒适地将导管插入尿道中。因此，优选是该导管的表面层布置为低摩擦材料，例如FEP、PTFE或亲水性材料例如聚偏二乙烯，而导管的其余部分布置为更强和更耐久的材料，例如热塑性弹性体材料、其它热塑性材料、可固化弹性体材料、聚酰胺树脂或弹性体，或者它们的混合物，即，该组可以包括材料PVC、PU、PE、乳胶和/或KratonTM。例如，在热塑性弹性体材料注入模具中之前，模具可以涂覆有亲水性材料。也可选择，可以将一种或多种热塑性弹性体材料顺序注入模具中。例如，亲水性材料或类似低摩擦材料例如硅氧烷、FEP等可以首先进行注入，以便形成导管的外层。随后，一种或多种材料(例如具有不同特性的材料)在一个或多个注入循环中注入，以便形成导管的其余部分。
作为注射模制方法的一个优点，导管的表面可以很容易提供有一定的表面粗糙度，从而确定了用于将低摩擦材料粘附在导管表面上的锚固点，例如用于将FEP或PTFE(TeflonTM)涂覆在该表面上的锚固点。
当在多个注入循环中注入材料时，所形成的导管既可以包括多层或多个叠层，也可以包括在长度方向上的多个单独部分。对于层叠结构，该层叠结构可能在机械应力方面更耐久。对于沿长度方向的单独部分，导管的第一部分(例如将插入尿道或类似身体管道中的导管部分)可以由比导管其余部分更软的材料制成，或者它可以制成另外的颜色，或者具有其它的滑溜性，即比不用于插入的部分更滑溜。
不同特性也可以涉及材料在固化后的柔软性、材料的颜色、材料的强度、材料在固化后的滑溜性、或者固化后的材料吸收液体物质的能力。
例如，用于插入身体管道中的导管部分可以染上与导管的其它部分不同的颜色。这样，用户可以很容易避免与导管的可插入部分接触。
为了减小插入身体管道中时的阻力，顶端的径向尺寸可以比导管的其余部分的径向尺寸更大。例如，该顶端可以形成洋葱形或球茎形圆头，或者该顶端可以形成有锥形形状。优选是，该顶端有第一端部，该第一端部在插入过程中朝向身体管道开口，并提供有较小径向尺寸。从该端部开始，顶端在中部增宽，直到径向尺寸超过导管本体部分的径向尺寸。在顶端的中部和导管本体部分之间，第二端部处的径向尺寸下降，直到导管本体部分的径向尺寸。
用于使体液从体腔排出并流入导管的进口开口可以布置在第一端部、中间部分或第二端部中，或者布置在多个部分中，或者甚至布置在所有部分中。例如，顶端可以形成为有多个在该顶端中的小孔。
根据第二方面，本发明涉及一种通过上述方法形成的导管，并包括上述特征。
附图的简要说明
下面将参考附图详细介绍本发明的优选实施例，附图中：
图1表示了具有顶端和连接器的注射模制导管；
图2表示了球茎形导管顶端；
图3表示了锥形导管顶端；
图4表示了球形导管顶端；
图5表示了具有用于收集体液的储存器的导管；以及
图6表示了成伸长的实心核形式的导管，它有多个叶片，这些叶片从核上沿整个长度径向伸出。
参考图1，本发明涉及一种通过将流体导管材料注入模具中形成导管1的方法，该模具用于构成可插入导管顶端3和导管本体4，并该模具中的材料随后固化。如图所示，导管连接器部分7可以与导管本体形成一个部件。而且，用于将该导管安装在外周物件上的装置8可以在模制处理过程中与导管本体形成一个部件，该外周物件用于使导管的操作容易。
在可插入端，即在顶端附近，排出孔2使体液能够从体腔流入导管的内部管中。该内部管将流体输送给连接器部分，在该连接器部分处，流体可以分配到袋中，或者分配到处理位置。
图1的导管在它的可插入部分提供有减摩擦材料5，且在它的不可插入部分提供有高摩擦材料6。该减摩擦材料使得导管能够安全和容易地插入体腔例如尿道中，而高摩擦材料使得更容易抓住非插入部分，从而能够更容易操作该导管。材料5和6的特性还在于有不同颜色，以便向用户指示导管的哪一部分将用于插入。它的特性还在于可插入部分相对于不可插入部分有不同弹性，例如能够使插入部分很容易遵循弯曲的身体管道，例如能够绕过前列腺经过尿道。
图2、3和4表示了三种不同的可选顶端形状，即图2的球茎形顶端10、图3的锥形顶端20和图4的球形顶端25。该顶端布置在导管本体11的插入端，并在模制处理过程中与该本体形成一个部件。该顶端形成有：第一端部12，该第一端部12的径向尺寸小于导管本体的径向尺寸；中间部分13，该中间部分13的径向尺寸大于导管的径向尺寸；以及第二端部14，该第二端部14的尺寸下降至导管的径向尺寸。为了使体液能够排入导管的内部管内，排出孔布置在顶端的一个或多个部分中。在图2和3中，排出孔15布置在第一端部，排出孔17布置在第二端部。该顶端内部模制有管16，该管16用于将流体导向导管的本体部分。如图4所述，排出孔可以布置在顶端，这样，开口指向导管本体的轴向方向。重要的是，孔的边缘应当光滑磨圆，以便不会伤害人体管道。
图5表示了导管30和储存器31，该储存器31与该导管模制成一个部件，用于收集体液例如血液或尿。储存器可以通过组合注射模制方法和吹塑模制方法而在注射模制处理过程中形成。在该处理过程中，压缩空气用于使导管产品的储存器部分膨胀成塑料袋或塑料瓶形状的物件。在模制处理过程中，储存器可以提供有充满程度指示标记33，并可以在内部提供有用于将液体物质转变成基本固体或凝胶状物质的亲水性材料。
图6表示了成实心核36形式的导管，该核36有多个径向延伸的叶片37。该叶片形成用于在该核和身体排出通道例如尿道之间排尿的排出通道。

Claims (22)

1.一种用于制造导管的方法，该导管有具有不同特性的部分，所述方法包括以下步骤：
在一个以上的注入循环中将至少两种不同的流体导管材料注入模具中，该模具用于将可插入人体管道的导管顶端和导管本体确定成一个部件；以及随后
在模具中固化该材料以形成具有层叠结构的导管。
2.根据权利要求1所述的方法，其中：在多个注入循环中将该导管材料注入到模具内。
3.根据权利要求2所述的方法，其中：在各个注入循环中注入具有不同特性的导管材料。
4.根据权利要求3所述的方法，其中：该特性涉及材料在固化后的柔软性。
5.根据权利要求3或4所述的方法，其中：该特性涉及材料的颜色。
6.根据权利要求3或4所述的方法，其中：该特性涉及材料的强度。
7.根据权利要求3或4所述的方法，其中：该特性涉及材料在固化后的滑溜性。
8.根据权利要求3或4所述的方法，其中：该特性涉及固化后的材料吸收液体物质的能力。
9.一种注射模制的导管，它有顶端，并有具有不同特性的部分，所述导管包括至少两种不同的导管材料，其在液态时在一个以上的注入循环中注入模具，并在模具中固化，以形成具有层叠结构的导管。
10.根据权利要求9所述的导管，还包括：连接装置，该连接装置与该导管本体和顶端成为一个部件，用于使该导管与处理装置相连。
11.根据权利要求10所述的导管，还包括：用于将该导管安装在外周物件上的装置，该装置与导管本体和/或连接装置成为一个部件。
12.根据权利要求9-11中任意一个所述的导管，还包括：用于在插入过程中操作导管的装置。
13.根据权利要求9-11中任意一个所述的导管，还包括：储存器，用于收集体液。
14.根据权利要求9-11中任意一个所述的导管，还包括：用于将该导管固定在体腔中的装置。
15.根据权利要求9-11中任意一个所述的导管，其中，所述材料中的一种材料的特性使得该材料在插入身体管道中的过程中比其它材料更滑溜。
16.根据权利要求9所述的导管，其中：所述材料中的一种材料的特性使得该材料比其它材料更软。
17.根据权利要求9-11中任意一个所述的导管，其中：所述材料中的一种材料的特性使得该材料比其它材料更容易通过x-射线或超声波图像进行检测。
18.根据权利要求9-11中任意一个所述的导管，其中：至少一种材料从以下组中选择：热塑性弹性体材料、其它热塑性材料、可固化弹性体材料、聚酰胺树脂或其它弹性体，或者它们的混合物。
19.根据权利要求9-11中任意一个所述的导管，其中：至少一种材料是憎水性聚合物材料。
20.根据权利要求9-11中任意一个所述的导管，其中：至少一种材料是亲水性聚合物材料。
21.根据权利要求15所述的导管，其中：该更滑溜的材料形成导管的可插入部分的外表面。
22.根据权利要求15所述的导管，其中：所述材料中的一种材料的特性使得该材料比其它材料更软。
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