CN1183991A - 用于安全导管的充气密封垫 - Google Patents

用于安全导管的充气密封垫 Download PDF

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CN1183991A
CN1183991A CN97119292A CN97119292A CN1183991A CN 1183991 A CN1183991 A CN 1183991A CN 97119292 A CN97119292 A CN 97119292A CN 97119292 A CN97119292 A CN 97119292A CN 1183991 A CN1183991 A CN 1183991A
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sleeve pipe
cylindrical parts
parts
head end
blood
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CN1155419C (zh
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D·L·波格尔特
A·布罗克维
D·勾拉尔
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Ethicon Endo Surgery Inc
Ethicon Inc
Smiths Medical ASD Inc
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Surgikos Inc
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    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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    • A61M25/00—Catheters; Hollow probes
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    • A—HUMAN NECESSITIES
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Abstract

一种静脉内导管插入装置,更确切地说,一种安全导管血液腔用的挤压的塑性血液密封垫。在套管和血液垫之间相对滑移时,一个套管伸过血液垫并保证其间是密封。另外,公开了一种方法,一个制作安全导管用的原位吹制挤压塑性密封垫的方法,这种安全导管适于在密封条件下顺滑地接纳套管,而且操作过程简单,费用低廉。

Description

用于安全导管的充气密封垫
总的来说，本发明与静脉内导管的插入装置有关，特别地适用于安全导管的血液腔的血液密封垫。在套管和血液密封垫之间可相对滑动并且密封的条件下，套管通过血液密封垫延伸出去。本发明介绍一种新的，形成安全导管的原位吹制密封垫的方法，使这种安全导管在密封连接条件下很顺滑地接收套管，而且生产过程简单，费用低廉。
依据本发明的特殊性质，各种安全导管结构都必须要预备一个血液密封垫，例如呈空心钢针形状，能够在密封连接条件下很光滑地穿过。通常，静脉内导管插入装置的一个部件，如安装在容纳血液腔的罩子上的头端或防护部分，有一个形成于其中的贯穿孔，包括一个凹进的穴，套管通过该凹进的穴延伸。在头端内部以及在套管周围延伸的塑性材料的突出部分，被定位于该穴内，以使内孔表面与套管的外围密封接触，这之后，所述套管即发挥作用；实际上，轴向地在血液密封垫中往复移动，以保证它能相对于导管插入装置的头端部分滑动。
临床上使用的穿刺病人皮肤的尖锐的空针或套管的设备，特别是用这样的针进行静脉穿刺的导管，在医学技术上是众所周知的，而且被医务人员广泛地用于注射液体和药物直接进入病人的血流，或用于从病人身上放血。另外，在外科手术或处理期间，可能频繁地需要金身输血和肠外输注液体，以利于病人经受这样的外科处理。基本上，与熟悉的和已经使用了相当长时间的方法一样，这样向病人的心血管系统输入液体和抽取血液样本，都需要用一个中空的、有一个连接针管和静脉内输注液体的近端连接部位的坚硬的针进行静脉穿刺。
前述的医学技术中通过静脉穿刺给病人输注液体的方法引起某些相当严重的问题。因此，必须强调的首要的问题是关于针的固有硬度，这样的针近年普遍由外科质量的钢制成，当插入病人的静脉时，为了安全，在整个输液或输血过程中需要钢针保持固定在静脉穿刺点的位置上，可以想象，这样的过程可能耗费相当长的时间。除了上面所述外，有时病人需要周期地取血样和/或连续不断地给病人进行静脉内输注液体，因此需要病人承受一系列或多次静脉穿刺，特定时间和身体上不同位置的每一次静脉穿刺，都会由于这些重复的，有些疼痛感和不愉快感受的静脉穿刺，使病人产生外伤的体验。
为了改善，或者甚至可能消除前述问题，医务界近来习惯的作法是引进一种诸如硅化橡胶或特氟隆等，低摩擦材料制成的柔性管状导管，进入病人的血管，并且允许导管的管子因治疗的目的而较长时间保留在这样的一个位置上；例如，周期地输液，包括肠外输注液体，输入血液/血浆，液状的药物以及包括血样的采集等。在这种情形下，以前遇到的，由重复的静脉穿刺引起的外伤，渗出和渗入都可以大大地避免，对于在体内长时间留下一根硬针的病人来说，危险性和不舒服基本上被克服。因此，将这种柔性导管的远端定位在病人身体体腔内，诸如血管腔或静脉腔，通常使用套管；或者实质上在套管内有一个空心的尖形的针以做穿刺。这样，在针进行静脉穿刺后，这个柔性的导管套叠并光滑且同轴地安装在套管或空心针的外周，于是形成象袖子一样的，并在静脉内长于针的长度。此后，可以将针从导管内抽出，而允许导管在穿刺点保留在病人的体内，此针最好废弃而不宜再用。
由于针在穿刺前已预先位于病人体内以形成静脉穿刺，这可能暴露于感染源，例如病人感染获得性免疫缺陷综合症(AIDS)，这种实际上最后往往是死亡的疾病，或其它严重的感染情况如肝炎，临床工作人员有在工作中无意或偶然地被从肝炎病人体内抽出的针刺伤的危险或可能性。于是就有被感染甚至有死亡的可能。因此，从病人体内抽出的针，一般应回收于被保护的环境，如针尖防护容器或结构内，随后被安全的处理。
另外使用一个血液密封垫在安全导管内或采集血样的血液腔室内是众所周知的，并已发明了一种在安全导管内形成塑料血液密封垫的方法，但当前所使的方法有些复杂，而且需要液体黏合剂或使用紫外线处理。因此，依据本发明的方法，将一个其中有空心钢针或针尖部分的套管，被安置在设备的塑料头端部分，所述头端部分通常由模制的塑料构成，在中心有一个孔以接收套管，从而相对于头端部分很光滑，在头端部分有一个与中心孔同心的大直径的穴，被套管横穿而过。之后用适当的黏合剂倒入穴内充填在套管周围，再用紫外线处理。通过紫外炉加热，随着套管被轴向地往复移动，从而保证它能相对于插入装置的头端部分滑动。这种特殊的“原位形成的密封垫”需要使用液体黏合剂和/或使用紫外线处理密封垫材料，需要扩大停工时间和在生产过程引起浪费。
因此，为改善现有生产密封垫，尤其是血液密封垫的方法，安置于安全导管或导管插入设备头端的孔中的是一个经过挤压的塑料元件，此元件具有中空的环柱形结构，经挤压的塑料元件的外径大小和结构被配置成能够防止它被移置到头端之外。继而，套管滑入头端，并穿过挤压部分的孔，此孔的孔径稍大于套管的外径。套管的一端连接到罩于架上，这种罩子可以是一个血液腔，而套管的另一端向外延伸，并且有一个用于插入病人身体的锐利的尖端或头部。
套管被感应加热，在形成密封垫的挤出物的塑性材料中混入非活性物质而造成它的孔周围的挤出物的内表面发泡，和辐射状的向里扩张。发泡剂的激活温度高于挤出元件的挤出物熔化所需的温度。面且发泡剂仅仅当被感应的热以高于挤出物熔化温度加到套管时，才被激活。通常，在被感应加热前，用于形成血液密封垫的挤出物的内部或孔的直径比安装在其中而且穿过它延伸的套管的外径大约0.001到0.055英寸，使得套管加热到包含在用于血液密封垫的挤出物中的发泡剂的活动温度和套管被运用温度之上时；实际上轴向的循环往复运动，在套管和挤出的孔表面之间产生一片薄而柔性的泡沫片，因此在挤压物或密封垫孔的整体长度和套管之间产生一种好的血液密封。
可将防粘介质如硅树脂，和别的润滑剂掺入挤出材料中，或者涂在挤出物的内部或孔径上，和/或涂在套管的表面，以保证没有任何泡沫黏在套管上。
另外，也可以通过在塑性材料中掺入非活性发泡介质或高压力的起泡合成物来模制头端自身来利用形成充气血液密封垫的方法中的特殊观念。头端的内部孔或孔径的表面与套管的表面耦合，从而消除了用于分离位于头端内部的、形成密封垫的挤出物的必要性。也由于减少元件而简化了整体结构。
由此，本发明的目的是提供一种用于导管插入装备的套管的原位吹制血液密封垫的新方法。
本发明的一个更特殊的目的是提供一种制作所述类型的血液密封垫的方法，在定位于导管插入装备头端的塑性材料挤出物中含有发泡介质或发泡剂，继而在挤出物的孔中插入套管并加热套管，使发泡介质被激活，从而形成一层泡沫，封闭套管表面，使得套管能相对于头端和血液密封垫轴向的运动。
以下是参考附图对本发明的最佳实施例的详细说明，在其中：
图1a-1d表示了根据该方法生产的一种原位形成的血液密封垫方法的各个阶段；
图2a-2d表示本发明原位形成血液密封垫，以密封接触导管插入装置的套管的方法的各个阶段；
详细地参考附图，特别地是，图1a-1d的形成血液密封垫的一种通用使用方法，图1a示出安全导管(未示出)的头端10，该安全导管的头端通常由坚固的模压塑料材料构成，被安装在罩子14的前端12上。钢套管16可随着前者自病人身体抽出而通过头端10抽回到罩子14内，以保护临床人员或医师受到针刺。
伸到罩子14内的套管16的后部端口18被固定连在血液室22的端口20，以便它能与内部空间24联系，并且此后部端口18也要适应于在套管16的周围延伸的粘性物，以便像下面所描述的那样，使套管16持久地紧固在血液室22上。
被固定地安置在罩子14的端头或前端12上并由模压塑料材料构成的头端10一般有一个柱状的外部轮廓28，这样的轮廓28具有经过间隙或孔30的中心，套管通过它延伸，以便可滑动地与孔30的较低的部位32接触。头端10的前端33具有较大直径的阶梯穴34，该穴36内形成与装有套管16的孔部分32的联系，而且围绕着套管16有环形空间38，40。如图1b显示的那样，黏合剂26被恰当地注入到头端的穴34，36中以便完全填满套管16周围的空间38，40。此后，如图2c所示，当黏合剂26仍然保持与穴34，36的表面之间的密闭性时，黏合剂26通过暴露于紫外线灶44而被热处理，而套管16通过沿着其轴长的纵向方向作来回往复运动，如图1d双箭头A所示，以便保证它能相对于黏合剂26保持滑动性。通过在穴34，36中黏合剂26的引入和处理来形成血液密封垫的这种特殊方法，在制作过程中需要很多停工时间和很多的浪费，所述黏合剂26包括液态黏合剂和/或者可调理材料的紫外线处理。
为了改进以前生产血液密封垫所用的方法，如图2a-2d揭示的一样，本发明提供一种充气血液密封垫的生产方法。在这个实施例中，与图1a-1d所述的一样或类似的元件，分别以相同的参考数据代表，因此不再详细讨论它们，这些元件被认为是了解本发明所必须的。
在本发明的具体实施例中，其头端50最好也是由模压塑性材料构成，它一般是柱形的而且朝着前端53渐渐地变小，以致于有点像截头圆锥。头端50的内部有大直径的通孔54，朝着后端略为扩宽，扩展到锥形外罩56中。所述头端的后端58被构造成与图1a-1d中的结构一致，适于安装在包含血液室22的罩子14上面。套管16由黏合剂26固定在血液室上，并通过头端50向前突出，如图2b所示。通常为中空的柱形结构的塑料挤出件52被插入到头端50的一个孔54里。挤出件52有一个朝向头端50后面的端头56，这个端头辐射状向外形成囊或加宽，以便防止它在孔54中沿着轴线方向被移位。正如所示那样，挤出件52纵向地包含中心孔59，通过此孔，一端被固定在血液室22上的套管16可以通过头端50滑动，如图2b所示。而且在套管16和孔壁59之间具有一环状的空间60。挤出件52的孔58的内径比钢套管16的外径大差不多0.001至0.050英寸。位于头端50内的挤出件52最好由含有发泡剂的适当的塑性材料构成，并且发泡剂在在挤出件52的挤压物熔化温度时是非活性的。如图2b所示，通过头端50和挤压件52插入套管16后，最好通过感应加热装置62将套管16加热到比发泡剂的激活温度高，并且与头端50比，也比挤压件52的塑性材料的温度高的温度。如图2c所示。引起挤压件52的内部或孔表面59起泡，形成一个沿着它自己与套管16接触的长度方向的密封连接，后者沿着双箭头B的方向作轴向来回往复运动，从而保证其位移在被起泡的挤压物52和头端50之间而维持一个适当的血液密封，后者通过一种在套管16的表面和挤压物52的起泡孔59产生的柔软的泡沫片64生成。
为了保证没有任何来自挤出件52的泡沫粘连和潜在地污染套管16的表面，被涂在挤出件52的孔59的表面和/或在套管16上涂层，或另一种可选择地方式是，挤出件52的塑性材料中所含的混合物可以是适当的防粘介质，如硅树脂和别的润滑剂。
另外，依据本发明的简单改型，代替在头端50中提供挤出件52，头端50可由含有起泡剂和发泡剂的适当的塑性物质模塑而成，而且其中的头端锥体50的内径或孔径是接近或略大于套管16的外径，凭借加热套管16，将使得头端的孔起泡，并以上文叙述的方式，密封地靠近套管周围。在这种情形下，虽然这种方法基本上与图2a-2d描述的方法一致，但在那里已取消头端锥体50中的挤出件52，因此进一步简化了安全导管的构造，使得生产起来更经济。
从前面的叙述很快能明白，本发明的原位吹制安全导管的血液密封垫的方法，从技术上，和生产费用方面都与现在通用的方法有本质上的简化，而且能产生极好的血液密封性。
虽然以上图示和叙述的是关于本发明的最佳实施例，当然可以理解，可以得出形式上或细节上的各种改型和变化而不违背本发明的精神。因此，可以设想本发明既不限于以上的图示和叙述的精确形式和细节，也不比以下权利要求中揭示的发明整体少任何东西。

Claims (22)

1.一种制造安全导管用的血液密封密封垫的方法，其中所说的安全导管包括在其中具有轴向可滑动地定位于长套管的头端部附，所说的套管具有一个从头端突出的第一端，它固定连接到便于接收和含纳来自病人的血液的室内结构，还有第二端，它从所说头端的相反端伸出，用以便于插入病人的静脉中；所说的方法包括：
(a)在通过所说的头端部件轴向延伸的中心孔中，安装一个突出的中空圆柱形塑性部件；
(b)通过所说的中空圆柱形部件中的轴向孔延伸所说的套管，所述空圆柱形部件的轴向孔用于接收所说的套管，其尺寸被定成能在所说的套管周围提供一个环形空间；
(c)加热所说的套管，使得所说的圆柱形部件的轴向孔的内表面的材料发泡，并向内部辐射状地膨胀，以密封地耦合于所说的套管的外表面；
(d)让套管在所说的圆柱形部件发泡孔表面内作轴向往复运动，以抑制在套管和圆柱形部件之间的结合，使所说的套管相对于所说的头端部件能作轴向移动，同时又能保持和圆柱形部件密封地耦接，使后者形成所说的血液密封垫。
2.一种如权利要求1所述的方法，其特征在于所说的圆柱形部件由含发泡剂的塑性材料构成，这种发泡剂具有比用于挤压圆柱形部件的挤压物温度高，而比套管被加热的温度低的激活温度。
3.一种如权利要求1所述的方法，其特征在于加热步骤(c)先实现的所说挤压圆柱形部件的内径比所说套管外径大大约0.001至0.050英寸。
4.一种如权利要求1所述的方法，其特征在于套管的加热，所述圆柱形部件内部表面的发泡在所说套管和圆柱形部件的轴向孔的长度方向间形成一个柔软的泡沫片。
5.一种种如权利要求1所述的方法，其特征在于所说的套管加热包括应用感应加。
6.一种如权利要求1所述的方法，其特征在于所说的圆柱形部件的挤出件的塑性材料含有防粘介质，以防止套管与所说的圆柱形部件的粘连。
7.一种如权利要求1所述的方法，其特征在于所述防粘介质包括硅树脂。
8.一种如权利要求1所述的方法，其特征在于所说的套管涂以防粘介质，以防止套管与所说的圆柱形部件的粘连。
9.一种如权利要求8所述的方法，其特征在于所述防粘介质包括硅树脂。
10.一种如权利要求1所述的方法，其特征在于所说的头端部件包含模塑的塑性材料。
11.一种如权利要求10所述的方法，其特征在于所说的圆柱形部件与所说的头端部件模压成一个整体。
12.一种制造安全导管用的血液密封垫的方法，其中所说的安全导管包括在其中具有轴向可滑动地定位于长套管的头端部件，所说的套管具有一个从头端突出的第一端，它固定连接到便于接收和含纳来自病人的血液的室内结构，还有第二端，它从所说的头端的相反端伸出，用以插入病人的静脉中；所说的方法包括：
(a)在通过所说的头端部件轴向延伸的中心孔中，安装一个突出的中空圆柱形塑性部件；
(b)通过所说的中空圆柱形部件中的轴向孔延伸所说的套管，所述圆柱形部件的轴向孔用于接收所说的套管，其尺寸被定成能在所说的套管周围提供一个环形空间；
(c)加热所说的套管，使得所说的圆柱形部件的轴向孔的内表面的材料发泡，并向内部辐射状地膨胀，以密封地耦合于所说的套管的外表面；从而使套管在所说的圆柱形部件发泡孔表面内作轴向往复运动，以便防止在套管和圆柱形部件之间的结合，使所说的套管相对于所说的头端部件能作轴向移动，同时又能保持和圆柱形部件密封地耦合，使后者形成所说的血液密封垫。
13.一种如权利要求12所述的密封垫，其特征在于所说的圆柱形部件由含发泡剂的塑性材料构成，这种发泡剂具有比用于挤压圆柱形部件的挤压物温度高，而比套管被加热的温度低的激活温度。
14.一种如权利要求12所述的密封垫，其特征在于起泡步骤实现的所说的挤压圆柱形部件的内径、比所说套管的外径大大约0.001至0.050英寸。
15.一种如权利要求12所述的密封垫，其特征在于响应于套管的加热，所述圆柱形部件的内表面的起泡在所说套管和圆柱形部件的轴向孔的长度方向间形成一个柔软的泡沫片。
16.一种如权利要求12所述的密封垫，其特征在于所说的套管加热包括应用感应加热。
17.一种如权利要求12所述的密封垫，其特征在于所说的圆柱形部件的挤出件的塑性材料含有防粘介质，以防止套管与所说的圆柱形部件的粘连。
18.一种如权利要求12所述的密封垫，其中所述的防粘介质包括由硅树脂。
19.一种如权利要求1所述的密封垫，其特征在于所说的套管涂以防粘介质，以防止套管与所说的圆柱形部件的粘连。
20.一种如权利要求19所述的密封垫，其中的防粘介质包括由硅树脂。
21.一种如权利要求12所述的密封垫，其特征在于所说的头端部件包含模塑的塑性材料。
22.一种如权利要求21所述的密封圈，其特征在于所说的圆柱形部件与所说的头端部件模塑成一体。
CNB971192928A 1996-08-19 1997-08-19 安全导管用的血液密封垫及其制造方法 Expired - Fee Related CN1155419C (zh)

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US08/699,631 US5810785A (en) 1996-08-19 1996-08-19 Blown-in-place blood gasket for a safety catheter
US699,631 1996-08-19

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US5810785A (en) 1998-09-22
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AU3428597A (en) 1998-02-26
MX9706322A (es) 1998-08-30
EP0824926A3 (en) 1999-11-17
BR9704424A (pt) 1998-11-03
AR008301A1 (es) 1999-12-29
HK1004379A1 (en) 1998-11-27
DE69729830T2 (de) 2005-07-07
SG50881A1 (en) 1998-07-20
KR19980018966A (ko) 1998-06-05
AU720604B2 (en) 2000-06-08
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TW362980B (en) 1999-07-01

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