CN1077492C - 用于成形导管斜面端头的处理过程 - Google Patents
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Abstract
介绍了一种导管端头成形处理过程,在此过程中,具有一内表面可形成理想的导管端头外表面的模具有两个不同温度区,第一个高温区大致位于导管末端,而低温区在高温区末端,将需端头整形的导管放在芯棒或针轴上,模具被加热,当将导管和芯棒***模具时,导管材料软化并开始在模具内流动;高温区提供软化管材所需热量,管材流至低温区,在低温区,低温致使管材变得更粘稠或重新固化,在变得更加粘稠后;管材在最末端起拦坝作用防止材料的再流动;进而消除自模具端部的泄出。
Description
本发明涉及方便注射的导管斜面端头的制作方法,尤其涉及体表静脉导管斜面端头的成形方法。
人们早已知道体表***导管上的斜面端头可使导管***病人体内的过程变得更为容易。静脉注射导管可用于将血液、血浆、药物或其它流体注入病人体内,也可用于抽血或允许类似更细导管的其它物质通过皮肤开口处***。由初始原材料制做导管时是由管材切割或挤压成形。管材或挤压成形的导管通常具有圆钝粗糙的端头,有可能在***时引起外伤。因此,许多体表***导管从末稍向上一定距离内是一斜面,比如可以使用3度的斜锥形和在各种针头的一个很短的部分上采用一个27°斜锥形末端,以使最初的***就像一根带有导管的针穿入病人体内那样容易。
现代技术中,已有许多使导管端头成为锥形的方法为人所知。如美国专利4661300,冠名为“静脉导管无毛刺制尖法及其装置”,该专利展示一种模压法,此法中,导管的一端在模压过程中即被剪去。美国专利5397512;5425903以及5484422展示了用激光使导管端形成斜面尖头的方法,该法中,3度锥形最初已在导管上形成,然后通过激光接触导管腐蚀其表面形成27度锥形。
本发明涉及在一模具内提供热梯度用于导管尖端成形。该热梯度为模具的第一部分提供较高温度,致使导管聚合材料溶化并流动。第二部分温度较低,使流经的聚合材料变得更粘稠或开始再硬化,并起拦坝作用防止聚合材料的进一步流动。
本发明提出在导管上形成斜面端头的处理过程,包括:
a)安置一根管状导管在一柱销上,以柱销在所述管状导管内延伸,使其穿过导管端头伸出;
b)加热一模具,该模具内表面构成一理想的导管外斜面端头表面,所述模具当被加热时有一高温区和位于其末端的低温区;
c)将所述柱销和导管***所述模具,使所述柱销至少到达所述内表面的末端,以形成至少部分地被所述柱销和所述模具表面限定的一个空间;
d)继续推进所述导管进入所述空间,所述高温区致使所述导管材料软化并流动直至所述材料接触所述低温区,所述低温区使所述材料更粘稠并作为一拦坝,防止所述材料的进一步流动和允许斜面端头的形成而无多余泄出;
e)从所述模具取出所述导管。
另外,也提出在导管上形成斜面端头的处理过程,包括:
a)加热一模具,该模具内表面可形成一理想的导管外斜面端头表面,所述模具具有从那里伸出的一个柱销以在其上接纳所述导管,所述模具当被加热时有一高温区和在其末端的低温区;
b)将所述柱销***管状导管,推动所述导管进入模具;
c)继续推动所述导管进入所述模具,所述高温区致使所述导管材料软化并流动直至所述材料接触所述低温区,所述低温区使所述材料更粘稠并作为一拦坝,防止所述材料的进一步流动,和允许斜面端头的形成而无多余泄出。
为做到这一点,需用一根芯棒或针来固定并支撑被加工导管。内部结构为锥形的端子模头被加热。端头模子的外形可提供足够热量融化导管并可快速冷却。以使模具的至少一个部分冷却。该模具装在一支承架内向芯棒或针棒移动。芯棒或针棒移动穿过整个模子直至穿出,被加热的模子起软化导管管材的作用,然后被冷却,使管材充填整个模子内空间。可即时使用集中风冷快速冷却材使其产生必要的粘度变化保证内部模型的充分充填。外形提供的热梯度产生在模具的内部结构上。这样,就可使材料被加热成流体并被快速冷却以充填模子内空间。端头模子可用两种或多种带有不同热导率的材料构成,以可能的方式为多种塑料提供热梯度达到在模子内停止流动的效果。另外,集中加热可提供热源的精确定位,这就可以使模子的整个内空间得到充填而无任何毛刺。
我们将参照附图描述本发明,其中:
图1是用于端头作业的模具和芯棒的横截面图;
图2是用本发明操作程序加工过端头的导管之横截面图;
图3是部分放大横截面图,显示本发明加工时所用模具之端头部位;以及
图4是本发明另一实施例的横截面图。
作为正规的导管成形操作的一部分,形成一个预型件,它具有一个以套管形式连接在向远端延伸的、欲置入病人体内的管状部位上。这种没有斜面端头的预型件就是本发明操作的对象。预型件***在同心柱销上。口径为20号的导管,需用0.0282英寸的柱销***该导管内并突出于导管末端。柱销最好由不锈钢或其它可精确加工至所需尺寸型状的金属材料制成。优选地柱销材料应比模具材料软一些,这样可减少对模具的损害和磨损。在至少一个本发明实施例中,导管1和柱销2相互基本为一个整体同时移动。
模具3至少有两个部分,高温部4和低温部5,两者用陶瓷隔离体6隔开。高温部4优选地应用不锈钢或其它传导金属做成,要根据特性以及热传导和热滞留(即比热)选择模具材料。隔离体6(图4)最好是陶瓷,目的是减少或防止从高温部4到低温部5的热传导。低温部5应由陶瓷(图1)或诸如含6%铝、4%钒的钛合金(图4)制成,其尺寸的选择应使其热质量低于高温部4。
低温部5有一限定的开口7,柱销2穿其而过。如使用0.0282英寸的柱销,开口直径应为0.0285英寸,以便为柱销提供间隙,保证塑料在模具推进时空气和气体的流通。高温部内表面8在那里形成了柱表面9和锥表面10。锥表面10形成锥度为3度的圆锥形,这样,在制模时就在管材末端形成一个平缓的锥度。低温部5可由陶瓷制成,这样可免去隔离陶瓷隔离体。
低温部内表面11形成一个截头圆锥形表面12,形成在导管末端所需的27度锥体。现在可以看到当柱销2在模3中到位时,柱销2的外表面与柱表面9、锥表面10和12一起构成一个形状,其空间构成理想的导管末端构造。就是说,模具的内表面和柱销的外表面构成了将要生成的导管管壁。
模具3有一锥形外表面13。如图1所见,面13在靠近低温部5处有一略微下降的部分。加热块14用来加热模具。块14做为一个大热源,目的是把热快速传给模具。模具3被放入内侧具有适合的锥面的加热块内,模具的外表面13接触加热块,因而接受加热块对模具的热传导。低温部5与加热块的间隙5A防止或大量减少了从加热块到模具的这一部分的热传导。如果低温部由陶瓷制成,间隙5A仍有好处,但在图4实施例中,5A更显有利。人们很容易看出,一旦模具被加热至恰当温度,高温部已接收来自加热块的部分热传导,而低温部也已接收减弱了的或很少一点由加热块传来的热。这样模具就形成从高湿部4到低温部5有一个温度梯度的状态。图中显示模具与加热块在制模操作时是相接触的。实际应用中,在***导管允许模具冷却以重新固化聚合物之前,它们是分离的。在全部制模操作完成后,模具与加热块重新接触加热为下一制模操作做准备。
在一氟化乙烯丙烯聚合物导管优选实施例中,高温部约为华氏575-650度,而低温部约小于华氏100度。之后,柱销2被***模具。在一优选实施例中,柱销已套上导管1,当其穿过模具伸出模具末端(即靠近低温部的端部)时,管材被压入由柱销、柱表面9、锥表面10,锥表面12限定的空间。导管用类似氟化乙烯丙烯聚合物或聚氨甲基酸脂等热塑材料制成。就氟化乙烯丙烯聚合材料而言,其软化温度为华氏550度,因而高温部被加热至华氏575-650度。当接触或接近此高温部时,导管1软化并开始流动。正如所见,流动并不见得是液体状,而是一种可塑状态并因加热和材料的软化而易于材料的塑生变形。当导管进入模具空间时,流动的管材沿锥表面10流动并与其相贴直至接触内表面11。内表面11比内表面10有更足够的低温使管材开始再硬化或至少比在高温部时更具粘性。这样,接触到内表面11的材料开始起拦坝作用防止材料进一步流动,并使模具得到充分充填而没有多余的毛刺。
柱销2的尺寸要小于开口7,在其通过开口7时要留有细微间隙。此间隙可使模具内管材前方的气体排出。但制模材料不会泄出内表面11,因为较凉爽温度致使流动的管材变得更加粘稠,使管材通过模端细微间隙泄出几乎不可能。
显而易见,我们只能提供模具的高温部和低温部的形状而不是它们不同的材料(得用户自己定)。比如说,在低温部可以***散热片以促进模具在该区的冷却,而高温部有很大的热质量提供热储备,从而降低其冷却能力。这样,低温部被冷却区将提供与被热能包围的高温部的温度梯度以产生流动热塑材料的阻抑效果。
在一替换实施例中,柱销2可永远置于模具内,或从末稍端进入并穿过模具。此后,导管材料末端穿过柱销头从而将导管置于柱销上,沿柱销滑动直至接触模具内表面并在模内进一步推进到模具内,使软化材料从高温部向低温部流动。在最终导管产品成形后,柱销可通过模具顶部(相对于导管插放入的模具的远端)抽出,导管在销抽出之前或之后均可从模具中取出。
我们已结合优选实施例对本发明做了介绍。所附权利要求书实指本发明。尽管对上述优选实施例中描述的内容,人们可以做多种变动,但这些变动仍与所附权利要求书的精神和涉及范围相一致。
Claims (21)
1.在导管上形成斜面端头的处理过程,包括:
a)安置一根管状导管在一柱销上,以柱销在所述管状导管内延伸,使其穿过导管端头伸出;
b)加热一模具,该模具内表面构成一理想的导管外斜面端头表面,所述模具当被加热时有一高温区和位于其末端的低温区;
c)将所述柱销和导管***所述模具,使所述柱销至少到达所述内表面的末端,以形成至少部分地被所述柱销和所述模具表面限定的一个空间;
d)继续推进所述导管进入所述空间,所述高温区致使所述导管材料软化并流动直至所述材料接触所述低温区,所述低温区使所述材料更粘稠并作为一拦坝,防止所述材料的进一步流动和允许斜面端头的形成而无多余泄出;
e)从所述模具取出所述导管。
2.根据权利要求1所述的过程,其特征在于所述模具的加热是通过温度高于所述模具的加热块与所述模具外表面接触将热传至所述模具实现的。
3.根据权利要求2所述的过程,其特征在于所述模具的所述高温区用第一种材料制成,所述低温区用热导率较低的第二种材料制成。
4.根据权利要求2所述的过程,其特征在于所述模具的形状设计成使加热块对所述低温区的热传送低于其对所述高温区的热传导。
5.根据权利要求4所述的过程,其特征在于所述模具所述高温区与所述加热块接触,而所述低温区不接触加热块。
6.根据权利要求2所述的过程,其特征在于所述模具形状设计成使所述低温区冷却快于所述高温区。
7.根据权利要求1所述的过程,其特征在于所述柱销和所述导管可从所述模具中取出。
8.根据权利要求1所述的过程,其特征在于先从所述模具和导管取出所述柱销,然后取出所述导管。
9.根据权利要求2所述的过程,其特征在于所述模具在所述高温区和低温区之间有一隔离区。
10.在导管上形成斜面端头的处理过程,包括:
a)加热一模具,该模具内表面可形成一理想的导管外斜面端头表面,所述模具具有从那里伸出的一个柱销以在其上接纳所述导管,所述模具当被加热时有一高温区和在其末端的低温区;
b)将所述柱销***管状导管,推动所述导管进入模具;
c)继续推动所述导管进入所述模具,所述高温区致使所述导管材料软化并流动直至所述材料接触所述低温区,所述低温区使所述材料更粘稠并作为一拦坝,防止所述材料的进一步流动,和允许斜面端头的形成而无多余泄出。
11.根据权利要求10所述的过程,其特征在于所述模具的加热是通过温度高于所述模具的加热块与所述模具外表面接触,将热传至所述模具实现的。
12.根据权利要求11所述的过程,其特征在于所述模具的形状设计成使加热块对所述低温区的热传送低于其对所述高温区的热传导。
13.根据权利要求11所述的过程,其特征在于所述模具形状设计成使所述低温区冷却快于所述高温区。
14.根据权利要求11所述的过程,其特征在于在加热期间,所述模具以所述高温区与所述加热块接触,而所述低温区不接触加热块。
15.根据权利要求10所述的过程,其特征在于所述模具的所述高温区用第一种材料制成,所述低温区用热导率较低的第二种材料制成。
16.根据权利要求10所述的过程,其特征在于所述模具的所述高温区用第一种材料制成,制成所述低温区的第二种材料比热较低。
17.根据权利要求10所述的过程,其特征在于所述导管在此之后从所述模具中取出。
18.根据权利要求10所述的过程,其特征在于先从所述模具和导管取出所述柱销,然后取出所述导管。
19.根据权利要求10所述的过程,其特征在于所述模具在所述高温区和所述低温区之间有一隔离体。
20.根据权利要求10所述的过程,其特征在于一冷却气流吹向模具使模具冷却并使导管再固化。
21.根据权利要求20所述的过程,其特征在于冷却气流至少集中于低温部分的某一区域。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US767267 | 1996-12-13 | ||
US08/767,267 US6048485A (en) | 1996-12-13 | 1996-12-13 | Thermal gradient beveling of catheters |
US767,267 | 1996-12-13 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1195609A CN1195609A (zh) | 1998-10-14 |
CN1077492C true CN1077492C (zh) | 2002-01-09 |
Family
ID=25078983
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN97120886A Expired - Fee Related CN1077492C (zh) | 1996-12-13 | 1997-12-13 | 用于成形导管斜面端头的处理过程 |
Country Status (21)
Country | Link |
---|---|
US (1) | US6048485A (zh) |
EP (1) | EP0847771B1 (zh) |
JP (1) | JP3936050B2 (zh) |
KR (1) | KR100495459B1 (zh) |
CN (1) | CN1077492C (zh) |
AR (2) | AR010774A1 (zh) |
AT (1) | ATE235281T1 (zh) |
AU (1) | AU725425B2 (zh) |
BR (1) | BR9705643A (zh) |
CA (1) | CA2224514C (zh) |
CO (1) | CO4750849A1 (zh) |
DE (1) | DE69720153T2 (zh) |
DK (1) | DK0847771T3 (zh) |
ES (1) | ES2195093T3 (zh) |
IL (1) | IL122579A (zh) |
MY (1) | MY129082A (zh) |
NO (1) | NO312818B1 (zh) |
NZ (1) | NZ329386A (zh) |
RU (1) | RU2219969C2 (zh) |
SG (1) | SG65039A1 (zh) |
TW (1) | TW366290B (zh) |
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US6841114B2 (en) * | 2001-03-28 | 2005-01-11 | Mitsubishi Cable Industries, Ltd. | Molding method and apparatus for resin long body |
WO2004091471A2 (en) * | 2003-04-04 | 2004-10-28 | Berger, Constance, F. | Apparatus for heating bottles and method of manufacturing same |
US7972350B2 (en) * | 2004-01-29 | 2011-07-05 | Boston Scientific Scimed, Inc. | Catheter tip |
US20050273076A1 (en) * | 2004-06-07 | 2005-12-08 | C.R. Bard, Inc. | Subcutaneous infusion devices |
US7261850B2 (en) * | 2004-06-30 | 2007-08-28 | Cordis Corporation | Methods of making balloon catheter tip |
US20060027063A1 (en) * | 2004-08-09 | 2006-02-09 | Currier Jonathan M | Tooling apparatuses and processes for providing precision shapes in medical catheters |
US7435077B2 (en) * | 2004-08-13 | 2008-10-14 | Boston Scientific Scimed, Inc. | Catheter balloon molding device |
GB0625755D0 (en) * | 2006-12-22 | 2007-02-07 | Smiths Group Plc | Apparatus and methods for end forming tubes |
US20100160862A1 (en) * | 2008-12-22 | 2010-06-24 | Cook Incorporated | Variable stiffness introducer sheath with transition zone |
JP5897310B2 (ja) * | 2011-11-28 | 2016-03-30 | 株式会社カネカ | 医療用チューブの製造方法 |
US9868238B1 (en) * | 2013-03-03 | 2018-01-16 | Catheter Dynamics, Inc. | Moldable material shaping systems and methods of use |
WO2018218236A1 (en) | 2017-05-26 | 2018-11-29 | Piper Access, Llc | Catheter delivery devices, systems, and methods |
CN110218934B (zh) * | 2019-07-26 | 2020-06-09 | 南昌工程学院 | 一种Fe-Ga-Ce-B合金棒材及其制备方法和一种冷却铜模具 |
US20220401692A1 (en) * | 2021-06-22 | 2022-12-22 | Northeast Scientific, Inc. | Method for straightening bent catheters for use |
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- 1997-12-11 CO CO97072331A patent/CO4750849A1/es unknown
- 1997-12-11 RU RU97120886/14A patent/RU2219969C2/ru not_active IP Right Cessation
- 1997-12-11 CA CA002224514A patent/CA2224514C/en not_active Expired - Fee Related
- 1997-12-12 ES ES97310059T patent/ES2195093T3/es not_active Expired - Lifetime
- 1997-12-12 AU AU48337/97A patent/AU725425B2/en not_active Ceased
- 1997-12-12 AR ARP970105869A patent/AR010774A1/es active IP Right Grant
- 1997-12-12 DE DE69720153T patent/DE69720153T2/de not_active Expired - Lifetime
- 1997-12-12 AT AT97310059T patent/ATE235281T1/de not_active IP Right Cessation
- 1997-12-12 IL IL12257997A patent/IL122579A/en not_active IP Right Cessation
- 1997-12-12 NZ NZ329386A patent/NZ329386A/xx not_active IP Right Cessation
- 1997-12-12 JP JP36289697A patent/JP3936050B2/ja not_active Expired - Fee Related
- 1997-12-12 MY MYPI97006028A patent/MY129082A/en unknown
- 1997-12-12 DK DK97310059T patent/DK0847771T3/da active
- 1997-12-12 EP EP97310059A patent/EP0847771B1/en not_active Expired - Lifetime
- 1997-12-12 NO NO19975863A patent/NO312818B1/no unknown
- 1997-12-12 KR KR1019970068068A patent/KR100495459B1/ko not_active IP Right Cessation
- 1997-12-12 SG SG1997004435A patent/SG65039A1/en unknown
- 1997-12-13 CN CN97120886A patent/CN1077492C/zh not_active Expired - Fee Related
- 1997-12-15 BR BR9705643A patent/BR9705643A/pt not_active IP Right Cessation
-
1998
- 1998-02-13 TW TW086118732A patent/TW366290B/zh not_active IP Right Cessation
-
2005
- 2005-10-04 AR ARP050104192A patent/AR054692A2/es not_active Application Discontinuation
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Also Published As
Publication number | Publication date |
---|---|
SG65039A1 (en) | 1999-05-25 |
EP0847771A3 (en) | 1998-07-22 |
DE69720153T2 (de) | 2004-01-08 |
TW366290B (en) | 1999-08-11 |
EP0847771B1 (en) | 2003-03-26 |
CA2224514A1 (en) | 1998-06-13 |
AU725425B2 (en) | 2000-10-12 |
RU2219969C2 (ru) | 2003-12-27 |
EP0847771A2 (en) | 1998-06-17 |
BR9705643A (pt) | 1999-07-06 |
JP3936050B2 (ja) | 2007-06-27 |
AR010774A1 (es) | 2000-07-12 |
NO975863L (no) | 1998-06-15 |
JPH10179753A (ja) | 1998-07-07 |
NO975863D0 (no) | 1997-12-12 |
IL122579A0 (en) | 1998-06-15 |
AR054692A2 (es) | 2007-07-11 |
US6048485A (en) | 2000-04-11 |
ATE235281T1 (de) | 2003-04-15 |
MY129082A (en) | 2007-03-30 |
DK0847771T3 (da) | 2003-06-10 |
CA2224514C (en) | 2007-04-10 |
MX9710061A (es) | 1998-10-31 |
NO312818B1 (no) | 2002-07-08 |
KR100495459B1 (ko) | 2005-09-14 |
IL122579A (en) | 2002-12-01 |
DE69720153D1 (de) | 2003-04-30 |
CO4750849A1 (es) | 1999-03-31 |
AU4833797A (en) | 1998-06-18 |
NZ329386A (en) | 1999-03-29 |
KR19980064069A (ko) | 1998-10-07 |
CN1195609A (zh) | 1998-10-14 |
ES2195093T3 (es) | 2003-12-01 |
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