CN1182892C - 在静脉导管上制作端头的方法 - Google Patents

在静脉导管上制作端头的方法 Download PDF

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CN1182892C
CN1182892C CNB971297649A CN97129764A CN1182892C CN 1182892 C CN1182892 C CN 1182892C CN B971297649 A CNB971297649 A CN B971297649A CN 97129764 A CN97129764 A CN 97129764A CN 1182892 C CN1182892 C CN 1182892C
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conduit
flash
plug
catheter
cutting
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CN1196959A (zh
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J��M�����ض�
J·M·帕特尔
�޾ջ�
D·比尔勒基
J·J·常
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Ethicon Endo Surgery Inc
Ethicon Inc
Smiths Medical ASD Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C57/00—Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor, e.g. collapsible mandrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081—Soft tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2793/00—Shaping techniques involving a cutting or machining operation
    • B29C2793/009—Shaping techniques involving a cutting or machining operation after shaping
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters

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  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

本发明包括一种用于制作导管端头的两步骤方法。在第一步中，将一个管状导管置于一个芯棒上，并将该芯棒及导管的组件***具有模具内表面的模具中，模制一锥形导管端头。然后将带有溢料的模制导管由模具中撤出，并将芯棒由导管中撤出。将该导管和溢料***限定一个开口的夹具中，溢料伸出该开口。由一个切割表面限定该开口，溢料伸出该切割表面。然后沿切割表面移动一个切刀，以便在沿导管长度方向的一个适当点处精确地切除该溢料，从而保留一个制得的修整导管。然后将该导管由夹具中移出，以便进一步加工。

Description

在静脉导管上制作端头的方法
技术领域
本发明涉及一种用于制造医器械的方法，特别是一种在静脉导管上制作端头的方法。
背景技术
为了便于***过程，早已公知将导管、尤其是外部***的静脉导管端头制成锥形。进一步发现今天的许多产品在导管端头处形成双斜面，第一斜面具有大约3°的锥度，第二斜面具有大约27°的锥度。
这些端头的制作可以通过例如利用激光切割，如美国专利US.5,425,903所述，或者利用模制，如授予Daugherty的美国专利US.4,661,300所述。
Daugherty的专利描述了一种模制方法，其中采用了单一步骤操作来形成并夹紧导管。那就是，采用将管材料伸出芯棒外，而使导管置于一个芯棒上，然后将此装置***一个已加热的模具中，以形成导管的外表面。使芯棒前进至一点处，在该处它使模具表面在一个单一步骤中夹紧导管的溢料。
然而，这种单一步骤方法的显著不利之处在于，由于其模具和芯棒都用作切削装置，因而必须接合并互相磨损，从而工具寿命较短。这意味着，在使用过程中，导管上形成的外表面随着芯棒和模具之间的接触对模具内表面的磨损而变化。另外，为了在模具上保持锋利边缘以提供精确的切割操作，必须更换刀具。
发明内容
本发明致力于一种在静脉导管上制作端头的方法，包括在一个伸到导管端部以外或突出的端头区域的芯棒上设置一个管状导管的步骤。将一个具有符合制成导管所需外表面的锥形模具内表面的模具加热，并将该带导管的芯棒***所述模具中，使导管材料与模具内表面接合。导管材料与模具内表面的接合使导管材料软化并与模具内表面一致，从而形成伸到所需导管端头外的溢料。当材料冷却后，从中撤去所述导管和芯棒，然后再从导管中撤去芯棒。另外，也可一步完成，从导管中撤去芯棒，再从模具中取出导管。
在另一操作中，将带有溢料的导管***一个具有限定一个开口的切削表面的夹具中。导管向夹具的***允许其溢料通过所述开口伸出至其切削表面外。一个切刀沿所述切割表面移动，切下伸出该表面的溢料，并将此溢料与导管的其余部分分离开。这就制得了一个修整的导管，它随后由夹具中移出，以便进一步处理。
可将所述夹具制成为限定一个通道，该通道终止于所需开口。所述通道可与导管外表面一致，以便于设置导管使其溢料伸出适当距离。所述切刀可以是单面或者复合的刀片，例如手持操作的剃须刀片。刀片的厚度可优选为从约0.0762毫米(0.003英寸)至约0.254毫米(0.010英寸)，导管可由例如聚四氟乙烯(PTFE)或聚氨酯材料制成。
附图说明
下面参照附图对本发明进行描述，其中：
图1为本发明的模制过程的图示；以及
图2为本发明的切割夹具和切割过程的图示。
具体实施方式
本发明涉及一种用于制作导管端头的简化而精确的方法。特别地，在制作锥形导管端头时，必须既形成锥形还要去除可能形成的任何溢料。
在本方法中，将由例如聚四氟乙烯或聚氨酯制成的管状导管1设置于一个同轴芯棒2上。芯棒2容纳于导管套管的内腔3之内，并从导管的端部5伸出。模具6具有与所需最终导管外表面一致的锥形内表面7。例如，它可优选为沿导管的一定长度形成约3°的小角度锥形，并在导管的最为端头处提供一个例如27°的较尖锐的斜面，以使导管表面向上拉延，使与通过导管内腔的针头套管相符。将模具加热至适于软化导管材料的温度。例如，对于20号(即直径1.143毫米或0.045英寸)的聚四氟乙烯导管，该温度为从约343摄氏度(650华氏度)至约399摄氏度(750华氏度)。或者，对于聚氨酯导管，将模具加热至从约232摄氏度(450华氏度)至约288摄氏度(550华氏度)。以公知方法将导管1和芯棒2***模具6中，以使导管材料与加热的模具表面相接合。模具材料受热软化，并流入围绕芯棒的模具内的空隙。一部分导管材料流出所需模制区域，形成一个溢料8。
应当指出，本方法的芯棒2通往溢料端之外，用以支撑它，使得在冷却时柱状的溢料8伸出至所需导管端头之外。此溢料8后面将加以去除，并以如下方式延伸，以提供模具的连续填料，也提供一个由接下去的切割过程去除的连续部分。
使模具6和导管1得以冷却，从而使导管1和芯棒2由内模具通道中撤出。然后从导管内撤出芯棒，并将芯棒***一个阴夹具9(图2)。阴夹具9有一个通过它的通道10，该通道与最终导管所需外表面一致。该通道10止于上切割表面11，该上切割表面11相对于通道10精确地位于导管需要被切割之处。
通过导管1在该通道之内的***，溢料8伸出切割表面11，并露出夹具之外。然后将一切割刀片沿切割表面11运动，以切下溢料8并将其由导管端部去除。该切割刀片12应当薄至能够满足切割导管材料的足够强度，以便在切割过程中防止导管自身破裂。显而易见的是，一个钝的或厚的切割刀锋在沿切割表面移动时，易于将与刀片接触的起始侧向相对侧而被压碎，从而损坏导管和最终切割。
于是，从导管1的端头去除溢料，从阴夹具9中撤出导管，以便进一步加工。
已经接合附图及其优选实施例对本发明进行了描述。对本发明可作出些微改动，而不超出所述发明的范围。

Claims (7)

1、一种在静脉导管上制作端头的方法，包括如下步骤：
a)在一个芯棒上设置一个管状导管，使所述芯棒伸出所述导管的端部；
b)将一个具有锥形模具内表面的模具加热；
c)将该所述导管和芯棒***所述模具中，使所述导管材料与所述模具内表面接合；
d)使所述导管材料软化并与所述模具内表面一致，从而形成伸出所需导管管头的溢料；
e)从所述模具中撤出所述导管和芯棒，并从所述导管中撤去芯棒；
f)将该导管***一个具有限定一个开口的切削表面的夹具中，使得所述溢料通过所述开口伸出所述切削表面；
g)使一个切刀沿所述切割表面移动，以将伸出所述表面外的溢料从所述导管的其余部分切下，从而制得一个修整的导管；以及
h)将所述修整的导管由所述夹具中移出。
2、如权利要求1所述的方法，其特征在于，所述夹具限定了一个止于所述开口的通道，该通道与所述导管的外表面一致，以精确地将所述导管固定进行修整。
3、如权利要求1所述的方法，其特征在于，所述切刀为一个单一的或复合的刀片。
4、如权利要求3所述的方法，其特征在于，所述刀片厚度为0.0762毫米至0.254毫米厚。
5、如权利要求1所述的方法，其特征在于，所述切刀为沿所述表面手动地切除所述溢料的剃刀片。
6、如权利要求1所述的方法，其特征在于，所述导管由聚四氟乙烯材料制成，并将所述模具加热至从343摄氏度至399摄氏度。
7、如权利要求1所述的方法，其特征在于，所述导管由聚氨酯材料制成，并将所述模具加热至从232摄氏度至288摄氏度。
CNB971297649A 1996-12-30 1997-12-30 在静脉导管上制作端头的方法 Expired - Fee Related CN1182892C (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/773,942 US5843356A (en) 1996-12-30 1996-12-30 Catheter tip mold and cut process
US773942 1996-12-30
US773,942 1996-12-30

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AT (1) ATE213654T1 (zh)
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ES2171846T3 (es) 2002-09-16
US5843356A (en) 1998-12-01
KR100515106B1 (ko) 2005-12-02
DK0850655T3 (da) 2002-03-25
IL122786A0 (en) 1998-08-16
CN1196959A (zh) 1998-10-28
ATE213654T1 (de) 2002-03-15
CA2226053A1 (en) 1998-06-30
JPH10201848A (ja) 1998-08-04
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AU4924497A (en) 1998-07-02
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SG55443A1 (en) 1998-12-21
AR011337A1 (es) 2000-08-16
IL122786A (en) 2004-02-19
MY126380A (en) 2006-09-29
NO976135D0 (no) 1997-12-30
EP0850655A2 (en) 1998-07-01
EP0850655B1 (en) 2002-02-27
AU717056B2 (en) 2000-03-16
RU2177807C2 (ru) 2002-01-10
EP0850655A3 (en) 1998-11-18
CO4761075A1 (es) 1999-04-27
BR9706495A (pt) 1999-07-27
KR19980064779A (ko) 1998-10-07
NZ329542A (en) 1999-09-29
NO976135L (no) 1998-07-01
DE69710694D1 (de) 2002-04-04

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