JPS6122985B2 - - Google Patents
Info
- Publication number
- JPS6122985B2 JPS6122985B2 JP54150142A JP15014279A JPS6122985B2 JP S6122985 B2 JPS6122985 B2 JP S6122985B2 JP 54150142 A JP54150142 A JP 54150142A JP 15014279 A JP15014279 A JP 15014279A JP S6122985 B2 JPS6122985 B2 JP S6122985B2
- Authority
- JP
- Japan
- Prior art keywords
- tube body
- intravascular indwelling
- indwelling catheter
- blood vessel
- inner needle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- 210000004204 blood vessel Anatomy 0.000 claims description 12
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 3
- 239000005977 Ethylene Substances 0.000 claims description 3
- 229920001577 copolymer Polymers 0.000 claims description 3
- 238000012360 testing method Methods 0.000 description 8
- 238000005452 bending Methods 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 239000004812 Fluorinated ethylene propylene Substances 0.000 description 5
- 229920009441 perflouroethylene propylene Polymers 0.000 description 5
- 239000004033 plastic Substances 0.000 description 4
- 229920003023 plastic Polymers 0.000 description 4
- 229920000840 ethylene tetrafluoroethylene copolymer Polymers 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 206010067482 No adverse event Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 230000007059 acute toxicity Effects 0.000 description 1
- 231100000403 acute toxicity Toxicity 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 230000007681 cardiovascular toxicity Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 231100000989 no adverse effect Toxicity 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- BFKJFAAPBSQJPD-UHFFFAOYSA-N tetrafluoroethene Chemical group FC(F)=C(F)F BFKJFAAPBSQJPD-UHFFFAOYSA-N 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Landscapes
- Materials For Medical Uses (AREA)
Description
この発明は血管内部との連通を保存するために
用いられる血管内留置カテーテル又は留置針に関
する。
血管内留置カテーテルは一般に内部に血管穿刺
用内針を挿入するための両端開口チユーブ体と、
該チユーブ体の一端に固着されたハブ部とからな
り、該チユーブ体内に内針を挿入した状態で血管
内に穿刺し、ついで内針を引抜いたのち、チユー
ブ体を血管内にさらに押込んだ状態で留置して使
用する。しかして、血管内留置カテーテルのチユ
ーブ体はある程度の機械的強度を有し、血管内へ
の挿入が可能であり、外力によつて容易に折曲し
ないこと、先端がテーパ状に成形可能であるこ
と、先体適合性が良好なことなどが要求されてい
る。さらに近年、このチユーブ体の肉厚をできる
だけ薄くし、外径が同一であつても、できるだけ
多くの流体通過量を得ることができること、又穿
刺が確実に行なえるように全体の腰を強くするた
め太い内針を使用することができることなどが要
求されつつある。
従来、この種の血管内留置カテーテルのチユー
ブ体の材料としてポリエチレン、ポリプロピレ
ン、テトラフルオロエチレン、弗化エチレン、プ
ロピレンコポリマー等を使用したものが知られて
いる。しかし、これらの従来のプラスチツク材料
でチユーブ体を成形した場合、チユーブ体の肉厚
を必要な程度に薄くすると機械的強度が小さくな
り、折曲し易くなり、内針を引抜いて、チユーブ
体のみをさらに血管内に挿入する場合にその操作
が困難となるなどの問題が生じ、逆にこのような
取扱上支障をきたさない程度の肉厚にすると、流
量を十分に大きくすることができないなどの問題
があつた。さらに、このチユーブ体は血管内に内
に留置するため血液凝固作用、毒性等の生体への
影響のないものを選択しなければならないなど、
材質選択上、多くの問題があつた。
この発明は上記事情に鑑みてなされたものであ
つて、生体への悪影響がなく、しかも機械的強度
を著るしく損うとなく肉厚を著しく薄くすること
ができる材質を用いて、血管内留置カテーテルの
チユーブ体を形成することを目的とする。
すなわち、この発明は両端が開口し、内部に血
管穿刺用内針を挿入し得る内径を有するチユーブ
体と、該チユーブ体の一端に固着されたハブ部と
を具備してなる血管内留置カテーテルであつて、
該チユーブ体がエチレン・テトラフルオロエチレ
ン共重合体から成形されたものであることを特徴
とする血管内留置カテーテルを提供するものであ
る。
以下、この発明を図示の一実施に基づいて説明
する。
図中１は血管内留置カテーテルであつて、両端
が開口したチユーブ体２と、このチユーブ体２の
一端に接着剤３を介して固着されたハブ部４とか
らなつている。このチユーブ体２はエチレン−テ
トラフルオロエチレン共重合体すなわち、一般
式、（−CH2−CH2−CF2−CF2）−の繰り返し単位
を有する材料をたとえば押出し成形してつくつた
ものである。このエチレン・テトラフルオロエチ
レン共重合体は急性毒性、筋肉内移植試験、およ
び皮内反応試験（米国薬局方、19版、プラスチツ
ク容器の生物学的試験）、さらに溶血性試験（日
本薬局方、第９改正輪液用プラスチツク容器規
準）をおこなつた結果、いずれも問題がないこと
が確認された。エチレン・テトラフルオロエチレ
ンはこのように生体に対し不活性であるととも
に、曲げ強度等の機械的強度も比較的大きく、従
来の材料の場合よりもチユーブ体２の肉厚を著し
く小さくすることが可能であり、成形体表面の平
滑性もよく血管内にカテーテル１を押し込む際の
皮膚との摩擦抵抗が少なくスムーズな挿入が可能
であることなども良好であることが見出された。
この血管内留置カテーテル１を使用する場合
は、第２図に示す如くまず内針５およびその一端
に固着された透明ハブ６からなる穿刺針７の内針
５をチユーブ体２内に挿入し、透明ハブ６を血管
内留置カテーテル１のハブ部４の内腔８内に嵌合
させる。このように穿刺針７を血管内留置カテー
テル１内に十分に嵌合させると、内針５の先端が
チユーブ体２の先端から若干突出した状態とな
る。しかして、この状態で血管壁を穿刺し、つい
で穿刺針７を抜き、血管内留置カテーテル１のみ
をさらに血管内に押し込み、これによつて血管内
部との連通状態を保持することができる。つぎ
に、本発明に係わる血管内留置カテーテルのチユ
ーブ体の肉厚と曲げ強度の関係を、従来の弗化エ
チレン・プロピレンコポリマー（FEPを略記す
る）からつくられたものと比較した試験結果につ
いて述べる。
まず、表１の如く本発明の血管内留置カテーテ
ルのゲージ数18G（外径のもの(A)と従来のFEP製
のゲージ数18G（外径）のもの(B)および(C)を用
い、曲げ強度について比較試験をおこなつた。
The present invention relates to an intravascular indwelling catheter or indwelling needle used to maintain communication with the inside of a blood vessel. Intravascular indwelling catheters generally have a tube body with openings at both ends into which an internal needle for vascular puncture is inserted;
It consists of a hub part fixed to one end of the tube body, and the tube body is punctured into the blood vessel with an inner needle inserted into the tube body, and after the inner needle is pulled out, the tube body is further pushed into the blood vessel. Leave it in place and use it. Therefore, the tube body of the intravascular indwelling catheter has a certain degree of mechanical strength, can be inserted into the blood vessel, is not easily bent by external force, and the tip can be formed into a tapered shape. In addition, good acrosome compatibility is required. Furthermore, in recent years, the wall thickness of this tube body has been made as thin as possible to obtain as much fluid passage as possible even if the outer diameter is the same, and the overall stiffness has been strengthened so that puncturing can be performed reliably. Therefore, there is an increasing demand for the ability to use thicker inner needles. Heretofore, it has been known to use polyethylene, polypropylene, tetrafluoroethylene, fluorinated ethylene, propylene copolymer, etc. as the material for the tube body of this type of intravascular indwelling catheter. However, when the tube body is molded from these conventional plastic materials, if the wall thickness of the tube body is made thin enough, the mechanical strength decreases and it becomes easy to bend. If the tube is further inserted into a blood vessel, it may become difficult to manipulate, and if the wall thickness is made thick enough to avoid such handling problems, the flow rate may not be sufficiently large. There was a problem. Furthermore, since this tube body is placed inside the blood vessel, it must be selected to have no effects on the living body such as blood coagulation or toxicity.
There were many problems in material selection. This invention was made in view of the above circumstances, and uses a material that has no adverse effect on the living body and can be made extremely thin without significantly impairing mechanical strength. The purpose is to form the tube body of the catheter. That is, the present invention provides an intravascular indwelling catheter comprising a tube body that is open at both ends and has an inner diameter into which an internal needle for puncturing a blood vessel can be inserted, and a hub portion fixed to one end of the tube body. It's hot,
The present invention provides an intravascular indwelling catheter characterized in that the tube body is molded from an ethylene/tetrafluoroethylene copolymer. Hereinafter, the present invention will be explained based on one embodiment shown in the drawings. In the figure, reference numeral 1 denotes an intravascular indwelling catheter, which is composed of a tube body 2 with both ends open, and a hub portion 4 fixed to one end of the tube body 2 via an adhesive 3. The tube body 2 is made by extrusion molding an ethylene-tetrafluoroethylene copolymer, that is, a material having repeating units of the general formula (-CH 2 -CH 2 -CF 2 -CF 2 )-. . This ethylene-tetrafluoroethylene copolymer has been tested for acute toxicity, intramuscular implantation, and intradermal reaction (United States Pharmacopoeia, 19th edition, Biological Testing of Plastic Containers), as well as hemolytic testing (Japanese Pharmacopoeia, 19th Edition, Biological Tests for Plastic Containers). As a result of carrying out the 9th revised standard for plastic containers for liquids, it was confirmed that there were no problems. In this way, ethylene/tetrafluoroethylene is inert to living organisms, and also has relatively high mechanical strength such as bending strength, making it possible to make the wall thickness of the tube body 2 significantly smaller than in the case of conventional materials. It was also found that the surface of the molded product has good smoothness, and when the catheter 1 is pushed into a blood vessel, there is little frictional resistance with the skin, and smooth insertion is possible. When using this intravascular indwelling catheter 1, as shown in FIG. 2, first insert the inner needle 5 of the puncture needle 7, which consists of an inner needle 5 and a transparent hub 6 fixed to one end thereof, into the tube body 2. The transparent hub 6 is fitted into the lumen 8 of the hub portion 4 of the intravascular indwelling catheter 1. When the puncture needle 7 is fully fitted into the intravascular indwelling catheter 1 in this way, the tip of the inner needle 5 will slightly protrude from the tip of the tube body 2. In this state, the blood vessel wall is punctured, the puncture needle 7 is then removed, and only the intravascular indwelling catheter 1 is further pushed into the blood vessel, thereby maintaining communication with the inside of the blood vessel. Next, we will discuss test results comparing the relationship between the wall thickness and bending strength of the tube body of the intravascular indwelling catheter according to the present invention with that of a catheter made from a conventional fluorinated ethylene propylene copolymer (abbreviated as FEP). . First, as shown in Table 1, using the intravascular indwelling catheter of the present invention with a gauge number of 18G (outer diameter (A)) and the conventional FEP catheter with a gauge number of 18G (outer diameter) (B) and (C), A comparative test was conducted on bending strength.
【表】
その結果を第３図に示す。この比較試験は各チ
ユーブ体を水平に保ち、ついで各チユーブ体の先
端に５ｇのおもりを垂下させたとき、各チユーブ
体の先端の水平位置からの垂下距離（mm）をチユ
ーブ支点の距離を変えながら測定したものであ
る。
この試験結果から明らかなように、従来の
FEPからつくられたゲージ数18Gで内針ゲージ数
21のもの(B)と比較した場合、本発明のもの(A)はそ
れよりも肉厚が著しく小さいにも拘らず、曲げ強
度は大きくなつている。さらにFEPを用いた本
発明のもの(A)と同一外径、肉厚にしたもの(C)との
比較から、明らかに本発明に係わるチユーブ体の
曲げ強度の著るしい向上が認められよう。
このような試験の結果から、本発明に係わるチ
ユーブ体はゲージ数が従来のものよりも小さい内
針を使用することが可能であることが確認され
た。たとえばチユーブ体のゲージ数と該チユーブ
体に使用可能な内針のゲージ数の関係を示すと下
記表２の如くなる。[Table] The results are shown in Figure 3. In this comparative test, each tube body was held horizontally, and then a 5g weight was suspended from the tip of each tube body, and the hanging distance (mm) from the horizontal position of the tip of each tube body was varied by changing the distance from the tube fulcrum. It was measured while As is clear from this test result, the conventional
Gauge number 18G made from FEP, inner needle gauge number
When compared with the product (B) of No. 21, the product (A) of the present invention has a higher bending strength even though the wall thickness is significantly smaller than that of the product (A). Furthermore, from a comparison between the structure of the present invention (A) using FEP and the structure having the same outer diameter and wall thickness (C), it is clear that the bending strength of the tube body according to the present invention has been significantly improved. . From the results of such tests, it was confirmed that the tube body according to the present invention allows the use of an inner needle with a smaller gauge number than conventional ones. For example, Table 2 below shows the relationship between the gauge number of the tube body and the gauge number of the inner needle that can be used in the tube body.
【表】【table】
【表】
以上、詳述したように、本発明によれば血管内
留置カテーテルのチユーブ体としてエチレン・テ
トラフルオロエチレン共重合体を使用することに
よつて、チユーブ体の肉薄化を図ることができ、
そのため、従来のこの種のカテーテルと比較し
て、単位時間当り、より大きい流量を通過させる
ことができ、太い内針が使用できるため、穿刺針
の腰が強く、しかもその肉薄化に拘らず曲強度等
の機械的強度も実用上十分なものとすることがで
き、さらに生体に対する悪影響がないなど多くの
利点を有する血管内留置カテーテルを提供するこ
とができる。[Table] As detailed above, according to the present invention, by using an ethylene-tetrafluoroethylene copolymer as the tube body of an intravascular indwelling catheter, the thickness of the tube body can be made thinner. ,
Therefore, compared to conventional catheters of this type, a larger flow rate can be passed per unit time, and a thicker inner needle can be used, making the puncture needle strong and bendable despite its thin wall. It is possible to provide an intravascular indwelling catheter which has many advantages such as mechanical strength such as strength that is sufficient for practical use and has no adverse effects on the living body.
第１図は本発明に係わる血管内留置カテーテル
の断面図、第２図は第１図のカテーテル内に挿入
される穿刺針の断面図、第３図は本発明の血管内
留置カテーテルの曲げ強度を従来例と比較して示
す線図である。
図中、１……血管内留置カテーテル、２……チ
ユーブ体、３……接着剤、４……ハブ部、５……
内針、６……透明ハブ、７……穿刺針。
FIG. 1 is a sectional view of an intravascular indwelling catheter according to the present invention, FIG. 2 is a sectional view of a puncture needle inserted into the catheter of FIG. 1, and FIG. 3 is a sectional view of the bending strength of the intravascular indwelling catheter of the present invention. FIG. In the figure, 1... Intravascular indwelling catheter, 2... Tube body, 3... Adhesive, 4... Hub portion, 5...
Inner needle, 6...Transparent hub, 7...Puncture needle.
Claims (1)
し得る内径を有するチユーブ体と、該チユーブ体
の一端に固着されたハブ部とを具備してなる血管
内留置カテーテルであつて、 上記チユーブ体がエチレン・テトラフルオロエ
チレン共重合体から成形されたものであることを
特徴とする血管内留置カテーテル。 ２ チユーブ体の外径ゲージ数ＧTが内針の外径
ゲージ数ＧIとの関係において、ＧT＝ＧI−２
（式中ＧI は15≦ＧI ≦26、ＧT は13≦ＧT ≦24であ
る）である特許請求の範囲第１項記載の血管内留
置カテーテル。[Scope of Claims] 1. Intravascular indwelling device comprising: a tube body that is open at both ends and has an inner diameter into which an inner needle for puncturing a blood vessel can be inserted; and a hub portion fixed to one end of the tube body. An intravascular indwelling catheter, characterized in that the tube body is molded from an ethylene/tetrafluoroethylene copolymer. 2 In the relationship between the outer diameter gauge number G T of the tube body and the outer diameter gauge number G I of the inner needle, G T = G I −2
The intravascular indwelling catheter according to claim 1, wherein G I is 15≦ G I ≦26, and G T is 13≦ G T ≦24.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP15014279A JPS5672871A (en) | 1979-11-20 | 1979-11-20 | Blood vessel inside retaining catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP15014279A JPS5672871A (en) | 1979-11-20 | 1979-11-20 | Blood vessel inside retaining catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS5672871A JPS5672871A (en) | 1981-06-17 |
| JPS6122985B2 true JPS6122985B2 (en) | 1986-06-03 |
Family
ID=15490406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP15014279A Granted JPS5672871A (en) | 1979-11-20 | 1979-11-20 | Blood vessel inside retaining catheter |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS5672871A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002089629A1 (en) * | 2001-05-07 | 2002-11-14 | Eugen Seibold | Piercing article and intermediate product for manufacturing such a piercing article |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5077432A (en) * | 1973-11-13 | 1975-06-24 | ||
| JPS5343756A (en) * | 1976-09-30 | 1978-04-20 | Dow Corning | Method of forming tubular product of oriended fiber reinforced elastic material |
| JPS5476685A (en) * | 1977-11-29 | 1979-06-19 | Ohji Rubber & Chem | Method of making laminate composed of fluoroplastics and rubber |
| JPS54103184A (en) * | 1978-01-27 | 1979-08-14 | Toppan Printing Co Ltd | Bag for freezing preservation |
| JPS54111998A (en) * | 1978-02-21 | 1979-09-01 | Toppan Printing Co Ltd | Protection method for packaging bag for low-temperature freezing |
-
1979
- 1979-11-20 JP JP15014279A patent/JPS5672871A/en active Granted
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5077432A (en) * | 1973-11-13 | 1975-06-24 | ||
| JPS5343756A (en) * | 1976-09-30 | 1978-04-20 | Dow Corning | Method of forming tubular product of oriended fiber reinforced elastic material |
| JPS5476685A (en) * | 1977-11-29 | 1979-06-19 | Ohji Rubber & Chem | Method of making laminate composed of fluoroplastics and rubber |
| JPS54103184A (en) * | 1978-01-27 | 1979-08-14 | Toppan Printing Co Ltd | Bag for freezing preservation |
| JPS54111998A (en) * | 1978-02-21 | 1979-09-01 | Toppan Printing Co Ltd | Protection method for packaging bag for low-temperature freezing |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002089629A1 (en) * | 2001-05-07 | 2002-11-14 | Eugen Seibold | Piercing article and intermediate product for manufacturing such a piercing article |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS5672871A (en) | 1981-06-17 |
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