JP3265563B2 - Synthetic resin medical needle - Google Patents
Synthetic resin medical needleInfo
- Publication number
- JP3265563B2 JP3265563B2 JP07882393A JP7882393A JP3265563B2 JP 3265563 B2 JP3265563 B2 JP 3265563B2 JP 07882393 A JP07882393 A JP 07882393A JP 7882393 A JP7882393 A JP 7882393A JP 3265563 B2 JP3265563 B2 JP 3265563B2
- Authority
- JP
- Japan
- Prior art keywords
- synthetic resin
- needle
- medical needle
- less
- resin medical
- 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 - Fee Related
Links
Description
【０００１】[0001]
【産業上の利用分野】本発明は輸液セットの導液針や溶
解液注入針などとして採用される合成樹脂製医療用針に
関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a synthetic resin medical needle used as a liquid guide needle or a solution injection needle for an infusion set.
【０００２】[0002]
【従来の技術】従来、輸液治療に際しては、輸液バッグ
のゴム栓に輸液セットの穿刺針（導液針と言う）を刺通
してバッグ内の薬液を輸液セットに導入しており、ま
た、抗癌剤や抗生物質、血液製剤等の粉末製剤、あるい
は凍結乾燥製剤等、そのまま輸液剤に混注して用いると
配合割合が変化しやすく、また、液状の薬剤として保存
しておくと薬効が低下するような薬剤は、使用直前に溶
解液注入用の両頭針（溶解液注入針という）を用いてバ
イアル内に溶解液容器内の溶解液を導入し、これを溶解
液で溶解して輸液剤を調製している。2. Description of the Related Art Conventionally, at the time of infusion treatment, a puncture needle (referred to as a liquid guide needle) of an infusion set is pierced through a rubber stopper of an infusion bag to introduce a drug solution in the bag into the infusion set. Powders such as antibiotics and blood products, or freeze-dried products, etc., which can change their mixing ratio when used as they are infused into infusions as they are, or whose drug efficacy decreases when stored as a liquid drug Introduce the dissolving solution in the dissolving solution container into the vial using a double-ended needle for dissolving solution injection (referred to as a dissolving solution injection needle) immediately before use, dissolve it with the dissolving solution to prepare an infusion solution I have.
【０００３】これらの導液針や両頭針の針管の形成材料
としては、通常、ステンレスなどの金属や、ＡＢＳ樹脂
やポリカーボネート、ポリプロピレンなどの合成樹脂が
用いられており、合成樹脂としては、特にＡＢＳ樹脂が
繁用されている。しかしながら、従来の合成樹脂製の医
療用針は、摺動性が悪いため刺通抵抗が大きい、薬液が
流れにくい、コアリングが生じやすい、などの欠点を有
しており、また、ＡＢＳ樹脂は、上記の欠点の他にも、
耐熱性が悪いためオートクレーブ滅菌が出来ない、ＥＯ
Ｇ滅菌ではガスの残留が問題になる、などの欠点を有し
ており、これらの欠点を改良した合成樹脂製医療用針の
開発が切望されていた。As a material for forming the needle tubes of these liquid guide needles and double-ended needles, metals such as stainless steel, and synthetic resins such as ABS resin, polycarbonate, and polypropylene are usually used. Resin is widely used. However, conventional synthetic resin medical needles have drawbacks such as high puncture resistance due to poor slidability, difficulty in flowing chemicals, and easy coring. , Besides the above disadvantages,
Autoclave sterilization is not possible due to poor heat resistance, EO
G sterilization has drawbacks such as the problem of residual gas, and the development of a synthetic resin medical needle that has improved these drawbacks has been desired.
【０００４】[0004]
【発明の解決しようとする課題】本発明は上記の事情に
鑑みてなされたもので、刺通抵抗が小さく、薬液流動性
に優れ、コアリングの起こりにくい合成樹脂製医療用針
を提供することを目的とする。SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and has as its object to provide a synthetic resin medical needle which has a small piercing resistance, has excellent fluidity of a drug solution, and is less likely to coring. With the goal.
【０００５】[0005]
【課題を解決するための手段】本願発明者らは、刺通抵
抗を改良するために、物性の異なる種々の高摺動性ポリ
エチレン系樹脂で医療用針を作成して試験を行ったとこ
ろ、驚くべきことには、ある特定の高摺動性ポリエチレ
ン系樹脂を用いた医療用針では、刺通抵抗および薬液の
流動性が顕著に改善されるとともに、コアリングが起こ
らなくなることを見出し、本発明に到達した。すなわ
ち、本発明は上記の課題を解決するために、密度０．９
６０〜０．９７０g/cm3 、ロックウエル硬度（ＡＳＴＭ
Ｄ７８５、２３℃、Ｒスケール）７５以上、動摩擦係
数０．１８以下、磨耗係数２２０×１０-10cm3/kg ・m
以下、熱変形温度（ＡＳＴＭ Ｄ６４８、４．６Kg/c
m2）８０℃以上の高摺動性ポリエチレン系樹脂で形成さ
れてなる合成樹脂製医療用針を採用している。 そし
て、上記の高摺動性ポリエチレン系樹脂としては、特
に、ロックウエル硬度が８５以上、磨耗係数が１８０×
１０-10cm3/kg ・m 以下、熱変形温度が８５℃以上のも
のが好ましい。また、溶解液注入針の外表面にシリコー
ンオイルを塗布することにより、刺通抵抗を改善しても
よい。Means for Solving the Problems In order to improve the piercing resistance, the inventors of the present invention prepared medical needles using various highly slidable polyethylene resins having different physical properties and conducted tests. Surprisingly, it has been found that, with a medical needle using a specific high-sliding polyethylene resin, the piercing resistance and the fluidity of the drug solution are remarkably improved, and coring does not occur. The invention has been reached. That is, the present invention has a density of 0.9 to solve the above problem.
60 to 0.970 g / cm 3 , Rockwell hardness (ASTM
D785, 23 ° C, R scale) 75 or more, dynamic friction coefficient 0.18 or less, wear coefficient 220 × 10 −10 cm 3 / kg · m
Hereinafter, the heat distortion temperature (ASTM D648, 4.6 kg / c)
m 2 ) A synthetic resin medical needle made of a highly slidable polyethylene resin at 80 ° C. or higher is used. In particular, the high slidability polyethylene resin has a Rockwell hardness of 85 or more and a wear coefficient of 180 ×.
Those having a temperature of 10 −10 cm 3 / kg · m or less and a heat distortion temperature of 85 ° C. or more are preferred. The penetration resistance may be improved by applying silicone oil to the outer surface of the solution injection needle.
【０００６】[0006]
〔実施例１〕密度０．９７０、ロックウエル硬度８９、
動摩擦係数０．１８、磨耗係数２２０×１０-10cm3/kg
・m 、熱変形温度９１℃の高摺動性ポリエチレン系樹脂
（三井石油化学（株）製）を用い、図１に示すような薬
液通路の長さ２７mm、外径５．４mm、内径４mm、薬液通
路を２つに仕切る隔壁の厚み０．７mmの溶解液注入針を
製造し、その外表面にシリコーンオイルを塗布したもの
と、塗布していないもの各１０本について刺通抵抗およ
び流動性の試験を行ったところ表１のような結果が得ら
れた。表１から、溶解液注入針の形成材料として高摺動
性ポリエチレン系樹脂を採用することにより、刺通抵抗
および流動性が大幅に改善されていることが分かる。
尚、刺通抵抗試験は、オートグラフ（Ｓ−５００−Ｄ、
（株）島津製作所製）を用いて、溶解液注入針を速度１
００mm /min で口径１８．５mm のバイアルの口部に打
栓された直径１９mm、刺通部分の肉厚２．６mm のブチ
ルゴム製ゴム栓に刺通することにより行い、刺通抵抗は
刃先がゴム栓を完全に貫通した状態における値を採用し
た。また、流動性試験は、バイアルと溶解液容器とを溶
解液注入針で連通したものを用意し、溶解液容器とバイ
アルが交互に上になるように反転して、溶解液の溶解液
容器からバイアルへの流れおよび、バイアルから溶解液
容器への流れを観察することにより行った。[Example 1] Density 0.970, Rockwell hardness 89,
Coefficient of dynamic friction 0.18, wear coefficient 220 × 10 -10 cm 3 / kg
M, using a highly slidable polyethylene resin (manufactured by Mitsui Petrochemical Co., Ltd.) having a heat deformation temperature of 91 ° C., as shown in FIG. 1, the length of the chemical passage is 27 mm, the outer diameter is 5.4 mm, the inner diameter is 4 mm, A 0.7 mm thick dissolution liquid injection needle having a partition wall for dividing the chemical liquid passage into two was manufactured, and the piercing resistance and the fluidity were measured for each of 10 needles with and without silicone oil applied to the outer surface. When the test was performed, the results shown in Table 1 were obtained. From Table 1, it can be seen that the piercing resistance and fluidity are significantly improved by employing a highly slidable polyethylene resin as the material for forming the solution injection needle.
The puncture resistance test was performed using an autograph (S-500-D,
(Manufactured by Shimadzu Corporation) at a speed of 1
The penetration is performed by piercing a butyl rubber rubber stopper with a diameter of 19 mm and a piercing portion of 2.6 mm in thickness, which is stoppered at the mouth of a vial having a diameter of 18.5 mm at 00 mm / min. The value in the state where the stopper was completely penetrated was adopted. Also, for the fluidity test, prepare a vial and a dissolving solution container that are connected by a dissolving solution injection needle, and invert so that the dissolving solution container and the vial are alternately on the upper side. This was done by observing the flow to the vial and the flow from the vial to the lysate container.
【０００７】〔比較例１〜２〕ＡＢＳ樹脂（デンカＡＢ
Ｓ、ＧＲ−１００、電気化学工業（株）製）およびＰＭ
ＭＡ（サイロライト、Ｇ−２０、ダイセル化学工業
（株）製）を用いて実施例１と同様の溶解液注入針を各
１０本製造し同様の試験を行ったところ表１のような結
果が得られた。表１からＡＢＳ樹脂やＰＭＭＡで製せら
れた溶解液注入針では特に流動性に問題があることが分
かる。また、溶解液注入針の外表面にシリコーンオイル
を塗布した場合、実施例、比較例とも、刺通抵抗が大幅
に改善されることが分かる。[Comparative Examples 1-2] ABS resin (DENKA AB)
S, GR-100, manufactured by Denki Kagaku Kogyo KK) and PM
Using MA (Silolite, G-20, manufactured by Daicel Chemical Industries, Ltd.), ten dissolution solution injection needles similar to those in Example 1 were manufactured and the same test was performed. The results shown in Table 1 were obtained. Obtained. From Table 1, it can be seen that the dissolution liquid injection needle made of ABS resin or PMMA has a problem particularly in fluidity. In addition, when silicone oil is applied to the outer surface of the solution injection needle, it can be seen that the piercing resistance is significantly improved in both the examples and the comparative examples.
【０００８】[0008]
【表１】 [Table 1]
【０００９】〔実施例２〕実施例１の溶解液注入針を１
００個製造し、テフロン（商標名）でラミネートされた
市販のＭ社のゴム栓を刺通してコアリングの有無を試験
したところ、シリコーンオイルの塗布の有無に係わらず
コアリングは１つも発生しなかった。[Embodiment 2] The solution injection needle of Embodiment 1 is
When a test was performed to determine the presence or absence of coring by piercing a commercially available M company rubber stopper laminated with Teflon (trade name), and no silicone oil was applied, no coring occurred. Was.
【００１０】〔比較例３〜４〕比較例１の溶解液注入針
をＡＢＳ樹脂とＰＭＭＡについて各１００個製造しその
外表面にシリコーンオイルを塗布して実施例２と同様の
試験を行ったところ、シリコーンオイルを塗布したもの
について、ＡＢＳ樹脂では７件、ＰＭＭＡでは１６件の
コアリングが発生した。[Comparative Examples 3 and 4] The dissolution liquid injection needles of Comparative Example 1 were manufactured for ABS resin and PMMA 100 each, and the outer surface thereof was coated with silicone oil and subjected to the same test as in Example 2. In the case where silicone oil was applied, 7 cases of ABS resin and 16 cases of PMMA in PMMA occurred.
【発明の効果】以上説明してきたことから明らかなよう
に、本発明を採用することにより、刺通抵抗が小さく、
薬液流動性に優れ、コアリングの起こりにくい合成樹脂
製医療用針を提供することができる。As is apparent from the above description, by employing the present invention, the piercing resistance is small,
It is possible to provide a synthetic resin medical needle which is excellent in chemical liquid flowability and is less likely to cause coring.
フロントページの続き (56)参考文献 特開 昭61−62468（ＪＰ，Ａ) 特開 昭62−243564（ＪＰ，Ａ) 特開 平３−295566（ＪＰ，Ａ) 特開 昭62−57565（ＪＰ，Ａ) 特開 昭62−22660（ＪＰ，Ａ) (58)調査した分野(Int.Cl.7，ＤＢ名) A61M 5/158 Continuation of the front page (56) References JP-A-61-62468 (JP, A) JP-A-62-243564 (JP, A) JP-A-3-295566 (JP, A) JP-A-62-57565 (JP) , A) JP-A-62-22660 (JP, A) (58) Fields investigated (Int. Cl. 7 , DB name) A61M 5/158
Claims (3)
ックウエル硬度（ＡＳＴＭ Ｄ７８５、２３℃、Ｒスケ
ール）７５以上、動摩擦係数０．１８以下、磨耗係数２
２０×１０-10cm3/kg ・m 以下、熱変形温度（ＡＳＴＭ
Ｄ６４８、４．６Kg/cm2）８０℃以上の高摺動性ポリ
エチレン系樹脂で形成されてなる合成樹脂製医療用針。1. Density 0.960 to 0.970 g / cm 3 , Rockwell hardness (ASTM D785, 23 ° C., R scale) 75 or more, dynamic friction coefficient 0.18 or less, wear coefficient 2
20 × 10 -10 cm 3 / kg · m or less, heat distortion temperature (ASTM)
D648, 4.6 kg / cm 2 ) A medical needle made of a synthetic resin formed of a highly slidable polyethylene resin at 80 ° C. or higher.
が８５以上、磨耗係数が１８０×１０-10cm3/kg ・m 以
下、熱変形温度が８５℃以上である請求項１に記載の合
成樹脂製医療用針。2. The synthetic resin medical device according to claim 1, wherein the polyethylene resin has a Rockwell hardness of 85 or more, a wear coefficient of 180 × 10 −10 cm 3 / kg · m or less, and a heat deformation temperature of 85 ° C. or more. Needle.
項１または２に記載の合成樹脂製医療用針。3. The synthetic resin medical needle according to claim 1, wherein the outer surface is coated with silicone.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP07882393A JP3265563B2 (en) | 1993-03-12 | 1993-03-12 | Synthetic resin medical needle |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP07882393A JP3265563B2 (en) | 1993-03-12 | 1993-03-12 | Synthetic resin medical needle |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH06261945A JPH06261945A (en) | 1994-09-20 |
| JP3265563B2 true JP3265563B2 (en) | 2002-03-11 |
Family
ID=13672559
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP07882393A Expired - Fee Related JP3265563B2 (en) | 1993-03-12 | 1993-03-12 | Synthetic resin medical needle |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3265563B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8074472B2 (en) | 2007-07-31 | 2011-12-13 | Zircoa Inc. | Grinding beads and method of producing the same |
-
1993
- 1993-03-12 JP JP07882393A patent/JP3265563B2/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8074472B2 (en) | 2007-07-31 | 2011-12-13 | Zircoa Inc. | Grinding beads and method of producing the same |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH06261945A (en) | 1994-09-20 |
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