JP2003047642A - Medical tool - Google Patents

Medical tool

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Publication number
JP2003047642A
JP2003047642A JP2001238867A JP2001238867A JP2003047642A JP 2003047642 A JP2003047642 A JP 2003047642A JP 2001238867 A JP2001238867 A JP 2001238867A JP 2001238867 A JP2001238867 A JP 2001238867A JP 2003047642 A JP2003047642 A JP 2003047642A
Authority
JP
Japan
Prior art keywords
mass
medical device
oxygen
less
composition
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.)
Pending
Application number
JP2001238867A
Other languages
Japanese (ja)
Inventor
Yoshikazu Kakimoto
義和 垣本
Tetsushi Morita
哲史 森田
Kensho Shirahama
憲昭 白濱
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SB Kawasumi Laboratories Inc
Original Assignee
Kawasumi Laboratories Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Kawasumi Laboratories Inc filed Critical Kawasumi Laboratories Inc
Priority to JP2001238867A priority Critical patent/JP2003047642A/en
Publication of JP2003047642A publication Critical patent/JP2003047642A/en
Pending legal-status Critical Current

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  • Compositions Of Macromolecular Compounds (AREA)

Abstract

PROBLEM TO BE SOLVED: To provide a medical tool suitably usable as a high-unit and long-term platelet storage vessel excellent in oxygen permeability, compared with a conventional one, and having a blocking strength between sheets (bag inner surfaces) resistant to actual use. SOLUTION: This medical tool is formed of a composition of (1) 80-85% by mass of polyethylene obtained by copolymerizing ethylene with a<3-12> C α- olefin by use of a metallocene catalyst and having a density of 0.860-0.900 g/cm<3> and a maximum melting peak temperature by differential scanning calorimetry(DSC) of 90 deg.C or lower; and (b) 15-20% by mass of a styrene- ethylene-butylene-styrene copolymer.

Description

【発明の詳細な説明】Detailed Description of the Invention

【0001】[0001]

【発明の属する技術分野】本発明は、血液バッグ、血小
板保存バッグ、輸液(薬液)バッグ、人工透析用バッ
グ、医療用チューブ等の医療用具に関するもので、特に
ガス透過性、血小板保存性を改良した医療用具を提供す
るものである。
TECHNICAL FIELD The present invention relates to a medical device such as a blood bag, a platelet storage bag, an infusion (medicinal solution) bag, an artificial dialysis bag, a medical tube, and the like, and particularly improved gas permeability and platelet storage property. The present invention provides a medical device.

【0002】[0002]

【従来技術および発明が解決しようとする課題】例えば
医療用具として血小板を保存したり運搬したりするため
に使用されている血小板保存容器は、柔軟性・透明性・
酸素透過性および酸素、二酸化炭素透過のバランスが要
求され、現在使用されている主な材料はポリオレフィン
系樹脂の混合組成物がある。我が国において通常の血小
板の保存単位、保存期間は20単位、3日間とされてい
たが日本赤十字社により検査制度工場を目的としたNA
T検査が導入され、それに伴い検査に要する時間が延長
されたため、保存期間延長の必要性が議論され始めた。
このことより高単位・長期間(20単位・7日間)の血
小板保存能を有する容器が要求されるようになった。こ
のため酸素透過能が高く、高単位を長期間保存できうる
容器の開発が望まれていた。これまでポリオレフィン系
樹脂の混合組成物によるものとして、ポリエチレン(P
E)70質量%、スチレン−エチレン−ブチレン−スチ
レン共重合体(SEBS)30質量%の組成材料を使用
していた。しかしこの材料組成では、血小板の保存能は
20単位、5日間が限界であった。そこで本発明者らは
以上の課題を解決するために鋭意検討を重ねた結果次の
発明に達した。
2. Description of the Related Art For example, a platelet storage container used for storing and transporting platelets as a medical device has flexibility, transparency,
A balance between oxygen permeability and oxygen / carbon dioxide permeability is required, and the main material currently used is a mixed composition of polyolefin resins. In Japan, the usual storage unit for platelets, the storage period was 20 units, and the storage period was 3 days.
With the introduction of the T-test and the time required for the test being extended accordingly, the need to extend the storage period began to be discussed.
As a result, a container having a high unit / long-term (20 units / 7 days) platelet storage capacity has been required. Therefore, it has been desired to develop a container having high oxygen permeability and capable of storing a high unit for a long period of time. So far, polyethylene (P
E) A composition material containing 70% by mass of styrene-ethylene-butylene-styrene copolymer (SEBS) and 30% by mass was used. However, with this material composition, the storage capacity of platelets was limited to 20 units and 5 days. Therefore, the inventors of the present invention have made extensive studies in order to solve the above problems, and have arrived at the following invention.

【0003】[0003]

【課題を解決するための手段】[1]本発明は(a)エ
チレンと炭素数3〜12のα−オレフィンとをメタロセ
ン触媒を用いて共重合させて得られ、かつ密度が0.8
60〜0.900g/cm、示差走査熱量測定法(D
SC)による最大融解ピ−ク温度が90℃以下のポリエ
チレン80〜85質量%と、(b)スチレン−エチレン
−ブチレン−スチレン共重合体15〜20質量%の組成
物からなる医療用具を提供する。 [2]本発明は前記組成物の厚さが150〜400μm
で、単位厚さあたりの酸素透過率が810ml・mm/
2・day・atm以上でかつ二酸化炭素透過率が4
500ml・mm/m2・day・atm以下でありか
つ酸素と二酸化炭素の透過比が5.0以下である[1]
に記載の医療用具を提供する。
Means for Solving the Problems [1] The present invention is obtained by copolymerizing (a) ethylene and an α-olefin having 3 to 12 carbon atoms with a metallocene catalyst and having a density of 0.8.
60-0.900 g / cm 3 , differential scanning calorimetry (D
A medical device comprising a composition comprising 80 to 85% by mass of polyethylene having a maximum melting peak temperature of 90 ° C. or less according to SC) and (b) 15 to 20% by mass of styrene-ethylene-butylene-styrene copolymer. . [2] In the present invention, the composition has a thickness of 150 to 400 μm.
And the oxygen transmission rate per unit thickness is 810 ml · mm /
m 2 · day · atm or more and carbon dioxide permeability of 4
It is less than 500 ml · mm / m 2 · day · atm and the permeation ratio of oxygen and carbon dioxide is less than 5.0 [1].
The medical device according to 1. is provided.

【0004】[0004]

【発明の実施の形態】本発明に(a)成分として用いら
れているポリエチレンはメタロセン触媒を用いて重合さ
せたものが使用される。前記触媒を用いて製造されるポ
リエチレンは分子量が狭いため、均一に結晶核の成長が
進み、結晶のラメラ構造が薄く均一であるためガス透過
が高くなる。本発明の成分(a)の配合量は80〜85
質量%が好ましい。本発明の成分(b)の配合量は15
〜20質量%が好ましい。成分(a)が80質量%未満
では、後述する比較例2(表1、表2参照)のように酸
素透過度が低下するので好ましくない。また成分(a)
が85質量%を超えると後述する比較例1(表1、表4
参照)のようにシ−トのべたつきが発生し、ブロッキン
グするため好ましくない。また成分(b)が20質量%
を超えると、後述する比較例2(表1、表2参照)のよ
うに酸素透過度が低下するので好ましくない。また成分
(b)が15質量%未満では後述する比較例1(表1、
表4参照)のように滅菌時ブロッキングして実使用に耐
えない。
BEST MODE FOR CARRYING OUT THE INVENTION The polyethylene used as the component (a) in the present invention is polymerized using a metallocene catalyst. Since polyethylene produced using the catalyst has a narrow molecular weight, the growth of crystal nuclei progresses uniformly, and the lamella structure of the crystal is thin and uniform, so that gas permeation is high. The compounding amount of the component (a) of the present invention is 80 to 85.
Mass% is preferred. The compounding amount of the component (b) of the present invention is 15
-20 mass% is preferable. When the content of the component (a) is less than 80% by mass, the oxygen permeability is lowered as in Comparative Example 2 (see Table 1 and Table 2) described later, which is not preferable. Also the component (a)
Is more than 85% by mass, Comparative Example 1 (Table 1, Table 4) described later
(See), the sheet becomes sticky and blocks, which is not preferable. Further, the component (b) is 20% by mass.
If it exceeds, oxygen permeability is lowered as in Comparative Example 2 (see Tables 1 and 2) described later, which is not preferable. Further, when the component (b) is less than 15% by mass, Comparative Example 1 (Table 1,
As shown in Table 4, it blocks during sterilization and cannot withstand actual use.

【0005】また、前記ポリエチレンの密度は、0.8
60〜0.900g/cm3、好ましくは、0.870
〜0.890g/cm3である。密度が、0.860未
満では、強度が低下し、成形品の表面にベタツキが発生
し外観を損ねるので好ましくない。また、密度が、0.
900g/cm3を超えると酸素透過率が下がるので好
ましくない。また、前記ポリエチレンの示差走査熱量測
定法(DSC)による最大融解ピーク温度は90℃以下
である。ここで最大融解ピーク温度とは、示差走査熱量
計を用いて、4℃/minの速度で昇温した時に得られ
るサーモグラムの最高ピーク温度である。本発明の医療
用具の酸素透過度を得るためには、ポリエチレンの示差
走査熱量測定法(DSC)による最大融解ピーク温度は
90℃以下であることが必要である。
The density of the polyethylene is 0.8
60-0.900 g / cm 3 , preferably 0.870
Is about 0.890 g / cm 3 . When the density is less than 0.860, the strength is lowered, and the surface of the molded product becomes sticky, which deteriorates the appearance, which is not preferable. Further, the density is 0.
If it exceeds 900 g / cm 3 , the oxygen permeability is lowered, which is not preferable. In addition, the maximum melting peak temperature of the polyethylene by differential scanning calorimetry (DSC) is 90 ° C or lower. Here, the maximum melting peak temperature is the maximum peak temperature of the thermogram obtained when the temperature is raised at a rate of 4 ° C./min using a differential scanning calorimeter. In order to obtain the oxygen permeability of the medical device of the present invention, the maximum melting peak temperature of polyethylene by differential scanning calorimetry (DSC) needs to be 90 ° C or lower.

【0006】医療用具は血液バッグ、血小板保存バッグ
等の袋状本体の構成材料となり、厚さが150から40
0μmの範囲に設定され、単位厚さ当たりの酸素透過率
(PO2)が、810(ml・mm/m2・day・at
m)以上でかつ単位厚さ当たりの二酸化炭素透過率(P
CO2)が、4500(ml・mm/m2・day・at
m)以下である。また酸素と二酸化炭素の透過比が5.
0以下である。
The medical device is a constituent material of a bag-shaped body such as a blood bag and a platelet storage bag, and has a thickness of 150 to 40.
The oxygen permeability (PO 2 ) per unit thickness is set to 0 μm, and the oxygen permeation rate (PO 2 ) is 810 (ml · mm / m 2 · day · at).
m) or more and carbon dioxide permeability per unit thickness (P
CO 2 is 4500 (ml ・ mm / m 2・ day ・ at
m) or less. Also, the transmission ratio of oxygen and carbon dioxide is 5.
It is 0 or less.

【0007】本発明の医療用具において、厚さ、P
2、PCO2、酸素と二酸化炭素の透過比を上記範囲に
設定した理由は、これらの範囲で血小板保存性、ガス透
過性、およびシートへの加工性が最も良いからである。
シートの厚さが150μ以下では、シートの物性が低
下して好ましくない。シートの厚さが400μm以上で
は、成形が困難となるのでこのましくない。PO2が8
10(ml・mm/m2・day・atm)未満では、
高単位、長期間の血小板保存性が低下するので好ましく
ない。 PCO2が4500(ml・mm/m2・day
・atm)を超えると、高単位、長期間の血小板保存性
が低下するので好ましくない。酸素と二酸化炭素の透過
比が5.0を超えると血小板保存初期にpHの増加が認
められ、低単位での血小板保存性が低下するので好まし
くない。
In the medical device of the present invention, the thickness, P
The reason why the permeation ratios of O 2 , PCO 2, and oxygen and carbon dioxide are set in the above ranges is that the platelet preservability, gas permeability, and sheet processability are the best in these ranges.
When the thickness of the sheet is 150 μ or less, the physical properties of the sheet are deteriorated, which is not preferable. If the thickness of the sheet is 400 μm or more, the molding becomes difficult, which is not preferable. PO 2 is 8
Below 10 (ml ・ mm / m 2・ day ・ atm),
It is not preferable because the high unit and long-term storage of platelets are reduced. PCO 2 is 4500 (ml ・ mm / m 2・ day
-Atm) is not preferable because the high unit and long-term storage stability of platelets decrease. If the permeation ratio of oxygen and carbon dioxide exceeds 5.0, an increase in pH is observed in the early stage of platelet storage, and the platelet storage property in a low unit decreases, which is not preferable.

【0008】一般に本発明の医療用具を製造する方法と
しては、重合体成分をブレンドするために従来技術で知
られているいかなる方法を用いてもよい。これらの配合
物をあらかじめドライブレンドし、押し出し機等の混練
機等で溶融混合することで、均一な医療用具が得られ
る。また本発明の組成物は、シートのみならず、例えば
インフレーション成形機により、チューブ状に成形する
ことができる。
In general, any method known in the art for blending polymer components may be used to produce the medical device of the present invention. A uniform medical device can be obtained by dry-blending these compounds in advance and melt-mixing them with a kneader such as an extruder. Further, the composition of the present invention can be formed into not only a sheet but also a tube by, for example, an inflation molding machine.

【0009】最も均質なブレンド物を得るためには、通
常使われているミキシングロール、ニーダー、バンバリ
ーミキサーおよび押出機のような各種の混練機を使用し
て溶融混練する方法が好ましい。溶融混練する前に、こ
れらの配合物をヘンシルミキサー、タンブラーのような
混合機を用いてあらかじめドライブレンドし、該混合物
を溶融混練することにより均質な医療用具が得られる。
なお、本発明に使用される組成物は上記必須主要成分の
ほかに、用途に応じて、柔軟性、耐熱性、強度、成形性
および安全性を阻害しない程度の量の各種の可塑剤、シ
リコンオイル、ブロッキング防止剤、紫外線吸収剤、滑
剤、結晶核剤、着色剤、無機充填剤等を含有することも
可能である。
In order to obtain the most homogeneous blend, the method of melt kneading using various kneaders such as mixing rolls, kneaders, Banbury mixers and extruders which are commonly used is preferable. Prior to melt-kneading, these blends are dry-blended in advance using a mixer such as a Hensyl mixer or a tumbler, and the mixture is melt-kneaded to obtain a homogeneous medical device.
The composition used in the present invention, in addition to the above essential essential components, depending on the application, flexibility, heat resistance, strength, moldability and various plasticizers in an amount that does not impair safety and silicone, It is also possible to contain oils, antiblocking agents, ultraviolet absorbers, lubricants, crystal nucleating agents, colorants, inorganic fillers and the like.

【0010】[0010]

【実施例】以下実施例および比較例によって本発明を具
体的に説明する。 (a)ポリエチレン(b)水添ブロック共重合体を表1
に示す各種組成(実施例1・2と比較例1・2)にブレ
ンドして、シートに成形し、このシートを用いて次の各
種試験を行った。本実施例では、(a)ポリエチレンと
して、カーネルKS240(日本ポリケム社製)を使用
し、(b)水添ブロック共重合体として、クレイトンG
1652(シェルジャパン社製)を使用した。
EXAMPLES The present invention will be specifically described below with reference to Examples and Comparative Examples. Table 1 shows (a) polyethylene (b) hydrogenated block copolymer.
Various compositions shown in (Examples 1 and 2 and Comparative Examples 1 and 2) were blended to form a sheet, and the following various tests were performed using this sheet. In this example, Kernel KS240 (manufactured by Nippon Polychem) was used as (a) polyethylene, and Kraton G as (b) hydrogenated block copolymer.
1652 (manufactured by Shell Japan) was used.

【0011】[0011]

【表1】 ガス透過性試験 表1に記載した実施例1・2および比較例1・2の各種
組成にブレンドし、300μmの厚さに成形したシート
を(株)東洋精機製ガス透過率測定装置MC−3を用い
て、酸素および二酸化炭素の透過率(ml/m2・da
y・atm)および単位面積あたりの透過率(ml・m
m/m2・day・atm)を23℃で測定した。結果
を表2に示す。表2より、本発明の実施例1・2の酸素
透過率は810〜860ml・mm/m2・day・a
tmであり、比較例2と比較して明らかに高いことが分
かる。
[Table 1] Gas permeability test Various examples 1 and 2 and comparative examples 1 and 2 listed in Table 1
Sheets blended with the composition and molded to a thickness of 300 μm
Using a gas permeability measuring device MC-3 manufactured by Toyo Seiki Co., Ltd.
Oxygen and carbon dioxide permeability (ml / m2・ Da
y · atm) and transmittance per unit area (ml · m
m / m2・ Day · atm) was measured at 23 ° C. result
Is shown in Table 2. From Table 2, oxygen of Examples 1 and 2 of the present invention
Transmittance is 810-860ml ・ mm / m2・ Day ・ a
tm, which is clearly higher than in Comparative Example 2.
Light

【0012】[0012]

【表2】 (2)血小板保存試験 表1に記載した実施例1・2および比較例1の300μ
m厚のシートを用いた製品状に製袋した1000ml容
量のバッグで20単位の血小板の保存試験を行った。保
存後72・120・168時間後の血小板のpHを調べ
た。結果を表3に示す。表3より、本発明の実施例1・
2と比較例1は168時間後でもpHの低下は認められ
ず6.5以上であり、20単位まで良好に保存可能と分
かる。比較例2は168時間後ではpHが6.2まで低
下し、20単位7日間の保存には適さない。
[Table 2] (2) Platelet preservation test 300 μ of Examples 1 and 2 and Comparative Example 1 described in Table 1
A storage test of 20 units of platelets was carried out in a 1000 ml capacity bag made into a product using an m-thick sheet. The pH of the platelets 72, 120, and 168 hours after storage was examined. The results are shown in Table 3. From Table 3, Example 1 of the present invention
In 2 and Comparative Example 1, no decrease in pH was observed even after 168 hours and the pH was 6.5 or more, indicating that good storage up to 20 units was possible. In Comparative Example 2, the pH decreased to 6.2 after 168 hours, which is not suitable for storage for 20 units for 7 days.

【0013】[0013]

【表3】 [Table 3]

【0014】(3)ブロッキング性試験 表1に記載した実施例1・2および比較例1の300μ
m厚のシートを用いた製品状に製袋したバッグを60℃
・10時間の条件で滅菌処理を行った。このサンプルの
バッグ表面・裏面のシートを合わせた状態で3cm幅×
10cmの長さで切り抜き、バッグ内面のブロッキング
強度を東洋精機製引っ張り試験機ストログラフE−Lを
用いて測定した。試験速度は200mm/min。結果
を表4に示す。本発明の実施例1・2は滅菌後でもバッ
グ内面のブロッキングは小さく1.5〜2.6N/cm
であり充分実使用に耐えうる。比較例1は4.0N/c
m以上となり、実使用には耐えない。
(3) Blocking Test 300 μ of Examples 1 and 2 and Comparative Example 1 shown in Table 1
A bag made into a product using an m-thick sheet at 60 ° C
-The sterilization was performed under the condition of 10 hours. 3cm width with the sheets on the front and back of this sample bag combined
It was cut out at a length of 10 cm, and the blocking strength of the inner surface of the bag was measured using a tensile tester Strograph EL manufactured by Toyo Seiki. The test speed is 200 mm / min. The results are shown in Table 4. In Examples 1 and 2 of the present invention, the blocking on the inner surface of the bag was small even after sterilization and was 1.5 to 2.6 N / cm.
It can withstand practical use. Comparative Example 1 is 4.0 N / c
It is over m and cannot withstand actual use.

【0015】[0015]

【表4】 [Table 4]

【0016】[0016]

【発明の作用効果】本発明の医療用具は従来のものと比
較して優れた酸素透過性を持ち、シート同士(バッグ内
面)のブロッキング強度も実使用に耐えうるため、特に
高単位・長期間の血小板保存容器として好適に使用でき
る。
The medical device of the present invention has excellent oxygen permeability as compared with the conventional ones, and the blocking strength between the sheets (the inner surface of the bag) can withstand practical use. Can be suitably used as a platelet storage container.

Claims (2)

【特許請求の範囲】[Claims] 【請求項1】(a)エチレンと炭素数3〜12のα−オ
レフィンとをメタロセン触媒を用いて共重合させて得ら
れ、かつ密度が0.860〜0.900g/cm、示
差走査熱量測定法(DSC)による最大融解ピーク温度
が90℃以下のポリエチレン80〜85質量%と、
(b)スチレン−エチレン−ブチレン−スチレン共重合
体15〜20質量%の組成物からなることを特徴とする
医療用具。
1. (a) Obtained by copolymerizing ethylene and an α-olefin having 3 to 12 carbon atoms using a metallocene catalyst, and having a density of 0.860 to 0.900 g / cm 3 and a differential scanning calorie. 80 to 85% by mass of polyethylene having a maximum melting peak temperature of 90 ° C. or less by a measuring method (DSC),
(B) A medical device comprising a composition of 15 to 20% by mass of a styrene-ethylene-butylene-styrene copolymer.
【請求項2】前記組成物の厚さが150〜400μm
で、単位厚さあたりの酸素透過率が810ml・mm/
2・day・atm以上でかつ二酸化炭素透過率が4
500ml・mm/m2・day・atm以下でありか
つ酸素と二酸化炭素の透過比が5.0以下であることを
特徴とする請求項1に記載の医療用具。
2. The composition has a thickness of 150 to 400 μm.
And the oxygen transmission rate per unit thickness is 810 ml · mm /
m 2 · day · atm or more and carbon dioxide permeability of 4
The medical device according to claim 1, wherein the medical device has a volume ratio of 500 ml · mm / m 2 · day · atm or less and a permeation ratio of oxygen to carbon dioxide of 5.0 or less.
JP2001238867A 2001-08-07 2001-08-07 Medical tool Pending JP2003047642A (en)

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Publication Number Publication Date
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Family

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Country Link
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018510019A (en) * 2015-03-31 2018-04-12 ガンブロ ルンディア アー・ベー Package for acidic dialysate concentrates containing citrate and glucose

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018510019A (en) * 2015-03-31 2018-04-12 ガンブロ ルンディア アー・ベー Package for acidic dialysate concentrates containing citrate and glucose

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