JP6552640B2 - イムノクロマトグラフキットの製造方法 - Google Patents
イムノクロマトグラフキットの製造方法 Download PDFInfo
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- JP6552640B2 JP6552640B2 JP2017556336A JP2017556336A JP6552640B2 JP 6552640 B2 JP6552640 B2 JP 6552640B2 JP 2017556336 A JP2017556336 A JP 2017556336A JP 2017556336 A JP2017556336 A JP 2017556336A JP 6552640 B2 JP6552640 B2 JP 6552640B2
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Images
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
- B29C66/812—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the composition, by the structure, by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
- B29C66/8126—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the composition, by the structure, by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps characterised by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
- B29C66/81264—Mechanical properties, e.g. hardness
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- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/92—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
- B29C66/929—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools characterized by specific pressure, force, mechanical power or displacement values or ranges
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- 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
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Description
しかしながら、特許文献2においては、上部ケースと下部ケースとが嵌め合いにより係合されているため、両ケース間は密閉状態にならない場合があった。
第2の樹脂製部材を支持する冶具と、冶具と対向して配置された、第1の樹脂製部材と接するホーンとにより、被溶着部位同士を接触させた第1の樹脂製部材と第2の樹脂製部材とに押圧力を付与しつつ、ホーンを介して第1の樹脂製部材に超音波振動を与えることにより、第1の樹脂製部材と第2の樹脂製部材とを溶着する超音波溶着方法であって、
冶具として、第2の樹脂製部材を支持する支持面が弾性体である冶具を用いることを特徴とする。
第1の樹脂製部材と第2の樹脂製部材とを接合する方法として、本発明の超音波溶着方法を用いることを特徴とする。
超音波溶着装置50は、超音波発振器52と、超音波発振子54、コンバータ56、ホーン58および図示していない加圧機構を備えている。
超音波発振器52は、外部から入力された50/60Hzの電気信号を内部で超音波(概ね20kH以上の周波数)の電気信号に変換する。
超音波発振子54は接続ケーブル53により超音波発振器52と接続されており、超音波発振器52で生成された電気信号が超音波発振子54へと伝達される。超音波発振子54は、超音波発振器52からの信号を振動エネルギーに変換するものである。超音波発振器52からの電気信号を振動エネルギーに変換して超音波発振子54は振動し、この機械的振動がコンバータ56に伝達される。
コンバータ56にはブースター機能が備えられており、超音波発振子54から伝達される振動がコンバータ56において増幅され、振幅調整がなされた上でホーン58に伝達される。
ホーン58は、後述の被溶着物を後述の冶具との間で挟むと共に、超音波振動を被溶着物に伝達する機能を有する。
なおここで、弾性体のヤング率はISO527、ショアA硬さはISO23529に準じて測定した値とする。
本実施形態の超音波溶着方法によれば、第2の樹脂製部材を支持する支持面が弾性体により形成されてなる冶具を用いることにより、密着初期に上部の第1の樹脂製部材と下部の第2の樹脂製部材の均一な密着状態が実現されて超音波による振動が均一に伝わる、と推察され、樹脂製部材同士の良好な接合が可能となる。
ここで、本発明の超音波溶着方法が適する、柔軟性を有する材料とは、破断伸びが100%から1000%の樹脂である。例えば、ポリプロピレンや低密度のポリエチレンを用いることにより、このような破断伸びを示す樹脂製部品を成形することができる。なお、ここで破断伸び(引張伸び)とは、試験片を破断するまで伸ばした時の元の長さに対する伸び率であり、ISO37の規格に準拠した方法によって測定するものとする。
樹脂製容器を構成する樹脂は、柔軟性、成形性、耐熱性および耐薬品性等の観点からその樹脂製容器の用途により適宜選択される。具体的な樹脂材料としては、ポリスチレン、ポリエチレン、ポリ塩化ビニル、ポリプロピレン、ポリカーボネート、ポリエステル、ポリメチルメタクリレート、ポリビニルアセテート、ビニル−アセテート共重合体、スチレン−メチルメタアクリレート共重合体、アクリルニトリル−スチレン共重合体、アクリルニトリル−ブタジエン−スチレン共重合体、ナイロン、ポリメチルペンテン、シリコン樹脂、アミノ樹脂、ポリスルフォン、ポリエーテルスルフォン、ポリエーテルイミド、フッ素樹脂およびポリイミド等が挙げられる。これらの樹脂の中では、柔軟性、成形性等の観点で、オレフィン系樹脂が好ましく、その中でも、ポリエチレン、ポリプロピレンおよびポリ塩化ビニルが好ましく、特に好ましいのはポリプロピレンである。
また中間部材30は、ポット収容部32の上流側にポット収容部32の底面から延在する流路形成部35を備えている。流路形成部35は、後述の検査領域L1、確認領域L2および増幅指標領域L3の上方位置に一致して配置され、これらの領域L1〜L3を視認可能とするために透明な材料で形成されている。
また、上部ケース10には、試料液滴下用開孔16が設けられており、この開孔16から検査用ストリップ1の標識保持パッド3上に試料液が滴下される。開孔16と標識保持パッド3との位置が一致するように、標識保持パッド3の位置を調整することで、標識保持パッド3上に確実に試料液を点着することが可能となる。また、上部ケース10は、中間部材30の流路形成部35に対応する位置は3つの領域L1〜L3を視認するための観察窓18を備えている。
銀増幅を実現させるために、第1の増幅液として銀イオンを含む溶液を、第2の増幅液として銀イオンのための還元剤を含む還元剤液を用いればよい。
第2の凸状変形部14も、指等で押すことにより、容易に変形して凹部状となる。この押圧後には凹部状が戻らず、送液用パッド4を第2のポット45中に押し込んだ状態を維持できる構成となっていることが好ましい。
曲げ弾性率を測定する材質について、幅b(mm)、厚さh(mm)の板状の試験片を作成し、支点間距離をL(mm)とした2つの支点で試験片を支える。支点間の中心にF(N)の荷重をかけ、荷重をかけた方向へのたわみ量(mm)を測定する。横軸にたわみS(mm)、縦軸に荷重F(N)とした、たわみ−荷重曲線を作成する。この曲線の原点での接線を求め、その傾き(荷重の変化量ΔF(N)、たわみの変化量ΔS(mm)とした場合、(ΔF/ΔS))を算出し、以下の式を用いて曲げ弾性率E(MPa)が算出できる。
曲げ弾性率E=(L3/(4bh3))×(ΔF/ΔS) 式(1)
下部ケース20の不溶性担体収容部21および吸収パッド収容部22に検査用ストリップ1の不溶性担体2および吸収パッド6を固定する。次に、第2のポット45を、シート部材48を上にして下部ケース20のポット収容部24に装着し、第1のポット40を、シート部材43を下にして中間部材30のポット収容部32に装着する。そして、上部ケース10と下部ケース20とを外周の被溶着部位同士10a、20aが接触するように嵌め合わせる。
上部ケース10と下部ケース20とを嵌め合わせた状態で、超音波溶着装置50の冶具60にセットする。ここで用いる冶具60は、下部ケース20を受容する凹部62aを有する金属製の冶具本体62と、凹部62a上に配置された弾性体64とから構成されたものである。下部ケース20の底面が凹部62aの弾性体64に接触するようにセットした状態で、超音波溶着を行う。ホーン58と冶具60とで両ケース10、20を挟み込み、加圧しながら、ホーン58を介して超音波振動を上部ケース10に与えることにより、上部ケース10と下部ケース20との被溶着部位同士10a、20aを溶着させる。以上のようにして、ケース外周において良好な密閉状態で均一に溶着された、増幅液等の漏れを生じないイムノクロマトグラフキット100を作製することができる。
これに対し、本発明の超音波用溶着方法のように、第2の樹脂製部材の支持面60aに弾性体64を備えた冶具60を使用することにより、気密性の高い超音波溶着を実現することができる。
冶具として、本体が金属製(ステンレス:SUS)からなり、下部ケースを支持する支持面が弾性体からなるものを用いた。各実施例の支持面を構成する弾性体の材質およびショアA硬さ、超音波溶着条件である押圧力および超音波出力は、後記表1に示す通りとした。なお、弾性体の厚みはいずれも1mm厚とした。
なお、実施例において用いた弾性体について、シリコーンゴムのショアA硬さと弾性率(ヤング率)およびニトリルゴムのショアA硬さと弾性率を表2に別途示した。なお、弾性率の測定は、ISO527の規格に従って行った。
冶具として、本体部分および下部ケースを支持する支持面のいずれをも金属製(ステンレス:SUS)からなるものを用いた。各比較例における超音波溶着条件である押圧力、および超音波出力は、後記表1に示す通りとした。
新たに作製した負圧印加装置を用いて、上部ケースの試料液滴下用開孔から−60kPaの負圧をハウジングケース内に印加し、負圧の印加終了後、30秒間経過した時点における−60kPaの負圧からの圧力の変化を圧力変動として測定した。各例の条件で作製した各5個のケースについて同一の測定を行い、個々のケースについてそれぞれ以下のように評価した。
圧力変動が50kPa以内であれば、気密性は良好である。
圧力変動が50kPa超100kPa以内であれば許容範囲であり、気密性は可である。
圧力変動が100kPaを超えると許容できず、気密性は不良である。
A:5個のケース全て気密性が良好であった。
B:5個のケースのうち気密性が良好なものは4個以下であり、残りは全て可であった。
C:5個のケースのうち1個〜4個が不良であった。
D:5個のケース全てが不良であった。
2 不溶性担体
3 標識保持パッド
4 送液用パッド
6 吸収パッド
9 ハウジングケース
10 上部ケース
10a 上部ケースの外周の被溶着部位
12 第1の凸状変形部
14 第2の凸状変形部
16 試料液滴下用開孔
18 観察窓
20 下部ケース
20a 下部ケースの外周の被溶着部位
21 不溶性担体収容部
22 吸収パッド収容部
24 第2のポット収容部
30 中間部材
32 第1のポット収容部
35 流路形成部
40 第1の増幅液用の第1のポット
43 シート部材
45 第2の増幅液用の第2のポット
48 シート部材
50 超音波溶着装置
52 超音波発振器
53 接続ケーブル
54 超音波発振子
56 コンバータ
58 ホーン
60 冶具
60a 支持面
62 冶具本体
62a 第2の樹脂製部材を受容する凹部
64 弾性体
70 樹脂製容器
71 第1の樹脂製部材
71a 被溶着部位
72 第2の樹脂製部材
72a 被溶着部位
100 イムノクロマトグラフキット
Claims (8)
- 下部ケースの所定の収容部に、増幅液が収容されたポットと、検査用ストリップとを配置し、
前記下部ケースと共にハウジングケースを構成する上部ケースと、前記下部ケースとの被溶着部位同士を接触させて嵌め合せ、
支持面が弾性体である治具の前記支持面に、嵌め合せた前記下部ケースと前記上部ケースを、前記下部ケースが前記支持面に接触するように前記治具にセットし、
前記治具と、該治具と対向して配置されたホーンとにより、前記上部ケースと下部ケースを挟み込み、加圧しながら、前記ホーンを介して超音波振動を前記上部ケースに与えることにより、前記上部ケースと前記下部ケースの前記被溶着部位同士を溶着することにより、
前記増幅液が収容されたポットと前記検査用ストリップが前記ハウジングケース内に収容されたイムノクロマトグラフキットを製造するイムノクロマトグラフキットの製造方法。 - 前記治具が、金属製の本体と、前記弾性体とから構成される請求項1に記載のイムノクロマトグラフキットの製造方法。
- 前記弾性体のショアA硬さが、A20以上A80以下である請求項1または2に記載のイムノクロマトグラフキットの製造方法。
- 前記弾性体のヤング率が、1MPa以上60MPa以下である請求項1または2に記載のイムノクロマトグラフキットの製造方法。
- 前記弾性体が、シリコーンゴム、ニトリルゴム、またはブタジエンゴムからなる請求項1から4のいずれか1項に記載のイムノクロマトグラフキットの製造方法。
- 前記加圧の押圧力を100kPa以上300kPa以下とする請求項1から5のいずれか1項に記載のイムノクロマトグラフキットの製造方法。
- 前記上部ケースと前記下部ケースが、オレフィン系樹脂からなる請求項1から6のいずれか1項に記載のイムノクロマトグラフキットの製造方法。
- 前記上部ケースが、軟化剤入りオレフィン系樹脂からなる請求項7に記載のイムノロマトグラフキットの製造方法。
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JP5276568B2 (ja) * | 2009-11-05 | 2013-08-28 | 富士フイルム株式会社 | アッセイ用デバイス |
WO2011111108A1 (ja) | 2010-03-11 | 2011-09-15 | Dicプラスチック株式会社 | 酵素免疫測定器具及び酵素免疫測定方法 |
JP5613512B2 (ja) * | 2010-09-27 | 2014-10-22 | 株式会社クラレ | 熱可塑性液晶ポリマーフィルム融着物の製造方法 |
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