JP2005527401A - 医療グレード製品用の複数層ポリマーベースの薄いフィルム構造体 - Google Patents
医療グレード製品用の複数層ポリマーベースの薄いフィルム構造体 Download PDFInfo
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- JP2005527401A JP2005527401A JP2003578138A JP2003578138A JP2005527401A JP 2005527401 A JP2005527401 A JP 2005527401A JP 2003578138 A JP2003578138 A JP 2003578138A JP 2003578138 A JP2003578138 A JP 2003578138A JP 2005527401 A JP2005527401 A JP 2005527401A
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- layer
- component
- skin
- core
- propylene
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/07—Flat, e.g. panels
- B29C48/08—Flat, e.g. panels flexible, e.g. films
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
- B29C48/185—Articles comprising two or more components, e.g. co-extruded layers the components being layers comprising six or more components, i.e. each component being counted once for each time it is present, e.g. in a layer
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- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
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- C08L23/10—Homopolymers or copolymers of propene
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- C08L25/04—Homopolymers or copolymers of styrene
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Abstract
Description
本願は、米国特許出願第09/498,674号(2000年2月7日出願)の一部継続出願である;米国特許出願第09/498,674号は、米国特許出願第09/334,957号(1999年6月17日出願、現在米国特許第6,261,655号)の一部継続出願である;米国特許出願第09/334,957号は、米国特許出願第08/153,602号(1993年11月16日出願、現在米国特許第5,998,019号)の継続出願である。これらは全て、本明細書中に参考として援用され、本発明の一部を構成する。
本発明は、一般に、フィルムを製造するためのポリマーブレンドに関し、より詳細には、小さなひずみを有し、蒸気滅菌の際に非接着性であり、無線周波数封止性であり、かつ可撓性医療用容器を製造するために適切であるフィルムに関する。
有益な薬剤が集められ、加工され、そして容器中で保存され、輸送され、そして治療効果を達成するために患者へと注入により最終的にチューブを介して送達される医療分野では、これらの容器を製造するために用いられる材料は、独特の特性の組み合わせを有さねばならない。例えば、微粒子容器について溶液を目視試験するためには、これらの容器は、光学的に透明でなければならない。容器中に空気を導入することなく、容器の壁をつぶすことによって容器から溶液を注入するために、壁を形成する材料は、充分に可撓性でなければならない。この材料は、広範囲の温度にわたって機能的でなければならない。この材料は、その可撓性および靱性を維持することにより、低温で機能しなければならない。なぜなら、いくつかの溶液(例えば、特定のプレミックス薬物溶液)は、薬物の分解を最小にするために、−25℃〜−30℃のような温度にて容器中で保存および輸送されるからである。この材料はまた、滅菌(大部分の医療用パッケージおよび栄養製品が輸送前に供されるプロセス)の熱に耐えるために、高温で機能的でなければならない。この滅菌プロセスは通常、代表的には121℃の温度でかつ上昇した圧力での蒸気へのこの容器の曝露を含む。従って、この材料は、顕著なひずみを伴うことなく温度および圧力に耐える必要性がある(「加熱ひずみ抵抗性」)。
本発明によれば、特定の複数ポリマーベースの構造体が開示される。このフィルムは、医療用グレードの物品(例えば、医療用溶液または血液製剤を保存するための容器、血液バッグ、および関連品目または複数層構造体から構築される他の製品)へと製造され得る。
本発明は、多くの異なる形態で可能であり、本明細書中に詳細に記載されるが、本発明の好ましい実施形態が開示され、本開示が本発明の原理の例示とみなされるべきであり、本発明の広範な局面を例示された実施形態に限定することを意図しないと理解される。
(a)ASTM D−882に従って測定した、40,000psi未満の機械的モジュール;
(b)最初の20%変形の後での約70%以上の長さ回復パーセント;
(c)構成物が厚さ9ミルのフィルムに加工された場合に、ASTM D−1003に従って測定した、約30%未満、好ましくは20%未満のオプティカルヘイズ;
(d)融解処理温度にて測定した、1Hzにおける約1.0よりも大きい損失正接;
(e)約0.1重量%未満の元素ハロゲン含有量;
(f)約0.1%未満の低分子量水溶性画分;
(g)構成物の1MHZと60MHZとの間での、25℃〜250℃の温度にわたって測定した場合の、約0.05以上の誘電損;
(h)27psi荷重下にて1時間、1インチのストリップに関して121℃にて測定した場合の、約60%以下のサンプルクリープ;および
(i)1分間あたり約20インチ(50cm)という中程度の速度にて約100%伸長(元の長さの2倍)へとひずみを掛けられた後にひずみ白色化を示さないこと。
Claims (53)
- 複数層構造体であって、該構造体は、以下:
第1スキン層;
該第1スキン層に接着した無線周波数(「RF」)感受性層であって、該RF層は、第1成分であるプロピレンベースポリマー、第2成分である非プロピレンポリオレフィン、第3成分である無線周波数感受性ポリマー、および第4成分であるポリマー相溶化剤を有する、RF層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある第2スキン層;
を備え、該構造体は、以下の範囲:
a<40,000psi;
b>=70%;
c<30%;
d>1.0;
e<0.1%;
f<0.1%;
g>=0.05;
h<=60%;
i=0;
の物理的特性を有し、ここで:
aは、構成物の、ASTM D−882に従って測定した機械的モジュールであり;
bは、最初の20%変形後の該構成物の長さ回復パーセントであり;
cは、厚さ9ミルのフィルムに加工した該構成物の、ASTM D−1003に従って測定した、オプティカルヘイズであり;
dは、該構成物の、融解処理温度で測定した、1Hzにおける損失正接であり;
eは、該構成物の重量の元素ハロゲン含有量であり;
fは、該構成物の低分子量水溶性画分であり;
gは、該構成物の1MHZと60MHZとでの間の、25℃〜250℃の温度にわたる、誘電損であり;
hは、27psi荷重下にて該構成物の1インチのストリップに関して121℃にて測定したサンプルクリープであり;そして
i:該構成物は、1分間あたり約20インチ(50cm)という中程度の速度にて約100%伸長(元の長さの2倍)へとひずみを掛けられた後にひずみ白色化を示さず、そしてひずみ白色化の存在(1により示される)またはひずみ白色化が無いこと(0により示される)が示される、構造体。 - 複数層構造体であって、該構造体は、以下:
プロピレン含有ポリマーの第1スキン層;
該第1スキン層に接着した無線周波数(「RF」)感受性層であって、該RF層は、プロピレンベースポリマーである第1成分、非プロピレンポリオレフィンである第2成分、無線周波数感受性ポリマーである第3成分、およびポリマー相溶化剤である第4成分を有するRF層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある第2スキン層
を備え、該第2スキン層は、プロピレン含有ポリマーである、構造体。 - 前記RF層の前記非プロピレンポリオレフィンが、超低密度ポリエチレンを含むエチレンコポリマー、ポリブテン、ブテンエチレンコポリマー、約18%〜約50%の間の酢酸ビニル含有量を有するエチレン酢酸ビニルコポリマー、約20%〜約40%の間のアクリル酸メチル含有量を有するエチレンアクリル酸メチルコポリマー、20%〜40%の間のアクリル酸n−ブチル含有量を有するエチレンアクリル酸n−ブチルコポリマー、約15%より高いアクリル酸含有量を有するエチレンアクリル酸コポリマーの群より選択される、請求項2に記載の構造体。
- 前記無線周波数感受性ポリマーが、ポリアミド、18重量%〜50重量%の量の酢酸ビニルを有するエチレン酢酸ビニル、20重量%〜40重量%の量のアクリル酸メチルを有するエチレンアクリル酸メチルコポリマー、15%〜70%の量のビニルアルコールを有するエチレンビニルアルコールからなる群より選択される、請求項2に記載の構造体。
- 前記ポリアミドが、2〜13の範囲内の炭素数を有するジアミンの縮合反応から生じる脂肪族ポリアミド、2〜13の範囲内の炭素数を有する二酸の縮合反応から生じる脂肪族ポリアミド、ダイマー脂肪酸の縮合反応から生じるポリアミド、およびアミド含有コポリマーからなる群より選択される、請求項4に記載の構造体。
- 前記RF層のポリマー相溶化剤が、スチレンエチレン−ブテンスチレンブロックコポリマーである、請求項2に記載の構造体。
- 前記スチレンエチレン−ブテンスチレンブロックコポリマーが、無水マレイン酸で官能基化されている、請求項6に記載の構造体。
- 前記第1スキン層と前記RF層との間に挟まれた第1の非無線周波数感受性コア層をさらに備える、請求項2に記載の構造体。
- 前記第1コア層が、
ポリオレフィンである第1成分;
超低密度ポリエチレン、ポリブテンコポリマーからなる群より選択される第2成分;ならびに
相溶化剤である第3成分
を含む、請求項8に記載の構造体。 - 前記第1コア層の第1成分であるポリオレフィンが、ポリプロピレンである、請求項9に記載の構造体。
- 前記第1コア層の第2成分が、超低密度ポリエチレンである、請求項9に記載の構造体。
- 前記第1コア層の第3成分が、スチレンエチレン−ブテンスチレンブロックコポリマーである、請求項9に記載の構造体。
- 前記第1コア層が、廃品材料からなる第4成分を含む、請求項9に記載の構造体。
- 前記第1コア層と前記第1スキン層との間に挟まれた廃品材料層をさらに備える、請求項9に記載の構造体。
- 前記第1コア層と前記無線周波数感受性層との間に挟まれた廃品材料層をさらに備える、請求項9に記載の構造体。
- 前記第1スキン層とは反対側で前記第1コア層に接着した廃品層;および
該第1コア層とは反対側で該廃品層に結合した第2コア層
をさらに備える、請求項9に記載の構造体。 - バリア層をさらに備える、請求項9に記載の構造体。
- 前記バリア層が、前記第1コア層と前記RF層との間に挟まれている、請求項17に記載の構造体。
- 前記バリア層が、前記第1コア層と前記第1スキン層との間に挟まれている、請求項17に記載の構造体。
- 前記第1スキン層とは反対側で前記第1コア層に接着したバリア層;および
該第1コア層とは反対側で該バリア層に接着した第2コア層
をさらに備える、請求項9に記載の構造体。 - 2つの連結層をさらに備え、各連結層が前記バリア層の両側に接着している、請求項20に記載の構造体。
- 前記バリア層が、エチレンビニルアルコール、および高度にガラス質の結晶性ポリアミドからなる群より選択される、請求項17に記載の構造体。
- 前記連結層が、改変エチレンおよびプロピレンコポリマーである、請求項21に記載の構造体。
- 複数層構造体であって、該複数層構造体は、以下:
プロピレン含有ポリマーの第1スキン層;
該第1スキン層に接着した無線周波数(「RF」)感受性層であって、該RF層は、該RF層の30重量%〜60重量%の範囲内の量のプロピレンベースポリマーである第1成分、該RF層の0重量%〜60重量%の範囲内の量の非プロピレンポリオレフィンである第2成分、該RF層の3重量%〜40重量%の範囲内の量の無線周波数感受性ポリマーである第3成分、および該RF層の5重量%〜40重量%の範囲内の量のポリマー相溶化剤である第4成分を有する、RF層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある第2スキン層
を備え、該第2スキン層が、プロピレン含有ポリマーである、構造体。 - 前記RF感受性層の第1成分が、ポリプロピレンである、請求項24に記載の構造体。
- 前記RF感受性層の第2成分が、超低密度ポリエチレンおよびポリブテン−1の群より選択される、請求項25に記載の構造体。
- 前記第3成分が、脂肪酸ポリアミドである、請求項26に記載の構造体。
- 前記第4成分が、スチレンエチレン−ブテンスチレンブロックコポリマーである、請求項27に記載の構造体。
- 前記スチレンエチレン−ブテンスチレンブロックコポリマーが、無水マレイン酸で官能基化されている、請求項28に記載の構造体。
- 前記RF層の前記成分が、該RF層の重量百分率として、
第1成分35%〜45%;
第2成分35%〜45%;
第3成分7%〜13%;および
第4成分7〜13%
の範囲内の量にある、請求項29に記載の構造体。 - 前記脂肪酸ポリアミドが、ダイマー脂肪酸ポリアミドである、請求項30に記載の構造体。
- 複数層構造体であって、該複数層構造体は、以下:
プロピレン含有ポリマーの第1スキン層;
一方の側が該第1スキン層に接着したコア層;
該コア層に該第1スキン層とは反対側で接着した無線周波数(「RF」)感受性層であって、該RF層は、該RF層の重量の30%〜60%の範囲内の量のプロピレンベースポリマーである第1成分、該RF層の重量の25%〜50%の範囲内の非プロピレンポリオレフィンである第2成分、該RF層の3重量%〜40重量%の範囲内の無線周波数感受性ポリマーである第3成分および該RF層の5重量%〜40重量%の範囲内のポリマー相溶化剤である第4成分から構成される、RF層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある、第2スキン層
を備え、該第2スキン層は、プロピレン含有ポリマーである、構造体。 - 前記コア層が、無線周波数非感受性である、請求項32に記載の構造体。
- 前記RF感受性層の第2成分が、超低密度ポリエチレンおよびポリブテン−1の群から選択され、前記無線周波数感受性ポリマーが、ダイマー脂肪酸ポリアミドであり、該RF感受性層の第4成分が、SEBSブロックコポリマーであり、前記コア層が、
ポリオレフィンである第1成分;
超低密度ポリエチレンおよびポリブテンコポリマーからなる群より選択される第2成分;ならびに
相溶化剤である第3成分
を含む、請求項33に記載の構造体。 - 前記コア層のポリオレフィンである第1成分が、ポリプロピレンである、請求項34に記載の構造体。
- 前記コア層の第2成分が、超低密度ポリエチレンである、請求項35に記載の構造体。
- 前記コア層の相溶化剤である第3成分が、スチレンエチレン−ブテンスチレンブロックコポリマーである、請求項36に記載の構造体。
- 前記コア層が、廃品材料である成分をさらに含む、請求項37に記載の構造体。
- 積層層の複数層構造体であって、該構造体は、以下:
プロピレン含有ポリマーの第1スキン層;
無線周波数(「RF」)感受性層であって、該RF層は、該RF層の重量の30%〜60%の範囲内の量のプロピレンベースポリマーである第1成分、該RF層の重量の25%〜50%の範囲内の量の非プロピレンポリオレフィンである第2成分、該RF層の3重量%〜40重量%の範囲内の量の無線周波数感受性ポリマーである第3成分、および該RF層の5重量%〜40重量%の範囲内の量のポリマー相溶化剤である第4成分から構成される、RF層;
該第1スキン層と該RF層との間の第1コア層;ならびに
該コア層に結合した廃品層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある、第2スキン層
を備え、該第2スキン層が、プロピレン含有ポリマーである、構造体。 - 前記第1スキン層の一方の側が、前記コア層に結合しており、前記廃品層が、該第1スキン層とは反対側で該コア層に結合しており、そして前記RF感受性層が、該コア層とは反対側で該廃品層に結合している、請求項39に記載の構造体。
- 前記第1スキン層の一方の側が、前記廃品層に結合しており、前記コア層は、該第1スキン層とは反対側で該廃品層に結合しており、そして前記RF感受性層が、該廃品層とは反対側で該コア層に結合している、請求項39に記載の構造体。
- 前記コア層と前記RF感受性層との間に挟まれた第2コア層をさらに備える、請求項41に記載の構造体。
- 前記RF感受性層の第2成分が、超低密度ポリエチレンおよびポリブテン−1の群より選択され、前記無線周波数感受性ポリマーが、ダイマー脂肪酸ポリアミドであり、該RF感受性層の第4成分が、SEBSブロックコポリマーであり、前記第1コア層が、
ポリオレフィンである第1成分;
超低密度ポリエチレンおよびポリブテンコポリマーからなる群より選択される第2成分;ならびに
相溶化剤である第3成分
を含む、請求項39に記載の構造体。 - 複数層構造体であって、該複数層構造体は、以下:
プロピレン含有ポリマーの第1スキン層;
無線周波数(「RF」)感受性層であって、該RF層は、該RF層の重量の30%〜60%の範囲内の量のプロピレンベースポリマーである第1成分、該RF層の重量の25%〜50%の範囲内の量の非プロピレンポリオレフィンである第2成分、該RF層の3重量%〜40重量%の範囲内の量の無線周波数感受性ポリマーである第3成分、および該RF層の5重量%〜40重量%の範囲内の量のポリマー相溶化剤である第4成分から構成される、RF層;
該第1スキン層と該RF層との間の第1コア層;
該コア層に結合したバリア層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある第2スキン層
を備え、該第2スキン層は、プロピレン含有ポリマーである、構造体。 - 前記第1スキン層の一方の側が、前記バリア層に結合しており、前記コア層が、該第1スキン層とは反対側で該バリア層に結合しており、そして前記RF感受性層が、該バリア層とは反対の側で該コア層に結合している、請求項44に記載の構造体。
- 前記第1スキン層の一方の側が、前記コア層に結合しており、前記バリア層が、該第1スキン層とは反対側で該コア層に結合しており、そして前記RF感受性層が、該コア層とは反対の側で該バリア層に結合している、請求項39に記載の構造体。
- 第2コア層が、前記コア層と前記RF感受性層との間に挟まれている、請求項45に記載の構造体。
- 前記RF感受性層の第2成分が、超低密度ポリエチレンおよびポリブテン−1の群より選択され、前記無線周波数感受性ポリマーが、ダイマー脂肪酸ポリアミドであり、該RF感受性層の第4成分が、SEBSブロックコポリマーであり、ここで、前記バリア層が、エチレンビニルアルコールおよび高度にガラス質のポリアミドからなる群より選択される、請求項44に記載の構造体。
- 2つの連結層をさらに備え、各連結層が前記バリア層の両側に接着している、請求項44に記載の構造体。
- 前記連結層が、改変エチレンおよびプロピレンコポリマーである、請求項49に記載の構造体。
- 複数層構造体であって、該複数層構造体は、以下:
プロピレン含有ポリマーの第1スキン層;
一方の側が該第1スキン層に接着したコア層;
該コア層に該第1スキン層とは反対側で接着した無線周波数(「RF」)感受性層であって、該RF層は、該RF層の重量の30%〜60%の範囲内の量の高融解温度かつ可撓性のポリプロピレン、該RF層の5重量%〜20重量%の範囲内の無線周波数感受性ポリマーおよび該RF層の5重量%〜20重量%の範囲内のポリマー相溶化剤から構成される、RF層;ならびに
該RF層に接着しかつ該第1スキン層とは反対側にある、第2スキン層
を備え、該第2スキン層は、プロピレン含有ポリマーである、構造体。 - 前記RF感受性層の無線周波数感受性ポリマーが、ダイマー脂肪酸ポリアミドであり、前記ポリマー相溶化剤が、スチレンエチレン−ブテンスチレンブロックコポリマーである、請求項51に記載の構造体。
- 前記コアが、以下:
ポリオレフィンである第1成分;
超低密度ポリエチレンおよびポリブテンコポリマーからなる群より選択される第2成分;ならびに
相溶化剤である第3成分
を含む、請求項52に記載の構造体。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US10/105,559 | 2002-03-21 | ||
US10/105,559 US6964798B2 (en) | 1993-11-16 | 2002-03-21 | Multi-layered polymer based thin film structure for medical grade products |
PCT/US2003/008102 WO2003080333A1 (en) | 2002-03-21 | 2003-03-17 | Multilayered polymer based thin film structure for medical grade products |
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JP2005527401A true JP2005527401A (ja) | 2005-09-15 |
JP5022559B2 JP5022559B2 (ja) | 2012-09-12 |
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JP2003578138A Expired - Fee Related JP5022559B2 (ja) | 2002-03-21 | 2003-03-17 | 医療グレード製品用の複数層ポリマーベースの薄いフィルム構造体 |
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US (1) | US6964798B2 (ja) |
EP (1) | EP1490220A4 (ja) |
JP (1) | JP5022559B2 (ja) |
KR (1) | KR20040094822A (ja) |
CN (1) | CN1642736B (ja) |
AU (1) | AU2003220331B2 (ja) |
BR (1) | BR0308565A (ja) |
CA (1) | CA2484122C (ja) |
CO (1) | CO5611185A2 (ja) |
HK (1) | HK1075230A1 (ja) |
MX (1) | MXPA04009143A (ja) |
WO (1) | WO2003080333A1 (ja) |
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WO2015151264A1 (ja) * | 2014-04-03 | 2015-10-08 | キユーピー株式会社 | 注射液用袋及び注射用製剤 |
CN106456441A (zh) * | 2014-04-03 | 2017-02-22 | 丘比株式会社 | 注射液用袋及注射用制剂 |
US9907726B2 (en) | 2014-04-03 | 2018-03-06 | Kewpie Kabushiki Kaisha | Injection bag and injection preparation assembly |
JP2016179569A (ja) * | 2015-03-24 | 2016-10-13 | 三菱樹脂株式会社 | 医療用フィルムおよび高周波ウェルダー加工包装体 |
US11512189B2 (en) | 2019-03-29 | 2022-11-29 | Borealis Ag | Recycled polyethylene-polypropylene blends comprising a compatibilizer |
Also Published As
Publication number | Publication date |
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CN1642736B (zh) | 2010-12-08 |
JP5022559B2 (ja) | 2012-09-12 |
MXPA04009143A (es) | 2004-11-26 |
BR0308565A (pt) | 2005-02-01 |
CN1642736A (zh) | 2005-07-20 |
EP1490220A1 (en) | 2004-12-29 |
CA2484122A1 (en) | 2003-10-02 |
CA2484122C (en) | 2010-09-28 |
AU2003220331B2 (en) | 2008-02-07 |
US6964798B2 (en) | 2005-11-15 |
EP1490220A4 (en) | 2008-06-04 |
AU2003220331A1 (en) | 2003-10-08 |
KR20040094822A (ko) | 2004-11-10 |
WO2003080333A1 (en) | 2003-10-02 |
HK1075230A1 (en) | 2005-12-09 |
CO5611185A2 (es) | 2006-02-28 |
US20020164492A1 (en) | 2002-11-07 |
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