TW443924B - Lancing device having a releasable connector - Google Patents

Lancing device having a releasable connector Download PDF

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Publication number
TW443924B
TW443924B TW089103112A TW89103112A TW443924B TW 443924 B TW443924 B TW 443924B TW 089103112 A TW089103112 A TW 089103112A TW 89103112 A TW89103112 A TW 89103112A TW 443924 B TW443924 B TW 443924B
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Taiwan
Prior art keywords
bracket
spring
blood collection
collection device
patent application
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TW089103112A
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English (en)
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Richard Wayne Levaughn
John M Purlee
Christopher John Ruf
William C Taylor
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Lifescan Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/14Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/15192Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/1519Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Surgical Instruments (AREA)

Description

443924 A7 __Β7 五、發明説明(1 ) 發明背景 1. 發明範疇 本發明關於一種穿刺皮膚以取得血液樣本之採血裝 置;特別是一種具有較短行程以於採企之後射出刺血針之 5 採血裝置。 2. 相關技藝背景 採血裝置對數以百萬計的糖尿病患者而言是生命中 的不幸事實,因為他們必須每天作血糖濃度測試五次或更 多次。他們通常使用採血裝置自手指抽取一滴血,將血液 10加到一張拋棄式試紙上,然後以一計量器測量血糖濃度。 此等採血裝置之明顯目標為對使用者以最小疼痛、最少不 便性和最低花費取得足量血液樣本。 1985年3月12日授與Cornell等人之美國專利第 4, 503, 856號揭示一種採血裝置’該裝置具有一管狀殼體' 15 一可滑動刺血針支架及一可壓縮彈簧,其中該刺血針支架 位在該殼體内’該彈簧提供使該支架直線移動至一穿刺皮 膚位置之力量且在此之後回到一中性位置。 1985年7月9日授與Burns之美國專利第4, 527, 561 經濟部智慧財產局員工消費合作社印製 號揭示一種刺血針總成,該總成包括一第二彈簧以在刺血 20 針刺穿使用者皮膚之後縮回刺血針支架(亦參見美國專利 第 4, 535, 769 號和 4, 553, 541 號)。 1990年1月23日授與Bodicky等人之美國專利第 4, 895,147號揭示一種採血裝置,該裝置包括一穿刺深度選 擇器以及一個用以在刺穿皮膚後產生真空之機構以協助自 25 穿刺處抽取血液。 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 經濟部智慧財產局員工消費合作社印製 443924 A7 ____________B7_ 五、發明説明(2 ) - 1990年12月11日授與Niet〇等人之美國專利第 4, 976’ 724號揭示一種採企裝置,該裝置包括—個許可使用 者彈出使用過之刺血針而不接觸該刺血針之機構。 1994年6月7日授與Lange等人之美國專利第 5 & 318, 584號揭示一種採血裝置,該裝置包括一轉動/滑動 傳動系統,該系統以較少疼痛之方式作穿刺。 發明概诚 本發明提出一種用以抽取血液樣本之採血裝置。該裝 1〇置,含-大致細長形殼體,該殼體有一蓋且在蓋的前财 了穿透孔’且在後端’相對於前端有一閉合件;該殼體包括 (a) -刺血針支架,其可滑動地安裝於該殼體内; (b) 第彈簧’其用以將該支架向前推,該第一彈 5 簧之第—職倾殼體且其第二魏住該支架; (c) -滑件,其可滑動地絲於該殼體之—壁内,該 滑件包含: (i) 一凸出部,其突出該壁之外;及 (ii) -推動裂置’其可逆向地與該支架接合,用 -謂該支架推回至—待刺出位置及將一刺 血針自該装置向前推; ⑷-第二彈簧,其用以將該支架後推,該第二彈菩 之第-端抵住該支架且其第二端抵住該滑件; ω-按鈕’其可在一第一位置和—第二位置間移動 巧 ,該按鈕在該第—位置時’ «置待且該支 本紙張尺度it财目ϋ( C.NS ) Α4» (^Ι〇χ297^^7
4439 2 4 A7 B7 經 濟 部 智 慧 財 產 局 員 工 消 費 合 作 社 印 製 五、發明説明(3 ) 架受限制,該按赵在該第二位置時,該支架所受 阻制已去除’可讓該第一彈簧將該支架向前推; 及 Cf)一可釋放連接器’其安裝於殼體内,用以當滑件 5 向前移而自裝置射出刺血針時使支架不動。 本裝置之可釋放連接器有若干優點。首先,其允許刺 出準備及射出非直接連接之機構,允許一縮短之行程。較 短之行程便於一手操作裝置。此外,較短之行程允許較短 之狹縫(slot)以供滑件行進用。使用較短之狹縫,可提供 狹縫一遮蓋以防止碎物(debris)滲入,而遮蓋於刺血針射 出期間不會干涉啟動器。 可釋放連接器之另一優點為:於刺血針射出期間,其 產生滑件與殼體之間之干涉,此提供摩擦回饋以讓使用者 知道裝置是在射出模式。此干涉也消除提供張力給滑件之 回動彈簧之需求》如果沒有干涉,滑件會(不受歡迎地) 自由四處移動。 可釋放連接器之又另一優點為:當蓋被移除時,防止 滑件不經意向前移動《代替地,滑件因第二(縮回)彈簧 被迫向前抵靠在連接器上之一止動件。連接器藉此允許蓋 被移除且再次固緊而不受滑件之干涉。 10 15 20 25 去除 麗式簡單說明 圖1為一本發明裝置之透視圖,該裝置有一半殼體經 圖2為圖1裝置處於休止位置之橫剖面 圖 本紙張尺度適财si國⑭準(CNS) A4规格(210;;97公釐) 4439 2 4 發明説明( 圖3為圖1裝置錢人制綠態之橫剖面圖。 圖4為圖1裝置處於過量制出位置之横剖面圖。 圖5為圓1裝置處於待刺出狀態之橫剖面圖。 圖6為圖1裝置刺出時之橫剖面圖。 圖7示出刺血針自本發明I置射出之橫剖面圖。 哭圖7A1為圖7之—部分之放大圖,示出可釋如 接Is之各種選擇實施例 圖 8為本發明裝置在刺金針射出之後之橫剖面 圖 經濟部智慧財產局員工消費合作社印製 10 憂細說明 。本發明提出一種採血裝置,該裝置併入—可釋放連接 器而為更簡單之構造且更易操作。 圖1繪出本發明之採血裝置1〇,圖中殼體之一侧經去 除以觀看其内部。該褒置的前端有蓋12,該蓋具備穿透扎 15 14。蓋12可拆卸地與殼體16連結(例如以螺紋旋接),該 殼體方便地分成兩部分。圖中顯示—半體16A,而另一半 體已經去除。设體16在與蓋12相向之該裝置後端與圓頭 18連結。圓頭18具有懸臂指狀件18A,該等指狀件提供機 械式止動作用,指狀件的位置能藉由將該圓頭附著於該殼 20體之螺紋如螺旋形螺紋改變。該機械止動作用最好由懸臂 指狀件内部之切口(undercuts)所提供〇 一刺血針支架20在該裝置運作過程中支承並導引一 拋棄式刺血針。一驅動彈簧22儲存驅使該刺血針前行所需 之能量。驅動彈簧22包容於支架20内且抵住該殼體之支 25柱23。—第二 '縮回#彈簧24亦包容於支架2〇内,其提 本紙張尺度適用中國國家標準(CNS > A4規格(210X297公酱) ----r----i|_ ... (諳先閩讀背面之注意事項再洛寫本頁) -訂 4439?4 A7 B7 經濟部智慧財產局員工消費合作社印製 五、發明説明(5 ) 供用以使該刺血針刺穿皮膚後移離皮膚之機構。縮回彈簧 24的彈簧常數實質上小於驅動彈簧22之彈簧常數;因此 ,驅動彈簧22實質上 '、較強〃。滑件26可滑動地安裝於殼 體16上且有一凸出部26A在該毅體外側,該凸出部可以手 5動方式移動—向後移使該裝置成待刺出狀態及向前移以彈 出該刺灰針。當該裝置處於待刺出狀態時,滑件26與支架 2〇接合。按鈕30穿過該殼體安裝,以垂片3〇A伸入該殼體 内側。在該裝置成待刺出狀態後,按下按鈕3〇則釋放對刺 血=支架20的阻制以讓彈簧22將該支架向前推。元件3〇 以按鈕稱之並非意味著該致動元件僅有圖中所示形式 。在本說明書及後附申請專利範圍中所用、、按鈕',一辭應 作廣義解釋,其可為能釋放對該刺血針支架之阻制的任意 致動器,涵蓋任意習知類型。 »亥採jk裝置的運作方式能由依序顯示該裝置運作期 間各元件形態之一系列圖式協助了解。 圖2顯示該裝置處於休止狀態之橫剖面圖,其中滑件 26的内部零件施抵著可釋放連接器28的頂部⑽。驅動 彈簧22和縮回彈簧24處於平衡狀態而互抵。此二彈兽均 受,縮,驅㈣簧22的_f小於_彈簧24,因為其 彈簧常數大得多。刺血針4〇和針頭42在蓋12内部。 圖3顯示該裝置處於要進人待刺出狀態之—中間位置 的橫剖面圖’此時滑件26向後移動(向圖3右方移動)。 =件26的推動元件26C之向後運動所施加的力量使縮回弹 簧24比圖2所示更為壓縮。驅動彈簧22因其大得多之弹 簧常數,所以仍維持相對較未受壓縮。 10 15 20 25 本紙張尺度適用中國國家i準(CNS )八4職(21 〇χ 297^J- (請先閱讀背面之注意事項再填寫本頁) "裝. 訂_ 443924 A7 B7 五、發明説明(δ ) 圖4顯示該採血裝置處於、過量待刺出"位置,亦即 滑件26已移動至其行程之最後端位置。刺血針支架20的 懸臂延伸部44已略為移到殼體止動件46後方(右側)。驅 -----------yM! Γ- {請先聞讀背面之注意事項再填寫本頁j 動彈簧22跫壓縮且縮回彈簧24維持與圓3所示大約相 5 壓縮量。 〃圖5顯示該採血裝置處於待刺出且休止之狀態。軀動 彈簧22迫使刺血針支架20之延伸部44抵住殼體止動件46 。滑件26已回到其原始(圖2)位置。縮回彈簧24之壓 縮量較圖3和4所示為小。若在此時壓下按^,垂片3〇a ίο會壓下延伸部44使其(自下方)脫離止動件46,且促使 刺血針支架2〇因壓縮的驅動彈簧22所施力量而向前(向 左)推進。 此系列作用造成圖6所示之瞬時狀態,其中刺血針4〇 已到達其極左位置,針頭42伸出蓋開口 14。刺血針支架 15 20已因圓頭18内部元件之懸臂指狀件18A的突起部停止其 _ 經濟部智慧財產局員工消費合作社印製 向則(向左)運動。如先前所述,該等懸臂指狀件略為撓 曲,藉此吸收—些振動並減少噪音以對使用者引起較少疼 痛。滑件26仍處於其原始位置。驅動彈簧22已連同支架 20向前推進且未受壓縮。縮回彈簧24受壓縮,如此其會 20對支架20施加向後(向右)力量,結果為刺血針4〇和針 頭42後縮’各元件回到圖2所示形態。 在牙刺操作之後,已使用過之刺金針必須自裝置移除 。圖7不出當可釋放連接器2 8為一懸臂閂件時,刺血針 射出之局部切開剖面圖。蓋1 2必須首先被移除。當滑件 25 2 6向前移動時,其將閂件頂部2 向下壓,迫使閂件 8 本紙張尺度適用中國國蘇準) A4規格(训謂7公着)- BP'4439 ?
五、發明説明(7 ) 2 8上之齒部5 0與支架2 〇上對應之齒部5 2囑合,防 止支架向前移動,而滑件2 6之推動元件2 6C將用過之 刺血針4〇推出裝置。藉由在過程中將支架鎖在適當位置 ,合思的較短滑件行程用以實現此射出。此外,在射出步 5驟期間,於滑件與頂部28A之間之摩擦提供合意之有觸覺 之回饋給使用者。 圖7A著重於懸臂閂件2 8及其嚅合支架2 〇上之對 應齒邛5 2之齒部5 0之結構。如圖所示,兩組齒部是非 對稱的,其為較佳之理由如下。雖然裝置最好經由向後移 10動滑件2 6來作刺出準備,如上述圖3, 4及5所討論的 ,但其也可藉由在用過之刺血針已被射出之後,將一新刺 血針4 0推入裝置而作刺出準備。在此情形下,懸臂閂件 及支糸之齒部仍然嚅合,如圖7A所示。但是不對稱之齒 部仍允許支架向後移動(向右)以順序到達圖3,4及5 15 所示之位置。 圖8示出裝置之元件,顯示當滑件2 6已被向前推到 其行程尾端,致使滑件26之推動元件26C自裝置驅動 刺血針(未示出)。 雖然圖7及圖7A示出較佳之可釋放連接器2 8, | 20中懸臂閂件有一懸臂用以可釋放接觸支架2 〇且閃件上、 | 齒部5◦銜接支架上之齒部5 2,其他可釋放連接器尤實 2 施例也可於本發明中預期的。於一系列圖中示出可選择 件之元件。 I 可釋放連接器之元件之焦點視圖,對應於圖7A之懸臂門 消 費 合 作 社 圖7B示出一連接器, 本紙張尺度適用中國國家標率(cys ) A4規格(210X297公釐) 443924 A7 ----:____B7___ 五、發明説明(8 ) 〜 而非懸臂式。 圖7C示出一連接器’其中臂2 2 8是彈簧加载,由 片簀2 2 8A及2 2 8B所支持。报明顯地,其他型式之彈 簧,如螺旋形彈簧也可使用。圖7C說明了一個事實,即 5 “臂”不必然解釋為一伸長元件;相反地,其簡單地指出 此元件承載銜接機構。 圖7D示出一連接器,其中臂3 28可旋轉地安裝在 軸3 2 8A上,由一扭轉彈簧328B彈簧加載。 圖7E示出一實施例,其中支架2 0有一可逆向變形 10 表面,其被連接器428變形以使支架不動。 圖7F示出一實施例,其中懸臂式連接器528有一粗 糙表面5 5 0,其銜接支架上之粗糙表面5 5 2以使支架 不動。 習於此技藝者會了解到以上說明及圖式僅為實行本 15 發明之範例而不具限制意圖。可在不脫離本發明精神及範 圍下對本文所述細節作出修改。 經濟部智慧財產局員工消費合作社印製 (請先閲讀背面之注意事項再灰寫本頁)
格 A4 I釐 公 7 9· 2

Claims (1)

  1. 經濟部智慧財產局員工消費合作杜印製 4 4 靈 D8 六、申請專利範圍 1. 一種用以抽取血液樣本之採血裝置,該裝置包含一大 致細長形殼體,該殼體有一在其前端有一穿透孔之蓋 ,且在後端,相對於前端有一閉合件;該殼體包括: (a) —刺血針支架,其可滑動地安裝於該殼體内; (b) —第一彈簧,其用以將該支架向前推,該第一彈 簧之第一端抵住該殼體且其第二端抵住該支架; (c) —滑件,其可滑動地安裝於該殼體之一壁内,該 滑件包含: (i) 一凸出部,其突出該壁之外;及 (ii) 一推動裝置,其可逆向地與該支架接合,用 以將該支架推回至一待刺出位置及將一刺 血針自該裝置向前推; (d) —第二彈簧,其用以將該支架後推,該第二彈簧 - 之第一端抵住該支架且其第二端抵住該滑件; (e) —按鈕,其可在一第一位置和一第二位置間移動 ,該按鈕在該第一位置時,該裝置待刺出且該支 架受限制,該按鈕在該第二位置時,該支架所受 阻制已去除,可讓該第一彈簧將該支架向前推; 及 (f) 一可釋放連接器,其安裝於殼體内,用以當滑件 向前移而自裝置射出刺血針時使支架不動。 2. 如申請專利範圍第1項之採血裝置,另包括一剌血針 ,其安裝於剌血針支架中,該剌灰針包括一針頭,具 有一針尖用以穿過蓋之孔以實施一穿刺作業。 3. 如申請專利範圍第1項之採血裝置,其中該可釋放連 11 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) (請先閱讀背面之注意事項再填寫本頁) ---;丨訂---------. JL 4 43 9 2 4 滢 D8 六、申請專利範圍 接器包含一懸臂。 4. 如申請專利範圍第1項之採血裝置,其中該可釋放連 接器包含一樞軸臂。 5. 如申請專利範圍第1項之採血裝置,其中該可釋放連 接器包含一彈簧加載臂。 6. 如申請專利範圍第1項之採血裝置,其中該可釋放連 接器有一粗糙表面靠近一前端,用以摩擦地銜接支架 上之一粗糖表面。 7. 如申請專利範圍第1項之採血裝置,其中該可釋放連 接器有至少一齒部靠近一前端,用以銜接支架内之至 少一凹部。 8. 如申請專利範圍第7項之採血裝置,其中該可釋放連 接器有多數非對稱齒部,用以銜接支架上之多數非對 稱齒部。 9. 如申請專利範圍第1項之採血裝置,其中該支架有一 逆向可變形表面,該逆向可變形表面被可釋放連接器 變形以逆向地使支架不動。 — — — — — — — — — — — ΙΛ —— — — — — II 7— — — — — — — — — ( 戈 言 务^ (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐)
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EP1031319A1 (en) 2000-08-30
US6197040B1 (en) 2001-03-06
ATE281787T1 (de) 2004-11-15
JP2000262498A (ja) 2000-09-26
KR20010014499A (ko) 2001-02-26
DE60015625T2 (de) 2005-11-03
CN1265870A (zh) 2000-09-13
CA2299007A1 (en) 2000-08-23
DE60015625D1 (de) 2004-12-16
CN1230121C (zh) 2005-12-07
KR100674398B1 (ko) 2007-01-26
CA2299007C (en) 2007-08-07
EP1031319B1 (en) 2004-11-10
JP4472094B2 (ja) 2010-06-02

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