TW513299B - Lancing device causing reduced pain - Google Patents

Lancing device causing reduced pain Download PDF

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Publication number
TW513299B
TW513299B TW089103111A TW89103111A TW513299B TW 513299 B TW513299 B TW 513299B TW 089103111 A TW089103111 A TW 089103111A TW 89103111 A TW89103111 A TW 89103111A TW 513299 B TW513299 B TW 513299B
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Taiwan
Prior art keywords
bracket
casing
spring
lancet
pushing
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TW089103111A
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English (en)
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William C Taylor
Richard Wayne Levaughn
John M Purlee
Christopher John Ruf
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Lifescan Inc
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Publication of TW513299B publication Critical patent/TW513299B/zh

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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
    • A61B5/150007Details
    • A61B5/150175Adjustment of penetration depth
    • A61B5/150198Depth adjustment mechanism at the proximal end of the carrier of the piercing element
    • 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
    • A61B5/151Devices 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
    • A61B5/150206Construction 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)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Hematology (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Description

513299 A7 五、發明説明(1 ) '~~^ 發明背景 1.發明範疇 本毛月關於#穿刺皮膚以取得金液樣本之採血 裝置;制是—種對使用者引起較少疼痛之採血裝置。 5 L相關技藝 抓血1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A裝置自手指抽取一滴血, 將血液加到-雜棄式試紙上,然後以—計量器測量血 10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、一可’骨動刺血針支架及一可壓縮彈簧,其中該刺血 15針支架位在該殼體内,該彈簣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 φ 4,527,561號揭示一種刺血針總成,該總成包括一第二 彈簧以在刺A針刺穿使用者皮膚之後縮回刺血針支架 20 (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 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s'寫本頁 -訂-----1 . 線_ 經濟部智慧財產局員工消費合作社印製 A7 --—______ B7 五、發明説明~ ~~— 4,895,147號揭示-種採血裝置,該裝置包括_穿刺深 度選擇器以及-個用以在刺穿皮膚後產生真空之機構以 協助自穿刺處抽取血液。 1990年12月11日授與Niet〇等人之美國專利第 5 4,976, 724號揭示一種採血裝置,該裝置包括一個許可 使用者彈出使用過刺血針而不接觸該刺血針之機構。 1994年6月7日授與Lange等人之美國專利窠 5,318,584號揭不一種採血裝置,該裝置包括一轉動/滑 動傳動系統,該系統以可調整/可重複穿刺深度及較少疼 10 痛之方式作穿刺。 發明概诚 15 經濟部智慧財產局員工消費合作社印製 20 本發明提出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,該殼體有一蓋且在蓋的前 端有一穿透孔,且該殼體包容: (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) 一滑件,其可滑動地嵌於該殼體之一壁内,該 滑件包含: ( CNST^ ( 210X297^ 513299 A7 B7 五、發明説明(3 ) ~ ~ —— (1) 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; 5 (d) 一第二彈簧,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 10 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) 一處於後端的圍蔽件,其包含: (i)複數個前伸元件,其用以使該支架之前行 15 運動停止於一預定位置;及 經濟部智慧財產局員工消費合作社印製 (i i)調整·裝置,其用以可控制地改變及重設該 預定位置。 本裝置在採血過程中引起較少疼痛,因為針頭振動 和π呆音較習知採血裝置為小。此外,由該裝置後端控制 20穿刺深度比由前端控制穿刺深度之裝置有利。如此使本 衣置此具有較便且的纟丨』盖’此對前蓋受污染而可能需要 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) A7 B7 五、發明説明(4 ) 更換的需求而言相當有利。此外,藉由自該裝置後端控 制穿刺深度,深度設定部位較不易受到握持此裝置的手 指所遮掩。 5 圖式簡單說明 圖1為一本發明裝置之透視圖,該裝置有一半殼體 經去除。 圖1A為圖1裝置之後端放大圖。 圖2為圖1裝置處於休止位置之剖面圖。 10 圖3為圖1裝置要進入待刺出狀態之剖面圖。 圖4為圖1裝置處於過量待刺出位置之剖面圖。 圖5為圖1裝置處於待刺出狀態之剖面圖。 圖6為圖1裝置刺出時之剖面圖。 15 發明詳細說明 本發明提出一種採血裝置,該裝置具備一減音減震 機構以在採血過程中引起較少疼痛。圖丨繪出本發明之 採血裝置10,圖中殼體之一側經去除以觀看其内部。診 裝置的前端有蓋12,該蓋具備穿透孔14。蓋丨2可拆卸 20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。圖中顯示一半體16A,而另一半體已經去除。 f請先閲讀背面之注意事項ιρρ寫本頁) 壯衣 訂 經濟部智慧財產局員工消費合作社印製 尺 張 紙 本 準 標 家 國 國 中 用 適 2 6 五、發明説明(5) ' ' ---——--- '又體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f指狀件m,該等指狀件提供機械式止動 乍用扣狀件的位置能藉由將該圓頭附長於該殼體之螺 紋如螺旋形螺紋改變。 5 一刺血針支架20在該裝置運作過程中支承並導引 經濟部智慧財產局員工消費合作社印製 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。驅動彈簣22包容於支架20内且抵住該殼 體之支柱23。一第二、、縮回〃彈簧24亦包容於支架2〇 内,其提供用以使該刺血針刺穿皮膚後移離皮膚之機 10構。縮回彈簧24的彈簧係數實質,小於驅動彈簧22 > 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在該殼體外側,該鈐出 邰可以手動方式移動一向後移使該裝置成待刺出狀態及 向月ίι移以彈出該刺血針。當該裝置處於刺出狀態時, 15滑件%與支架20接合。按鈕3〇穿過該殼體安裝,以垂 片30Α伸入該殼體内側。在該裝置成待刺出狀態後,按 下按紐30則釋放對刺血針支架2〇的阻制以讓彈簧22 將該支架向前推。元件30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 20利範圍中所用、、按鈕〃一辭應作廣義解釋,其可為能釋 放對该刺血針支架之阻制的任意致動器,涵蓋任意習知 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ297公釐) 513299 A7 B7 10 15 經濟部智慧財產局員工消費合作社印製 20 五、發明説明(6) '~類型。 圖1A為採血裝置10之後端部分放大圖。在機械式 止動特貝之一較佳貫施例中,如圖所示,自圓頭1 8前伸 之懸臂‘狀件18A具有下凹前端,如此構成内伸突起 5邛。當支架20如圖左方箭頭方向所示向前移動時,支架 凸框20A最終與懸臂指狀件18A的突起部接觸。支架凸 框20A的力里使该專指狀件撓曲,如此抑制或吸收衝擊 振動並減少噪音。此二效應均減少對使用、者造成的疼 痛。該等突起部相對於該裝置前端的位置決定刺血針刺 穿皮膚的深度。此位置能以轉動圓頭18的方式作調整, 忒圓頭架在螺紋18B上。該圓頭上的指標18c結合該殼 體上的記號(圖中未示)可將該裝置設定在給定之可變 且可重複之牙刺深度。可變穿刺深度為吾人所要,因為 使用者通常希望只採取足以測試的血液量且使用者的手 指特性各有叾同。II由將大約18公厘的深度範圍分成 大約7等份’幾乎能夠滿足所有可能使用者的需求。 该採血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剖面圖,其中滑件 26的内部零件_抵著可釋放連接器28的頂部28A。驅 動彈簧22和縮回彈f 24處於平衡狀態而互抵。此二彈 (諸先閲讀背面之注意事項 寫本頁) 养 訂 線 本紙張尺舰 513299 A7 經濟部智慧財產局員工消費合作社印製 五、發明説明(7) 更均叉壓縮,驅動彈簧22的壓縮量小於縮回彈簧24, 因為其彈簧係數較大。刺血針40和針頭42在蓋12内 部。 / 圖3顯示該裝置處於要進入待刺出狀態之一中間位 5置的剖面圖,此時滑件26向後移動(向圖3右方移動)。 滑件26的推動元件26C之向後運動所施加的力量使縮回 彈簧24比圖2所示更為壓縮。驅動彈簧22因其彈簧係 數較大所以仍維持相對較未受壓縮。 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)。驅動彈簧22受壓縮且縮回彈簧24維持與圖3所示 大約相同壓縮·量。 圖5顯示該採血裝置處於待刺出且休止之狀態。驅 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。若在此時壓下按鈕 30,垂片30A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20因壓縮的驅動彈簧&所施 20 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 10 15 (請先閱讀背面之注意事項寫本頁} βϋ I»—·— —ysmw Bn·— ι_ι·1— M»m B>i C3ti-i —i - '裝 訂 線_ 經濟部智慧財產局員工消費合作社印製 ---—---- 五、發明説明(。) 40Γ到達其極左位置,針頭42伸出蓋開口14。刺血針 ,二20已因圓頭18内部元件之懸臂指狀件18Α的突起 部停止其向前(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%^疼痛。在圖示較佳實施例中,這些效應因指 狀件18Α之突起部和凸框2〇Α切成配合角度以在較大面 =接觸而得以提昇。滑件26仍處於其原始位置。驅動彈 η 22已連同支架2〇向前推進且未受壓縮。縮回彈簧 欠壓縮’如此其會對支架20施加向後(向右)力量,而 果為刺血針40和針頭42後縮,各元件回到目2所 態。 ^ 10 24 結 省於此技藝者會了解到以上說明及圖式僅為實行 本發明之範例而不具限制意圖。可在不脫離本發明精^ 及範圍下對本文所述細節作出修改。 (請先閱讀背面之注意事項寫本頁} -裝 15 ^ ------I —Ϊ - ^紙張尺度適用中國國家標準(CNS ) Α4規格(210X297公|

Claims (1)

  1. 513299 A8 B8 C8 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,且該殼體包容: (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) 一滑件,其可滑動地嵌於該殼體之一壁内, 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-端抵住該支架且其第二端抵住該滑 件; I (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’可讓該第一彈菁將該支 架向前推;及 (〇 —處於後端的圍蔽件,其包含: 閱 背 面 之 注 意 事 項 再 填 本 頁 祖 I I I I 訂 ki 經濟部智慧財產局員工消費合作社印製 11 513299 A8 B8 C8 D8 六、申請專利範圍 (i) 複數個前伸元件,其用以使該支架之前行 運動停止於一預定位置;及 (ii) 調整裝置,其用以可控制地改變及重設該 預定位置。 2. 如申請專利範圍第1項之採血裝置,其中該等前伸 元件包含具有内伸突起部以接合該支架之一表面 的懸臂指狀件。 3. 如申請專利範圍第1項之採血裝置,其中該調整裝 置包含一螺旋狀螺紋以使該圍蔽件附著於該殼 體,從而以該圍蔽件在該殼體上轉動之方式使該等 前伸元件前後移動定位。 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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CA2296778C (en) 2006-12-19
KR100684479B1 (ko) 2007-02-22
DE60005421T2 (de) 2004-07-01
CN1180748C (zh) 2004-12-22
ES2207462T3 (es) 2004-06-01
US6045567A (en) 2000-04-04
JP2000237172A (ja) 2000-09-05
KR20010020623A (ko) 2001-03-15
EP1031318A1 (en) 2000-08-30
CN1264571A (zh) 2000-08-30
CA2296778A1 (en) 2000-08-23
ATE250387T1 (de) 2003-10-15
DE60005421D1 (de) 2003-10-30
JP4486729B2 (ja) 2010-06-23
EP1031318B1 (en) 2003-09-24

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