JPH06277201A - センサーの埋込装置及び埋込方法 - Google Patents

センサーの埋込装置及び埋込方法

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Publication number
JPH06277201A
JPH06277201A JP5334718A JP33471893A JPH06277201A JP H06277201 A JPH06277201 A JP H06277201A JP 5334718 A JP5334718 A JP 5334718A JP 33471893 A JP33471893 A JP 33471893A JP H06277201 A JPH06277201 A JP H06277201A
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tube
lumen
needle
housing
sensor
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JP3573775B2 (ja
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John J Mastrototaro
ジョン・ジェイ・マストロトタロ
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Eli Lilly and Co
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Eli Lilly and Co
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Soil Working Implements (AREA)

Abstract

(57)【要約】 【目的】 信頼性があり、簡易で迅速な皮下へのインビ
ボセンサーの埋込装置及び方法を提供することを目的と
する。 【構成】 センサー埋込装置（１０）は、ハウジング
（１１）と、該ハウジングに取り付けられる二重内腔管
（１２）と、一方の内腔内に受け入れられるニードル
（１３）と、他方の内腔に受け入れられるセンサー（１
４）とを備える。二重内腔管（１２）は皮膚を突き刺し
て皮下に挿入され、所望の位置に到達した後、ハンドル
（１６）によりニードル（１３）のみが取り除かれ、セ
ンサー（１４）は皮下に残される。次いでカバー（１
５）が閉鎖され、センサー（１４）はモニタリングに供
される。

Description

【発明の詳細な説明】
【０００１】
【産業上の利用分野】本発明は、インビボ(in vivo)セ
ンサーの埋込装置及び該埋込方法に関し、特に、センサ
ーの埋込のための最小侵入方法に関する。
【０００２】
【従来の技術】使用に一致した形態にてセンサーが埋め
込まれるべきことが要求されるグルコースセンサー等の
ある種のセンサーは、インビボで使用されている。しか
しながら、埋込方法は素早く、容易で簡便であることが
所望されている。埋込方法は、患者へ投与する医療従事
者、及び被験者により安易になされるという利点があ
る。被験者は、医療訓練を受けないであろうから、セン
サーからの読み取りが正確であるような信頼性のある方
法でなければならない。
【０００３】本発明は、グルコース等のセンサーの埋込
を容易になす方法を提供し、該方法は素早く正確な結果
を与える装置を用いる。皮下の小さな容器内へのカテー
テルの導入装置は存在するけれども、この態様における
インビボセンサーの導入は示唆されていない。
【０００４】１９８３年１１月２９日付けにて、フラン
クハウザー(Frankhouser)らに発行された米国特許第
４，４１７，８８６号明細書には、カテーテル導入セッ
トが開示されている。該フランクハウザー特許は、導入
器ニードルに載置されたカテーテルを含む組立体を記述
し、該ニードルのチップは、該カテーテルの端部のわず
かに後方に伸長する。ワイヤガイドがニードル内に受け
入れられ、ニードルから後方に伸長するガイド管に取り
付けられる。使用に際して、該ニードルは、容器の内腔
に挿入され、スプリングワイヤガイドが容器内に進めら
れ、次いで、カテーテルが前方に進められ、容器内のス
プリングワイヤガイドを所望の位置まで追跡する。その
後、スプリングワイヤガイド及びニードルは取り除かれ
る。
【０００５】ワイヤガイドなしではあるが比較できる装
置が、現在、ミニメド テクノロジー オブ シルマー
(MiniMed Technologies of Sylmar California)により
「ＳＯＦ−ＳＥＴ」の名称にて販売されている。この装
置は、ショート２４ゲージカテーテル内に受け入れられ
る２４ゲージニードルを備える。該ニードルはハンドル
を備え、皮膚を突き通すことにより身体にカテーテルを
導入するために用いられる。カテーテルは支持体から伸
長し、皮膚に固定される。管の全長も支持体から伸長
し、ニードルの引きにしたがってカテーテルと連絡す
る。
【０００６】二重内腔カテーテルの導入のための方法及
び装置もまた特定されている。二重内腔カテーテルは、
血液試料の引き出し及び薬の投入等のための容器への２
つのアクセス手段を提供するものとして注目されてい
る。二重内腔ニードルを備えてはいるがフランクハウザ
ー特許に記載されていると同様の導入ニードル組立体
が、１９９０年６月１９日付けにてルイス(Lewis)に発
行された米国特許第４，９３５，００８号明細書に開示
されている。同様にアロウ インターナショナル社(Arr
ow International Inc.)製の「ＴＷＩＮ ＣＡＴＨ」
（商標）は、二重内腔カテーテルを含む導入器を備えて
いる。カテーテルの一方の内腔は、ニードル取り巻い
て、ニードルを受け入れ、他方の内腔は、Ｃ字型横断面
を有し、取り巻かれた内腔の一部を取り囲む。
【０００７】
【発明が解決しようとする課題】本発明の目的は、信頼
性があり、簡易で、素早くインビボセンサーを埋め込む
ことのできるセンサーの埋込装置及び該埋込方法を提供
することにある。
【０００８】さらに本発明の別の目的は、ユーザーの皮
膚直下の所望の位置に、インビボセンサーを信頼性良く
定置する装置及び方法を提供することにある。
【０００９】
【課題を解決するための手段】本発明によれば、ハウジ
ングと、該ハウジングに取り付けられる二重内腔管と、
該管の第１の内腔内に受け入れられるセンサーと、該管
の第２の内腔内に受け入れられるニードルと、を備える
センサー埋込装置が提供される。該管及びニードルは、
該ニードルが皮膚の下に、ハウジングのレベルまで挿入
され、センサーの所望の定置を与えるような寸法であ
る。次いでニードルは取り除かれ、装置の残部は所望の
センサーモニタリングタイムの間、皮膚に固定される。
該装置に関連したインビボセンサーの埋込方法もまた提
供される。
【００１０】
【実施例】本発明の趣旨の理解を促進する目的のため
に、図面に示した実施態様を参照し、実施態様を説明す
るために特別の語いを用いる。本発明は、この実施態様
に限定されるものではなく、当業者が通常、想到すると
思われる装置の変形及び発明の趣旨の適用等も含むこと
を理解されたい。
【００１１】本発明は、効果的に且つ容易に用いること
ができるインビボ(in vivo)センサーを埋め込むための
装置及び方法を提供する。該装置は、構造が簡単で、医
療従事者若しくはセンサーのユーザーにより容易に使用
される。この装置及び方法は、この態様にて埋め込みに
適するセンサーにおける使用への幅広い適用を有する。
グルコースセンサーでの使用に関する例示により、本発
明を記述するが、本発明はこれらのタイプのセンサーの
使用に限定されるものではない。
【００１２】特に図面を参照して、皮下へのセンサーの
埋め込みのための装置１０が示されている。該装置は、
ハウジング１１と、該ハウジングに取り付けられ、該ハ
ウジングの底部表面の外方に伸長する二重内腔管１２と
を含む。ニードル１３が該管１２の一方の内腔内に受け
入れられ、センサー１４が他方の内腔内に受け入れられ
る。該ニードルは、該管を皮下に導入するために用いら
れ、その後、該管及びセンサー１４を使用のために皮膚
直下に維持したまま、該ニードルは取り除かれる。
【００１３】ハウジング１１は、埋め込み装置全体に関
して幾つかの機能を提供する。ハウジングは、使用に先
立ち、管１２を支持し、ニードル１３を包含する軽量構
造を備える。好ましい形状において、該ハウジングは管
１２の基端部、したがってニードル１３にアクセスする
カバー１５を含む。該ニードルは、ハンドル１６を含
み、埋め込みが完全になされた後に、管１２からの除去
を確実にする。ハウジング１１は、該ハンドルが受け入
れられ、該カバー１５を開放することによりアクセスさ
れる腔を規定する。カバーは、さらに、該ニードルが取
り除かれた後、及びセンサーが使用されている間、該腔
したがって管１２の基端部を閉鎖する。
【００１４】基端部にてハウジングに取り付けられるの
は、二重内腔管１２である。この管は、第１の内腔１７
及び三日月型形状の第２の内腔１８を規定する。第１の
内腔は、好ましくはニードル１３を取り巻き、且つ受け
入れる。センサー１４は第２の内腔１８内に受け入れら
れる。好ましくは、管１２は、末端部にて開口１９を含
む。センサー１４は感応要素２０を含み、該感応要素は
該管の外方に伸長すべく該開口１９内に位置される。
【００１５】ニードル１３は、管１２及び連結したセン
サー１４を皮膚表面直下に挿入するために用いられる。
該ニードルは、皮膚に刺し通すための先鋭末端チップ２
１を有する。管１２は、末端方向に内方に向かってテー
パー（先細り）する外部表面を有し、ゆえに皮膚を通し
ての挿入のために偏平な末端部２２を含む。管の末端部
のテーパーは、ニードルを越えて管を「引き降ろす」こ
とにより簡便になされる。ニードルの先鋭チップは、管
の末端部の外方にわずかな距離だけ伸長する。
【００１６】使用に際して、装置１０はハウジング１１
により堅持され、ニードルが強制的に皮膚を通される。
密接形状管１２は、導入ニードルにより皮膚を通して運
ばれ、該管の末端部はこうして皮膚表面直下に定置され
る。管の定置後、カバー１５が開放され、ニードルがハ
ンドル１６の使用により、管から取り除かれる。次い
で、カバーが閉鎖される（図４）。ハウジングの底部表
面は、好ましくは接着層２３を具備し、センサーの埋め
込みに際して、ハウジングを皮膚に取り付ける。
【００１７】センサー１４は、インビボ使用に供される
センサー及び記述された装置及び方法の使用により埋め
込みに適用されるセンサーであれば、いかなる種類のセ
ンサーであってもよい。例えば、センサーは、「可撓性
基板上の電気酵素(electroenzymatic)グルコースセンサ
ーの再生可能な微細構造」（R.J.Morff, D.Lipson, K.
W.Johnson, J.J.Mastrototaro, C.C.Andrew, A.R.Potvi
n, 第１回ワールド コングレス オン バイオセンサ
ー 予稿集、１９９０年５月２日〜４日）及び「可撓性
基板上に構成された電気酵素グルコースセンサー」（J.
J.Mastrototaro,K.W.Johnson, R.J.Morff, D.Lipson,
C.C.Andrew, 第３回化学センサー国際会議 予稿集、
１９９年９月２４日〜２６日）に記載されたセンサー等
のグルコースセンサーでもよく、該記載は参照により本
願に取り込まれている。該記述されたグルコースセンサ
ーは、第２の内腔１８内に簡便に受け入れられるような
寸法及び形状を有する。
【００１８】感応要素から離隔された位置まで、感応要
素からの情報を連絡する手段が設けられる。好ましくは
センサーは、可撓性基板を含み、該基板上に感応要素及
び感応要素に連絡するワイヤが載置されている。この態
様において、感応要素２０は、好ましくは開口１９内に
定置され、基板２４及び支持されたワイヤ２５が、第２
の内腔１８を通して感応要素から共に伸長する。ワイヤ
及び基板は、管の基端部に隣接して管を出る。フィラー
２６がハウジングへの管の固定を補助するために用いら
れても良く、さらに管の基端部から出るワイヤ２５を含
むこともできる。これらのワイヤは感応要素からの情報
を受け入れるための手段に連結され、該手段はハウジン
グ１１内に簡便に配置されても良い。なお、ワイヤリー
ドは外部装置に連結されても良く、この場合、コネクタ
ー（図示せず）が含まれても良い。内部であろうと外部
であろうと、感応された情報を表示する及び／又は記録
する手段が具備されても良い。
【００１９】該装置は簡単に且つ容易に製造される。構
成部品は、医療適用に適する種々の公知の材料から形成
することができ、特に、ニードル、二重内腔管等の皮膚
直下に挿入されるものの製造に用いられる生体適合性材
料から形成される。管１２のための典型的な材料は、ポ
リエチレン、ポリテトラフルオロエチレン、ポリウレタ
ン及びシリコンを含み、シリコンは大きな可撓性を与え
る。装置の寸法は、用いられるべきセンサーの性能及び
皮下へのセンサーの所望定置により、決定される。典型
的な例において、管１２は１９ゲージ管を備え、２１〜
２７ゲージシリンジニードルが円形中央内腔に用いられ
る。
【００２０】本発明の装置及び方法は、素早く簡単に正
確なインビボセンサーの定置を提供する。該装置及び方
法は、医療従事者の必要なしに簡易に用いられる。した
がって埋込は自宅等で簡便に行うことが可能である。ニ
ードルは埋込の間の迅速性を与えるが、管の除去に際し
て、局部刺激を減少させ、且つユーザーの安楽性を増す
べく望ましい可撓性を有する。
【００２１】装置は、滅菌包装にて提供され、ユーザー
は簡単に装置を取り出し、記述したように埋込に供す
る。装置は必要な記録／表示手段を含んでも良く、若し
くはワイヤリードを適当な外部のモニタ装置に連結する
ためのコネクターが設けられても良い。
【００２２】本発明は前述の記載において詳細に記述さ
れているが、本発明はこれらに限定されるものではな
く、単に実施態様を記述したに過ぎず、保護されるべき
本発明の精神内でのあらゆる変更及び変形がなされても
良いことを理解されたい。
【図面の簡単な説明】
【図１】図１は、本発明にしたがって構成されたインビ
ボセンサーの皮下埋込のための装置の部分横断面側面図
である。
【図２】図２は、本発明に有効な二重内腔管を図１の線
２−２に沿って切り取った横断面図であり、矢印方向に
て見た図である。
【図３】図３は、本発明に有効な二重内腔管を図１の線
３−３に沿って切り取った横断面図であり、矢印方向に
て見た図である。
【図４】図４は、センサーの皮下への埋込に用いられる
図１の装置の部分横断面側面図であり、特に取り除かれ
たニードル及び閉鎖位置でのカバーを有する装置を示す
図である。

Claims (21)

    【特許請求の範囲】
  1. 【請求項１】 皮膚表面直下へのセンサーの埋込装置で
    あって、 ハウジングと、 該ハウジングに取り付けられた基端部と、該ハウジング
    から突出する末端部と、を有する二重内腔管であって、
    該末端部を含む管が第１の内腔と第２の内腔とを規定す
    る前記二重内腔管と、 該管の第１の内腔内に受け入れられるニードルであっ
    て、基端部と、該管の末端部の外方に伸長する先鋭末端
    部と、を含む前記ニードルと、 該管の第２の内腔内に受け入れられるセンサーであっ
    て、該管の末端部に隣接し且つ該ハウジングの外側にお
    いて該第２の内腔内に配置される感応要素を含み、さら
    に該感応要素が、該感応要素により感応された情報を該
    感応要素から離隔された位置へ連絡する手段を含む、か
    ような前記センサーと、を備え、こうして、該ニードル
    及び該管を強制的に皮膚表面直下の所望の位置内へ案内
    することにより、センサーの埋め込みが成されることを
    を特徴とする前記センサーの埋込装置。
  2. 【請求項２】 前記センサーがグルコースセンサーであ
    ることを特徴とする請求項１の装置。
  3. 【請求項３】 前記連絡する手段が、感応要素から第２
    の内腔を通して前記管の基端部まで伸長するワイヤリー
    ドを含むことを特徴とする請求項１の装置。
  4. 【請求項４】 前記ハウジングが、前記感応要素からの
    情報を受け取り且つ感応状態に関する情報を表示する手
    段を含むことを特徴とする請求項３の装置。
  5. 【請求項５】 前記管が、第２の内腔の一部に露出する
    末端部に開口を含み、前記感応要素が、前記管の外部に
    露出されるべき該開口内に定置されていることを特徴と
    する請求項１の装置。
  6. 【請求項６】 前記連絡する手段が、前記感応要素から
    第２の内腔を通して前記管の基端部まで伸長するワイヤ
    リードを含むことを特徴とする請求項５の装置。
  7. 【請求項７】 前記ニードルが第１の内腔に取り除き可
    能に受け入れられ、且つ前記ニードルが前記第１の内腔
    から前記ニードルを取り除く手段を含むことを特徴とす
    る請求項１の装置。
  8. 【請求項８】 前記ニードルを取り除く手段が、前記ニ
    ードルの基端部に取り付けられたハンドルを含むことを
    特徴とする請求項７の装置。
  9. 【請求項９】 前記ハウジングが腔を規定し、前記ニー
    ドルのハンドルが該腔内に受け入れられることを特徴と
    する請求項８の装置。
  10. 【請求項１０】 前記ハウジングが、前記腔を閉鎖する
    第１の位置と前記腔を開放する第２の位置とを有するカ
    バーをさらに含み、該カバーが閉鎖位置にある際に前記
    ニードルの前記ハンドルが前記腔内に受け入れ可能であ
    り、該カバーが開放位置にある際に前記ニードルが前記
    管及びハウジングから取り除き可能であることを特徴と
    する請求項９の装置。
  11. 【請求項１１】 前記管が、末端方向にて内方にテーパ
    ードされている外部表面を有する末端部を含むことを特
    徴とする請求項１の装置。
  12. 【請求項１２】 前記第２の内腔が三日月型形状である
    ことを特徴とする請求項１の装置。
  13. 【請求項１３】 さらに前記ハウジングを支持体表面に
    固定する手段を含むことを特徴とする請求項１の装置。
  14. 【請求項１４】 前記ハウジングが底部表面を含み、該
    底部表面から前記管が突出し、前記固定する手段が、該
    ハウジングの底部表面に配置される接着材料を含むこと
    を特徴とする請求項１３の装置。
  15. 【請求項１５】 皮膚表面直下にセンサーを埋め込む方
    法であって、 ａ）ハウジングと、 該ハウジングに取り付けられた基端部と該ハウジングか
    ら突出する末端部とを有し、末端部を含む管が第１の内
    腔と第２の内腔とを規定する二重内腔管と、 該管の第１の内腔内に受け入れられ、且つ基端部及び該
    管の末端部の外方に伸長する先鋭末端部を含むニードル
    と、 該管の第２の内腔内に受け入れられ、且つ該管の末端部
    に隣接して且つハウジングの外側において該第２の内腔
    内に定置される感応要素を含むセンサーであって、更に
    該感応要素により感応された情報を該感応要素から離隔
    した位置まで連絡する手段を含むセンサーと、を含む埋
    込装置を提供し、 ｂ）該ニードルを皮膚表面を通して皮膚表面直下の所望
    の位置まで、該管の末端部を定置させるべく押圧する工
    程を備える前記埋込方法。
  16. 【請求項１６】 前記ｂ）工程の後に、さらに前記管か
    ら前記ニードルを取り除く工程を含むことを特徴とする
    請求項１５の方法。
  17. 【請求項１７】 前記ニードルがハンドルを含み、前記
    ニードルを取り除く工程が前記管から前記ニードルを取
    り除くために該ハンドルを引く工程を備えることを特徴
    とする請求項１６の方法。
  18. 【請求項１８】 前記ｂ）工程の後に、さらに前記ハウ
    ジングを皮膚表面に固定する工程を含むことを特徴とす
    る請求項１５の方法。
  19. 【請求項１９】 前記ハウジングが底部表面を含み、該
    底部表面から前記管が突出し、該底部表面は接着コーテ
    ィングを含み、前記ハウジングを固定する工程がハウジ
    ングの該底部表面を皮膚表面に接着する工程を含むこと
    を特徴とする請求項１８の方法。
  20. 【請求項２０】 前記ｂ）工程の後に、前記ニードルを
    前記管から取り除く工程をさらに含むことを特徴とする
    請求項１８の方法。
  21. 【請求項２１】 前記ｂ）工程が、前記管の末端部を皮
    下組織内のある位置に定置する工程を備えることを特徴
    とする請求項１５の方法。
JP33471893A 1993-01-22 1993-12-28 センサーの埋込装置 Expired - Lifetime JP3573775B2 (ja)

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US08/008,611 US5299571A (en) 1993-01-22 1993-01-22 Apparatus and method for implantation of sensors
US008611 1995-12-14

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ZA94106B (en) 1994-08-19
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CA2111897A1 (en) 1994-07-23

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