JP3573775B2 - センサーの埋込装置 - Google Patents
センサーの埋込装置 Download PDFInfo
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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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
- A61B5/145—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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Description
【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に関する。
【0002】
【従来の技術】
使用に適した態様で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、埋込は、素早く、容易で簡便に行うことができることが望まれている。そうであれば、医療従事者及び被験者のいずれによっても容易になされるという利点がある。被験者は、医療訓練を受けていないであろうから、そのような者でもセンサーからの読み取りを正確に信頼性高く行えるようでなければならない。
【0003】
本発明は、被験者でも素早く正確な結果を得られる装置を提供する。従来技術においては、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(Arrow 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。
【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21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.Potvin, 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 (13)
- 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の内腔内に取り除き可能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、前記第1の内腔から該ニードルを取り除く手段と、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。 - 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。
- 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。
- 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。
- 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。
- 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。
- 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1の装置。
- 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7の装置。
- 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8の装置。
- 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。
- 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。
- 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。
- 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12の装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/008,611 US5299571A (en) | 1993-01-22 | 1993-01-22 | Apparatus and method for implantation of sensors |
US008611 | 1993-01-22 |
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Publication Number | Publication Date |
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JPH06277201A JPH06277201A (ja) | 1994-10-04 |
JP3573775B2 true JP3573775B2 (ja) | 2004-10-06 |
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Application Number | Title | Priority Date | Filing Date |
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JP33471893A Expired - Lifetime JP3573775B2 (ja) | 1993-01-22 | 1993-12-28 | センサーの埋込装置 |
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US (1) | US5299571A (ja) |
EP (1) | EP0607682B1 (ja) |
JP (1) | JP3573775B2 (ja) |
AT (1) | ATE185081T1 (ja) |
AU (1) | AU667994B2 (ja) |
CA (1) | CA2111897C (ja) |
DE (1) | DE69326605T2 (ja) |
ES (1) | ES2138998T3 (ja) |
ZA (1) | ZA94106B (ja) |
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-
1993
- 1993-01-22 US US08/008,611 patent/US5299571A/en not_active Expired - Lifetime
- 1993-12-15 AT AT93310113T patent/ATE185081T1/de not_active IP Right Cessation
- 1993-12-15 DE DE69326605T patent/DE69326605T2/de not_active Expired - Lifetime
- 1993-12-15 EP EP93310113A patent/EP0607682B1/en not_active Expired - Lifetime
- 1993-12-15 ES ES93310113T patent/ES2138998T3/es not_active Expired - Lifetime
- 1993-12-20 CA CA002111897A patent/CA2111897C/en not_active Expired - Lifetime
- 1993-12-28 JP JP33471893A patent/JP3573775B2/ja not_active Expired - Lifetime
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1994
- 1994-01-07 ZA ZA94106A patent/ZA94106B/xx unknown
- 1994-01-11 AU AU53124/94A patent/AU667994B2/en not_active Ceased
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CA2111897C (en) | 2005-08-16 |
JPH06277201A (ja) | 1994-10-04 |
DE69326605T2 (de) | 2000-04-06 |
EP0607682B1 (en) | 1999-09-29 |
ZA94106B (en) | 1994-08-19 |
AU5312494A (en) | 1994-07-28 |
AU667994B2 (en) | 1996-04-18 |
EP0607682A2 (en) | 1994-07-27 |
ATE185081T1 (de) | 1999-10-15 |
ES2138998T3 (es) | 2000-02-01 |
DE69326605D1 (de) | 1999-11-04 |
CA2111897A1 (en) | 1994-07-23 |
EP0607682A3 (en) | 1995-09-06 |
US5299571A (en) | 1994-04-05 |
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