JP5653217B2 - 外部薬剤ポンプ - Google Patents
外部薬剤ポンプ Download PDFInfo
- Publication number
- JP5653217B2 JP5653217B2 JP2010527595A JP2010527595A JP5653217B2 JP 5653217 B2 JP5653217 B2 JP 5653217B2 JP 2010527595 A JP2010527595 A JP 2010527595A JP 2010527595 A JP2010527595 A JP 2010527595A JP 5653217 B2 JP5653217 B2 JP 5653217B2
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- vial
- stopper
- distal end
- screw
- housing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Images
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Landscapes
- Health & Medical Sciences (AREA)
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- Life Sciences & Earth Sciences (AREA)
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- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Mechanical Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
本出願は、Grossらの2007年10月2日出願の米国仮特許出願番号第60/997,459号「外部薬剤ポンプ(External drug pump)」の利益を主張し、この仮出願の全開示内容は、参照により本明細書に組み込まれる。
人に送出される流体を収容するためのリザーバと、
リザーバから人に流体を供給するための流体輸送デバイスであって、流体輸送デバイスは、リザーバと流体連通する近位端と、流体輸送デバイスを通る患者への流体送出を促進するために、人の皮膚を貫通する貫通部材を有する遠位端とを含む、流体輸送デバイスと、リザーバおよび流体輸送デバイスを収容する筐体であって、筐体は、人に流体輸送デバイスの遠位端を注入する際にその遠位端を受けるための出口ポートと、人の皮膚に筐体の第1壁を固定するための手段とを含む、筐体と、筐体内の第1位置から、出口ポートを通して第2位置に、筐体の外部におよび人の皮膚内に貫通部材を駆動するために、流体輸送デバイスと接触する駆動構造体を含む、注入促進デバイスと、を含む。
Flahertyの米国特許第6,749,587号
Campbellの米国特許出願公報第2007/0118405号
本装置は、
物質を収容するバイアルと、
バイアルに摺動可能に結合された、バイアル内のストッパと、
(a)バイアルに対して回転可能であり、(b)第1ねじ構造部材の回転の間、バイアルに対して近位方向に実質的に移動しない、第1ねじ構造部材と、
第1ねじ構造部材とねじ式に結合された第2ねじ構造部材と、を含み、
第2ねじ構造部材の少なくとも遠位端はバイアルに対して実質的に回転不可能であり、
第2ねじ構造部材の遠位端は第2ねじ構造部材をストッパに結合する結合部分を画定し、
第1ねじ構造部材は、回転することにより、ストッパおよび第2ねじ構造部材の少なくとも遠位端をバイアルの遠位端の方向に直線的に前進させる。
バイアルおよびねじ構造部材を収容するバイアルの筐体ユニットと、
バイアルの筐体ユニットに結合され、この筐体ユニットに緩く結合された針の筐体ユニットと、
針の筐体ユニットに収容された針と、
針の周囲に少なくとも部分的に配置されたカニューレと、を含み、
装置はカニューレを通して対象者に物質を投与するように構成される。
装置はさらに、バイアルに摺動可能に結合された、バイアル内の分割ストッパを含み、
バイアルは、遠位区画および近位区画を含み、遠位区画は粉末を収容し、近位区画は液体を収容し、分割ストッパは、遠位区画と近位区画との間の流体連通を可逆的に阻止し、
第1ねじ構造部材は、回転することにより、分割ストッパをバイアルの遠位端の方向に前進させることによって、粉末と液体とを混合する。
第1ねじ構造部材の近位端に結合可能であり、回転することにより、第1ねじ構造部材を回転させるように構成された少なくとも1つの歯車と、
歯車を回転させるように構成されたモータと、
歯車およびモータがそれに結合される筐体上部と、を含む。
モータに接続された制御ユニットと、
対象者の生理学的パラメータを検出し、そのパラメータに応じて制御ユニットに信号を送信するように構成されたセンサと、を含み、
制御ユニットは信号に応じてモータを制御するように構成される。
筐体ベースに結合された1つ以上の磁気部材と、
筐体上部に結合された1つ以上の磁気部材と、を含み、
磁気部材は、筐体ベースと筐体上部とが位置合わせされると、筐体ベースを筐体上部に磁力により可逆的に結合するように構成される。
バイアルおよびねじ構造部材がその中に挿入されるように構成された、筐体ベースと、
筐体ベースに結合された針と、
針の周囲に少なくとも部分的に配置されたカニューレと、を含み、
針は、対象者の皮膚を穿刺し、対象者の皮膚にカニューレを挿入するように構成され、針は穿刺後に後退するように構成され、装置はカニューレを通して対象者に物質を投与するように構成される。
針駆動構造体は、
対象者が力を加えるための対象者に接触する面と、
対象者に接触する面に対して対象者が加える力がしきい値を超えると移動するように構成された、力を受ける部材と、を含み、
針は、しきい値を超える力のため、力を受ける部材の移動に応じて皮膚を容易に穿刺するように構成される。
バイアルおよびねじ構造部材がそれに挿入されるように構成された、筐体ベースと、
筐体ベースに結合され、対象者の皮膚を穿刺するように構成された針と、を含み、
装置は、針を通して対象者に物質を投与するように構成される。
バイアルおよびねじ構造部材がそれに挿入されるように構成された、筐体ベースと、
筐体ベースに結合され、対象者の皮膚を穿刺するように構成された、複数の極微針と、を含み、
装置は、複数の極微針により対象者に物質を投与するように構成される。
本方法は、
物質を収容し、ストッパにより密封されるバイアルと、
バイアル内に配置するための第1および第2ねじ構造部材であって、第1および第2ねじ構造部材は相互にねじ式に結合され、第2ねじ構造部材の遠位端はストッパに結合するためのものである、第1および第2ねじ構造部材と、を設けるステップと、
筐体ベースにバイアルを挿入するステップであって、ねじ構造部材はバイアルに挿入され、第2ねじ構造部材の遠位端はストッパに結合されている、ステップと、
ストッパおよび第2ねじ構造部材の少なくとも遠位端をバイアルの遠位端の方向に前進させることによりバイアルの物質を押し出すステップであって、前進は、
バイアルに対して第1ねじ構造部材を回転させることと、
第1ねじ構造部材の回転の間、バイアルに対する第1ねじ構造部材の近位の直線運動を防止することと、
バイアルに対する第2ねじ構造部材の少なくとも遠位端の回転運動を防止することと、により実行されるステップと、
を含む。
本装置は、
物質を収容するバイアルと、
バイアルに摺動可能に結合された、バイアル内のストッパと、
バイアル内のシャフトであって、シャフトの遠位部分はストッパに結合されているシャフトと、
シャフトに結合され、シャフトを回転させることによりバイアルの遠位端の方向にストッパを直線的に前進させるように構成された、バイアルの近位に置かれた回転構造体と、を含み、
シャフトの回転の間は常に、
(a)シャフトの遠位端はストッパの遠位端の近位に留まるように構成されることと、
(b)シャフトの近位端は回転構造体の近位端の近位に留まるように構成されることと、
を含む。
本方法は、
ストッパにより密封され、内部にストッパに結合されたシャフトを有する、物質を収容するバイアルを設けるステップと、
筐体ベースにバイアルを挿入するステップであって、回転構造体がバイアルの近位の筐体ベースに結合される、ステップと、
シャフトを回転させることによってストッパを前進させて、バイアルから外に物質を押し出すステップと、
シャフトの回転中に常にストッパの遠位端の近位にシャフトの遠位端を維持するステップと、
シャフトの回転の間、シャフトの遠位端を常に回転構造体の近位端に対して遠位に維持するステップと、を含む。
本装置は、
物質を収容するバイアルと、
バイアルに摺動可能に結合された、バイアル内のストッパと、
(a)バイアルに対して回転可能であって、(b)第1ねじ構造部材の回転の間、バイアルに対して近位方向には実質的に移動しない、第1ねじ構造部材と、
第1ねじ構造部材にねじ式に結合された第2ねじ構造部材であって、第2ねじ構造部材の少なくとも遠位端はバイアルに対して実質的に回転不可能であって、第2ねじ構造部材の遠位端は第1ねじ構造部材の回転の間は常にストッパの遠位端の近位に留まり、第1ねじ構造部材は、回転することにより、ストッパおよび第2ねじ構造部材の少なくとも遠位端をバイアルの遠位端の方向に直線的に前進させる、第2ねじ構造部材と、
を含む。
本方法は、
物質を収容し、ストッパにより密封されるバイアルと、
バイアル内に配置するための第1および第2ねじ構造部材であって、第1および第2ねじ構造部材は相互にねじ式に結合され、第2ねじ構造部材の遠位端はストッパに結合するためのものである、第1および第2ねじ構造部材と、を設けるステップと、
筐体ベースにバイアルを挿入するステップであって、ねじ構造部材はバイアルに挿入され、第2ねじ構造部材の遠位端はストッパに結合されている、ステップと、
ストッパおよび第2ねじ構造部材の少なくとも遠位端をバイアルの遠位端の方向に前進させることによりバイアルの物質を押し出すステップであって、前進は、
バイアルに対して第1ねじ構造部材を回転させることと、
第1ねじ構造部材の回転の間、バイアルに対する第1ねじ構造部材の近位の直線運動を防止することと、
バイアルに対する第2ねじ構造部材の少なくとも遠位端の回転運動を防止することと、により実行される、ステップと、
第1ねじ構造部材の回転の間、第2ねじ構造部材の遠位端を常にストッパの遠位端の近位に維持するステップと、を含む。
Claims (24)
- 対象者に物質を投与するための装置であって、
筐体と、
前記筐体内に固定して位置決めされ、および円筒形内面を有する、前記物質を収容するためのバイアルと、
前記バイアルに摺動可能に結合され、および前記円筒形内面と摺動摩擦接触している、前記バイアル内のストッパであって、前記摩擦接触が前記バイアルに対して前記ストッパの回転を妨げる回転摩擦成分と、前記ストッパの遠位方向への直線的な進行を妨げる線形摩擦成分とを含む、当該ストッパと、
(a)前記バイアルに対して回転可能であり、(b)回転している間、前記バイアルに対して実質的に直線的に移動しない、第1ねじ構造部材と、
前記第1ねじ構造部材にねじ式に結合された第2ねじ構造部材とを備え、
前記第2ねじ構造部材の遠位端が前記ストッパに結合する結合部分を形成し、
前記第1ねじ構造部材が回転することにより、前記線形摩擦成分に打ち勝って、前記第2ねじ構造部材と前記ストッパとを前記バイアルの遠位端の方向に直線的に移動させ、
前記ストッパと前記円筒形内面との間の回転摩擦成分のみが、前記バイアル内部における前記ストッパと前記第2ねじ構造部材の回転を実質的に妨げる構造であることを特徴とする装置。 - 前記第2ねじ構造部材の前記遠位端は、少なくとも部分的に前記ストッパ内に置かれることを特徴とする請求項1に記載の装置。
- 円筒形内面が平滑であることを特徴とする請求項1に記載の装置。
- 前記バイアルに摺動可能に結合された、前記バイアル内の分割ストッパをさらに備え、
前記バイアルは、遠位区画および近位区画を含み、前記遠位区画は粉末を収容し、前記近位区画は液体を収容し、前記分割ストッパは、前記遠位区画と前記近位区画との間の流体的な連通を可逆的に阻止し、
前記第1ねじ構造部材は、回転することにより、前記分割ストッパを前記バイアルの前記遠位端の方向に前進させることによって、前記粉末と前記液体とを混合することを特徴とする請求項1に記載の装置。 - 前記第2ねじ構造部材の遠位端は、前記第1ねじ構造部材の回転の間は常に前記ストッパの遠位端の近位に留まるように構成されていることを特徴とする請求項1に記載の装置。
- 前記バイアルおよび前記ねじ構造部材を収容するバイアルの筐体ユニットと、
前記バイアルの筐体ユニットに結合され、かつ前記筐体ユニットに緩く結合されている、針の筐体ユニットと、
前記針の筐体ユニットに収容された針と、
前記針の周囲に少なくとも部分的に配置されたカニューレと、
をさらに含み、
前記装置は前記カニューレを通して前記対象者に前記物質を投与するように構成されていることを特徴とする請求項1に記載の装置。 - 前記第1ねじ構造部材はねじを備え、前記第2ねじ構造部材は前記ねじの周囲に少なくとも部分的に置かれるナットを含むことを特徴とする請求項1に記載の装置。
- 前記ねじはテレスコピックねじを備え、前記ねじは、前記バイアルの前記遠位端の方向に前記テレスコピックねじを突き出すことにより、前記ナットの遠位端を前記バイアルの前記遠位端の方向に前進させるように構成されていることを特徴とする請求項7に記載の装置。
- 前記ナットはテレスコピックナットを備え、前記ねじは、前記テレスコピックナットを前記バイアルの前記遠位端の方向に突き出すことにより、前記ナットの遠位端を前記バイアルの前記遠位端の方向に前進させるように構成されていることを特徴とする請求項7に記載の装置。
- 前記第1ねじ構造部材はナットを備え、前記第2ねじ構造部材は前記ナットの内側に少なくとも部分的に置かれるねじを備えることを特徴とする請求項1に記載の装置。
- 前記ねじはテレスコピックねじを備え、前記ナットは、前記テレスコピックねじを前記バイアルの前記遠位端の方向に突き出すことにより、前記ねじの遠位端を前記バイアルの前記遠位端の方向に前進させるように構成されていることを特徴とする請求項10に記載の装置。
- 前記ナットはテレスコピックナットを備え、前記ナットは前記テレスコピックナットを前記バイアルの前記遠位端の方向に突き出すことにより、前記ねじの遠位端を前記バイアルの前記遠位端の方向に前進させるように構成されていることを特徴とする請求項10に記載の装置。
- 対象者に物質を投与するための装置であって、
筐体と、
前記筐体内に固定して位置決めされ、および円筒形内面を有する、前記物質を収容するためのバイアルと、
前記バイアルに摺動可能に結合され、および前記円筒形内面と摺動摩擦接触している、前記バイアル内のストッパであって、前記摩擦接触が前記バイアルに対する前記ストッパの回転を妨げる回転摩擦成分と、前記ストッパの遠位方向への直線的な進行を妨げる線形摩擦成分とを含む、ストッパと、
(a)前記バイアルに対して回転可能であり、(b)回転している間、前記バイアルに対して実質的に直線的に移動しない、第1ねじ構造部材と、
前記第1ねじ構造部材にねじ式に結合された第2ねじ構造部材と、を備え、
前記第2ねじ構造部材の遠位端は、前記第1ねじ構造部材の回転の間は常に前記ストッパの遠位端の近位に留まり、
前記第1ねじ構造部材は、回転することにより、前記線形摩擦成分に打ち勝って、前記第2ねじ構造部材と前記ストッパとを前記バイアルの遠位端の方向に直線的に移動させ、
前記ストッパと前記円筒形内面との間の回転摩擦成分のみが、前記バイアル内部における前記ストッパと前記第2ねじ構造部材の回転を実質的に妨げる構造であることを特徴とする装置。 - 前記第1ねじ構造部材のピッチに対する最大直径の比は、前記ストッパの回転が、前記ねじ構造部材のピッチによって前記ストッパの直線的な進行を妨げるよりも大幅に大きく妨げられるようにされていることを特徴とする請求項1又は13に記載の装置。
- 前記第1ねじ構造部材のピッチに対する最大直径の比は、前記ストッパの回転が、前記ねじ構造部材のピッチによって前記ストッパの直線的な進行を妨げるよりも大幅に大きく妨げられるようにされていることを特徴とする請求項13に記載の装置。
- 前記バイアルを前記バイアルの筐体ユニット内に挿入する間、前記第1および第2ねじ構造部材と前記ストッパとは前記バイアルの遠位端の方向に移動することを特徴とする請求項6に記載の装置。
- 前記バイアルと、前記第1ねじ構造部材と、前記第2ねじ構造部材とが前記筐体に挿入される構造であり、
前記筐体の一部は、前記バイアル、前記第1及び第2ねじ構造部を前記筐体内に挿入する際に、前記第1及び第2ねじ構造部材と前記ストッパとを前記バイアルの遠位端の方向に移動するように機能することを特徴とする請求項1に記載の装置。 - 前記筐体の前記一部は、前記第1及び第2ねじ構造部材と前記ストッパとを移動させる際に十分な力を加えることにより、前記バイアルと接触する前記ストッパの長期間の保存に起因する、前記ストッパとバイアルとの間の摩擦に打ち勝つように構成されていることを特徴とする請求項17に記載の装置。
- 筐体に結合され、および対象者の皮膚に挿入するように構成されたカニューレをさらに備え、
前記筐体は、前記第1及び第2ねじ構造部材と前記ストッパとを移動させることにより、前記カニューレの遠位端を通してガスを放出するように構成されていることを特徴とする請求項17に記載の装置。 - 前記筐体の前記一部は、前記第1及び第2ねじ構造部材と前記ストッパとを移動させることにより、前記カニューレの前記遠位端を通して前記物質の少なくとも一部を放出するように構成されている、請求項19に記載の装置。
- 前記筐体の前記一部は、前記バイアルの近位端の一部を基準にして配置されており、これにより、前記バイアルと前記第1及び第2ねじ構造部材とを前記筐体内に挿入する間、前記筐体の前記一部と前記バイアルの前記近位端の前記一部との間の相対運動が、前記第1及び第2ねじ構造部材と前記ストッパとを前記バイアルの前記遠位端の方向に移動させることを特徴とする請求項17に記載の装置。
- 前記筐体の前記一部は、前記筐体の前記一部と前記バイアルの前記近位端の前記一部との間の摺動運動が、前記第1及び第2ねじ構造部材と前記ストッパとを前記バイアルの前記遠位端の方向に進行させるように配置されていることを特徴とする請求項21に記載の装置。
- 前記バイアルと前記第1及び第2ねじ構造部材とは、前記筐体内に挿入されるように構成され、さらに、前記筐体に結合された針と、前記針の周囲に少なくとも部分的に配置されたカニューレとを備え、
前記針は前記対象者の皮膚に刺入し、前記対象者の皮膚にカニューレを挿入するように構成され、
前記針は刺入の後に引き抜くように構成され、
前記装置は前記カニューレを通して前記対象者に前記物質を投与するように構成されていることを特徴とする請求項1に記載の装置。 - 前記針に結合された針駆動機構をさらに備え、
前記針駆動機構は、
対象者が力を加えるための対象者接触面と、
前記対象者により前記対象者接触面に加えられる力がしきい値を超えると、移動するように構成された力受入れ部材とを備え、
前記針は、前記力が前記しきい値を超えることにより前記力受入れ部材が移動すると、前記皮膚にすばやく刺入するように構成されていることを特徴とする請求項23に記載の装置。
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CN101868273A (zh) | 2010-10-20 |
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EP2195052B1 (en) | 2019-09-04 |
BRPI0817907A8 (pt) | 2015-04-07 |
US11590291B2 (en) | 2023-02-28 |
US11504481B2 (en) | 2022-11-22 |
BRPI0817907B1 (pt) | 2020-03-10 |
CN101868273B (zh) | 2014-10-15 |
BRPI0817907B8 (pt) | 2021-06-22 |
JP2010540156A (ja) | 2010-12-24 |
US20090093792A1 (en) | 2009-04-09 |
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WO2009044401A3 (en) | 2010-01-07 |
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BRPI0817907A2 (pt) | 2009-04-09 |
US20130331791A1 (en) | 2013-12-12 |
EP2195052A2 (en) | 2010-06-16 |
EP2195052A4 (en) | 2016-12-14 |
WO2009044401A2 (en) | 2009-04-09 |
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