JP6258929B2 - 表皮下の電気的警告デバイス - Google Patents
表皮下の電気的警告デバイス Download PDFInfo
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- JP6258929B2 JP6258929B2 JP2015517682A JP2015517682A JP6258929B2 JP 6258929 B2 JP6258929 B2 JP 6258929B2 JP 2015517682 A JP2015517682 A JP 2015517682A JP 2015517682 A JP2015517682 A JP 2015517682A JP 6258929 B2 JP6258929 B2 JP 6258929B2
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Description
Claims (17)
- 患者の表皮を通り表皮下組織の中へと貫通する2つの電極と、
前記2つの電極により前記表皮下組織に送られる電気的な警告信号を生成するDC信号生成器と、
を有する、介入が必要な場合に患者に警告を行う表皮下の電気的警告デバイスであって、
前記DC信号生成器が、前記2つの電極に単極の電気パルスを印加する回路を含み、前記単極の電気パルスは、急速なスイッチオンおよびアースに対する急速なスイッチオフにより、表皮下組織の中に交番する正及び負の極性の両極性の電流パルスを生成することを特徴とする、表皮下の電気的警告デバイス。 - 前記正及び負のパルスが、1から100ミリ秒以内で互いに追従しており、これらのパルス対が、0.2から5秒の時間間隔で互いに追従することを特徴とする、請求項1に記載の表皮下の電気的警告デバイス。
- 前記電気的な警告信号が、患者により認識され、確認されるまで、時間経過と共に増加する強度で送出されることを特徴とする、請求項1から2までの一項に記載の表皮下の電気的警告デバイス。
- 前記電気的な警告信号が、異なる警告メッセージについては、異なるリズムで送出されることを特徴とする、請求項1から3までの一項に記載の表皮下の電気的警告デバイス。
- 制御要素が入力信号に従って前記電気的な警告信号の生成を行うことを特徴とする、請求項1から4までの一項に記載の表皮下の電気的警告デバイス。
- センサ・システムにより測定された生命徴候に対する異常値があった場合、前記電気的な警告信号を生成する前記制御要素に入力信号を送るように構成されたセンサ・システムをさらに備える、請求項1から5までの一項に記載の表皮下の電気的警告デバイス。
- 前記センサ・システムが、分析物の濃度を測定するための、皮下的に埋め込まれたセンサを備えることを特徴とする、請求項6に記載の表皮下の電気的警告デバイス。
- ポンプ・システムの機能的な異常があった場合、前記電気的な警告信号を生成する前記制御要素に入力信号を送るように構成された皮下に液を注入するためのポンプ・システムをさらに備える、請求項1から7までの一項に記載の表皮下の電気的警告デバイス。
- 接着層で覆われた前記デバイスの皮膚取付けプレートにより皮膚への取付けを確保することを特徴とする、請求項1から8までの一項に記載の表皮下の電気的警告デバイス。
- 前記接着層が、皮膚へ取付けるための第1面と、前記第1面とは反対側に皮膚取付けプレートへ取り付けるための第2面とを有し、前記第2面が、皮膚へ取付けるための前記第1面より小さいことを特徴とする、請求項9に記載の表皮下の電気的警告デバイス。
- 前記デバイスの接触面上に固定された前記接着層の前記減少させた面は、前記接着層が取り付けられない前記デバイスの前記接触面上の縁部から生ずることを特徴とする、請求項10に記載の表皮下の電気的警告デバイス。
- 皮膚の中に前記電極の表皮下挿入を行うための挿入手段をさらに備える、請求項1から11までの一項に記載のデバイス。
- 前記挿入手段が、使用準備済み位置にあるとき、皮膚を、デバイス・ケーシングの底部により固定的に配置された前記電極の先端部と接触させないようにし、作動されたとき、皮膚を、高速で前記電極の前記先端部の方向に引っ張り、皮膚の穿刺と、前記電極の表皮下挿入を行うように構成されることを特徴とする、請求項12に記載のデバイス。
- 前記挿入手段が、皮膚への取付けを確保するための接着層で覆われ、且つ前記電極が通過可能な穴又は凹部を有する皮膚取付け面と、
前記皮膚取付け面を、前記取り付けられた皮膚と共に前記電極の前記先端部の方向に引っ張る、前記皮膚取付け面のばねタイプの後退機構と、
前記電極の前記先端部が、前記皮膚取付け面により隠され、且つ皮膚への接触が阻止されるように、前記後退機構を、前記使用準備済み位置で事前に応力が加えられた状態に保持する制止手段と、
前記制止手段による前記後退機構の阻止を解放し、且つ前記後退機構を弛緩させることにより前記電極の皮膚挿入を実行させて、前記皮膚取付け面に取り付けられた前記皮膚を前記電極の前記先端部に対して引っ張り、且つ前記制御要素を作動させる解放及び作動要素と
を備える、請求項13に記載のデバイス。 - 前記皮膚取付け面が剛性のあるプレートであり、また前記後退機構が、前記使用準備済み位置にあるとき、且つ前記皮膚取付けプレートを前記デバイス・ケーシングの前記底部の方向に後退させる間にわたり、前記剛性のある皮膚取付けプレート及び前記デバイス・ケーシングの前記底部を互いに平行に保つように構成されることを特徴とする、請求項14に記載のデバイス。
- 前記皮膚取付け面が、前記デバイス・ケーシングの前記底部に、その周辺で取り付けられる可撓性のある、分割された面であり、前記後退機構が、前記使用準備済み位置で、前記接触面の中央部分を、前記デバイス・ケーシングの前記底部から離れるように伸ばして、前記取付け面にカップ又は切妻を形成させるように構成されることを特徴とする、請求項14に記載のデバイス。
- 前記可撓性のある接触面の前記後退機構が、強制された緊張位置から弛緩させることにより急速な運動をさせるために、前記可撓性のある接触面のばね状の弾性を利用することを特徴とする、請求項16に記載のデバイス。
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EP12173390.1A EP2679154A1 (en) | 2012-06-25 | 2012-06-25 | Sub-epidermal electric warning device |
PCT/EP2013/062180 WO2014001091A1 (en) | 2012-06-25 | 2013-06-12 | Sub-epidermal electric warning device |
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US20200254240A1 (en) * | 2016-05-15 | 2020-08-13 | Biolinq, Inc. | Devices and Methods For The Incorporation Of A Microneedle Array Analyte-Selective Sensor Into An Infusion Set, Patch Pump, Or Automated Therapeutic Delivery System |
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US6685675B1 (en) | 1995-05-22 | 2004-02-03 | Hoffmann-La Roche Inc. | Medical device adhering to the skin |
US6175763B1 (en) * | 1996-03-29 | 2001-01-16 | Alza Corporation | Electrotransport drug delivery device having tactile signaling means |
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US8224410B2 (en) * | 2003-12-22 | 2012-07-17 | Hadvary Paul | Dermally affixed sensor device |
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