JP6033347B2 - 治療法管理開発プラットホーム - Google Patents
治療法管理開発プラットホーム Download PDFInfo
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Description
本特許は、治療法管理システムおよび方法の開発を対象とし、具体的には、治療法と併せて使用される医療デバイスまたはシステムの構造および/または動作の修正を伴う治療法管理システムおよび方法の開発を対象とする。
本発明は例えば、以下の項目を提供する。
(項目1)
治療法管理開発を提供する方法であって、該方法は、
複数の機能性レベルを有する治療法管理開発プラットホームを提供することであって、該プラットホームは、治療法管理を提供することが可能な医療デバイスを含む、ことと、
該医療デバイスに対して該プラットホームを該機能性への第1のアクセスレベルに設定することと、
該プラットホームを使用して、該医療デバイスの動作を修正することと、
該プラットホームの該機能性へのアクセスレベルを第2のアクセスレベルに変更する承認の指示を受信することと、
該承認の指示の受信に応じて、該プラットホームの該機能性への該第2のアクセスレベルに該プラットホームを設定することと
を含む、方法。
(項目2)
各アクセスレベルは、前記医療デバイスの試験における段階に対応し、該段階は、ベンチ試験、動物試験、ヒト臨床試験、およびヒトでの使用のうちの1つを含む、項目1に記載の方法。
(項目3)
前記アクセスレベルを変更する前記承認の指示は、地理的位置と関連し、前記方法は、前記医療デバイスが該地理的位置に配置されているか否かを決定することをさらに含む、項目1または2に記載の方法。
(項目4)
前記医療デバイスの前記動作を修正することは、プロトタイプセンサを有する該医療デバイスを使用すること、または治療法管理を制御するために該医療デバイスによって使用される制御アルゴリズムの動作を変更することを含む、項目1〜3のうちのいずれか一項に記載の方法。
(項目5)
前記医療デバイスの前記動作を修正した後に、前記プラットホームを使用して該医療デバイスを試験することをさらに含む、項目1〜4のうちのいずれか一項に記載の方法。
(項目6)
前記プラットホームを使用して前記医療デバイスを試験することは、仮想の生理学的モデルおよびセンサモデルを使用することを含む、項目5に記載の方法。
(項目7)
前記医療デバイスは、ポンプと、ポンプコントローラとを備える、項目1〜6のうちのいずれか一項に記載の方法。
(項目8)
前記プラットホームの前記アクセスレベルに従って、顧客料金を設定することをさらに含む、項目1〜7のうちのいずれか一項に記載の方法。
(項目9)
(i)ポンプ入力/出力インターフェースを有するポンプコントローラであって、該ポンプ入力/出力インターフェースは該ポンプコントローラに連結される、ポンプコントローラと、
(ii)インターフェースモジュールコントローラと、モジュールセンサ入力/出力インターフェースとを含むインターフェースモジュールであって、該モジュールセンサ入力/出力インターフェースは、少なくとも1つの標準化入力ポートと、少なくとも1つの標準化出力ポートと、少なくとも1つの標準化電力接続とを有する、インターフェースモジュールと
を備え、
該インターフェースモジュールコントローラは、該モジュールセンサ入力/出力インターフェースに連結されたセンサから、および該ポンプコントローラからデータを受信し、該ポンプコントローラに命令を提供して、そこに連結されたポンプの動作を変化させるように、カスタマイズ可能にプログラムされる、治療法管理開発プラットホーム。
(項目10)
前記インターフェースモジュールコントローラをカスタマイズ可能にプログラムするために使用されるべきグラフィックユーザインターフェースを有する開発ツールキットをさらに備える、項目9に記載のプラットホーム。
(項目11)
演算デバイスをさらに備え、前記ツールキットは、該演算デバイス上で動作する、項目10に記載のプラットホーム。
(項目12)
前記ツールキットは、コマンドの標準化ライブラリを備える、項目10または11に記載のプラットホーム。
(項目13)
前記ポンプコントローラおよび前記インターフェースモジュールは、無線周波または赤外線の伝送器および受信器を介して無線で通信する、項目9〜12のうちのいずれか一項に記載のプラットホーム。
(項目14)
前記インターフェースモジュールは、地理的位置と関連したアクセスレベルの指示を受信し、前記ポンプコントローラおよび該インターフェースモジュールが該地理的位置に配置されているか否かを決定する、項目9〜13のうちのいずれか一項に記載のプラットホーム。
(項目15)
前記アクセスレベルの前記指示は、前記ポンプコントローラと関連したポンプの試験における段階に対応し、該段階は、ベンチ試験、動物試験、ヒト臨床試験、およびヒトでの使用のうちの1つを含む、項目14に記載のプラットホーム。
Claims (8)
- 治療法管理を提供する医療デバイスを備える治療法管理システムの開発を促進する方法であって、該方法は、
コンピュータ化した治療法管理開発プラットホームを提供することであって、該コンピュータ化した治療法管理開発プラットホームは、該治療法管理システムと通信可能なように連結されるように構成されることと、
該治療法管理システムの非治療機能性への第1のアクセスレベルを提供するように、該コンピュータ化した治療法管理開発プラットホームを構成することであって、ここで、該第1のアクセスレベルは、該治療法管理システムを用いて該医療デバイスを試験または開発するためのものである、ことと、
該コンピュータ化した治療法管理開発プラットホームにおいて、該コンピュータ化した治療法管理開発プラットホームを構成する承認の指示を受信して、該治療法管理システムの非治療機能性への第2のアクセスレベルを提供することであって、ここで、該第2のアクセスレベルは、該治療法管理システムを用いて該医療デバイスを試験または開発するためのものであり、該第1のアクセスレベルとは異なる、ことと、
該承認の指示の受信に応じて、該治療法管理システムの非治療機能性への該第2のアクセスレベルを提供するように、該コンピュータ化した治療法管理開発プラットホームを構成することと
を含む、方法。 - 前記第1のアクセスレベルは、前記医療デバイスの試験における段階に対応し、該段階は、ベンチ試験、動物試験、および、ヒト臨床試験での使用のうちの1つを含む、請求項1に記載の方法。
- 前記治療法管理システムの前記非治療機能性への該第2のアクセスレベルを提供するように前記コンピュータ化した治療法管理開発プラットホームを構成する前記承認の指示は、地理的位置と関連し、前記方法は、前記医療デバイスが該地理的位置に配置されているか否かを決定することをさらに含む、請求項1または2に記載の方法。
- 前記治療法管理システムの試験または開発は、プロトタイプセンサを有する該治療法管理システムを使用すること、または治療法管理を制御するために該治療法管理システムによって使用される制御アルゴリズムの動作を変更することを含む、請求項1〜3のうちのいずれか一項に記載の方法。
- 前記治療法管理システムの前記非治療機能性への第1のアクセスレベルを提供するように、前記プラットホームを構成している間に、前記コンピュータ化した治療法管理開発プラットホームを使用して前記医療デバイスを試験することをさらに含む、請求項1〜4のうちのいずれか一項に記載の方法。
- 前記コンピュータ化した治療法管理開発プラットホームを使用して前記医療デバイスを試験することは、仮想の生理学的モデルおよびセンサモデルを使用することを含む、請求項5に記載の方法。
- 前記医療デバイスは、ポンプと、ポンプコントローラとを備える、請求項1〜6のうちのいずれか一項に記載の方法。
- 前記コンピュータ化した治療法管理開発プラットホームの前記アクセスレベルに従って、顧客料金を設定することをさらに含む、請求項1〜7のうちのいずれか一項に記載の方法。
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WO2010120625A1 (en) | 2010-10-21 |
JP2012524337A (ja) | 2012-10-11 |
SG191634A1 (en) | 2013-07-31 |
CN102395976B (zh) | 2014-07-30 |
US20130079710A1 (en) | 2013-03-28 |
KR20180099940A (ko) | 2018-09-05 |
CA2943752C (en) | 2018-05-15 |
KR101994485B1 (ko) | 2019-06-28 |
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US8315885B2 (en) | 2012-11-20 |
AU2010236758A1 (en) | 2011-11-03 |
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US10546101B2 (en) | 2020-01-28 |
CA2758641C (en) | 2021-11-09 |
BRPI1014229A2 (pt) | 2016-04-12 |
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