JP2012519027A - 薬物送達管理システム及び方法 - Google Patents
薬物送達管理システム及び方法 Download PDFInfo
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Abstract
【選択図】図1
Description
本特許出願は、「Medical Module for Drug Delivery Pen」と題する2009年2月27日付で出願された仮特許出願第S.N.61/156,386号(代理人整理番号第LFS−5196USPSP号)、「Drug Delivery System」と題する2009年2月27日付で出願された仮特許出願第S.N.61/156,421号(代理人整理番号第LFS−5196USPSP1号)、「Drug Delivery Management Systems and Methods」と題する2009年2月27日付で出願された仮特許出願第S.N.61/156,472号(代理人整理番号第LFS−5196USPSP2号)、「DRUG DELIVERY MANAGEMENT SYSTEMS AND METHODS」と題する2009年3月27日付で出願された仮特許出願第S.N.61/164,250号(代理人整理番号第LFS−5196USPSP3号)に対し、米国特許法35 USC§119に基づく優先権の利益を主張し、これら全ては参照により本明細書にそれらの全てが組み込まれる。
図1は、薬物送達ペン224と、拡張医療通信モジュール202と、例えば血糖メータ300、携帯電話400、パーソナルコンピュータ500(モバイルコンピュータを含む)又はネットワークサーバ600のような、拡張モジュールとの直接的な又は本明細書に記載した代表的なデータ管理ユニット装置の組み合わせによる通信のためのデータ管理ユニットDMUと、を含む、糖尿病管理システムを図示する。拡張モジュール202は、薬品送達装置224の活動をモニタリングするように構成され得る。拡張通信モジュール202及び薬品送達装置224の両方を単一ユニットとしてともに係合するように構成してもよい。本明細書で使用するとき、「DMU」の参照は、疾病管理システムにおいて個々のユニット300、300、500若しくは600を別々に、又はデータ管理ユニット300〜600全てをまとめて表す。
異なる薬物送達装置(例えばインスリンペン)が代替的な連結手法を必要とし得ることを認識し、出願者らは、先行実施形態のように薬物送達装置の一端の上に挿入されるのでなく側部から取り付けられるように設計された代替品を提供した。図13は、DMU 300とともに使用するための薬物送達ペン124及び拡張通信モジュール102を含むシステムを図示する。携帯電話(又は例えばApple iPhoneのような演算プラットフォーム)400、パソコン500、又はネットワーク600のような他のDMUも本明細書に記載されるモジュールと別個に又は全てのDMUなどとの組み合わせにおいて利用できることを理解されたい。図13、14及び15に図示されるように、拡張モジュール102及び薬物送達ペン124をともに嵌め合わせることができる。
本明細書に記載されているシステムを使用して、糖尿病患者に臨床利益を提供することができる。一実施例において、医療提供者(「HCP」)は、パスワードを入力するか又はよりセキュリティを強めるために暗号化によるセキュリティキー(例えばUSBセキュリティPKIトークン)を使用してHCP選択メニューにログインすることにより、DMU 300に治療プロトコルを設定することができる。あるいは、信頼できる遠隔端末若しくは携帯電話400、コンピュータ500、又はネットワークサーバセンター600を介してログインプロセスを実行して、メニュー選択を遠隔操作で実行することができる。ログインが成功したら、HCPは、例えば「長期作用型」プロトコル、「混合」プロトコル又は頻回注射(Multiple Daily Injection)(「MDI」)プロトコル等の複数の治療プロトコルのうちの1つを選択することができる。
Claims (37)
- 糖尿病管理システムであって、
メモリと、
前記メモリに連結されたプロセッサと、
前記プロセッサに連結されたディスプレイと、
データを送受信するためのトランシーバと、
を含む、データ管理ユニットと、
第1の端部から第2の端部まで延在する概ね管状のペンハウジングを備え、前記ハウジングが、前記第1の端部に近接して配置された薬物カートリッジに連結されたプランジャ棒の少なくとも一部分を包囲し、前記ペンハウジングが、投与量インジケータ窓、及び前記プランジャ棒に連結された投与量セレクタを含む、薬物送達ペンと、
第1の長手方向軸に沿って第1のハウジング端部から第2のハウジング端部まで延在する拡張ハウジングを備える、拡張通信ユニットと、
を含む、薬物送達システムと、
を備える、糖尿病管理システムであって、前記拡張ハウジングは、前記ペンハウジングの少なくとも一部分を囲み前記薬物送達ペンから分離され得る係合部分を含み、前記ハウジングは、
メモリユニットと、
前記メモリに連結されたプロセッサと、
前記ペンの前記投与量セレクタに取り付けられた投与量センサに連結されたA−D変換器であって、前記変換器が、前記投与量セレクタの変位に応じてデータを提供するように前記プロセッサに連結されている、A−D変換器と、
前記薬物カートリッジ内の薬物投与量の投与量送達に関係するデータを前記データ管理ユニットとの間で送受信するトランシーバと、
を含む、糖尿病管理システム。 - 前記係合部分が、第1及び第2の延長部を含み、前記延長部のそれぞれが第1及び第2の位置決め中子を有し、各位置決め中子が前記第1及び第2の延長部のそれぞれを超えて突出して、前記拡張ハウジングを前記投与量インジケータ窓に固定する、請求項1に記載のシステム。
- 前記投与量センサが、前記拡張ハウジング内に配置され、前記第1の長手方向軸の1つの側に位置づけられており、
電源が、前記ハウジング内に配置され、前記第1の長手方向軸のもう1つの側に前記投与量センサから間隔を空けて位置づけられており、
マイクロコントローラが、前記第1の長手方向軸に近接して前記ハウジング内に配置され、前記投与量センサと前記電源との間に位置づけられている、請求項2に記載のシステム。 - 前記投与量センサが、前記長手方向軸に沿って摺動可能な長手方向部材を備え、前記長手方向部材が、前記第2のハウジング端部に近接して前記拡張ハウジングから延出する追従部分に接続され、前記追従部分が、前記薬物送達ペンの前記投与量セレクタに連結されて、前記ペンハウジングに対する前記投与量セレクタの回転に応じて長手方向に移動する、請求項3に記載のシステム。
- 前記追従部分が位置決めフォークを備える、請求項4に記載のシステム。
- 前記追従部分が、前記投与量セレクタと入れ子になった構成の回転式ノブを備える、請求項4に記載のシステム。
- 前記拡張ハウジングが、
前記第1の長手方向軸に対して概ね平行な第2の長手方向軸を部分的に囲む第1及び第2の延長部を備え、前記第1及び第2の延長部が前記薬物送達ペンの外面と摩擦接触する、請求項1に記載のシステム。 - 前記拡張ハウジングが、第2の長手方向軸を囲む概ね管状の延長部を備えて、前記ハウジングの前記概ね管状の延長部の一部分を貫通して延在する中空穴を画定することにより、前記薬物送達ペンを前記中空穴内に挿入することを可能にする、請求項1に記載のシステム。
- 前記薬物送達ペンが、使い捨てインスリンペンを備える、請求項1に記載のシステム。
- 前記薬物送達ペンが、再利用可能なインスリンペンを備える、請求項1に記載のシステム。
- 前記投与量センサが、レジスタンス、キャパシタンス、光学、磁気、又はこれらの組み合わせからなる群から選択される、請求項1に記載のシステム。
- 前記薬物カートリッジの配向を決定するために前記拡張ハウジング内に配置された慣性センサを更に備える、請求項1に記載のシステム。
- 前記薬物送達ペンの交換及び/又は正しい位置づけの決定を可能にするために前記拡張ハウジング内に配置されたマイクロスイッチを更に備える、請求項1に記載のシステム。
- 前記薬物カートリッジが、長期作用型インスリン、速効型インスリン、長期作用性及び速効性混合型インスリン、NPH、成長ホルモン、GLP−1類似体、シムリン、又はこれらの組み合わせから本質的になる群から選択される薬物を収容する、請求項1に記載のシステム。
- 前記データ管理ユニットが、ユーザの体液の検体値を示す信号を提供するために前記プロセッサに連結された検体センサを更に備える、請求項1に記載のシステム。
- 前記データ管理ユニットが、携帯電話を備える、請求項1に記載のシステム。
- 前記データ管理ユニットが、モバイルコンピュータを備える、請求項1に記載のシステム。
- 前記データ管理ユニットが、前記通信モジュールから遠隔の場所に位置づけられたネットワークサーバを含む、請求項1に記載のシステム。
- 第1の端部から第2の端部まで延在する概ね管状のペンハウジングを有する薬物送達ペンによってユーザに薬物を送達する方法であって、前記ハウジングの前記第1の端部が、前記ハウジングの前記第2の端部に近接して配置された薬物カートリッジに連結されたプランジャを包囲し、前記ペンハウジングの前記第1の端部が、投与量インジケータ窓、及び前記プランジャに連結された投与量セレクタを有し、この方法は、
通信モジュールを前記薬物送達ペンの前記第1及び第2の端部のうちの1つに装着する工程と、
前記プランジャの作動によって薬物の投与量をユーザに送達する工程と、
前記ユーザに送達される前記薬物の実際の投与量を測定する工程と、
前記薬物カートリッジから送達される薬物の実際の投与量に関係するデータを前記通信モジュールのメモリに保存する工程と、
を含む、方法。 - 前記装着する工程が、
前記薬物送達ペンの前記第1の端部を前記通信モジュールの中空穴に挿入する工程と、
前記投与量セレクタを前記通信モジュールの回転式ノブに連結する工程と、を含む、請求項19に記載の方法。 - 前記測定する工程が、
前記プランジャを、前記通信モジュール内に配置された変位センサと接続する工程であって、前記変位センサ及び前記プランジャが単一のユニットとして移動するように構成される、工程と、
前記プランジャの運動を前記ユーザに実際に送達される薬物の投与量と相関させる工程と、を含む、請求項19に記載の方法。 - 前記保存する工程が、実際に送達される薬物の投与量に日付及び時間をフラグする工程を含む、請求項21に記載の方法。
- 前記保存する工程が、前記データを遠隔受信ユニットに送信する工程を含む、請求項19に記載の方法。
- 血糖メータ及び薬物送達ペンを用いてユーザの糖尿病を管理する方法であって、前記血糖メータはマイクロプロセッサと、メモリと、ディスプレイと、データの無線トランシーバとを有し、前記送達ペンは第1の端部から第2の端部まで延在する概ね管状のペンハウジングを有し、前記ハウジングの前記第1の端部は前記ハウジングの前記第2の端部に近接して配置された薬物カートリッジに連結されたプランジャを包囲し、前記ペンハウジングの前記第1の端部は投与量インジケータ窓、及び前記プランジャに連結された投与量セレクタを有し、この方法は、
前記ユーザの治療条件に基づいて治療投薬プロトコルを前記血糖メータのコントローラにロードする工程と、
前記ユーザの体液の複数の血糖レベル測定値を前記血糖メータのコントローラに保存する工程と、
前記複数の血糖レベル測定値に基づいて推奨される薬物投与量を表示する工程と、
前記薬物送達ペンの前記第1及び第2の端部のうちの1つに通信モジュールを装着する工程であって、前記通信モジュールが処理ユニット及びトランシーバを有する工程と、
前記薬物カートリッジに対する前記プランジャの作動によって前記推奨される薬物投与量を前記ユーザに送達する工程と、
前記ユーザに送達される前記薬物の実際の投与量を測定する工程と、
前記薬物の実際の投与量に関係するデータを前記通信モジュールのメモリによって保存する工程と、
前記データを、前記通信モジュールの前記トランシーバを介して前記血糖メータに送信する工程と、
前記治療投薬プロトコルの遵守を示す情報を表示する工程と、
を含む、方法。 - 前記装着する工程が、
前記薬物送達ペンの前記第1の端部を前記通信モジュールの中空穴に挿入する工程と、
前記投与量セレクタを前記通信モジュールの回転式ノブに連結する工程と、を含む、請求項19又は24に記載の方法。 - 前記測定する工程が、
前記プランジャを、前記通信モジュール内に配置された変位センサの一部分と接続して、前記変位センサの前記一部分及び前記プランジャが単一のユニットとして移動するように構成される工程と、
前記プランジャの運動を前記ユーザに実際に送達される薬物の投与量と相関させる工程と、を含む、請求項19又は24に記載の方法。 - 前記保存する工程が、実際に送達される薬物の投与量に日付及び時間をフラグする工程を含む、請求項26に記載の方法。
- 前記測定する工程が、前記薬物送達装置がプライミングされたかどうかを決定する工程を含む、請求項19又は24に記載の方法。
- 前記測定する工程が、前記薬物送達カートリッジ内の薬物の混合物が混合されたかどうかを決定する工程を含む、請求項19又は24に記載の方法。
- 前記薬物送達装置のプライミングがなされなかったことを前記ユーザに警告する工程を更に含む、請求項19又は24に記載の方法。
- 針を交換するように前記ユーザに警告する工程を更に含む、請求項19又は24に記載の方法。
- 前記投与量送達ボタンの作動に際し薬物送達イベントの時間を計る工程と、既定の時間をカウントダウンする工程と、薬物送達時間が不十分な場合に前記ユーザに警告する工程と、を更に含む、請求項19又は24に記載の方法。
- 薬物送達を行うときを前記ユーザに通知する工程、
前記薬物送達をし損ねたことを警告する工程、又は
不適切な投与量を警告する工程
を更に含む、請求項19又は24に記載の方法。 - 前記ユーザがペンを使用した持続時間、又は
前記薬物カートリッジが使い果たされるまでの残り時間、又は
前記薬物カートリッジ内の薬物の残量、
のうち1つを追跡する工程を更に含む、請求項19又は24に記載の方法。 - 前記通信モジュール上の場所検索スイッチの起動によって、所在が不明の血糖メータの場所を検索する工程、又は
前記グルコースメータ上の場所検索スイッチの起動によって、所在が不明の通信モジュールの場所を検索する工程
を更に含む、請求項24に記載の方法。 - 前記薬物が、遅効型インスリン、速攻型インスリン、成長ホルモン、GLP−1類似体、シムリン、又はこれらの組み合わせから本質的になる群から選択される、請求項19又は24に記載の方法。
- 前記メータをオフにする工程と、
メータをオンにした際に、最後の投与量送達、並びに前記通信モジュール及び前記メータからの最後のデータ通信の時間に関する情報を表示する工程と、を更に含む、請求項24に記載の方法。
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