JP7379416B2 - 患者の装置プログラム選択を許容する在宅治療装置 - Google Patents
患者の装置プログラム選択を許容する在宅治療装置 Download PDFInfo
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- JP7379416B2 JP7379416B2 JP2021099211A JP2021099211A JP7379416B2 JP 7379416 B2 JP7379416 B2 JP 7379416B2 JP 2021099211 A JP2021099211 A JP 2021099211A JP 2021099211 A JP2021099211 A JP 2021099211A JP 7379416 B2 JP7379416 B2 JP 7379416B2
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Description
[00165]ここで図2を参照すると、患者による居宅での腎臓治療装置100の使用を準備するための例示のプロセス200について説明している。長円をした開始においてプロセス200が始められると、ブロック202で示したように患者は先ず診療所設定において腎臓治療装置100に関して訓練を受ける。訓練に用いられる腎臓治療装置100はその患者に特異的なものではなく、診療所設定において複数の患者によって使用することができる。訓練用装置100は、患者の居宅に配置させる装置100を少なくとも厳密に模したものである。
[00171]医療製品や薬剤は、腎臓治療装置100が処置中に使用するために患者の居宅に出荷又は送達される。医師の処方指示に従って承認された治療製品や薬剤だけを患者の居宅に出荷させることが可能である。米国では、処方指示は1年間継続する。システムハブ120内には各患者向けの1つ又は複数の処方指示が記憶されている。各腎臓治療装置100は処方指示に従った補給品及び設定値を使用する。患者の処方指示が変更された場合や処方指示が追加された場合には、その患者の診療担当者はウェブポータル150を用いて腎臓治療装置100の設定値を更新し、その処方指示を変更又は追加する。腎臓治療装置100の設定値が更新された場合にシステムハブ120は、上で考察したようにこの更新された設定値を接続サービスを介して腎臓治療装置100に送る。
[00174]処置を始める前に(例えば、前日の消毒後に)、腎臓治療装置100のACPU112は、エージェント114を介した接続サービスが当該の腎臓治療装置100に関して更新した処方指示をポストしたかどうかをチェックする。チェックを行うためには一実施形態では、腎臓治療装置100及びシステムハブ120が接続サービスを通じて処方指示バージョンの数を比較し、腎臓治療装置100が最新更新の処方指示を得ているかどうかを判定する。最新バージョンで得ていない場合は、最新の処方指示バージョンが治療装置100に送達される。
[00181]ACPU112が腎臓治療装置100上で動作させるソフトウェア(本明細書ではファームウェアと呼ぶこともある)は、時にはアップグレードを要することがある。在宅医用デバイスシステム110は、製品開発チーム128とサービス要員132a~132nとを一体化したファームウェアをアップグレードするためのシームレスで高信頼の方式を提供している。
[00188]診療担当者は、その診療担当者の患者のリスト及び各患者ごとにその患者に対する処置がどのように知らされたかを示すファイルを参照することが可能である。処置ファイルは、達成した流量、限外ろ液除去、達成した限外ろ過速度、治療進行全体にわたる血圧、体重、その他を含め、腎臓治療装置100内のログファイルから導出される。診療担当者は例えば血液透析(例えば、短時間毎日、夜間、隔日及び隔夜のような下位カテゴリをもつ)、腹膜透析(例えば、連続周期的腹膜透析(「CCPD」)、タイダルのような下位カテゴリをもつ))などの受け取った処置の種別、監督する医師、又は以下で説明する通知を含む多数のカテゴリを基準として患者のリストを分類することが可能である。診療担当者はまた、患者スナップショット及びその週、その月又はその他の期間ごとの概要を参照することが可能である。
[00194]一実施形態ではシステム110は、ある種の変更を実装可能にする前に検証情報を要求することによってセキュリティ機能を提供する。一例ではシステム110は、すでに認証を受けると共にウェブポータル150にログインしているユーザが、ある種の変更をした後にその変更を実際に実装する前に再度自分のパスワードをウェブポータル150に入力しなければならないことを必要とする。ここではそのセキュリティ機能は第2ユーザ認証を含む。さもなければシステム110は、ある変更が第2のユーザによって承認された場合にのみシステム内にその変更が実装されることを必要とすることがある。ここではそのセキュリティ機能は、権限を与えられた承認者によって入力された承認である。
[00201]診療担当者及び患者は、在宅医用デバイスシステム110に関する情報に対して、システムハブ120を介してシステム110の残りの部分にリンクさせたウェブポータル150を介してアクセスすることが可能である。図8は、ウェブポータル150からの患者へのアクセスが可能な様々なページを説明している患者の表示デバイス(Patient’s display device)192上の例示の患者サイトマップ800を示している。患者は、サイトマップ800のランディングページ(Landing Page)802に到達し、ログインページ(Login)804においてログインするようにプロンプトを受ける。ログインが失敗した場合は、ログイン失敗ページ(Login Failure)806が表示され、この後で患者は再度ログインを試みることができる。数回にわたって(例えば、3回)ログインを失敗すると、システム110はアカウントロックページ(Locked Account)808を提供する。患者が以前にログインしたことがなければシステム110は、ページ(Create Password)810においてアカウント及びパスワードを生成するように、またページ(Accept Term and Conditions)812において諸条件を受け容れるように患者にプロンプトを出す。患者が首尾よくシステム110にログインした後に、システム110は患者に対して患者ダッシュボード(Patient Dashboard)814を表示する。患者ダッシュボード814から患者は、処方画面(View Prescription)816において自分のデバイスプログラムをまた在庫画面(View At Home Inventory)818において患者の居宅内在庫を参照することが可能である。処方画面816は装置100が患者について現在実行する処置(又は、複数の処方指示が使用可能な場合は処置選択肢)を示している。在庫画面818は、患者が目下の居宅に有しておくべき補給品を示している。患者は、システム110にとって入手できない情報によって在庫画面818を更新する(例えば、使えなくなった在庫品や患者の居宅内在庫からなくなった在庫品を差し引く)ことがある。システム110は、患者がこのような調整を行ったことをログ記録することがある。
[00209]図12Aは、診療担当者の表示デバイス192上に表示される診療所向けの例示のダッシュボード画面1200を示している。ダッシュボード画面1200は一実装形態では、ウェブポータル150にログインした際に見る最初の画面である。ダッシュボード画面1200は、当該診療所が扱っている患者に関する情報の概要を提供する。ダッシュボード画面内の情報は患者の健康又は状態に関する臨床的評価ではなくまた医学的助言を提供するものではなく、患者に関する情報の概要を診療担当者に提供するものであることを理解されたい。患者は、縦列1202に示した名前(患者名)を基準としてリスト表示されている。ダッシュボード1200は、診療担当者がドロップダウンメニュー1212に示したようなフィルタを適用することを可能にしてもよい。例えば診療担当者は図示した実施形態では、患者種別(図示せず)によって、ドロップダウンメニュー1212における担当医によって、又は患者のステータス(図示せず)によってダッシュボード内の情報をフィルタリングすることが可能である。診療担当者はまたダッシュボード内の情報を、チェックボックス1214を用いて通信が存在していない処置だけを表示させるように、或いはチェックボックス1216を用いてフラグが作成されている処置だけを表示させるようにフィルタリングすることが可能である。このフィルタによって診療担当者は、所望の特定の情報に焦点を合わせることが可能である。
[00224]図16A~16Gは、腎臓治療装置100が患者の居宅において腎臓処置をどのように実行するかを制御するパラメータの値を診療担当者が設定することを可能にする、診療担当者の表示デバイス192上に表示される例示のデバイスプログラム画面1600を示している。図16A~16Gでは、様々なフィールドやパラメータが診療担当者によって指定される。このフィールドやパラメータは、患者に関する医師の処方指示から得られたものである。以下に示すようなフィールドやパラメータによって患者は、1つ又は複数のパラメータについてある値の範囲から値を選択することが可能となる。
[00253]図18Aは、診療担当者の表示デバイス192上に表示されるユーザ画面1800の例示の画面ショットである。一実施形態では、診療所管理者のみがユーザタブ1223にアクセス可能である。ユーザタブ1223が選択されると診療所管理者は、図18Aに示したように画面の左側においてユーザリストの参照1802、ユーザのメンテナンス1804及びユーザの追加1806を行うことができる。図示した実施形態ではその診療所管理者は、ハイライトで表したようにユーザリスト参照1802を選択している。ユーザリストにおいて診療所管理者は、電子メールアドレス(ユーザ名)1808、ユーザの名前1810、ユーザのロール(Role)1812、ユーザのステータス1814及びユーザリスト内の当該ユーザエントリ上で実行し得る様々な措置(Actions)1816を参照することが可能である。
[00257]図19~29は、診療担当者の表示デバイス192上に表示されるウェブポータル150において診療担当者に提示される例示のレポートを示している。このレポートにはレポートタブ1221(図12A)からアクセスすることが可能である。図19は、診療担当者に対して処置日付(Treatment Start Date)1902を含む表形式とした患者の処置履歴、利用したデバイス処方指示(又は、デバイスプログラム)の名称(Device Prescription Applied)1904、処置の平均継続時間(Average Duration of Treatment)1906、事象フラグの平均数(Average Number of Event Flags)1908、平均収縮期拡張期血圧(処置前)(Average Systolic Diastolic BP Pre)1910、平均収縮期拡張期血圧(処置後)(Average Systolic Diastolic BP Post)1912、処置前後の平均パルス(Average Pulse Pre/Post)1914、処置前後の平均体重(Average Weight Pre/Post)1916、平均目標体重(Average Target Weight)1918、処置前後の除去済み平均UF体積(Average UF Volume Removed Pre/Post)1920、及び処置前後の1キロ当たりの平均UF流量(Average UF Rate per Kilo Pre/Post)1922の参照を可能にするような、診療担当者の表示デバイス192上に表示される例示の患者処置履歴レポート1900を示している。
[00267]図1Aに示したように、一実施形態ではタブレット122はカメラ136を含む。カメラ136は、腎臓治療装置100で用いられる補給品や腎臓治療装置100の構成品上にある又はこれに関連付けされたバーコードやその他の識別用記号を読み取るために用いられることがある。カメラ136は、バーコード、赤外線、レーザー、熱式及びサーモグラフィという種類のうちのいずれとすることもできる。
[00271]ここで図30A~43Dを参照すると、診療担当者に観察される画面に関する様々な実施形態及び態様を示している。様々な機能によって、治療の処方指示と最適化及び患者処置監視など診療担当者が実行する特定のタスクについて有益となる方式で画面が一体に結び合わされている。様々な機能には、遠隔式の補給品注文及び処方指示の設定、テンプレートの再使用可能性、異なる画面で入力された値の相互依存性、腎臓治療パラメータに関する矛盾する値の入力の防止、及び患者の居宅にある治療装置とシステムハブとの間での通信をオンとオフに切替えている接続エージェントを介したデータ(例えば、処方指示設定値、処置を記録するログファイル及びファームウェアアップグレードを含む)のフロー制御が含まれる。図30A~43Dで説明したこれらの機能のうちの少なくとも幾つかは、図10~18Eと連携して使用することができる。
[00330]上で記載したようにウェブポータル150は、システムハブ120にアクセスするために診療担当者によっても患者によっても使用されることがある。一実施形態ではウェブポータル150は、患者の居宅にあるタブレット122又は治療装置100の専用の表示デバイス上で参照し得る患者ダッシュボードを提供している。図44は、タブレット122又は装置100の専用の表示デバイス上に表示される患者ダッシュボード4400の例示の画面ショットを示している。図44で指摘したように患者ダッシュボード4400は、居宅(Home)タブ4402、自分のアカウント(Your Account)タブ4404及びヘルプ(Help)タブ4406を表示している。一実施形態では居宅タブ4402は、患者の補給品注文に関して患者に情報を提供している。図示した実施形態ではメッセージ4408は患者に対して、25日で患者から次の注文が見込まれることを示している。患者は、リンク4410を介して補給品を発注することができる。居宅タブ4402はまた、患者の最近の注文(Your recent orders)4412並びに患者の注文のカレンダー(Your calendar)参照4414を表示する。図示した実施形態では最近の注文情報4412は、最近の注文日付及び注文数、並びにこれらの注文ステータス(例えば、送達済みか保留中か)を含む。注文カレンダー4414は、注文が出された日にアイコンを表示させ、注文ステータスを提供する。
[00340]本明細書に記載した主題の態様は、単独で役立つことも、本明細書に記載した他の態様のうちの任意の1つ又は幾つかとの組合せにより役立つこともある。上記の説明を制限するものではないが本開示の1番目の態様では、在宅医用デバイスシステムは、患者に対して在宅治療を実行する複数の在宅治療装置と、接続サーバと、接続サーバを通して在宅治療装置に結合されたシステムハブと、システムハブにアクセスするように構成されたウェブポータルと、ウェブポータルを介してシステムハブに接続された複数の診療所と、ウェブポータルを介してアクセス可能なウェブサイトであって、複数の在宅治療装置を用いている患者にとって使用可能な患者部分を含み、さらに診療所が在宅治療装置を管理することを可能にする診療担当者部分を含むウェブサイトと、を備える。
[態様1]
患者に対して在宅治療を実行する複数の在宅治療装置(100)と、
接続サーバ(118)と、
前記接続サーバ(118)を通して前記在宅治療装置(100)に結合されたシステムハブ(120)と、
前記システムハブ(120)にアクセスするように構成されたウェブポータル(150)と、
前記ウェブポータル(150)を介して前記システムハブ(120)に接続された複数の診療所(152)と、
前記ウェブポータル(150)を介してアクセス可能なウェブサイトであって、前記複数の在宅治療装置(100)を用いて患者にとって使用可能な患者部分(800)を含み、さらに前記診療所(152)が前記在宅治療装置(100)を管理することを可能にする診療担当者部分(900)を含むウェブサイトと、
を備える在宅医用デバイスシステム(110)。
[態様2]
前記在宅治療が腎臓治療を含む、態様1に記載の在宅医用デバイスシステム(110)。
[態様3]
前記腎臓治療が、血液透析、腹膜透析、血液ろ過、血液透析ろ過又は持続的腎代替のうちの1つ又は幾つかを含む、態様2に記載の在宅医用デバイスシステム(110)。
[態様4]
前記在宅治療装置(100)が、
(i)血液透析装置、(ii)腹膜透析装置、(iii)血液ろ過装置、(iv)血液透析ろ過装置、(v)持続的腎代替装置、(vi)医用送達装置、又は(vii)栄養治療を実施する装置、
からなる群より選択される少なくとも1つのタイプのものである、態様1に記載の在宅医用デバイスシステム(110)。
[態様5]
各在宅治療装置(100)が、前記在宅治療装置(100)によって実行された処置を記録するログファイルを作成すると共に前記ログファイルを前記接続サーバ(118)を通して前記システムハブ(120)に送る、態様1に記載の在宅医用デバイスシステム(110)。
[態様6]
前記接続サーバ(118)が、対応する在宅治療装置(100)がオンになるまで前記診療所(152)からデータを受け取って記憶し、
その後で、前記データが、前記対応する在宅治療装置(100)に転送される、態様1に記載の在宅医用デバイスシステム(110)。
[態様7]
転送された前記データが新たなデバイスプログラムを含む場合に、前記対応する在宅治療装置(100)に関する患者が前記新たなデバイスプログラムが対応する在宅治療装置(100)によって実行される前に前記新たなデバイスプログラムを受け容れなければならないように構成されている、態様6に記載の在宅医用デバイスシステム(110)。
[態様8]
前記ウェブサイトの前記診療担当者部分(900)が、前記在宅治療装置(100)のうちの1つを動作させるために前記患者の居宅又は居所で必要となる補給品を指定するための治療処方指示画面(1000)を含む、態様1に記載の在宅医用デバイスシステム(110)。
[態様9]
前記ウェブサイトの前記診療担当者部分(900)が、前記在宅治療装置(100)のうちの1つを動作させるパラメータを設定するためのデバイスプログラム画面(1600、3400)を含む、態様1に記載の在宅医用デバイスシステム(110)。
[態様10]
前記デバイスプログラム画面(1600、3400)は、同じ在宅治療装置(100)と患者について異なるデバイスプログラムにおいて前記パラメータを異なる設定にすることが可能である、態様9に記載の在宅医用デバイスシステム(110)。
[態様11]
前記パラメータのうちの少なくとも1つが範囲として設定され、前記患者により、前記在宅治療装置(100)で動作させるために前記範囲内で選択可能とされている、態様9に記載の在宅医用デバイスシステム(110)。
[態様12]
前記デバイスプログラム画面(1600、3400)は、複数の前記パラメータに事前に選択した値を埋め込むためのテンプレートを呼び出すことを可能にする、態様9に記載の在宅医用デバイスシステム(110)。
[態様13]
前記ウェブサイトの前記診療担当者部分(900)が、診療担当者が少なくとも1つの処置表示の様子を設定することを可能にする患者設定値画面(1530、3500)を含む、態様1に記載の在宅医用デバイスシステム(110)。
[態様14]
前記ウェブサイトの前記診療担当者部分(900)が、
患者のリストと、
各患者に関連付けされている、処置中に事前定義の処置条件又はアラートが生じたかどうかを示す通知と、
を含む診療担当者ダッシュボード(1200、3000)、
を含む、態様1に記載の在宅医用デバイスシステム(110)。
[態様15]
前記ダッシュボード(1200、3000)が前記患者のリスト内の各患者を、
(i)前記患者に関する詳細な処置データを提供する処置概要、又は、
(ii)前記患者に関する履歴処置データを提供する患者スナップショット、
のうちの少なくとも一方に関連付ける、態様14に記載の在宅医用デバイスシステム(110)。
[態様16]
前記システムハブ(120)と通信する製品開発クライアント(128)を含み、前記製品開発クライアント(128)は、前記システムハブ(120)及び前記接続サーバ(118)を介して、前記在宅治療装置(100)にダウンロード可能なファームウェアアップグレードを提供することが可能である、態様1に記載の在宅医用デバイスシステム(110)。
[態様17]
前記システムハブ(120)と通信するサービス要員監督者(134)を含み、前記サービス要員監督者(134)は、前記複数の在宅治療装置(100)のうちの1つ又は幾つかに関する前記ファームウェアアップグレードを、承認を受ける在宅治療装置(100)に前記ファームウェアアップグレードがダウンロードされる前に承認することができる、態様16に記載の在宅医用デバイスシステム(110)。
[態様18]
前記システムハブ(120)と通信する少なくとも1人のサービス要員(132)を含み、各サービス要員(132)は、前記複数の在宅治療装置(100)のうちの少なくとも1つに対して専従であり、前記少なくとも1人のサービス要員(132)により、前記ファームウェアアップグレードを前記サービス要員監督者(134)による承認後にいつ前記少なくとも1つの専用の在宅治療装置(100)に送達させるか、を決定可能とされている、態様17に記載の在宅医用デバイスシステム(110)。
[態様19]
前記接続サーバ(118)が、
(i)パケット状のデータ内のすべてのデータが実際に送られたこと、又は、
(ii)データが適正な在宅治療装置(100)に送られたこと、
のうちの少なくとも一方のチェックを提供するように構成されている、態様1に記載の在宅医用デバイスシステム(110)。
[態様20]
治療装置(100)を個人別設定するための方法であって、
患者に対する一意の患者IDを作成するステップと、
前記患者に関する情報を作成するステップであり、前記情報が処方指示に基づく治療装置設定値を含む、当該ステップと、
前記患者ID及び第2の患者識別子を前記治療装置(100)に入力することによって前記治療装置(100)を前記患者にリンクさせるステップであり、前記情報が前記治療装置(100)に送られるようにさせるリンクさせるステップと、
を含む方法。
[態様21]
前記治療装置(100)が第2の治療装置であると共に、
診療所(152)内に第1の治療装置を設けるステップと、 前記第1の治療装置を動作させて前記診療所(152)において腎臓治療を実行するように患者を訓練するステップと、
前記第2の治療装置を前記患者の居宅又は居所に送るステップであって、前記リンクさせるステップが前記第2の治療装置を前記患者の居宅又は居所に送る前記ステップの後で行われている送るステップと、
をさらに含む、態様20に記載の方法。
[態様22]
第2の治療装置内に前記患者IDが診療担当者によって入力される、態様20に記載の方法。
[態様23]
前記治療装置(100)が第2の治療装置であると共に、前記リンクさせるステップが患者によって使用される第1の治療装置が機能不全となった後に実行される、態様20に記載の方法。
[態様24]
第2の患者IDが前記患者の生年月日である、態様20に記載の方法。
[態様25]
第2の治療装置が最初に前記治療装置設定値に従って動作する、態様20に記載の方法。
[態様26]
腎臓治療装置(100)を用いて患者の居宅又は居所において腎臓治療を実行するための方法であって、
腎臓治療に関する医師の処方指示を取り出すステップと、
前記医師の処方指示に基づいて、前記患者の居宅又は居所以外の第1の箇所において透析器を含む補給品を選択するステップと、
前記補給品及び前記腎臓治療装置(100)を前記患者の居宅又は居所に送るステップと、
を含む方法。
[態様27]
腎臓治療装置(100)を用いて患者の居宅又は居所において腎臓治療を実行するための方法であって、
腎臓治療に関する医師の処方指示を取り出すステップと、
前記医師の処方指示に基づいて、前記腎臓治療装置(100)を動作させるために前記患者の居宅又は居所以外の第1の箇所において設定値を選択するステップと、
前記設定値に従って前記患者に対して腎臓治療を実行するステップと、
を含む方法。
[態様28]
前記第1の箇所において前記腎臓治療装置(100)を動作させるための前記設定値を変更するステップと、
前記患者の居宅又は居所において前記変更した設定値に従って前記患者に対して腎臓治療を実行するステップと、
をさらに含む、態様27に記載の方法。
[態様29]
前記設定値が、パラメータと、前記パラメータに関する許容される値の範囲と、を含む、態様27に記載の方法。
[態様30]
前記設定値が前記パラメータに関する患者編集可能な設定値をさらに含み、且つ前記患者編集可能な設定値が有効である場合に前記患者により、前記パラメータに関する前記許容される値の範囲内で前記パラメータの前記値を変更可能とされている、態様29に記載の方法。
[態様31]
在宅治療装置(100)を動作させるための方法であって、
前記在宅治療装置(100)を用いて処置を実行するステップと、
前記処置に関係するログファイルを記憶するステップと、
システム通信を用いて前記ログファイルを接続サーバ(118)に送るステップと、
を含む方法。
[態様32]
前記在宅治療装置(100)を用いて前記処置を実行する前に、前記在宅治療装置(100)の更新された設定値に関して前記接続サーバ(118)に問合せするステップと、
更新された設定値が存在する場合に、前記更新された設定値をシステム通信を介して前記在宅治療装置(100)に送るステップと、
をさらに含む、態様31に記載の方法。
[態様33]
前記処置に関係する前記ログファイルを記憶した後で且つ前記ログファイルを前記接続サーバ(118)に送る前に少なくとも1つの事後処置動作を実行するステップ、
を含む、態様31に記載の方法。
[態様34]
在宅治療装置(100)に関するファームウェアをアップグレードする方法であって、
複数の在宅治療装置(100)に関してアップグレードされたファームウェアを作成するステップと、
前記複数の在宅治療装置(100)に関する前記アップグレードされたファームウェアを承認するステップと、
前記アップグレードされたファームウェアを第1の箇所にアップロードするステップと、 前記承認された在宅治療装置(100)のうちのどれが前記アップグレードされたファームウェアを受け取るべきかを決定するステップと、
前記アップグレードされたファームウェアを受け取るべきとされた各在宅治療装置(100)について、
(i)前記第1の箇所から前記アップグレードされたファームウェアを受け取るべきとされた各在宅治療装置(100)に関連付けされた接続サーバ(118)に前記アップグレードされたファームウェアをアップロードするサブステップと、
(ii)前記アップグレードされたファームウェアを前記アップグレードされたファームウェアを受け取るべきとされた各在宅治療装置(100)に送る時点を選択するサブステップと、
(iii)前記アップグレードされたファームウェアを前記選択された時点で前記接続サーバ(118)から前記アップグレードされたファームウェアを受け取るべきとされた各在宅治療装置(100)に送るサブステップと、
を含む方法。
[態様35]
前記アップグレードされたファームウェアを受け取る前記在宅治療装置(100)に関連付けされた各患者に前記アップグレードされたファームウェアをインストールするかどうかについてプロンプトを出すステップ、
を含む、態様34に記載の方法。
[態様36]
前記アップグレードされたファームウェアをインストールするかどうかについての前記アップグレードされたファームウェアを受け取る前記在宅治療装置(100)による決定を含む、態様34に記載の方法。
[態様37]
前記アップグレードされたファームウェアを受け取る前記在宅治療装置(100)に関連付けされた各患者に前記アップグレードされたファームウェアをインストールすることを承認するためのプロンプトを出すステップと、
前記アップグレードされたファームウェアが承認済みであるかどうかについての前記アップグレードされたファームウェアを受け取る前記在宅治療装置(100)による決定と、
を含む、態様34に記載の方法。
[態様38]
治療エントリ、変更及び報告の情報を表示するためのウェブサイトと、
前記ウェブサイトと患者に対して在宅治療を実行する複数の在宅治療装置(100)との間の情報の流れを管理するためのシステムハブ(120)と、
を備える治療エントリ、変更及び報告システム(110)であって、
前記ウェブサイトが、
前記在宅治療装置(100)のうちの1つを動作させるために前記患者の居宅又は居所で必要となる補給品を指定するための治療処方指示画面(1000)と、
前記在宅治療装置(100)のうちの1つが動作する際にパラメータを設定するためのデバイスプログラム画面(1600、3400)と、
患者のリストと、各患者に関連付けされている、処置中に事前定義の処置条件又はアラートが生じたかどうかを示す通知と、を有する診療担当者ダッシュボード(1200、3000)と、
を含む、治療エントリ、変更及び報告システム(110)。
[態様39]
前記デバイスプログラム画面(1600、3400)が第1のパラメータと第2のパラメータとを含み、且つ前記第2のパラメータに入力可能な値が前記第1のパラメータに入力された値に依存する、態様38に記載の治療エントリ、変更及び報告システム(110)。
[態様40]
前記デバイスプログラム画面(1600、3400)が第1のデバイスプログラム画面であると共に第2のデバイスプログラム画面を含み、前記第1のパラメータが前記第1のデバイスプログラム画面上に出現し且つ前記第2のパラメータが前記第2のデバイスプログラム画面上に出現するようにした、態様39に記載の治療エントリ、変更及び報告システム(110)。
[態様41]
前記第2のデバイスプログラム画面への診療担当者のアクセスが前記第1のデバイスプログラム画面上でパラメータに入力された値に依存する、態様40に記載の治療エントリ、変更及び報告システム(110)。
[態様42]
ユーザインターフェース(122)を有する在宅治療装置(100)によって使用される補給品を検証する方法であって、
在宅治療に関する医師の処方指示を取り出すステップと、
補給品を前記在宅治療装置(100)に接続するステップであり、前記補給品は自身に関する情報を示したコードを含む接続するステップと、
前記在宅治療装置(100)の前記ユーザインターフェース(122)を用いて前記コードを取得するステップと、
前記取得したコードから前記補給品に関する前記情報を決定するステップと、
前記補給品に関する前記決定された情報を前記処方指示と比較するステップと、
前記補給品に関する前記決定された情報が前記処方指示と適合する場合に在宅治療を実行するステップと、
を含む方法。
[態様43]
前記補給品が医薬品に関する容器を含み、前記処方指示が前記在宅治療で使用すべき前記医薬品の濃度を含み、且つ前記コードが前記容器内の前記医薬品の実際の濃度を示している、態様42に記載の方法。
[態様44]
前記補給品が透析器を含み、前記処方指示が透析器の種類を含み、且つ前記コードが透析器の前記種類を示している、態様42に記載の方法。
[態様45]
前記ユーザインターフェース(122)が前記在宅治療装置(100)とワイヤレスで通信する、態様42に記載の方法。
[態様46]
前記ユーザインターフェース(122)が前記コードを読み取るように動作可能なカメラ(136)を含む、態様42に記載の方法。
[態様47]
在宅治療装置(100)に対して、
前記在宅治療装置(100)上に記憶された複数の処方指示からのある処方指示の患者選択を可能にすることと、
前記選択した処方指示に従って前記在宅治療装置(100)を使用して処置を実行することと、
前記在宅治療装置(100)を消毒することと、
前記在宅治療装置(100)によって実行された前記処置を記録するログファイルを作成することと、
を行わせるように構築された命令を記憶するコンピュータ読み取り可能媒体。
[態様48]
前記命令が前記在宅治療装置(100)に対して、
前記ログファイルをシステムハブ(120)に送ることと、
(i)前記複数の処方指示から前記処方指示のうちの1つに関する更新、又は(ii)新たな処方指示のうちの少なくとも一方について前記システムハブ(120)に問合せすることと、
を行わせるようにさらに構築されている、態様47に記載のコンピュータ読み取り可能媒体。
[態様49]
前記命令が前記在宅治療装置(100)に対して、水処理デバイス(108)、重量計(106)、血圧測定用腕帯又はタブレット(122)のうちの少なくとも1つからデータを受け取らせるようにさらに構築されている、態様47に記載のコンピュータ読み取り可能媒体。
[態様50]
前記在宅治療装置(100)が前記重量計(106)、前記血圧測定用腕帯又は前記タブレット(122)のうちの少なくとも1つにワイヤレスで接続される、態様49に記載のコンピュータ読み取り可能媒体。
[態様51]
コンピューティングデバイス(192)に対して診療担当者による複数の在宅治療装置(100)の管理を可能にさせる診療担当者ユーザインターフェースを表示させるように構築された命令を記憶するコンピュータ読み取り可能媒体であって、前記診療担当者ユーザインターフェースが、
(i)前記在宅治療装置(100)のうちの1つが処置を実行させるパラメータを設定するためのデバイスプログラム画面(1600、3400)と、
(ii)診療担当者ダッシュボード(1200、3000)であって、 (a)患者のリストと、
(b)各患者に関連付けされている、処置中に事前定義の条件が生じたかどうかを示す通知と、
を含む診療担当者ダッシュボード(1200、3000)と、
を含む、コンピュータ読み取り可能媒体。
[態様52]
前記命令が前記コンピューティングデバイス(192)に対して、
前記デバイスプログラム画面(1600、3400)上で第1のパラメータに入力された第1の値を記憶することと、
前記第1の値に基づいて、第2の値を前記デバイスプログラム画面(1600、3400)上で第2のパラメータに入力することが可能であるかどうかを決定することと、
を行わせるようにさらに構築されている、態様51に記載のコンピュータ読み取り可能媒体。
[態様53]
前記命令が前記コンピューティングデバイス(192)に対して、前記デバイスプログラム画面(1600、3400)、前記在宅治療装置(100)のうちの1つに関する補給品を注文するための治療処方指示画面(1000)、患者に対して処置を出現させる方法を制御するための患者設定値画面(1530、3500)、又は前記在宅治療装置(100)上で処置を実行する方法以外の設定値を制御するためのシステム設定値画面(1570、3600)のうちの少なくとも1つに事前に選択した値を埋め込むために呼び出すことが可能なテンプレートを記憶させるようにさらに構築されている、態様51に記載のコンピュータ読み取り可能媒体。
[態様54]
前記命令が前記コンピューティングデバイス(192)に対して、
前記処置の間に生じる可能性がある処置事象をリストした規則画面(1750、3800)を表示することと、
前記規則画面(1750、3800)内に前記診療担当者が入力した前記処置事象に関連する条件を記憶することと、
前記条件に基づいて前記在宅治療装置(100)から受け取ったログファイルを評価して前記通知を作成することと、
を行わせるようにさらに構築されている、態様51に記載のコンピュータ読み取り可能媒体。
[態様55]
前記命令が前記コンピューティングデバイス(192)に対して、前記通知に関連付けされた前記条件を同じ診療担当者が検討したか異なる診療担当者が検討したかを示しているインジケータを表示させるようにさらに構築されている、態様51に記載のコンピュータ読み取り可能媒体。
Claims (20)
- 在宅治療装置の少なくとも1つのプロセッサによって実行される命令を記憶したコンピュータ読み取り可能媒体であって、
前記命令は、前記在宅治療装置に、
前記在宅治療装置の接続エージェントが起動状態とされたときにのみ、前記在宅治療装置に記憶される複数の装置プログラムを受信することであって、在宅治療の実行中に前記接続エージェントは非起動状態となる、当該受信することと、
前記複数の装置プログラムのうち一の装置プログラムに従って、前記在宅治療装置から提供された流体転送機を用いて前記在宅治療を実行することと、
前記在宅治療の実行中に生成されたデータを受信することと、
受信された前記データに基づいて、少なくとも1つのログファイルを生成することと、
前記在宅治療装置の前記接続エージェントが起動状態とされたときに、接続サーバからシステムハブへの転送のために、前記接続サーバへ前記少なくとも1つのログファイルを送信することと、
を行わせるように構築された命令であり、
前記接続エージェントが起動状態とされたときにのみ、前記接続エージェントは、前記在宅治療装置を前記接続サーバと通信可能とし、
前記接続エージェントは、前記在宅治療の実行中に前記在宅治療装置が前記接続サーバとの間でデータ送受信を行わないように、前記在宅治療の実行中は非起動状態とされ、
前記在宅治療の終了後は、前記少なくとも1つのプロセッサによって実行される命令が前記接続エージェントを起動状態とする、
コンピュータ読み取り可能媒体。 - 前記命令は、前記在宅治療装置に、
(i)前記複数の装置プログラムのうち少なくとも1つの装置プログラムに関する更新、および、(ii)新たな装置プログラム、のうちの少なくとも1つについてチェックすること、
を行わせるようにさらに構築されている、
請求項1に記載のコンピュータ読み取り可能媒体。 - 前記命令は、前記在宅治療装置に、
後続の治療を行う前に、前記少なくとも1つの装置プログラムに関する更新又は前記新たな装置プログラムを受け入れることを、患者に要求すること、
を行わせるようにさらに構築されている、
請求項2に記載のコンピュータ読み取り可能媒体。 - 前記命令は、
前記少なくとも1つのログファイルを送信する前に、前記在宅治療装置を消毒するように、さらに構築されている、
請求項2に記載のコンピュータ読み取り可能媒体。 - 前記在宅治療の実行中に生成され受信されたデータは、
水処理デバイス、重量計、血圧測定用腕帯、および、前記在宅治療装置に係るリモートユーザインターフェース、のうち少なくとも1つからのデータを含む、
請求項1に記載のコンピュータ読み取り可能媒体。 - 前記在宅治療装置は、前記重量計、前記血圧測定用腕帯、および、前記リモートユーザインターフェース、のうち少なくとも1つにワイヤレスで接続される、
請求項5に記載のコンピュータ読み取り可能媒体。 - 前記在宅治療装置は、
(i)血液透析装置、(ii)腹膜透析装置、(iii)血液ろ過装置、(iv)血液透析ろ過装置、(v)持続的腎代替装置、(vi)医用送達装置、又は、(vii)栄養治療を実施する装置である、
請求項1に記載のコンピュータ読み取り可能媒体。 - 在宅腎臓治療装置の少なくとも1つのプロセッサによって実行される命令を記憶したコンピュータ読み取り可能媒体であって、
前記命令は、前記在宅腎臓治療装置に、
前記在宅腎臓治療装置の接続エージェントが起動状態とされたときにのみ、前記在宅腎臓治療装置に記憶される複数の装置プログラムを受信することであって、在宅腎臓治療の実行中に前記接続エージェントは非起動状態となる、当該受信することと、
前記複数の装置プログラムのうち一の装置プログラムに従って、前記在宅腎臓治療装置から提供された流体転送機を用いて前記在宅腎臓治療を実行することと、
前記在宅腎臓治療の実行中に生成されたデータを受信することと、
受信された前記データに基づいて、少なくとも1つのログファイルを生成することと、
前記在宅腎臓治療装置の接続エージェントが起動状態とされたときに、接続サーバからシステムハブへの転送のために、前記接続サーバへ前記少なくとも1つのログファイルを送信することと、
を行わせるように構築された命令であり、
前記接続エージェントが起動状態とされたときにのみ、前記接続エージェントは、前記在宅腎臓治療装置を前記接続サーバと通信可能とし、
前記接続エージェントは、前記在宅腎臓治療の実行中に前記在宅腎臓治療装置が前記接続サーバとの間でデータ送受信を行わないように、前記在宅腎臓治療の実行中は非起動状態とされ、
前記在宅腎臓治療の終了後は、前記少なくとも1つのプロセッサによって実行される命令が前記接続エージェントを起動状態とする、
コンピュータ読み取り可能媒体。 - 前記命令は、前記在宅腎臓治療装置に、
(i)前記複数の装置プログラムのうち少なくとも1つの装置プログラムに関する更新、(ii)新たな装置プログラム、および、(iii)ファームウェアアップグレード、のうちの少なくとも1つについてチェックすること、
を行わせるようにさらに構築されている、
請求項8に記載のコンピュータ読み取り可能媒体。 - 前記命令は、前記在宅腎臓治療装置に、
後続の治療を行う前に、(i)前記少なくとも1つの装置プログラムに関する更新、(ii)前記新たな装置プログラム、又は、(iii)前記ファームウェアアップグレードを受け入れることを、患者に要求すること、
を行わせるようにさらに構築されている、
請求項9に記載のコンピュータ読み取り可能媒体。 - 前記在宅腎臓治療の実行中に生成され受信されたデータは、
水処理デバイス、重量計、血圧測定用腕帯、および、前記在宅腎臓治療装置に係るリモートユーザインターフェース、のうち少なくとも1つからのデータを含む、
請求項8に記載のコンピュータ読み取り可能媒体。 - 前記在宅腎臓治療装置は、前記重量計、前記血圧測定用腕帯、および、前記リモートユーザインターフェース、のうち少なくとも1つにワイヤレスで接続される、
請求項11に記載のコンピュータ読み取り可能媒体。 - 前記在宅腎臓治療装置は、(i)血液透析装置、(ii)腹膜透析装置、(iii)血液ろ過装置、(iv)血液透析ろ過装置、(v)持続的腎代替装置、(vi)医用送達装置、又は、(vii)栄養治療を実施する装置である、
請求項8に記載のコンピュータ読み取り可能媒体。 - 前記命令は、水処理デバイスから前記在宅腎臓治療装置へ送信されたデータに係る少なくとも1つのログファイルを前記接続サーバへ送信するようにさらに構築されている、
請求項8に記載のコンピュータ読み取り可能媒体。 - 前記命令は、前記在宅腎臓治療装置に、
前記少なくとも1つのログファイルを記憶した後に、事後処置動作および終了動作のうち少なくとも1つを行わせるようにさらに構築されている、
請求項8に記載のコンピュータ読み取り可能媒体。 - 在宅腎臓治療装置の少なくとも1つのプロセッサによって実行される命令を記憶したコンピュータ読み取り可能媒体であって、
前記命令は、前記在宅腎臓治療装置に、
前記在宅腎臓治療装置の接続エージェントが起動状態とされたときにのみ、前記在宅腎臓治療装置に記憶される複数の装置プログラムを受信することであって、在宅腎臓治療の実行中に前記接続エージェントは非起動状態となる、当該受信することと、
前記複数の装置プログラムのうち一の装置プログラムの少なくとも1つのパラメータの値を、許容範囲内での修正する機会を在宅腎臓治療患者のために提供することと、
修正された装置プログラムに従って、前記在宅腎臓治療装置から提供された流体転送機を用いて前記在宅腎臓治療を実行することと、
前記在宅腎臓治療の実行中に生成されたデータを受信することと、
受信された前記データに基づいて、少なくとも1つのログファイルを生成することと、
前記在宅腎臓治療装置の接続エージェントが起動状態とされたときに、目的のサーバへ前記少なくとも1つのログファイルを送信することと、
を行わせるように構築された命令であり、
前記接続エージェントが起動状態とされたときにのみ、前記接続エージェントは、前記在宅腎臓治療装置を前記目的のサーバと通信可能とし、
前記接続エージェントは、前記在宅腎臓治療の実行中に前記在宅腎臓治療装置が前記目的のサーバとの間でデータ送受信を行わないように、前記在宅腎臓治療の実行中は非起動状態とされ、
前記在宅腎臓治療の終了後は、前記少なくとも1つのプロセッサによって実行される命令が前記接続エージェントを起動状態とする、
コンピュータ読み取り可能媒体。 - 前記命令は、前記在宅腎臓治療装置に、
(i)前記複数の装置プログラムのうち少なくとも1つの装置プログラムに関する更新、および(ii)新たな装置プログラム、のうちの少なくとも1つについてチェックすること、
を行わせるようにさらに構築されている、
請求項16に記載のコンピュータ読み取り可能媒体。 - 前記命令は、前記在宅腎臓治療装置に、
前記少なくとも1つのログファイルを接続サーバ経由で前記目的のサーバへ送信させるように、さらに構築されている、
請求項17に記載のコンピュータ読み取り可能媒体。 - 前記命令は、前記在宅腎臓治療装置に、
後続の治療を行う前に、(i)少なくとも1つの装置プログラムに関する更新又は(ii)新たな装置プログラムを受け入れることを、患者に要求すること、
を行わせるようにさらに構築されている、
請求項16に記載のコンピュータ読み取り可能媒体。 - 前記在宅腎臓治療の実行中に生成され受信されたデータは、
水処理デバイス、重量計、血圧測定用腕帯、および、前記在宅腎臓治療装置に係るリモートユーザインターフェース、のうち少なくとも1つからのデータを含む、
請求項16に記載のコンピュータ読み取り可能媒体。
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