JP2014193377A - 動向および警告生成を有する透析システム - Google Patents
動向および警告生成を有する透析システム Download PDFInfo
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- JP2014193377A JP2014193377A JP2014100593A JP2014100593A JP2014193377A JP 2014193377 A JP2014193377 A JP 2014193377A JP 2014100593 A JP2014100593 A JP 2014100593A JP 2014100593 A JP2014100593 A JP 2014100593A JP 2014193377 A JP2014193377 A JP 2014193377A
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- removal
- peritoneal dialysis
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Abstract
【解決手段】透析システムは、アドレスまたは個人識別番号でコード化される無線インターフェース受信機を含む透析機104を備え、透析機が、アドレスまたは個人識別番号と共に、血圧モニタからの血圧データまたは体重計からの患者体重データを無線で受信し、透析機により実行される治療において限外濾過除去データを生成し、UF除去データと、血圧データまたは患者体重データをサーバ114に送信し、コード化されたアドレスまたは個人識別番号が血圧データまたは患者体重が他の透析機の受信機によるのではなく無線インターフェース受信機により受信されたことを保証する。
【選択図】図15A
Description
(項目1)
自動腹膜透析(「APD」)機(104、104a、104b)と、
前記APD機(104、104a、104b)と通信しているサーバコンピュータ(114、118)であって、前記サーバコンピュータ(114、118)およびAPD機(104、104a、104b)は、前記APD機(104、104a、104b)が患者限外濾過(「UF」)除去データを前記サーバコンピュータ(114、118)に送信することができるようにプログラムされ、医師/臨床医(110、120)が前記データを再検討し、必要であれば治療調整を行うために好適な移動平均UF除去動向を含む形態で、前記UF除去データを出力するようにプログラムされる、サーバコンピュータと
を備える、腹膜透析システム(10)。
(項目2)
前記形態は、毎日のUF除去動向を含む、項目1に記載の腹膜透析システム(10)。
(項目3)
前記毎日のUF除去動向は、UFの上限および下限のうちの少なくとも1つを含み、前記少なくとも1つの限度は、治療調整が必要であるかどうかを判定するために、前記動向UF除去データとともに使用される、項目2に記載の腹膜透析システム(10)。
(項目4)
前記APD機(104、104a、104b)は、警告条件が満たされた場合に警告を前記サーバコンピュータ(114、118)に送信するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度との前記日々のUF除去データの比較に少なくとも部分的に基づく、項目3に記載の腹膜透析システム(10)。
(項目5)
サーバコンピュータ(114、118)は、警告条件が満たされた場合に警告を生成するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度との前記日々のUF除去データの比較に少なくとも部分的に基づく、項目3に記載の腹膜透析システム(10)。
(項目6)
前記少なくとも1つの限度は、(i)因数およびUF範囲の積を(ii)所与の日にわたる移動UF除去平均に加算すること、または、減算することのいずれかによって決定される、項目3に記載の腹膜透析システム(10)。
(項目7)
前記サーバコンピュータ(114、118)および前記APD機(104、104a、104b)はさらに、前記APD機(104、104a、104b)が、血圧および患者体重データのうちの少なくとも1つを前記サーバコンピュータ(114、118)に送信することができるように構成される、項目1に記載の腹膜透析システム(10)。
(項目8)
論理インプリメンタ(94、104、112、114、118)とともに動作可能な無線インターフェース受信機(122)を含み、計量器(126)および血圧モニタ(124)のうちの少なくとも1つは、無線インターフェース伝送器を含み、前記血圧および患者体重データのうちの少なくとも1つは、前記計量器(126)および前記血圧モニタ(124)のうちの少なくとも1つから、前記無線インターフェース受信機(122)に無線で送信される、項目7に記載の腹膜透析システム(10)。
(項目9)
前記移動平均UF除去動向は、毎日、5日、7日、30日、または、90日の動向である、項目1に記載の腹膜透析システム(10)。
(項目10)
前記動向は、UFの上限および下限のうちの少なくとも1つを含み、前記少なくとも1つの限度は、治療調整が必要であるかどうかを判定するために、前記移動平均UF除去動向とともに使用される、項目1に記載の腹膜透析システム(10)。
(項目11)
前記APD機(104、104a、104b)は、警告条件が満たされた場合に警告を前記サーバコンピュータ(114、118)に送信するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度との前記移動平均UF除去動向の比較に少なくとも部分的に基づく、項目10に記載の腹膜透析システム(10)。
(項目12)
サーバコンピュータ(114、118)は、警告条件が満たされた場合に警告を生成するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度との前記移動平均UF除去動向の比較に少なくとも部分的に基づく、項目10に記載の腹膜透析システム(10)。
(項目13)
前記移動平均UF除去動向は、第1の動向であり、前記少なくとも1つの限度は、(i)因数およびUF範囲の積を(ii)第2の移動平均動向に加算すること、または、減算することのいずれかによって決定される、項目10に記載の腹膜透析システム(10)。
(項目14)
前記第2の移動平均動向は、前記第1の移動平均動向よりも長い持続時間である、項目13に記載の腹膜透析システム(10)。
(項目15)
自動腹膜透析(「APD」)機(104、104a、104b)と、
前記APD機(104、104a、104b)と通信しているサーバコンピュータ(114、118)であって、前記サーバコンピュータ(114、118)および前記APD機(104、104a、104b)は、治療調整が行われる必要があるかどうかを判定するために医師/臨床医(110、120)が使用することができる、腹膜透析データ動向を生成するようにプログラムされ、前記腹膜透析データ動向は、移動平均UF除去動向を含む、サーバコンピュータと
を備える、腹膜透析システム(10)。
(項目16)
前記腹膜透析動向データは、(i)限外濾過液除去データ、(ii)血圧データ、および(iii)患者体重データから成る群より選択される種類である、項目15に記載の腹膜透析システム(10)。
(項目17)
前記APD機(104、104a、104b)は、前記動向について前記データを収集/生成するようにプログラムされ、前記サーバコンピュータ(114、118)は、前記データの前記動向を生成するようにプログラムされる、項目15に記載の腹膜透析システム(10)。
(項目18)
前記APD機(104、104a、104b)は、前記動向について前記データを収集/生成し、前記データの前記動向を生成するようにプログラムされる、項目15に記載の腹膜透析システム(10)。
(項目19)
前記APD機(104、104a、104b)はさらに、治療調整が行われる必要がある可能性が高いと前記データ動向が示すときに、警告を前記サーバコンピュータ(114、118)に送信するようにさらに構成される、項目18に記載の腹膜透析システム(10)。
(項目20)
前記治療調整は、(i)透析液の種類の変更、(ii)透析液のデキストロース濃度の変更、(iii)治療時間の変更、(iv)充填容量の変更、(v)夜間充填交換の数の変更、および(vi)日中変更が行われるか否かから成る群より選択される種類である、項目15に記載の腹膜透析システム(10)。
(項目21)
患者(102、102a、102b)から限外濾過液(「UF」)を除去し、どれだけ多くのUFが除去されたかを記録するように構成される、自動腹膜透析(「APD」)機(104、104a、104b)と、
(i)第1の移動平均UF除去動向を形成し、(ii)前記第1の移動平均UF除去動向の周囲の動向範囲を判定し、(iii)前記動向範囲からUF除去の上限および下限のうちの少なくとも1つを判定し、(iv)第2の移動平均UF除去動向を形成し、(v)第2の移動平均UF除去動向が少なくとも1つの除去UF限度の外側に移動した場合に警告するように構成される、論理インプリメンタ(94、104、112、114、118)と
を備える、腹膜透析システム(10)。
(項目22)
前記論理インプリメンタ(94、104、112、114、118)は、前記APD機(104、104a、104b)および前記APD機(104、104a、104b)と通信しているサーバコンピュータ(114、118)のうちの1つに格納される、項目21に記載の腹膜透析システム(10)。
(項目23)
前記第1の移動平均UF除去動向は、前記第2の移動平均UF除去動向よりも長い持続時間である、項目21に記載の腹膜透析システム(10)。
(項目24)
前記上限は、前記動向範囲を乗じた因数を、前記第1の移動平均UF除去動向に加算することによって形成され、前記下限は、前記動向範囲を乗じた前記因数を、前記第1の移動平均UF除去動向に減算することによって形成される、項目21に記載の腹膜透析システム(10)。
(項目25)
前記警告は、(i)前記UF除去動向が、ある連続日数にわたって前記少なくとも1つのUF除去限度の外側に移動した場合、または(ii)前記UF除去動向が、前記少なくとも1つのUF除去限度の外側に移動し、前記患者の血圧が、限度を上回って上昇した場合に提供される、項目21に記載の腹膜透析システム(10)。
ここで図2Aを参照すると、腹膜血管からの断面図が血管の3つの細孔を図示する。3つの細孔はそれぞれ、3細孔モデルと呼ばれる1つの動力学モデルにつながる、各自の毒素およびUFクリアランスを有する。3細孔モデルは、溶液除去、体液移行、治療変数、および生理学的特性の時間的経過の間の関係を表し、相関し、予測する、数学的モデルである。3細孔モデルは、本開示の出願人によって市販されている、Dianeal(R)、Physioneal(R)、Nutrineal(R)、およびExtraneal(R)透析液等の、異なる種類の透析液に使用することができる予測モデルである。
式中、
VDは、腹水容量であり、
JVCは、図2Aに示された細胞間細孔またはアクアポリンを通る流体の流量であり、
JVSは、図2Aに示された小孔を通る流体の流量であり、
JVLは、図2Aに示された大孔を通る流体の流量であり、
Lは、腹膜リンパ流である。
あるAPDデバイスは、充填および排出流体容量を非常に正確に測定できることが分かっている。例えば、本開示の出願人によって提供されるHomeChoice(R)/HomeChoicePRO(R)APD機は、1%または+/−10mLの総充填および排出容量精度を報告している。複数の交換サイクルを採用するAPD機は、主要動力学パラメータを推定するために必要なデータ点を増加させ、同時に、患者の残存溶液容量による誤差を導入する可能性を低減する。したがって、小溶質(または毒素)の現在の良好な予測を維持または改善しながら、UF予測精度を改善させるために、新規PETが提案される。
(身体コンパートメント)
拡散物質移動速度は、物質移動面積係数KPAおよび濃縮物勾配(CB−CD)の積である。KPAは順に、溶質膜透過性(p)および移動面積(A)の積に等しい。対流物質移動速度は、正味水除去(UF)率QU、溶質ふるい係数s、および平均膜溶質濃度
(透析液容量)
式中、(i)VD lは、注入直後の透析液容量(mL)であり、(ii)LPA’は、透水率輸送速度(mL/分/mmol/L)であり、(iii)Ki *は、第i溶質の物質移動面積係数の値(mL/分)マイナス1.5QL 0であり、(iv)siは、第i溶質のふるい係数、(v)CD,i lは、注入直後の第i溶質の透析液濃度(mmol/L)であり、(vi)CB,i lは、注入直後の第i溶質の血液濃度(mmol/L)であり、(vii)tは、時間(分)であり、(viii)QL 0は、リンパ系吸収(ml/分)である。したがって、UFは、注入容量、溶液濃度、および滞留時間を知る上記の方程式から計算することができる。上記の方程式は、すべて、最初は、Pyle−Popovich2プールモデル(Vonesh et al,1991)に基づいており、その後、Vonesh et al(1999)によって修正されて、3細孔モデルの主要な局面を組み込み、修正された2プールモデルをもたらし、これは、修正された3細孔モデル(Vonesh et al,1999)とも称される。以後、2プールモデルまたは3細孔モデルに対するすべての言及は、Vonesh et al(1999)によって記載されている修正されたモデルを意味する。
(自動投薬計画生成)
図1で見られるように、本システム10は、治療投薬計画生成モジュール14を含む。投薬計画生成モジュール14は、複数の予測アルゴリズムを含む。予測アルゴリズムは、投薬計画を生成するために、PET12からの上記の計算された患者輸送およびUF特性、標的情報、および他の治療入力情報を使用する。投薬計画生成モジュール14は、一実施形態では、治療入力情報と、計算された患者輸送およびUF特性とを使用して、入力された標的要件を満たす可能な治療投薬計画の全てを生成する。生成される投薬計画は、以下で示されるように多数である。次いで、処方生成モジュール16が、モジュール14において生成された投薬計画をフィルタにかけ、特定の患者に対してAPD機上で行うことができる、有限数の最適化された処方を生じる。
既述のように、表3は、1.5%夜間デキストロース濃度で可能な270個の有効な組み合わせのうちの10個を図示する。同じ270個の組み合わせはまた、2%デキストロース濃度、2.5%等の夜間デキストロース濃度にも存在する。日中充填が追加されると、等しい数の有効な組み合わせが、それぞれの可能なデキストロース濃度について作成される。さらに、さらに多くの有効な組み合わせを作成するように、最後の充填滞留時間を変動させることができる。
(処方フィルタリング)
上記で示されるように、システム10は、医師/臨床医が、患者充填容量、総治療容量、総治療時間等の臨床標的および治療入力の値を処方することを可能にし、臨床要件の全てを満たす全ての治療を含有する、表3等の表を生成する。次いで、臨床要件の全てを満たす治療の表を、自動的にフィルタにかけ、総夜間治療時間、治療溶液費用、治療重量等のパラメータに基づいて並べ替えることができる。
ここで図10から13を参照すると、システム10の在庫追跡サブシステムまたはモジュール18の一実施形態が図示されている。本明細書で論議されるように、システム10は、図8Aから8Cに関連して示されるような、高UF、標準UF、および低UF処方等の合意した処方を生成する。異なる処方が、図10で見られるように、異なる溶液を必要とする。図10は、標準UF処方が12リットルの1.5%Dianeal(R)透析液および2リットルのExtraneal(R)透析液を使用することを示す。高UF処方は、(使用される代替透析に応じて)15から18リットルの1.5%Dianeal(R)透析液および2リットルのExtraneal(R)透析液を使用する。低UF処方は、12リットルの1.5%Dianeal(R)透析液および3リットルの2.5%Dianeal(R)透析液を使用する。
図5で上記に示されるように、システム10は、利用可能な異なるブランドまたは種類の透析液のそれぞれに、複数の異なるデキストロース濃度を使用することを検討し、それは、患者に対する処方を最適化する際に医師/臨床医の選択肢を増加させる。デキストロースによるトレードオフは概して、より高濃度のデキストロースがより多くのUFを除去するが、より高いカロリー入力を有し、患者の体重制御をより困難にすることである。逆もまた真実である。透析液(少なくともある種類)は、0.5%、1.5%、2.5%、および4.25%を含む、異なる標準デキストロース濃度で提供される。図6で見られるように、夜間デキストロース、最後の充填のデキストロース、および日中デキストロースは、上記の標準割合のうちのいずれかを有するように、あるいは2.0%、2.88%、3.38%、または3.81%の混成デキストロース濃度を有するように選択することができる。システム10は、標準割合を混合して混成割合を作成するために、透析器具104を使用する。標準デキストロース濃度透析液のそれぞれがFederal Drug Administration (「FDA」)によって承認されており、混成デキストロース濃度が承認濃度以内であるため、そのような混合はFDA承認に容易に合うと考えられる。
表4に示された1:1または1:3混合を使用することにより、より多くのデキストロース溶液を生成し、臨床医にとってより多くの治療選択肢を提供する。同時に、これらの混合比は、容器の中の溶液を全て使用し、無駄を生じない。
ここで図15Aを参照すると、ネットワーク100aは、患者102、医師110、および透析センター120の間で、PET、投薬計画生成、処方フィルタリング、在庫追跡、動向、および処方修正情報(以下)を伝達するための1つの無線ネットワークまたは通信モジュール20(図1)を図示する。ここで、患者102は、モデム108aと有線通信しているルータ106aと無線通信する、透析器具104を操作する。医師110は、モデム108bと有線通信しているルータ106bと無線通信する、医師の(または看護師の)コンピュータ112a(医師のネットワークサーバに接続することもできる)を操作する。透析センター120は、モデム108cと有線通信しているルータ106cと無線通信する、臨床医のネットワークサーバ114に接続される、複数の臨床医のコンピュータ112bから112dを含む。モデム108aから108cは、インターネット116、広域ネットワーク(「WAN」)、またはローカルエリアネットワーク(「LAN」)を介して相互と通信する。
PETモジュール12、投薬計画生成モジュール14、および処方最適化またはフィルタリングモジュール16は、透析治療を実行するためにネットワーク100(ここでは加えてネットワーク100cおよび100dを指す)が使用するデータを出力する。この点で、システム10のネットワーク114および118は、すでに行われた分析からの結果を使用する。ネットワーク100cで見られるように、システム10はまた、追跡および分析のために(センター120の)サーバ114または118に供給される、リアルタイムの日々の患者データも生成する。このリアルタイムデータは、治療パラメータ入力および治療標的入力とともに、システム10のデータ収集モジュール22(図1)を構成する。
本明細書で見られるようなシステム10の動向分析および統計モジュール24(図1)は、以下で示される日々のUFの短期および長期移動平均ならびに他の患者データを計算する。実際の測定された日々のUFを監視することだけでは、透析器具104の残留量および測定誤差による雑音を過度に生じる。したがって、モジュールまたは特徴24の動向体制は、日々のデータ、ならびに1つ以上の期間にわたって平均化されるデータを見て動向化する。
動向モジュール24は、一実施形態では、短期および長期移動平均を形成するために、以下の方程式を使用する:UFma(n)=1/k*(UF(n)+UF(n−1)+UF(n−2)・・・+UF(n−k))。短期移動平均については、kの典型的な値は、例えば、7日等の3〜14日となり得る。長期移動平均については、kの典型的な値は、28日等の15〜45日となり得る。
ΔUF=UFtarget-UFma
UFtargetは、医師が処方したUFであり、UFmaは、測定された実際の日々のUFの移動平均値である(日々の測定値または短期移動平均については2〜3日)。ΔUFは、正または負となり得る。ΔUF/UFtargetの絶対値が医師によって事前設定された条件閾値を超えると、システム10は、(機械104レベルで、またはサーバ114/118を介して)患者および医師110および/または臨床医120に警告し、それは、以下で論議されるように、処方調整または他の反応を誘起することができる。
δ(生成された警告)=|△UF/UFtarget|>Y日間でX%
X%は、医師または臨床医によって事前設定することができ、典型的な値は、30〜50パーセントであってもよい。Yもまた、医師または臨床医によって事前設定することができ、典型的な値は、3〜7日であってもよい。
P%は、医師または臨床医によって事前設定することができ、典型的な値は、150%から250%であってもよい。Qもまた、医師または臨床医によって事前設定することができ、典型的な値は、2〜3日であってもよい。上記の方程式は、日々の測定UFと標的UFとの間の差異を計算し、割合の誤差を判定するように、標的UFの割合として差異を表す。次いで、誤差の割合が、数日、例えば、2〜3(Q)日にわたって累積される。累積誤差が閾値(P%)を超える場合、システム10は、UF警告を生成する。以下の実施例は、上記のアルゴリズムを例証する。
P=150%、Q=3日
第1日に、患者が治療を飛ばし、UF誤差=100%であり、第2日に、患者が治療を飛ばし、UF誤差=100%であり、第3日に、患者が治療を行い、UF誤差=10%であり、累積UF誤差=210%>150%であると、警告を生成する。
P=150%、Q=3日
第1日に、患者が治療を飛ばし、UF誤差=100%であり、第2日に、患者が治療を行い、UF誤差=20%であり、第3日に、患者が治療を行い、UF誤差=10%であり、累積UF誤差=130%<150%であると、警告は生成されない。
ΔBW=BWm−BWtarget>Yw日間のXwであって、式中、
BWmは、測定された日々の体重であり、BWtargetは、標的体重(医師110または臨床医120によって設定される)であり、Xwは、標的を超える体重の限度(医師110または臨床医120によって設定される)であり、Ywは、日数(医師110または臨床医120によって設定される)である。
患者Aは、ちょうど2ヶ月前に腹膜透析治療を開始し、依然として残存腎機能(「RRF」)を有する。患者のUF標的は、800mL/日である。医師は、日々のUF偏差、UF偏差累積、および標的体重を見るように、警告観察を設定した。ここで、偏差限度Xは、7日間のうち4日間に等しい期間Yで30%に選択された。3日間のUF偏差の累積誤差は、150%に選択された。標的体重は、7日間で+5ポンドの安全限度差分を伴って、240ポンドに選択された。以下の表は、7日間の期間にわたる測定された日々の24時間UF、BP、およびBWの例である。
患者Aについて上記で示された治療の週では、木曜の日々のUFのみが、30%下限閾値を下回る。3日間の累積UF偏差は、150%を超えない。患者の体重は、最後の2日以外の全てで限度以下(+5ポンド)にとどまる。ここでは、システム10は警告を生成しない。
患者Bについて上記で示された治療の週では、日々の24時間UF値のうちのいずれも、20%下限閾値を下回らない。3日間の累積UF偏差は、いずれの日にも150%を超えない。患者の体重は、+5ポンドの閾値を決して超えない。したがって、システム10は、この週に動向警告を生成しない。
患者Cについて上記で示された治療の週では、患者の日々のUFは、ハイライトされているように、月曜、木曜、金曜、および土曜に25%下限閾値を下回った。3日間の累積UF偏差は、土曜の治療後に150%限度を超えた。患者の体重も、4回、すなわち、月曜、木曜、金曜、および土曜に、+5ポンドの体重限度を超える。したがって、システム10は、この週の後に動向警告を送信する。
また、不安定性および異常な状況を識別するために、統計的過程制御(「SPC」)を使用することも検討される。ここで図26を参照すると、5日間の平均UF(ドット)および過去30日間の平均UF(基準中央線)を示す、1つの移動平均または動向例が示されている。範囲は、過去30日間にわたる最低および最高UF値の間の差異となるように計算される。所与の日の上部管理限界線(「UCL」、それを通してXを伴う線)は、UCL=(所与の日の移動平均)+(定数、例えば、0.577、*所与の日の範囲)となるように計算され、下部管理限界線(「LCL」、それを通して/を伴う線)は、LCL=(所与の日の動平均)−(定数、例えば、0.577、*所与の日の範囲)となるように計算される。
システム10はまた、図1に関連して示され、説明される、処方呼び戻しおよび修正特徴26も含む。ここで図28を参照すると、処方呼び戻しおよび調整特徴またはモジュール26が、より詳細に図示されている。処方呼び戻しおよび調整特徴またはモジュール26は、改良型PET特徴12、投薬計画生成特徴14、処方フィルタリング特徴16、および動向警告生成特徴24等の、システム10の他の特徴に依存し、かつそれらと連動する。図28で見られるように、処方呼び戻しおよび調整特徴またはモジュール26の一側面は、治療のための承認された処方のうちの1つの選択である。
(項目1)
自動腹膜透析(「APD」)機と、
上記APD機と通信しているサーバコンピュータであって、上記サーバコンピュータおよびAPD機は、上記APD機が患者限外濾過(「UF」)除去データを上記サーバコンピュータに送信することができるようにプログラムされ、医師/臨床医が上記データを再検討し、必要であれば治療調整を行うために好適な形態で、上記UF除去データを出力するようにプログラムされる、サーバコンピュータと
を備える、腹膜透析システム。
(項目2)
上記形態は、毎日のUF除去動向を含む、項目1に記載の腹膜透析システム。
(項目3)
上記動向は、UFの上限および下限のうちの少なくとも1つを含み、上記少なくとも1つの限度は、治療調整が必要であるかどうかを判定するために、上記動向UF除去データとともに使用される、項目2に記載の腹膜透析システム。
(項目4)
上記APD機は、警告条件が満たされた場合に警告を上記サーバコンピュータに送信するようにプログラムされ、上記警告条件は、上記少なくとも1つの限度との上記日々のUF除去データの比較に少なくとも部分的に基づく、項目3に記載の腹膜透析システム。
(項目5)
サーバコンピュータは、警告条件が満たされた場合に警告を生成するようにプログラムされ、上記警告条件は、上記少なくとも1つの限度との上記日々のUF除去データの比較に少なくとも部分的に基づく、項目3に記載の腹膜透析システム。
(項目6)
上記少なくとも1つの限度は、予期された日々のUF除去量を乗じた因数である、項目3に記載の腹膜透析システム。
(項目7)
上記サーバコンピュータおよび上記APD機はさらに、上記APD機が、血圧および患者体重データのうちの少なくとも1つを上記サーバコンピュータに送信することができるように構成される、項目1に記載の腹膜透析システム。
(項目8)
論理インプリメンタとともに動作可能な無線インターフェース受信機を含み、計量器および血圧モニタのうちの少なくとも1つは、無線インターフェース伝送器を含み、上記血圧および患者体重データのうちの少なくとも1つは、上記計量器および上記血圧モニタのうちの少なくとも1つから、上記無線インターフェース受信機に無線で送信される、項目7に記載の腹膜透析システム。
(項目9)
上記UF除去データ形態は、移動平均UF除去動向を含む、項目1に記載の腹膜透析システム。
(項目10)
上記動向は、UFの上限および下限のうちの少なくとも1つを含み、上記少なくとも1つの限度は、治療調整が必要であるかどうかを判定するために、上記移動平均UF除去動向とともに使用される、項目9に記載の腹膜透析システム。
(項目11)
上記APD機は、警告条件が満たされた場合に警告を上記サーバコンピュータに送信するようにプログラムされ、上記警告条件は、上記少なくとも1つの限度との上記移動平均UF除去動向の比較に少なくとも部分的に基づく、項目10に記載の腹膜透析システム。
(項目12)
サーバコンピュータは、警告条件が満たされた場合に警告を生成するようにプログラムされ、上記警告条件は、上記少なくとも1つの限度との上記移動平均UF除去動向の比較に少なくとも部分的に基づく、項目10に記載の腹膜透析システム。
(項目13)
上記移動平均UF除去動向は、第1の動向であり、上記少なくとも1つの限度は、第2の移動平均動向を乗じた因数である、項目10に記載の腹膜透析システム。
(項目14)
上記第2の移動平均動向は、上記第1の移動平均動向よりも長い持続時間である、項目13に記載の腹膜透析システム。
(項目15)
自動腹膜透析(「APD」)機と、
上記APD機と通信しているサーバコンピュータであって、上記サーバコンピュータおよび上記APD機は、治療調整が行われる必要があるかどうかを判定するために医師/臨床医が使用することができる、腹膜透析データ動向を生成するようにプログラムされる、サーバコンピュータと
を備える、腹膜透析システム。
(項目16)
上記腹膜透析動向データは、(i)限外濾過液除去データ、(ii)血圧データ、および(iii)患者体重データから成る群より選択される種類である、項目15に記載の腹膜透析システム。
(項目17)
上記APD機は、上記動向について上記データを収集/生成するようにプログラムされ、上記サーバコンピュータは、上記データの上記動向を生成するようにプログラムされる、項目15に記載の腹膜透析システム。
(項目18)
上記APD機は、上記動向について上記データを収集/生成し、上記データの上記動向を生成するようにプログラムされる、項目15に記載の腹膜透析システム。
(項目19)
上記APD機はさらに、治療調整が行われる必要がある可能性が高いと上記データ動向が示すときに、警告を上記サーバコンピュータに送信するようにさらに構成される、項目18に記載の腹膜透析システム。
(項目20)
上記治療調整は、(i)透析液の種類の変更、(ii)透析液のデキストロース濃度の変更、(iii)治療時間の変更、(iv)充填容量の変更、(v)夜間充填交換の数の変更、および(vi)日中変更が行われるか否かから成る群より選択される種類である、項目15に記載の腹膜透析システム。
(項目21)
患者から限外濾過液(「UF」)を除去し、どれだけ多くのUFが除去されたかを記録するように構成される、自動腹膜透析(「APD」)機と、
(i)第1の移動平均UF除去動向を形成し、(ii)上記第1の移動平均UF除去動向の周囲の動向範囲を判定し、(iii)上記動向範囲からUF除去の上限および下限のうちの少なくとも1つを判定し、(iv)第2の移動平均UF除去動向を形成し、(v)第2の移動平均UF除去動向が少なくとも1つの除去UF限度の外側に移動した場合に警告するように構成される、論理インプリメンタと
を備える、腹膜透析システム。
(項目22)
上記論理インプリメンタは、上記APD機および上記APD機と通信しているサーバコンピュータのうちの1つに格納される、項目21に記載の腹膜透析システム。
(項目23)
上記第1の移動平均UF除去動向は、上記第2の移動平均UF除去動向よりも長い持続時間である、項目21に記載の腹膜透析システム。
(項目24)
上記上限は、上記動向範囲を乗じた因数を、上記第1の移動平均UF除去動向に加算することによって形成され、上記下限は、上記動向範囲を乗じた上記因数を、上記第1の移動平均UF除去動向に減算することによって形成される、項目21に記載の腹膜透析システム。
(項目25)
上記警告は、(i)上記UF除去動向が、ある連続日数にわたって上記少なくとも1つのUF除去限度の外側に移動した場合、または(ii)上記UF除去動向が、上記少なくとも1つのUF除去限度の外側に移動し、上記患者の血圧が、限度を上回って上昇した場合に提供される、項目21に記載の腹膜透析システム。
Claims (25)
- 無線インターフェース受信機(122)を含む自動腹膜透析(「APD」)機(104、104a、104b)と、
前記APD機(104、104a、104b)と通信しているサーバコンピュータ(114、118)であって、前記サーバコンピュータ(114、118)およびAPD機(104、104a、104b)は、前記APD機(104、104a、104b)が患者限外濾過(「UF」)除去データを前記サーバコンピュータ(114、118)に送信することができるようにプログラムされ、前記サーバコンピュータ(114、118)は、医師/臨床医(110、120)が前記データを再検討し、必要であれば治療調整を行うために好適な移動平均UF除去動向を含む形態で、前記UF除去データを出力するようにプログラムされる、サーバコンピュータ(114、118)と、 患者の体重計(126)または血圧モニタ(124)のうちの少なくとも1つであって、無線インターフェース伝送器を含み、前記患者の体重計および/または前記血圧モニタは、患者の血圧データおよび/または患者の体重データをそれぞれ前記無線インターフェース受信機に無線で送信するように動作可能である、患者の体重計(126)または血圧モニタ(124)のうちの少なくとも1つと
を備える、腹膜透析システム(10)。 - 前記動向は、毎日のUF除去動向を含む、請求項1に記載の腹膜透析システム(10)。
- 前記毎日のUF除去動向は、UFの上限および下限のうちの少なくとも1つの限度を含み、前記少なくとも1つの限度は、治療調整が必要であるかどうかを決定するために、動向UF除去データとともに使用される、請求項2に記載の腹膜透析システム(10)。
- 前記APD機(104、104a、104b)は、警告条件が満たされた場合に警告を前記サーバコンピュータ(114、118)に送信するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度と、毎日のUF除去データとの比較に少なくとも部分的に基づく、請求項3に記載の腹膜透析システム(10)。
- 前記サーバコンピュータ(114、118)は、警告条件が満たされた場合に警告を生成するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度と、毎日のUF除去データとの比較に少なくとも部分的に基づく、請求項3に記載の腹膜透析システム(10)。
- 前記少なくとも1つの限度は、(i)因数およびUF範囲の積を(ii)所与の日にわたる移動UF除去平均に対して加算または減算することのいずれかによって決定される、請求項3に記載の腹膜透析システム(10)。
- 前記サーバコンピュータ(114、118)および前記APD機(104、104a、104b)は、前記APD機(104、104a、104b)が、前記血圧または前記患者体重データのうちの少なくとも1つを前記サーバコンピュータ(114、118)に送信することができるようにさらに構成される、請求項1に記載の腹膜透析システム(10)。
- 前記APD機(104、104a、104b)は、(a)アドレス、および(b)個人識別番号のうちの少なくとも1つを含み、前記無線インターフェース伝送器は、(a)前記アドレス、および(b)前記個人識別番号のうちの少なくとも1つを前記無線インターフェース受信機(122)に送信するように動作可能である、請求項7に記載の腹膜透析システム(10)。
- 前記移動平均UF除去動向は、毎日、5日、7日、30日、または、90日の動向である、請求項1に記載の腹膜透析システム(10)。
- 前記動向は、UFの上限および下限のうちの少なくとも1つの限度を含み、前記少なくとも1つの限度は、治療調整が必要であるかどうかを決定するために、前記移動平均UF除去動向とともに使用される、請求項1に記載の腹膜透析システム(10)。
- 前記APD機(104、104a、104b)は、警告条件が満たされた場合に警告を前記サーバコンピュータ(114、118)に送信するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度と、前記移動平均UF除去動向との比較に少なくとも部分的に基づく、請求項10に記載の腹膜透析システム(10)。
- サーバコンピュータ(114、118)は、警告条件が満たされた場合に警告を生成するようにプログラムされ、前記警告条件は、前記少なくとも1つの限度と、前記移動平均UF除去動向との比較に少なくとも部分的に基づく、請求項10に記載の腹膜透析システム(10)。
- 前記移動平均UF除去動向は、第1の動向であり、前記少なくとも1つの限度は、(i)因数およびUF範囲の積を(ii)第2の移動平均動向に対して加算または減算することのいずれかによって決定される、請求項10に記載の腹膜透析システム(10)。
- 前記第2の移動平均動向は、第1の移動平均動向よりも長い持続時間である、請求項13に記載の腹膜透析システム(10)。
- 自動腹膜透析(「APD」)機(104、104a、104b)と、
前記APD機(104、104a、104b)と通信しているサーバコンピュータ(114、118)であって、前記サーバコンピュータ(114、118)および前記APD機(104、104a、104b)は、
(i)治療調整が行われる必要があるかどうかを決定するために医師/臨床医(110、120)が使用することができる腹膜透析データ動向を生成することであって、前記腹膜透析データ動向は、移動平均UF除去動向を含む、ことと、
(ii)前記データ動向から異常データをフィルタにかけることと
を行うようにプログラムされる、サーバコンピュータ(114、118)と
を備える、腹膜透析システム(10)。 - 前記腹膜透析データ動向は、(i)限外濾過液除去データ、(ii)血圧データ、および(iii)患者体重データから成る群より選択される種類のデータである、請求項15に記載の腹膜透析システム(10)。
- 前記APD機(104、104a、104b)は、前記動向について前記データを収集/生成するようにプログラムされ、前記サーバコンピュータ(114、118)は、前記データの前記動向を生成するようにプログラムされる、請求項15に記載の腹膜透析システム(10)。
- 前記APD機(104、104a、104b)は、前記動向について前記データを収集/生成し、前記データの前記動向を生成するようにプログラムされる、請求項15に記載の腹膜透析システム(10)。
- 前記APD機(104、104a、104b)は、治療調整が行われる必要がある可能性が高いと前記データ動向が示すときに、警告を前記サーバコンピュータ(114、118)に送信するようにさらに構成される、請求項18に記載の腹膜透析システム(10)。
- 前記治療調整は、(i)透析液の種類の変更、(ii)透析液のデキストロースレベルの変更、(iii)治療時間の変更、(iv)充填容量の変更、(v)夜間充填交換の数の変更、および(vi)日中変更が行われるか否かから成る群より選択される種類の治療調整である、請求項15に記載の腹膜透析システム(10)。
- 患者(102、102a、102b)から限外濾過液(「UF」)を除去することと、どれだけ多くのUFが除去されたかを記録することとを行うように構成される自動腹膜透析(「APD」)機(104、104a、104b)と、
(i)第1の移動平均UF除去動向を形成することと、(ii)前記第1の移動平均UF除去動向の周囲の動向範囲を決定することと、(iii)前記動向範囲からUF除去の上限および下限のうちの少なくとも1つの限度を決定することと、(iv)第2の移動平均UF除去動向を形成することと、(v)前記第2の移動平均UF除去動向が少なくとも1つの除去UFの限度の外側に移動した場合に通知を提供することと、(vi)前記通知が少なくとも(a)患者の順守の欠如、または(b)治療処方の問題に起因するか否かを決定することとを行うように構成される、論理インプリメンタ(94、104、112、114、118)と
を備える、腹膜透析システム(10)。 - 前記論理インプリメンタ(94、104、112、114、118)は、前記APD機(104、104a、104b)、または、前記APD機(104、104a、104b)と通信しているサーバコンピュータ(114、118)のうちの1つに格納される、請求項21に記載の腹膜透析システム(10)。
- 前記第1の移動平均UF除去動向は、前記第2の移動平均UF除去動向よりも長い持続時間の動向である、請求項21に記載の腹膜透析システム(10)。
- 前記上限は、前記動向範囲を乗じた因数を、前記第1の移動平均UF除去動向に加算することによって形成され、前記下限は、前記動向範囲を乗じた前記因数を、前記第1の移動平均UF除去動向から減算することによって形成される、請求項21に記載の腹膜透析システム(10)。
- 前記通知は、(i)前記UF除去動向が、ある連続日数にわたって前記少なくとも1つのUF除去の限度の外側に移動した場合、または(ii)前記UF除去動向が、前記少なくとも1つのUF除去の限度の外側に移動し、前記患者の血圧が、限度を上回って上昇した場合に提供される、請求項21に記載の腹膜透析システム(10)。
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