JP2021130013A - 肺健康管理のためのシステムおよび方法 - Google Patents
肺健康管理のためのシステムおよび方法 Download PDFInfo
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- JP2021130013A JP2021130013A JP2021083714A JP2021083714A JP2021130013A JP 2021130013 A JP2021130013 A JP 2021130013A JP 2021083714 A JP2021083714 A JP 2021083714A JP 2021083714 A JP2021083714 A JP 2021083714A JP 2021130013 A JP2021130013 A JP 2021130013A
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Abstract
Description
[0001]本出願は、2016年5月3日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/331,328号と、2016年5月5日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/332,352号と、2016年5月10日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/334,076号と、2016年6月24日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS
AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/354,437号と、2016年9月23日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/399,091号と、2016年11月1日出願の「DISPOSABLE PULMONARY DRUG DELIVERY
APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/416,026号と、2016年11月16日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/422,932号と、2016年12月1日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/428,696号と、2017年1月20日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/448,796号と、2017年3月15日出願の「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE(使い捨て肺薬剤送達装置および使用方法)」という名称の米国仮特許出願第62/471,929号との米国特許法第119条に基づく利益を主張する。各出願の内容は、その全体が参照により本明細書に組み込まれる。
ある液滴サイズをもつ、正確な、一貫した、検証可能な投薬量を送達するデバイスを提供することである。肺胞を通る、肺の深部肺領域への薬物の有効な送達は、特に小児および高齢者、ならびに病態の人々に、それらの人々の限られた肺容量と呼吸通路(breathing passageway)の狭窄とにより、問題を常に提示してきた。狭窄した肺通路の影響は、患者の深い吸気、ならびに吸気および呼気を含む呼吸サイクルとの投与された投薬量の同期を制限する。
クチュエータプレートに結合されている他の実装形態では、アクチュエータプレートが、エアロゾル液滴の有向エアロゾルストリームまたはプルームを生成するための周波数および電圧で、圧電発振器によって発振させられる。
並列管をもつ、層流要素によって与えられ、本明細書で説明されるように、吸入デバイス100のエアロゾル送達管の空気入口端部に配置される。層流要素は、層空気流106を生成するために十分に小さいが、層流要素の入口側と層流要素の出口側の間の有意な圧力差を生じるために小さすぎない直径を有する多くの並列流通路に空気流を分割することによって、層空気流106を生成する。小さい流れだけが各層流要素通路を通過するので、各通路を通る流れのレイノルズ数は、層流106が維持されるほど十分に小さい。いくつかの実装形態では、吸入デバイス100に引き込まれる空気は、層流要素を通して空気が引き込まれるので層流の特性を有し、開口プレートの面にわたって一掃し、放出された粒子を同伴し、軌道においてさらなる下流の患者104の気道に搬送する。
の包含によって達成され得る。たとえば、デバイスのマウスピースまたは液滴出口キャビティの内側で、ASTMA監視および診断のための呼気中の一酸化窒素の濃度を分析するために、MEMSセンサーが使用され得る。さらに、吐き出されたVOCの濃度の変動が、特異的疾患のためのバイオマーカーとして働き得、健康な患者を病気である患者から区別するために使用され得る。
それが自動的に非アクティブになる。流量トリガ型投与(flow triggered
dispense)モードでは、患者104は、デバイスをアクティブにし、吸入する。吸入デバイス200は、提供者によって設定された、特定の吸入流量に対応するトリガポイントにおいて投薬量をトリガする。吸入デバイス200は、良好な投与をシグナリングし、電源切断する。トレーニング済みトリガ型投与(trained triggered dispense)モードでは、患者104は、吸入デバイス200をオンにし、吸入と呼息との完全呼吸サイクルの間、数回呼吸をする。吸入デバイス200は、圧力センサー206を使用して自動的に検出されるトリガポイントにおいて、投薬量を記録し、投与する。吸入デバイス200は、良好な投与をシグナリングし、非アクティブになる。トレーニングまたは診断(training or diagnostic)モードでは、患者104は、吸入デバイス200をオンにし、吸入デバイス200またはユーザデバイス204は、呼吸サイクルを通して患者104を促す。診断インジケータおよび他の肺健康データが、吸入デバイス200を用いてキャプチャされ、それらは、次いでコントローラ222上にアーカイブされ、ならびに/あるいはリンク220および/またはユーザデバイス204を介して空気分析器に通信される。吸入デバイス200が非アクティブになる。
ピューティングデバイスと通信し得る。
いての肺機能の変化がいつあるかを確定するために、前の記憶されたデータと肺健康管理データとの比較を通して空気分析を生成し得、さらに、COPDの急激な悪化を予測し得る。一般的使用パターン、吸気体積および生体サイクル状態、各使用の日付/時間および局所的なロケーション、疾患タイプおよび重大度、年齢、(1つまたは複数の)薬剤タイプ、および一般化された患者の履歴などの一般的ユーザ分類データを決定するために、複数の患者からの肺健康管理情報が空気分析器402によって匿名化され得る。吸入デバイス100の各々についての動作パラメータがさらに、トラブルシューティング、改善などのために空気分析生成において使用するために、空気分析器402によってキャプチャされ、処理され得る。
4を含み得る。空気品質インターフェース514は、呼吸器疾患に対する様々な大気汚染状態および汚染物質の相関関係および影響を含み得る。呼吸器の問題の発現を監視または予測するためにあるいは屋内にとどまるように提案するための警告を生成するために、環境センサーによってキャプチャされる入力として、温度、露、気圧、湿度および風速などの気象状態に加えて、たとえば、PM2.5、PM10、O3、NO2、SO2、およびCOなどの空気品質ファクタが採用される。
関された、吸入デバイス100によってキャプチャされた診断インジケータを含み得る。何らかの環境または他の原因を識別するために、ならびに集団の全体的な病態を監視するために、(1つまたは複数の)特定の地理的ロケーションについて、疾病状態の出現率の概要が与えられ得る。ヘルスケア情報506は、処置、診断、病態などを追跡するために個々の患者または患者のグループによって使用され得る。デバイス情報508は、トラブルシューティング、改善、品質管理などのための吸入デバイス100の動作に関する情報を含み得る。様々なタブ502〜508および512に対応する様々なアラートおよび/または傾向が、1人または複数の患者、グループ、および/または吸入デバイス100の管理のためにアラート/傾向210中に含まれ得る。
メータ以外の情報を収集および分配する。追加のユーザデータは、吸入空気の温度、湿度、オゾンおよび二酸化窒素レベル、患者104呼息中の様々なガスの量、ならびにさらには吸入された空気中の微粒子レベルを含み得る。空気分析器402に伝達されると、警告が、リアルタイム環境および肺健康管理情報に基づいて、個人ユーザまたはユーザグループに発行され得る。
展開を患者104に通知し、新発見の相関関係をユーザに警告する。
、それは1秒における努力呼気の空気の体積である。理想的には、肺機能測定は、それが呼吸に対するユーザ筋肉努力に依存しないように行われるであろうが、現在の医療診断機器は、呼吸に対する気道および肺胞の制限を評価するために、ユーザを囲む圧力を変動させるユーザを囲むチャンバの使用によって、呼吸に対する筋肉努力の変動要因を除去する。一般に、FEV1は、完全吸気(full inspiration)に後続する努力呼気(forced expiration)によって1秒において吐き出された空気の体積として表される。この数は、肺活量のパーセンテージとして表される。
分析にとって有益な診断インジケータを医師に与えることができる。(肺線維症などの)拘束性肺疾患では、肺活量は正常レベル以下に低減されるが、呼息の割合は正常である。(喘息、気腫、気管支炎などの)閉塞性肺疾患では、肺組織は損傷を与えられず、それのコンプライアンスは変化していないので、肺活量は正常である。喘息では、小気道(細気管支)が収縮し、空気流に対する抵抗を増加させる。肺活量は正常であるが、増加した気道抵抗は、呼気をより困難にし、より長い時間を必要とする。閉塞性障害は、FEV1およびFEV25〜75などの努力呼気の割合を測定する試験によって診断され、これらの値における著しい減少が、閉塞性肺疾患を示唆する。
口腔圧力P1bについて 流量Fb=(P2−P1b)/R
[00117]これらの条件における流量および圧力は、気道抵抗についての値を下記によって直接計算するために使用され得る。
[00118]これは、気道抵抗と肺胞圧力の両方が、呼吸サイクルの間の肺および気道ジオメトリの変化とともに著しく変化するので、2つの口腔圧力間の比較的迅速な遷移を仮定することに留意されたい。圧力の迅速な遷移によって、2つの圧力の間のほぼ一定の肺胞圧力の仮定は、真である。空気および流れ抵抗のコンプライアンスは、ローパスフィルタが高周波信号を最小化するほど、変動を効果的に除去するので、圧力がどれくらい迅速に変動させられ得るかには限界がある。
R=(P1c−P1d)/(P1c/Rc−P1d/Rd)を生じる。
R=(P1c−P1d)/(P1c/Rc−P1d/KRc) またはR=(1/Rc)*(P1c−P1d)/(P1c−P1d/K)になる。
[00124]空気分析器402は、肺コンプライアンスに関する追加の空気分析を生成し得、異なるサイクル時間を用いた上記の2圧力試験を行うことによって、気道抵抗の位置が評価され得る。この場合、2つの異なる圧力間でサイクルする代わりに、吸入デバイス100における流れ抵抗は、線形信号処理の仮定に近似するように正弦曲線として変動させられる。
ことができない場合、可変抵抗バルブの大気側において追加の圧力を作成するために、小型ファンが使用され得る。ファンを積み重ねることによって、追加の圧力が生成され得るので、総圧力は各ファンにおける圧力利得の和である。
これらの態様の説明は、例にすぎず、限定するものではない。
[00147]図9A〜図9Cを参照すると、一実装形態では、吸入デバイス100は、ハンドル900と、マウスピース904を囲むハウジング902と、使い捨てまたは再利用可能カートリッジ908を受けるためのカートリッジマウント906と、層流要素910と、マウスピース904によって画定される開口912とを含む。
図14Aに示されている一実装形態では、圧力センサーアセンブリ914は、エアロゾル管928の内部の空気流量制限にわたる圧力差を検出することによって空気流を検知するために、第1の圧力センサー1000と第2の圧力センサー1002とを含む。図14Bは、1つの圧力センサー1002をもつ圧力センサーアセンブリ914を示し、ここで、制限は層流スクリーン910であり、圧力は、管928の内部と管928の外側の圧力との間の差として検知される。第1の圧力センサー1000および第2の圧力センサー1002は、空気流が入口1004から出力1006まで移動するとき、エアロゾル管928の内部エリアと外部エリアとの間の圧力差を検出することによる、噴霧検証のために使用され得る。圧力センサーアセンブリ914は、吸入サイクルの間のピーク期間の間に噴霧をアクティブにするためのトリガポイントを識別するために、患者104についての呼吸サイクルをさらに協調させ得る。
圧力範囲; +/−500Pa範囲;周囲に対するデルタP測定値
絶対精度; 3%またはより良好
再現性; 3%またはより良好
FS分解能; 1%またはより良好
デジタルまたはアナログ出力; デジタルが選好される;I2CまたはSPI
電源電圧; 3VDC+/−5%
オフセット、自動ゼロ化; オンになった後;
保管温度: −20〜+60C;
動作温度: 10〜45C;
[00154]センサーアセンブリ914は、低差動圧力における感度、オフセットドリフト、およびヒステリシスに関して、従来の圧電抵抗膜センサーよりも優れ得る。これらの性能パラメータは、低い圧力における増加した分解能およびより正確な測定値を可能にする。これらの性能パラメータは、低い肺出力をもつ子供および高齢患者にとって特に重要である。
Claims (22)
- 肺健康管理のための方法であって、前記方法は、
ネットワークを介して1つまたは複数の吸入デバイスから肺健康管理情報を受信するステップであって、前記1つまたは複数の吸入デバイスの各々が、前記吸入デバイスの管を通る空気流の流量を測定する1つまたは複数の圧力センサーを有する、受信するステップと、
前記1つまたは複数の吸入デバイスが配備された1つまたは複数の地理的ロケーションについての環境データを受信するステップであって、前記環境データが、1つまたは複数の環境センサーを使用してキャプチャされ、かつ前記1つまたは複数の地理的ロケーションの各々の周囲空気状態に対応する、受信するステップと、
少なくとも1つのコンピューティングユニットを使用して、少なくとも1つの管理パラメータに基づいて、前記肺健康管理情報を前記環境データと相関させるステップと、
前記少なくとも1つのコンピューティングユニットを使用して、前記相関させられたデータから空気分析を生成するステップと
を含む、方法。 - ユーザデバイス上の表示のために前記空気分析を出力するステップをさらに含む、請求項1に記載の方法。
- 前記ユーザデバイスが、患者デバイスまたは提供者デバイスのうちの少なくとも1つである、請求項2に記載の方法。
- 前記少なくとも1つの管理パラメータが、疾患タイプ、患者プロファイル、噴霧検証タイプ、環境状態タイプ、デバイスエラータイプ、または汚染物質タイプのうちの少なくとも1つを含む、請求項1に記載の方法。
- 前記空気分析が、空気品質分析、疾患分析、ヘルスケア分析、デバイス分析、アラート、または傾向のうちの少なくとも1つを含む、請求項1に記載の方法。
- 患者のための肺健康管理のための方法であって、前記方法は、
前記患者によって吸入の間に達成されたピーク吸気流測定値を受信するステップであって、前記ピーク吸気流測定値が、前記吸入の間の空気流の最小圧力に基づいて生成される、受信するステップと、
前記患者についての肺出力を受信するステップであって、前記肺出力が、呼息の間に達成された最大流を測定することによって決定される、受信するステップと、
少なくとも1つのコンピューティングユニットを使用して、前記患者についての肺健康管理情報を生成するステップであって、前記肺健康管理情報が、前記ピーク吸気流測定値と前記肺出力とに基づいて生成される肺健康プロファイルを含む、生成するステップと、
前記肺健康管理情報を出力するステップと
を含む、方法。 - 前記肺健康プロファイルがさらに、前記呼息中の一酸化窒素の濃度値に基づいて生成される、請求項6に記載の方法。
- 前記肺健康管理情報が、ユーザデバイスを用いた提示のために出力される、請求項6に記載の方法。
- 前記肺健康プロファイルがさらに、気道抵抗に基づいて生成される、請求項6に記載の方法。
- 前記肺健康管理情報が、ユーザデバイスによってネットワークを介して空気分析器に通信される、請求項6に記載の方法。
- 経時的な前記肺健康管理情報の変化を追跡するステップをさらに含む、請求項6に記載の方法。
- 前記肺健康プロファイルが、肺状態の診断または前記肺状態のための処置のうちの少なくとも1つを含む、請求項6に記載の方法。
- 患者のための肺健康管理のための方法であって、前記方法は、
前記患者による吸入サイクルの開始を識別するステップと、
1つまたは複数の圧力センサーを使用して空気流の流量を測定することによって、前記吸入サイクルにおけるトリガポイントを決定するステップと、
エアロゾルプルームを前記空気流に噴霧するステップと、
エジェクタアセンブリを使用して、前記トリガポイントにおいて前記エアロゾルプルーム(plume)中への液滴(droplets)のセット(set)の放出を自動的に生成するステップと、
液滴の前記セットの前記放出を確認するステップと
を含む、方法。 - 前記1つまたは複数の圧力センサーが、前記空気流中の上流に配設された第1のセンサーと、前記空気流の外部に配設された第2のセンサーとを含み、前記第1のセンサーが内圧を測定し、前記第2のセンサーが外圧を測定し、前記流量が、前記内圧と前記外圧との間の圧力差から測定される、請求項13に記載の方法。
- 前記流量が、前記空気流と周囲大気との間の圧力低下に基づいて測定される、請求項13に記載の方法。
- 液滴の前記セットが、各々が5ミクロン以下のサイズを有する1つまたは複数の液滴を含む、請求項13に記載の方法。
- 前記トリガポイントが、前記吸入サイクルにおけるピークに対応する、請求項13に記載の方法。
- 液滴の前記セットの前記放出が、前記エアロゾルプルーム中の放出質量の速度を検出することによって確認される、請求項13に記載の方法。
- 液滴の前記セットの前記放出が、前記エアロゾルプルームの横断面および長さを検出することによって確認される、請求項13に記載の方法。
- 前記トリガポイントがあらかじめ設定される、請求項13に記載の方法。
- ユーザデバイスを使用して、確認情報を空気分析器に通信するステップであって、前記確認情報が、液滴の前記セットの前記放出の前記確認に基づいて生成される、通信するステップをさらに含む、請求項13に記載の方法。
- 前記確認情報に基づいてフィードバックを生成するステップをさらに含む、請求項21に記載の方法。
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