JP6606067B2 - モジュール型生理学的モニタリング・システム、キット、および方法 - Google Patents
モジュール型生理学的モニタリング・システム、キット、および方法 Download PDFInfo
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Description
本出願は、2013年6月6日に出願された、「Modular Physiological Monitoring Systems,Kits,and Methods」という名称の、LandyTothらの米国仮特許出願第61/832,131号の利益および優先権を主張する国際出願であり、この仮特許出願の内容全体は、あらゆる目的で参照により本明細書に組み込まれる。
態様では、本開示によるシステムは、身体上の単一の部位から取得され得るよりも高いレベルの機能を生成するおよび/または臨床的に関連するデータを増加させるために、複数のパッチまたはパッチ/モジュール対を含み得る。そのような適用例のいくつかの非限定的な例としては、多電極心電図、外傷性脳損傷評価、触覚回復、歩容分析、心呼吸系評価、代謝評価、呼吸/歩容同期、血圧モニタリング、複合読み取り分析(すなわち、被験体の状態または健康状態または疾患状態の程度のより深い理解を明らかにするためにEEGなどの第1の機能をHRVなどの別の機能と組み合わせる)がある。
本開示によるパッチは、基材と、この基材に固定された1つまたは複数の相互接続部とを含み得、各相互接続部は、本開示によるモジュールと整合するための構成および寸法にされた1つまたは複数のコネクタを含む。このパッチは、被験体上での留置後に隣接する皮膚表面と整合するように配置された基材と結合された本開示による1つまたは複数のセンサを含み得、このセンサは、1つまたは複数の相互接続部と電気的に、機械的に、および/または光学的に結合する。態様では、センサのうちの1つまたは複数は電極であってよい。任意選択で、パッチは、基材または1つもしくは複数の相互接続部に埋め込まれるまたはこれに取り付けられ、パッチに含まれる相互接続部と1つまたは複数の関連センサとの間で情報を伝達するように構成された超小型回路を含み得る。態様では、パッチは、基材と結合されるまたはこれに組み込まれ、パッチが被験体の表面(すなわち、被験体の皮膚)に適用され得るように構成された接着剤または取り付け層を含み得る。
本開示によるシステムは、各々本開示による1つまたは複数のモジュールを含み得る。このモジュールは、本開示によるパッチと整合するように構成され得る。態様では、モジュールは、本開示による1つまたは複数の信号(たとえば、生理学的信号、電気生理学的信号、および/または物理的信号)またはフィードバック信号を生成するように構成された、電源、ハウジング、1つまたは複数の相互接続部、信号調節回路、通信回路、プロセッサ、トランシーバ、トランスデューサ、1つまたは複数のセンサ、アンテナ、ブザー、ボタン、光源などを含み得る。この信号調節回路は、モニタリング・セッション、較正セッション、取り付けイベントなどの間にトリガを増幅、雑音除去(de-noise)、プレフィルタリング、生成し、態様を分析し、1つまたは複数の生理学的信号および/または物理的信号からメトリックを抽出するなどのように構成され得る。
本開示による、被験体の身体から1つまたは複数の生理学的信号および/または物理的信号をモニタリングするための方法は、各々本開示による1つまたは複数のパッチを被験体の身体に適用すること、および(すなわち、本開示による1つまたは複数のパッチ/モジュール対を形成するように)各々本開示による対応する数のモジュールをパッチに取り付けること、モジュール間でボディ・エリア・ネットワークを確立すること、およびモニタリング・セッション中に(すなわち、方法の所望の目的に適したの期間、たとえば、10秒、1分、1時間、8時間、24時間、1週間、1か月、3か月、長期などにわたって)パッチおよびモジュールを使用して被験体から生理学的信号および/または物理的信号を収集することを含む。
態様では、パッチは、モニタリング・セッション中にそれから信号をより良く捕捉するように、身体の特定の領域の輪郭を示すように形作られ得る。態様では、モジュールは、モジュールをより良く隠すおよび/または手順中の思わぬ障害(snag)を減少させるために、薄型を維持し、鋭いエッジなどがないように設計され得る。
本開示によるシステムは、モニタリング・キットの一部として提供され得る。態様では、本開示によるモニタリング・キットは、1つもしくは複数のモジュールと、再充電ベイと、1つもしくは複数のパッチ、またはパッチのセット(すなわち、被験体上で特定のタイプのモニタリングを実行するような構成および寸法とされる一連のパッチ)と、(任意選択で)接着剤除去拭き取り/噴霧、皮膚準備ツール、命令、ソフトウェア・アクセスなどの1つまたは複数の付属物とを含み得る。
態様によれば、顧客が使用関連情報(たとえば、モニタリング、請求などの目的)を含むプロファイルを割り当てられる購読(subscription)サービスと、1つまたは複数の関連モニタリング・セッションにおいて使用するためのタイムリーな一連のパッチを顧客に提供するように構成された自動パッチ配布システムと、1つまたは複数のモニタリング・セッション中に顧客から取得されたデータを記憶、分析などするように構成されたデータ・センタと、1つまたは複数のモニタリング・セッション中に取得されたデータに基づいて1つまたは複数のモニタリング・レポートを生成するように構成されたレポート生成サービスと、消費された数またはパッチ、記憶されたデータ、生成されたレポートなどに基づいて顧客に請求するように構成された繰り返し請求システムとを含む、顧客からの生理学的データの収集を管理するためのサービスが提供される(すなわち、任意選択でサービス・システムの形態で実施される)。
態様では、ホスト・デバイスは、被験体によって動作可能に着用/保持されてもよいし、被験体の近くに設置されてもよいし、ベッドサイド・アラーム・クロックに統合されてもよいし、付属物(たとえば、財布、バックパック、札入れなど)に収容されてもよい。態様では、ホスト・デバイスは、モバイル・コンピューティング・デバイス(たとえば、スマートフォン、タブレット・コンピュータ、ページャなど)であってよい。態様では、ホスト・デバイスは、ローカル・ルータ、データ・レコーダ、ネットワーク・ハブ、サーバ、第2のモバイル・コンピューティング・デバイス、ルータ、リピータなどであってよい。
Claims (15)
- 被験体からの1つまたは複数の生理学的信号、物理的信号、および/または電気生理学的信号をモニタリングするためのパッチ・インタフェースであって、
− 可撓性の伸縮可能材料を含む基材であって、前記基材は基材の第1の面と前記基材の第1の面に対抗する基材の第2の面を有する基材と、
− 接着剤層の第1の面と接着剤層の第2の面を有する接着剤層であって、前記接着剤層の第1の面が前記基材の第2の面に結合され、前記接着剤層の第2の面が前記被験体の皮膚への取り付けのために構築された接着剤層と、
− 1つまたは複数の超小型回路を含むモジュールへの前記パッチ・インタフェースの取り付けのために前記基材に埋め込まれた1つまたは複数のパッチ相互接続部と、
− 1つまたは複数のセンサおよび1つまたは複数の電極の少なくとも1つであって、
前記基材に埋めこまれ、および前記基材の第2の表面に取り付けられるかの少なくとも一方であり、前記接着剤層の第2の面が前記被験体の皮膚へ取り付けられたときに前記被験体と整合(interface)するような配置、構成、および寸法にされた、1つまたは複数のセンサおよび1つまたは複数の電極の少なくとも1つと、
− 前記基材の第2面と前記接着剤層の第1の面の間の1つまたは複数の伸縮可能な電気的伝導性インクを含む電気的伝導性トレースであって、前記センサおよび前記電極のいずれか一方とパッチ相互接続部とを結合するように配置された前記1つまたは複数の伸縮可能な電気的伝導性インクを含む電気的伝導性トレースと、
を備え、
前記1つまたは複数のパッチ相互接続部は、前記パッチ・インタフェースと前記モジュールの前記1つまたは複数の小型回路に電気的伝導性インタフェースを提供する、
パッチ・インタフェース。 - 前記接着剤層は、前記基材の第2の面の1つまたは複数の露出領域を形成するように前記基材の第2の面上にパターニングされ、前記1つまたは複数のセンサおよび/または前記1つまたは複数の電極のうちの少なくとも1つは前記露出領域内に配置され、1つまたは複数の前記電極の少なくとも1つは、本質的に伝導性のまたはイオン的に伝導性のゲル接着剤層の一方を含む、請求項1に記載のパッチ・インタフェース。
- 少なくとも1つの前記電極が、前記皮膚の角質層に侵入するための、1つまたは複数のマイクロファイバー、逆とげ、マイクロニードル、またはスパイクを備える電極機構を含む、請求項1に記載のパッチ・インタフェース。
- 前記電極機構は、前記皮膚との係合中に前記皮膚に2mm未満で侵入するように構成された請求項3に記載のパッチ・インタフェース。
- 前記ゲル接着剤層は、前記電極が前記皮膚と接触した後および圧力が前記電極に加えられた後のいずれか一方において、1時間よりも長く、前記皮膚への改善された電気接続を維持するように構成される、請求項2乃至4のいずれか1項に記載のパッチ・インタフェース。
- 前記パッチ・インタフェースが予想伸張方向を有し、1つまたは複数の前記パッチ相互接続部が前記予想伸長方向に略垂直な軸に沿って前記基材上に配向する、請求項1乃至5のいずれか1項に記載のパッチ・インタフェース。
- 1つまたは複数の前記パッチ相互接続部は複数のコネクタを備え、前記コネクタは前記基材によって互いに物理的に接続され、前記パッチ・インタフェースは、前記パッチ・インタフェースが前記皮膚と係合している間、前記コネクタのうちの1つまたは複数を前記皮膚から分離するように配置された分離用領域を備える、請求項1乃至6のいずれか1項に記載のパッチ・インタフェース。
- 前記パッチ・インタフェースは、所定の形状を自立状態で保持することができなくなるほど十分に物理的に脆弱である、請求項1乃至7のいずれか1項に記載のパッチ・インタフェース。
- 前記基材に取り付けられた一時的補強部材をさらに備え、前記一時的補強部材は、前記被験体への取り付けの前に前記パッチ・インタフェースの前記形状の保持を提供するように構成され、前記一時的補強部材は、前記被験体への取り付け後に前記基材から除去可能である、請求項8に記載のパッチ・インタフェース。
- 前記被験体の前記皮膚からの前記パッチ・インタフェースの除去は、前記パッチ・インタフェースが引き裂かれることなく、前記パッチ・インタフェースの前記形状の恒久的損失をもたらす、請求項8または9に記載のパッチ・インタフェース。
- 前記接着剤層は、0.02N/mmよりも大きい、哺乳動物の皮膚に対するピール・タックを有する、請求項1乃至10のいずれか1項に記載のパッチ・インタフェース。
- 前記基材は軟質擬似弾性材料から形成され、前記パッチ・インタフェースは、25%よりも大きくまで伸長されたとき、動作を維持するように構成される、請求項1乃至11のいずれか1項に記載のパッチ・インタフェース。
- 前記パッチ・インタフェースは、200g/m2/24時間から20,000g/m2/24時間の間の透湿度を有するように構成される、請求項1乃至12のいずれか1項に記載のパッチ・インタフェース。
- 被験体からの1つまたは複数の生理学的信号、物理的信号、および/または電気生理学的信号をモニタリングするためのモジュールであって、
− ハウジングと、
− 1つまたは複数の超小型回路を備える回路基材と、
− 請求項1乃至13のいずれか1項に記載のパッチ・インタフェース上への前記モジュールの留置および結合のために構成された前記超小型回路のうちの1つまたは複数に結合された1つまたは複数のモジュール相互接続部と
を備えるモジュール。 - 前記1つまたは複数のモジュール相互接続部は前記回路基材に埋め込まれ、前記回路基材は前記ハウジングの少なくとも一部分を構成する、請求項14に記載のモジュール。
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