JP2022514697A - インプラント可能な心臓センサ - Google Patents
インプラント可能な心臓センサ Download PDFInfo
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- JP2022514697A JP2022514697A JP2021536176A JP2021536176A JP2022514697A JP 2022514697 A JP2022514697 A JP 2022514697A JP 2021536176 A JP2021536176 A JP 2021536176A JP 2021536176 A JP2021536176 A JP 2021536176A JP 2022514697 A JP2022514697 A JP 2022514697A
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Abstract
Description
この出願は、2018年12月21日に出願された仮出願第62/783,902号、2018年12月21日に出願された仮出願第62/783,935号、2019年5月9日に出願された仮出願第62/845,386号、2019年8月30日に出願された仮出願第62/894,260号及び2019年9月16日に出願された仮出願第62/901,105号の利益を主張し、これらをすべて、あらゆる目的のためにその全体の参照により本明細書に取り込む。
本開示は、血圧などの生理学的パラメータを測定するためのシステム、より具体的には、心臓の生理学的パラメータを測定するためのシステムに関する。
過去10年の間に、米国における冠状動脈死の数は、医学及び治療の進歩のおかげで着実に減少したが、心不全による死亡の相対的な数は増加し、より多くの人々がこれまで以上に心不全の高いリスクとともに生きていることを示している。一般に、心不全は心臓が体に十分な血液を供給できないときに発生する。その結果、体積排出量が少ないと、排出力の不足を補うのを支援するために左心の充満圧が高くなる。より少量の体積排出量はまた、腎臓又は腎臓の灌流の減少を含む、より低い臓器灌流を引き起こす。腎臓の灌流が減少すると、過剰な流体が保持されることがありうる。急性代償不全発症は、体液レベルが上昇したり、及び/又は、血管の血液分布が低下したりして、患者が倦怠感及び呼吸困難(呼吸困難)を経験し、病院に送る状態になることである。治療せずに放置すると、深刻な合併症を引き起こし、最終的には死に至る可能性がある。
本明細書に開示されるのは、心臓内で測定を行うための、インプラント可能な測定デバイスなどのメディカルデバイスである。
前記医療システムは、右心房圧及び左心房圧を感知するように構成された少なくとも1つのセンサ、感知された右心房圧及び感知された左心房圧に対応する測定データを受信し、受信された測定データを表示デバイスに出力するように構成されたレシーバを含み、前記病状は左心不全、右心不全及び原発性肺障害からなる群より選ばれる少なくとも1つである。
添付の図面は、本開示のさらなる理解を提供するために含まれ、本明細書に取り込まれ、その一部を構成し、実施形態を示し、記載とともに、本開示の原理を説明するのに役立つ。
本開示は、限定的な方法で読まれることを意図するものではない。例えば、本出願で使用される用語は、その分野の用語がそのような用語に帰する意味の文脈で広く読まれるべきである。
Claims (38)
- 病状を有する患者の治療計画を決定するための医療システムであって、前記システムは、
右心房圧及び左心房圧を感知するように構成された少なくとも1つのセンサ、
感知された右心房圧及び感知された左心房圧に対応する測定データを受信し、受信された測定データを表示デバイスに出力するように構成されたレシーバ、
を含み、前記病状は左心不全、右心不全及び原発性肺障害からなる群より選ばれる少なくとも1つである、医療システム。 - 受信された測定データ及び患者の病状を格納するように構成されたメモリユニット、及び、
受信された測定データ及び患者の病状に基づいて、患者の治療計画を決定するように構成されたプロセッサ、
をさらに含む、請求項1記載の医療システム。 - 患者の治療計画を決定するために、前記プロセッサは、
感知された右心房圧をベースライン右心房圧と比較し、そして、
感知された左心房圧をベースライン左心房圧と比較するように構成されている、請求項2記載の医療システム。 - 患者の治療計画を決定するために、前記プロセッサは、感知された右心房圧と感知された左心房圧とを比較するように構成されている、請求項2又は3のいずれか1項記載の医療システム。
- 患者の治療計画を決定するために、前記プロセッサは、治療計画の投薬量を増加させるための通知を提供するように構成されている、請求項2~4のいずれか1項記載の医療システム。
- 患者の治療計画を決定するために、前記プロセッサは、治療計画の投薬量を減少させるための通知を提供するように構成されている、請求項2~4のいずれか1項記載の医療システム。
- 前記プロセッサはインプラント可能なメディカルデバイスに組み込まれている、請求項2~6のいずれか1項記載の医療システム。
- 前記プロセッサは患者の外部に配置されたデバイスに組み込まれている、請求項2~6のいずれか1項記載の医療システム。
- 患者の治療計画を決定するために、前記プロセッサは、以下の治療剤:血管拡張薬、利尿薬、肺血管拡張薬、神経ホルモン拮抗薬、ベータ遮断薬及び変力薬からなる群より選ばれる少なくとも1つの治療剤を増加させるための通知を提供するように構成されている、請求項2~8のいずれか1項記載の医療システム。
- 患者の治療計画を決定するために、前記プロセッサは、以下の治療剤:血管拡張薬、利尿薬、肺血管拡張薬、神経ホルモン拮抗薬、ベータ遮断薬及び変力薬からなる群より選ばれる少なくとも1つの治療剤を減少させるための通知を提供するように構成されている、請求項2~8のいずれか1項記載の医療システム。
- 病状を有する患者の治療計画を決定するためのコンピュータ実施方法であって、前記方法は、
患者の感知された右心房圧に対応する少なくとも1つの測定値を受信すること、
患者の感知された左心房圧に対応する少なくとも1つの測定値を受信すること、及び、
前記感知された右心房圧に対応する少なくとも1つの測定値、前記感知された左心房圧に対応する少なくとも1つの測定値を表示デバイスに出力すること、
を含み、前記病状は左心不全、右心不全及び原発性肺障害からなる群より選ばれる少なくとも1つである、方法。 - 感知された右心房圧に対応する少なくとも1つの測定値、感知された左心房圧に対応する少なくとも1つの測定値及び患者の病状に基づいて患者の治療計画を決定することをさらに含む、請求項11記載の方法。
- 患者の治療計画を決定することは、
感知された右心房圧をベースライン右心房圧と比較すること、及び、
感知された左心房圧をベースライン左心房圧と比較すること、
を含む、請求項12記載の方法。 - 患者の治療計画を決定することは、感知された右心房圧と感知された左心房圧とを比較することを含む、請求項11~13のいずれか1項記載の方法。
- 患者の治療計画を決定することは、治療計画の投薬量を増加させるための通知を提供することを含む、請求項12~14のいずれか1項記載の方法。
- 患者の治療計画を決定することは、治療計画の投薬量を減少させるための通知を提供することを含む、請求項12~14のいずれか1項記載の方法。
- 患者の治療計画を決定することは、以下の治療剤:血管拡張薬、利尿薬、肺血管拡張薬、神経ホルモン拮抗薬、ベータ遮断薬及び変力薬からなる群より選ばれる少なくとも1つの治療剤を増加させるための通知を提供することを含む、請求項12~16のいずれか1項記載の方法。
- 患者の治療計画を決定することは、以下の治療剤:血管拡張薬、利尿薬、肺血管拡張薬、神経ホルモン拮抗薬、ベータ遮断薬及び変力薬からなる群より選ばれる少なくとも1つの治療剤を減少させるための通知を提供することを含む、請求項12~16のいずれか1項記載の方法。
- 左心圧及び右心圧に関連する測定値を受信するように構成されたレシーバ、
受信された測定値を格納するように構成されたメモリユニット、
表示デバイス、及び、
左心圧に関連する測定値と右心圧に関連する測定値を比較し、そして、その比較を表示デバイスに出力するように構成された処理デバイス、
を含む、モニタリングシステム。 - 前記処理デバイスは、比較に基づいて、患者の治療計画を決定するようにさらに構成されている、請求項19記載のモニタリングシステム。
- 前記左心圧に関連する測定値は左心房圧測定値である、請求項19~20のいずれか1項記載のモニタリングシステム。
- 前記左心圧に関連する測定値は左心圧の代理指標であり、前記代理指標は、以下の代理指標:肺動脈圧(PAP)、肺動脈楔入圧(PAWP)、肺動脈収縮期圧(PASP)、肺動脈拡張期圧(PADP)、右心室収縮期圧(RVSP)、推定肺動脈拡張期圧(ePAD)及び左心室拡張末期圧(LVEDP)からなる群より選ばれる少なくとも1つの代理指標である、請求項19~21のいずれか1項記載のモニタリングシステム。
- 前記右心圧に関連する測定値は右心房圧測定値である、請求項19~22のいずれか1項記載のモニタリングシステム。
- 前記右心圧に関連する測定値は右心圧の代理指標であり、前記代理指標は、以下の代理指標:右心室拡張末期圧(RVEDP)、中心静脈圧(CVP)及び頸静脈圧(JVP)からなる群より選ばれる少なくとも1つの代理指標である、請求項19~23のいずれか1項記載のモニタリングシステム。
- 治療は以下の治療:診断、投薬滴定、高度治療、IV投薬、ライフスタイルの変更、心房内シャント、弁の修復/交換、ICD、CRT及びアブレーションからなる群より選ばれる少なくとも1つの治療を含む、請求項20~24のいずれか1項記載のモニタリングシステム。
- 前記投薬滴定は、以下の滴定:血管拡張薬、利尿薬、肺血管拡張薬、神経ホルモン拮抗薬、ベータ遮断薬及び変力薬の滴定の群より選ばれる少なくとも1つの滴定を含む、請求項25記載のモニタリングシステム。
- 前記高度治療は、心室補助デバイス(VAD)のインプラント処置、機械的サーキュレータサポート(MCS)のインプラント処置、移植又はその両方からなる群より選ばれる1つ以上を含む、請求項25~27のいずれか1項記載のモニタリングシステム。
- 前記ライフスタイルの変更は、食事の変更、活動の増加又はその両方のライフスタイルの変更の群から選ばれる少なくとも1つのライフスタイルの変更を含む、請求項25~26のいずれか1項記載のモニタリングシステム。
- 左心圧及び右心圧に関連する測定値を感知するように構成されたセンサをさらに含む、請求項19~28のいずれか1項記載のモニタリングシステム。
- 前記処理デバイスは、決定された治療を表示デバイスに出力するようにさらに構成されている、請求項19~29のいずれか1項記載のモニタリングシステム。
- 前記処理デバイスは、比較に基づいて患者を診断するようにさらに構成されている、請求項19~30のいずれか1項記載のモニタリングシステム。
- 前記モニタリングシステムは、測定値の傾向データが薬剤の自動調剤へ変更を通知する閉ループシステムである、請求項19~31のいずれか1項記載のモニタリングシステム。
- 前記薬剤は利尿薬、血管拡張薬又はその両方である、請求項32記載のモニタリングシステム。
- 前記モニタリングシステムは、測定値の傾向データが心室補助デバイスへ変更を通知する閉ループシステムである、請求項19~33のいずれか1項記載のモニタリングシステム。
- 前記モニタリングシステムは心室補助デバイスにおけるRPM変化を決定するために使用される、請求項19~34のいずれか1項記載のモニタリングシステム。
- 前記処理デバイスは機械学習を使用して治療計画を変更する、請求項20~35のいずれか1項記載のモニタリングシステム。
- 前記処理デバイスは、左心房圧、左心房圧の平均、右心房圧、右心房圧の平均、測定値の傾向矢印、測定値の経時的な線グラフ、測定値の波形、及び、測定値に関連する患者の1つ以上の投薬うちの1つ以上を表示デバイスに出力するようにさらに構成されている、請求項20~36のいずれか1項記載のモニタリングシステム。
- 治療計画を決定するための医療システムであって、前記システムは、
右心房圧及び左心房圧を感知するように構成された少なくとも1つのセンサ、
患者の病状、及び、感知された右心房圧及び感知された左心房圧に対応する測定データを受信するように構成されたレシーバ、
受信された測定データ及び患者の病状を格納するように構成されたメモリユニット、ならびに、
受信された測定データ及び患者の病状に基づいて、患者の治療計画を決定するように構成されたプロセッサ、
を含み、
前記病状は左心不全、右心不全及び原発性肺障害からなる群より選ばれる少なくとも1つである、医療システム。
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