JP2019509085A - 薬物送達システムのための可視化及び解析ツール - Google Patents
薬物送達システムのための可視化及び解析ツール Download PDFInfo
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
- A61M2005/1726—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure the body parameters being measured at, or proximate to, the infusion site
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
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- A61M2230/00—Measuring parameters of the user
- A61M2230/005—Parameter used as control input for the apparatus
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- A61M2230/00—Measuring parameters of the user
- A61M2230/20—Blood composition characteristics
- A61M2230/201—Glucose concentration
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- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
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- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
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Abstract
Description
本出願は、米国特許法第119条の関連部分に基づき、2016年2月5日出願の米国特許出願第62/291,792号に対する優先権を主張するものであり、その全ての内容が参照により本明細書に組み込まれる。
本発明は、概して、グルコース管理の分野に関し、より詳細には、インスリン送達調節アルゴリズムによって制御される、人工膵臓などのインスリンを送達するシステム、及びユーザーのグルコースの変化に対するシステム応答を検出する関連方法に関する。可視化ツールは、意味のあるデータ解析を可能にし、また治療決定を支持することによってインスリン治療を向上させるために使用することもできる。
Claims (19)
- インスリン送達システムであって、
インスリン送達をベースライン送達速度に対して調節するように制御可能なポンプと、
患者のグルコースレベルを測定するためのセンサと、
前記ポンプ及び前記センサに連結されたコントローラであって、前記ポンプ及び前記センサからの測定信号を利用する自律的調節アルゴリズムに基づいてインスリン送達を算出するように構成された、コントローラと、
前記コントローラと係合可能な可視化及び解析ツールであって、少なくとも1つの活動事象の検出及び表示を可能にする、可視化及び解析ツールと、を含み、前記コントローラは、スケジュールされたインスリン送達を前記システムによるインスリンの実際の送達と比較し、前記スケジュールされたインスリン及び前記送達されたインスリンの両方の周期的なサンプル平均化に基づいて前記少なくとも1つの活動事象の存在を決定する、インスリン送達システム。 - 前記コントローラが、ある期間にわたる前記システムによって行われたインスリン送達及びスケジュールされた基礎レートの逐次平均化を実施するように構成されており、前記少なくとも1つの活動事象の前記検出は、システムによって送達されたインスリンの量の、対応するスケジュールされた量に対する比が、治療的に妥当な比よりも小さいか又は大きいかに基づいている、請求項1に記載の送達システム。
- 前記少なくとも1つの活動事象は、システムによって送達されたインスリンの、対応するスケジュールされた量に対する比が、治療的に妥当な比より小さいときの低血糖活動事象、又はシステムによって送達されたインスリンの量の比が治療的に妥当な比より大きいときの高血糖活動事象のいずれかとして指定される、請求項2に記載の送達システム。
- 前記可視化及び解析ツールが、長期間にわたってプロットを作成し、検出された活動事象の回数は、長期間にわたって時刻に基づいて表示される、請求項1に記載の送達システム。
- 前記長期間が、1週間超である、請求項4に記載の送達システム。
- 前記長期間が、2週間超である、請求項4に記載の送達システム。
- 前記コントローラによる前記インスリンの送達が、モデル予測制御によって決定される、請求項1に記載の送達システム。
- 前記長期間が、選択可能である、請求項4に記載の送達システム。
- システムデータは、前記ツールによって、少なくとも1つの表形式で表示される、請求項1に記載の送達システム。
- 前記少なくとも1つの活動事象は、前記センサによって検出された患者のグルコースレベルが依然として許容可能な目標範囲内にある間でも発生し得る、請求項1に記載の送達システム。
- インスリン送達システムを改善するための方法であって、前記システムは、インスリン送達デバイスと、患者のグルコースレベルを測定するための少なくとも1つのセンサと、自律的調節に基づいて前記インスリン送達デバイスによってインスリンを送達するように構成されたコントローラと、を含み、前記方法が、
前記センサからのグルコースレベルデータ及びポンプからのインスリン送達データを可視化ツールに提供する工程と、
自律的調節送達アルゴリズに基づいて前記システムによって送達されたインスリンと所定の基礎レートとの間の所定の差異に基づいて、少なくとも1つの活動事象を検出及び表示する工程と、を含む、方法。 - 前記検出工程が、
所定の時刻に関して、予想されるインスリン送達を、インスリンの実際の送達と比較することを更に含む、請求項11に記載の方法。 - 前記検出工程が、所定の時間的間隔にわたって前記システムによって行われたインスリン送達及び基礎レートの逐次平均化と、システムによって送達されたインスリンと所定の基礎レートとを比較した少なくとも2つの連続した平均が、所定の閾値を満たすことを決定することと、を更に含む、請求項12に記載の方法。
- 前記活動事象が所定の期間にわたって存在することを示す、少なくとも1つのプロット又は表を表示する工程を含む、請求項13に記載の方法。
- 前記所定の期間が長期間であり、前記方法が、検出された活動事象の回数を前記長期間にわたって時刻に基づいて詳細に示すグラフィカルプロットを作成及び表示する工程を更に含む、請求項14に記載の方法。
- 前記長期間が、1週間超である、請求項15に記載の方法。
- 前記長期間が、2週間超である、請求項15に記載の方法。
- 前記少なくとも1つの検出及び表示された活動事象は、前記センサによって測定された患者のグルコースレベルが依然として許容可能な目標範囲内にある間でも発生し得る、請求項14に記載の方法。
- 自律的調節が、モデル予測制御によって行われる、請求項11に記載の方法。
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US201662291792P | 2016-02-05 | 2016-02-05 | |
US62/291,792 | 2016-02-05 | ||
PCT/US2017/014291 WO2017136155A1 (en) | 2016-02-05 | 2017-01-20 | Visualization and analysis tool for a drug delivery system |
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JP2019509085A true JP2019509085A (ja) | 2019-04-04 |
JP6976957B2 JP6976957B2 (ja) | 2021-12-08 |
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US (1) | US10583249B2 (ja) |
EP (1) | EP3411109A4 (ja) |
JP (1) | JP6976957B2 (ja) |
KR (1) | KR20180109980A (ja) |
CN (1) | CN108697880B (ja) |
AU (1) | AU2017216336B2 (ja) |
BR (1) | BR112018015910A2 (ja) |
CA (1) | CA3012444C (ja) |
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JP7481036B2 (ja) | 2020-03-23 | 2024-05-10 | イーオーフロウ カンパニー リミテッド | 薬液注入制御方法及びコンピュータプログラム |
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US11432720B2 (en) * | 2017-08-18 | 2022-09-06 | Nicolette, Inc. | Portable device having user interface for visualizing data from medical monitoring and laboratory equipment |
US10818390B1 (en) * | 2017-12-27 | 2020-10-27 | Verily Life Sciences Llc | Pattern discovery in continuous glucose monitoring data |
CN111632228B (zh) * | 2020-05-19 | 2021-05-25 | 中国科学院深圳先进技术研究院 | 一种基于可穿戴监测方法的闭环人工胰腺系统 |
CN116705230B (zh) * | 2023-06-15 | 2023-12-19 | 北京理工大学 | 具有胰岛素灵敏度自适应估计的mdi决策系统及方法 |
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AU2017216336A1 (en) | 2018-08-23 |
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CA3012444A1 (en) | 2017-08-10 |
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BR112018015910A2 (pt) | 2018-12-26 |
CA3012444C (en) | 2022-06-14 |
WO2017136155A1 (en) | 2017-08-10 |
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JP6976957B2 (ja) | 2021-12-08 |
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