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Development, evaluation, standard and regulation of cuffless blood pressure

Research Project

Project/Area Number 17K01440
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionWaseda University

Principal Investigator

Tamura Toshiyo  早稲田大学, 次世代ロボット研究機構, その他(招聘研究員) (10142259)

Project Period (FY) 2017-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2021)
Budget Amount *help
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2019: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2018: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2017: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywordsレギュラトリーサイエンス / カフレス血圧計 / 標準規格 / 医療機器承認 / レギュラトリサイエンス / 国際標準規格 / (独)医薬品医療機器総合機構 / 国際標準化機構 / 米国電気電子協議会規格委員会 / 国際標準化ISO / 血圧計 / カフレス / 光電脈波法(PPG) / 心電図(EEG) / 脈波伝搬時間(PWT) / 家庭内血圧 / ISO / レグラトリ―サイエンス / 光電脈波 / 心電図 / 脈波伝搬時間 / 医療・福祉 / 循環器・高血圧 / 標準 / 医療認証 / 健康機器
Outline of Final Research Achievements

Aims of this research are 1) To develop a cuffless sphygmomanometer and evaluate the device with static accuracy and long-term stability. 2) To propose a new standard of cuffless sphygmomanometer and 3) To discuss a suitable protocol to evaluate the cuffless sphygmomanometer. The results of this research show 1) developed cuffless sphygmomanometer had a good accuracy within 5±8 mmHg which is enough accuracy of cuff-based sphygmomanometer. 2) We proposed a standard of cuffless sphygmomanometer to ISO.TC121/S3/JWG7, but the proposal was rejected. 3) to discuss the regulatory authority of PMDA, the protocol of cuffless sphygmomanometer was good and the obtained accuracy, is acceptable, but the that of long-term stability continuously needed to improved.
In conclusion, the cuffless sphygmomanometer may use as an alternative blood pressure monitor and the accuracy, stability and reliability tests are required to approve as medical device.

Academic Significance and Societal Importance of the Research Achievements

カフレス血圧計は廉価で取扱いが容易で、精度、安定性が保証されれば、日常生活における在宅での健康管理や健診時のスクリーニングに最適である。今回の研究では、精度については満足できる結果を得ることはできた。今後医療機器としての承認に向けて安定性の検証を行い、医療機器として承認されれば、健康管理面での学問的、社会的意義は大きい。

Report

(6 results)
  • 2021 Annual Research Report   Final Research Report ( PDF )
  • 2020 Research-status Report
  • 2019 Research-status Report
  • 2018 Research-status Report
  • 2017 Research-status Report
  • Research Products

    (37 results)

All 2021 2020 2019 2018 2017

All Journal Article (11 results) (of which Int'l Joint Research: 4 results,  Peer Reviewed: 8 results,  Open Access: 7 results) Presentation (24 results) (of which Int'l Joint Research: 17 results,  Invited: 13 results) Book (2 results)

  • [Journal Article] Approval of Non-invasive Cuffless Blood Pressure Monitors : Report by the Strategic International Standards Promotion Committee for Non-Invasive Cardiovascular Monitors2021

    • Author(s)
      田村 俊世、山口 潤
    • Journal Title

      Transactions of Japanese Society for Medical and Biological Engineering

      Volume: 59 Issue: 2-3 Pages: 76-79

    • DOI

      10.11239/jsmbe.59.76

    • NAID

      130008079226

    • ISSN
      1347-443X, 1881-4379
    • Year and Date
      2021-06-10
    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Cuffless Blood Pressure Monitors: Principles, Standards and Approval for Medical Use2021

    • Author(s)
      Tamura Toshiyo
    • Journal Title

      IEICE Transactions on Communications

      Volume: E104.B Issue: 6 Pages: 580-586

    • DOI

      10.1587/transcom.2020HMI0002

    • NAID

      130008046541

    • ISSN
      0916-8516, 1745-1345
    • Year and Date
      2021-06-01
    • Related Report
      2021 Annual Research Report 2020 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Discussion of Cuffless Blood Pressure Prediction Using Plethysmograph Based on a Longitudinal Experiment: Is the Individual Model Necessary?2021

    • Author(s)
      Kido Koshiro、Chen Zheng、Huang Ming、Tamura Toshiyo、Chen Wei、Ono Naoaki、Takeuchi Masachika、Altaf-Ul-Amin Md.、Kanaya Shigehiko
    • Journal Title

      Life

      Volume: 12 Issue: 1 Pages: 11-11

    • DOI

      10.3390/life12010011

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Trends in International Standards for Cuffless Blood Pressure Monitors: Report on the 2019 Meeting of the Committee for Promotion of Strategic International Standardization of Non-Invasive Cardiovascular Monitors2020

    • Author(s)
      田村 俊世、山口 潤
    • Journal Title

      Transactions of Japanese Society for Medical and Biological Engineering

      Volume: 58 Issue: 4-5 Pages: 168-172

    • DOI

      10.11239/jsmbe.58.168

    • NAID

      130007931639

    • ISSN
      1347-443X, 1881-4379
    • Year and Date
      2020-09-10
    • Related Report
      2020 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Draft Proposal of an Optical Cuffless Blood Pressure Device2020

    • Author(s)
      Tamura Toshiyo、on behalf of strategic committee of new standard development
    • Journal Title

      Health and Technology

      Volume: 10 Issue: 5 Pages: 1129-1136

    • DOI

      10.1007/s12553-020-00435-4

    • Related Report
      2020 Research-status Report
    • Peer Reviewed
  • [Journal Article] ウェアラブルセンサ、非接触センサの医療応用2020

    • Author(s)
      田村 俊世
    • Journal Title

      医療機器学

      Volume: 90 Pages: 11-23

    • NAID

      130007831038

    • Related Report
      2019 Research-status Report
  • [Journal Article] カフレス血圧計開発の現状と今後2020

    • Author(s)
      田村 俊世
    • Journal Title

      医療機器学

      Volume: 90 Pages: 24-31

    • NAID

      130007831035

    • Related Report
      2019 Research-status Report
  • [Journal Article] Progress of Home Health Care Sensor in Our Experience: Development of Wearable and Unobtrusive Monitoring2019

    • Author(s)
      田村 俊世
    • Journal Title

      Transactions of Japanese Society for Medical and Biological Engineering

      Volume: 57 Issue: 4-5 Pages: 119-125

    • DOI

      10.11239/jsmbe.57.119

    • NAID

      130007769217

    • ISSN
      1347-443X, 1881-4379
    • Year and Date
      2019-09-10
    • Related Report
      2019 Research-status Report
    • Open Access
  • [Journal Article] Ubiquitous healthcare monitoring2019

    • Author(s)
      Park Kwang Suk、Tamura Toshiyo
    • Journal Title

      Biomedical Engineering Letters

      Volume: 9 Issue: 1 Pages: 1-2

    • DOI

      10.1007/s13534-019-00099-8

    • Related Report
      2018 Research-status Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Current progress of photoplethysmography and SPO2 for health monitoring2019

    • Author(s)
      Tamura Toshiyo
    • Journal Title

      Biomedical Engineering Letters

      Volume: 9 Issue: 1 Pages: 21-36

    • DOI

      10.1007/s13534-019-00097-w

    • Related Report
      2018 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] A Chair-Based Unobtrusive Cuffless Blood Pressure Monitoring System Based on Pulse Arrival Time.2017

    • Author(s)
      Tang Z, Tamura T, Sekine M, Huang M, Chen W, Yoshida M, Sakatani K, Kobayashi H, Kanaya S.
    • Journal Title

      IEEE J Biomed Health Inform.

      Volume: 21(5) Issue: 5 Pages: 1194-1205

    • DOI

      10.1109/jbhi.2016.2614962

    • Related Report
      2017 Research-status Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Presentation] Wearable sensors for cardiovascular monitoring2021

    • Author(s)
      Toshiyo Tamura
    • Organizer
      EEE EMBS WSAIM 2021
    • Related Report
      2021 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] A cuffless sphygmomanometer: Its effectiveness and limitations2021

    • Author(s)
      T.Tamura
    • Organizer
      IECBES2020
    • Related Report
      2020 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] The Relationship between Arterial Blood Pressure and Pulse Transit Time During Dynamic Exercise2020

    • Author(s)
      K.Hayashi, T.Toshimura, T.Tamura, and J.Yamaguchi
    • Organizer
      IEEE EMBC2020
    • Related Report
      2020 Research-status Report
    • Int'l Joint Research
  • [Presentation] 非侵襲連続血圧計の規格作成動向とカフレス血圧計の標準化2019

    • Author(s)
      田村俊世
    • Organizer
      日本生体医工学
    • Related Report
      2019 Research-status Report
    • Invited
  • [Presentation] Current healthcare system to monitor the blood pressure of clients with an unobtrusive device2019

    • Author(s)
      Tamura, Toshiyo
    • Organizer
      IEEE symposium on Medical Measurements ad Applications(MeMeA)
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] 連続血圧モニタリングにおける脈波伝播時間の検出方法に関する検討2019

    • Author(s)
      前田祐佳、関根正樹 田村俊世 水谷孝一
    • Organizer
      日本生体医工学
    • Related Report
      2019 Research-status Report
  • [Presentation] Current Development and Regulation of Continuous Blood Pressure Monitors in Japan2019

    • Author(s)
      Tamura, Toshiyo
    • Organizer
      IEEE Engineering in Medicine and Biology Conference 2019
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] The Fluctuation of Pulse Transit Time in Continuous Cuff-Less Blood Pressure Monitoring2019

    • Author(s)
      Maeda Y, Sekine M. Tamura, T and Mizutani K.
    • Organizer
      IEEE Engineering in Medicine and Biology Conference 2019
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Regulation and Approval of Continuous Non-invasive Blood-pressure Monitoring Devices2019

    • Author(s)
      Tamura Toshiyo
    • Organizer
      The 15th Mediterranean Conference on Medical and Biological Engineering and Computing.
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] U-healthcare in Japan Past-present and future2019

    • Author(s)
      Tamura Toshiyo
    • Organizer
      ソウル大学医学部生体医工学研究所40周年記念講演会
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] 最新の健康管理センサ2019

    • Author(s)
      田村俊世
    • Organizer
      最先端生体計測研究会2019
    • Related Report
      2019 Research-status Report
  • [Presentation] カフレス血圧計の標準化動向2018

    • Author(s)
      田村俊世
    • Organizer
      日本生体医工学会
    • Related Report
      2018 Research-status Report
  • [Presentation] Development of a Chair-based Cuffless Blood Pressure and a Work for Standardization2018

    • Author(s)
      Toshiyo Tamura
    • Organizer
      IUPESM
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] Developing Cuffless Blood Pressure Monitoring Devices in Japanese Industries2018

    • Author(s)
      Toshiyo Tamura
    • Organizer
      IEEEEMBC2018
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] The effect of measurement condition on cuffless and continuous monitoring of blood pressure in daily life2018

    • Author(s)
      Yuka Maeda. Msaki Sekine. Toshiyo Tamura, Kazuo Mizutani.
    • Organizer
      IEEEEMBC2018
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] The precision verification on pulse transit time detecting methods for cuff-less blood pressure monitoring2018

    • Author(s)
      Yuka Maeda. Msaki Sekine. Toshiyo Tamura, Kazuo Mizutan
    • Organizer
      LE2018ユビキタスヘルスケア部会オーガナイズドセッション
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] IoTによる健康管理とカフレス血圧推定の標準化への動向2018

    • Author(s)
      田村俊世
    • Organizer
      日本高血圧学会
    • Related Report
      2018 Research-status Report
    • Invited
  • [Presentation] 最新の生体計測の動向について2018

    • Author(s)
      田村俊世
    • Organizer
      最先端計測研究会
    • Related Report
      2018 Research-status Report
  • [Presentation] 循環系領域におけるConnected HealthcareとAI2018

    • Author(s)
      田村俊世
    • Organizer
      東日本医工学研究会
    • Related Report
      2018 Research-status Report
  • [Presentation] CONNECTED HEALTHCARE MONITORING2018

    • Author(s)
      Toshiyo Tamura
    • Organizer
      International conference on Electrical, Electronic, Communication and Control Engineering(ICEECC )
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] The 2025 problem -the near future of Japan’s aging-and connected healthcare2018

    • Author(s)
      Toshiyo Tamura
    • Organizer
      IEEE EMBS conference on Biomedical Engineering and Sciences (IECBES2018)
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Propose of connected healthcare system and its regulation2018

    • Author(s)
      Toshiyo Tamura
    • Organizer
      U-healthcare2018
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Development of a Chair-based cuffless blood pressure monitor and a work to standardization2017

    • Author(s)
      Toshiyo Tamura
    • Organizer
      IEEE EMBC2017 Workshop (Jeju Island, South Korea)
    • Related Report
      2017 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Current development of wearable and invisible blood pressure monitor and approach to the ISO standards2017

    • Author(s)
      Toshiyo Tamura, Zunyi Tang, Wenxi Chen, HIroshi Kobayashi
    • Organizer
      MDBS-BHE2017 (Shenzhen, China)
    • Related Report
      2017 Research-status Report
    • Int'l Joint Research / Invited
  • [Book] Seamless Healthcare Monitoring2018

    • Author(s)
      Toshiyo Tamura and Wenxi Chen
    • Total Pages
      469
    • Publisher
      SPringer Ineternatoinal Publishing AG
    • ISBN
      9783319693613
    • Related Report
      2018 Research-status Report
  • [Book] Seamless Healthcare MOnitoring2018

    • Author(s)
      Toshiyo Tamura and Wenxi Chen Eds.
    • Total Pages
      469
    • Publisher
      Springer
    • ISBN
      9783319693613
    • Related Report
      2017 Research-status Report

URL: 

Published: 2017-04-28   Modified: 2023-01-30  

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