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臨床は薬事申請中

現在は、米国では、非臨床、
治験、創薬、医学研究、
及び動物、ラット等
で使用されています



ブルーツース搭載の無線で連続測定

非観血連続測定
ワイヤレス血圧計


従来にない小型で携帯可が特徴

研究用、実験用、試験用、教育用

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Non-invasive Blood Pressure Analyzer

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医学ご研究のテーマを提言


米国 Empirical Technologies 社が開発した ワイヤレス 非観血血圧計は、 リアルタイムな血圧情報を提供します。
それは、波形と数値及び波形解析数値です。 下記のような医学のテーマを非観血に行えます。
また、同時に、心拍のRR間隔の テキストファイルが出力されています。
また、MRI中のオンラインかつリアルタイム計測が可能です。
特に、心臓からの第一波を正確に抽出する方法は、観血式血圧測定と同等な結果を 提供しています。

1、 人体の動きによる血圧波形と値の変化、自律神経変化
2、 定期的な測定、一定時間、一定期間毎の測定
3、 人体への負荷による血圧波形と値の変化、自律神経変化
4、 血管の変化、血流の変化、心拍出量の変化に対する血圧の応答、
5、 肝臓、腎臓、末梢などの病気の変化
6、 薬効効果に対する血圧波形と値の変化、自律神経変化
7、 感情や心の動きによる血圧波形と値の変化、自律神経変化
8、 MRI中、fMRI中の計測
9、 アルツファイマ―、難病などの兆候の発見の研究
10、 遠隔診療法への適応
11、 心カテ、血管造影中の計測
12、 其の他新分野計測、

観血血圧のケアテイカの血圧値は、観血血圧の相当することが証明されました、
米国FDAに認可されました、


httpswww.ncbi.nlm.nih.govpmcarticlesPMC5361833
BMC Anesthesiol. 2017; 17: 48.
Published online 2017 Mar 21. doi: 10.1186/s12871-017-0337-z
Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgeryIrwin Gratz,1 Edward Deal,1 Francis Spitz,1 Martin Baruch,2 I. Elaine Allen,3 Julia E. Seaman,4 Erin Pukenas,1 and Smith Jean1Author information Article notes Copyright and License information DisclaimerThis article has been cited by other articles in PMC.
Background
Despite increased interest in non-invasive arterial pressure monitoring, the majority of commercially available technologies have failed to satisfy the limits established for the validation of automatic arterial pressure monitoring by the Association for the Advancement of Medical Instrumentation (AAMI). According to the ANSI/AAMI/ISO 81060–2:2013 standards, the group-average accuracy and precision are defined as acceptable if bias is not greater than 5 mmHg and standard deviation is not greater than 8 mmHg. In this study, these standards are used to evaluate the CareTaker® (CT) device, a device measuring continuous non-invasive blood pressure via a pulse contour algorithm called Pulse Decomposition Analysis.
Methods
A convenience sample of 24 patients scheduled for major abdominal surgery were consented to participate in this IRB approved pilot study. Each patient was monitored with a radial arterial catheter and CT using a finger cuff applied to the contralateral thumb. Hemodynamic variables were measured and analyzed from both devices for the first thirty minutes of the surgical procedure including the induction of anesthesia. The mean arterial pressure (MAP), systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements, a Bland-Altman analysis, and polar and 4Q plots were created.
Results
The correlation of systolic, diastolic, and mean arterial pressures were 0.92, 0.86, 0.91, respectively (p<0.0001 for all the comparisons). The Bland-Altman comparison yielded a bias (as measured by overall mean difference) of −0.57, −2.52, 1.01 mmHg for systolic, diastolic, and mean arterial pressures, respectively with a standard deviation of 7.34, 6.47, 5.33 mmHg for systolic, diastolic, and mean arterial pressures, respectively (p<0.001 for all comparisons). The polar plot indicates little bias between the two methods (90%/95% CI at 31.5°/52°, respectively, overall bias=1.5°) with only a small percentage of points outside these lines. The 4Q plot indicates good concordance and no bias between the methods.
ConclusionsIn this study, blood pressure measured using the non-invasive CT device was shown to correlate well with the arterial catheter measurements. Larger studies are needed to confirm these results in more varied settings. Most patients exhibited very good agreement between methods. Results were well within the limits established for the validation of automatic arterial pressure monitoring by the AAMI.



MRI 中の バイタルサイン監視に最適であることが判明しました

タイプ4-薬事未認可


観血血圧波形と同じ波形を表示します。

非臨床用、研究用、実験用、スポーツ用、等に対して、デモ器をご用意しました。

ご要請をお待ちしております。

なお、メーカよりの指示で、当面、臨床用には、販売致しません。臨床用のモデルが製造され次第、薬事申請致します。




細い透明なプラスティックチューブを、厚い扉の角から中へ、臨時に通しています

想定されるご研究

高血圧研究、低血圧研究、

心疾患研究、血管研究、

糖尿病、腎臓病、肝臓病、

末梢血管研究、

神経研究、脳血管研究、等



基本的原理

1、 当ソフトウエアは、指の動脈波形を分析します

2、 この波形は、三つの異なった波形の合成です。

3、 その第一の波形(P1)が、心臓から送られてくる駆出波です。

4、 その第二の波形(P2)が、胸部大動脈と腹部大動脈の繋ぎ部からの反射波です。

5、 その第三の波形(P3)が、腹部大動脈と脚部動脈との繋ぎ部からの反射波です。

6、 当ソフトウエアは、この三つの振幅と時間差を解析して、血圧波とそれらの値と、
血管パラメータを表示します。



無線連続非観血血圧計が提示する機能と今後の応用の期待

1、一拍毎の、リアルタイムの血圧波・血圧値を表示します

2、出血度合いを測定し、表示できるように思われます

3、心拍数を心電図より、より正確に測定しています

4、大動脈瘤の検出と位置を検診の際に診断できる能力があるように思われます

5、心疾患を診断できるように思われます。各種心疾患診断との併用等

6、夜行性高血圧症を検診、或いは予後診断できるように思われます

7、睡眠障害を検診、或いは予後診断できるように思われます 8、電話回線による常時監視に容易に応用できます

9、呼吸パターン、不整脈パターンを解析できるように思われます

10、透析中、集中治療中、手術中、カテ中、各種治療中、救急車中、等の測定

11、パソコン心電図、パソコン超音波診断、パソコン各種診断との同時使用等の測定

12、MRI,CT,X線診断との併用の可能性  他に新しい診断方法をご提供できるように思われます。


2010年最新海外文献紹介
(日本の先生も引用多数)
代表的な文献はこちら
カタログ ダウンロード表紙  二頁   三頁   四頁

パンフレット

歴史的新機能が検証されました、非観血で、観血相当血圧をモニターできます、

httpswww.ncbi.nlm.nih.govpmcarticlesPMC5361833

 

BMC Anesthesiol. 2017; 17: 48.

Published online 2017 Mar 21. doi: 10.1186/s12871-017-0337-z

PMCID: PMC5361833

PMID: 28327093

Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery

Irwin Gratz,1 Edward Deal,1 Francis Spitz,1 Martin Baruch,2 I. Elaine Allen,3 Julia E. Seaman,4 Erin Pukenas,1 and Smith Jean1

Author information Article notes Copyright and License information Disclaimer

This article has been cited by other articles in PMC.

 

Associated Data

Data Availability Statement

The datasets generated during and analysed for the current study are available from the corresponding author on reasonable request.

 

Abstract

Background

Despite increased interest in non-invasive arterial pressure monitoring, the majority of commercially available technologies have failed to satisfy the limits established for the validation of automatic arterial pressure monitoring by the Association for the Advancement of Medical Instrumentation (AAMI). According to the ANSI/AAMI/ISO 81060–2:2013 standards, the group-average accuracy and precision are defined as acceptable if bias is not greater than 5 mmHg and standard deviation is not greater than 8 mmHg. In this study, these standards are used to evaluate the CareTaker® (CT) device, a device measuring continuous non-invasive blood pressure via a pulse contour algorithm called Pulse Decomposition Analysis.

Methods

A convenience sample of 24 patients scheduled for major abdominal surgery were consented to participate in this IRB approved pilot study. Each patient was monitored with a radial arterial catheter and CT using a finger cuff applied to the contralateral thumb. Hemodynamic variables were measured and analyzed from both devices for the first thirty minutes of the surgical procedure including the induction of anesthesia. The mean arterial pressure (MAP), systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements, a Bland-Altman analysis, and polar and 4Q plots were created.

Results

The correlation of systolic, diastolic, and mean arterial pressures were 0.92, 0.86, 0.91, respectively (p<0.0001 for all the comparisons). The Bland-Altman comparison yielded a bias (as measured by overall mean difference) of −0.57, −2.52, 1.01 mmHg for systolic, diastolic, and mean arterial pressures, respectively with a standard deviation of 7.34, 6.47, 5.33 mmHg for systolic, diastolic, and mean arterial pressures, respectively (p<0.001 for all comparisons). The polar plot indicates little bias between the two methods (90%/95% CI at 31.5°/52°, respectively, overall bias=1.5°) with only a small percentage of points outside these lines. The 4Q plot indicates good concordance and no bias between the methods.

Conclusions

In this study, blood pressure measured using the non-invasive CT device was shown to correlate well with the arterial catheter measurements. Larger studies are needed to confirm these results in more varied settings. Most patients exhibited very good agreement between methods. Results were well within the limits established for the validation of automatic arterial pressure monitoring by the AAMI.

Keywords: Non-Invasive, CareTaker, Central blood pressure, Finger cuff, Intra-Arterial pressure


文献の新規作成に最適な方法をご提供できるとご提案します

アナログ波形出力は、ディスクトップパソコンにDAボード追加必要となります

 海外研究の例 夜間低血糖値症、夜尿、睡眠障害、等の監視
CareTaker is a new Monitoring Device for the Detection and Warning of Nocturnal Hypoglycemia,
Nocturnal Dip, Sleep Disorders, and Adherence and Efficacy of Treatments.
CareTaker is a comfortable physiological monitor that can be worn all night without disturbing sleep.
It tracks blood pressure beat by beat, heart rate, heart rate variability, breathing rate,
blood pressure variability, hand temperature, and other parameters.
The device is the size of a bar of soap, fits in the palm of the hand, and
records physiological parameters for ten hours.


海外研究の例 胸部大動脈圧受容反射
experienced RE practitioners are able to control the baroreceptors of the thoracic aorta
in a unique fashion. The upshot is that RE practice may help keep
the thoracic aorta elastic, an important aspect of maintaining central blood pressure
and lasting cardiovascular health
.


海外研究の例 MRI下の血圧連続モニター
Continuous Noninvasive Blood Pressure for Human MRI Applications
The NIBP-MRI is a wireless and noninvasive physiological monitoring system
that tracks blood pressure, using Pulse- Decomposition Analysis (PDA) technology,
as well as heart rate. NIBP-MRI operates passively at a low constant coupling pressure of 40 mmHg.
After being provided a calibrated blood pressure reading, the device tracks blood pressure
by analyzing the timing and amplitudes of the primary left ventricular ejection pulse
as well as the arterial pulse reflections, at the middle phalange of the middle finger,
at the wrist, or upper arm.
The system provides relative, real-time, beat-to-beat pressure measurement values
during magnetic resonance imaging.


海外研究の例 Android でデータ収集
CareTaker Persona: blood pressure, heart rate, and other vitals. CareTaker Personal
Allows Android to interact with remote device using a comfortable,
finger cuff. Optional Bluetooth glucometer, oximeter, bathroom scale,
and thermometer can be slaved. Data automatically uploaded to a server.


ケアテイカのタイプが追加されます

初期のタイプ: ケアテイカ タイプ1、

テレメディシンタイプ(左図):ケアテイカ タイプ2、 スマートホンタイプ;ケアテイカ タイプ3



タイプ 1


タイプ 2


タイプ 3 

ディスクリート ウエイブレット法による、

基線安定、ノイズ除去で、P波自動検出により心房細動を自動解析します、

Theory of the P wave detection

The algorithm first finds the  the possible positive and negative wave peaks based on zero transition searching, then validates them with comparing to reference P waves.

The P wave detection needs high amplitude resolution. This value is better, than 0.6 uV / bit in the Cardiospy system.  With this resolution and the effective filter system which uses wavelet transformation, the Cardiospy system is able to detect P waves less than 50 uV of amplitude.

 

Validation of the P wave detector

The validation is carried out on 10 pcs 12 channel and 10 pcs 3 channel ECG reference records. The reference records include the P wave  annotation.  12 of the 20 records are taken from the MitBih database, 8 records are taken from the Labtech database (30000 – 30007). 

12 ch records

s0014lre, s0292lre, s0302lre, s0331lre, s0364lre, s0422_re, s0431_re, s0437_re, s0549_re, s0550_re

3 ch records

mgh001, mgh007, 30000, 30001, 30002, 30003, 30004, 30005, 30006, 30007

 

Validation result:

Sensitivity:                       95.42%

Positive predictivity:         97.16%


 

心房細動は、ディスクリート ウエイブレットにより、

基線安定化・ノイズ除去・サンプリングの自動調整等により、

世界で初めて低価格なパソコン式で可能にしました、

ご評価を期待申し上げます、
画像例は下記をご参照願います。

http://www.din.or.jp/~meditekn/medi_hp/
上記の一番下部に解説付きで、応用例を掲載

http://www.din.or.jp/~meditekn/medi_hp/duna/
http://www.din.or.jp/~meditekn/medi_hp/masterblue/
ラブテック社製マスターステップの使用例掲載

http://www.din.or.jp/~meditekn/medi_hp/duna2/
医大検査室での使用例、画面例及び記録例も掲載

http://www.din.or.jp/~meditekn/medi_hp/remoterunning12ecgs/
ソニーの超小型パソコンを利用したランニング仕様の用途例

http://www.din.or.jp/~meditekn/medi_hp/aerobicacc/
米国循環器学会で推奨された心臓病患者への心臓リハビリ法としての
エアロビックの効能についての発表

http://www.din.or.jp/~meditekn/medi_hp/gtec/
出力のRR間隔データの解析例、これは別売のソフトウエアとなります。

http://www.din.or.jp/~meditekn/medi_hp/stressdata/
負荷試験での重要な医学的指標、米国心臓病学会のスタンダードとして発布

http://www.din.or.jp/~meditekn/medi_hp/labtechholter/
ラブテックパソコンホルタのご紹介

http://www.din.or.jp/~meditekn/medi_hp/labtech1/
ラブテック社製品としてのパソコン式の利用価値 等を掲載しております。

アルテリオグラフ24 血管脈波検査装置 ハンガリ国Tensiomed社製 薬事認可取得済

ご注意:中心血圧及び関連パラメータは、薬事認可より除外されています、検証を求められています、

Central blood pressure: current evidence

and clinical importance

Carmel M. McEniery1*, John R. Cockcroft2, Mary J. Roman3,

Stanley S. Franklin4, and Ian B.Wilkinson1

1Clinical Pharmacology Unit, University of Cambridge, Addenbrooke’s Hospital, Box 110, Cambridge CB22QQ, UK; 2Department of Cardiology,Wales Heart Research Institute, Cardiff

CF14 4XN, UK; 3Division of Cardiology,Weill Cornell Medical College, New York, NY 10021, USA; and 4University of California, UCI School of Medicine, Irvine, CA 92697-4101, USA

Received 29 April 2013; revised 27 November 2013; accepted 17 December 2013; online publish-ahead-of-print 23 January 2014

and central pressure. Therefore, basing treatment decisions on central, rather than brachial pressure, is likely to have important implications

for the future diagnosis and management of hypertension. Such a paradigm shift will, however, require further, direct evidence that selectively

targeting central pressure, brings added benefit, over and above that already provided by brachial artery pressure.

Keywords Central pressure Blood pressure Anti-hypertensive treatment Cardiovascular risk

Introduction

The brachial cuff sphygmomanometer was introduced into medical

practice well over 100 years ago, enabling the routine, non-invasive,

measurement of arterial blood pressure. Life insurance companies

were among the first to capitalize on the information provided by

cuff sphygmomanometry, by observing that blood pressure in

largely asymptomatic individuals relates to future cardiovascular

risk—observations that are nowsupported by a wealth of epidemiological

data.1 The most recent Global Burden of Disease report2

identified hypertension as the leading cause of death and disability

worldwide. Moreover, data from over 50 years of randomized controlled

trials clearly demonstrate that lowering brachial pressure,

in hypertensive individuals, substantially reduces cardiovascular

events.1,3 For these reasons, measurement of brachial blood pressure

has become embedded in routine clinical assessment throughout the

developed world, and is one of the most widely accepted ‘surrogate

measures’ for regulatory bodies.

The major driving force for the continued use of brachial blood

pressure has been its ease of measurement, and the wide variety of

devices available for clinical use. However, we have known for over

half a century that brachial pressure is a poor surrogate for aortic

pressure, which is invariably lower than corresponding brachial

values. Recent evidence suggests that central pressure is also more

strongly related to future cardiovascular events4 7 than brachial

pressure, and responds differently to certain drugs.8,9 Appreciating

this provides an ideal framework for understanding the much publicized

inferiority of atenolol and some other beta-blockers,10 compared

with other drug classes, in the management of essential

hypertension. Although central pressure can now be assessed noninvasively

with the same ease as brachial pressure, clinicians are unlikely

to discard the brachial cuff sphygmomanometer without

robust evidence that cardiovascular risk stratification, and monitoring

response to therapy, are better when based on central rather

than peripheral pressure. Central pressure assessment and accuracy

will also have to be standardized, as it has been for brachial pressure

assessment with oscillometric devices. This review will discuss our

current understanding about central pressure and the evidence

required to bring blood pressure measurement, and cardiovascular

risk assessment into the modern era.

Physiological concepts

Arterial pressure varies continuously over the cardiac cycle, but in

clinical practice only systolic and diastolic pressures are routinely

reported. These are invariably measured in the brachial artery

using cuff sphygmomanometry—a practice that has changed little

over the last century. However, the shape of the pressure waveform

* Corresponding author. Tel: +44 1223 336806, Fax: +44 1223 216893, Email: cmm41@cam.ac.uk

Published on behalf of the European Society of Cardiology. All rights reserved. &The Author 2014. For permissions please email: journals.permissions@oup.com

European Heart Journal (2014) 35, 1719–1725 doi:10.1093/eurheartj/eht565

 

Pressure measured with a cuff and sphygmomanometer in the brachial artery is accepted as an important predictor of future cardiovascular risk.However, systolic pressure varies throughout the arterial tree, such that aortic (central) systolic pressure is actually lower than corresponding brachial values, although this difference is highly variable between individuals. Emerging evidence now suggests that central pressure is better related to future cardiovascular events than is brachial pressure. Moreover, anti-hypertensive drugs can exert differential effects on brachial and central pressure. Therefore, basing treatment decisions on central, rather than brachial pressure, is likely to have important implications for the future diagnosis and management of hypertension. Such a paradigm shift will, however, require further, direct evidence that selectively targeting central pressure, brings added benefit, over and above that already provided by brachial artery pressure.As discussed earlier, a full synthesis of the available evidence concerning

central pressure and the risk of future cardiovascular events is now required. However, it will also be necessary to determine the clinical relevance of differences between brachial and central pressure

for the individual patient, especially given the relatively high correlation between the two. Emerging data support the prognostic superiority of both 24-h ambulatory blood pressure monitoring

(ABPM)79 81 andhomemonitoring81 in comparison with office measurements. Interestingly, a recent study82 demonstrated that 24-h ambulatory cuff pressures were comparable with office central pressure

measurements in the prediction of risk, although the significance of this study awaits confirmation.83 As yet, there are no data comparing the predictive value ofhomemonitoring vs. central pressure in the

prediction of risk. Ultimately, it will be necessary to evaluate the prognostic value of 24-h ambulatory central pressure.With the recent development of ambulatory central pressure systems,84,85 this is now

possible and it may be reasonable to hypothesize that 24-h central, rather than brachial ABPM would be superior in terms of risk prediction.

Medical Teknika 高血圧、動脈硬化、脳卒中、心筋梗塞 ウエアラブル生体モニター
ホルター心電計 先天性心疾患ソフトウエア 多種類ワイヤレス
マイクロセンサー
ワイヤレス心電計 動脈硬化指標、中心血圧、非観血血 12誘導心電図伝送
非観血血圧波形連続測定
解析付きワイヤレス
救命救急用生体情報モニタ 医工連携

非観血血圧付き心電図ホルタの文献   負荷心電図検査の医学文献   

 エアロビックの効果   心電・血圧ホルタ記録器 ブルーツース     デュナ 

 デュナの実例     遠隔同時表示    ラブテック製品    Labtech products