Ultimate Solution. for Healthy Life. HANBYUL Overview

Transcription

1 Ultimate Solution for Healthy Life

2 1. SP-S2 / SP-S3 (electronic stethoscope) 2. PP-2000 (diagnosis system for atherosclerosis) 3. GAON21A (diagnosis system for cardiac function) 4. ER-1000 (single channel portable ECG device) 5. Sleep Sense (snore detection sensor / algorithm) 6. Pulse Sense (heart rate detection sensor / algorithm)

3 1. Electronic Stethoscope (SP-S2 / SP-S3) Provides clear and loud sounds (26dB amplification) Improves low frequency sounds characteristics with the use of PVDF contact microphone Analog output port for the transmission of sounds (SP-S2) 3V Lithium Battery (SP-S2) / 1.5V AAA battery (SP-S3) High performance speaker for clear and loud sounds PVDF contact microphone Heart/Lung sounds Analysis software - Realtime display and analysis of the sounds Possible to share the sounds with others Mode selection (Bell / Diaphragm / Wide) MPU controlled automatic power off (3 minutes) Digital volume control Application Area Listening and diagnosing heart & lung disease Application for healthcare home network system : transmission of the sounds to the remote health centers Research & education : acquisition and storage of the sound signals for analysis / teach the students with audio outputs Good for oriental medicine and animal clinics as well as hospitals 1

4 2. Diagnosis System for Atherosclerosis (PP-2000) PWV (pulse wave velocity) Young normal aorta Old stiff aorta - flow wave : flow of the blood itself - doppler - diameter wave : diameter change (volume change) of the artery Infrared - pressure wave : waveform through the arterial wall pressure sensor 2

5 2. Diagnosis System for Atherosclerosis (PP-2000) PWV (Pulse Wave Velocity) : Velocities of Pulse waves traveling through the arterial wall between two recording sites provides useful noninvasive index for diagnosing arterial aging and stiffness Carotid artery PCG Sensor ECG Electrode PTT 1 PTT 2 Radial artery Femoral artery PWV = Distance PTT 1 Dorsalis Pedis artery High PWV reflects arterial aging caused by decreasing arterial elasticity and increasing systolic pressure 3

6 2. Diagnosis System for Atherosclerosis (PP-2000) Measurement of an elasticity of the arteries based on PWV (pulse wave velocity) theory Quantitative diagnosis : compliance of the arteries / risk factors for specific vascular disease Possible to measure regional (aorta, arm, leg) PWVs : carotid artery, radial artery, femoral artery, dorsalis pedis artery Easy to follow up the patient s treatment effect PWV (pulse wave velocity) Measurement - Sensor technology - Signal processing PWV (pulse wave velocity) Measurement - System integration - User interface technology Diagnosis Report - Clinical evaluation - Clinical database Carotid artery ECG Electrode Carotid Femoral Radial artery Femoral artery PTT 1 PTT 2 Dorsalis Pedis artery Radial Dorsalis Low arterial compliance high PWV value Regional PWV values Application Area Cardiac center, diabetic center, health check center Diagnosis for arterial aging and arterial stiffness Diagnosis for central and peripheral arterial disease Diagnosis for metabolic syndrome Degree of arterial stiffness Risk factors for disease 4

7 3. Diagnosis System for Cardiac Function (GAON21A) forward wave from the heart reflected from bifurcation 5

8 3. Diagnosis System for Cardiac Function (GAON21A) Carotid Pulse (Young Normal Aorta) Resistance artery 6

9 3. Diagnosis System for Cardiac Function (GAON21A) Carotid Pulse (Old Stiff Aorta) Resistance artery 7

10 (mmhg) (mmhg) 3. Diagnosis System for Cardiac Function (GAON21A) - stiffness Increased Left Ventricular Load (LV) Aortic Systole (msec) Diastole Reducing the Coronary Artery Pressure Aortic Systole (msec) Diastole The area under the pressure-time curve during systole is by definition of LV load Increase in LV load accelerates increase in LV mass and increases risk of LV hypertrophy The pressure that is perfusing the coronary arteries during the critical diastole period is reduced increasing the risk of myocardial ischemias 8

11 3. Diagnosis System for Cardiac Function (GAON21A) AIx (Augmentation Index) Definition : AIx(%) = AG/PP*100 AG : Augmentation PP : Pulse Pressure 9

12 3. Diagnosis System for Cardiac Function (GAON21A) Central Blood Pressure A Study for the comparison of newly developed medicines Atenolol/Bendroflumethiazide vs. Amlodipine/Perindopril New medicine reduced the fatal and non-fatal Stroke up to 23% New medicine reduced the death rate caused by cardiovascular disease and myocardial infarction up to 16% However, there were no differences in the Brachial Blood Pressure values ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) CAFE (conduit artery function evaluation) 10

13 3. Diagnosis System for Cardiac Function (GAON21A) Central Pressure (Comparison between Actual and Estimated) RADI pressure wire SBP Analysis system PP 11

14 3. Diagnosis System for Cardiac Function (GAON21A) Simple and accurate measurement of radial arterial pulse using multi-array pressure sensors Estimation of central aortic pulse waveform from radial arterial pulse using transfer function Application of PWA (pulse wave analysis) : central blood pressure, augmentation index (AIx), and various valuable indices Quantitative diagnosis for cardiac function specifically focused on the aorta Measurement of radial pressure pulse - Multiple array sensor technology - Application of tonometry sensor PWA (pulse wave analysis) - Transfer function & signal processing - System integration Diagnosis Report - Clinical evaluation - Clinical database R 1 R 9.36mm R 4.5mm R 5.5mm 5.2mm 4-array Pressure PCB Connector sensor Sensor Housing Gel central Transfer function Sensing element Sensor PCB mm Gel Bonding Sensor Housing *Connector Pin No.( ) 1: Power 2~ 9: Sensor signal 10: GND Accurate measure of radial pulse - Single sensor is not enough for coverage - Use of applanation tonometry sensor radial Clinical Evaluation Central pressure waveform - Blood pressure - Aortic stiffness (AIx) Radial blood pressure Central blood pressure Degree of arterial stiffness Application Area Internal medicine, cardiac center, and health check center Cardiovascular function test Diagnosis for coronary artery disease Diagnosis for metabolic syndrome Risk factors for disease 12

15 4. Single Channel Portable ECG Device (ER-1000) Abnormal ECG waveforms do not appear continuously (it appears intermittently) It is necessary to measure ECG waveform at the time of chest pain, under stress, or other related symptoms The device stores the raw waveforms and provides preliminary analysis results for 30 seconds of ECG waveforms Clinicians could download the patient s ECG waveforms and diagnose based on the waveforms Biomeasurement Technology - Analog circuit design - Signal processing (ECG analysis) System integration - Firmware technology and data transmission - User interface technology Diagnosis & Management - Clinical evaluation - Clinical database USB Data transmission data acquisition : 30 seconds data storage : 300 diagnosis : 13 categories data transmission : USB Printout 30 seconds of ECG waveform Normal waveform without symptom Application Area Cardiac center, internal medicine, oriental medicine Carries the device and measure ECG whenever the symptom appears Diagnosis for various arrhythmic heart activities Replaces the current Holter monitor and Event recorder Abnormal waveform at the time of having chest pain and dizziness 13

16 5. Snore Detection Sensor / Algorithm (Sleep Sense) Detection of snoring without any sensor attachment to the user : sensors are placed inside the pillow Accurate algorithm discriminate the snoring sounds from movement or ambient noise Upon snoring detection, pump inside the pillow will inflate the airbag inside the pillow (3 levels of inflation) Movement of the neck and head by inflated airbag provides airway through trachea, and snoring stops Detection of snoring - Sensor technology : use of PVDF contact microphone - Digital signal processing Inflation of airbag upon snoring detection - System integration and user interface technology - Motor driving technology Contact microphone inside the pillow - detection of vibration (not the sound) transmitted through bone - strong for ambient noise Analysis algorithm for extracting snoring sound from ambient noise - filtering, enveloping, thresholding - snoring pattern (shallow or deep) could be obtained Sleep sense Pillow Operating switches and connectors Operation of pump once the snoring is detected - inflation of airbag inside the pillow - move the head and neck to allow air flow through trachea Application Area Consumer product to be used at home Diagnosis for clinical sleep disorders Stored snoring data could be analyzed by clinicians for diagnosis Cardiac centers are interested in sleep disorders because it is related to the vascular disease 14

17 6. Heart Rate Detection Sensor / Algorithm (Pulse Sense) Sensor design for detecting radial pulse : MEAS s PVDF sensors Signal processing algorithm for calculating heart rate Application of sensor and algorithm in the wrist watch device Alarm for emergency situation 15

18 Ongoing Projects 1. Short-term Projects 2. Mid-term Projects 3. Long-term Projects 16

19 1. Short-term Projects Wireless Electronic Stethoscope (Upgrade) Bluetooth-based wireless transmission of the sound - transmitter : stethoscope chest piece - receiver : PC, headset, and speaker Rechargeable battery Selection of heart sound or lung sound Ambient noise reduction Single Channel ECG Device (Upgrade) Transmission of the data using USB / Bluetooth Utilized for the home healthcare service Adopted to the Intel/LG s PHS5000 system Sleep Monitoring Pillow / Pad Transmission of sleep data to the PHS5000 respiration Sleep Comfortness Heart rate Display raw data Signal processing Body movement - sleep comfortness - deep sleep / sleep pattern LG CNS & Intel s PHS5000 Development Plan Specifications Applications Step 1 Step 2 Step 3 Adopted to the PHS5000 Clinical use Consumer product noninvasive/nonintrusive measurement use of pressure sensor and PVDF Monitoring signals : heart rate, respiration, snoring, and body movement Monitoring of sleep disorders Providing sleep habit adjustment Received 5sets of prototype order from MEAS, USA Adopted to the home healthcare system : LG CNS & Intel Possible global marketing channel - Measurement Specialties (USA) - Nihon Koden (Japan), Mitzubishi (Japan) 17

20 Sleep Monitoring (Sleep Doctor) Acquire physiological data during sleep : heart rate, respiration, body movement, and snoring Provide quantitative values to be used by clinicians for diagnosis Follow up the trends of daily changes as well as during one night sleep Data acquisition without sensor attachment to the user : sensors are placed inside the pillow and pad Display acquired sleep data Display time information Hourly variation of sleep data Overall sleep evaluation - average heart rate - average respiratory rate - ratio of snoring time - ratio of body movement time Daily variation of sleep data Application Area Evaluation of the sleep status for providing appropriate care during daytime Sleep study at home Deciding appropriate feedback for comfortable sleep such as providing proper light, sound, or temperature changes Emergency call for the hospital in case of sleep disorders such as apnea 18

21 2. Mid-term Project Wrist Watch-type Cuffless Blood Pressure Monitoring Device BP (blood pressure) values continuously fluctuate 24 hours, and BP values drops during sleep at night (dipper status) If BP values do not drop during sleep at night, vascular-related disease risk factor increases The best way of measuring BP is 24-hour continuous monitoring Central aortic BP values are much more important than traditional brachial BP values CAFE (conduit artery function evaluation) Study Central BP tells much more than Brachial BP Normal Dipper Reverse Dipper Non-Dipper It s time to adopt central BP measurement Preliminary Study with Samsung Electronics (Proto development) - Wrist watch-type cuffless BP device - Compare results with existing manual and automatic BP devices - Provides better performance than existing devices Developed Proto Sample manual automatic proto Highest correlation Development Plan Specifications Applications Step 1 Brachial BP pressure sensor design for radial pulse detection (MEAS, USA) calibration of force applied to the radial artery utilize existing reliable automatic BP device (cooperation with A&D, Japan) Step 2 Brachial & central BP without using calibration BP device Step 3 Brachial BP/ central BP / aortic stiffness estimation of central BP values using transfer function use of existing technology of PP-2000 and GAON adoption to the PHS5000 Marketing channel - MEAS, USA - A&D, Japan 19

22 Paradigm Change of BP Monitoring Traditional Automatic Cuffless 20

23 24-Hour Blood pressure Monitoring Blood Pressure Values Tells the Status of Cardiovascular Activities More Important Factor is Despite more stringent hypertension treatment guidelines and new classes of anti-hypertensive agents being used the reduction in incidences of strokes and heart attacks have not been very encouraging. Your BP Fluctuates over the 24-hour period!!! It s time we adopt a different approach to the management of hypertension! 21

24 Dipper Status Normal Dipper Reverse Dipper Normal Pattern Nocturnal Hypertension Extreme Dipper Non-Dipper Systolic & Diastolic Hypertension with Night-Time Drop Systolic & Diastolic Hypertension without Night-Time Drop 22

25 Importance of Dipper Status 25% 20% 22.0% 15% 12.0% 10% 7.6% 5% 6.1% 0% Extreme Dippers Dippers Non-Dippers Reverse Dippers Kario, K. et al., Stroke prognosis and abnormal nocturnal blood pressure falls in older hypertensives, Hypertension, 38(4), 852-7, Intra-Cranial Haemorrhage Occurrence of Ischemic Strokes During Sleep 30% 29.0% 30% 27.0% 20% 20% 10% 7.7% 10% 8.6% 0% Other Subgroups Reverse Dippers 0% Extreme Dippers Other Subgroups 23

26 Importance of ABPM Superiority of Ambulatory over Clinic Blood Pressure Measurement in Predicting Mortality, Eamon Dolan et al., Hypertension, 46: , ABPM is a stronger predictor of cardiovascular mortality than CBPM Nighttime is superior to daytime ABPM in predicting cardiovascular mortality Allows the practice of evidence-based medicine, allowing customization of treatment options for the individuals: a) what (which class, long- or short-acting); b) when (time to take the drug); c) how much (dosage adjustment); anti-hypertensive drug to give. 24

27 Preliminary Studies Proto #1 Single sensor Proto #2 4-array sensor Proto #3 4-array sensor and ECG 25

28 Preliminary Studies (Evaluation) Sphygmomanometer Automatic device Proto Systolic Sphygmomanometer Automatic device Proto Diastolic 26

29 IP Status (cuffless BP monitoring device and methods) IP number Drawings Pending P 시작 601 제 1 구간설정 ( T 1 ~T 2) - T 1 : 1 차미분최고점 - T2 : systolic peak 차미분수행 개 양의기울기 영점교차수 2 개이상 존재하지않는경우 2 차미분수행 V a l l e y 최대인영점교차 개양의기울기 2 개이상영점교차수존재하지않는경우 3 차미분수행 최대 p e a k 와그다음 p e a k 크기비교 개이상 음의기울기 Registered 영점교차수존재하지 2 0% 이하 1 개 V a l l e y 최대인영점교차 L P F C u ff 을 1 5H z 로변경후 이상 않는경우절흔점검출제 2 구간설정 (T 2~ T 3 ) - T 2 : s y s t o l i c p e ak - T 3 : d i c r o t i c n o t c h A V a l l e y 최대인 621 영점교차 A 구간설정 ( 1 차미분신호의최대 v al l e y ~ 전체 p u l s e 의 2 /3 ) 필터링 619 A 차미분수행 1 차미분수행 A3 A 존재하는경우양의기울기영점교차수존재하지않는경우 2 차미분수행 개음의기울기영점교차수존재하지않는경우 V a l l e y 최대인 3 차미분수행 영점교차 양의기울기영점교차수존재하지않는경우 2 차미분수행 2 개이상 641 존재하는경우 A7 A9 존재하는경우 음의기울기영점교차수존재하지 A13 않는경우첫번째영점교차 3 차미분수행 643 A 음의기울기영점교차수 1 개 A u g m e n ta ti o n p o i n t 2 개이상 647 V a l l e y 최대인영점교차 양의기울기를갖는 영점교차들중 R a d i a l 절흔점과근접한영점교차 절흔점 A15 A17 종료

30 3. Long-term Project U-Healthcare Monitoring Module Increase the quality of life by changing healthcare paradigm from hospital to residential Control of metabolic syndrome : hypertension / Obesity / Diabetes / Dyslipidemia - 24-hour BP monitoring, quantify calorie consumption, and alarm arrhythmia and sudden cardiac death Daily monitoring of critical healthcare information at home helps doctors for accurate diagnosis Reduce medical expenses by early detection of serious disease Diet Manager blood pressure blood glucose Healthcare Devices Interface module Healthcare Network Server Cyber Doctor Health Trainer ECG Calorie tracker Stress evaluation body fat Weight Waist size Development Plan Specifications Applications Step 1 Step 2 Well-being management service Ambulance call system Management of metabolic syndrome and 24-hour BP Management of calorie consumption by analyzing activity Diagnosing heart activity based on ECG analysis Cyber Doctor (Healthcare) : health diary and health manager Diet Manager (Nutrient) : healthy food recipe Health Trainer (Exercise) : guide for exercise / beauty service Service specialization - food/dietary company - beauty related company - insurance company - credit card company 1:1 personal healthcare fitting service 28