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New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management WirelessContinuousSmall
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Medical Teknika Ltd.2 CareTaker™ Multi-Functional Vital Signs Monitor
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Medical Teknika Ltd.3 CareTaker™ Tracks beat by beat blood pressure in real time Measures and tracks hemorrhaging Measures pulse rate as accurately as ECG Appears to have screening capability for aortic aneurisms (detection and location) Appears to detect heart problems Useful for detection of nocturnal hypertension or sleep disorders Could easily be used as a full function monitor for trans-telephonic monitoring Records breathing patterns, arrhythmias, & more
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Medical Teknika Ltd.4 Old paradigm for pulse detection and recording The Sphygmograph 1850 to 1920
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Medical Teknika Ltd.5 Structure of Human Pulse -A New Paradigm for recording the pulse Diastolic Peak 115 ms 0.2 Seconds 121 ms 193 ms 172 ms 168 ms Second Systolic Peak Diastolic Floor Systolic Peak Pressure (mmHg) Actual, raw data, pulse pressure wave signature as detected by CareTaker™
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Medical Teknika Ltd.6 Old paradigm for pulse origins
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Medical Teknika Ltd.7 Origin of Human Pulse -A New Paradigm for where the pulse comes from ~ 17 % Reflection of Primary Pulse ~ 40 % Reflection of Primary Pulse Re-Reflections The Human Pulse as detected at the finger is composed of a primary pulse ejected from the heart followed by reflections (or echoes) – A widely misunderstood concept Latham, RD et. al, Regional wave travel and reflections along the human aorta: a study with six simultaneous micromanometric pressures. Circulation 72, 1985, 1257-69. Kriz J. et al, Force plate measurement of human hemodynamics, http://arxiv.org/abs/physics/0507135 http://arxiv.org/abs/physics/0507135
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Medical Teknika Ltd.8 Origin of the Pulse Pressure Wave #1 Primary systolic pulse -- P1 #2 Second systolic pulse (renal reflection) -- P2 #3 Diastolic pulse (iliac reflection) -- P3 #4 Resonance between #2 and #3 #5 More resonance between #2 and #3 #6 Aneurysm or damage to aorta ???
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Medical Teknika Ltd.9 Old paradigm for pulse analysis
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Medical Teknika Ltd.10 Pulse Wave Decomposition -A New Paradigm for analysis of the pulse Detect the heart beats and decompose them, beat by beat, in real time. –Measures heart rate and its variability (HRV) Calculate the peak height of the second systolic peak relative to the first: P2P1 –Tracks central systolic blood pressure –Measures breathing rate and pulsus paradoxus Calculate the time interval between the first peak and the third peak: T13 –Tracks central pulse pressure: systolic minus diastolic –Tracks hemorrhaging
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Medical Teknika Ltd.11 TECHNICAL APPROACH Capture the pulse pressure wave form Decompose the pulse into its constituent parts Relate the amplitudes of the constituent pulses and the arrival times referenced to the primary systolic pulse to: Blood pressure Systolic Diastolic Mean Perform this analysis on a beat-by-beat basis
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Medical Teknika Ltd.12 P1, P2, P3 are often visible Pulse of a 21 year old athlete with clearly discernible component pulses.
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Medical Teknika Ltd.13 Display for CareTaker Beat by beat blood pressure Raw data of pulse Reconstructed pulse Vertical lines show P1, P2, and P3 Individual pulse parameters Data saving options
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Medical Teknika Ltd.14 Tabs show parameter history Tab for observation of continuous blood pressure Tab for continuous observation of T13
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Medical Teknika Ltd.15 Beat by Beat Blood Pressure Example: dialysis Insert area showing breathing signal Red squares show automatic cuff measurement
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Medical Teknika Ltd.16 Lower Body Negative Pressure Chamber to Simulate Hemorrhage
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Medical Teknika Ltd.17 Detection of Occult Hemorrhage T13 is a parameter that tracks pulse pressure Pulse pressure has been correlated with hemorrhaging Normal T13 values for healthy adults are about 250 - 300 msec T13 changes during hemorrhaging and can be used as a monitor of hemorrhaging. A simulated hemorrhaging method was used on 15 volunteers
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Medical Teknika Ltd.18 T13 and Pulse Pressure Due to Simulated Hemorrhaging Subject #3 had zero observable effect in pulse pressure as measured by a conventional blood pressure system. T13 has marked effect and clear rebound after negative pressure release Oscillations due to breathing
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Medical Teknika Ltd.19 Palm Sized Caretaker New Design for Summer 2009 LCD for radio-free operation
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Medical Teknika Ltd.20 Using Lower Body Negative Pressure (LBNP) Chamber, verified that CareTaker can detect and monitor hemorrhaging Built and tested remote monitoring system for first responders – CareTaker, cellular engine, GPS, remote FTP site, automatic data logging Tested CareTaker on primates and dogs for pharmaceutical applications – cardiovascular risk of new drugs - ongoing Completed (NHLBI funded Phase I ) 43 dialysis runs, 23 runs compared to aortic catheter – provided verification of tracking ability and accuracy Completed 6 runs for aneurysm detection – before and after corrective surgery for NIH proposal – all were detected and located ACCOMPLISHMENTS
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Medical Teknika Ltd.21 Nocturnal Dip A potentially explosive health issue The next slides show –How daytime hypertension is not much of a problem even if untreated –How nocturnal hypertension is a big problem and needs to be treated immediately –Why is nocturnal BP dipping greater than 20% also a problem? Because kidneys, heart, and brain need reasonable blood pressure for perfusion to work
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Medical Teknika Ltd.22 Systolic blood pressure (mmHg) 2-year incidence of cardiovascular endpoints 0.20 0.16 0.12 0.08 0.04 0.00 90110130150170190210230 Night-time 24-h Daytime Conventional Conventional, 24-h, Daytime and Night-time SBP as Predictors of Cardiovascular Endpoints – Syst-Eur Placebo Cohort Staessen JA et al. JAMA 1999;282:539–46
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Medical Teknika Ltd.23 Night time 24-hour Daytime Clinic Night time 24-hour Daytime Clinic 5-YEAR RISK OF CARDIOVASCULAR DEATH Relation to Clinic and Ambulatory BP - The Dublin Outcome Study Adjusted for other covariates N = 5292 Dolan et al. Hypertension 2005;46:1-6
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Medical Teknika Ltd.24 IDACO - Characteristics by categories of the night:day ratio of SBP (n = 7458) IDACO - Characteristics by categories of the night:day ratio of SBP (n = 7458) Dipping class Limits Number of patients Women, % Age, y AH treatment, % Diabetes mellitus, % CV disorder, % extreme <0.80 1513 44.2 59 22 7 9 normal ≥0.80 to <0.90 3754 46.0 55 19 7 decreased ≥0.90 to <1.00 1754 47.4 57 25 8 9 reverse ≥1.00 437 42.6 63 37 12 14
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Medical Teknika Ltd.25 CONCLUSIONS –PORTABLE, BEAT-BY-BEAT BLOOD PRESSURE TRACKER Bluetooth enabled, 12 hour continuous use 4 ounces in weight, polyurethane finger cuffs Comfortable even during sleep –PORTABLE HEMORRHAGE DETECTOR –NEW VITAL SIGNS MONITOR IDEALLY SUITED FOR COMBAT CASULATY CARE EMERGENCY MEDICINE HOME CARE OTHER PARAMETERS SUCH AS CARDIAC OUTPUT CHANGES AND STROKE VOLUME CHANGES WILL BE ADDED
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