new vital signs monitor medical teknika ltd. stress testing activity monitoring diabetes monitoring...
TRANSCRIPT
New vital signs monitor
Medical Teknika Ltd.
• Stress Testing• Activity Monitoring• Diabetes Monitoring
• Metabolic Activity• Cardiology• Hypertension Management
Wireless Continuous Small
Medical Teknika Ltd. 2
CareTaker™ Multi-FunctionalVital Signs Monitor
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
Medical Teknika Ltd. 4
Old paradigm for pulse detection and recording
The Sphygmograph 1850 to 1920
Medical Teknika Ltd. 5
Structure of Human Pulse-A New Paradigm for recording the pulse
Diastolic Peak
115 ms
0.2 Seconds
121 ms193 ms
172 ms
168 ms
Second Systolic Peak
DiastolicFloor
SystolicPeak
Pre
ssur
e (m
mH
g)
Actual, raw data, pulse pressure wave signature as detected by CareTaker™
Medical Teknika Ltd. 6
Old paradigm for pulse origins
Medical Teknika Ltd. 7
Origin of Human Pulse -A New Paradigm for where the pulse comes from
Thoracic aorta5.2 m/s, 2.3 - 2.0 cm
Abdominal aorta5.7 - 9.2 m/s, 1.3 cm
Aortic arch 4.4 m/s, 2.6 cm
Iliac arteries 8.8 m/s, 0.79 cm
Radial Artery7.3 m/s, 0.30 cm
Brachial Artery7.3 m/s, 0.36 cm
Reflection Site I
Reflection Site II
Renal arteries
~ 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
Medical Teknika Ltd. 8
Origin of the Pulse Pressure Wave
Thoracic aorta5.2 m/s, 2.3 - 2.0 cm
Abdominal aorta5.7 - 9.2 m/s, 1.3 cm
Aortic arch 4.4 m/s, 2.6 cm
Iliac arteries 8.8 m/s, 0.79 cm
Radial Artery7.3 m/s, 0.30 cm
Brachial Artery7.3 m/s, 0.36 cm
Reflection Site I
Reflection Site II
Renal arteries
• #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 ???
Medical Teknika Ltd. 9
Old paradigm for pulse analysis
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
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
Medical Teknika Ltd. 12
P1, P2, P3 are often visible
Pulse of a 21 year old athlete with clearly discernible component pulses.
P3P2P1
Medical Teknika Ltd. 13
Display for CareTakerBeat by beat blood pressure
Raw data of pulse
Reconstructed pulseVertical lines show P1, P2, and P3
Individual pulse parameters
Data saving options
Medical Teknika Ltd. 14
Tabs show parameter history
Tab for observation of continuous blood pressure
Tab for continuous observation of T13
Medical Teknika Ltd. 15
0.0 0.5 1.0 1.5 2.0 2.50.8
0.9
1.0
1.1
1.2
1.3
1.4
1.5
146
148
150
152
154
156
158
160
162
164
P2
P1
Ra
tio
(u
nitle
ss)
Time (Hours)
CareTaker
Brachial Cuff Readings
Systo
lic B
loo
d P
ressu
re (
mm
Hg
)
0.0 0.5 1.0 1.5 2.0 2.5230
240
250
260
270
280
290
58
60
62
64
66
68
70
T1
3 D
ela
y T
ime
(m
illis
eco
nd
s)
Time (Hours)
CareTaker
Brachial Cuff Readings
Pu
lse
Pre
ssu
re (
mm
Hg
)
Beat by Beat Blood PressureExample: dialysis
Insert area showing breathing signal
Red squares showautomatic cuff measurement
Medical Teknika Ltd. 16
Lower Body Negative Pressure Chamber to Simulate Hemorrhage
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
Medical Teknika Ltd. 18
T13 and Pulse PressureDue 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
0 1000 2000 3000 400022
24
26
28
30
32
34
36
38
40
Pul
se P
ress
ure
(m
mH
g)
Time (Seconds)
Subject #3
0 1000 2000 3000 4000
200
250
300
350
T1
3 D
ela
y T
ime
(m
illis
eco
nd
s)Time (Seconds)
Oscillations due to breathing
Medical Teknika Ltd. 19
Palm Sized CaretakerNew Design for Summer 2009
LCD forradio-freeoperation
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
Medical Teknika Ltd. 21
Nocturnal DipA 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
Medical Teknika Ltd. 22
Systolic blood pressure (mmHg)
2-y
ear
incid
en
ce o
f card
iovascu
lar
en
dp
oin
ts
0.20
0.16
0.12
0.08
0.04
0.00
90 110 130 150 170 190 210 230
Night-time
24-h
Daytime
Conventional
Conventional, 24-h, Daytime and Night-time SBP as Conventional, 24-h, Daytime and Night-time SBP as Predictors of Cardiovascular Endpoints Predictors of Cardiovascular Endpoints
– – Syst-Eur Placebo CohortSyst-Eur Placebo Cohort
Staessen JA et al. JAMA 1999;282:539–46
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 = 5292Dolan et al. Hypertension 2005;46:1-6
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
7
decreased
≥0.90 to <1.00
1754
47.4
57
25
8
9
reverse
≥1.00
437
42.6
63
37
12
14
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