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New vital signs monitor Medical Teknika Ltd. Stress Testing • Activity Monitoring • Diabetes Monitoring Metabolic Activity • Cardiology • Hypertension Management Wireless Continuous Small

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Page 1: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

New vital signs monitor

Medical Teknika Ltd.

• Stress Testing• Activity Monitoring• Diabetes Monitoring

• Metabolic Activity• Cardiology• Hypertension Management

Wireless Continuous Small

Page 2: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 2

CareTaker™ Multi-FunctionalVital Signs Monitor

Page 3: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 4: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 4

Old paradigm for pulse detection and recording

The Sphygmograph 1850 to 1920

Page 5: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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™

Page 6: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 6

Old paradigm for pulse origins

Page 7: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 8: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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 ???

Page 9: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 9

Old paradigm for pulse analysis

Page 10: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 11: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 12: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 12

P1, P2, P3 are often visible

Pulse of a 21 year old athlete with clearly discernible component pulses.

P3P2P1

Page 13: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 14: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 14

Tabs show parameter history

Tab for observation of continuous blood pressure

Tab for continuous observation of T13

Page 15: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 16: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 16

Lower Body Negative Pressure Chamber to Simulate Hemorrhage

Page 17: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 18: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 19: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

Medical Teknika Ltd. 19

Palm Sized CaretakerNew Design for Summer 2009

LCD forradio-freeoperation

Page 20: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 21: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 22: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 23: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 24: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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

Page 25: New vital signs monitor Medical Teknika Ltd. Stress Testing Activity Monitoring Diabetes Monitoring Metabolic Activity Cardiology Hypertension Management

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