2. Presents:
CareTaker™

3. CareTaker™

4. 24/7 Beat by beat blood pressure Heart rate: accurate as ECG
VAST APPLICATIONS (EXAMPLES)
REPLACEMENT OF ARTERIAL CATHETERS
HOME DIALYSIS REQUIRED
Heart rate: accurate as ECG
NO ELECTRODES OR ADHESIVES
NO WIRES
NO DERMATITUS
Respiration rate
NO CHEST BANDS
NO ELECTRODES
INSPIRATORY EFFORT
NO IRRITATION

5. CareTaker Physiological Monitor
Extracts pulse signal from finger
Analyzes (decomposes) pulse wave form into the five characteristic constituent pulses
Tracks beat by beat blood pressure
Systolic, Diastolic, Mean, Pulse pressure
Heart rate as accurately as ECG
Respiration rate
Detects hemorrhaging before shock sets in

6. How does this pulse sensor work?
What is the magic?

7. PULSE
Actual raw data
If the arteries are flexible, all five constituent pulses can often be observed

8. PULSE
44 year old male
With flexible arteries
Actual Raw data

9. Pulse Pressure Wave Form
P2P1 is the ratio between the amplitude of the second systolic peak,P2 ( the first reflection), and P1, the primary systolic peak.
P2P1 tracks systolic pressure.
T13 P1 P2
T13 is the time that elapses between the primary (first systolic peak) and the diastolic peak second reflection).
T13 tracks the pulse pressure.
The first reflection (~17% of the pulse energy) occurs near the renal artery at the aorta and the second occurs near the iliac artery bifurcation (~40%).
Example of actual raw data of pulse shape obtained by CareTaker at the finger.

10. What Can CareTaker Do?

11. CARETAKER FOLLOWS ECG ALMOST PERFECTLY
21 year old
R = 0.998

12. 65 year old man with right side bundle branch block
NOTE POOR QUALITY OF ECG FOR HEART RATE DETERMINATION NOTE GOOD QUALITY OF CARETAKER SIGNALN (RED TRACE)

13. HRV Differences in inter-beat interval (heart rate variability, HRV)
Large HRV is a sign of good health
Low HRV is associated with illness (deteriorates before symptoms)
HRV
Each point is a heart beat

14. cNIBP CONTINUOUS NONINVASIVE BLOOD PRESSURE (cNIBP)
Necessary and required for home dialysis systems
Overall correlation of SYSTOLIC PRESSURES from 43 dialysis runs.
Overall correlation of PULSE PRESSURES from 43 dialysis runs.
NHLBI SBIR Phase I, Continuous BP Monitor for dialysis applications, 1R43HL A1

15. cNIBP
Trends in brachial cuff systolic pressure (red squares) and P2P1 over a 2.25 hr dialysis session (patient 24). Detail inset displays inspiratory-based modulations.
Trends in brachial cuff pulse pressure (red squares) and T13 over a 2.25 hr dialysis session (patient 24). Detail inset displays inspiratory-based modulations.
NHLBI SBIR Phase I, Continuous BP Monitor for dialysis applications, 1R43HL A1

16. CARETAKER TRACKS CENTRAL BLOOD PRESSURE
65 year old man
Overlap between CareTaker (red) and central catheter (black) for 90 second observation

17. All Results of Central Catheter Comparison with CareTaker
3,417 Heart Beats

18. Bland-Altman Analysis Central Line Study

19. Lower Body Negative Pressure Chamber to Simulate Hemorrhage

21. CareTaker Tracks Hemorrhaging World’s First Hemorrhage monitor
16 tests in lower body negative pressure chamber
All showed strong dependence on T13 as a function of simulated hemorrhaging.
15 of 16 showed no relationship of conventional cuff measured BP to hemorrhaging.
T13 changes from a normal value of about 300 msec to about 200 msec for loss of one liter of blood.
500
1000
1500
2000
200
220
240
260
280
300
0 mmHg
-60 mmHg
-45 mmHg
-30 mmHg
-15 mmHg
T13 (milliseconds)
Time (Seconds)
PDA - T13
Statistical comparison between 15 cuff measurements taken simultaneously with T13.
Statistically, pulse pressure can measure hemorrhaging, but not in an individual measurement.
ONR SBIR Phase II with options, N C0204, Anti-Terrorism-Consequence Management and Recovery

22. Statistical Results of 15 LBNP Tests
Tests at University of British Columbia

23. LBNP Comparison Finometer and CareTaker
Hemorrhaging (simulated)
LBNP Comparison Finometer and CareTaker
The Finometer Pro at $40,000 a copy
Note digital noise
Note higher resolution of CareTaker
Test at USAISR, San Antonio

24. T13 - THE HEMORRHAGE PARAMETER
T13 as tracked by CareTaker tracks T13 (red) and as by central catheter (black)

25. Detection of Occult Hemorrhage
T13 is a parameter that tracks pulse pressure
Pulse pressure correlates with hemorrhaging
T13 values for adults are about msec
T13 changes during hemorrhaging and can be used as a monitor of hemorrhaging.

26. Applications to Combat Casualty Care
Real time vital sign for casualties on ground
Detects and monitors hemorrhaging
Warns caregivers, via radio, of out of range vital signs (example: tachycardia)- Triage
Could serve as continuous noninvasive blood pressure (cNIBP) input to algorithmic resuscitation systems in development by both the Army and Navy

27. Nocturnal Dip A potentially explosive health issue
The next slides show
Daytime hypertension may not be much of a problem even if untreated
Nocturnal hypertension may be 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 higher blood pressure for perfusion to work

28. – Syst-Eur Placebo Cohort
Conventional, 24-h, Daytime and Night-time SBP as Predictors of Cardiovascular Endpoints
– Syst-Eur Placebo Cohort
Systolic blood pressure (mmHg)
2-year incidence of cardiovascular endpoints
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
Very Dangerous
Staessen JA et al. JAMA 1999;282:539–46

29. Dolan et al. Hypertension 2005;46:1-6
5-YEAR RISK OF CARDIOVASCULAR DEATH Relation to Clinic and Ambulatory BP - The Dublin Outcome Study
Night time
24-hour
Daytime
Clinic
Adjusted for other covariates
N = 5292
Dolan et al. Hypertension 2005;46:1-6

30. IDACO - Characteristics by categories of the
night:day ratio of SBP (n = 7458)
Nocturnal hypertension is not treated in US
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
6% !
Across the 4 groups, all characteristics were significantly different with the exception of the proportion of women. Reverse dippers were older, more patients with a history of DM or previous CVD. And importantly reverse dipperes were more often on AHT.

31. Tabs show parameter history
Tab for continuous observation of T13
Tab for observation of continuous blood pressure

32. Display for CareTaker Raw data of pulse Beat by beat blood pressure
Individual pulse parameters
Reconstructed pulse
Vertical lines show P1, P2, and P3

33. LIKELY measurements available with CareTaker multi-parameter physiological system:
Augmentation Index for arthrosclerosis
Sleep apnea monitor, screening/diagnosis device
Obstructive sleep apnea
Central sleep apnea
CPAP efficacy monitor
Hemorrhagic shock monitor/predictor
Aortic aneurism detector
Fatigue or stress indicator
Cardiac output measurement
Circadian clock tracker
Advanced warning for nocturnal hypoglycemia
Predictor of disease state before symptoms

34. Other Uses for CareTaker
Safer Dialysis sessions, home dialysis machines
Replaces most arterial catheters (80 – 90%)
Home uses for elderly and worried well
Remote monitoring, observation, dosage adjustment, self medication, arrhythmia detection and classification
Home use for recovery from surgery
Can send data to doctor rather than go to ER
CareTaker has detected and located aortic aneurisms
Under evaluation (predicted & located 5 of 5 in tests)
Leg amputees are vulnerable to abdominal aneurysms

35. CareTaker for MRI and fMRI Presently used in Six Countries
33 feet of Teflon tubing separate the CareTaker unit from the finger cuff
Brachial artery better than finger because of signal losses in tubing
CARETAKER IS THE ONLY cNIBP SYSTEM THAT WORKS IN AN MRI

36. Modified Early Warning System (MEWS now NEWS)
Display windows show trends over hours or days of:
Heart rate, breathing rate, blood pressure, SPO2, Core Temperature and possibly other parameters
All parameters transmitted via radio to server
Nurses never have to touch the patient
Patients need not be waked up during the night
Near immediate results of drug/treatment efficacy
Allows dosage adjustment over short times
Continuous record of patient’s vital signs
Provides triage plan for disasters using limited staff

37. MEWS
The MEWS, specifically five selected parameters, may be used as a rapid, simple triage method to identify medical patients in need of hospital admission and those at increased risk of inhospital death.
Modified early warning score predicts the need for hospital admission and inhospital mortality
(VC Burch, G Tarr, C Morroni, Emerg Med J 2008;25: oi: /emj )

38. Why CareTaker is Necessary
Exponential decrease in per capita number of physicians over next 10 to 15 years
Exponential increase in per capita need for physicians over next 10 to 15 years
System breaks down at without telemedicine
World’s largest economies will transition to remote diagnosis, treatment, and monitoring

39. Telemedicine funding at VA - a huge opportunity for CareTaker
Ischemia: 1 in 3 Viet Nam Vets (200K) due to Agent Orange
Sleep apnea: High incidence
Diabetes: High incidence
Many vets live in rural areas not near hospitals
5.5 M Vets already enrolled
1400 points of service
18,000 doctors

40. Sleep Studies and Long Surgeries
Detroit Sleep Studies in Progress – continuous blood pressure of spinal cord injured patients
Cooperative data sharing agreement with VA
Cooper University – 8 exploratory surgeries for five to seven hours in study
Comparison with arterial catheters, instruments
New method to determine arterial stiffness discovered – patent in preparation
Manuscript in preparation

41. Aortic Aneurysms and Sudden Cardiac Arrest
Detected and located five of five aortic aneurysms – monitored before/ after surgery
Characteristic signals disappeared after surgery
Blind study – University of Virginia
All signals obtained from the hand
Tested CareTaker to determine Pulselessness at Cleveland Clinic – Published
Applications to sudden cardiac arrest warning system built into wrist watch

42. Rheoencephalography
Neuro ICU for detection of vasospasms, now nearly undetectable, but often fatal
Trials at NMRC (Walter Reed) for monitoring traumatic brain injury (TBI)
Trials in neuro ICU of University of Virginia
Requires CareTaker and conventional EEG and trans cranial impedance (TCI)

43. MRI Use of CareTaker
Installed in about 40 MRIs and fMRIs around the world as the only available beat by beat blood pressure monitor.
Primarily used to study psychological effects.
Manuscripts being prepared.
Use in Japan to study antihypertensive medicines and use during dialysis.

44. New Relationships Forming
China: clinical trials at Beijing Union Hospital (highest rated hospital, #1) planned for June 2013
Relations with Suning of China are progressing for remote home health care monitor
ONR: current funding $850K. Option to start 2012 for $990K, resuscitation, HRWatch development
Animal and human resuscitation trial at UTMB, algorithmic fluid resuscitation, waiting on contract

45. More New Relationships
BioPac Systems: worldwide distributor of CareTaker for MRI use (not Japan). 35 sold
Upcoming presentation to Telstra (Australia), possible 3700 beds
Trials in Tanzania for Dr. Ellegala for remote hospital care. Planned for 2012
Medica Teknika: Japanese distributor of CareTaker about 30 units

46. FDA Trials for CareTaker
University of Virginia in progress.
Trial design approved by FDA. 60 cohorts.
Actual arterial line comparisons for four hours each.
Progress: 25% of data analyzed. All patients completed.
FDA: approvals for 510k are normally completed within 90 days
Predicted approval – summer 2013

47. First US Market Penetration of CareTaker into Markets
7 million arterial catheters used annually
About 0.2% cause blood borne infections or blood clots
Average cost of treating blood born infection is $35,000 to $65,000
CareTaker could eliminate about 85+% of invasive catheter use
Cost of CareTaker is about the cost of one catheter and the surgical insertion