DiaCeph Step by Step Slides A Non-Invasive Program for Hydrocephalus A Mobile Phone Application

Property of: Stephen Dollewww.DolleCommunications.com

U.S. Patent No. 6,241,660

DiaCeph Step by Step SlidesA Non-Invasive Program for

Hydrocephalus

A Mobile Phone Application

http://www.dollecommunications.com/

Presentation Contents

Slide 4 DiaCeph’s Core Technology

Slide 5 Applications and Utilization

Slide 6 DiaCeph Test Parameters

Slide 7 Processor Features and Steps

Slide 8 DiaCeph Test Output (Results)

Slide 9 DiaCeph Monitoring Paper Form

Slide 10 DiaCeph Output Paper Graph

Slides 11-23 Two Sample Patients, Histories, with Test Results (tables, graphs, discus)

Slide 24 Single ICP Tandem Application plus Match with Valve Bench Tests

Test Notes in progressProgram best when include training sessions to est. technique, test defaults i.e. primary complaints and best positional test, specific’s of user’s shunt, and accuracy.

CREATE a NPH walking test?

CREATE new cognitive tests (dig rec test)

IntroductionDisease management software has been in use in the U.S. for more than 20 years, yet only minimally in the home setting. The patented DiaCeph Test is a standardized approach to non-invasively monitor key patient complaint markers of a hydrocephalus patient in real time, as indicators of shunt performance, and analyze these for diagnostic decision-making and care management - both by the physician and family. These snapshots of data can then be referenced over weeks and months and used to measure outcomes after shunt and ETV procedures, determine settings in programmable shunts, identify shunt malfunction, and in shunt selection. As a software application for a mobile phone, DiaCeph could be made widely available and inexpensive. It would serve patients at home, at work, in school, and in the medical setting. Hydrocephalus, a condition whereby excess cerebral spinal fluid (CSF) accumulates within the brain, is typically treated with the insertion of a “shunt,” and when possible by ETV. Its care and treatment faces specific diagnostic challenges today that are yet to be adequately addressed by other means, such as shunt tap or diagnostic imaging. DiaCeph would improve treatment outcomes, reduces costs and risks, and improve quality of life of the patient.

Core Technology

Software Application for Mobile Phones/PCs Standardized Protocol allows Patients/Family to

record Clinical Markers on the Status of the Patient Data is Readily Processed by Phone Application,

and/or by Web Server and Physician Office PC Test Renders Approximate Levels of Patient ICP Test Matches Patient Markers to Probability of 14

Different Causes of Shunt Malfunction Test Works with Medication/other Interventions Concept Applicable to other Disease Monitoring

Applications and Utilization

1. 24/7 Monitoring of Shunt Performance by Patients, Care Givers, and School Staff

2. Office Assessments & Staff Training

3. Discharge Monitoring Post Shunt and ETV

4. Tandem Use with a Single ICP Tap

5. Identify Settings in Programmable Shunts

6. Diagnostic Assessments of NPH

7. R&D and Clinical Trials of New Shunts

8. QA of Shunt & ETV Outcomes & Reports

DiaCeph Test Parameters (Markers)

1. Activity: At Waking, Rest, Tasking, Play, Physical

2. Headache 0 1 2 3

3. Nausea 0 1 2 3

4. Bal/Dizzy/Eye Signs 0 1 2 3

5. Cognitive 0 1 2 3

6. Posture Test(ICP) - + N/C Indeter.

7. Prox. Refill -2 -1 0 +1 +2

8. Prox. Visual -Swell/Pain +Swell/Pain +Swell

9. Distal Visual -Swell/Pain +Swell/Pain +Swell

10. Interventions ↑ ↓ NC Indeter.

Markers can be re-weighted in system settings

Interventions Sit/Lay Down (Rest) Going from Sitting/Standing to Supine Posture (Lay Down) Exercise and Straining Going from Supine to Upright Posture Stand and Bend Over at Waist, Head Down Finger/Toll Pressure over Neck Catheter Reduce CSF, Raise ICP Elastic Wrap over Abdomen to Increase Cavity Pressure/Outflow Resistance Manipulation of Abdomen/Distal End of Shunt Catheter Lower Outside Body/Shunt Pressure: Trip to Mountains/Barometric Chamber Raise Outside Body/Shunt Pressure: Submerge under Water/Barometric Chamber Percutaneous Flushing of Shunt Valve Finger Snap/Vibration Device over Shunt Valve Lift and Loosen Scalp Over ASD /SCD Shunt Change/Pillow Pressure Over ASD /SCD Shunt Diamox Intervention and Therapy (must be known candidate) Palliative Meds and Interventions Biofeedback, Stress Reduction, Visualization Techniques Tandem Monitoring with a Single ICP Shunt Tap Assessment

Processor Features and Steps

1. Patient Collects Parameter (Markers) Data on: Headache, Nausea, Balance (or Malaise), Cognitive, Postural Test, and Reservoir Assessment.

2. Selected Cognitive Games Provide Cognitive Assessment

3. Markers are combined to form weighted score (slanted to patient’s predominate complaint(s)), score then matched to + or – ICP (from Postural Test and Interventions) to determine Final Data Point Score.

4. Parameters Processed to Determine: Data is Weighted and matched to ICP Value (+ or – ICP) and Activity; then to 14 possible Outcomes/Types of Malfunction. Non-matching data due to erroneous technique is nullified. Interventions used to confirm/void inconclusive results.

5. Results Displayed via upload to Web Server or PC program. Displays individual Parameters, Probability to 14 Diagnostic Possibilities, Graphs of Parameters v. Time, Calculated ICP, Baseline Comparison. Compare to with clinical exams, shunt taps, other tests.

Algorhythms1. Algorithm determines relative ICP from the following parameter

values:nausea scoreheadache scoremalaise, eye signs, or balance scorecognitive scorepositional test score 2. Algorithm determines shunt patency from the following parameter

values:nausea scoreheadache scoremalaise, eye signs, or balance score relative ICP scorepercutaneous finger assessment of patency

Display1. Graph of shunt patency values with overlay to baseline2. Graph of relative ICP values with overlay to baseline3. Graph of individual parameters with overlay to baseline4. Graph of cognitive values with overlay to baseline5. Graph of interventional data with overlay to prior

samplings6. Display of most probable malfunction(s) from list of 14

possible7. Display of relative ICP values for each monitoring point8. Display of shunt patency values of proximal, distal, and

refill scoring

DiaCeph Test Output (Results)

1. Diagnosis: Data are Matched to Possible Outcomes/ Types of Shunt Malfunction below:

A. Prox. Catheter Obstruction H. ASD/SCD Overfunction

B. Prox. Obstr./Collapsed Vent I. Distal Cath./Valve Obstr.

C. Prox. Disconnection J. Distal Catheter Mal-pos.

D. Prox. Obstr. w/ Infection K. Distal Disconnection

E. Normal Shunt Function L. Distal Obstr. w/Infection

F. Shunt Underdrainage M. Other Pathology

G. Shunt Overdrainage N. Uncompensated Hydro.

2. Graphs: ICP Values v. Ea. Parameter v. Baseline Data v. Time

DiaCeph Monitoring Paper Form

DiaCeph Output Paper Graph

Start NEW Monitoring Series1. Set up a NEW monitoring series [sel]

2. Go back to Home page

3. EXIT

DiaCeph Test Main MenuChoose your selection to begin the program:

1. Set up or change your Profile information

2. View a recorded monitoring series

3. View previous data entries

4. Start/Set-up a NEW monitoring series [sel]

5. Modify an existing monitoring series

6. Collect data for a SCHEDULED series

7. Collect data for an ILLNESS or ILL event

8. Collect data per DOCTOR instructions

9. Upload/Copy files to web or PC to view or print

10. PLAY the DiaCeph Test demo

11. View DiaCeph user instructions

12. Look up HELP?

13. EXIT

Set up NEW monitoring series1. Select patient name: [sel] “John Smith”

2. Select protocol [click view]: [standard] [custom]

3. Select start date: [sel] [calendar box opens]

4. [start day/date = sel] Friday March 28, 2009

5. Select end date [sel] [calendar box opens]

6. [end day/date=sel] Friday April 17, 2009

7. Select [modify] total days [click ALL days on box]

8. Select no. of points/day: 3 [8am-3pm-8pm]

4 [8am-12pm-4pm-8pm]5 [7am-10am-1pm-5pm-9pm]

6 [ 7am-9am-12pm-4pm-7pm-10pm8. Select to [modify] or use Preset times [Preset]9. Select type of alarm [vibrate] [tone] [vibrate/tone][EXIT} [Main page] [Start Monitoring]

Select Current ActivitySelect the activity associated with this data point:

A. Awoke from night time sleep

B. Resting laying down in day time

C. Other restful activity laying down

D. Sitting: reading, studying, or non-physical work or school activity

E. Up and about at home or friend/relative home

F. Out and about on your feet, non-physical

G. Physical activity, any sport, long walk, etc.

[continue] [go back] [exit] [main page]

Identify level of Headache (0 to 3)1. Select the number corresponding to headache:

0 = no headache

1 = mild headache

2 = moderate headache

3 = severe headache


Identify level of Nausea (0 to 3)1. Select the number corresponding to nausea:

0 = no nausea

1 = mild nausea

2 = moderate nausea

3 = severe nausea


Identify balance/ dizzy level (0 to 3)(can sub eye signs for this marker)

1. Select the number corresponding to balance and/or dizziness:

0 = no dizziness

1 = mild dizziness

2 = moderate dizziness

3 = severe dizziness

OR

2. Select to run NPH balance and walk test


Identify level of cognitive difficulty1. Select the number corresponding to cognitive

difficulty:

0 = no apparent difficulty

1 = mild difficulty

2 = moderate difficulty

3 = severe difficulty

OR

2. Select to run COGNITIVE test


Select your Positional(Valsalva) Test(set default in profile, use also as IVs)

1. Lay down (3-10 minutes)

[improved] [no change/unsure] [worse]

2. Stand upright (3-10 minutes)


3. Stand & bend over at waste (10-20 sec)


4. Hold breathe & bear down, sitting (5 sec)


5. Affect after a sneeze



Shunt System Visual Check1. Shunt valve/reservoir [pain/swelling] [pain/no swelling] [no pain/swelling]

[no pain/no swelling] [cannot determine]

2. Catheter along head/neck [pain/swelling] [pain/no swelling] [no pain/swelling]


3. Catheter in chest/abdomen [pain/swelling] [pain/no swelling] [no pain/swelling]


Sample Patient #1: History and Treatment

Patient is a 16 yr-old female first shunted 4 months ago with a programmable shunt. The initial pressure setting at 100 mm H2O. After complaining of HA felt related to high pressure, shunt was adjusted to 70 mm H2O and DiaCeph monitoring ordered.

Monitoring was performed at these set times: 7am, 10am, 12pm, 3pm, 6pm, and 9pm during the week of 8/13/01. See Data Table for 8/17/01.

Data Table 8/17/01: Setting=70mmH2O

Time Act. Nau-sea

HA Bal-ance

Cog Test

Post Test

ICP Valu

Prox Refil

Vis-ual

7am Wake 0 0 1 0 Ind +/-.2 0 -

10am Task 1 2 1 1 - -1.25 0 -

12pm Play 1 2 2 1 - -1.5 0 -

3pm Play 1 2 2 2 - -1.75 0 -

6pm Rest 1 1 1 1 - -1.0 0 -

9pm Rest 0 1 1 1 - -.75 0 -

Status Post 8/17/01: Setting=70mm H2O

1. The 8/17/01 Data Table reveals near normal ICP Value upon waking, with low ICP Values through the morning and afternoon, with upright posture. Shunt patency (Proximal Refill) reported as normal. DiaCeph processor matched Data with Shunt Overdrainage. In-office ICP reading revealed -5 cm H20 sitting, 15 cm H20 supine, concurring with DiaCeph Data and verified collection technique.

2. Valve setting then raised to 110 mm H2O, and monitoring performed again at same times. See 9/14/01 Data Table and Graph.

Data Table 9/14/01: Setting=110mmH2O

Time Act. Nau-sea

HA Bal-ance

Cog Test

Post Test

ICP Valu

Prox Refil

Vis-ual

7am Wake 1 2 2 1 + +1.5 +1 -

10am Task 0 1 1 0 - -.5 0 -

12pm Play 1 1 1 1 - -1.0 0 -

3pm Play 1 1 1 1 - -1.0 0 -

6pm Rest 1 2 2 1 - -1.5 0 -

9pm Rest 0 1 1 0 - -.5 0 -

Patient #1: Graph 8/17/01 vs. 9/14/01ICP Values/Proximal Refill vs. Time

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

7am 10am 12pm 3pm 6pm 9pm

ICP=8/17ICP=9/14Refil=8/17Refil=9/14

Status Post 9/14/01: Implant ofAnti-Siphon Device

1. The 9/14/01 Data Table and program reported continued daytime Shunt Overdrainage, yet raised ICP Values upon waking finds Shunt Underdrainage - suggesting the 110 mm H2O setting was slightly too high. In light of this persistent overdrainage, she was fitted with a siphon control device (SCD), and shunt pressure was set down to 100 mm H20.

2. After the above, her c/o were improved and DiaCeph monitoring confirmed by data. See following Data Table, plus Graph on 9/24/01.

Data Table 9/24/01: Setting=100 w/ ASD

Time Act. Nau-sea

HA Bal-ance

Cog Test

Post Test

ICP Valu

Prox Refil

Vis-ual

7am Wake 0 0 0 0 NC 0 0 -

10am Task 0 1 0 0 - -.25 0 -

12pm Play 0 0 0 0 NC 0 0 -

3pm Play 0 0 1 0 Ind +-.25 0 -

6pm Rest 0 0 0 0 NC 0 0 -

9pm Rest 0 0 0 0 NC 0 0 -

Patient #1: Graph 8/17/01 and 9/14/01, 9/24/01 (w/ SCD): ICP Values vs. Time

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

7am 10am 12pm 3pm 6pm 9pm

ICP=8/17ICP=9/14ICP=9/24

Sample Patient #2: History and Treatment

Patient #2 is an 8 yr-old male shunted 4 years with a standard DP medium pressure shunt. He has been complaining of intermittent headache, nausea, and difficulty at school of a 4 week duration. Neurological exam and MRI were unremarkable.

DiaCeph monitoring was performed by mother for one week at set times of: 7am, 12pm, 3pm, 6pm, and 8pm (12pm lunch), for the week beginning on 9/10/01. See Data Tables and comparison Graph of 9/10/01 and 9/13/01 in Slide 20.

Patient #2: Data Table 9/10/01

Time Act. Nau-sea

HA Bal-ance

Cog Test

Post Test

ICP Valu

Prox Refil

Vis-ual

7am Wake 0 1 0 1 + .5 0 -

12pm Task 0 1 0 0 + .25 0 -

3pm Play 0 1 0 0 - -.25 0 -

6pm Rest 0 0 1 0 Ind +/-.2 0 -

8pm Rest 0 1 1 0 + .5 0 -

Patient #2: Data Table 9/13/01

Time Act. Nau-sea

HA Bal-ance

Cog Test

Post Test

ICP Valu

Prox Refil

Vis-ual

7am Wake 2 2 2 2 + 2.0 -1 -

12pm Task 1 1 2 1 + 1.25 -1 -

3pm Play 0 1 1 1 + .75 0 -

6pm Rest 1 2 1 1 + 1.25 -1 -

8pm Rest 1 1 1 0 + .75 0 -

Patient # 2: Graph 9/10/01 vs. 9/13/01ICP Values/Proximal Refill vs. Time

-1.5

-1

-0.5

0

0.5

1

1.5

2

2.5

7am 12pm 3pm 6pm 8pm

ICP=9/10ICP=9/13Prox=9/10Prox=9/13

Patient #2: Status Post 9/10-9/14 Monitoring

1. The 9/10/01 Data Table reveals slightly elevated ICP (+1) upon waking, which the program matched with Shunt Underdrainage. The ICP Values and program found Normal Shunt Function the remainder of the day.

2. The 9/13/01 Data Table reveals more dramatic a.m. rise in ICP (+2), with abnormal Proximal Refill (-1) value, and consistent throughout the day. The program matched data to Proximal Obstruction (A and B). The (-1) Proximal Refill and (+2) ICP correlate on the Graph.

3. In-Office ICP Tap 9/14/01 revealed 70 mm H20 supine, 25 mm H20 upright, verifying DiaCeph data and mother’s technique. Isotope clearance exam concurred. The patient’s proximal catheter and shunt were revised, and he improved.

Single ICP Measurement can Corroborate Accuracy of DiaCeph Test

We suggest NSGs obtain a “single” in-office ICP measurement via a manometer in tandem with DiaCeph monitoring. In is best obtained the same day as DiaCeph monitoring performed. ICP tap verifies test accuracy and correct use of DiaCeph system. DiaCeph results can be matched against in-vitro bench test data courtesy of Aschoff et. al. SEE “Shunt Selection Model” paper at www.diaceph.com.

http://www.diaceph.com/

Integration of DiaCeph Test to In-Vitro Bench Testing (Aschoff et.al.)

OSV v. Siphon Guard v. Phoenix Diamond Valve, Aschoff et. al.

End of Presentationby: Stephen DolleDolle Communications

For more information contact:Dolle Communications3908 ½ River Avenue

Newport Beach, CA 92663www.DolleCommunications.com

Tel. (949) 642-4592

http://www.dollecommunications.com/

Documents

DiaCeph Step by Step Slides A Non-Invasive Program for Hydrocephalus A Mobile Phone Application