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DiaCeph (Disease) Monitoring Software for Hydrocephalus

Last News: by Stephen Dolle, Neuroscientist & DiaCeph Test Inventor

DiaCeph Test Predicts Perfect Outcome in 2008: read the full case study here. 

      In February of 2009, Stephen Dolle, inventor of the DiaCeph Test and a CNS shunt user finally heard great news from his neurosurgeon after revision to the Orbis Sigma or OSV2 shunt. He used the DiaCeph Test and authored this Shunt Selection Model paper as he directed this corrective surgery in 2008, his first true successful shunt surgery in 16 years. The invention of the DiaCeph Test will be chronicled later in a book entitled the DiaCeph Story. You may write me with your thoughts, or to my home & office, or if you have immediate questions call (949) 642-4592.

    As a result of a lot of inquiries over the last several years, I have begun offering individualized DiaCeph shunt monitoring and consultations for persons with hydrocephalus who are not doing so well with their present shunt and treatment. The monitoring is based on my patented DiaCeph monitoring system of which I have some 13 years of experience. I am still hopeful that DiaCeph can be made available as a device or an app for a mobile phone. Please see my main hydrocephalus section for details.

    We hope to secure a sale or licensing agreement on this technology, to possibly include our prospective applications in neuro-monitoring and disease management (see other uses DiaCeph, New ICP Tap Protocol). The DiaCeph Power Point presentation here provides a step by step application using two sample patients. For more use details, see DiaCeph Test Description. DiaCeph could run as an application for a mobile phone today.

    Stephen Dolle, inventor of the DiaCeph Test, the first non-invasive test for monitoring CNS shunts, says he felt the same personal passion as did Albert Einstein, Henry Ford, and the Wright brothers. In fact, Einstein was was known for his quote on "imagination." As a patient user implanted with a shunt, Stephen knew that innovation was necessary for he and others with hydrocephalus to live a normal life.

    In 1996, Stephen Petitioned the Food & Drug Administration on problem outcomes with certain anti-siphon shunts. He collected scientific data and literature spanning more than 30 years in the care and treatment of hydrocephalus. Routine diagnostic tests were (and still) are not able to detect these. Higashi et. al. and many other neurosurgeons reported diagnostic difficulties with anti-siphon shunts, which Higashi's team termed "functional obstructions," not detectable through routine CT, MRI, and shunt malfunction tests. By contrast, FDA, never viewed as championing change said such monitoring was not technologically possible, noted in Petition Ruling Comments to #3 and #7 Regarding Test Technology. 

   Ongoing correspondence with FDA suggests that they do not understand CNS shunt technology nor the critical role diagnostic testing should play in their everyday use. CNS shunts are classified as Class II medical devices under the FDA. Manufacturers are required to identify maintenance procedures for their safe and efficacious use. It would seem, based upon the rate of failure and diagnostic difficulties with CNS shunts, that manufacturers have not met the troubleshooting requirements set forth in the Code of Federal Regulations (CFRs) covering CNS shunts. Industry has merely passed on the problem to user neurosurgeons, who are not in the technology business. In 1999, the FDA held a special one-day International STAMP Conference in Washington, D.C., to better address the issues Stephen raised in his 1996 Petition and other correspondence. Stephen authored a STAMP Paper of Recommendations in support of this STAMP Conference. Stephen then requested the FDA prioritize its goals with CNS shunts in this 1999 Letter to Larry Kessler, Ph.D., and Dept. Head of the STAMP Conference. Stephen specifically noted the need for STAMP support of home shunt monitoring, but Larry Kessler's Response termed it "discretionary technology." As of 2006, the FDA has failed to meet few if any of the consensus positions as determined by STAMP.

    The photo below is of Stephen in 1998 after completing the design of his DiaCeph Test and using it to direct his Feb. 1998 shunt revision. It took him 5 years to determine he had been incorrectly implanted with a Delta shunt. Still without corrective surgery, it caused him to pursue a series of algorithms that enabled him to non-invasively determine what was wrong with his shunt - a method later hailed by Dr. Eldon Foltz, of the University of California at Irvine, as "the formula [he] had sought for years." The photo of Stephen as a shunt pioneer parallels similar efforts of the late John Holter.

    Upon completion and validation of the method, Stephen named it the "DiaCeph Test,"  meaning "dia" to diagnose and "ceph" having to do with the brain. Stephen's 17-year career in nuclear medical imaging and in math/physics provided critical knowledge in drafting the algorithms. The DiaCeph Test employs a sophisticated software design to run on PDAs and mobile phones, and connect to a PC or Internet network to display results. DiaCeph's proprietary protocol and algorithms non-invasively track shunt performance data and generate a diagnostic profile on the user-patient. Up to 15 separate states of shunt malfunction and hydrocephalus are assessed.

   In 1999, the DiaCeph Test was featured in the Orange County Business Journal. A patent was issued in 2001, with a second patent optioned. Patent representation has been provided by the prestigious firm of Knobbe Martens Olsen & Bear.  In 1997, AI monitoring and disease algorithms were very new. Today, new applications of AI in Medical Devices are on the rise in disease management (asthma, congestive heart failure, diabetes), medical imaging, hospital monitoring, medical devices, and in patient data mining.

    In 2005, we introduced a tandem protocol that incorporates an ICP shunt tap along with DiaCeph monitoring, as described in Shunt Selection Model. Our paper includes comparative shunt data from Aschoff, et. al. at the University of Heidelberg. The tandem protocol is critical as it raises both tests' accuracy and reliability: corroborating DiaCeph data with widely recognized shunt tap/ICP assessments. One in-office ICP measurement can validate weeks and months of critical DiaCeph monitoring, and help the patient and family better realize its benefits. The DiaCeph Test already has a built-in logic processor to identify and resolve any "erroneous data" that might be mistakenly entered by a patient, guardian, or family member. But matching incident DiaCeph data to supine/upright manometer readings, further elevates DiaCeph's efficacy, while corroborating the ICP readings.

    Widespread use of this tandem protocol can reduce the costs and risks associated with CT, MRI, in-office ICP taps, isotope imaging, and in-hospital monitoring. It can lead to fewer unnecessary shunt revisions, and render in-office shunt re-programming more accurate to the patient. We were able to match months of DiaCeph data monitoring with a single shunt/ICP evaluation. It widens DiaCeph's applications in 24/7 home monitoring, where only 48 hour ICU in-hospital monitoring provided such capability. With new interests in non-invasive monitoring, DiaCeph's applications are broad and economical. 

    Reliable shunt function remained a leading issue among shunt users, where programmable shunts (which comprise about 50% of all shunts) are prone to accidental reprogramming by a variety of household devices and appliances. DiaCeph is an ideal home diagnostic tool to identify accidental reprogramming. There remains a pressing need for routine home patient monitoring and improvements in QA with respect to specifications and wider understanding of CNS shunts.

The DiaCeph Test meets five (5) areas of need in patients with CNS shunts:

1) Provides a real-time mobile method of documenting CNS shunt performance and shunt malfunction, as well as a tandem single in-office ICP tap;

2) Reveals complex intermittent shunt malfunction often with specificity, unobtainable thru other available diagnostic tests, via an elaborate "diagnostic decision tree;"

3) Enables accurate in-vivo comparison of shunts for pre-surgical shunt selection and planning, utilizing Aschoff et. al. bench test flow charts and mfr specs, rivaling information not available thru any diagnostic test, including 24-48 hour in-hospital ICP monitoring;

4) Serves as a standardized in-vivo assessment of CNS shunt outcomes, post discharge monitoring in ETV procedures, and comparative analysis of patient status over the long term; and

5) Enables the neurosurgeon along with the patient to more efficaciously determine the optimal opening pressure in programmable shunts, including, enabling a home determination in the event a programmable shunt should loose its setting.

Satellites and Shunts Have More in Common

    Stephen's DiaCeph Monitoring System is similar in many ways to the "Mariner Satellite" pictured at left. The DiaCeph Test, like the Mariner Satellite, integrates an interactive AI (artificial intelligence) design into its programming. But, whereas DiaCeph monitors the neurological condition, hydrocephalus, the Mariner is monitoring activity on the surface on the planets and stars. DiaCeph too enables monitoring in real time. In March 2007, DiaCeph was submitted to the American Electronics Association (AeA) 2007 High Technology Awards Contest, where it fared well with this Awards Presentation and 2007 Application.

    CNS shunts involve fairly complicated consideration of fluid flows, gravitational forces,  device opening pressures, performance measurements, and device failure. When CNS shunts fail to operate as intended, the patient's status will reflect changes in specific markers, or complaint parameters, that can be quantified and analyzed and made into a probable determination of the shunt's status. The DiaCeph Test also allows for in-vivo comparison of selected pressure settings in programmable shunts, and similarly, can be used in tandem with an ICP tap. A more detailed look at CNS shunt operation is explained through this Shunt Technology Perspectives presentation by Aschoff et. al. from the University of Heidelberg. Here is our recommended Codman programmable shunt method for achieving the most physiological setting with Codman programmable shunts.

THE DIACEPH CNS SHUNT MONITORING SYSTEM 

Patent No. 6,241,660        Of Counsel: Knobbe Martens Olson & Bear

The Device

A method and computerized instrument for measuring CNS shunt performance in an individual with a hydrocephalus shunt by sampling specific clinical parameters as indicators of shunt performance, and intracranial pressure. Initial patient baseline monitoring is preferable, and where possible, to compare to incident and subsequent patient data all collected over a set time period. It is a palm device, but its method may also be constructed as a downloadable application for a mobile phone, where each employs several algorithms that translate non-invasive patient status data into diagnostic information. It is intended for patients who are conscious and four (4) years of age through late senior age, who are able to respond to queries, similar to a physician interview or standard hearing test. The results are stored with the patient’s history and default settings. Where the shunt may not be operating properly, the instrument further evaluates the data by comparison to earlier baseline and event data, and matches this to any of fourteen (14) known types of shunt malfunction.

Results would be available within the unit, via download to a PC or Internet web site, and via mobile phone uplinks to physicians for reviewing at remote locations. Test results would aid the physician in further diagnostic testing, surgical revision, and shunt and pressure selection. It functions as an advanced disease management program by compiling on-going detailed data on the patient's hydrocephalus status over the long term. It is intended for use by patients, family members, care givers, medical office staff, physicians, and researchers.

 The Concept and Current Standard

The concept for this product follows that shunt malfunction and changes in intracranial pressure are accompanied by specific clinical complaints that may vary by patient, but are diagnostic when analyzed appropriately. Its methodology lies in real time assessment, first by baseline data and then at suspected periods of shunt malfunction. Samples are also collected in series at set times over a day. The device offers a reliable preliminary method of shunt evaluation, with acceptable test sensitivity and specificity.

A recent multi-center study by J. Kestle et. al., reported that CNS shunts overall had  a 52% survival rate in the first two years post implantation. The study reported the Codman programmable shunt required re-programming in 70% of the cases during the first 6 months. A 1998 patient survey conducted by the Hydrocephalus Association of 422 respondents, in concert with the FDA’s Center for Devices and Radiologic Health (CDRH) and its 1999 STAMP Conference, found that the majority of respondents were deeply concerned about revisions, mechanical failures, infections, long term complications, and difficulty in assessing whether or not the shunt is functioning properly. Respondents were also concerned over quality of life issues, and 81% raised concerns that would be addressed by DiaCeph monitoring.

With respect to patient education, a July 2000 survey commissioned by the Medtronic Foundation reported 84% of Americans are taking more personal responsibility today in health matters than they did 10 years ago. Yet, 77% report today they do not have satisfactory control over their own health care. It is very common in patients implanted with programmable shunts (30-40 percent of population) for the devices to loose their correct setting. A 2005 paper, “The Billion Dollar a Year Cost of Hydrocephalus Treatment,” reported the average surgical shunt procedure now cost $35, 816. There are no accurate disability figures on hydrocephalus, which follows poor outcomes after shunting, but this figure is viewed as substantial.

Currently CT and MRI scanning currently are the staple tests for determining shunt malfunction in the emergency room. These tests face limitations in that less than 50 percent will demonstrate a measurable change in ventricular volume during malfunction, and only after sufficient time and interruption of CSF outflow. Shunt taps of ICP and drip rate currently offer some assessment, but are invasive and only beneficial if the patient is obstructed at the time of the exam. Patients are also examined for papilledema (increased ICP) and cranial nerve changes, but again, there must be significant interruption in shunt CSF outflow at time of exam. The clinician must factor each patient’s degree of shunt dependency and shunt type.

Prospective Test Applications

1. Home and anytime documentation of intermittent and acute shunt malfunction.  

2. Early home determination of accidental recalibration of programmable shunts.

3. Efficaciously determine the most optimal pressure setting in programmable shunts.

4. Enable medical office and school nurse evaluation of shunt function.

5. Post-discharge monitoring of patient status following CNS shunt and ETV procedures.

6. Improved shunt selection and pre-surgical planning prior to shunt revision.

7. Broadens and corroborates application on the single in-office ICP tap procedure.

8. Evaluation of NPH and mild stage hydrocephalus, in tandem with Acetazolamide Challenge Test.

9. A patient management tool for the home setting, and an aid to daily activities planning.

10. A performance standard for in-vivo assessment of shunt systems in clinical trials.

11. Enable improvement in quality of life and independence in shunted teens and adults.