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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. 

      Early technology pioneers like Henry Ford and Wilber and Oroville Wright each had personal passions vested in their inventions. They were committed to seeing their technology (automobiles, airplanes, respectively) become a reality despite fierce criticism from industry and colleagues. 

    In February of 2009, as inventor of the DiaCeph Test and a CNS shunt user, Stephen Dolle finally heard great news from his neurosurgeon following revision to the Orbis Sigma or OSV2 shunt. He used the DiaCeph Test and this Shunt Selection Model paper he authored to direct this corrective surgery in 2008, his first successful shunt surgery amid 6 failed surgeries in 16 years. His routine case of hydrocephalus was misdiagnosed by numerous neurosurgeons over these years because of the unavailability of diagnostic information on CNS shunts, and that some shunt manufacturers misrepresented performance specifications and required neurosurgery instructions on their shunt devices. The invention of the DiaCeph Test will be out in a book entitled the DiaCeph Story. DiaCeph is still very needed today. It could run as an application for a mobile phone. Write me with your interest here.

    Stephen Dolle, inventor of the DiaCeph Test and first non-invasive test for monitoring CNS shunt operation, 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 Dolle knew the innovation that was necessary for he and others with hydrocephalus to live a normal life. The photo below is of him 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. He eventually petitioned the Food & Drug Administration (1996). Upon petitioning FDA and addressing the diagnostic challenges posed by CNS shunts, Stephen drew up a series of algorithms that enabled him to non-invasively determine what was wrong with his shunt - a method hailed by Dr. Eldon Foltz, of the University of California at Irvine, as "the formula [he] had sought for years." Upon completion and validation, Stephen named it the "DiaCeph Test." Stephen's 17-year career in nuclear medical imaging and physics provided the requisite knowledge in drafting the algorithms. The photo of Stephen is an image of a true pioneer in shunt devices, much like John Holter. DiaCeph monitoring and a critical shunt paper by Dr. Alfred Aschoff, of the University of Heidelberg, Shunt Selection Model were critical in his prediction of outcomes with various shunt valves.

Satellites and Shunts Have More in Common

    Stephen's DiaCeph Monitoring System is similar in many ways to the "Mariner Satellite" pictured below. 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. And DiaCeph too enables real time monitoring. In March 2007, DiaCeph was submitted into 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. Like most complex things, there are proven methods through which one should approach them. When CNS shunts fail to operate as intended, this is usually accompanied by specific criteria, or complaint parameters, that emerge from the user that can be quantified and analyzed, and made into a probable determination of device status. Here is our recommended Codman programmable shunt method for determining the most physiologic setting in user patients. The DiaCeph Test allows for physiologic in-vivo performance comparison of selected pressure settings in programmable shunts, and similarly, can be used in tandem with a single ICP tap to ascertain additional information on shunt setting and shunt patency. 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. 

    The DiaCeph Test employs a sophisticated software program that runs on today's handheld PDAs and mobile phones, and connects to a PC or Internet network for display of 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. When used regularly, DiaCeph can dramatically improve the outlook for most patients with hydrocephalus.

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.

    The DiaCeph Test was pioneered by Stephen Dolle, today an expert in AI (artificial intelligence) and AI assistive technologies. This passion came as a result of a 1992 brain injury and CNS shunt placement after an automobile accident. He initially conceived the DiaCeph Test to provide diagnostic data which was otherwise unobtainable on complex and intermittent shunt malfunction, i.e. anti-siphon shunts (mfr PS Medical, Heyer Schulte). By late 1997 as it was completed, it was broadened to provide diagnostic data on nearly every make and model of CNS shunt. In 1998, Stephen used the DiaCeph Test to direct his own corrective surgery.

    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.  The name DiaCeph comes from two words: "Dia" to diagnose, and "Ceph" referring to the brain. 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.

    The limited available of diagnostic data on the operational status of a user's CNS shunt leads to thousands of patients each year delayed from corrective surgery, mistakenly revised, incorrectly re-programmed, incorrectly referred for psychiatric treatment, and/or placed on permanent disability. This has been widely reported in the medical literature since the 1960s, and where in addition, intermittent shunt malfunction continues to widely occur amidst the poor availability of real time diagnostic technology. This void has led to substantially higher health care costs and rates of complication. By 1996, Higashi et. al. and many other neurosurgeons also reported specific diagnostic difficulties with anti-siphon shunts and ASD and SCD devices. Higashi's team termed these "functional obstructions," and as not detectable through routine CT, MRI, and shunt malfunction tests. They would often produce a "false negative" test result.

    In 1996, Stephen Petitioned the Food & Drug Administration on problem outcomes with PS Medical and Heyer-Schulte 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. He has proposed that DiaCeph be adopted as an "industry standard" on shunt outcomes. Yet, FDA believed such monitoring was not technologically possible, see Petition Ruling Comments to #3 and #7 Regarding Test Technology. 

    Ongoing correspondence with FDA suggests that they do not understand CNS shunt technology, and the critical role that diagnostic information 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 much of the consensus positions as was determined by STAMP.

    In 2006, reliable shunt function still remains the leading issue among shunt users, where programmable shunts (which comprise about 50% of all shunts) are very 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. This calls for a renewed commitment to CNS shunts, and we have responded with the following paper, "Shunt Selection Model."

    We introduced this tandem protocol to incorporate an ICP shunt tap assessment along with DiaCeph monitoring, described in this 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. 

    We hope to secure a sale or licensing agreement on this technology, to possibly include our prospective applications in neuro-monitoring, disease management, and drug/device post market surveillance, i.e. Vioxx. See Other Uses of DiaCeph, New ICP Tap Protocol, and AI applications under AI Research and Technology. The DiaCeph Power Point presentation provides a step by step application with two sample patients.

    A test overview is provided below. For more details, see the DiaCeph Test Description. We provide two free patient-user paper forms, the DiaCeph Monitoring Form© and ICP Graph, for your immediate patient monitoring.

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 that employs several algorithms that translate non-invasive patient status data into diagnostic information. The program can also be downloaded onto later model mobile phones and PDAs. 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 can be available within the unit, via download to its PC software program, and via Internet and mobile phone uplinks for physician review at remote locations. Test results serve to aid the physician toward further specific diagnostic testing, surgical revision, and shunt type selection. It also functions as an advanced disease management by compiling and archiving on-going detailed data on the patient's hydrocephalus condition for comparison over the longer 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.

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.