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

    Similarly, Stephen Dolle, inventor of the DiaCeph Test, the first non-invasive test for monitoring CNS shunt operation, felt the same personal passion as patient-user of a CNS shunt as did Ford and the Wright brothers. His DiaCeph Monitoring System is similar in many ways to the "Mariner Satellite." DiaCeph, like Mariner, integrates an interactive (artificial intelligence design) program - but, for monitoring the neurological condition, hydrocephalus. Like Mariner, DiaCeph too enables real time monitoring. In March 2007, DiaCeph was submitted into the American Electronics Association (AeA) 2007 High Technology Awards Contest, with this Awards Presentation and 2007 Application.

Photo: Mariner satellite en route to Mars.

    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 Codman Hakim programmable shunt method to determine the most physiologic setting in programmable shunts. The following User (Paper Form) Graph illustrates how DiaCeph can be used alone, and in tandem with an ICP tap, to determine patient status/probable CNS shunt operation. 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 addresses four (4) areas of need in patients with CNS shunts:

1) Provides a real-time method of early documenting of CNS shunt performance and shunt malfunction;

2) Documents complicated and intermittent shunt malfunction, including, "functional obstructions" of anti-siphon shunts;

3) Enables in-vivo comparison of shunt outcomes to each other, including, pre and post operative surgical outcomes and status assessment; and

4) Establishes a "standardized in-vivo model" for all CNS shunt monitoring, capable of providing critical information on patient status and shunt performance over the longer term, and comparison of standardized data to earlier points in time.

    The DiaCeph Test was pioneered by Stephen Dolle, who today is an expert in AI (artificial intelligence) technologies. His 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 that had been previously unavailable on certain shunt malfunctions with anti-siphon shunts (manufactured by Medtronic/PS Medical and Integra/Heyer Schulte). By late 1997 when DiaCeph 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 Medtronic/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. However, the FDA mistakenly decided such monitoring was not technologically possible, per its Petition Ruling and Comments to #3 and #7 Regarding a 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, and manufacturers are required to identify maintenance procedures for the safe and efficacious use of these devices. It would appear, based upon the known failure rates and diagnostic difficulties with CNS shunts, that manufacturers never fully met the troubleshooting requirements earlier set forth in the Code of Federal Regulations (CFRs) covering CNS shunts. Industry simply passed the problem on to the user neurosurgeon, 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. We believe this calls for a renewed commitment to CNS shunt use, and we have drafted the following new 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. Corroborates and verifies proper use in tandem with single in-office ICP shunt tap.

3. Determine more precise pressure setting in patients implanted with 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 patient matching in cases of 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.