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DiaCeph at AeA Awards


AeA 2007 Innovation Awards Application - The “DiaCeph Test”

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Message from the inventor:

Wikipedia describes “innovation” as the act of creating and introducing something new or better. An even broader view is problem solving. Innovation comes from persons with a passion, from persons with a vision and entrepreneurial spirit, and through others with the need to survive. World War II was evidence of the need to survive. The need to survive is the ultimate test of innovation, and it led me to conceive the DiaCeph Test in 1997.

The “DiaCeph Test” was conceived after five years of my own unsuccessful CNS shunt surgeries. Clearly, hydrocephalus then and today posed key diagnostic and care challenges which had been unanswered by new technology and know how.  In 1999, Dr. Eldon Foltz of UCI described me as a pioneer, ahead of the field. But, as I would soon discover, to bring a medical device to market requires many synchronous events, and several key events were horribly out of touch between 1998 and 2006.  Today, holds new hope for DiaCeph. In 2005, I was again to undergo corrective shunt surgery, DiaCeph and my new “Shunt Selection Model” paper unveiled new critical solutions to more efficacious shunting, that demand a call to action.

I cannot think of any single item in the care of hydrocephalus that can have the level of impact as DiaCeph. It is more than business. It is the survival and well-being of almost one million Americans.


Categories for this nomination:

[X ]  Software/Internet

[X ]  Computers & Related Products

[X ]  Medical Device Technology/Instrumentation


No. 1.  Name(s), title(s), and location(s) of individuals responsible for product/technology innovation and describe the role/contribution of each:

Stephen Dolle, IP owner, responsible for DiaCeph information and all materials


No. 2.  Describe, specifically, the product/technology, its features and benefits.  Attach two sets of available literature, specification sheets, brochures, videos, etc. that best explain the product/technology:

The following documents and files are attached:

1. A AEA Master Presentation DiaCeph.Music (PPT)

2. Dolle.FDA.STAMP Paper of Recommendations (PDF – 9 pages).

3. DiaCeph Test Description.6pages (Word).

4. DiaCeph Std Monitoring Form (PDF).

5. DiaCeph Blank 18 Hour graph (PDF)

6. Shunt Technology Perspective (PPT).

7. DiaCeph Test System Presentation (PPT).

8. DiaCeph Shunt Selection Model.Web (Word – 11 pages).

9. DiaCeph.PatientDataGraph (PDF).

10. VygonUS.Leaity.comments (Outlook)

11. OCBJ.1999.DolleInterviewDiaCeph (PDF).

12 FDAs Favorable Response on DiaCeph.1999 (PDF).

13. DiaCeph.Dr.Betsy Parker Email Comments (PDF)

14. DiaCeph Revenues.2000.OTousa (Excel)

15. Song files “Evening Solstace” x 2 (wav and mp3) plays in Master Power Point.


As an innovative disease management electronic processor and journal, the DiaCeph Test affords 24/7 anytime monitoring (self or assisted) of the neurological condition, hydrocephalus, in the normal routine of the patient, through its application embedded into its stand-alone hand held device, or onto a suitable PDA or mobile phone. It affords collection of invaluable real time shunt performance data during periods of intermittent shunt failure, and shunt mis-match, a key problem with CNS shunts still today. It then renders more efficacious use of (costly and invasive) diagnostic radiology procedures and shunt taps. It also supports easy periodic monitoring in patients who have undergone ETV procedures, whose outcomes can revert back. DiaCeph can be used as an aid in the dispensing of medications, and monitoring of interventional therapies, such as Diamox, used to treat early stage NPH, or normal pressure hydrocephalus. NPH can also be masked by Parkinsons and Alzheimers Disease. DiaCeph monitoring can also be carried out in tandem with a single in-office ICP manometer tap, where the tandem test widens the information obtained from each. DiaCeph monitoring provides an “approximate” value on ICP (intracranial pressure), eg. normal, low, high, or moderately high. And when instructed by a treating physician, it can evaluate shunt patency. An impressive benefit of DiaCeph is its ability to render real time in-vivo performance comparison of various CNS shunts, resulting in more optimized shunt outcomes, reduced care and treatment costs, and fewer surgeries. Routine use of the DiaCeph Test will substantially reduce treatment risks and costs.

DiaCeph comes as a stand alone device, but could come as a stand alone PC application, or an application for newer PDA and cell phone models. Once the initial set-up is configured, the test runs on the touch of a button, prompting the user to answer and select specific patient observations on the menu. It can prompt the user to monitor at preset times each day, and results can be used with biofeedback training, and for scheduling activities around good periods. DiaCeph increases access to patient care, while also reducing diagnostic exam costs. The program alerts the user when data has been collected incorrectly. Graphic and data results are printed via an accompanying PC program, in Time v. Event Level (complaints) and approximate ICP graphs, similar to that of ICP monitoring. Program includes many common cognitive assessment tests. Where available, results can be sent remotely over the Internet or via cell phone.


No. 3.  Describe the innovative aspects of the product/technology.  Explain how these innovations represent a significant advance over current and competing products/technology.  List any patents or patent applications:

DiaCeph received a U.S. patent in June of 2001, under patent no. 6,241,660. Patent and trademark work were handled by the firm Knobbe, Martens, Olsen & Bear.

The 1st innovative aspect of DiaCeph is that it permits simple and inexpensive “real time” collection of diagnostic information on almost any shunt, and on most patient’s CNS shunt status (from age 4 to 80 plus), that can be later shared with a treating physician to better direct other costly and invasive diagnostic tests, and assist the physician in selecting a replacement physiologic matched CNS shunt. The 2nd innovation aspect is that it allows treating physicians to jointly implement (with the patient) various interventions and therapies, including persons suspected of having NPH, and track the results in real time. The 3rd innovative aspect is that it allows for patient users to carry it with them at all times, like a diabetic does with a glucometer, and gives them a “tool” to better manage their life and common associated complaints.  It can also be employed for post discharge following of patients after ETV procedures. The 4th innovative aspect is that the real time data, when necessary, can be sent remotely over the Internet or a cell phone to a physician’s office or treatment center. The 5th innovative aspect of this technology is that similar applications could be written for a variety of disease treatment/management, and pre and post monitoring of long term prescription drug use, for real time assessment of risk indicators, and outcomes.

These innovations represent a major advance over the current treatment, as there is no present home, school, or office means to monitor shunt function. The last new substantive test on shunt status to find widespread use were that of CT and MRI scanners. In 2004, a device called the “ShuntCheck” was introduced as a non-invasive test, but requires 20 minutes or time and an ice pack and has not found much acceptance. There has been talk for 10 plus years of implantable “telesensor” devices that might collect shunt user data. There appears to be a void in commitment in the care and treatment of hydrocephalus. People such as myself, with hydrocephalus, and as many as 1 million other Americans have been living with great uncertainty and unnecessary health hardship due to suboptimal shunt outcomes and shunt status. CNS shunts last on average less than five years, and are known to frequently experience intermittent malfunctions and complaints in user patients. DiaCeph would facilitate more productive visits and use of invasive costly tests, and enable patients some capability to track their own progress/decline against their own baseline, without guessing, and better manage and schedule activities.


No. 4.  When was (or will) the product be introduced into the marketplace?  Please provide evidence, if any, of market acceptance or peer recognition:

There are an estimated one million people in the U.S. with hydrocephalus, with the major portion, or perhaps well over half implanted with CNS shunts. The remaining portion includes those with successful ETV procedures (10 percent), those untreated from birth and since advised against any treatment, and those yet to be diagnosed with (masked over) NPH. The treatment today is essentially the same as it was 50 years ago, and chronic unresolved complaints and repeat surgeries are common, lending it to a diagnostic medicine and shunt devices “nightmare” in attempts at treatment.

It would seem today the “who is going to pay” and the “when” are upon us, and DiaCeph should find immediate funding, introduction, and adoption. Even Congress and the President are finally demanding a more “consumer driven” and cost-effective health care model. DiaCeph and other disease monitoring technologies will now become key matters of business, with necessary investment and payors forthcoming. It has been a very long and difficult journey for stakeholders.

When the DiaCeph Test design was conceived in 1997, integration of medical information into personal devices and over the Internet had not yet come about, and patients played a small role in their care as compared to 2007. As DiaCeph was so new and innovative, it had its nay-sayers. Then in 1999, Stephen found enthusiastic support and favorable peer review from Eldon Foltz, M.D. and Professor of Neurosurgery at UCI , who advocated the forming of DiaCeph, Inc., and helped assemble an advisory board consisting of UCI ’s Betsy Parker, Ph.D, Ed Doyle, and Mike O’Tousa. Mr. O’Tousa had come from the business development section of Medtronic’s neurosurgical devices division, and was able to offer his insights into the financial aspects of the start-up. Also in 1999, the STAMP Committee of the Food & Drug Administration after Stephen attended a special conference in Washington , D.C. , gave their vote of support. Over the following two years, Stephen obtained very favorable peer review from two pre-eminent U.S. neuroscientists involved in research with hydrocephalus, Marvin Sussman, Ph.D., and Pat McAllister, Ph.D.

Stephen’s team believed managed care insurance, and shunt manufacturers as well, were good prospects as payors and/or distributors.  But, the team did not include any persons who were influential in obtaining an agreement with either an insurance carrier, or a shunt manufacturer. And as a single product, DiaCeph’s return on investment was modest with respect to venture capital investors. Additional applications and spin-off technologies were thought to hold promise in concussion, stroke, depression, and disease monitoring.

Some critics did not believe patients would adopt the technology. Some objected to their patients’ having access to diagnostic information, and others were less enthused about their patient’s participation in what is termed today, the “consumer driven medicine model.” In 2000, developers introduced similar monitoring technology for asthma, diabetes, and CHF. One popular device was the “Health Buddy,” which found support through Aetna Insurance. At the time, there was a sizable ground swell of interest in remote patient disease monitoring that never found broad integration. The key issue with adoption was the same as it is today: Who is going to pay?

Stephen’s efforts on behalf of DiaCeph between 1998 through 2002, included development planning at the University of California at Irvine , and later, at Wayne State University in Detroit , along with presentations to medical manufactures.

Tragically, both university development projects were halted due to “ownership issues” surrounding grants funding, which should not have occurred. This predated the OCTANe organization and more recent UCI rules changes. During all of this, Stephen also had to work through his own health limitations with hydrocephalus, that in all truth, would be improved once DiaCeph were completed and adopted. But, in late 2002, DiaCeph, Inc., had to be closed due to financial hardships, and Stephen continued on with his research activities in assistive technologies, and with DiaCeph.

In 1998, Stephen utilized the paper forms version of DiaCeph, now available on his web site, to direct his own complex corrective surgery. And in November 2005, these same DiaCeph forms confirmed shunt malfunction with this present shunt, where monitoring was matched in tandem with a single in-office ICP tap. These findings are presented in the paper, “Shunt Selection Model,” with reference to his findings on the DiaCeph Patient Data Graph.pdf. In spite of the findings, Stephen has felt compelled to postpone his corrective surgery in favor of when he can receive a better outcome – when neurosurgery practices can incorporate more accurate scientific information on shunt performance and specifications. A key feature of DiaCeph is its ability to provide reasonably accurate in-vivo shunt performance data, and comparisons among shunts. Stephen finds similarities in his plight to that which the U.S. faced during WWII when radar was finally adopted to overcome the threats posed by German submarines.

As of 2007, would be user hydrocephalus patients across the U.S. are clamoring for a home assessment test. In late 2005, Stephen conceived and introduced a tandem ICP shunt tap and DiaCeph monitoring procedure in his paper, “Shunt Selection Model.” This tandem procedure greatly increases DiaCeph’s utility. DiaCeph is now under the support and web site of Dolle Communications.


No. 5.  Technical questions regarding the product:  Please contact Stephen Dolle.


No. 6.  Attached documents and files:   SEE List in No. 2 and attached.


Respectfully Submitted,

Stephen Dolle

IP Owner of the DiaCeph Test