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CY 2001 PRESENTATIONS



JANUARY 17, 2001

A Minimally Invasive Blood Glucose Monitor

Geoff McGarraugh (TheraSense, Inc.)


A person with diabetes must be able to measure the glucose in their blood in order to successfully balance their medication, food intake, and physical activity. Many people perform this measurement three to four times a day. The FreeStyle Blood Glucose Monitoring System manufactured by TheraSense Inc., Alameda, CA, measures blood glucose in a 0.3 l sample of capillary blood. Most glucose monitors require at least ten times as much blood, and the blood is obtained by lancing the fingertip where there is a relatively large blood supply. Unfortunately, the fingertip also has a high density of pain receptors, which makes fingertip testing relatively painful. The small blood volume required for the FreeStyle system can be extracted from the forearm. In clinical studies most people said testing on their forearm was painless, and 9 out of 10 people said testing with FreeStyle was less painful than testing with their finger stick monitor.

Like many glucose monitors, the FreeStyle system uses electrochemistry to measure glucose. An electrochemical measurement is made by conducting a chemical reaction that produces electrons, which are measured on an electrode surface. The commercial electrochemical glucose monitors that preceded FreeStyle measure the current produced from the enzymatic reaction of glucose, which is proportional to the glucose concentration (amperometric measurement). In order to obtain a steady state current, the analyte must not be significantly depleted, therefore the amount of glucose required must be large compared to the actual amount measured. The FreeStyle system measures charge (coulometric measurement) rather than current. In order to obtain an accurate measure of glucose from a charge measurement, all of the glucose in the sample must react, and the volume of sample must be well controlled. Since all of the glucose is consumed, coulometric measurements are ideal for measuring in a very small sample size without degradation of the signal. Amperometric measurements are subject to many interferences that are eliminated when the coulometric technique is employed. The FreeStyle monitor provides a minimally invasive measurement without sacrificing accuracy.

In this seminar the technology of the FreeStyle measurement will be described, and the clinical accuracy of the measurements will be presented.

Geoff McGarraugh obtained a bachelor's degree in chemistry from UCLA and a master's degree in bioorganic chemistry from UC Santa Cruz. In his early industrial career he worked as an analytical chemist. In January 1982 he joined a handful of people that comprised LifeScan Inc. to develop products to monitor blood glucose, and over the course of 17 years he participated in the development of three major product lines - GlucoScan, One Touch, and SureStep. Geoff joined TheraSense in December of 1998 and was instrumental in the development of the FreeStyle Blood Glucose Monitoring System.



FEBRUARY 21, 2001

New Frontiers in Cardiovascular Device Development

Paul G. Yock, MD (Stanford University School of Medicine)


Some of the most dramatic advances in devices for minimally invasive intervention have occurred in the area of cardiovascular medicine, particularly for coronary artery disease. In the next ten years there are several areas where there seems to be potential for major new breakthroughs:

Treatment of Restenosis

The single most stubborn problem in interventional cardiology is restenosis. Radiation treatment (brachytherapy) has been the first modality to show significant potency in limiting restenosis. Other, more user-friendly technologies are showing early promise, including drug-eluting stents, sonotherapy and drug-mediated phototherapy.

Angiogenesis

The growth of new vessels in an area of ischemia or infarction has been demonstrated convincingly in peripheral territories and in a preliminary fashion in the heart. Major challenges include localization, minimizing the risk of side effects and developing appropriate delivery technologies.

Vulnerable Plaque

One of the most daunting clinical problems in cardiovascular medicine is the early detection of the vulnerable plaque--that is, a plaque that is at risk for rupture/erosion and thereby myocardial infarction. Several new imaging technologies have shown promise in this area, including radiopharmaceutical-based detection systems, near infrared spectroscopy, optical coherence tomography (OCT) and intravascular MRI.

Novel Bypass Technologies

Several new approaches are being developed for bypass surgery, including robotic-assisted "conventional" CABG, in-situ bypass and LV-coronary shunting. In addition, there is good progress in conditioning vein grafts to resist intimal hyperplasia and in developing tissue-engineered grafts having characteristics that are similar to arterial conduit.

Biography

Dr. Yock is an interventional cardiologist at Stanford and director of a research group which develops and tests new technologies in cardiovascular medicine. He has invented several devices, including the Rapid Exchange angioplasty system, the "Smart Needle" the mechanical intravascular ultrasound catheter and the guided directional atherectomy device. He was a founder of Cardiovascular Imaging Systems, (now Boston Scientific, San Jose) and serves on the scientific advisory boards of a number of device companies.



MARCH 21, 2001

Applications of Microbubbles in Echocardiography Imaging

Dr. David Liang, Assistant Professor
Division of Cardiovascular Medicine
Dept. of Internal Medicine
Stanford University School of Medicine


Cardiac ultrasound (echocardiography) is one of the most important and commonly used diagnostic tools available to cardiologists. There are however many limitations to this popular technology. The addition of Microbubble contrast agents provides a means for addressing many of these limitations.

The development of contrast agents, which can cross the pulmonary circulation and the use of harmonic imaging have made these applications of contrast ultrasound clinically feasible.

Ultrasound contrast agents are being used clinically to enhance Doppler signals as well as to improve visualization of the cardiac chambers. They also hold potential as tools for assessing cardiac perfusion. Future applications may include targeted Microbubbles for specific imaging of plaque and thrombus.

The talk will review the ultrasonic characteristics of Microbubbles, their current clinical applications and their potential future applications.

David Liang received a B.S. degree in electrical engineering from MIT in 1981, and the MS and PhD degrees in electrical engineering from Stanford University in 1984 and 1989, respectively, and an MD degree from Stanford in 1989. He subsequently completed clinical training in Internal Medicine in 1992 and cardiovascular medicine in 1995 at Stanford University Hospital. In 1998 he joined the faculty in the Division of Cardiovascular Medicine at Stanford University, where he is now an assistant professor.

His research and clinical interests are in cardiac imaging, in particular cardiac ultrasound. His research has focused on new technologies in ultrasound.



APRIL 18, 2001

Antique and Quack Medical Devices

Robert S. Behl (RadioTherapeutics Corp.)


After research by D'Arsonval demonstrated that frequencies over 10 kHz were unlikely to stimulate tissue, the use of electro-therapeutic devices exploded in both Europe and in the United States. On the one hand, serious medical research culminated in the first really clinically useful commercial devices developed by Bovie and Cushing in the 1920's. On the other, an enormous growth occurred in quack devices that were meant to be sold to a gullible public. Curiously, some of these quack devices are still sold today in one form or another; others have been shown to have actual medicinal properties, although in some cases these properties are in applications very different from those originally promoted.

We will follow the development of the medical research of the period, then take a look at some of the "other" products popular during the period. Healthy individuals (you definitely wouldn't want to use this on someone who was ill!) are welcome to test out an "Elec-Treat Mechanical Heart" from my collection.

Mr. Behl has over 30 years of experience in the medical device industry. Since 1994, he has been Founder and Chairman of RadioTherapeutics Corporation. Mr. Behl was formerly the Founder, President and Chairman of InnerDyne Medical (surgical access and thermal ablation products. Prior to InnerDyne, he served as President and CEO of Menlo Care (specialty catheters), and was Founder and General Manager of the Clinical Technology Division of Sybron Corporation (electrosurgery, ultrasonic surgical aspirators and sterility assurance products).

Mr. Behl received a BSME from California State University-Northridge, an MS in Biomedical Engineering from USC, and earned an MBA in Finance and Economics as a Simon Fellow at the University of Rochester. He holds fourteen U.S. Patents in the medical device area. Mr. Behl is particularly interested in early electro-surgery and diathermy and has a personal collection of electrical/pseudo-electrical quack medical devices.



MAY 16, 2001

The Intravascular SONOTHERAPY System for the Prevention of Restenosis within Stents

Menahem (Meno) Nassi
PharmaSonics, Inc.


The decade of the nineties has seen stent technology become the dominant revascularization tool for the treatment of coronary obstructions. However, stents are metal implants that, while maximizing lumen size and scaffolding the artery, also provoke a hyperplastic response which re-occludes the artery in about 25% of cases. PharmaSonics has developed the intra-vascular SONOTHERAPY system to inhibit neointimal hyperplasia within a stent. Therapeutic levels of low frequency ultrasound (1MHz), delivered via a 1.67 mm coronary catheter for 10-15 minutes, have been tested in experimental models and in over 100 patients undergoing safety and feasibility pilot testing.

Some of the relevant biomedical engineering design considerations and clinical implementation challenges will be discussed.

Menahem (Meno) Nassi completed a BSc and a MSc ('75) in Mechanical Engineering at the Technion, Israel Institute of Technology, Haifa, Israel. He obtained a MSc ('78) in Electrical Engineering and a Ph.D. in Bio-engineering ('81) at Stanford University, Stanford, California.

Dr. Nassi has been throughout his 30 years of professional career involved in pioneering biomedical engineering developments while starting and leading, as CEO, two medical device start-ups (Cardiometrics, Inc.'91-97, and Pharma-Sonics, Inc. '97-present). Dr. Nassi has been a co-inventor and a co-author in various non-invasive and invasive imaging and blood flow applications, and most recently in the application of therapeutic ultrasound device technology for the prevention of stent restenosis.



JUNE 20, 2001

An Introduction to Bioanalytical Chips

Mary X. Tang (Stanford Nanofabrication Facility)
Associate Professor / Department of Urology
Mary X. Tang


Miniaturization technologies, long established in the manufacture of microelectronic devices, are now defining a new paradigm in biological analysis. Miniaturization reduces the amount of reagents required and decreases analysis times -- both particularly advantageous when limited quantities of sample are available and/or increased resolution or throughput is desired. Miniaturization facilitates multiplexed analysis; high-throughput screening of genes and drug candidates are prime areas of rapid development in this area. Miniaturization also facilitates vertical integration so that sequential process steps can be linked in a single device. And especially important for basic life sciences research, miniaturization facilitates control of the experimental environment at the microscale range, allowing exquisite manipulation and detection of biological processes at the cellular and subcellular level. This presentation is designed to serve as an introduction to biochips, focusing on the technical issues of miniaturization in bioanalytical systems.

Biography

Mary X. Tang received a BS in chemistry from Occidental College, a MS in Chemical Engineering from Stanford University and her Ph.D. in bioengineering from UC Berkeley and UCSF. Her research focussed on DNA biophysics in self-assembling nanoparticles for therapeutic drug delivery.

From 1984 to 1991 she was a manufacturing process engineer and senior development engineer at Intel Corp., where she worked on various aspects of semiconductor processing. In 1997 she was a post-doctoral researcher at UC Berkeley Department of Chemistry. There she was involved in research in DNA electrophoretic sequencing on glass chips.

From 1998 to the present she has been a biotech liaison at the Stanford Nanofabrication Facility, where she promotes interdisciplinary research activities for the NSF-funded National Nanofabrication User's network. Some of these activities include facilitating cross-disciplinary collaborations, organizing educational seminars and symposia, and initiating biochip-related research projects. Her current research areas of focus are bioanalytical devices, microfluidics, and self-assembling systems for nanoelectronics.



SEPTEMBER 12th, 2001

A Novel Self-Applied Sleep Apnea Monitor

Leonard Kaufer / Principal Engineer
Sleep Solutions, Inc.


This home sleep apnea monitor uses adaptive noise cancellation for detection of respiration.

There are up to 20 million undiagnosed cases of Obstructive Sleep Apnea Syndrome (OSAS) in the United States. The traditional method of diagnosis includes an over-night stay at a sleep lab for a polysomnograph (PSG) study. This presents numerous problems including a backlog that is often several months long.

One solution to the problem uses a subset of traditional PSG channels applied by the patient at home. Respiratory airflow, respiratory effort, snoring sound, SpO2 and heart rate are monitored for three nights. Firmware within the device detects and records apneas and hypopneas. Post-processing on a PC generates a comprehensive report.

The device uses a novel method to detect respiratory airflow that provides dramatic improvements over the traditional nasal thermistor. One microphone captures all ambient sound, including snoring. A second microphone captures the breath sounds contaminated with the ambient sound. Patented cancellation techniques are used to remove the ambient sounds from the breath signal, resulting in a respiratory signal that has a fast response time and is linear to airflow.

The device contains many design features that enable it to be used by the patient in the home without assistance. The entire process is further simplified by using the internet to enable ordering, product delivery, and presentation of the results to the physician for diagnosis.

In this presentation, Leonard Kaufer will describe the technology and discuss clinical results.

Leonard Kaufer is the principal firmware engineer for Sleep Solutions, Inc. He has over fifteen years of medical device development experience and has worked with the FDA and industry associations on the development of apnea device monitoring standards. He began his career with eight years in the semiconductor industry.



OCTOBER 10, 2001

Image-Based Modeling for Cardiovascular Disease Research and Treatment Planning

Charles A. Taylor
Assistant Professor of Surgery and Mechanical Engineering
Stanford University


The combination of volumetric medical imaging and computer simulation has enabled a new approach to modeling blood flow in the human cardiovascular system: image-based modeling. New methods to examine the relationship between blood flow and cardiovascular disease are emerging. This fusion of imaging and modeling has led to a new approach for cardiovascular treatment planning in which the physician utilizes computational tools to construct and evaluate a combined anatomic/physiologic model to predict the outcome of alternate treatment plans for an individual patient. Applications of medical imaging to quantify biomechanical forces in human arteries will be discussed. Recent progress in constructing subject specific anatomic models from imaging data, planning treatments, and modeling blood flow will be described. Results from in vivo studies utilizing magnetic resonance imaging techniques to validate computational flow solutions will be presented. Finally, current challenges in developing image-based modeling technology will be discussed.

Professor Taylor received his B.S. degree in Mechanical Engineering in 1987 from Rensselaer Polytechnic Institute. He then joined the Engineering Physics Laboratory at GE Research & Development Center in Schenectady, New York. He received his M.S. degree in Mechanical Engineering in 1991 and his M.S. Degree in Mathematics in 1992 from Rensselaer Polytechnic Institute. He earned his Ph.D. degree in 1996 at Stanford in the Applied Mechanics Division for his work on finite element modeling of blood flow. Dr. Taylor joined the faculty in 1997 and is currently an Assistant Professor in the Departments of Surgery and Mechanical Engineering. He founded and directs the Stanford Cardiovascular Biomechanics Laboratory and teaches courses in Cardiovascular Biomechanics in the School of Engineering. He is internationally recognized for the development of computer modeling techniques for cardiovascular disease research, device design and surgery planning.



NOVEMBER 13, 2001

Identifying Superior Athletes Using a Unique Non-Invasive Metabolic Tester

Eugene Vasin, ND, Ph.D, European MD
Fitos- Alternative Medicine Research


A new technique for measuring a person's athletic performance involving metabolic factors has been derived using electrocardiogram measurements from a person's Wilson points. A first derivative of an electrocardiogram measurement is calculated. A ratio is calculated of the absolute value of the positive spike of the first derivative to the sum of the absolute values of the positive and negative spikes. The ratio is multiplied by a constant to determine some metabolic factors; other operations are performed on the ratio to determine other metabolic factors. In some embodiments, a garment is provided for easily locating Wilson points. Methods and devices are provided for taking and processing ECG measurements to determine metabolic factors and for using metabolic factors to optimize an exercise program.

The non-invasive technique and quick response of this product allows large scale screening of people. One of the results derived from this testing has shown certain athletes that have a high metabolic factor exhibit superior athletic performance. In addition to the technical descriptions of this product, clinical results and applications will be described.

Dr. Eugene Vasin has over 20 years of experience in medicine and medical science. In 1979 he entered to Vinnitsa (Ukraine) Medical University and in 1979 graduated from Voroshilovgrad (Lugansk) Medical University as a physician and doctor of internal medicine.

In 1981 he graduated from Odessa Medical University as a Clinical and Sports Physiologist. Since 1982 he has been Chief Physiologist and Sporting Medicine Physician of Olympic National Tea of former USSR. Dr. Vasin worked with leading Biochemical and Biophysiology laboratories of Lesgoft Institute of Sports Medicine and Physical Fitness Leningrad and Central Biochemical Laboratory of Moscow Institute of Sport Medicine.

In 1989 Dr. Vasin received a Ph.D. degree in medical science from Kiev Institute of Physical Culture. In 1996 Dr. Vasin received a PhD degree in Alternative Medicine at IAMPR in Arkansas. In 1996 he established his practice in California as consultant in Alternative Medicine and Physiology. His invention was filed for a patent in July, 2001.



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