Critical Care Plus-Smart Shirt Provides Wireless Body Data
By Don Long
In a decade or two, the aftermath of the Human Genome Project could change the face of medicine. But a more immediate and achievable advance in health care could come from "a rich source of data, acquired continuously, concerning how the body acts in real situations," says Sundareyan Jayaraman, PhD, a professor in the School of Textile and Fiber Engineering at the Georgia Institute of Technology, Atlanta.
Achieving the rich data stream envisioned by Jayaraman may be just around the corner, and can be produced by the shirts on our backs. They could be interwoven with plastic polymer optical sensors and then made into a basic T-shirt. Dubbed the Smart Shirt, the special optical fibers in the material can provide an ongoing stream of vital sign information while a person goes about his or her day-to-day activities—that is, truly at the point of care.
The challenge to develop a type of monitoring clothing first came from a U.S. Navy grant, but Jayaraman says he soon realized that the concept’s greatest benefit would be in a variety of potential health care applications. These could range from shirts worn by congestive heart failure patients to pajamas for infants feared at risk for sudden infant death syndrome.
These and other broad applications for the material will now be developed through an agreement between Georgia Tech Research Corp. and SensaTex, New York, a start-up company funded by Seed One Ventures of New York.
Jeffrey Wolf, chief executive officer of SensaTex, said that, in essence, the shirt is a "wearable motherboard, providing information from a wearable environment." He said an additional key to the system is its wireless technology: "You can monitor patients, for instance, with a Holter monitor, without wires down through patient’s body," Wolf says. "What it also means, he says, "is that you can integrate additional sensors to get even more information than you can get now because of reducing the need for wires, and you can have these [sensors] speak to one another."
SensaTex plans to seek Food and Drug Administration clearance for the device, and sees the technology’s commercialization coming as early as early 2001.
Besides monitoring heart patients and others at risk, the next most usable application will be in monitoring subjects participating in clinical trials, to continuously read their reactions to drugs or devices, for measuring sports performance, and in geriatrics. These can then be expanded to a wealth of uses in the military, and police and fire protection.
Smart Shirt’s ability to produce accurate, real-time results, says Wolf, "represents a quantum leap in health care monitoring."
The Heart That Wears a Jacket
In another recent development in medical "clothing," the heart of a 41-year-old woman was recently fitted with a kind of jacket to provide it greater support. Performed at the Hospital of the University of Pennsylvania, Philadelphia, the procedure involved implanting a special mesh-like polyester material around her heart to give it support and constraint. The surgeons also repaired a leaking mitral valve in the process. The woman was suffering cardiomyopathy, a balloon-like expansion of the heart muscle, resulting in a gradual loss of pumping function.
Known as the Cardiac Support Device (CSD) and made by Acorn Cardiovascular, St. Paul, MN, the jacket was slipped around the heart and then stitched in place. It is designed to prevent further enlargement of the heart muscle and boost its compromised efficiency. The jacket is slipped around the heart through open-chest surgery similar to that required during coronary-artery bypass grafts.
Michael Acker, MD, led the first U.S. implantation. He had previously participated in an implant procedure at a hospital in Berlin, Germany, where a clinical trial is showing positive results, according to Acorn.
Five million Americans are diagnosed with congestive heart failure, and 400,000 new cases are discovered every year, according to the American Heart Association (Dallas, Texas). The CSD "may offer a new approach for treating heart failure," said Donald Rohrbaugh, president and CEO of Acorn. He called the first U.S. implant "an important step in our clinical investigation and is supported by the broad-based research we have conducted."
The continuing U.S. trials will involve two randomized patient groups: those treated with the CSD and those without. "It is our belief, based on extensive studies, that those patients in whom the jacket is implanted will have improved heart function," says Acker. "If we can sustain the clinical improvement for an appropriate length of time, the heart jacket’ may prevent the need for transplantation in some patients."
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