Press Release

 
 

Toy-Like Anesthesia System Comforts Children During Medical Procedures

Design Continuum and Physician Inventor Create PediSedate™
WEST NEWTON, Mass., June 26, 2002 – For many children, medical procedures are stressful events that evoke fear and anxiety. Design Continuum Inc. and Boston-area anesthesiologist Geoffrey A. Hart, M.D. today announced an innovative, pediatric sedation headset that mitigates children’s fear and anxiety during medical procedures. Called PediSedate™, the headset helps children face medical procedures with comfort and familiarity by empowering them with a choice of playing with a Nintendo Game Boy® system or listening to music during sedation. PediSedate is receiving positive responses from children, parents and physicians in clinical trials at Floating Hospital for Children at Tufts-New England Medical Center in Boston.

PediSedate consists of a colorful, toy-like headset that connects to a Nintendo Game Boy system or a portable CD player. Once the child places it on his or her head and swings the snorkel down from its resting place atop the head, PediSedate transparently monitors respiratory function and distributes nitrous oxide, an anesthetic gas. The child comfortably becomes sedated while playing with a Nintendo Game Boy system or listening to music. This dramatically improves the experience for the child, parents and healthcare providers.

Human Empathy Drives Innovation

While working as an emergency medicine physician at Albert Einstein Medical Center in Philadelphia, Penn., Dr. Hart invented the concept for PediSedate when he saw how traumatized children became during medical procedures. He turned to the health and medical group at Design Continuum to develop a product that would dramatically improve the childhood healthcare experience.

Continuum prototyped and tested many models to better understand how children react to putting something over their heads and faces. Current sedation devices on the market cover the face and can prove scary for children to put on. To address this, Continuum solved the engineering challenge of delivering anesthesia from one side of the face rather than both through a unique, movable snorkel. In addition, to ensure that PediSedate™ would comfortably fit children ages three through nine, Continuum designed an adjustable headset with earpieces that flex to fit the contour of the head.

“Providing children with a painless medical experience is a major problem facing many physicians. PediSedate goes a long way toward making pediatric medical procedures more comfortable and humane for children and their parents,” said Dr. Hart. “Design Continuum did a fantastic job transforming the idea for PediSedate into an attractive, fun, entertaining product for children and providing healthcare workers with a state-of-the-art anesthesia monitoring and delivery system.”

The National Institutes of Health’s (NIH) Small Business Innovation Research (SBIR) program funded the research and development of PediSedate with the support of Albert Einstein Healthcare Network, which holds the patent for the technology.

Ongoing Trial Results Positive

PediSedate is currently undergoing Phase II SBIR clinical trials at the Floating Hospital for Children at Tufts - New England Medical Center. Throughout its clinical trials, PediSedate has received positive reactions from children, parents, nurses and physicians:

· Child acceptance: Most of the children in the clinical trials have accepted PediSedate as they would a familiar toy.
· Child anxiety: Markedly reduced. Children relax playing the Nintendo Game Boy® system or music of their choice while listening through the PediSedate headset.
· Child pain relief during sedation: Children are relaxed and carefree while breathing nitrous oxide under a physician’s supervision. Several have accepted an intravenous line without noticing.
· Child safety: To date, no child has experienced breathing or airway problems.
· Child side effects: Several children have experienced nausea from the nitrous oxide – a common side effect of the anesthetic.
· Parent acceptance: Very positive. Comments include, “Where has this device been throughout my child's care?”
· Healthcare provider acceptance: Many nurses observing the clinical trials have requested PediSedate for their young relatives undergoing pediatric surgery.

“At Continuum, we focus on making technology usable,” said David Chastain, Principal Engineer at Design Continuum and PediSedate Principal Investigator. “In the case of PediSedate, we made the technology usable by integrating a medical device with an entirely new product that is appealing and desirable for those who use it. It’s gratifying to see children accepting the PediSedate headset like a familiar toy.”

Clinical trials are expected to conclude in 2002. Dr. Hart and Albert Einstein Healthcare Network are currently seeking a licensee to manufacture and distribute PediSedate.

About Albert Einstein Healthcare Network

Albert Einstein Healthcare Network is a private, not-for-profit organization and one of the largest providers of healthcare services in the Philadelphia region. Subsidiaries include Albert Einstein Medical Center, Germantown Community Health Services, Willow Terrace (a nursing home), MossRehab, Willowcrest (a center for subacute care) and Belmont Behavioral Health. Einstein also operates many outpatient and satellite locations and Einstein Neighborhood Healthcare, a primary care network. Einstein is a member of the Jefferson Health System. For more information, visit www.einstein.edu.

About Nintendo

As the worldwide leader and innovator in the creation of interactive entertainment, Nintendo Co. Ltd., of Kyoto, Japan, manufactures and markets hardware and software for its popular home video game systems. The systems include Game Boy®, Nintendo® 64, Game Boy Advance and NINTENDO GAMECUBE™. Since the release of its first home video game system in 1983, Nintendo has sold more than 1.4 billion video games worldwide, creating enduring industry icons such as Mario™ and Donkey Kong® and launching such franchises as Zelda™ and Pokémon®. As a wholly owned subsidiary, Nintendo of America Inc., based in Redmond, Wash., serves as headquarters for Nintendo's operations in the Western Hemisphere. For more information about NINTENDO GAMECUBE or any other Nintendo product visit the company’s Web sites, www.nintendo.com or www.nintendogamecube.com.

About Continuum
Design Continuum Inc. is an international design firm that identifies opportunities and brings consumer, technology and medical innovations to a state of market readiness. The company leverages user-focused research to guide product design and development toward successful commercialization. Since 1983, Continuum has extended the research, design and development capabilities of companies worldwide including Andersen Windows, Aspect Medical Systems, BMW, Master Lock, Moen, Procter & Gamble, Samsung, Sunbeam, and Zeiss. Continuum has offices in Boston, Milan and Seoul. For more information, visit www.dcontinuum.com, e-mail info@dcontinuum.com or call 1-800-625-5115.

All trademarks, service marks and company names are the property of their respective owners.


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