Given Imaging contracted Scapa Medical to devise a way for reusable antennas to be placed onto the patient's skin and then be removed after 8 hours, without damaging the antenna or hurting the patient.

The Given diagnostic system, a wireless endoscopy system manufactured by Given Imaging (Norcross, GA), has revolutionized the diagnostic process for cancers and other disorders of the small intestine. Rather than relying on invasive diagnostic equipment, this wireless endoscopy system is made up of the M2A capsule endoscope. This is a disposable miniature video camera contained in a pill-size capsule that is ingested by the patient. The capsule passes naturally through the digestive track, remotely transmitting high-quality color images through a transdermal sensor and antenna network to a data recorder worn around the patient’s waist.

The unit has quickly gained acceptance among gastroenterologists for producing high-quality images of the small bowel without causing discomfort. It is flexible so that a patient can continue a normal daily routine. Because the patient is continuing with a regular routine, the external antenna, which picks up the transmitted data and forwards it to the data recorder, must remain comfortable and secure for 8 hours. The key to the success of the system is ensuring that the antennas stay adhered to the patient’s skin.

To ensure the comfort and security of the antenna network, Given Imaging contacted Scapa Medical (Windsor, CT) to devise a way for the reusable antennas to be placed on the patient’s skin and then be removed after 8 hours. Removal had to occur without damage to the antenna or hurting the patient.

Scapa Medical worked closely with Given’s engineers and designers to create a die-cut pocket device laminated with medical-grade transdermal adhesive. Eight of these pockets, each containing a reusable antenna, are placed on the patient’s abdomen before the test. Once the test is completed, the physician pulls apart the pocket to retrieve the antenna. The pocket is then removed from the skin and discarded.

The pocket consists of multiple layers of laminated materials, including an adhesive layer. Engineers faced a number of challenges during the design process. For example, Given Imaging required that the pocket had to be flexible to eliminate interference with daily routines. The material had to breathe to prevent sweat buildup that could erode the adhesive, causing the pocket to detach early and impair the results of the medical test.

Scapa selected potential materials and adhesives carefully so that the pocket could be designed for comfort and manufactured economically. The research and development process for the antenna pockets took 15 months from initial discussion to design completion.

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