Moisture vapor transport channels for the improved attachment of a medical device to the human body.
Attachment of a small, medical device to the human body for an extended period of time in an ambulatory setting requires the careful consideration of the physical form of the device and the physiological constraints limiting the time a device will stay on the skin. Factors such as the size of the device, the area of the device available for attachment to the skin, and the occlusive nature of the materials in the device are likely to affect adhesion. Here, plastic acrylic disks, 25 mm in diameter, containing a crisscross pattern of air-filled channels were tested on the forearm and abdomen using a moderately aggressive, unsupported, pressure-sensitive transfer adhesive in a pilot human clinical study. After vigorous exercise, droplets of moisture were observed in the channels followed by evaporation of the droplets over time. Disks without channels remained attached to the skin for about a day and a half, while disks containing 450 microm deep channels remained on the skin about three times longer. Little difference was found when the channel-to-channel spacing was increased from 1.3 to 1.6 mm, however 230 microm deep channels were less effective than 450 microm deep channels. Overall, the moisture vapor transport channels appear capable of reducing the moisture content of the outermost stratum corneum layer of the skin, increasing the strength of the stratum corneum, and increasing the time a device remains attached to the skin. The median trial-to-trial relative standard deviation of 45% observed in the pilot study can be used to design appropriately powered studies for the comparison of different device designs.
Cunningham
David D
DD
Abbott Laboratories, Diagnostics Division, Department 9MS, Abbott Park IL 60046-6015, USA. david.cunningham@abbott.com
Lowery
Michael G
MG
D000268:Adhesiveness; D000553:Ambulatory Care / Q000379:methods*; D001672:Biocompatible Materials / Q000737:chemistry*; D004864:Equipment and Supplies; D006801:Humans; D008297:Male; D010865:Pilot Projects; D012867:Skin; D014014:Tissue Adhesives / Q000737:chemistry*; D014867:Water / Q000737:chemistry*
D001672:Biocompatible Materials; D014014:Tissue Adhesives; D014867:Water