A Novel Portable Cooling Device for Storing and Delivering ProKera, a Sutureless Amniotic Membrane

Abstract

Purpose: : ProKera ^TM is an FDA approved type II medical device, consisting of an ophthalmic conformer fastened with a sheet of cryopreserved amniotic membrane. It is designed and manufactured by Bio-Tissue to assist in ocular surface wound repair and wound healing by providing anti-scarring, anti-angiogenic, and anti-inflammatory properties, and by supporting epithelial proliferation underneath. Utilization of ProKera^TM can be hampered if the medical facilities do not possess suitable refrigeration facilities and therefore have not been feasible to deploy this ocular healing membrane at the scene of eye trauma. Of particular interest is ProKera^TM’s application to wounded military service members given the high incidence of eye trauma due to the deleterious effects of roadside bombs. Research results of several field portable refrigerated containers oriented toward ambulatory ProKera^TM applications will be discussed.

Methods: : ProKera^TM was obtained from Bio-Tissue, Inc. (Miami, FL). A prior validation study indicated that the storage temperature of one to ten degrees Celsius could maintain the integrity of ProKera^TM for at least 3 months. ProKera^TM samples were placed from a negative seventy degree Celcius freezer into an insulating apparatus containing ammonium nitrate and water and put into an oven.

Results: : Thermocouple readings indicated that the internal temperature of the insulating apparatus remained below chilled below freezing for more than an hour. Longer time period results are pending.

Conclusions: : ProKera^TM is a medical device to aid in ocular surface wound repair. Short term stability of ProKera^TM allows for the use of portable cooling devices utilizing endothermic salts and specialized vacuum insulated vessels for temporary storage and delivery of ProKera to the battle field for wounded soldiers.

Keywords: wound healing