Abstract A dry absorbable synthetic surgical element of a polymer subject to hydrolytic degradation to non-toxic, tissue-compatible, absorbable components, such as a polyglycolic acid suture, is packaged in an air-tight sealed container which is substantially impervious to water vapor such as a laminate film having a metallic foil layer. The gaseous contents of the envelope are, prior to sealing the suture within the envelope, either evacuated or replaced with a gas which is inert towards said surgical element and which is substantially free from water. The water content should be below 0.5 percent by weight of the weight of the surgical element, and preferably is and remains below 0.05 percent by weight. Polyglycolic acid sutures and other elements thus packaged retain acceptable levels of strength for at least one year at storage temperatures of 72*F. and ambient humidity outside the package. The contents may be sterilized by using ethylene oxide.
The method of claim 1 in which the sterile surgical element is a polyglycolic acid suture, and the water content is less than 0.05 percent.
Claim 2
Dependent Claim
236 words
a strippable outer envelope fabricated from a laminate of polyethylene and the polymeric ester of ethylene glycol and terephthalic acid; and wherein the interenvelope space of said dual envelope package is sterile, which comprises: a. inserting a polyglycolic acid suture into the inner envelope described above, b. sterilizing the inner envelopE and its contents by contacting them with a gas containing about 12 percent by volume ethylene oxide and 88 percent by volume dichlorodifuloromethane for 4 to 20 hours at 70* to 100*F. and 5 to 30 psig., said gas having ambient moisture content, c. heating said envelope and its contents for about one hour at 82*-88*C. and an absolute pressure of 1 to 5 mm Hg, d. maintaining the dry suture in a substantially dry and sterile environment while awaiting completion of packaging, e. evacuating the gaseous contents of the inner envelope and sealing said envelope with an air-tight moisture proof seal to produce a vacuum packaged suture, f. sealing the sealed inner envelope within the outer envelope described above to form a dual envelope package, and g. sterilizing the inter space of the dual envelope package by contacting the package with a gas containing 12 percent by volume ethylene oxide and 88 percent by volume dichlorodifluoromethane for 16-24 hours at 72*-100*F. and 10-27 psig, said gas having an ambient relative humidity, which permeates the seals of the outer envelope, and sterilizes the interenvelope space.
Claim 3
Independent Claim
10 words
The method for making a dual envelope suture package comprising