METHOD FOR STERILIZING A MEDICAL DEVICE
A method of producing a ready-to-use medical device with a functional coating includes the steps of bringing the medical device, at least with its functional coating, in contact with a composition which prevents or retards degradation of the functional coating and sterilizing the medical device and the composition via radiation. A method leads to an improved product, namely an improved ready-to-use medical device which does not suffer a loss of quality during sterilization and storage. The composition comprises carboxymethyl cellulose or a derivative or salt thereof and/or an antioxidant selected from gallic acid or a derivative thereof.
1 . A method of producing a ready-to-use medical device with a functional coating, comprising:
bringing the medical device, at least with its functional coating, in contact with a composition which prevents or retards degradation of the functional coating; and
sterilizing the medical device and the composition via radiation,
wherein the composition comprises carboxymethyl cellulose or a derivative or salt thereof and/or an antioxidant selected from gallic acid or a derivative thereof.
2 . The method according to claim 1 , wherein the antioxidant of the composition is an ester, amide or oxadiazole derivative of gallic acid.
3 . The method according to claim 1 , wherein gallic acid or a derivative thereof is present in the composition in an amount of 0.001% to 5% by weight based on the total weight of the composition.
4 . The method according to claim 1 wherein the composition comprises the sodium salt of carboxymethyl cellulose.
5 . The method according to claim 1 , wherein carboxymethyl cellulose or a derivative or salt thereof is present in an amount of 0.1% to 10% by weight based on the total weight of the composition.
6 . The method according to claim 1 , wherein the composition comprises carboxymethyl cellulose or a derivative or salt thereof and gallic acid or a derivative thereof selected from an ester, amide or oxadiazole derivative of gallic acid, preferably propyl gallate.
7 . The method according to claim 6 , wherein gallic acid or a derivative thereof is present in an amount of 0.001% to 1% by weight, based on the total weight of the composition.
8 . The method according to claim 1 , wherein the composition comprises a solution enhancer.
9 . The method according to claim 1 , wherein the composition further comprises an aqueous or oil based base solution or a lipid media or a combination thereof.
10 . The method according to claim 9 , wherein the aqueous base solution of the composition is selected from distilled water, deionized water, reverse osmosis water, filtered water or a saline solution.
11 . The method according to claim 9 , wherein the aqueous base solution is present in the composition in an amount of 50% to 99.99% by weight based on the total weight of the composition.
12 . The method according to claim 1 , wherein the composition further comprises a stabilizer and/or a buffer solution.
13 . The method according to claim 1 , wherein the solution enhancer is selected from ethylene glycol, diethylene glycol, propylene glycol, or glycerol and is present in an amount of 0.1% to 49.8% by weight based on the total weight of the composition.
14 . The method according to claim 12 , wherein the buffer solution has a pH of from 2.0 to 7.4.
15 . The method according to claim 1 , wherein the energy dose of radiation during radiation sterilization is in a range from 1 kGy to 50 kGy, preferably 15 kGy to 45 kGy, more preferably 25 kGy to 45 kGy.
16 . The method according to claim 1 , further comprising:
providing the medical device;
coating the medical device at least in parts with the functional coating;
activating the functional coating of the medical device by bringing it into contact with the composition which prevents or retards degradation of the functional coating, and;
packing the medical device and the composition into a vapour-tight package.
17 . The method according to claim 1 , wherein the medical device is a catheter.
18 . The method according to claim 17 , wherein the functional coating is a hydrophilic coating.
19 . The method according to claim 18 , wherein the catheter comprises a catheter shaft which is coated with the hydrophilic coating at least along its insertable length and which is tightly surrounded by a retractable sleeve and wherein the retractable sleeve and/or the catheter have a liquid-tight closure at a distal end and at a proximal end so that any liquid present in the retractable sleeve or the catheter shaft remains within the retractable sleeve and the catheter as long as the liquid-tight closure is not broken.
20 . (canceled)