Rigid sterile barrier
A rigid sterile barrier for protecting and maintaining a sterile environment for a medical device is disclosed. The rigid sterile barrier comprises a thermoformed tray and a top foil comprising a desiccant.
1 . A rigid sterile barrier for a medical device ( 400 ):
a thermoformed tray ( 100 ) comprising:
a cavity ( 106 );
a lip ( 110 ) extending above and disposed around a perimeter of the cavity; and
a flange ( 112 ) extending around the lip ( 110 );
an oxygen scavenger ( 300 ) disposed in a bottom ( 107 ) of the cavity ( 106 ); and
a top foil ( 200 ) adhered to the lip ( 110 ) of the thermoformed tray, the top foil ( 200 ) being non-permeable and comprising a desiccant, wherein the desiccant is integrated into a first polymer layer of the top foil, and wherein the first polymer layer comprising the desiccant is positioned between a second polymer layer and a third polymer layer, the second polymer layer and the third polymer layer having higher densities than the first polymer layer.
2 . The rigid sterile barrier of claim 1 , wherein the desiccant comprises calcium oxide.
3 . The rigid sterile barrier of claim 1 , wherein the medical device ( 400 ) is configured to be disposed between the oxygen scavenger and the top foil ( 200 ).
4 . The rigid sterile barrier of claim 1 , wherein the oxygen scavenger is thermally welded to the bottom ( 107 ) of the cavity ( 106 ) of the thermoformed tray ( 100 ).
5 . The rigid sterile barrier of claim 1 , wherein the thermoformed tray ( 100 ) comprises an aluminum layer ( 134 ).
6 . The rigid sterile barrier of claim 1 , wherein the thermoformed tray ( 100 ) is at least 300 microns thick.
7 . The rigid sterile barrier of claim 1 , wherein the thermoformed tray ( 100 ) is at approximately 350 microns thick.
8 . The rigid sterile barrier of claim 1 , wherein the top foil ( 100 ) is approximately 90 microns thick.
9 . The rigid sterile barrier of claim 1 , wherein the top foil ( 200 ) comprises an aluminum layer ( 228 ).
10 . The rigid sterile barrier of claim 1 , further comprising the medical device, and wherein the medical device ( 400 ) is a surgical staple cartridge.
11 . The rigid sterile barrier of claim 10 , wherein the surgical staple cartridge comprises a length of approximately 100 millimeters, a width of approximately 45 mm, and a thickness of approximately 16 millimeters.
12 . The rigid sterile barrier of claim 1 , wherein the cavity ( 106 ) does not comprise an additional desiccant.
13 . The rigid sterile barrier of claim 1 , wherein the thermoformed tray ( 100 ) does not comprise an additional desiccant integrated into the thermoformed tray ( 100 ).
14 . The rigid sterile barrier of claim 1 , wherein the thermoformed tray ( 100 ) does not comprise an additional oxygen scavenger integrated into the thermoformed tray ( 100 ).
15 . The rigid sterile barrier of claim 1 , wherein the top foil ( 200 ) does not comprise an additional oxygen scavenger integrated into the top foil ( 200 ).
16 . The rigid sterile barrier of claim 1 , wherein the cavity ( 106 ) is filled with an inert gas.
17 . The rigid sterile barrier of claim 16 , wherein the inert gas is nitrogen.