Package assembly

Abstract

A method and apparatus for packaging a medical device includes a package assembly that defines a multi-chambered interior. The interior chambers include a primary and a secondary chamber. A partition, which has a gas permeable vent, separates the primary chamber from the secondary chamber. The package is constructed from a variety of materials that provide the interior with a long term, low humidity, sterile environment.

1 . A dual compartment pouch comprising:
 front and back sheets of a flexible barrier film arranged in opposing face-to-face relation, each having an inner surface, a top edge, a bottom edge, and opposite side edges extending longitudinally from said top edge to said bottom edge;   an inner sheet of a flexible barrier film disposed between the front and back sheets and having a top edge, a bottom edge, and opposite side edges, the inner sheet defining first and second compartments within the pouch;   side seams extending longitudinally along said opposite side edges and joining the front and back sheets to the inner sheet;   a bottom seam extending transversely along said bottom edges and joining the front and back sheets to the inner sheet;   an opening formed in the inner sheet and providing communication between the first and second compartments;   a breathable membrane disposed on the inner sheet and covering said opening, said breathable membrane having a peripheral edge overlying the inner sheet and spaced from said side seams and bottom seam, the breathable membrane comprising a moisture vapor permeable, water-impermeable sheet material; and   a seam located at or adjacent the peripheral edge of the breathable membrane joining the membrane to the inner sheet.   
     
     
         2 . The pouch of  claim 1 , wherein the breathable membrane comprises paper or a nonwoven fabric. 
     
     
         3 . The pouch of  claim 1 , wherein the barrier film of the inner sheet includes a heat sealable thermoplastic material. 
     
     
         4 . The pouch of  claim 1 , wherein the top edge of the inner sheet is unconnected to the front sheet or the back sheet to define access openings into the first and second compartments. 
     
     
         5 . The pouch of  claim 1 , further comprising a frangible seal disposed between the front sheet and the inner sheet towards a bottom end of the pouch. 
     
     
         6 . The pouch of  claim 5 , wherein the frangible seal has a chevron shape with an apex directed towards the bottom edges of the back and inner sheets. 
     
     
         7 . The pouch of  claim 1 , wherein the breathable membrane has a surface area of at least about 1 square inch. 
     
     
         8 . The pouch of  claim 1 , wherein the breathable membrane has a surface area of at least about 9 square inches. 
     
     
         9 . The pouch of  claim 1 , wherein the top edges of the inner sheet and the back sheet extend beyond the top edge of the front sheet. 
     
     
         10 . The pouch of  claim 1 , wherein the opening in the inner sheet and the breathable membrane are circular, and are joined to each other by a continuous seam that is located at or adjacent the peripheral edge of the breathable membrane. 
     
     
         11 . A sterilizable dual compartment pouch comprising:
 front and back sheets of a flexible barrier film arranged in opposing face-to-face relation, each having an inner surface, a top edge, a bottom edge, and opposite side edges extending longitudinally from said top edge to said bottom edge;   an inner sheet of a flexible barrier film disposed between the front and back sheets and having a top edge, a bottom edge, and opposite side edges, the inner sheet defining first and second compartments within the pouch;   side seams extending longitudinally along said opposite side edges and joining the front and back sheets to the inner sheet;   a bottom seam extending transversely along said bottom edges and joining the front and back sheets to the inner sheet;   a top seam extending transversely along said top edges and joining the front and back sheets to the inner sheet and an opening formed in the inner sheet and providing communication between the first and second compartments;   a breathable membrane disposed on the inner sheet and covering said opening, said breathable membrane having a peripheral edge overlying the inner sheet and spaced from said side seams, top seam, and bottom seam, the breathable membrane comprising a moisture vapor permeable, water-impermeable sheet material; and   a continuous seam located at or adjacent the peripheral edge of the breathable membrane joining the membrane to the inner sheet.   
     
     
         12 . The sterilizable dual compartment pouch of  claim 11 , further comprising a medical device disposed in the second compartment. 
     
     
         13 . The sterilizable dual compartment pouch of  claim 12 , wherein the medical device is a stent that is coated with a therapeutic drug agent. 
     
     
         14 . The sterilizable dual compartment pouch of  claim 11 , further comprising one or more of a desiccant or scavenging agent disposed in the first compartment. 
     
     
         15 . A method of sterilizing an article comprising providing the pouch of  claim 1 ;
 introducing an article into the second compartment;   sealing the top edges of the inner sheet and the back sheet to each other;   introducing a sterilizing gas into the first compartment;   passing the sterilizing gas from the first compartment to the second compartment via the breathable membrane;   introducing one or more absorbents into the first compartment; and   sealing the top edge of the front sheet to the inner sheet.   
     
     
         16 . The method of  claim 15 , further comprising the step of flushing the first and second compartments with an inert gas prior to the introduction of one or more absorbents. 
     
     
         17 . The method of  claim 15 , wherein the article is a stent that is coated with a therapeutic drug agent. 
     
     
         18 . The method of  claim 15 , wherein the breathable membrane comprises paper or a nonwoven.