Packaging for surgical stapler buttress

Abstract

A packaging assembly is designed for an applicator that contains a buttress assembly that is used with a surgical stapler to reinforce a cut and stapled tissue site. The packaging assembly protects the buttress assembly from damage due to physical contact as well as exposure to adverse environmental factors like excess moisture, etc. In one example the packaging assembly includes a dual tray design with an inner tray that holds the applicator. The combined inner tray and applicator are hermetically sealed within a foil assembly or foil pouch. The foil pouch with the inner tray and applicator within is placed within the outer tray to protect the foil from damage.

1 .- 20 . (canceled) 
     
     
         21 . A packaging assembly, comprising:
 (a) an outer tray;   (b) a pouch including a hermetically sealed interior, wherein an exterior of the pouch is configured to be contacted by the outer tray;   (c) an inner tray configured to be positioned within the interior of the pouch such that the pouch separates the inner tray from the outer tray, wherein the inner tray is configured to retain an applicator operable to apply to a buttress assembly to a surgical stapler and is further configured to prevent the applicator from contacting at least a portion of the pouch; and   (d) a desiccant material, wherein the inner tray is configured to selectively retain the desiccant material in a position on an outer surface of the inner tray that inhibits contact between the desiccant material and the applicator.   
     
     
         22 . The packaging assembly of  claim 21 , wherein at least a portion the outer tray is configured to protect the pouch from damage by fitting closely against the pouch. 
     
     
         23 . The packaging assembly of  claim 21 , wherein the pouch is made of foil. 
     
     
         24 . The packaging assembly of  claim 21 , wherein the pouch is configured to closely follow a contour of the inner tray so as to protect the pouch from damage. 
     
     
         25 . The packaging assembly of  claim 21 , wherein the inner tray is further configured to selectively retain the applicator. 
     
     
         26 . The packaging assembly of  claim 21 , wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein the inner tray further includes a living hinge connecting the flap with the base. 
     
     
         27 . The packaging assembly of  claim 21 , wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein the flap is rotatable relative to the base between a closed position and an open position, wherein in the closed position the flap at least partially covers the applicator when the applicator is selectively retained within the base. 
     
     
         28 . The packaging assembly of  claim 21 , wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein the inner tray further comprises at least one fastening feature configured to selectively connect the flap with the base. 
     
     
         29 . The packaging assembly of  claim 28 , wherein the flap is rotatable relative to the base between a closed position and an open position, wherein the at least one fastening feature comprises first and second fastening members configured to engage one another when the flap is in the closed position when the applicator is properly positioned within the base, and wherein the first and second fastening members are further configured to not engage one another when the applicator is improperly positioned within the base. 
     
     
         30 . The packaging assembly of  claim 21 , wherein the inner tray is configured such that a first end of the applicator is only positionable within the inner tray facing one way. 
     
     
         31 . The packaging assembly of  claim 21 , wherein the desiccant material includes a plurality of engagement features configured to selectively retain the desiccant material relative to the inner tray such that the desiccant material does not contact the applicator. 
     
     
         32 . The packaging assembly of  claim 31 , wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein an outer surface of the flap includes a plurality of openings configured to engage the plurality of engagement features to selectively retain the desiccant material on the flap. 
     
     
         33 . The packaging assembly of  claim 21 , wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein the flap is rotatable relative to the base between a closed position and an open position, wherein when the flap is in the closed position the flap is configured to shield a buttress assembly of the applicator so that the buttress assembly is inaccessible. 
     
     
         34 . The packaging assembly of  claim 21 , wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein the flap has a peninsula portion configured for grasping when opening the flap. 
     
     
         35 . The packaging assembly of  claim 21 , wherein the inner tray comprises a molded plastic. 
     
     
         36 . An assembly, comprising:
 (a) an outer tray;   (b) an applicator supported by the outer tray, wherein the applicator is configured to apply a buttress assembly to an end effector of a surgical stapler;   (c) an inner tray configured to retain the applicator, wherein the inner tray includes a base and a flap hingedly coupled with the base, wherein the flap has a guide feature configured to engage and maintain the applicator in a longitudinally aligned orientation in which an open end of the applicator is aligned with a proximal end of the base, wherein the guide feature is configured to prevent the flap from closing fully against the base when the applicator is not in the longitudinally aligned orientation; and   (d) a pouch that encloses the inner tray and separates the inner tray from the outer tray.   
     
     
         37 . The assembly of  claim 36 , wherein the outer tray is configured to protect the pouch from damage. 
     
     
         38 . A method for packaging an applicator having a buttress assembly configured to be loaded onto an end effector of a surgical stapler, the method comprising:
 (a) positioning the applicator within a base of a tray such that a proximal end of the applicator is longitudinally aligned with a guide feature of a movable flap of the tray;   (b) securing the movable flap in a closed position relative to the base; and   (c) sealing the tray with the applicator between a first impermeable layer and a second impermeable layer.   
     
     
         39 . The method of  claim 38 , wherein the first and second impermeable layers comprise first and second foil layers that define a foil assembly, wherein the tray comprises an inner tray, further comprising positioning the foil assembly containing the inner tray with the applicator within an outer tray to prevent damage to the foil assembly. 
     
     
         40 . The method of  claim 38 , wherein positioning the applicator within the base of the tray comprises orienting the applicator in a predefined direction so that the applicator sits flat within the base of the tray and allows the movable flap to properly close.