Assembly for Wetting a Medical Device

Abstract

An assembly for wetting a medical device is provided. The assembly comprises a compartment for a fluid medium and a package for the medical device. The compartment and the package are separate elements, which are joined together. An outlet from the compartment is movable so as to be able to connect to an entrance to the package and hereby establish communication for the fluid. This way the medical device may be wetted. The fluid medium may contain an anti-microbial agent such as hydrogen peroxide. The medical device may be a urinary catheter. A method for manufacturing such an assembly and a method of using it is also provided.

1 . An assembly for wetting a medical device comprising a compartment for a fluid medium and a package for containing the medical device, where the package and the compartment are separate elements which are joined together, where an outlet from the compartment is movable from a storage-position out of contact with an entrance to the package to a use-position in contact with and connected to the entrance to the package such that upon connection communication between the fluid in the compartment and the interior of the package is established through means for providing a flow of the fluid between the compartment and the package. 
     
     
         2 . An assembly according to  claim 1 , wherein the medical device is a urinary catheter. 
     
     
         3 . An assembly according to  claim 1 , wherein the medical device has a hydrophilic coating. 
     
     
         4 . An assembly according to  claim 1 , where the outlet is movable in the longitudinal direction of the package and the movement between the storage-position and the use-position is at least 1 cm. 
     
     
         5 . An assembly according to  claim 1 , where the outlet in a storage-position faces away from the entrance and in a use-position faces the entrance. 
     
     
         6 . An assembly according to  claim 1 , where a movement of the outlet from the storage-position to the use-position follows a circular arc. 
     
     
         7 . An assembly according to  claim 1 , where a movement of the outlet from the storage-position to the use-position is a transverse movement 
     
     
         8 . An assembly according to  claim 1 , where the compartment comprises a rupturable pouch. 
     
     
         9 . An assembly according to  claim 1 , where a joint between the package and the compartment comprises hinge means. 
     
     
         10 . An assembly according to  claim 1 , where a joint between the package and the compartment comprises a detachable coupling. 
     
     
         11 . An assembly according  claim 1 , where a joint between the package and the compartment comprises a pivoting plunger for applying pressure to the fluid in the compartment 
     
     
         12 . An assembly according to  claim 1 , where the connection between the outlet and the entrance includes a friction-fit coupling. 
     
     
         13 . An assembly according to  claim 1  where the connection between the outlet and the entrance includes a snap-fit coupling. 
     
     
         14 . An assembly according to  claim 1  where the connection between the outlet and the entrance includes a spike-element and a rupturable membrane. 
     
     
         15 . An assembly according to  claim 1 , where the outlet from the compartment comprises a cut-off double lumen tube having a fluid channel and an air channel and where the entrance to package is a weak point. 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . A method for manufacturing an assembly comprising
 assembling a package including a medical device;   providing the package with an entrance;   sterilizing the package;   producing a compartment including a fluid medium;   providing the compartment with an outlet;   sterilizing the compartment separately from the package;   joining the package and the compartment to each other;   
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . A method according to  claim 25  wherein joining includes welding. 
     
     
         35 . A method according to  claim 25  wherein joining includes mechanically coupling the package and the compartment. 
     
     
         36 . (canceled) 
     
     
         37 . (canceled) 
     
     
         38 . A method according to  claims 25 , wherein sterilization of at least the package or the compartment is done by radiation. 
     
     
         39 . (canceled) 
     
     
         40 . A method according to  claim 25  and further including wetting the medical device comprising:
 a. moving the outlet from the compartment to a position so it may connect with the entrance to the package, and   b. connecting the outlet and the entrance to each other so as to allow for fluid communication.   
     
     
         41 . A method according to  claim 40  further comprising the step of providing an air-flow out of the package. 
     
     
         42 . A method according to  claim 41  wherein the air-flow out of the package is provided by opening the package. 
     
     
         43 . A method according to  claim 41  wherein the air-flow out of the package is provided through the connection between the outlet and the entrance and an air-channel in the compartment. 
     
     
         44 . A method according to  claim 41  wherein the air-flow out of the package is provided by an air-channel in the connection between the outlet and the entrance. 
     
     
         45 . (canceled) 
     
     
         46 . (canceled) 
     
     
         47 . (canceled) 
     
     
         48 . (canceled) 
     
     
         49 . (canceled) 
     
     
         50 . (canceled) 
     
     
         51 . A method according to  claims 40  wherein the moving of an outlet comprises detaching the compartment followed by re-attaching it in a position where the outlet faces the entrance to the package. 
     
     
         52 . (canceled) 
     
     
         53 . A method according to  claims 40  wherein the moving of an outlet comprises moving of a connecting device including the outlet from the compartment. 
     
     
         54 . A method according to  claim 53  wherein the moving is done in planes parallel to the longitudinal direction of the package.