Catheter assembly with resealable opening

Abstract

A medical device assembly is disclosed, comprising a medical device, preferably having a hydrophilic surface coating, and a package accommodating said medical device. The package if formed of two sheets of foil material, a first foil of which has been deep drawn into a trough shape, the package further comprising a resealable opening arranged within the bounds of the second foil. The medical device may e.g. be a urinary catheter.

1 . A medical device assembly comprising a medical device, preferably having a hydrophilic surface coating, and a package accommodating said medical device, wherein the package if formed of two sheets of foil material, a first foil of which has been deep drawn into a trough shape, the package further comprising a resealable opening arranged within the bounds of the second foil. 
     
     
         2 . The medical device assembly of  claim 1 , wherein the two sheets of foil material are joined along the edges of the foils. 
     
     
         3 . The medical device assembly of  claim 1 , wherein the two sheets of foil material are joined together by means of welding. 
     
     
         4 . The medical device assembly of  claim 1 , wherein the medical device is a catheter and the resealable opening is arranged at, and preferably overlying, the part of the package housing the non-insertable, rearward end of the catheter. 
     
     
         5 . The medical device assembly of  claim 1 , wherein the medical device is a catheter, and preferably a urinary catheter, and most preferably a urinary catheter for intermittent use. 
     
     
         6 . The medical device assembly of  claim 1 , wherein the resealable opening in the second sheet comprises a perforation line extending along a non-closed loop in one of said sheets, said perforation line defining a flap opening, and a third sheet connected by means of an adhesive over said flap opening, wherein said third sheet with a margin covers the entire flap opening. 
     
     
         7 . The medical device assembly of  claim 6 , wherein said adhesive is adapted to maintain a sterile closure of the package before use, and to be resealable after use. 
     
     
         8 . The medical device assembly of  claim 7 , wherein said third sheet further forms a tab not provided with adhesive, said tab providing a grip portion for peel opening of the package. 
     
     
         9 . The medical device assembly of  claims 6 , wherein the medical device is a catheter, and the non-closed loop defining the flap opening debouches towards the end of the package housing the insertion end of the catheter. 
     
     
         10 . The medical device assembly of  claim 8 , wherein the medical device is a catheter, and the non-closed loop defining the flap opening debouches towards the end of the package housing the insertion end of the catheter. 
     
     
         11 . The medical device assembly of  claim 6 , wherein the third sheet covers the entire flap opening with a margin exceeding 2 mm. 
     
     
         12 . The medical device assembly of  claim 10 , wherein the third sheet covers the entire flap opening with a margin exceeding 2 mm. 
     
     
         13 . The medical device assembly of  claim 6 , wherein the non-closed loop has loop ends directed towards the interior of the non-closed loop. 
     
     
         14 . The medical device assembly of  claim 12 , wherein the non-closed loop has loop ends directed towards the interior of the non-closed loop. 
     
     
         15 . The medical device assembly of  claim 1 , wherein the assembly further comprises a wetting fluid for activation of said hydrophilic surface coating, said wetting fluid being accommodated by said package. 
     
     
         16 . The medical device assembly of  claim 15 , wherein the wetting fluid is arranged separately from said medical device in said package, and preferably being arranged in a wetting fluid container arranged within said package. 
     
     
         17 . The medical device assembly of  claim 1 , further comprising a fourth sheet arranged on the first sheet, on the side of said package being opposed to the resealable opening, said fourth sheet being connected by means of an adhesive to said first sheet, and forming a tab not provided with adhesive, said tab providing a grip portion for exposure of said adhesive to form a holding arrangement for said package. 
     
     
         18 . The medical device assembly of  claim 1 , wherein the first and second sheets comprise laminated sheets, having a weldable inner layer and a protective outer layer. 
     
     
         19 . A method of producing a medical device assembly comprising the steps:
 providing a medical device, preferably having a hydrophilic surface coating or being formed of a hydrophilic material; and   accommodating the medical device in a package, said package comprising:   a first and a second sheets of foil material connected around the edges, a first foil of which has been deep drawn into a trough shape, the package further comprising a resealable opening arranged within the bounds of the second foil.