Catheters with lubricious linings and methods for making and using them

Abstract

Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.

1 . A liner assembly prepared by a process comprising the steps of:
 coating at least a first surface of a flexible elongate strip having first and second edges;   bringing the first and second edges of the flexible elongate strip into proximity of one another;   joining the first and second edges such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner; and   joining said flexible tubular liner with a generally tubular outer sheath to form a liner assembly.   
     
     
         2 . The liner assembly prepared by the process comprising the steps of  claim 1 , wherein coating further comprises coating a second surface of the flexible elongate strip. 
     
     
         3 . The liner assembly prepared by the process comprising the steps of  claim 1 , wherein coating comprises applying a hydrophilic material upon at least the first surface. 
     
     
         4 . The liner assembly prepared by the process comprising the steps of  claim 3 , wherein applying comprises spraying or dip-coating the hydrophilic material upon at least the first surface. 
     
     
         5 . The liner assembly prepared by the process comprising the steps of  claim 1 , further comprising irradiating the flexible elongate strip prior to bringing the first and second edges. 
     
     
         6 . The liner assembly prepared by the process comprising the steps of  claim 5 , wherein irradiating comprising irradiating the flexible elongate strip with ultraviolet light. 
     
     
         7 . The liner assembly prepared by the process comprising the steps of  claim 1 , further comprising heating the flexible elongate strip prior to joining the first and second edges. 
     
     
         8 . The liner assembly prepared by the process comprising the steps of  claim 1 , wherein bringing the first and second edges comprises drawing the first and second edges over a mandrel such that the flexible elongate strip transitions into a tubular form. 
     
     
         9 . The liner assembly prepared by the process comprising the steps of  claim 1 , wherein joining comprises fusing the first and second edges in a lap or butt joint. 
     
     
         10 . The liner assembly prepared by the process comprising the steps of  claim 1 , wherein joining comprises applying an adhesive film to the first and second edges. 
     
     
         11 . The liner assembly prepared by the process comprising the steps of  claim 1 , wherein joining comprises fusing a portion of the first and second edges to one another by applying heat to the portion. 
     
     
         12 . The liner assembly prepared by the process comprising the steps of  claim 1 , further comprising cutting the formed flexible tubular liner to length. 
     
     
         13 . A liner assembly prepared by a process comprising the steps of:
 coating at least a first surface of a flexible elongate strip having first and second edges with a hydrophilic material;   irradiating the flexible elongate strip;   drying the flexible elongate strip;   bringing the first and second edges of the flexible elongate strip into proximity of one another;   joining the first and second edges such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner; and   joining said flexible tubular liner with a generally tubular outer sheath to form a liner assembly.   
     
     
         14 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein coating further comprises coating a second surface of the flexible elongate strip. 
     
     
         15 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein coating comprises spraying or dip-coating the hydrophilic material upon at least the first surface. 
     
     
         16 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein irradiating comprises irradiating the flexible elongate strip with ultraviolet light. 
     
     
         17 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein drying comprises passing the flexible elongate strip through an oven. 
     
     
         18 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein bringing the first and second edges comprises drawing the first and second edges over a mandrel such that the flexible elongate strip transitions into a tubular form. 
     
     
         19 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein joining comprises fusing the first and second edges in a lap or butt joint. 
     
     
         20 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein joining comprises applying an adhesive film to the first and second edges. 
     
     
         21 . The liner assembly prepared by the process comprising the steps of  claim 13 , wherein joining comprises fusing a portion of the first and second edges to one another by applying heat to the portion. 
     
     
         22 . The liner assembly prepared by the process comprising the steps of  claim 13 , further comprising cutting the formed flexible tubular liner to length. 
     
     
         23 . A tubular device prepared by a process comprising the steps of:
 coating at least a first surface of an elongate strip having first and second edges;   bringing the first and second edges of the elongate strip into proximity of one another;   joining the first and second edges such that a tubular liner is formed having the coated first surface formed as an inner surface of the tubular liner; and   joining the tubular liner with a generally tubular outer sheath to form a tubular device.   
     
     
         24 . The tubular device prepared by the process comprising the steps of  claim 23 , wherein coating comprises applying a hydrophilic material upon at least the first surface. 
     
     
         25 . (canceled) 
     
     
         26 . The tubular device prepared by the process comprising the steps of  claim 23 , further comprising irradiating the elongate strip prior to bringing the first and second edges. 
     
     
         27 . (canceled) 
     
     
         28 . The tubular device prepared by the process comprising the steps of  claim 23 , further comprising heating the elongate strip prior to joining the first and second edges. 
     
     
         29 . The tubular device prepared by the process comprising the steps of  claim 23 , wherein bringing the first and second edges comprises drawing the first and second edges over a mandrel such that the elongate strip transitions into a tubular form. 
     
     
         30 . (canceled) 
     
     
         31 . The tubular device prepared by the process comprising the steps of  claim 23 , wherein joining comprises fusing a portion of the first and second edges to one another by applying heat to the portion. 
     
     
         32 . (canceled)