Catheter having a multilayered shaft section with a reinforcing mandrel

Abstract

A catheter having an elongated shaft having at least a section which is multilayered with a first layer and a second layer secured to the first layer, and a mandrel having at least a section between the first and second layers. In one presently preferred embodiment, the mandrel is in contact with an outer surface of the first layer and with an inner surface of the second layer.

1 . An intraluminal catheter, comprising: 
 a) an elongated shaft having a proximal end, a distal end, at least one lumen therein, and at least a section which is multilayered with a first polymeric layer and a second polymeric layer secured to the first polymeric layer; and    b) a mandrel having at least a section between the first and second polymeric layers of the multilayered section.    
     
     
         2 . The catheter of  claim 1  wherein the section of the mandrel between the first and second polymeric layers is in contact with an outer surface of the first polymeric layer and an inner surface of the second polymeric layer.  
     
     
         3 . The catheter of  claim 1  wherein the multilayered section with the first and second polymeric layers is a proximal shaft section.  
     
     
         4 . The catheter of  claim 3  wherein the multilayered proximal shaft section is about 50 to about 80% of the length of the shaft.  
     
     
         5 . The catheter of  claim 3  wherein the second polymeric layer has a distal end located distal to the distal end of the first polymeric layer, so that the second layer has a proximal section extending along the multilayered proximal shaft section and a distal section extending beyond the distal end of the multilayered proximal shaft section to at least in part form a distal shaft section of the shaft.  
     
     
         6 . The catheter of  claim 5  wherein the shaft includes a tapered section with a diameter tapering distally to a smaller diameter, formed at least in part by the multilayered proximal shaft section and the distal section of the second polymeric layer.  
     
     
         7 . The catheter of  claim 5  wherein the distal end of the first polymeric layer is truncated.  
     
     
         8 . The catheter of  claim 7  wherein the truncated distal end of the first polymeric layer is located at least in part between a proximal and a distal end of the tapered section of the second polymeric layer.  
     
     
         9 . The catheter of  claim 1  wherein the first polymeric layer is formed of polyetheretherketone, and the second polymeric layer is formed of a polyether block amide.  
     
     
         10 . The catheter of  claim 1  wherein the mandrel has a distal end located between and in contact with the first and second polymeric layers.  
     
     
         11 . The catheter of  claim 5  wherein the section of the mandrel between the first and second polymeric layers is a proximal section secured between the first and second polymeric layers from the proximal to the distal end of the first polymeric layer, and the mandrel has a distal section extending beyond the distal end of the first polymeric layer.  
     
     
         12 . The catheter of  claim 11  wherein the distal section of the mandrel is within the at least one lumen of the shaft and is not secured to the second polymeric layer.  
     
     
         13 . The catheter of  claim 11  wherein the distal section of the mandrel is about 20 to about 35% of the mandrel length.  
     
     
         14 . The catheter of  claim 11  wherein the proximal section of the mandrel has an oblong transverse cross section, and the distal section of the mandrel has a circular transverse cross section.  
     
     
         15 . The catheter of  claim 1  wherein the section of the mandrel between the first and second polymeric layers has a circumference, and about 75 to about 90% of the circumference of the mandrel is in contact with the first polymeric layer and about 10 to about 25% of the circumference of the mandrel is in contact with the second polymeric layer.  
     
     
         16 . The catheter of  claim 1  wherein the mandrel is a solid walled member formed of a material selected from the group consisting of a metallic material, and a polymeric material.  
     
     
         17 . The catheter of  claim 1  wherein the mandrel has an outer transverse dimension which is about 10 to about 20% less than a wall thickness of the first polymeric layer.  
     
     
         18 . The catheter of  claim 1  wherein the mandrel has an outer transverse dimension which is about 10 to about 20% greater than a wall thickness of the second polymeric layer.  
     
     
         19 . The catheter of  claim 1  wherein the length of the mandrel has a length which is about 75 to about 100% of the shaft length.  
     
     
         20 . The catheter of  claim 1  wherein the catheter is a balloon catheter having a balloon on a distal shaft section with an interior in fluid communication with the at least one lumen of the shaft.  
     
     
         21 - 28 . (canceled)  
     
     
         29 . A method of making a catheter having an elongated shaft and a reinforcing mandrel, comprising: 
 a) positioning a reinforcing mandrel within a groove in an outer surface of a first tubular member;    b) securing a proximal section of a second tubular member to the outer surface of the first tubular member, so that the mandrel has a proximal section located between the first and second tubular members and a distal section located within a lumen of the second tubular member and distal to a distal end of the first tubular member.    
     
     
         30 . The catheter of  claim 1  wherein the multilayered section is a proximal section with the first and second polymeric layers, and the shaft includes a distal section formed of a distal portion of the second polymeric layer extending beyond a distal end of the first polymeric layer and with an inner surface defining a lumen in the shaft distal section.  
     
     
         31 . The catheter of  claim 1  where the first layer has a groove in an outer surface thereof with the mandrel therein.