Unfused catheter body feature methods of manufacture

Abstract

The disclosure is directed to manufacturing tubular bodies for catheters. An inner tubular catheter body has an inner layer, a braided portion over the inner layer and an outer layer. The outer layer is fused to the braided portion for a selected length or lengths of the inner tubular body and is unfused for a selected length or lengths to achieve the desired combination of stiffness and flexibility.

1 - 25 . (canceled) 
     
     
         26 . A method of manufacture of a tubular member for a catheter, comprising:
 (a) providing a mandrel;   (b) applying an inner layer of a first polymer to the surface of the mandrel;   (c) applying a braided portion to the outside surface of the inner layer;   (d) applying an outer layer of a second polymer around the braided portion and the inner layer;   (e) fusing at least one selected length of the outer layer to the braided portion to form a fused region of the tubular member while refraining from fusing at least one selected length of the outer layer to the braided portion to provide an unfused region; and   (f) removing the mandrel to provide the tubular member.   
     
     
         27 . The method of  claim 26  wherein the inner and outer layers are applied by an extrusion process, and said fusing includes fusing the inner layer to the outer layer at the fused region. 
     
     
         28 . The method of  claim 26  wherein said applying the outer layer applies the same polymer material of the same material hardness and said fusing provides the unfused area as a selected length of the distal end portion of the flexible shaft, and the remainder of the outer layer is the fused region. 
     
     
         29 . The method of  claim 26  wherein said fusing fuses together the outer layer, braided portion and inner layer at the fused region. 
     
     
         30 . The method of  claim 26  wherein the second polymer of said fusing step said outer layer is a material selected from the group consisting of polyamides, polyimides, nylons, polyethylenes, PVDF, polyesterether block amides, polyurethanes and combinations thereof. 
     
     
         31 . The method of  claim 26  wherein the material of said fusing step outer layer has a Shore durometer hardness of not greater than about 72 D. 
     
     
         32 . The method of  claim 26  wherein the material of said fusing step outer layer has a Shore durometer hardness of from about 25 D to about 60 D. 
     
     
         33 . The method of  claim 26  wherein the material of said fusing step outer layer has a Shore durometer hardness of from about 35 D to about 55 D. 
     
     
         34 . The method of  claim 26  wherein the first polymer of said fusing step inner layer is formed from a material selected from the group consisting of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE) and high density polyethylene (HDPE). 
     
     
         35 . The method of  claim 26  wherein said applying step applies the braided portion to a pic count of from about 25 to about 140 pics/inch. 
     
     
         36 . The method of  claim 26  wherein said applying step applies the braided portion to a pic count of from about 60 to about 120 pics/inch. 
     
     
         37 . The method of  claim 26  wherein said fusing provides an unfused region having a defined radius and a defined length along which the braided portion and the outer layer are unfused to each other and are unfused to any and all other members along the defined length. 
     
     
         38 . The method of  claim 26  further comprising fixing a balloon to the tubular body along at least a portion of the length of the unfused region and radially external of the unfused region. 
     
     
         39 . The method of  claim 38  wherein said fusing extends the unfused region longitudinally beyond the balloon. 
     
     
         40 . The method of  claim 38  wherein said fusing provides the outer layer with a proximal end portion and a distal end portion, the outer layer being fused to the braided portion and to the inner layer for a selected length to define the fused region, and the fused region and unfused region are made of the same polymer material, wherein the unfused region is a selected length of the distal end portion of the tubular body, and the remainder of the outer layer is the fused region. 
     
     
         41 . A method of manufacture of a balloon catheter, comprising:
 (a) providing a mandrel;   (b) applying an inner layer of a first polymer to the surface of the mandrel;   (c) applying a braided portion to the outside surface of the inner layer;   (d) applying an outer layer of a second polymer around the braided portion and the inner layer;   (e) fusing at least one selected length of the outer layer to the braided portion to form a fused region of the tubular member while refraining from fusing at least one selected length of the outer layer to the braided portion to provide an unfused region thereby providing an inner tubular body;   (f) positioning a flexible shaft coaxial with the inner tubular member, the flexible shaft having a proximal portion and distal end portion, the shaft defining a lumen within which the inner tubular body is positioned, the tubular body including a distal end portion and an outer layer with a proximal and distal end;   (g) providing a balloon member having a proximal leg and a distal leg;   (h) securing the proximal leg of the balloon member to the distal end portion of the flexible shaft;   (i) securing the distal leg of the balloon member to the distal end portion of the tubular body;   (j) positioning the unfused length at a location radially inward of at least a portion of the balloon between the proximal leg and the distal leg of the balloon; and   (k) removing the mandrel upon formation of the inner tubular body or thereafter.   
     
     
         42 . The balloon catheter manufacturing method of  claim 41  wherein said positioning results in the unfused length extending substantially the entire length of the balloon. 
     
     
         43 . The balloon catheter manufacturing method of  claim 41  wherein said positioning results in the unfused length comprising one or more unfused lengths and extending between approximately the proximal end of the proximal leg of the balloon member to the proximal end of the distal leg of the balloon member. 
     
     
         44 . The balloon catheter manufacturing method of  claim 41  wherein said positioning results in the unfused length extending proximally of the proximal end of the distal leg of the balloon member.