Variable characteristic venous access catheter shaft

Abstract

A central venous catheter is provided having a proximal tube segment, a distal tube segment and a transition tube segment interposed between the proximal and distal tube segments which are preferably formed as a single integrated tube containing polymer material of different durometer and varying amounts of radiopaque filler material. The polymer durometer of the proximal segment is higher than the polymer durometer of the distal segment. By contrast, the percentage by weight of the filler material contained in the distal segment is higher than that of the proximal segment. The variation in the polymer durometer and the filler amount along the length of the tube provide the desired tensile strength, hardness, chemical resistance and fatigue resistance at the proximal segment and at the same time provide the desired flexibility and radiopacity at the distal segment.

1 . A catheter shaft, comprising:
 a monolithic tube comprising:
 a proximal tube segment comprising a polymer material of a first durometer and a first amount of a radiopaque filler; 
 a distal tube segment comprising a polymer material of a second durometer and a second amount of the radiopaque filler, wherein the first durometer is higher than the second durometer and the percentage by weight of the first amount of the radiopaque filler is lower than that of the second amount of the radiopaque filler; and 
 a transition tube segment seamlessly interposed between the proximal tube segment and the distal tube segment. 
   
     
     
         2 . The catheter shaft of  claim 1 , wherein the transition tube segment comprises a mixture of a first polymer material and a second polymer material having a different durometer than the first polymer material. 
     
     
         3 . The catheter shaft of  claim 1 , wherein the transition tube segment comprises a mixture of the polymer material of the first durometer and the polymer material of the second durometer. 
     
     
         4 . The catheter shaft of  claim 1  or  3 , wherein the durometer of the polymer material comprised therein the transition tube segment varies over the length of the transition tube segment. 
     
     
         5 . The catheter shaft of  claim 4 , wherein the durometer of the polymer material comprised therein the transition tube segment continuously decreases from a proximal end of the transition tube segment to a distal end of the transition tube segment. 
     
     
         6 . The catheter shaft of  claim 4 , wherein a proximal end of the transition tube segment is seamlessly connected to the proximal tube segment and a distal end of the transition tube segment is seamlessly connected to the distal tube segment, and wherein the durometer of the polymer material comprised therein the transition tube segment decreases from the first durometer at the proximal end of the transition tube segment to the second durometer at the distal end of the transition tube segment. 
     
     
         7 . The catheter shaft of  claim 6 , wherein the durometer of the polymer material comprised therein the transition tube segment continuously decreases from the first durometer at the proximal end of the transition tube segment to the second durometer at the distal end of the transition tube segment with no abrupt durometer shift. 
     
     
         8 . The catheter shaft of  claim 1 , wherein the transition tube segment comprises a radiopaque filler, and wherein the percentage by weight of the radiopaque filler comprised therein continuously varies over the length of the transition tube segment. 
     
     
         9 . The catheter shaft of  claim 8 , wherein a proximal end of the transition tube segment is seamlessly connected to the proximal tube segment and a distal end of the transition tube segment is seamlessly connected to the distal tube segment, and wherein the percentage by weight of the radiopaque filler comprised therein the transition tube segment increases from the proximal end of the transition tube segment to the distal end of the transition tube segment. 
     
     
         10 . The catheter shaft of  claim 1 , wherein the monolithic tube defines one or more lumens. 
     
     
         11 . The catheter shaft of  claim 1 , further comprising a hub component attached to the proximal tube segment and configured to remain outside of a patient body. 
     
     
         12 . The catheter shaft of  claim 1 , wherein the transition tube segment has greater flexibility than the proximal tube segment. 
     
     
         13 . The catheter shaft of  claim 12 , wherein the flexibility of the transition tube segment varies along the length of the transition tube segment. 
     
     
         14 . The catheter shaft of  claim 13 , wherein a proximal end of the transition tube segment is seamlessly connected to the proximal tube segment and a distal end of the transition tube segment is seamlessly connected to the distal tube segment, and wherein the proximal end of the transition tube segment is less flexible than the distal end of the transition tube segment. 
     
     
         15 . The catheter shaft of  claim 1 , wherein the transition tube segment is more flexible than the proximal tube segment, and wherein the distal tube segment is more flexible than the transition tube segment. 
     
     
         16 . The catheter shaft of  claim 1 , wherein the flexibility of the proximal tube segment is substantially equal to the flexibility at a proximal end of the transition tube segment and the flexibility of the distal tube segment is substantially equal to the flexibility of a distal end of the transition tube segment. 
     
     
         17 . The catheter shaft of  claim 1 , wherein the proximal tube segment comprises about 0 to about 30% radiopaque filler by weight, and wherein the distal tube segment comprises about 30 to about 50% radiopaque filler by weight. 
     
     
         18 . The catheter shaft of  claim 1 , wherein the monolithic tube is configured to have a high burst strength. 
     
     
         19 . The catheter shaft of  claim 18 , wherein the monolithic tube is configured to withstand injection pressures of up to about 300 psi without bursting. 
     
     
         20 . The catheter shaft of  claim 1 , wherein the proximal tube segment is configured to withstand higher pressures than the distal tube segment. 
     
     
         21 . A catheter shaft, comprising:
 a proximal tube segment comprising a polymer material of a first durometer and a first amount of a radiopaque filler;   a distal tube segment comprising a polymer material of a second durometer and a second amount of a radiopaque filler, wherein the first durometer is higher than the second durometer and the percentage by weight of the first amount is lower than that of the second amount;   a transition tube segment; and   a means for seamlessly interposing the transition tube segment between the proximal tube segment and the distal tube segment such that the proximal, distal and transition tube segments together form a monolithic tube.   
     
     
         22 . The catheter shaft of  claim 21 , wherein the transition tube segment comprises a mixture of a first polymer material and a second polymer material having a different durometer than the first polymer material. 
     
     
         23 . The catheter shaft of  claim 21 , wherein the transition tube segment comprises a mixture of the polymer material of the first durometer and the polymer material of the second durometer. 
     
     
         24 . The catheter shaft of  claim 22  or  24 , wherein the durometer of the polymer material comprised therein the transition tube segment continuously decreases from the first durometer at a proximal end of the transition tube segment to the second durometer at a distal end of the transition tube segment with no abrupt durometer shift. 
     
     
         25 . The catheter shaft of  claim 24 , wherein the percentage by weight of the radiopaque filler comprised therein the transition tube segment continuously increases from the proximal end to the distal end of the transition tube segment. 
     
     
         26 . The catheter shaft of  claim 21 , wherein the monolithic tube defines one or more lumens. 
     
     
         27 . The catheter shaft of  claim 21 , further comprising a hub component attached to the proximal tube segment and configured to remain outside of a patient body. 
     
     
         28 . A catheter shaft, comprising:
 a monolithic tube comprising:
 a proximal tube segment of a first durometer; 
 a distal tube segment of a second durometer, wherein the second durometer is lower than the first durometer; and 
 a transition tube segment seamlessly interposed between the proximal tube segment and the distal tube segment, wherein the durometer of the transition tube segment varies over the length of the transition tube segment. 
   
     
     
         29 . The catheter shaft of  claim 28 , wherein the durometer of the transition tube segment varies continuously over the length of the transition tube segment 
     
     
         30 . The catheter shaft of  claim 28 , wherein each of the respective proximal and distal tube segments comprise a radiopaque filler, and wherein the percentage by weight of radiopaque filler contained in the proximal tube segment is lower than the percentage by weight of radiopaque filler contained in the distal tube segment. 
     
     
         31 . The catheter shaft of  claim 28 , wherein the transition tube segment comprises a mixture of a first polymer material and a second polymer material having a different durometer than the first polymer material. 
     
     
         32 . The catheter shaft of  claim 28 , wherein the transition tube segment comprises a mixture of a polymer material of the first durometer and a polymer material of the second durometer. 
     
     
         33 . The catheter shaft of  claim 32 , wherein the durometer of the polymer material contained in the transition tube segment continuously decreases from the first durometer at a proximal end of the transition tube segment to the second durometer at a distal end of the transition tube segment with no abrupt durometer shift. 
     
     
         34 . The catheter shaft of  claim 33 , wherein the transition tube segment comprises a radiopaque filler, and wherein the percentage by weight of the radiopaque filler contained in the transition tube segment continuously increases from the proximal end of the transition tube segment to the distal end of the transition tube segment. 
     
     
         35 . The catheter shaft of  claim 28 , wherein the monolithic tube defines one or more lumens. 
     
     
         36 . The catheter shaft of  claim 28 , further comprising a hub component attached to the proximal tube segment and configured to remain outside of a patient body.