Venous access catheters and methods for portal venous system catheterization

Abstract

The present invention contemplates devices and methods to administer nutritional compositions and/or therapeutic drugs directly into a portal venous system. For example, total parenteral nutrition therapy may be administered directly into the hepatic portal venous system thus circumventing known side effects of conventional parenteral administration. Alternatively, hepatic diseases and disorders may be treated using locally administered therapeutic drugs. Devices capable of direct portal venous system administration include, but are not limited to, a direct portal access catheter or a transjugular access catheter.

1 - 10 . (canceled) 
     
     
         11 . A method for treating a subject exhibiting at least one symptom of a disorder, comprising:
 a) providing;
 i) a portal access catheter comprising a distal end, an anchor balloon at said distal end, and a main lumen terminating at said distal end; and 
 ii) a composition capable of reducing said at least one symptom of said disorder; 
   b) inserting said portal access catheter into a subject's portal venous system;   c) stabilizing said inserted portal access catheter in place by expanding said anchor balloon; and   d) administering said composition through said portal access catheter main lumen into said portal venous system under conditions such that said at least one symptom of said disorder is reduced.   
     
     
         12 . The method of  claim 11 , wherein said portal access catheter is a transjugular portal access catheter further comprising a central venous lumen. 
     
     
         13 . The method of  claim 11 , wherein said portal access catheter is a direct portal access catheter. 
     
     
         14 . The method of  claim 12 , wherein said transjugular portal access catheter is inserted via the jugular vein wherein the distal end of said catheter inserts into a hepatic portal vein and the distal end of said central venous lumen inserts into a cardiac right atrium. 
     
     
         15 . The method of  claim 13 , wherein said direct portal access catheter is a transabdominal catheter. 
     
     
         16 . The method of  claim 15 , wherein said transabdominal catheter is inserted via a percutaneous abdominal puncture. 
     
     
         17 . The method of  claim 11 , wherein said at least one symptom is selected from the group consisting of hepatic toxicity, a metabolic marker, hepatic cirrhosis, portal hypertension, elevated transaminase levels, viral titer, perisinusoidal fibrosis, elevated albumin levels, hepatocellular carcinoma size, and gastroesophageal varices size. 
     
     
         18 . The method of  claim 11 , wherein said composition is selected from the group consisting of a total parenteral nutrition composition and a therapeutic compound composition. 
     
     
         19 . The method of  claim 18 , wherein said total parenteral nutrition composition comprises a plurality of amino acids, vitamins and folic acid. 
     
     
         20 . The method of  claim 11 , wherein said disorder comprises a portal hypertension disorder. 
     
     
         21 - 24 . (canceled) 
     
     
         25 . The method of  claim 11 , wherein said disorder comprises a chronic viral hepatitis disorder. 
     
     
         26 - 27 . (canceled) 
     
     
         28 . The method of  claim 11 , wherein said administering said composition further comprises administering a total parenteral nutrition composition. 
     
     
         29 . (canceled) 
     
     
         30 . The method of  claim 11 , wherein said disorder comprises a liver transplant. 
     
     
         31 . (canceled) 
     
     
         32 . The method of  claim 11 , wherein said disorder comprises a hepatocellular carcinoma disorder. 
     
     
         33 - 37 . (canceled) 
     
     
         38 . The method of  claim 11 , wherein said disorder comprises a cirrhosis disorder. 
     
     
         39 . (canceled) 
     
     
         40 . The method of  claim 11 , wherein said disorder comprises a hepatic thrombosis. 
     
     
         41 . The method of  claim 18  wherein said therapeutic compound composition is selected from the group consisting of heparin, unfractionated heparin, low-molecular-weight heparin, aspirin, coumadin, warfarin, a vitamin K antagonist, and fondaparinux. 
     
     
         42 - 52 . (canceled) 
     
     
         53 . The method of  claim 13  wherein administering said composition further comprises administering at least two doses of said composition spaced apart in time while said direct portal access catheter remains inserted and stabilized. 
     
     
         54 . The method of  claim 13 , wherein providing said direct portal vein catheter further comprises providing an indwelling portal vein catheter having a subcutaneous port at a proximal end. 
     
     
         55 . The method of  claim 13 , wherein providing said direct portal vein catheter further comprises providing a portal vein catheter having a tissue ingrowth cuff having a circumference configured to receive tissue therein and decrease the potential for infection, said tissue ingrowth cuff being disposed between a proximal end of said catheter and said anchor balloon.