System, method, and composition for removing uremic toxins in dialysis processes

Abstract

Methods and devices for providing dialysis treatment are provided. The device comprises a cartridge for providing regenerative dialysis, the cartridge comprising: a body having an inlet and an outlet and defining an interior, the interior including at least a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, wherein at least two of the layers are blended together to provide a gradient of the two materials.

1 . A method for providing dialysis to a patient by using a dialysis system comprising a dialysate loop and a regeneration loop, the method comprising simultaneously dialyzing the patient in the dialysate loop and regenerating dialysate in the regeneration loop, wherein the dialyzing the patient in the dialysate loop comprises:
 a) supplying a first dialysate from a dialysate supply container into a patient through a catheter, wherein a spent dialysate forms from the patient;   b) passing the spent dialysate from the patient through a lumen side of the dialyzer of the dialysate loop to form a second dialysate;   c) recirculating the second dialysate between the patient and the dialyzer in the dialysate loop until a first standard in the second dialysate is reached; and   d) repeating a)-c); and   wherein the regenerating dialysate in the regeneration loop comprises:   e) pumping a first concentrate from a supply of concentrate through a shell side of the dialyzer of a dialysate loop to form a second concentrate and to prime the dialyzer;   f) passing the second concentrate through a sorbent cartridge of the regeneration loop to form a third dialysate;   g) recirculating the third dialysate between the dialyzer and the sorbent cartridge in the regeneration loop until a second standard in the third dialysate is reached; and   h) repeating e)-g).   
     
     
         2 . The method of  claim 1 , wherein supplying the first dialysate is pumping the first dialysate by using a dialysate pump positioned and arranged to fluidly communicate the first dialysate from the dialysate supply container along the dialysate loop. 
     
     
         3 . The method of  claim 1 , wherein water and small solutes in the spent dialysate are substantially removed after passing the spent dialysate from the patient through the dialyzer of the dialysate loop. 
     
     
         4 . The method of  claim 1 , wherein water and small solutes of the first concentrate is substantially removed after pumping the first concentrate from a supply of concentrate through the dialyzer of a dialysate loop. 
     
     
         5 . The method of  claim 1 , wherein the second dialysate is collected as a third concentrate after the first standard in the second dialysate is reached. 
     
     
         6 . The method of  claim 1 , wherein the sorbent cartridge includes (i) a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, and (ii) a concentrate port for receiving the first concentrate from the supply of concentrate. 
     
     
         7 . The method of  claim 1 , wherein the sorbent cartridge includes a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon; and a gas vent located downstream from the sorbent cartridge for venting gas from the regeneration loop. 
     
     
         8 . The method of  claim 1 , wherein the sorbent cartridge includes a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, the sorbent cartridge further including a gas separation chamber having a gas vent for venting gas from the gas separation chamber. 
     
     
         9 . The method of  claim 1 , wherein the sorbent cartridge includes a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, the sorbent cartridge further including an outlet cap, the outlet cap including (i) a dialysate fluid outlet, (ii) a gas vent for venting gas from the gas separation chamber, and (iii) a concentrate port for receiving the first concentrate from the supply of concentrate. 
     
     
         10 . The method of  claim 1 , wherein the third dialysate is collected as a fourth dialysate after the second standard in the third dialysate is reached. 
     
     
         11 . The method of  claim 1 , wherein the first standard comprises at least one of at least 5 mg/L of urea or 2 mg/L of creatinine. 
     
     
         12 . The method of  claim 1 , wherein the second standard comprises at least one from the group consisting of i) a urea concentration less than 10% of that in the first concentrate; ii) a creatinine concentration less than 20% of that in the first concentrate; and iii) a phosphate concentration less than 20% of that in the first concentrate. 
     
     
         13 . A method for providing dialysis to a patient by using a dialysis system comprising a dialysate loop, the method comprising:
 a) supplying a first dialysate from a dialysate supply container into a patient through a catheter in the dialysate loop, wherein a first spent dialysate forms from the patient;   b) passing the first spent dialysate from the patient through a lumen side of the dialyzer of the dialysate loop to form a second dialysate;   c) passing the second dialysate through a sorbent cartridge of the dialysate loop to form a third dialysate;   d) repeating b)-c) until a first standard in the third dialysate is reached;   e) supplying the third dialysate to the patient through the catheter in the dialysate loop, wherein a second spent dialysate forms from the patient; and   d) repeating b)-d).   
     
     
         14 . The method of  claim 13 , wherein the method further comprises:
 pumping a first concentrate from a supply of concentrate through a shell side of the dialyzer of the dialysate loop to form a second concentrate and to prime the dialyzer.   
     
     
         15 . The method of  claim 14 , wherein the method further comprises:
 i) passing the second concentrate through the sorbent cartridge of the dialysate loop to form a fourth dialysate;   ii) passing the fourth dialysate through a lumen side of the dialyzer of the dialysate loop to form a fifth dialysate; and   iii) repeating i)-ii) until the first standard in the fifth dialysate is reached.   
     
     
         16 . The method of  claim 13 , wherein supplying the first dialysate is pumping the first dialysate by using a dialysate pump positioned and arranged to fluidly communicate the first dialysate from the dialysate supply container along the dialysate loop. 
     
     
         17 . The method of  claim 13 , wherein water and small solutes in the spent dialysate are substantially removed after passing the first spent dialysate from the patient through the dialyzer of the dialysate loop. 
     
     
         18 . The method of  claim 13 , wherein the sorbent cartridge includes (i) a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, and (ii) a concentrate port for receiving the first concentrate from the supply of concentrate. 
     
     
         19 . The method of  claim 13 , wherein the sorbent cartridge includes a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon; and a gas vent located downstream from the sorbent cartridge for venting gas from the regeneration loop. 
     
     
         20 . The method of  claim 13 , wherein the sorbent cartridge includes a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, the sorbent cartridge further including a gas separation chamber having a gas vent for venting gas from the gas separation chamber. 
     
     
         21 . The method of  claim 13 , wherein the sorbent cartridge includes a layer comprising urease, a layer comprising zirconium oxide, a layer comprising zirconium phosphate, and a layer comprising carbon, the sorbent cartridge further including an outlet cap, the outlet cap including (i) a dialysate fluid outlet, (ii) a gas vent for venting gas from the gas separation chamber, and (iii) a concentrate port for receiving the first concentrate from the supply of concentrate. 
     
     
         22 . The method of  claim 13 , wherein the first standard comprises at least one of at least 5 mg/L of urea or 2 mg/L of creatinine.