Peritoneal dialysate fluid generation system

Abstract

Systems and methods of generating peritoneal dialysate are provided. The systems and methods use a water purification module, a sterilization module and concentrates to prepare a bolus of peritoneal dialysate from source water for use with an non-integrated cycler.

1 . A system, comprising:
 a water source;   a peritoneal dialysate generation flow path; wherein the peritoneal dialysate generation flow path is fluidly connectable to the water source;   one or more water purification modules fluidly connectable to the peritoneal dialysate generation flow path;   a concentrate source fluidly connectable to the peritoneal dialysate generation flow path;   the concentrate source containing one or more solutes; and   a sterilization module fluidly connectable to the peritoneal dialysate generation flow path.   
     
     
         2 . The system of  claim 1 , further comprising one or more dialysate containers fluidly connectable to the peritoneal dialysate generation flow path downstream of the sterilization module. 
     
     
         3 . (canceled) 
     
     
         4 . The system of  claim 1 , wherein the concentrate source comprises at least an osmotic agent source and an ion concentrate source. 
     
     
         5 . The system of  claim 4 , wherein the concentrate source comprises multiple osmotic agent sources, and/or multiple ion concentrate sources. 
     
     
         6 . The system of  claim 5 , wherein the osmotic agent sources contain osmotic agents selected from the group consisting of dextrose, icodextrin, glucose, and amino acids. 
     
     
         7 . The system of  claim 4 , wherein the ion concentrate source comprises one or more from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . (canceled) 
     
     
         14 . The system of  claim 1 , further comprising a control system, wherein the control system operates one or more pumps and valves to control movement of fluid through the system; wherein the control system either (a) comprises a timer, wherein the timer causes the control system to generate peritoneal dialysate at a predetermined time; and/or (b) comprises a user interface, wherein the user interface causes the control system to generate peritoneal dialysate at a selected time. 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . The system of  claim 1  wherein the sterilization module comprises one or more selected from the group of one or more ultrafilters, a UV light source, a heater, a flash pasteurization module, a microbial filter, and combinations thereof. 
     
     
         18 . The system  claim 17 , wherein the sterilization module comprises either or both of: a UV light source positioned downstream of an ultrafilter; and/or at least two ultrafilters. 
     
     
         19 . (canceled) 
     
     
         20 . The system of  claim 1 , wherein the water purification module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter, and a nanofilter. 
     
     
         21 . A method, comprising the steps of:
 pumping fluid from a water source to a water purification module in a peritoneal dialysate generation flow path;   adding one or more concentrate solutions to the fluid; and   pumping the fluid through a sterilization module.   
     
     
         22 . The method of  claim 21 , further comprising the step of pumping the fluid into one or more dialysate containers. 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . The method of  claim 21 , wherein the step of adding one or more concentrate solutions to the fluids comprises adding at least an osmotic agent and an ion concentrate to the fluid; wherein the osmotic agent and ion concentrate are added to the fluid from a single concentrate source; or wherein the osmotic agent and ion concentrate are added to the fluid from separate concentrate sources. 
     
     
         30 . (canceled) 
     
     
         31 . The method of  claim 29 , wherein the osmotic agent is one or more selected from the group consisting of glucose, dextrin, and icodextrin. 
     
     
         32 . (canceled) 
     
     
         33 . The method of  claim 29 , wherein multiple osmotic agents are added to the fluid from a single osmotic agent source or wherein multiple osmotic agents are added to the fluid from separate osmotic agent sources; and wherein each of the ion concentrates are added to the fluid from a single ion concentrate source or wherein multiple ion concentrates are added to the fluid from separate ion concentrate sources. 
     
     
         34 . (canceled) 
     
     
         35 . The method of  claim 29 , wherein the ion concentrate is added from one or more ion concentrate sources and comprises one or more from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate. 
     
     
         36 . (canceled) 
     
     
         37 . (canceled) 
     
     
         38 . (canceled) 
     
     
         39 . The method of  claim 21 , wherein the method is carried out by a peritoneal dialysate generation system; wherein the peritoneal dialysate generation system comprises either or both of (a) a timer, wherein the peritoneal dialysate generation system carries out the method at predetermined times; and/or (b) a user interface, wherein the method is carried out based on input from the user interface. 
     
     
         40 . (canceled) 
     
     
         41 . (canceled) 
     
     
         42 . The method of  claim 21 , wherein the water purification module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter and a nanofilter. 
     
     
         43 . The method of  claim 21 , wherein the sterilization module comprises one or more selected from the group of one or more ultrafilters, a UV light source, a microbial filter, and combinations thereof. 
     
     
         44 . The method of  claim 43 , wherein the sterilization module comprises either or both of the UV light source positioned downstream of the ultrafilter, and/or at least two ultrafilters. 
     
     
         45 . (canceled)