Systems and methods for peritoneal dialysis

Abstract

Systems and methods relating to dialysis therapy, particularly continuous flow dialysis therapy, are provided. The present invention includes a single closed fluid path along which a minimal amount of therapy fluid including dialysate is fed into, continuously circulated and cleaned such that a therapeutic effective amount of solutes, excess water and the like can be removed from the patient connected to the closed fluid loop during treatment.

1 . A system for providing peritoneal dialysis to a patient, the system comprising: 
 a catheter having an inflow lumen and an outflow lumen in communication with a peritoneal cavity of the patient;    a fluid circuit in fluid communication with the catheter thereby defining a closed fluid path capable of circulating fluid into, through and out of the peritoneal cavity;    a supply of dialysate coupled to the fluid circuit;    a cycler configured for continuously pumping the dialysate into the fluid circuit and circulating the dialysate during a treatment period along the closed fluid path to remove a therapeutically effective amount of solutes and ultrafiltrate from the patient;    a reservoir coupled fluidly to the fluid circuit via a pump and branching off the closed loop for moving fluid via the pump at a controlled flowrate from the fluid circuit to the reservoir and from the reservoir to the fluid circuit;    a cleaning device coupled to the fluid circuit wherein the cleaning device is capable of removing an amount of the solutes from the dialysate including at least a portion of urea; and    a discharge path coupled to the fluid circuit allowing the fluid circuit to be drained of fluid after the treatment period.    
   
   
       2 . The system of  claim 1  further comprising at least one pressure sensor connected to the closed fluid path.  
   
   
       3 . The system of  claim 1  further comprising a heater for warming the dialysate.  
   
   
       4 . The system of  claim 1  further comprising a flow volume sensing device operably coupled to the closed fluid path.  
   
   
       5 . The system of  claim 4  wherein the cleaning device includes a sorbent material including at least one of carbon and activated charcoal.  
   
   
       6 . The system of  claim 5  wherein the cleaning device does not include a material capable of selectively removing urea.  
   
   
       7 . The system of  claim 1  further comprising a supply of osmotic fluid coupled to the fluid circuit.  
   
   
       8 . The system of  claim 7  wherein the supply of osmotic fluid couples to the fluid circuit at a point nearer to the patient that the supply of dialysate.  
   
   
       9 . A system for providing peritoneal dialysis to a patient, the system comprising: 
 a catheter having an inflow lumen and an outflow lumen in communication with the patient's peritoneal cavity;    a fluid circuit in fluid communication with the catheter thereby defining a closed fluid path capable of circulating therapy fluids into, through and out of the peritoneal cavity;    a first supply of a first therapy fluid, the first therapy fluid including a dialysate coupled to the fluid circuit;    a cycler that pumps the dialysate into the fluid circuit and circulates the dialysate along the closed fluid path during a treatment period to remove a therapeutically effective amount of solutes and ultrafiltrate from the patient;    a second supply of a second therapy fluid, the second therapy fluid including an osmotic agent, the second supply coupled to the fluid circuit separately from the first supply and configured in the system for rapid delivery to the patient;    a cleaning device coupled to the fluid circuit wherein the cleaning device is capable of removing solutes from the fluids including a therapeutically effective portion of urea from the therapy fluid as the therapy fluid circulates along the closed fluid path; and    a discharge path coupled to the fluid circuit allowing the fluid circuit to be drained of the therapy fluid at an effective rate to compensate for an increase in therapy fluid volume in the fluid circuit due to the second supply of fluid and the ultrafiltrate.    
   
   
       10 . The system of  claim 9  wherein the second supply is closer to the inflow lumen than the first supply.  
   
   
       11 . The system of  claim 9  further comprising a pressure sensor operably connected to the closed fluid path.  
   
   
       12 . The system of  claim 9  further comprising at least one heater for warming the therapy fluids.  
   
   
       13 . The system of  claim 9  further comprising a filter capable of removing particles at least 0.22 microns in size.  
   
   
       14 . The system of  claim 9  wherein the second therapy fluid includes an osmotic agent solution is selected from the group consisting of a 2.5% dextrose-based solution, a 3.5% dextrose-based solution, a 4.25% dextrose-based solution, a greater than 4.25% dextrose-based solution and combinations thereof.  
   
   
       15 . The system of  claim 9  wherein the second therapy fluid includes an osmotic agent solution that contains about 4.25% or more of dextrose and a concentration of one or more electrolytes higher than a level of electrolytes in the first fluid.  
   
   
       16 . The system of  claim 9  wherein the cleaning device is capable of non-selectively removing solutes from the therapy fluids.  
   
   
       17 . The system of  claim 9  wherein the cleaning device includes a material capable of selectively removing at least a portion of the urea from the fluids and optionally, a sorbent material comprising at least one of carbon and activated charcoal.  
   
   
       18 . A system for providing peritoneal dialysis to a patient, the system comprising: 
 a catheter having an inflow lumen and an outflow lumen in communication with the patient's peritoneal cavity;    a fluid circuit in fluid communication with the catheter thereby defining a closed fluid path capable of circulating fluid into, through and out of the peritoneal cavity;    a supply of dialysate coupled to the fluid circuit;    a cycler that pumps the dialysate into the fluid circuit and circulates the dialysate during a treatment period along the closed fluid path to remove a therapeutically effective amount of solutes and ultrafiltrate from the patient;    a supply of an osmotic fluid coupled to the fluid circuit downstream from and separately from the supply of dialysate and coupled nearer to the patient than the supply of dialysate;    a cleaning device coupled to the fluid circuit, the cleaning device capable of removing an amount of the solutes from the dialysate including at least a portion of urea; and    a discharge path coupled to the fluid circuit for draining fluid from the fluid circuit.    
   
   
       19 . The system of  claim 18  wherein the system is capable of obtaining a clearance level including about 2.1 to about 2.6 for urea.  
   
   
       20 . The system of  claim 18  wherein the clearance level further includes about 72 l/wk to about 90 l/wk for creatinine.  
   
   
       21 . The system of  claim 18  wherein the clearance level further includes about 3.5 g/wk for phosphate.  
   
   
       22 . The system of  claim 18  wherein the clearance level further includes about 600 mg/wk for β2 microglobulin.  
   
   
       23 . The system of  claim 18 , further comprising a reservoir fluidly coupled to the fluid circuit via the cycler and one or more pumps and branching off the closed loop for moving fluid at a controlled flowrate from the fluid circuit to the reservoir and from the reservoir to the fluid circuit, and wherein the reservoir is adapted to provide a variable increase in volume capacity to the fluid circuit allowing the system to compensate for an increase in fluid volume in the fluid circuit during treatment.