System and Method for Delivery of Regional Citrate Anticoagulation to Extracorporeal Blood Circuits

Abstract

The present invention includes a comprehensive replacement fluid system and method for the delivery of regional citrate anticoagulation (RCA) to extracorporeal blood circuits, wherein the system may include an online clearance monitor (OCM) and a circuit effluent online sensor system (OSS) for the continuous determination of patient plasma content of ultrafilterable solutes.

1 . (canceled) 
     
     
         2 . A system for monitoring online dialysance conductivity for use in an extracorporeal blood circuit having an arterial blood line, a venous blood line, a hemofilter in fluid communication therebetween, a therapy fluid line entering the hemofilter, and an effluent fluid line exiting the hemofilter, the system comprising:
 a pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for introducing a bolus of a conductive solution into the arterial blood line;   a first conductivity sensor operably connected to the therapy fluid line and arranged to detect a first conductivity C1 in therapy fluid contained therein; and   a second conductivity sensor operably connected to the effluent fluid line and arranged to detect a second conductivity C2 in effluent fluid contained therein,   wherein C2(t)−C1(t) is used to determine the online dialysance conductivity.   
     
     
         3 . The system of  claim 2 , wherein the conductive solution includes a citrate anticoagulant-containing solution, the system further comprising a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a calcium- and magnesium-containing solution into blood in the venous blood line. 
     
     
         4 . The system of  claim 3 , wherein the system can detect an incorrect connection of the pre-filter infusion line and the post-filter infusion line due to a difference in the conductivities of the solutions contained therein. 
     
     
         5 . An online sensor system for use in an extracorporeal blood circuit having an arterial blood line, a venous blood line, a hemofilter in fluid communication therebetween, and an effluent fluid line exiting the hemofilter, the system comprising:
 an infusion line in fluid communication with the arterial blood line for infusing a pre-dilution solution therein; and   at least one solute sensor operably connected to the effluent fluid line for determining a concentration of at least one solute in an effluent fluid contained therein without contacting the effluent fluid.   
     
     
         6 . The system of  claim 5 , wherein the solute sensor uses Raman scatter spectroscopy to determine the solute concentration. 
     
     
         7 . The system of  claim 5 , wherein the solute sensor operates in a continuous mode. 
     
     
         8 . The system of  claim 5 , wherein the solute sensor operates in an intermittent mode. 
     
     
         9 . The system of  claim 5 , further comprising at least one pressure sensor operably connected to at least one of the arterial and venous blood lines. 
     
     
         10 . The system of  claim 5 , further comprising an air-in-fluid detector operably connected to the venous blood line. 
     
     
         11 . The system of  claim 5 , further comprising at least one blood-in-circuit detector operably connected to at least one of the arterial and venous blood lines. 
     
     
         12 . The system of  claim 5 , further comprising at least one line clamp operably connected to at least one of the arterial and venous blood lines. 
     
     
         13 . The system of  claim 5 , further comprising a backflow prevention device operably connected to the effluent fluid line upstream from the solute sensor. 
     
     
         14 . The system of  claim 13 , wherein the backflow prevention device includes at least one of an air gap device, a one-way valve device, and a reduced pressure zone device. 
     
     
         15 . The system of  claim 5 , wherein the solute sensor is operable to determine a citrate concentration. 
     
     
         16 . The system of  claim 5 , wherein the solute sensor is operable to determine a calcium concentration. 
     
     
         17 . The system of  claim 5 , wherein the solute sensor is operable to determine a magnesium concentration. 
     
     
         18 . The system of  claim 5 , wherein the solute sensor comprises:
 a flow-through light transparent chamber operably connected to the effluent fluid line;   opto-chemical probes provided in contact with the effluent fluid to allow binding of the probes to a solute within the effluent fluid;   a light source for providing light to the chamber; and   at least one optical detector for measuring a change in light intensity due to binding of the opto-chemical probes for determining solute concentration.   
     
     
         19 . The system of  claim 18 , wherein the opto-chemical probes are immobilized in the chamber. 
     
     
         20 . A control method for performing regional citrate anticoagulation in an extracorporeal blood circuit, the method comprising:
 receiving signals indicating selection of a treatment type, duration, and access connection;   receiving signals advising a status of a hemofilter, blood and infusion lines, an anticoagulant-containing solution, and a calcium- and magnesium-containing infusion solution;   performing priming checks with arterial and venous blood lines connected in a recirculation mode;   receiving input patient information and treatment information;   receiving confirmation of connection of a patient to the system;   performing safety checks and displaying alarms;   determining settings for a prescription for regional citrate anticoagulation, system settings, and dosing of the calcium- and magnesium-containing infusion solution;   analyzing input data; and   if necessary, recalculating the prescription.   
     
     
         21 . The method of  claim 20 , further comprising adjusting infusion of the calcium-containing infusion solution based on systemic citrate and calcium levels.