Batch filtration system for preparation of sterile fluid for renal replacement therapy

Abstract

A method and device for blood treatments that use fluids such as dialysate and replacement fluid for renal replacement therapy. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter from a fluid source to a replacement fluid container. The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering needn't match the rate of consumption during treatment. As a result, the sterilization filter can have a small capacity. In another embodiment, a filter is placed immediately prior to the point at which the sterile fluid is consumed by the treatment process. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.

1 . (canceled) 
     
     
         2 . A system for preparing a batch of treatment fluid, comprising:
 a controller with a user interface connected with a treatment machine that consumes a predefined treatment fluid;   a fluid purification element including a pump, a control valve, at least one sterile filter, a pressure sensor;   a batch element including batch heating element and a batch container, the batch container being connected to receive fluid through a connecting line from the fluid purification element, the pump and control valve being connected to control flow through the connecting line;   the controller being connected to control functions of the treatment machine, the fluid purification element pump and control valve, and the heating element;   a drain line connected to the batch container the drain line having a drain pump, the drain line having a conductivity sensor;   the controller being connected to control functions of the treatment machine, the fluid purification element pump and control valve, the drain pump, and the heating element;   the controller being further connected to receive pressure signals from the pressure sensor and the conductivity sensor;   the controller being configured to control the control valve and pump to draw fluid through the connecting line and through the filter into the batch container thereby to dilute concentrate in the batch container and to drain fluid from the batch container while sampling a conductivity signal from the conductivity sensor at least once thereafter, the conductivity signal indicating a conductivity of a diluted contents of the batch;   the controller being configured to output a signal responsive to difference between the conductivity signal and a predefined signal;   the controller being configured to operate the treatment machine responsively to a result of said output signal.   
     
     
         3 . The system of  claim 2 , wherein the controller closes the control valve responsively to a reading from the pressure sensor. 
     
     
         4 . The system of  claim 2 , wherein the batch container is at least partly enclosed in an insulated container. 
     
     
         5 . The system of  claim 4 , wherein the insulated container includes a thermostat. 
     
     
         6 . The system of  claim 2 , wherein the controller maintains a temperature of the batch container. 
     
     
         7 . The system of  claim 2 , wherein the controller tests the integrity of the filter by comparing the pressure signals to predefined range and prevents use of the treatment system responsively to said pressure signals. 
     
     
         8 . A system for preparing a batch of treatment fluid, comprising:
 a controller with a user interface connected with a treatment machine that consumes a predefined treatment fluid;   a fluid purification element including a pump, a control valve, at least one filter adapted for removing ionic species and biological contaminants, a pressure sensor;   a batch element including batch heating element and a batch container, the batch container being connected to receive fluid through a connecting line from the fluid purification element, the pump and control valve being connected to control flow through the connecting line;   the controller being connected to control functions of the treatment machine, the fluid purification element pump and control valve, and the heating element;   a drain line connected to the batch container the drain line having a drain pump, the drain line having a conductivity sensor;   the controller being connected to control functions of the treatment machine, the fluid purification element pump and control valve, the drain pump, and the heating element;   the controller being further connected to receive pressure signals from the pressure sensor and the conductivity sensor;   the controller being configured to control the control valve and pump to draw fluid through the connecting line and through the filter into the batch container thereby to dilute concentrate in the batch container and to drain fluid from the batch container while sampling a conductivity signal from the conductivity sensor at least once thereafter, the conductivity signal indicating a conductivity of a diluted contents of the batch;   the controller being configured to output a signal responsive to difference between the conductivity signal and a predefined signal;   the controller being configured to operate the treatment machine responsively to a result of said output signal.   
     
     
         9 . The system of  claim 8 , wherein the controller closes the control valve responsively to a reading from the pressure sensor. 
     
     
         10 . The system of  claim 8 , wherein the batch container is at least partly enclosed in an insulated container. 
     
     
         11 . The system of  claim 10 , wherein the insulated container includes a thermostat. 
     
     
         12 . The system of  claim 8 , wherein the controller maintains a temperature of the batch container. 
     
     
         13 . The system of  claim 8 , wherein the controller tests the integrity of the filter by comparing the pressure signals to predefined range and prevents use of the treatment system responsively to said pressure signals. 
     
     
         14 . A system for preparing a batch of treatment fluid, comprising:
 a controller with a user interface connected with a treatment machine that employs a predefined treatment fluid;   a fluid purification element including a pump, a control valve, at least one sterile filter, a pressure sensor;   a batch element including batch heating element and a batch container, the batch container being connected to receive fluid through a connecting line from the fluid purification element, the pump and control valve being connected to control flow through the connecting line;   the controller being connected to control functions of the treatment machine, the fluid purification element pump and control valve, and the heating element;   a drain line connected to the batch container the drain line, the drain line with a conductivity sensor;   the controller being connected to control functions of the treatment machine, the fluid purification element pump and control valve, and the heating element;   the controller being further connected to receive pressure signals from the pressure sensor and the conductivity sensor;   the controller being configured to control the control valve and pump to draw fluid through the connecting line and through the filter into the batch container thereby to dilute concentrate in the batch container and to drain a sample of fluid from the batch container while sampling a conductivity signal from the conductivity sensor at least once thereafter, the conductivity signal indicating a conductivity of a diluted contents of the batch;   the controller being configured to output a signal responsive to difference between the conductivity signal and a predefined signal;   the controller being configured to operate the treatment machine responsively to a result of said output signal.   
     
     
         15 . The system of  claim 14 , wherein the controller closes the control valve responsively to a reading from the pressure sensor. 
     
     
         16 . The system of  claim 14 , wherein the batch container is at least partly enclosed in an insulated container. 
     
     
         17 . The system of  claim 16 , wherein the insulated container includes a thermostat. 
     
     
         18 . The system of  claim 14 , wherein the controller maintains a temperature of the batch container. 
     
     
         19 . The system of  claim 14 , wherein the controller tests the integrity of the filter by comparing the pressure signals to predefined range and prevents use of the treatment system responsively to said pressure signals.