Apparatuses and processes for whole-body hyperthermia

Abstract

Apparatuses for use in whole body hypothermia include a high-flow hyperthermia circuit coupled to a low-flow dialysis circuit in a manner which reduces tensioning of membranes in the dialyzer of the dialysis circuit. The arrangement thereby allows proper membrane movement to assist in mixing a sorbent suspension circulated on the sorbent side of the dialyzer. Additional dialysis apparatuses include advantageous disposable packs including the dialyzer, sorbent heat exchangers arranged to cooperate with heating elements on base units of the apparatuses, and adaptations for very high flow rates useful in the hyperthermic treatment of cancers.

What is claimed is:  
     
         1 . A method for performing whole body hyperthermia on a patient, comprising: 
 circulating blood of said patient through a high-flow hyperthermia circuit at a rate of at least 1500 ml/min, said hyperthermia circuit including a blood access line for drawing blood from a patient, a pump, a heat exchanger for heating said blood to a temperature of at least 40° C., and a blood return line for returning said blood to said patient after heating in said heat exchanger;    diverting a portion of said blood circulating in said high-flow hyperthermia circuit to a low-flow dialysis circuit, and circulating said blood in said lowflow dialysis circuit at a rate of 200 to 800 ml/min, said low-flow dialysis circuit including: 
 a blood inflow line having a first end connected to said hyperthermia circuit, for diverting blood into said dialysis circuit from said hyperthermia circuit;  
 a dialyzer having a blood side and a sorbent side separated by dialysis membranes, said membranes being compliantly formed;  
 means for applying alternating negative pressure and positive pressure on said sorbent side of said dialyzer;  
 a blood inlet to said blood side of said dialyzer, a second end of said blood inflow line being connected to said blood inlet;  
 a blood outlet from said blood side of said dialyzer;  
 a blood outflow line having a first end connected to said blood outlet, and a second end connected to said hyperthermia circuit;  
 a sorbent circuit for circulating a sorbent suspension through said sorbent side of said dialyzer; and  
   wherein during operation of said high-flow hyperthermia circuit and said low-flow dialysis circuit, said dialyzer membranes expand and compress in response to said alternating negative pressure and positive pressure on said sorbent side of said dialyzer, so as to circulate and agitate a sorbent suspension in said sorbent side whereby effective mixing of said sorbent suspension is maintained.    
     
     
         2 . The method of    claim 1   , which also includes: 
 heating said sorbent suspension in a heat exchanger so as to decrease the transfer of heat from the blood to the sorbent suspension.    
     
     
         3 . The method of    claim 2   , which includes circulating blood in said high-flow hyperthermia circuit at a rate of 1500 ml/min to 4000 ml/min.  
     
     
         4 . The method of    claim 1   , wherein said blood inflow line is connected to said high-flow hyperthermia circuit at a location downstream of said blood outflow line.  
     
     
         5 . The method of    claim 4   , wherein said blood inflow line and said outflow line are connected to said hyperthermia circuit on opposed sides of said pump.  
     
     
         6 . The method of    claim 4   , wherein said sorbent suspension includes precipitated calcium phosphate, water, and a particulate surface adsorptive agent.  
     
     
         7 . The method of    claim 6   , wherein said surface adsorptive agent is carbon.  
     
     
         8 . The method of    claim 7   , wherein said expansion and contraction of said membranes causes circulation of the blood in said low-flow dialysis circuit.  
     
     
         9 . An apparatus for use in whole body hyperthermia treatment of a patient, comprising: 
 a high-flow hyperthermia circuit equipped to circulate blood therethrough at a rate of at least 1500 ml/min, said high-flow hyperthermia circuit including a blood access line for drawing blood from a patient, a pump, a heat exchanger for heating the blood to a temperature of at least 40° C., and a blood return line for returning the blood to the patient after heating in the heat exchanger;    a low-flow dialysis circuit equipped to circulate blood therethrough at a rate of 200 to 800 ml/min, said low-flow dialysis circuit being coupled to the hyperthermia circuit and effective to divert from said hyperthermia circuit a portion of the blood circulating therein, said low-flow dialysis circuit including: 
 a blood inflow line having a first end connected to the hyperthermia circuit, for diverting blood into said dialysis circuit from said hyperthermia circuit;  
 a dialyzer having a blood side and a sorbent side separated by dialysis membranes, said membranes being compliantly formed;  
 means for applying alternating negative pressure and positive pressure on said sorbent side of said dialyzer;  
 a blood inlet to said blood side of said dialyzer, a second end of said blood inflow line being connected to said blood inlet;  
 a blood outlet from said blood side of said dialyzer;  
 a blood outflow line having a first end connected to said blood outlet, and a second end connected to said hyperthermia circuit;  
 a sorbent circuit for circulating a sorbent suspension through said sorbent side of said dialyzer; and  
   wherein said apparatus is configured such that during operation of said high-flow hyperthermia circuit and said low-flow dialysis circuit, said dialyzer membranes expand and compress in response to said alternating negative pressure and positive pressure on said sorbent side of said dialyzer, so as to circulate and agitate a sorbent suspension in said sorbent side whereby effective mixing of said sorbent suspension is maintained.    
     
     
         10 . The apparatus of    claim 9   , which also includes: 
 a heat exchanger in the dialysis circuit, for heating heating the sorbent suspension.    
     
     
         11 . The apparatus of    claim 10   , wherein the blood inflow line is connected to the high-flow hyperthermia circuit at a location downstream of the blood outflow line.  
     
     
         12 . The apparatus of    claim 11   , wherein the blood inflow line and the outflow line are connected to the hyperthermia circuit on opposed sides of the pump.  
     
     
         13 . The apparatus of    claim 11   , wherein the sorbent suspension includes precipitated calcium phosphate, water, and a particulate surface adsorptive agent.  
     
     
         14 . The apparatus of    claim 13   , wherein said surface adsorptive agent is carbon.  
     
     
         15 . The apparatus of    claim 14   , wherein said expansion and contraction of said membranes causes circulation of said blood in said low-flow dialysis circuit.  
     
     
         16 . A disposable pack for use with a dialysis instrument, comprising: 
 a pack mount member; and    a plurality of components attached to the pack mount member, including: 
 a plate dialyzer having a blood side with a blood inlet and a blood outlet, and a sorbent side with a sorbent inlet and a sorbent outlet;  
 a blood inflow tube communicating with the blood inlet of the plate dialyzer, for passing blood from a patient into the blood side of the dialyzer;  
 a blood outflow tube communicating with the blood outlet of the plate dialyzer, for passing blood out of the blood side of the dialyzer;  
 sorbent circulation tubes communicating with the sorbent side of the dialyzer via the sorbent inlet and sorbent outlet, for circulating sorbent through the sorbent side of the dialyzer;  
 a flow-through heat exchanger communicating with said sorbent circulation tubes, for heating sorbent flowing through the heat exchanger.  
   
     
     
         17 . The disposable pack of    claim 16   , also comprising, attached to said pack mount member: 
 an accumulator reservoir communicating with said sorbent circulation tubes, said accumulator reservoir being operable to alternately accumulate and expel sorbent in response to positive pressure and negative pressure alternately applied to the accumulator reservoir.    
     
     
         18 . A process for preparing a sorbent suspension, comprising: 
 combining an aqueous solution having dissolved calcium ions with an aqueous solution having dissolved phosphate ions, wherein said combining is in the presence of a powdered surface adsorptive agent so as to form precipitated calcium phosphate both on the adsorptive agent and freely in the suspension.    
     
     
         19 . The process of    claim 18   , comprising: 
 (a) combining water, activated charcoal powder and a flow-inducing agent;    (b) adding separate solutions containing, respectively, dissolved calcium chloride and dissolved disodium phosphate, to the product of step (a);    (c) agitating the product of step (b);    (d) adding a sodium, calcium, magnesium and potassium-loaded cation exchange resin to the product of step (c);    (e) agitating the product of step (d);    (f) adding sodium bicarbonate powder to the product of step (e); and    (g) agitating the product of step (f).    
     
     
         20 . A dialysis system, comprising: a base unit equipped with: 
 a source of positive pressure and negative pressure;    a heating element; and    receiving means for receiving a heat exchanger in heat exchange relationship with the heating element; and    a disposable pack for use with said base unit, including:    pack mount member;    a plate dialyzer mounted to said pack mount member, said dialyzer having a blood side with a blood inlet and a blood outlet, and a sorbent side with a sorbent inlet and a sorbent outlet;    a blood inflow tube communicating with the blood inlet of the plate dialyzer, for passing blood from a patient into the blood side of the dialyzer;    a blood outflow tube communicating with the blood outlet of the plate dialyzer, for passing blood out of the blood side of the dialyzer;    sorbent circulation tubes communicating with the sorbent side of the dialyzer via the sorbent inlet and sorbent outlet, for circulating sorbent through the sorbent side of the dialyzer;    an accumulator reservoir mounted to said pack mount member, said accumulator reservoir communicating with said sorbent circulation tubes, said accumulator reservoir being operable to alternately accumulate and expel sorbent suspension in response to positive pressure and negative pressure alternately applied to the accumulator reservoir, the accumulator reservoir being connected to said source of positive pressure and negative pressure of said base unit;    a flow-through heat exchanger communicating with said sorbent circulation tubes, for heating sorbent flowing through the heat exchanger; said heat exchanger cooperating with said receiving means of said base unit to removably position the heat exchanger in heat exchange relationship with the heating element of said base unit.