Devices and Methods for Using Endovascular Cooling to Treat Septic Shock and Other Disorders

Abstract

Apparatus, systems and methods for cooling or warming the temperature of all or a portion of the body of a human or animal subject to treat disorders including but not limited to sepsis, septic shock or other inflammatory or infectious conditions which can result in shock, hypoxia, ischemia and/or multiple organ failure in human or animal subjects.

1 - 39 . (canceled) 
     
     
         40 . A system for hypothermic or hyperthermic treatment of a disorder in a human or animal subject, said system comprising:
 a heat exchanger that exchanges heat with the subject's body to thereby warm or cool the subject's body;   a sensor that senses changes in a symptom or physiological variable, other than body temperature, that is indicative of severity of the disorder;   a controller that receives signals from the sensor and controls the heat exchanger's warming or cooling of the subject's body based, at least in part, on signals received from the sensor.   
     
     
         41 . A system according to  claim 40  wherein the controller is programmed to cause the heat exchanger to:
 initially cool the subject's body to a hypothermic temperature; 
 maintain the hypothermic temperature for a period of time; and, thereafter 
 commence rewarming of the subject's body; 
 wherein the controller is further programmed to either continue, pause or reverse the rewarming in response to sensed changes in the symptom or variable. 
 
     
     
         42 . A system according to  claim 40  wherein the sensor measures or monitors at least one variable selected from the group consisting of:
 heart rate; 
 respiratory rate; 
 arterial blood pressure; 
 venous oxygen saturation (SvO2); 
 partial pressure of oxygen in mixed venous blood; 
 conjunctival oxygen tension (PcjO2); 
 lactate concentration in blood, serum, urine or other body fluids; 
 other cellular or humoral indicators of sepsis or septic shock; 
 heart rate above about 100; 
 SvO2 below about 70%; 
 serum lactate above about 4 mmol/l; 
 mean arterial blood pressure below about 65 mm Hg; and 
 systolic blood pressure less than about 90 mm Hg. 
 
     
     
         43 . A system according to  claim 40  wherein the controller is programmed to determine when the sensed variable exceeds a predetermined limit and to modify the heat exchanger's warming of cooling of the subject's body when sensed variable exceeds the predetermined limit. 
     
     
         44 . A system according to  claim 43  wherein the controller is further programmed to provide notification to an attendant when that the sensed variable exceeds the predetermined limit. 
     
     
         45 . A system according to  claim 43  wherein the controller is programmed to cause the heat exchanger to lower the subject's body temperature upon determining that the sensed variable has exceeded the predetermined limit. 
     
     
         46 . A system according to  claim 40  wherein the disorder causes a clinical variable to be outside of a known normal range for that clinical variable and wherein the desired change in said in said at least one symptom or clinical variable is when that clinical variable becomes within the normal range. 
     
     
         47 . A system according to  claim 41  wherein the disorder causes a symptom to occur and wherein the desired change is a predetermined amount of diminution or cessation of that symptom. 
     
     
         48 . A system for warming or cooling all or a portion of the body of a human or animal subject to treat a disorder, said system comprising:
 a heat exchange catheter that is insertable into the subject's vasculature and useable to warm or cool blood flowing through the subject's vasculature, thereby warming or cooling all or a portion of the subject's body;   a monitor for monitoring at least one symptom or clinical variable related to the disorder, and   a controller which receives signals from the monitor, said controller being programmed and operative to control at least one operational variable selected from i) the rate of warming or cooling of blood flowing through the subject's vasculature and ii) the temperature to which the subject's body or body portion is warmed or cooled, in response to the monitored symptom or clinical variable.   
     
     
         49 . A system according to  claim 48  wherein the monitor detects a desired change in said at least one symptom or clinical variable indicative of when the hyperthermia or hypothermia is having an intended effect and wherein the controller causes the subject's body or body portion to be warmed or cooled to a temperature at which the monitored operational variable indicates that the intended effect has been achieved and thereafter maintains the subject's body or body portion at or near that temperature for a period of time. 
     
     
         50 . A system according to  claim 48  wherein the disorder causes a clinical variable to be outside of a known normal range for that clinical variable and wherein the desired change in said in said at least one symptom or clinical variable is when that clinical variable becomes within the normal range. 
     
     
         51 . A system according to  claim 48  wherein the disorder causes a symptom to occur and wherein the desired change is a predetermined amount of diminution or cessation of that symptom. 
     
     
         52 . A system according to  claim 48  wherein the controller is programmed to cause the heat exchanger to:
 initially cool the subject's body to a hypothermic temperature; 
 maintain the hypothermic temperature for a period of time; and, thereafter 
 commence rewarming of the subject's body; 
 wherein the controller is further programmed to either continue, pause or reverse the rewarming in response to sensed changes in the symptom or variable. 
 
     
     
         53 . A system according to  claim 48  wherein the monitor monitors at least one variable selected from the group consisting of:
 heart rate; 
 respiratory rate; 
 arterial blood pressure; 
 venous oxygen saturation (SvO2); 
 partial pressure of oxygen in mixed venous blood; 
 conjunctival oxygen tension (PcjO2); 
 lactate concentration in blood, serum, urine or other body fluids; 
 other cellular or humoral indicators of sepsis or septic shock; 
 heart rate above about 100; 
 SvO2 below about 70%; 
 serum lactate above about 4 mmol/l; 
 mean arterial blood pressure below about 65 mm Hg; and 
 systolic blood pressure less than about 90 mm Hg. 
 
     
     
         54 . A system according to  claim 48  wherein the controller is programmed to determine when the monitored variable exceeds a predetermined limit and to modify the heat exchanger's warming of cooling of the subject's body when it is determined that the sensed variable has exceeded the predetermined limit. 
     
     
         55 . A system according to  claim 54  wherein the controller is further programmed to provide notification to an attendant when the monitored variable exceeds the predetermined limit.