Monitoring of chronobiological rhythms for disease and drug management using one or more implantable device

Abstract

The health state of a subject is automatically evaluated or predicted using at least one implantable device. In varying examples, the health state is determined by sensing or receiving information about at least one physiological process having a circadian rhythm whose presence, absence, or baseline change is associated with impending disease, and comparing such rhythm to baseline circadian rhythm prediction criteria. Other chronobiological rhythms beside circadian may also be used. The baseline prediction criteria may be derived using one or more past physiological process observation of the subject or population of subjects in a non-disease health state. The prediction processing may be performed by the at least one implantable device or by an external device in communication with the implantable device. Systems and methods for invoking a therapy in response to the health state, such as to prevent or minimize the consequences of predicted impending heart failure, are also discussed.

What is claimed is: 
     
         1 . A system comprising:
 a prediction criteria module, adapted to store information about one or more chronobiological rhythm prediction criteria;   a physiological information collection device, adapted to sense or receive information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease state;   an impending disease state prediction module, coupled to the prediction criteria module to receive the one or more chronobiological rhythm prediction criteria and coupled to the physiological information collection device to receive the chronobiological rhythm of the at least one physiological process, the impending disease state prediction module being adapted to predict an occurrence of impending disease using the one or more chronobiological rhythm prediction criteria and the chronobiological rhythm of the at least one physiological process; and   a therapy control module adapted to adjust or initiate a therapy using the predicted occurrence of impending disease, wherein the system is configured to monitor the efficacy of the therapy and to adjust the therapy to prevent or minimize the impending disease state.   
     
     
         2 . The system of  claim 1 , wherein at least one of the prediction criteria module, the physiological information collection device, or the impending disease state prediction module including an implantable portion. 
     
     
         3 . The system of  claim 1 , wherein the system monitors the efficacy of the therapy using a post-therapy chronobiological rhythm of the at least one physiological process. 
     
     
         4 . The system of  claim 1 , wherein the impending disease state prediction module is adapted to predict the occurrence of impending disease during a specified prediction time period. 
     
     
         5 . The system of  claim 1 , wherein the information about the at least one physiological process is sensed or received, at least in part, using an implantable device or sensor. 
     
     
         6 . The system of  claim 1 , wherein the at least one physiological process includes one or more of body temperature, heart rate, heart rate variability, respiration rate, respiration rate variability, minute ventilation, tidal volume, activity, blood pressure, posture, sleep pattern, thoracic impedance, or at least one heart sound. 
     
     
         7 . The system of  claim 1 , further comprising a timing circuit coupled to the physiological information collection device to provide an associated collection time to the chronobiological rhythm of the at least one physiological process; and
 wherein the associated collection time is used by the impending disease state prediction module to predict the occurrence of impending disease.   
     
     
         8 . The system of  claim 1 , further comprising an arrhythmia detector adapted to sense or receive information about an arrhythmia incidence; and
 wherein a time of the arrhythmia incidence is used by the impending disease state prediction module to predict the occurrence of impending disease.   
     
     
         9 . The system of  claim 1 , wherein the predicted occurrence of impending disease is computed using one or more stored weighting factor, each weighting factor corresponding to a chronobiological rhythm of a different one of the at least one physiological process. 
     
     
         10 . The system of  claim 1 , wherein the chronobiological rhythm prediction criteria are derived using one or more past physiological process observation from a subject in a non-disease state. 
     
     
         11 . The system of  claim 1 , further comprising an implantable drug pump, coupled to the therapy control module to receive one or more drug delivery instruction. 
     
     
         12 . The system of  claim 1 , further comprising a neural stimulation circuit, coupled to the therapy control module to receive one or more neurostimulation delivery instruction. 
     
     
         13 . The system of  claim 1 , further comprising at least one of a ventricular or atrial stimulation circuit, coupled to the therapy control module to receive one or more cardiac stimulation delivery instruction. 
     
     
         14 . A method comprising:
 sensing or receiving at an implantable device, information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease;   comparing the chronobiological rhythm of the at least one physiological process to one or more chronobiological rhythm prediction criteria;   at least one of predicting, detecting, or identifying an occurrence of disease using the comparison;   adjusting or initiating a therapy using the predicted, detected, or identified occurrence of disease; and   monitoring the efficacy of the therapy using a post-therapy chronobiological rhythm of the at least one physiological process.   
     
     
         15 . The method of  claim 14 , wherein predicting the occurrence of disease includes predicting an occurrence of impending disease occurring during a specified prediction time period. 
     
     
         16 . The method of  claim 14 , wherein sensing or receiving the information about the at least one physiological process includes sensing or receiving at least one of body temperature, heart rate, heart rate variability, respiration rate, respiration rate variability, minute ventilation, tidal volume, activity, blood pressure, posture, sleep pattern, thoracic impedance, or at least one heart sound. 
     
     
         17 . The method of  claim 14 , further comprising sensing or receiving information about at least one arrhythmia incidence; and
 wherein predicting the occurrence of disease includes using a time of day of the arrhythmia incidence.   
     
     
         18 . The method of  claim 14 , wherein adjusting or initiating the therapy includes determining a drug delivery time using the chronobiological rhythm of the at least one physiological process. 
     
     
         19 . The method of  claim 14 , wherein adjusting or initiating the therapy includes recovering the chronobiological rhythm of the at least one physiological process using one or both of drug delivery or neurostimulation. 
     
     
         20 . The method of  claim 14 , further comprising re-adjusting the therapy using the post-therapy chronobiological rhythm of the at least one physiological process.