Systems and Methods for Assessing the Effectiveness of a Therapy Including a Drug Regimen Using an Implantable Medical Device

Abstract

Systems and methods rely on feedback from an active medical device or devices (e.g., neurostimulator coupled to sensing and stimulation elements such as electrodes) to assess the effectiveness of a patient's drug regimen. Such reliance may include analyzing characteristics in physiological data acquired by the medical device(s), for example, in the form of responses evoked from the patient by electrical stimulation waveforms. Systems and methods further involved adjusting one or more parameters according to which a combination therapy consisting of at least a drug regimen and an electrical stimulation therapy are delivered to a patient, in an effort to optimize the therapeutic effect of the combination. The adjustments may be automatically by one or more implanted or external hosts working together or alone, and/or with the input of a physician.

What we claim is: 
     
         1 . A system including an implantable medical device for assessing the effect of a drug on a patient comprising:
 an implantable medical device configured to acquire, process and analyze physiological data sensed from a patient, the implantable medical device comprising:
 a sensing module configured to acquire and process the physiological data sensed from the patient by receiving and processing the sensed physiological data; 
 a detection module in operable communication with the sensing module and configured to analyze the sensed physiological data to identify at least one characteristic in the sensed physiological data, and configured to cause to be stored in a memory characteristic information which characteristic information includes a condition corresponding to a time at which each of the at least one characteristic occurs; 
   a system controller that is selectably in operable communication with the detection module and that is configured to:
 acquire the characteristic information; 
 communicate the characteristic event information to a user using at least one component configured to remain external to the patient at all times. 
   
     
     
         2 . The system of  claim 1 , further including at least one external component configured to generate and display to a user at least one graphical representation relating characteristic information. 
     
     
         3 . The system of  claim 2  wherein the system controller comprises a plurality of elements, and a first of the plurality of elements is provided in the at least one external component. 
     
     
         4 . The system of  claim 1  wherein the characteristic information further comprises representation of the sensed physiological data corresponding to each of the at least one characteristic. 
     
     
         5 . The system of  claim 4  wherein the representation of the sensed physiological data comprises an electrocorticogram or a digital approximation of an electrocorticogram and the condition corresponding to a time at which each of the at least one characteristic occurs includes a date/time stamp. 
     
     
         6 . The system of  claim 1  wherein the representation of the sensed physiological data comprises a digitization of at least one segment of an electrocorticographic signal. 
     
     
         7 . The system of  claim 1  wherein the condition corresponding to a time at which each of the at least one characteristic occurs includes a count associated with a sum of each of the at least one characteristic occurring in a selected time window occurring during a time when the patient is subjected to a drug regimen. 
     
     
         8 . The system of  claim 1  wherein the sensing module further includes a plurality of sensing channels and, for each sensing channel, at least one amplifier, and each sensing channel is programmable to receive a signal or a portion of a signal corresponding to the sensed physiological data, and the condition and a condition corresponding to a time at which each of the at least one characteristic occurs is one or more of: an indication of which channel or channels resulted in each of the at least one characteristics, an indication of which amplifiers, if any, receiving the signal or portion of the signal went into saturation, and an indication of for how long each amplifier, if any, was saturated. 
     
     
         9 . The system of  claim 1  wherein the implantable medical device further includes a stimulation module programmable with a set of stimulation parameters to generate an electrical stimulation signal and to output the electrical stimulation signal so that the electrical stimulation signal may be delivered to one or more target locations in the neural tissue of the patient to evoke a response from the patient such that the patient's evoked response to the electrical stimulation may be received and processed by the sensing module and analyzed by the detection module according to the detection parameters. 
     
     
         10 . A method for obtaining information using an implanted medical device for adjusting a drug therapy for a patient, the method comprising:
 processing and analyzing physiological data sensed from a patient with an implantable medical device having sensing module configured to receive and process the sensed physiological data, a detection module in operable communication with the sensing module and configured to analyze the sensed physiological data according to a programmed set of detection parameters to identify at least one characteristic in the sensed physiological data;   storing in a memory of the implantable medical device characteristic information which detected event information comprises a condition corresponding to a time at which each of the at least one characteristic occurs;   acquiring, with a control module of the implantable medical device that is selectably in operable communication with the detection module, the characteristic information;   communicating the characteristic information to at least one component configured to remain external to the patient at all times;   displaying to the user, using the at least one external component, at least one graphical representation relating to the characteristic information.   
     
     
         11 . The method of  claim 10 , further including prompting the user to select at least one time window during a time when the patient was subjected to a drug regimen and displaying to the user, using the at least one external component, a graphical representation of the frequency of the at least one characteristic over each of the at least one user-selected time window. 
     
     
         12 . The method of  claim 11 , further including prompting the user to decide whether to change any of the drug regimen parameters. 
     
     
         13 . The method of  claim 10  wherein storing in a memory of the implantable medical device detected event information further comprises storing characteristic information including storing a representation of the sensed physiological data corresponding to the at least one characteristic. 
     
     
         14 . The method of  claim 10 , further including:
 generating and outputting, with a stimulation module of the implantable medical device programmed with a set of stimulation parameters, an electrical stimulation signal and delivering the electrical stimulation signal to one or more locations of interest in the neural tissue of the patient to evoke a response from the patient;   determining whether any of the at least one characteristics occur in the evoked response.   
     
     
         15 . A method for adjusting the parameters according to which a therapy for a neurological disorder is delivered to a patient, the method comprising:
 delivering to one or more locations of interest in the patient's central nervous system with an implanted medical device according to at least one set of programmable therapy parameters, a form of therapy that, in combination with a drug therapy to which the patient is subjected independently and without use of the implantable medical device, is intended to modulate neuronal activity to achieve at least one goal of stimulation;   monitoring with the implanted medical device physiological data acquired from one or more sensors physiological data from the patient;   analyzing the monitored data with the implanted medical device according to at least one set of programmable detection parameters and determining with the implanted medical device whether at least one characteristic occurs;   determining whether each of the at least one goal of stimulation is achieved;   if each of the at least one goal of stimulation is not achieved, adjusting the at least one set of programmable therapy parameters until each of the at least one goal of stimulation is achieved or until a predetermined limit for a given programmable therapy parameter has been reached;   wherein the form of therapy includes at least one of a drug therapy, an electrical stimulation therapy, and an optical stimulation therapy;   wherein the at least one goal of stimulation includes one or more of a depolarization block state, an excitation state, an inhibition state, a long-term potentiation state, a long-term depression state and an increased local cerebral blood flow state; and   wherein the monitored physiological data includes one or more of: electrographic activity sensed from neural tissue; neurochemical levels, neurotransmitter levels, and extracellular levels of oxygen.   
     
     
         16 . The method of  claim 15  wherein the independent drug therapy is characterized by a set of independent drug therapy parameters and further including, if each of the at least one goal of stimulation is not achieved, adjusting a parameter of the independent drug therapy until each of the at least one goal of stimulation is achieved or until a predetermined limit for a given parameter of the independent drug therapy is reached. 
     
     
         17 . The method of  claim 16  wherein adjusting a parameter of the independent drug therapy further includes introducing at least one drug to a location of interest in the central nervous system by other than systemic delivery. 
     
     
         18 . The method of  claim 16  wherein the adjusting a parameter of the independent drug therapy is accomplished before adjusting a parameter of the programmable therapy parameters of the implanted medical devices is accomplished. 
     
     
         19 . The method of  claim 18  wherein adjusting the at least one set of programmable therapy parameters until each of the objectives of stimulation is achieved or until a predetermined limit for a given programmable therapy parameter has been reached further comprises automatically adjusting with the implanted medical device the at least one set of programmable therapy parameters. 
     
     
         20 . The method of  claim 18  wherein adjusting the at least one set of programmable therapy parameters until each of the objectives for stimulation is achieved or until a predetermined limit for a given programmable therapy parameter has been reached further comprises a user adjusting the at least one set of programmable therapy parameters by reprogramming the implantable medical device.