Systems and Methods for Assessing the Effectiveness of a Therapy Including a Drug Regimen Using an Implantable Medical Device
First Claim
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.
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Accused Products
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.
122 Citations
20 Claims
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1. A system including an implantable medical device for assessing the effect of a drug on a patient comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for obtaining information using an implanted medical device for adjusting a drug therapy for a patient, the method comprising:
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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. - View Dependent Claims (11, 12, 13, 14)
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15. A method for adjusting the parameters according to which a therapy for a neurological disorder is delivered to a patient, the method comprising:
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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. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification