Abstract: Techniques for controlling delivery of a therapy to a patient by a medical device, such as an implantable medical device (IMD), involve a sensitivity analysis of a performance metric. The performance metric may relate to efficacy or side effects of the therapy. For example, the performance metric may comprise a sleep quality metric, an activity level metric, a movement disorder metric for patients with Parkinson's disease, epilepsy, or the like. The sensitivity analysis identifies values of therapy parameters that defines a substantially maximum or minimum value of the performance metric. The identified therapy parameters are a baseline therapy parameter set, and a medical device may control delivery of the therapy based on the baseline therapy parameter set.

Abstract: A medical device, such as an implantable medical device (IMD), determines values for one or more metrics that indicate the quality of a patient's sleep, and controls delivery of a therapy based on the sleep quality metric values. For example, the medical device may compare a sleep quality metric value with one or more threshold values, and adjust the therapy based on the comparison. In some embodiments, the medical device adjusts the intensity of therapy based on the comparison, e.g., increases the therapy intensity when the comparison indicates that the patient's sleep quality is poor. In some embodiments, the medical device automatically selects one of a plurality of therapy parameter set available for use in delivering therapy based on a comparison sleep quality metric values associated with respective therapy parameter sets within the plurality of available therapy parameter sets.

Abstract: A device, such as an implantable medical device (IMD), programming device, or other computing device determines when a patient is attempting to sleep. When the device determines that the patient is attempting to sleep, the device determines values for one or more metrics that indicate the quality of a patient's sleep based on at least one physiological parameter of the patient. When the device determines that the patient is not attempting to sleep, the device periodically determines activity levels of the patient. Activity metric values may be determined based on the determined activity levels. A clinician may use sleep quality information and patient activity information presented by a programming device to, for example, evaluate the effectiveness of therapy delivered to the patient by a medical device.

Abstract: A system includes one or more sensors and a processor. Each of the sensors generates a signal as a function of at least one physiological parameter of a patient that may discernibly change when the patient is asleep. The processor monitors the physiological parameters, and determines whether the patient is asleep based on the parameters. In some embodiments, the processor determines plurality of sleep metric values, each of which indicates a probability of the patient being asleep, based on each of a plurality of physiological parameters. The processor may average or otherwise combine the plurality of sleep metric values to provide an overall sleep metric value that is compared to a threshold value in order to determine whether the patient is asleep. In addition, an electroencephalogram signal may be used to identify sleep states of the patient.

Abstract: An implantable medical device for delivering a therapeutic substance to a delivery site in a patient. A reservoir holds a supply of the fluid therapeutic substance. A catheter has a proximal end, a delivery region and a lumen extending from the proximal end to the delivery region. The proximal end of the catheter is operatively coupled to the reservoir. The delivery region of the catheter is adapted to be placed proximate the delivery site in the patient. The therapeutic substance is adapted to be delivered through the lumen to the patient. A sensing device is operatively coupled with the lumen of the catheter being capable of detecting a pressure of the therapeutic substance in the lumen. A controller is operatively coupled to the sensing device, the controller being capable of taking an action in response to the pressure in the lumen.

Abstract: A medical device delivers a therapy to a patient. The medical device may periodically determine an activity level of the patient, and associate each determined activity level with a current therapy parameter set. A value of at least one activity metric is determined for each of a plurality of therapy parameter sets based on the activity levels associated with that therapy parameter set. A list of the therapy parameter sets is presented to a user, such as a clinician, for evaluation of the relative efficacy of the therapy parameter sets. The list may be ordered according to the one or more activity metric values to aid in evaluation of the therapy parameter sets. Where values are determined for a plurality of activity metrics, the list may be ordered according to the one of the activity metrics selected by the user.

Abstract: At least one of a medical device, such as an implantable medical device, a monitor, and a computing device determines values for one or more metrics that indicate the quality of a patient's sleep. Sleep efficiency, sleep latency, and time spent in deeper sleep states are example sleep quality metrics for which values may be determined. In some embodiments, determined sleep quality metric values are associated with a current therapy parameter set. In some embodiments, a programming device presents sleep quality information to a user based on determined sleep quality metric values. A clinician may use the sleep quality information presented by the programming device to evaluate the effectiveness of therapy delivered to the patient by the medical device, to adjust the therapy delivered by the medical device, or to prescribe a therapy not delivered by the medical device in order to improve the quality of the patient's sleep.

Abstract: Methods and systems for determining whether a catheter malfunction is present in a catheter by analyzing changes in the pressure of fluids being pumped through the delivery lumen of the catheter. The pressure changes that may be monitored may include, e.g., the peak pressure within the catheter and/or the pressure decay profile. The catheter malfunctions that may be determined using the methods and systems of the invention may include, e.g., leaks, blockages, the presence of gas bubbles, etc.

Abstract: A medical device, programmer, or other computing device may determine values of one or more activity and, in some embodiments, posture metrics for each therapy parameter set used by the medical device to deliver therapy. The metric values for a parameter set are determined based on signals generated by the sensors when that therapy parameter set was in use. Activity metric values may be associated with a postural category in addition to a therapy parameter set, and may indicate the duration and intensity of activity within one or more postural categories resulting from delivery of therapy according to a therapy parameter set. A posture metric for a therapy parameter set may indicate the fraction of time spent by the patient in various postures when the medical device used a therapy parameter set. The metric values may be used to evaluate the efficacy of the therapy parameter sets.

Abstract: An implantable medical device for delivering therapeutic substance including a housing and a volume sensor assembly. The housing includes a stationary wall and maintains a reservoir containing the therapeutic substance and including a base wall movable relative to the stationary wall such that reservoir volume is a function of base wall/stationary wall spacing. The volume sensor assembly includes a cap, a shaft, a target, and circuitry. The cap defines a passage extending from an open end, and is mounted to the stationary wall such that the open end is open relative to a stationary wall inner face. The shaft has a first end attached to the base wall and a second end maintaining the target otherwise movably arranged within the passage. The circuitry generates information indicative of a longitudinal position of the target relative to the cap, and thus of the reservoir volume.

Abstract: A medical device delivers a therapy to a patient. The medical device or another device may periodically determine an activity level or gait parameter of the patient, and associate each determined level or parameter with a current therapy parameter set. A value of at least one activity metric is determined for each of a plurality of therapy parameter sets based on the activity levels or parameters associated with that therapy parameter set. Whether the patient is currently experiencing or anticipated to experience gait freeze caused by their neurological disorder, such as Parkinson's disease, may also be determined. Gait freeze events may be associated with current therapy parameters and used to determine activity metric values. In some examples, the activity metric associated with certain therapy parameters may be presented to a user.

Abstract: A medical device delivers a therapy to a patient. The medical device or another device may periodically determine an activity level of the patient, and associate each determined activity level with a current therapy parameter set. A value of at least one activity metric is determined for each of a plurality of therapy parameter sets based on the activity levels associated with that therapy parameter set. A list of the therapy parameter sets is presented to a user, such as a clinician, for evaluation of the relative efficacy of the therapy parameter sets. The list may be ordered according to the one or more activity metric values to aid in evaluation of the therapy parameter sets. Where values are determined for a plurality of activity metrics, the list may be ordered according to the one of the activity metrics selected by the user.

Abstract: A medical device delivers a therapy to a patient. Posture events are identified, e.g., a posture of the patient is periodically determined and/or posture transitions by the patient are identified, and each determined posture event is associated with a current therapy parameter set. A value of at least one posture metric is determined for each of a plurality of therapy parameter sets based on the posture events associated with that therapy parameter set. A list of the therapy parameter sets is presented to a user, such as a clinician, for evaluation of the relative efficacy of the therapy parameter sets. The list may be ordered according to the one or more posture metric values to aid in evaluation of the therapy parameter sets. Where values are determined for a plurality of posture metrics, the list may be ordered according to the one of the posture metrics selected by the user.

Abstract: Techniques for detecting a value of a sensed patient parameter, and automatically delivering therapy to a patient according to therapy information previously associated with the detected value, are described. In exemplary embodiments, a medical device receives a therapy adjustment from the patient. In response to the adjustment, the medical device associates a sensed value of a patient parameter with therapy information determined based on the adjustment. Whenever the parameter value is subsequently detected, the medical device delivers therapy according to the associated therapy information. In this manner, the medical device may “learn” to automatically adjust therapy in the manner desired by the patient as the sensed parameter of the patient changes. Exemplary patient parameters that may be sensed for performance of the described techniques include posture, activity, heart rate, electromyography (EMG), an electroencephalogram (EEG), an electrocardiogram (ECG), temperature, respiration rate, and pH.

Abstract: Techniques for detecting a value of a sensed patient parameter, and automatically delivering therapy to a patient according to therapy information previously associated with the detected value, are described. In exemplary embodiments, a medical device receives a therapy adjustment from the patient. In response to the adjustment, the medical device associates a sensed value of a patient parameter with therapy information determined based on the adjustment. Whenever the parameter value is subsequently detected, the medical device delivers therapy according to the associated therapy information. In this manner, the medical device may “learn” to automatically adjust therapy in the manner desired by the patient as the sensed parameter of the patient changes. Exemplary patient parameters that may be sensed for performance of the described techniques include posture, activity, heart rate, electromyography (EMG), an electroencephalogram (EEG), an electrocardiogram (ECG), temperature, respiration rate, and pH.

Abstract: A wearable ambulatory data recorder that senses physiological parameters of a patient, and stores physiological parameter data for later retrieval, as well as techniques for using such a wearable ambulatory data recorder, are described. The data recorder includes one or more sensors located on or within a housing. The data recorder may include an adhesive layer for attachment to a patient. In some embodiments, the housing may be within a patch, e.g., bandage, which includes the adhesive layer. The housing may be waterproof. Features of the data recorder such as size, waterproofness, and inclusion of an adhesive may allow the data recorder to be unobtrusively worn by a patient during a variety of daily activities. The data recorder may be for single use and thereafter disposable.

Abstract: Techniques for detecting a value of a sensed patient parameter, and automatically delivering therapy to a patient according to therapy information previously associated with the detected value, are described. In exemplary embodiments, a medical device receives a therapy adjustment from the patient. In response to the adjustment, the medical device associates a sensed value of a patient parameter with therapy information determined based on the adjustment. Whenever the parameter value is subsequently detected, the medical device delivers therapy according to the associated therapy information. In this manner, the medical device may “learn” to automatically adjust therapy in the manner desired by the patient as the sensed parameter of the patient changes. Exemplary patient parameters that may be sensed for performance of the described techniques include posture, activity, heart rate, electromyography (EMG), an electroencephalogram (EEG), an electrocardiogram (ECG), temperature, respiration rate, and pH.

Abstract: A wearable ambulatory data recorder that senses physiological parameters of a patient, and stores physiological parameter data for later retrieval, as well as techniques for using such a wearable ambulatory data recorder, are described. The data recorder includes one or more sensors located on or within a housing. The data recorder may include an adhesive layer for attachment to a patient. In some embodiments, the housing may be within a patch, e.g., bandage, which includes the adhesive layer. The housing may be waterproof. Features of the data recorder such as size, waterproofness, and inclusion of an adhesive may allow the data recorder to be unobtrusively worn by a patient during a variety of daily activities. The data recorder may be for single use and thereafter disposable.

Abstract: A device determines values for one or more metrics that indicate the quality of a patient's sleep based on sensed physiological parameter values. Sleep efficiency, sleep latency, and time spent in deeper sleep states are example sleep quality metrics for which values may be determined. The sleep quality metric values may be used, for example, to evaluate the effectiveness of a therapy delivered to the patient by a medical device. In some embodiments, determined sleep quality metric values are automatically associated with the therapy parameter sets according to which the medical device delivered the therapy when the physiological parameter values were sensed, and used to evaluate the effectiveness of the various therapy parameter sets. The medical device may deliver the therapy to treat a non-respiratory neurological disorder, such as epilepsy, a movement disorder, or a psychological disorder. The therapy may be, for example, deep brain stimulation (DBS) therapy.

Abstract: Values of a non-polysomnographic (non-PSG) physiological parameter set may be correlated to polysomnographically (PSG) determined sleep states. The correlated values of the non-PSG parameter set and sleep states may be analyzed, and a relationship between the values and sleep states may be determined. The relationship may allow determination of sleep states for any given patient based on values of the non-PSG physiological parameter set for the patient. The non-PSG physiological parameter set does not include physiological parameters typically required for PSG, such as brain electrical activity (EEG), eye movement (EOG), and jaw or neck muscular activity or tone (EMG). Medical devices, such as implantable medical devices (IMDs) that would generally be unable to monitor such physiological parameters, may apply the relationship to values of the non-PSG physiological parameter set for a patient to identify sleep states of the patient.